WorldWideScience

Sample records for voluntary informed consent

  1. Voluntary Informed Consent in Paediatric Oncology Research.

    Science.gov (United States)

    Dekking, Sara A S; Van Der Graaf, Rieke; Van Delden, Johannes J M

    2016-07-01

    In paediatric oncology, research and treatments are often closely combined, which may compromise voluntary informed consent of parents. We identified two key scenarios in which voluntary informed consent for paediatric oncology studies is potentially compromised due to the intertwinement of research and care. The first scenario is inclusion by the treating paediatric oncologist, the second scenario concerns treatments confined to the research context. In this article we examine whether voluntary informed consent of parents for research is compromised in these two scenarios, and if so whether this is also morally problematic. For this, we employ the account of voluntary consent from Nelson and colleagues, who assert that voluntary consent requires substantial freedom from controlling influences. We argue that, in the absence of persuasion or manipulation, inclusion by the treating physician does not compromise voluntariness. However, it may function as a risk factor for controlling influence as it narrows the scope within which parents make decisions. Furthermore, physician appeal to reciprocity is not controlling as it constitutes persuasion. In addition, framing information is a form of informational manipulation and constitutes a controlling influence. In the second scenario, treatments confined to the research context qualify as controlling if the available options are restricted through manipulation of options. Although none of the influences is morally problematic in itself, a combination of influences may create morally problematic instances of involuntary informed consent. Therefore, safeguards should be implemented to establish an optimal environment for parents to provide voluntary informed consent in an integrated research-care context. © 2015 John Wiley & Sons Ltd.

  2. RESEARCH Voluntary informed consent and good clinical practice ...

    African Journals Online (AJOL)

    of South Africa (1996) and applicable legislation, it is apparent that voluntary informed ... Seoul, 2008);4 Ethics in Health Research: Principles, Structures and. Processes (Department of Health 2004 – 'ethical guidelines' for the purpose of this ... workers have a legal duty to obtain a patient's informed consent for any medical ...

  3. A Qualitative Study into Dependent Relationships and Voluntary Informed Consent for Research in Pediatric Oncology.

    Science.gov (United States)

    Dekking, Sara A S; van der Graaf, Rieke; Schouten-van Meeteren, Antoinette Y N; Kars, Marijke C; van Delden, Johannes J M

    2016-04-01

    In pediatric oncology, many oncologists invite their own patients to participate in research. Inclusion within a dependent relationship is considered to potentially compromise voluntariness of consent. Currently, it is unknown to what extent those involved in pediatric oncology experience the dependent relationship as a threat to voluntary informed consent, and what they see as safeguards to protect voluntary informed consent within a dependent relationship. We performed a qualitative study among key actors in pediatric oncology to explore their experiences with the dependent relationship and voluntary informed consent. We conducted three focus groups and 25 semi-structured, in-depth interviews with pediatric oncologists, research coordinators, Research Ethics Committee members, parents of children with cancer, and adolescents with cancer. Professionals regarded the dependent relationship both as a potential threat to and as a positive influence on voluntary decision making. Parents and adolescents did not feel as though dependency upon the oncologist influenced their decisions. They valued the involvement of their own physician in the informed consent process. The professionals suggested three strategies to protect voluntariness: emphasizing voluntariness; empowering families; involvement of an independent person. Although the dependent relationship between pediatric oncologists, patients and parents may be problematic for voluntary informed consent, this is not necessarily the case. Moreover, the involvement of treating physicians may even have a positive impact on the informed consent process. Although we studied pediatric oncology, our results may also apply to many other fields of pediatric medicine where research and care are combined, for example, pediatric rheumatology, neurology and nephrology. Clinical trials in these fields are inevitably often designed, initiated and conducted by medical specialists closely involved in patient care.

  4. The ethics of managing affective and emotional states to improve informed consent: autonomy, comprehension, and voluntariness.

    Science.gov (United States)

    Braude, Hillel; Kimmelman, Jonathan

    2012-03-01

    Over the past several decades the 'affective revolution' in cognitive psychology has emphasized the critical role affect and emotion play in human decision-making. Drawing on this affective literature, various commentators have recently proposed strategies for managing therapeutic expectation that use contextual, symbolic, or emotive interventions in the consent process to convey information or enhance comprehension. In this paper, we examine whether affective consent interventions that target affect and emotion can be reconciled with widely accepted standards for autonomous action. More specifically, the ethics of affective consent interventions is assessed in terms of key elements of autonomy, comprehension and voluntariness. While there may appear to be a moral obligation to manage the affective environment to ensure valid informed consent, in circumstances where volunteers may be prone to problematic therapeutic expectancy, this moral obligation needs to be weighed against the potential risks of human instrumentalization. At this point in time we do not have enough information to be able to justify clearly the programmatic manipulation of human subjects' affective states. The lack of knowledge about affective interventions requires corresponding caution in its ethical justification. © 2010 Blackwell Publishing Ltd.

  5. Informed consent

    International Nuclear Information System (INIS)

    Bundy, A.L.

    1988-01-01

    Numerous articles on informed consent have appeared in medical and legal journals over the past few years. Many of these have been in the radiological literature. This chapter presents an overview of the legal principles behind this controversial topic. Recent articles are reviewed and specific suggestions are made where applicable. The doctrine of informed consent is both a product of and the basis for the physician-patient relationship. Their communications to each other establish the relationship, but once established, heightened degrees of expectations on the patient's part have dictated the need for a more sophisticated level of communication. Since patients and physicians often expect different things of each other, it is imperative that the relationship leads to effective and respectful conversation

  6. Voluntariness of consent to HIV clinical research: A conceptual and empirical pilot study.

    Science.gov (United States)

    Mamotte, Nicole; Wassenaar, Douglas

    2017-09-01

    Obtaining voluntary informed consent for research participation is an ethical imperative, yet there appears to be little consensus regarding what constitutes a voluntary consent decision. An instrument to assess influences on participants' consent decision and perceived voluntariness was developed and piloted in two South African HIV clinical trials. The pilot study found high levels of perceived voluntariness. The feeling of having no choice but to participate was significantly associated with lower perceived voluntariness. Overall the data suggest that it is possible to obtain voluntary and valid consent for research participants in ethically complex HIV clinical trials in a developing country context.

  7. [Informed consent].

    Science.gov (United States)

    López-Sáez, Asunción; López, de Teruel; Siso Martín, Juan

    2003-11-01

    Once the stage of health paternalism, exercised so many times under the pretext of the principle of benevolence, has been overcome, treatment relationships level off, they become symmetrical and balanced and in this climate of a "therapeutic alliance", both parties, the patient and the health professional, have to merge their capabilities and their limitations. The health professional can not impose general character operational methods to follow to a patient nor interventions, even though clinically correct, against a patient's will; but neither does a patient have the right to obtain treatment in accordance with his desires if these are found to be in disagreement with concrete clinical recommendations for the case dealt with according to the health professional's criteria. We can summarize what has just been stated in two basic principles: 1. The health professional is not obliged to follow the requests of a patient if he/she does not consider these clinically appropriate, but in order to follow a different treatment method, the health professional must have the consent of the patient. 2. In any case, if a patient opposes a treatment being applied to him/her, except in the few legally recognized exceptions, the health professional can try to persuade a patient to accept recommended treatment, but never can carry out treatment against the patient's will.

  8. Informed Consent and Routinisation

    DEFF Research Database (Denmark)

    Ploug, Thomas; Holm, Søren

    2013-01-01

    provide evidence of the routinisation of informed consent in various types of interaction on the internet; among these, the routinisation of consent to the exchange of health related information. We also provide evidence that the extent of the routinisation of informed consent is dependent...

  9. Informed consent in surgical trials.

    Science.gov (United States)

    Etchells, E

    1999-12-01

    All participants must provide a valid consent to surgical clinical trials. A valid consent requires patient capacity, adequate disclosure of information, and voluntariness. Capacity is the ability to understand information relevant to making a decision and to appreciate the reasonably foreseeable consequences of a decision or lack of decision. To protect vulnerable persons, an incapable person should not be enrolled in most clinical trials. The only exception is if the study can only be conducted on incapable persons. If the willing research participant is incapable, consent must be obtained from others through a process called substitute (or proxy) consent. Disclosure refers to the provision of relevant information to the patient and its comprehension by the patient. Most surgical trials carry more than minimal risks, so the requirement for careful disclosure of these risks to potential participants is generally stringent. Voluntariness refers to the freedom of a person to make a treatment decision. In specific circumstances related to emergency research, the requirement for consent may be waived. Waiver can be justified only if the delay required to obtain consent would prevent the research from occurring and only after prior consultation with from the "community" of potential research participants.

  10. Informed Consent in Dentistry.

    Science.gov (United States)

    Reid, Kevin I

    2017-03-01

    A review of literature regarding informed consent in dentistry reveals a paucity of information and minimal scholarship devoted to this subject. But this begs the question about informed consent somehow being different for dentistry than for medicine or other healthcare delivery. My account draws distinctions where appropriate but is rooted in the premise that informed consent is an ethical construct applicable to vulnerable people as patients independent of what type of treatment or body part being considered. This paper highlights the crucial importance of the process of informed consent and refusal in dentistry, underscoring its important place in oral healthcare. This paper will not address the unique circumstances involving consent in those without capacity or focus on informed consent in the research setting; our focus will be on those patients with full decisionmaking capacity in the clinical setting. I will emphasize the importance of disclosure of treatment options and highlight the benefits of shared-decision-making in the informed consent process.

  11. Changing trends in informed consent

    OpenAIRE

    Victor Lim

    2014-01-01

    Abstract: Consent is defined as the “voluntary agreement to or acquiescence in what another person proposes or desires”. In the context of medical practice it is now universally accepted that every human being of adult years and of sound mind has the right to determine what shall be done with his or her own body. Informed consent is now a central part of medical ethics and medical law. There has been a change in the public’s expectations of their role in medical decisi...

  12. From Informed Consent to Negotiated Consent.

    Science.gov (United States)

    Moody, Harry R.

    1988-01-01

    Considers informed consent standard inadequate for insuring autonomy in long term care. Argues for complex standard of "negotiated consent." Illuminates philosophical argument by qualitative data from interviews with physicians, nurses, and social workers in nursing homes, which demonstrated continuum of interventions ranging from…

  13. Informed consent in psychotherapy.

    Science.gov (United States)

    Beahrs, J O; Gutheil, T G

    2001-01-01

    The authors sought a rational approach to implementing informed consent within the practice of psychotherapy. The history of informed consent in psychotherapy was reviewed to define a common synthesis that maximizes the potential benefits and minimizes the potential hazards. The benefits of informed consent in psychotherapy include fostering a positive treatment outcome through enhancing patient autonomy, responsibility, and self-therapeutic activity; lessening the risks of regressive effects and therapist liability; and helping the practice of psychotherapy extend beyond particular parochialisms by providing checks and balances on therapist judgments. The hazards include the unpredictability of interactional outcomes and the possibilities of replacing positive expectancy with negative suggestion, replacing a therapeutic alliance with a legalistic stance, and misimplying that patients are passive recipients. Practical implementation of informed consent in psychotherapy must balance such tensions in service of optimal treatment. As a guiding principle, the authors recommend that psychotherapists convey to a prospective patient information that is material to the particular patient's decision. The level of detail needed in informed consent discussions varies directly with the cost and risks of the proposed treatment, the presence of viable alternatives and their relative grounding in scientific data and professional acceptance, and the presence of significant controversy. Unresolved is the question of how to address problematic or controversial psychotherapeutic trends that temporarily enjoy wide professional support.

  14. Informed Consent and Capacity to Give Consent in Mental Disorders

    Directory of Open Access Journals (Sweden)

    Zeynep Mackali

    2014-09-01

    Full Text Available Among four basic principles (respect for autonomy, beneficence, non-malfeasance, and justice which determine ethical behaviors in healthcare, informed consent is mostly related to and lsquo;respect for autonomy'. Also, it reflects patient/client's right for decision and the value given for the client and his/her autonomy. Informed consent is an information sharing process including both rational decision-making about the most appropriate method among many different options and the interaction between the clinician and the client. This concept sheds light on criteria regarding the limits of confidentiality, competency, appropriate and sufficient information sharing and voluntariness. In this theoretical review, the definitions and the content of informed consent were shared, and then a section regarding the required content of informed consent for psychotherapy process was provided. Then, the components of informed consent were discussed and the relationship between capacity to consent and mental disorders in terms of aforementioned diagnostic groups was examined. [Psikiyatride Guncel Yaklasimlar - Current Approaches in Psychiatry 2014; 6(3.000: 227-242

  15. Informed consent for braces.

    Science.gov (United States)

    Jharwal, Vikas; Trehan, Mridula; Rathore, Nidhi; Rathee, Pooja; Agarwal, Deepesh; Mathur, Nikunj

    2014-05-01

    The influence of law on the orthodontic profession has greatly increased in the last few decades. Dental law has emerged today as a full-fedged specialty dealing with a variety of areas, like professional negligence, doctor-patient contracts, consumer protection laws, ethics, general and special health legislations and practice regulatory mechanisms. This article highlights the concept of informed consent which is based on the premise that each individual has a right to make decisions concerning his health, disease and treatment. How to cite this article: Jharwal V, Trehan M, Rathore N, Rathee P, Agarwal D, Mathur N. Informed Consent for Braces. Int J Clin Pediatr Dent 2014;7(2):105-108.

  16. Nudging and informed consent.

    Science.gov (United States)

    Cohen, Shlomo

    2013-01-01

    Libertarian paternalism's notion of "nudging" refers to steering individual decision making so as to make choosers better off without breaching their free choice. If successful, this may offer an ideal synthesis between the duty to respect patient autonomy and that of beneficence, which at times favors paternalistic influence. A growing body of literature attempts to assess the merits of nudging in health care. However, this literature deals almost exclusively with health policy, while the question of the potential benefit of nudging for the practice of informed consent has escaped systematic analysis. This article focuses on this question. While it concedes that nudging could amount to improper exploitation of cognitive weaknesses, it defends the practice of nudging in a wide range of other conditions. The conclusion is that, when ethically legitimate, nudging offers an important new paradigm for informed consent, with a special potential to overcome the classical dilemma between paternalistic beneficence and respect for autonomy.

  17. Informed consent: not just for procedures anymore.

    Science.gov (United States)

    Feld, Andrew D

    2004-06-01

    The ethical and legal requirement to obtain informed consent prior to performing a procedure or administering a treatment derives from the concept of personal (patient) autonomy. The competent patient, after receiving appropriate disclosure of the material risks of the procedure or treatment, understanding those risks, the benefits, and the alternative approaches, makes a voluntary and uncoerced informed decision to proceed. This article will present a general overview of the modern concept of informed consent as a process (mutual communication) rather than an event (document signing). The historical evolution of this concept and the legal rulings that have shaped the requirements of informed consent will be cited. The benefits of informed decision making as a communication and risk management tool are presented. This review is intended as general information, and not as legal advice, which should be sought from a health-care attorney.

  18. Informed consent -- Building consensus

    International Nuclear Information System (INIS)

    Lovenheim, R.

    1990-01-01

    The author shares his observations and offers an approach to 'building consensus' for what he believes is the only environmentally sound option, i.e., safe, permanent disposal of low-level radioactive waste (LLRW). Consensus does not mean unanimity, acceptance, or harmony. The low-level radioactive waste disposal issue is fraught with fear and hysteria. The paper discusses major emotions that fracture public opinion regarding this issue. The author defines consensus as the informed consent of LLRW disposal strategies by a majority of citizens whose cooperation is required to achieve the goals of environmentally sound solution. The political aspects are reviewed. The need for US Department of Energy to fulfill its importance technical assistance role is discussed

  19. Informed Consent in Adult Psychiatry

    Directory of Open Access Journals (Sweden)

    Ahmed Bait Amer

    2013-07-01

    Full Text Available This article addresses some of the groundwork of informed consent in people with mental illness whose decision-making capacity has obviously been compromised. This article examines four crucial aspects in particular, namely: i the main elements of informed consent; ii difficulties pertaining to psychiatric illnesses; iii the effect of psychiatric disorders on the patient’s capability; iv how to assess situations in which consents may not be required.

  20. Nudging, informed consent and bullshit.

    Science.gov (United States)

    Simkulet, William

    2017-11-18

    Some philosophers have argued that during the process of obtaining informed consent, physicians should try to nudge their patients towards consenting to the option the physician believes best, where a nudge is any influence that is expected to predictably alter a person's behaviour without (substantively) restricting her options. Some proponents of nudging even argue that it is a necessary and unavoidable part of securing informed consent. Here I argue that nudging is incompatible with obtaining informed consent. I assume informed consent requires that a physician tells her patient the truth about her options and argue that nudging is incompatible with truth-telling. Instead, nudging satisfies Harry Frankfurt's account of bullshit. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  1. Informed consent: information or knowledge?

    Science.gov (United States)

    Berger, Ken

    2003-01-01

    A fiduciary relationship should be nurtured between patient and physician. This requires effective communication throughout all aspects of care - especially pertaining to treatment decisions. In the context of illness as experienced by the patient a unique set of circumstances is presented. However, communication in an illness context is fraught with problems. The patient is vulnerable and the situation may be overwhelming. Voluminous amounts of information are available to patients from a host of health care providers, family members, support groups, advocacy centers, books, journals, and the internet. Often conflicting and confusion, frequently complex, this information may be of greater burden than benefit. Some information is of high validity and reliability while other information is of dubious reliability. The emotional freight of bad news may further inhibit understanding. An overload of information may pose an obstacle in decision-making. To facilitate the transformation of information into knowledge, the health care provider must act on some occasions as a filter, on other occasions as a conduit, and on still other occasions simply as a reservoir. The evolution of patient rights to receive or refuse treatment, the right to know or not to know calls for a change in processing of overwhelming information in our modem era. In this paper we will discuss the difference between information and knowledge. How can health care providers ensure they have given their patients all necessary and sufficient information to make an autonomous decision? How can they facilitate the transformation of information into knowledge? The effect of knowledge to consent allows a more focused, relevant and modern approach to choice in health care.

  2. Click here to consent forever: Expiry dates for informed consent

    Directory of Open Access Journals (Sweden)

    Bart Custers

    2016-01-01

    Full Text Available The legal basis for processing personal data and some other types of Big Data is often the informed consent of the data subject involved. Many data controllers, such as social network sites, offer terms and conditions, privacy policies or similar documents to which a user can consent when registering as a user. There are many issues with such informed consent: people get too many consent requests to read everything, policy documents are often very long and difficult to understand and users feel they do not have a real choice anyway. Furthermore, in the context of Big Data refusing consent may not prevent predicting missing data. Finally, consent is usually asked for when registering, but rarely is consent renewed. As a result, consenting once often implies consent forever. At the same time, given the rapid changes in Big Data and data analysis, consent may easily get outdated (when earlier consent no longer reflects a user’s preferences. This paper suggests expiry dates for consent, not to settle questions, but to put them on the table as a start for further discussion on this topic. Although such expiry dates may not solve all the issues of informed consent, they may be a useful tool in some situations.

  3. Should we nudge informed consent ?

    OpenAIRE

    Brooks, Thom

    2013-01-01

    Critics argue that nudge theory manipulates rather than respects the informed consent of patients. Cohen (2013) convincingly argues that this criticism falls short of the mark. But we might go one step further: nudges are not only defensible, there are also inescapable. Cohen’s defence should be more robust and recognize the importance of context and unavoidable framing effects. The question is not whether nudges are acceptable, but rather how they might be better employed to improve informed...

  4. Informed consent and the readability of the written consent form.

    Science.gov (United States)

    Sivanadarajah, N; El-Daly, I; Mamarelis, G; Sohail, M Z; Bates, P

    2017-11-01

    Introduction The aim of this study was to objectively ascertain the level of readability of standardised consent forms for orthopaedic procedures. Methods Standardised consent forms (both in summary and detailed formats) endorsed by the British Orthopaedic Association (BOA) were retrieved from orthoconsent.com and assessed for readability. This involved using an online tool to calculate the validated Flesch reading ease score (FRES). This was compared with the FRES for the National Health Service (NHS) Consent Form 1. Data were analysed and interpreted according to the FRES grading table. Results The FRES for Consent Form 1 was 55.6, relating to the literacy expected of an A level student. The mean FRES for the BOA summary consent forms (n=27) was 63.6 (95% confidence interval [CI]: 61.2-66.0) while for the detailed consent forms (n=32), it was 68.9 (95% CI: 67.7-70.0). All BOA detailed forms scored >60, correlating to the literacy expected of a 13-15-year-old. The detailed forms had a higher FRES than the summary forms (p<0.001). Conclusions This study demonstrates that the BOA endorsed standardised consent forms are much easier to read and understand than the NHS Consent Form 1, with the detailed BOA forms being the easiest to read. Despite this, owing to varying literacy levels, a significant proportion of patients may struggle to give informed consent based on the written information provided to them.

  5. Futility, autonomy, and informed consent.

    Science.gov (United States)

    Trau, J M

    1994-03-01

    If clinicians deem a treatment medically futile, is it appropriate to mention such a treatment to patients? Do healthcare professionals violate informed consent if they do not offer patients an opportunity to decline futile treatments? The notion of futility involves an assessment of patient best interest--both short-term and long-term therapeutic benefit for a patient and the community in which he or she intends to survive and flourish. Although survival interests may be construed as long term, a treatment that offers survival without any promise of flourishing is not the goal of medicine and is futile. Flourishing requires some cognitive and affective function. The goal of informed consent practices is to ensure that patients accept the benefits of treatment with cognizance of the burdens and risks. Given the impact of illness on the emotional and psychological states of patients and their families and their resultant vulnerability, the omission of futile options from treatment plans is logical and exemplifies the best of paternalistic behavior. The claim that requests for futile treatment must be honored is based on a perverse understanding of patient autonomy. Rational medicine demands that patients' requests be reasonable from a clinical perspective, as well as from a subjective one. The practice of informed consent can be implemented as a balance between these two interests.

  6. Informed Consent and Capacity to Give Consent in Mental Disorders

    OpenAIRE

    Zeynep Mackali

    2014-01-01

    Among four basic principles (respect for autonomy, beneficence, non-malfeasance, and justice) which determine ethical behaviors in healthcare, informed consent is mostly related to and lsquo;respect for autonomy'. Also, it reflects patient/client's right for decision and the value given for the client and his/her autonomy. Informed consent is an information sharing process including both rational decision-making about the most appropriate method among many different options and the interacti...

  7. Placebo Effects and Informed Consent.

    Science.gov (United States)

    Alfano, Mark

    2015-01-01

    The concepts of placebos and placebo effects refer to extremely diverse phenomena. I recommend dissolving the concepts of placebos and placebo effects into loosely related groups of specific mechanisms, including (potentially among others) expectation-fulfillment, classical conditioning, and attentional-somatic feedback loops. If this approach is on the right track, it has three main implications for the ethics of informed consent. First, because of the expectation-fulfillment mechanism, the process of informing cannot be considered independently from the potential effects of treatment. Obtaining informed consent influences the effects of treatment. This provides support for the authorized concealment and authorized deception paradigms, and perhaps even for outright deceptive placebo use. Second, doctors may easily fail to consider the potential benefits of conditioning, leading them to misjudge the trade-off between beneficence and autonomy. Third, how attentional-somatic feedback loops play out depends not only on the content of the informing process but also on its framing. This suggests a role for libertarian paternalism in clinical practice.

  8. Enhancing informed consent for research and treatment.

    Science.gov (United States)

    Dunn, L B; Jeste, D V

    2001-06-01

    Increased scrutiny of informed consent calls for further research into decision making by patients who may be at risk for impairments. We review interventions designed to improve patient understanding of informed consent. A number of studies, within as well as outside psychiatry, have evaluated the effectiveness of specific interventions, as well as possible "predictors" of understanding of consent, such as subject characteristics, psychiatric symptoms, and cognitive impairment. Deficits in patients' understanding of informed consent may be partially related to poorly conceived, written, or organized informed consent materials; these deficits may be remediable with educational interventions. We find that effective interventions include corrected feedback, multiple learning trials, and more organized or simplified consent forms. Educational levels of patients generally correlate with levels of understanding. Even among individuals with psychiatric illness or cognitive impairment, deficits in understanding can be remedied with certain educational interventions. A variety of interventions can enhance understanding of informed consent.

  9. [The origin of informed consent].

    Science.gov (United States)

    Mallardi, V

    2005-10-01

    The principle of informed consent, aimed at the lawfulness of health assistance, tends to reflect the concept of autonomy and of decisional autodetermination of the person requiring and requesting medical and/or surgical interventions. This legal formula, over the last few years, has gained not only considerable space but also importance in the doctrinal elaboration and approaches, as well as juridical interpretations, thereby influencing the everyday activities of the medical profession. Informed consent is still the object of continuous explorations, not only asfar as concerns the already confirmed theoretical profile but, instead, the ambiguous practical and consequential aspect. Analysing how the concept and role of consensus was born and developed with the more adequate and reasonable excursions to make it valid and obtain it, it is impossible not to take into consideration, on the one hand, the very ancient philosophical origins and, on the other, the fact that it was conditioned by religion with the moral aspects and the accelerated deontological evolution with pathways parallel to the needs and the progress offered by new forms of treatment and novel biotechnological applications. The principle of consent is a relatively new condition. In fact, already in the times of not only the Egyptian civilisation, but also the Greek and Roman, documents have been found which show how the doctor's intervention had, in some way, first to be approved by the patient. Plato (law IV) had already foreseen the problems, the procedures and the modes of information which are, in synthesis, at the root of the principles of the present formula of informed consent and correlated the practice of the information and consensus with the quality and social position of the patient. The only guarantee that the patient might have, derived from a fundamental principle of medicine of all times: "in disease, focus on two aims, to improve and not to cause damage". A figure can be recognised

  10. Interactive informed consent: randomized comparison with paper consents.

    Directory of Open Access Journals (Sweden)

    Michael C Rowbotham

    Full Text Available Informed consent is the cornerstone of human research subject protection. Many subjects sign consent documents without understanding the study purpose, procedures, risks, benefits, and their rights. Proof of comprehension is not required and rarely obtained. Understanding might improve by using an interactive system with multiple options for hearing, viewing and reading about the study and the consent form at the subject's own pace with testing and immediate feedback. This prospective randomized study compared the IRB-approved paper ICF for an actual clinical research study with an interactive presentation of the same study and its associated consent form using an iPad device in two populations: clinical research professionals, and patients drawn from a variety of outpatient practice settings. Of the 90 participants, 69 completed the online test and survey questions the day after the session (maximum 36 hours post-session. Among research professionals (n = 14, there was a trend (p = .07 in the direction of iPad subjects testing better on the online test (mean correct  =  77% compared with paper subjects (mean correct = 57%. Among patients (n = 55, iPad subjects had significantly higher test scores than standard paper consent subjects (mean correct = 75% vs 58%, p < .001. For all subjects, the total time spent reviewing the paper consent was 13.2 minutes, significantly less than the average of 22.7 minutes total on the three components to be reviewed using the iPad (introductory video, consent form, interactive quiz. Overall satisfaction and overall enjoyment slightly favored the interactive iPad presentation. This study demonstrates that combining an introductory video, standard consent language, and an interactive quiz on a tablet-based system improves comprehension of research study procedures and risks.

  11. Value of informed consent in surgical orthodontics

    NARCIS (Netherlands)

    Brons, S.; Becking, A.G.; Tuinzing, D.B.

    2009-01-01

    PURPOSE: Informed consent forms an important part of treatment, especially in the case of elective treatment. The aim of this survey was to establish how much patients can recall of the information given during an informed consent interview before orthognathic surgery. During the consultation,

  12. Value of informed consent in surgical orthodontics

    NARCIS (Netherlands)

    Brons, S.; Becking, A.G.; Tuinzing, D.B.

    2009-01-01

    Purpose: Informed consent forms an important part of treatment, especially in the case of elective treatment. The aim of this survey was to establish how much patients can recall of the information given during an informed consent interview before orthognathic surgery. During the consultation,

  13. Value of informed consent in surgical orthodontics.

    NARCIS (Netherlands)

    Brons, S.; Becking, A.G.; Tuinzing, D.B.

    2009-01-01

    PURPOSE: Informed consent forms an important part of treatment, especially in the case of elective treatment. The aim of this survey was to establish how much patients can recall of the information given during an informed consent interview before orthognathic surgery. During the consultation,

  14. Value of informed consent in surgical orthodontics

    NARCIS (Netherlands)

    Brons, Sander; Becking, Alfred G.; Tuinzing, D. Bram

    2009-01-01

    Informed consent forms an important part of treatment, especially in the case of elective treatment. The aim of this survey was to establish how much patients can recall of the information given during an informed consent interview before orthognathic surgery. During the consultation, attention was

  15. Dynamic axes of informed consent in Japan.

    Science.gov (United States)

    Specker Sullivan, Laura

    2017-02-01

    Scholarship in cross-cultural bioethics routinely frames Japanese informed consent in contrast to informed consent in North America. This contrastive analysis foregrounds cancer diagnosis disclosure and physician paternalism as unique aspects of Japanese informed consent that deviate from American practices. Drawing on in-depth interviews with 15 Japanese medical professionals obtained during fieldwork in Japan from 2013 to 15, this article complicates the informed consent discourse beyond East-West comparisons premised on Anglo-American ethical frameworks. It expands professional perspectives to include nurses, medical social workers, clinical psychologists, and ethicists and it addresses informed consent for a broad range of conditions in addition to cancer. The results suggest that division of affective labor is an under-theorized dimension of informed consent that is perceived as at odds with principled demands for universal informed consent. These practical tensions are conceptualized as cultural differences, with Japan identified in terms of omakase as practical and supportive and the United States identified in terms of jiko kettei as principled and self-determining. These results have implications for the methodology of cross-cultural bioethics as well as for theories and practices of informed consent in both Japan and the United States. I conclude that responsible cross-cultural work in bioethics must begin from the ground up, incorporating all relevant stakeholder perspectives, attitudes, and experiences. Copyright © 2016 Elsevier Ltd. All rights reserved.

  16. The changing face of informed surgical consent.

    LENUS (Irish Health Repository)

    Oosthuizen, J C

    2012-03-01

    To determine whether procedure-specific brochures improve patients\\' pre-operative knowledge, to determine the amount of information expected by patients during the consenting process, and to determine whether the recently proposed \\'Request for Treatment\\' consenting process is viable on a large scale.

  17. HIV testing and informed consent - ethical considerations

    African Journals Online (AJOL)

    donation; and the protection of third parties, including the health care worker. .... closest available relative or, in the case of a minor, the consent of the medical ... case informed consent to the taking of blood is obviously mandatory. . Blood ...

  18. Use of informed consent with therapeutic paradox.

    Science.gov (United States)

    Farkas, M M

    1992-01-01

    Debate persists in the literature and among clinicians about the ethical appropriateness of paradoxical interventions. It has been suggested that informed consent with therapeutic paradox would alleviate ethical concerns of deception, manipulation, harm to the client, and withholding of information from the client in therapy. The purpose of this study was to explore health care consumer reactions to the benefits and risks of therapeutic paradox as stated in a consent for treatment form. The study explored the responses of 32 medical patients to a hypothetical consent for treatment form for therapeutic paradox. Data were collected in a brief semistructured interview after subjects read the hypothetical consent form. Utilizing a case study, the investigator then offered an example of a successful paradoxical intervention and additional subject comments were solicited. Content analysis of the responses was made. Health care consumers had mixed responses to the consent form. While the consent form served as an obstacle for some consumers, many were willing to sign the consent form and accept treatment even though they had internal reservations and questions. Appropriateness of the consent form format is discussed.

  19. [Dentistry and healthcare legislation 3: informed consent].

    Science.gov (United States)

    Brands, W G; van der Ven, J M; Eijkman, M A J

    2013-06-01

    The relationship between a dentist and his patient is based on trust. The principle of informed consent contributes to the quality of that relationship of trust. According to the professional standards for such a relationship, it is up to the dentist to make sure that the patient is well informed. Reliable information is necessary if the patient is to be in a position to give his or her consent for treatment. The Dutch Law of Agreement to Medical Treatment (WGBO) provides aframework for informed consent. Disciplinary judges establish the scope and if necessary the limits. It is clear that, among other things, not defining the risks beforehand can be the basis for a (disciplinary) complaint. Determining the requirements of informed consent calls for familiarity with the law and communication skills. Programmes in dental education ought to devote more attention to this issue.

  20. Informed consent comprehension in African research settings.

    Science.gov (United States)

    Afolabi, Muhammed O; Okebe, Joseph U; McGrath, Nuala; Larson, Heidi J; Bojang, Kalifa; Chandramohan, Daniel

    2014-06-01

    Previous reviews on participants' comprehension of informed consent information have focused on developed countries. Experience has shown that ethical standards developed on Western values may not be appropriate for African settings where research concepts are unfamiliar. We undertook this review to describe how informed consent comprehension is defined and measured in African research settings. We conducted a comprehensive search involving five electronic databases: Medline, Embase, Global Health, EthxWeb and Bioethics Literature Database (BELIT). We also examined African Index Medicus and Google Scholar for relevant publications on informed consent comprehension in clinical studies conducted in sub-Saharan Africa. 29 studies satisfied the inclusion criteria; meta-analysis was possible in 21 studies. We further conducted a direct comparison of participants' comprehension on domains of informed consent in all eligible studies. Comprehension of key concepts of informed consent varies considerably from country to country and depends on the nature and complexity of the study. Meta-analysis showed that 47% of a total of 1633 participants across four studies demonstrated comprehension about randomisation (95% CI 13.9-80.9%). Similarly, 48% of 3946 participants in six studies had understanding about placebo (95% CI 19.0-77.5%), while only 30% of 753 participants in five studies understood the concept of therapeutic misconception (95% CI 4.6-66.7%). Measurement tools for informed consent comprehension were developed with little or no validation. Assessment of comprehension was carried out at variable times after disclosure of study information. No uniform definition of informed consent comprehension exists to form the basis for development of an appropriate tool to measure comprehension in African participants. Comprehension of key concepts of informed consent is poor among study participants across Africa. There is a vital need to develop a uniform definition for

  1. Informed consent - a survey of doctors' practices in South Africa ...

    African Journals Online (AJOL)

    Informed consent - a survey of doctors' practices in South Africa. ... whether informed consent as envisioned by the law exists in reality. Cross-cultural research is needed to clarify patients' and parents' expectations of informed consent ...

  2. [Schizophrenia and informed consent to research].

    Science.gov (United States)

    Fovet, T; Amad, A; Thomas, P; Jardri, R

    2015-10-01

    Informed consent to research remains a complex issue, while sometimes staying difficult to obtain, even in the general population. This problem may be maximized with patients suffering from schizophrenia. This paper summarizes available data in the literature about informed consent for research involving patients suffering from schizophrenia. Medline and Google Scholar searches were conducted using the following MESH terms: schizophrenia, informed consent and research. Studies using dedicated standardized scales (e.g. MacCAT-CR) revealed a decrease in the capacity to consent of patients with schizophrenia when compared with healthy individuals. Keeping in mind that schizophrenia is an heterogeneous disorder, patients with the lowest insight as well as those with the most severe cognitive symptoms appeared more impaired in their capacity to consent. Such a poor capacity to understand and consent to trials was shown linked with alterations in decision-making. For these specific patients, interventions may be set up to increase their capacity to consent. Various strategies were proposed: enhanced consent forms, extended discussion, test/feedback method or multimedia interventions. Among them, interventions relying on communication and the growing field of information technologies (e.g. web-based tools) seem promising. Finally, associations grouping families and patients (like the French Association UNAFAM) may facilitate the involvement of patients in research programs with safer conditions. Patients suffering from schizophrenia appear able to consent to research programs when suitable interventions are proposed. Further studies are now needed to optimize and individualize such interventions. Copyright © 2014 L’Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.

  3. Legal protection of informed consent of minors.

    Science.gov (United States)

    Osuna, Eduardo

    2010-06-01

    One of the pillars of healthcare provision is respect for the autonomy of the patient's wishes, which is given substance by the process of obtaining informed consent. Minors deserve special protection, entitled to basic rights and increasingly autonomous as they develop. In certain situations, minors are deemed matures and able to consent to treatment without the involvement of a parent or guardian. The assessment of competence would be based on the child's functional ability, not on age or outcome of the decision. This manuscript includes a brief analysis of legal perspectives on informed consent of minors, and minors' capacities to make medical decisions. Remaining questions of how to evaluate capacity and balance parental and minor autonomy are explored. Considerations on informed consent in different situations as refusing treatment and termination of pregnancy by female children are analyzed.

  4. Getting meaningful informed consent from older adults: a structured literature review of empirical research.

    Science.gov (United States)

    Sugarman, J; McCrory, D C; Hubal, R C

    1998-04-01

    To perform a structured literature review of the published empirical research on informed consent with older adults in order to make recommendations to improve the informed consent process and to highlight areas needing further examination. Relevant literature was identified by searching electronic databases (AGELINE, BIOETHICSLINE, CancerLit, Ethics Index, Health, LegalTrac, MEDLINE, PAIS International, PsycInfo, and Sociofile). Studies were included if they were reports of primary research data about informed consent and, if patients or other subjects were used, older subjects were included in the sample. Data related to the aspect of informed consent under study (recruitment, decision-making capacity, voluntariness, disclosure of information, understanding of information, consent forms, authorization, and policies and procedures) were abstracted and entered into a specially designed database. Characterization of the population, age of subjects, setting, whether informed consent was being studied in the context of research or treatment, study design, the nature of outcome or dependent variables, independent variables (e.g., experimental conditions in a randomized controlled trial or patient/subject characteristics in a nonrandomized comparison), and results according to the aspect of informed consent under study. A total of 99 articles met all the inclusion criteria and posed 289 unique research questions covering a wide range of aspects of informed consent: recruitment (60); decision making capacity (21); voluntariness (6); disclosure (30); understanding (139); consent forms (7); authorization (11); policies (13); and other (2). In the secondary analyses of numerous studies, diminished understanding of informed consent information was associated with older age and fewer years of education. Older age was also sometimes associated with decreased participation in research. Studies of disclosure of informed consent information suggest strategies to improve

  5. The limits of informed consent.

    Science.gov (United States)

    1975-09-01

    The patient, a 59-year-old man, was referred to a psychiatric hospital with what appeared initially to be the signs and symptoms of mental disorder. In hospital a lesion of the brain was diagnosed and surgery was proposed to relieve the condition. The patient, however, during this and subsequent admissions to hospital, refused operation. His refusal to consent was regarded as valid as he seemed to have good insight into his condition. Finally, under section 26 of the Mental Health Act, he was treated surgically. Unfortunately the patient died six weeks later of intracranial haemorrhage. Three comments are made on this case - two by psychiatrists, Dr K Davison and Dr Ashley Robin, the other by a professor of Christian ethics, Professor F C Blackie. Both psychiatrists argue that when a patient's mind is affected by mental or organic illness to the degree that 'he cannot bring a rational and conscious mind' to the question of his treatment then the doctor, in consultation with the relatives, making clear to them the likely course of events if an operation is not performed, must take whatever is the proper course of action, in this case surgery. In this view, such an operation performed immediately the diagnosis was confirmed might not have been so complicated. Professor Blackie, commending 'the attempt to regard the patient as a responsible human being' with a 'moral right to be consulted on all aspects of treatment', questions in this patient the limits to which the appeal to reason was carried. He concludes that 'in this situation the advice and consent of the family must weigh more heavily than the statements of the patient'.

  6. Value of informed consent in surgical orthodontics.

    Science.gov (United States)

    Brons, Sander; Becking, Alfred G; Tuinzing, D Bram

    2009-05-01

    Informed consent forms an important part of treatment, especially in the case of elective treatment. The aim of this survey was to establish how much patients can recall of the information given during an informed consent interview before orthognathic surgery. During the consultation, attention was given to all aspects of the treatment. However, because of "insurance-related factors," the need for treatment because of functional reasons was stressed over esthetics. The recall of information given during an informed consent interview before orthognathic surgery was measured using a questionnaire. Patients with a mandibular deficiency with a low mandibular plane angle were questioned after an informed consent interview regarding surgical orthodontic treatment. Esthetics were more frequently and functional problems were less frequently recalled as the reason for operation than was expected. The risk of a change in the sensation of the lower lip by surgery was frequently recalled as a reason to refrain from the operation. The overall recall rate of the possible risks and complications of orthodontic surgery was 40%. No reports were found of comparable research on the preoperative recall after consultation before surgical orthodontic surgery. The aspects of communication that can improve recall must be clarified. A recall rate of 100% seems a utopia, although an arbitrary line is needed to determine the quality of an informed consent interview.

  7. Non-completion and informed consent.

    Science.gov (United States)

    Wertheimer, Alan

    2014-02-01

    There is a good deal of biomedical research that does not produce scientifically useful data because it fails to recruit a sufficient number of subjects. This fact is typically not disclosed to prospective subjects. In general, the guidance about consent concerns the information required to make intelligent self-interested decisions and ignores some of the information required for intelligent altruistic decisions. Bioethics has worried about the 'therapeutic misconception', but has ignored the 'completion misconception'. This article argues that, other things being equal, prospective subjects should be informed about the possibility of non-completion as part of the standard consent process if (1) it is or should be anticipatable that there is a non-trivial possibility of non-completion and (2) that information is likely to be relevant to a prospective subject's decision to consent. The article then considers several objections to the argument, including the objection that disclosing non-completion information would make recruitment even more difficult.

  8. Autonomy and informed consent: a mistaken association?

    Science.gov (United States)

    Kristinsson, Sigurdur

    2007-09-01

    For decades, the greater part of efforts to improve regulatory frameworks for research ethics has focused on informed consent procedures; their design, codification and regulation. Why is informed consent thought to be so important? Since the publication of the Belmont Report in 1979, the standard response has been that obtaining informed consent is a way of treating individuals as autonomous agents. Despite its political success, the philosophical validity of this Belmont view cannot be taken for granted. If the Belmont view is to be based on a conception of autonomy that generates moral justification, it will either have to be reinterpreted along Kantian lines or coupled with a something like Mill's conception of individuality. The Kantian interpretation would be a radical reinterpretation of the Belmont view, while the Millian justification is incompatible with the liberal requirement that justification for public policy should be neutral between controversial conceptions of the good. This consequence might be avoided by replacing Mill's conception of individuality with a procedural conception of autonomy, but I argue that the resulting view would in fact fail to support a non-Kantian, autonomy-based justification of informed consent. These difficulties suggest that insofar as informed consent is justified by respect for persons and considerations of autonomy, as the Belmont report maintained, the justification should be along the lines of Kantian autonomy and not individual autonomy.

  9. Current approaches for informed consent in pediatrics

    Directory of Open Access Journals (Sweden)

    Hatice Betül Gemici

    2014-09-01

    Full Text Available Today in medical practis; codes of ethic are becoming important. New aprroaches has emerged that about to participate with patient’s consent and child absent understand the own situation should be taken for treatment or process on child. Means of child informing is to given simple information about understandable language. Physicians should support to be shared with the patient’s medical decision according to the child’s age and understanding capacity. Informed consent in pediatric patients makes contribution to develepmont of future individuals; therefore that is an important ethic assignment for doctors. J Clin Exp Invest 2014; 5 (3: 496-503

  10. Simplifying informed consent for biorepositories: stakeholder perspectives.

    Science.gov (United States)

    Beskow, Laura M; Friedman, Joëlle Y; Hardy, N Chantelle; Lin, Li; Weinfurt, Kevin P

    2010-09-01

    Complex and sometimes controversial information must be conveyed during the consent process for participation in biorepositories, and studies suggest that consent documents in general are growing in length and complexity. As a first step toward creating a simplified biorepository consent form, we gathered data from multiple stakeholders about what information was most important for prospective participants to know when making a decision about taking part in a biorepository. We recruited 52 research participants, 12 researchers, and 20 institutional review board representatives from Durham and Kannapolis, NC. These subjects were asked to read a model biorepository consent form and highlight sentences they deemed most important. On average, institutional review board representatives identified 72.3% of the sentences as important; researchers selected 53.0%, and participants 40.4% (P = 0.0004). Participants most often selected sentences about the kinds of individual research results that might be offered, privacy risks, and large-scale data sharing. Researchers highlighted sentences about the biorepository's purpose, privacy protections, costs, and participant access to individual results. Institutional review board representatives highlighted sentences about collection of basic personal information, medical record access, and duration of storage. The differing mandates of these three groups can translate into widely divergent opinions about what information is important and appropriate to include a consent form. These differences could frustrate efforts to move simplified forms--for biobanking as well as for other kinds of research--into actual use, despite continued calls for such forms.

  11. Testing an alternate informed consent process.

    Science.gov (United States)

    Yates, Bernice C; Dodendorf, Diane; Lane, Judy; LaFramboise, Louise; Pozehl, Bunny; Duncan, Kathleen; Knodel, Kendra

    2009-01-01

    One of the main problems in conducting clinical trials is low participation rate due to potential participants' misunderstanding of the rationale for the clinical trial or perceptions of loss of control over treatment decisions. The objective of this study was to test an alternate informed consent process in cardiac rehabilitation participants that involved the use of a multimedia flip chart to describe a future randomized clinical trial and then asked, hypothetically, if they would participate in the future trial. An attractive and inviting visual presentation of the study was created in the form of a 23-page flip chart that included 24 color photographs displaying information about the purpose of the study, similarities and differences between the two treatment groups, and the data collection process. We tested the flip chart in 35 cardiac rehabilitation participants. Participants were asked if they would participate in this future study on two occasions: immediately after the description of the flip chart and 24 hours later, after reading through the informed consent document. Participants were also asked their perceptions of the flip chart and consent process. Of the 35 participants surveyed, 19 (54%) indicated that they would participate in the future study. No participant changed his or her decision 24 hours later after reading the full consent form. The participation rate improved 145% over that of an earlier feasibility study where the recruitment rate was 22%. Most participants stated that the flip chart was helpful and informative and that the photographs were effective in communicating the purpose of the study. Participation rates could be enhanced in future clinical trials by using a visual presentation to explain and describe the study as part of the informed consent process. More research is needed to test alternate methods of obtaining informed consent.

  12. Dare we rethink informed consent?

    African Journals Online (AJOL)

    2017-06-26

    Jun 26, 2017 ... the current phase of human societal development as fundamentally complex ... and informed decisions. This is ... contained or containable, packaged or like data on a memory stick/ ... Our intention is finally to promote patient autonomy ... verb 'to inform' (to shape, like a sculptor) illustrates the multifaceted,.

  13. Informed consent in Malaysia: an overview.

    Science.gov (United States)

    Che Ngah, Anisah

    2005-01-01

    The right of a person to control his body is a concept that has long been recognized in Malaysia under the law of torts. The purpose of requiring informed consent is to preserve that right in medical decision-making. Informed Consent is a relatively new concept in medical litigation cases. However in the late 1990's, it has become one of the important claims under negligence made against the doctor for failure to disclose relevant information to patients in respect of the treatment proposed. Whether Malaysia has begun to recognize patient's right to decision-making is yet to be seen. Furthermore the social-cultural relationship between doctors and patients had to be considered. In this respect, the researcher had conducted interviews with doctors and patients to gauge their reaction towards a shared process of decision-making, which is the central issue in the doctrine of informed consent. Findings suggest that in society where primary health care is the main thrust to achieve health for all, the possibility of recognition of the rights of patients to receive information before making decisions about treatment appears remote. The findings also underscore the importance of incorporating aspects of informed consent as part of providing quality service to patients.

  14. Informed consent needed for sterilization or research.

    Science.gov (United States)

    Barnett, B

    1998-01-01

    Informed choice involves enabling family planning clients to base their decisions about contraceptive use upon adequate information. It is a process in which clients give their permission to undergo a procedure, take a medication, or participate in a study after being fully informed. Informed consent protects an individual's freedom of choice, respects his or her autonomy, is important in both family planning programs and reproductive health research, and should always be available to clients seeking health services. Although written informed consent is not needed for most reproductive health services, it should be obtained from men and women who undergo sterilization, since that involves surgery and is considered permanent. In addition, people who volunteer to participate in contraceptive studies need to be fully informed of the risks and benefits of any new drugs or devices they receive. Volunteers should understand the potential effects of methods upon their physical health and other aspects of their lives. Ethical reviews need to be conducted before research begins.

  15. Learning Ethics through Everyday Problems: Informed Consent

    Science.gov (United States)

    Verdu, Fernando; Frances, Francesc; Castello, Ana

    2012-01-01

    The teaching of bioethics and its importance in clinical relationships is to a certain extent complicated when we address students of medicine, young people who are more used to dealing with and solving strictly clinical problems. Informed Consent is one of the aspects of professional practice that is generally and widely accepted in Western…

  16. Language, cultural brokerage and informed consent - will ...

    African Journals Online (AJOL)

    Language, cultural brokerage and informed consent - will technological terms impede telemedicine use? C Jack, Y Hlombe, M Mars. Abstract. Background. Telemedicine provides a solution to treatment of economically and geographically compromised patients and enhances the level of care. However, a problem has ...

  17. Tandheelkunde en gezondheidsrecht 3: informed consent

    NARCIS (Netherlands)

    Brands, W.G.; van der Ven, J.M.; Eijkman, M.A.J.

    2013-01-01

    De relatie tussen een tandarts en zijn patiënt is gebaseerd op vertrouwen. Het principe van informed consent draagt bij aan de kwaliteit van die vertrouwensrelatie. De relationele professionele standaard brengt met zich mee dat het op de weg van de tandarts ligt patiënten goed te informeren. Goede

  18. Recommendations for communication to enhance informed consent ...

    African Journals Online (AJOL)

    Recommendations for communication to enhance informed consent and enrolment at multilingual research sites. Claire Penn, Melanie Evans. Abstract. Language issues can affect HIV and AIDS research trial enrolment, but little is understood about variables in this process. Some evidence indicates barriers exist even ...

  19. Use of a simplified consent form to facilitate patient understanding of informed consent for laparoscopic cholecystectomy

    Directory of Open Access Journals (Sweden)

    Borello Alessandro

    2016-01-01

    Full Text Available Surgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion.

  20. Use of a simplified consent form to facilitate patient understanding of informed consent for laparoscopic cholecystectomy

    OpenAIRE

    Borello Alessandro; Ferrarese Alessia; Passera Roberto; Surace Alessandra; Marola Silvia; Buccelli Claudio; Niola Massimo; Di Lorenzo Pierpaolo; Amato Maurizio; Di Domenico Lorenza; Solej Mario; Martino Valter

    2016-01-01

    Abstract Background Surgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion. Methods This prospective, randomized study involved 70 adult patients awaiting cholecystectomy for gallstones. Consent was obtained after standard verbal explanation using either a grap...

  1. Informed consent: using a structured interview changes patients' attitudes towards informed consent.

    Science.gov (United States)

    Dawes, P J; O'Keefe, L; Adcock, S

    1993-09-01

    Patients want to know more about their condition and its proposed treatment. Gaining patients' confidence before treatment reduces the changes of their seeking legal redress for an unexpected outcome. As part of a prospective study of informed consent for surgery we have assessed the attitudes of patients towards informed consent when different types of consent interview are used. We found that most patients are happy to do as their doctor advises but think the informal consent interview is important because it gives them information; they also want to know about most, but not all, complications of the procedure. One quarter worried about the anaesthetic, about one eighth worried about 'not waking up' and similar proportions worried about complications and other things such as pain and nausea. Most patients think that the consent form is a legal document. In addition patients who had an informal interview felt obliged to sign the consent form and thought it had medicolegal implications. In contrast those who had a structured interview felt less obliged to sign the consent form and more involved in the decision to operate.

  2. Use of a simplified consent form to facilitate patient understanding of informed consent for laparoscopic cholecystectomy.

    Science.gov (United States)

    Borello, Alessandro; Ferrarese, Alessia; Passera, Roberto; Surace, Alessandra; Marola, Silvia; Buccelli, Claudio; Niola, Massimo; Di Lorenzo, Pierpaolo; Amato, Maurizio; Di Domenico, Lorenza; Solej, Mario; Martino, Valter

    2016-01-01

    Surgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion. This prospective, randomized study involved 70 adult patients awaiting cholecystectomy for gallstones. Consent was obtained after standard verbal explanation using either a graphically formatted (study group, n=33) or a standard text document (control group, n=37). Comprehension was evaluated with a 9-item multiple-choice questionnaire administered before surgery and factors affecting comprehension were analyzed. Comparison of questionnaire scores showed no effect of age, sex, time between consent and surgery, or document format on understanding of informed consent. Educational level was the only predictor of comprehension. Simplified surgical consent documents meet the goals of health literacy and informed consent. Educational level appears to be a strong predictor of understanding.

  3. Informed consent: attitudes, knowledge and information concerning prenatal examination

    DEFF Research Database (Denmark)

    Dahl, Katja; Kesmodel, Ulrik; hvidman, lone

    2006-01-01

    Background: Providing women with information enabling an informed consent to prenatal examinations has been widely recommended. Objective: The primary purpose of this review is to summarise current knowledge of the pregnant woman's expectations and attitudes concerning prenatal examinations, as w...

  4. Informed consent: is it a myth?

    Science.gov (United States)

    Herz, D A; Looman, J E; Lewis, S K

    1992-03-01

    The issue of informed consent at it relates to neurosurgical professional malpractice liability and litigation has been of concern for 20 years or more. The problem persists, and the subject has been addressed by providing patient education with full disclosure regarding neurosurgical procedures. In the process of imparting informed consent, the authors studied the effectiveness of specific neurosurgical health care teaching. One hundred six persons undergoing anterior cervical fusion or lumbar laminectomy were instructed by a neurosurgeon and clinical nurse specialist with a master's degree in neurosurgery. Written testing was performed in each case immediately after a formal teaching session before surgery. Questions were simple and covered only four general topics: 1) diagnosis and surgical techniques; 2) operative risks; 3) postoperative care; and 4) goals and benefits relating to surgery. The mean score on testing immediate retention of information revealed a 43.5% overall performance rate. When patients were tested approximately 6 weeks later, the score dropped to 38.4%. This was statistically significant (chi 2, P less than 0.05). The authors encourage the concept of patient education. The data in the current study, however, suggest that the reasonable and prudent neurosurgeon making a concerted effort at patient education, with the assistance of a professional educator, cannot necessarily expect accurate patient or family recall or comprehension. Fulfillment of the doctrine of informed consent by neurosurgeons may very well be mythical.

  5. Role of the informed consent, from mesotherapy to opioid therapy.

    Science.gov (United States)

    Mammucari, M; Lazzari, M; Maggiori, E; Gafforio, P; Tufaro, G; Baffini, S; Maggiori, S; Palombo, E; de Meo, B; Sabato, A F

    2014-01-01

    Informed consent is part of a process of communication useful to obtain an agreement (conscious, voluntary and free) between doctors and patients. Mesotherapy is based on the introduction of drugs by intradermal route in order to obtain a dose-sparing effect with respect to deeper administration. Opioids are the most appropriate therapy for patients who do not respond to other therapies. Proper communication between doctor and patient, including an explanation of the potential benefits, limitations and risks (even mild), is recommended both in clinical practice and research. Active participation of the patient has the advantage of better control of adverse events, both of mesotherapy and opioid-based therapy. This information-education process returns to the fundamental concept of "first do no harm" and set a "therapeutic partnership" with patients.

  6. [Pediatric autopsy and informed parental consent].

    Science.gov (United States)

    Rambaud, C; Guilleminault, C

    2005-10-01

    In French legal terminology, the definition of autopsy is "organs'withholding". This phrase is ambiguous, meaning both removing the organs for their macroscopic exam and their retention for subsequent histology. The autopsy of a child requires an informed consent from both parents. The issue is that the pathologist who performs the autopsy is not the one who delivers the information and gets the parents' consent: therefore, he does not know what they were told and what they actually agreed upon. A questionnaire was sent to 3 groups of paediatricians (N=891) to approach their knowledge regarding autopsy. Among 362 paediatricians who answered the questionnaire, 57.2% never attended an autopsy and procedures were badly known. They did not know whether or not organs, were systematically sampled especially brain. Regarding the possibility of conservation of organs, a majority thought that one should not solely answer to parents'queries (63.8%) but rather that one should point out every possibility, without giving the ins and outs (60.8%). The majority favoured organs retention and use for research. We make 3 suggestions: to register autopsy in the Natioanal Securite Sociale nomenclature, to establish information and consent forms for organs'removal, retention and disposal, and to offer parents the possibility of an interview with the pathologist before and/or after the autopsy, in association with the paediatrician.

  7. Informed consent: Do not be afraid

    Directory of Open Access Journals (Sweden)

    Dominique Sprumont

    2017-04-01

    Full Text Available Informed consent is the cornerstone of the doctor–patient relationship. At least this is how it is presented in theory. In practice, doctors struggle with their obligation to inform their patient before obtaining their approval prior to a medical intervention. In Taiwan, the culture is often mentioned to justify the doctor's reluctance to speak openly with their patient. Invoking the importance of the family in the society, doctors tend to rely less on their patients and more on their relatives to make important decisions. Yet, the cultural argument for not seeking the patients' informed consent sounds more like a mere excuse than the real cause of the difficulties doctors face today in obtaining their patients' consent. This paper argues that today the doctors in Taiwan are mostly governed by the same fear that was the rule in the USA and Europe until the 1980s. It may be time for changing the paradigm, admitting that patients are able to handle even the most dramatic diagnosis. It seems also important to get away from the sterile opposition of doctor's paternalism versus patient's autonomy and to introduce a true partnership between doctors and patients.

  8. An approach to radiotherapy under informed consent

    International Nuclear Information System (INIS)

    Okazaki, Atsushi; Maehara, Tadayuki; Baba, Sadaaki; Nakamura, Yuji; Kamitani, Hiroshi

    1996-01-01

    Over the past two years, we have attempted to practice radiotherapy in accordance with the principle of informed consent. The procedure used in our radiotherapy, which consists of informing the patient of the seriousness of his or her disease (malignant and benign) and receiving signed consent forms, is a new system in Japan. This is a report of our experience with this system and its advantages and disadvantages. We are satisfied with the clinical results of the attempt. Radiotherapy in accordance with informed consent has now become routine at our hospital. We feel that this practice will produce the mutual enhancement of our responsibility to patients and their trust in us, and improve cure rates. In promoting mutual understanding between our patients and ourselves, we must keep in mind that we, radiation oncologists, are not only radiotherapists but also health-care providers in our capacity as medical and surgical doctors. It is also necessary to achieve the best radiotherapeutic system in Japan. (author)

  9. Competence to consent to voluntary psychiatric hospitalization: a test of a standard proposed by APA. American Psychiatric Association.

    Science.gov (United States)

    Appelbaum, B C; Appelbaum, P S; Grisso, T

    1998-09-01

    In the wake of the U.S. Supreme Court's 1990 decision in Zinermon v. Burch, renewed attention has been given to capacities patients must have to be considered competent to consent to voluntary hospitalization. An American Psychiatric Association (APA) task force suggested that strong policy interests support the establishment of a low threshold for competence in this situation. The study examined whether, as previous research suggested, patients would have difficulty meeting even this lenient standard. One hundred voluntarily hospitalized psychiatric patients were read two brief paragraphs, one explaining the purposes of psychiatric hospitalization and and the other explaining policies for discharge. The paragraphs' readability measured about eighth-grade level. After each paragraph, participants were read two sets of questions, one testing recall of the presented information and the other testing recognition of the information in a true-false format. The scores of patients grouped by selected demographic and clinical variables were compared. The vast majority of patients were able to comprehend the information that the APA task force suggested was relevant to their decision. However, a subgroup of patients who were initially admitted involuntarily had significantly poorer performance and may constitute a group who need special educational efforts focused on the consequences of voluntary admission.

  10. Informed Consent: An Ethical Obligation or Legal Compulsion?

    OpenAIRE

    Satyanarayana Rao, K H

    2008-01-01

    Informed consent is a vital document while performing all surgical and aesthetic procedures, particularly in the current day practice. Proper documentation and counseling of patients is important in any informed consent.

  11. The patient's opinion of informed consent

    International Nuclear Information System (INIS)

    Pinto, I.; Paul, L.; Chimeno, P.; Fernandez, J. L.; Vigil, D.

    1999-01-01

    To evaluate the quality of the information provided by informed consent forms for angiography and interventional radiology on the basis of the patients opinion. A descriptive study was performed based on an anonymous survey distributed among patients who were to undergo angiography and interventional radiology, and had previously been informed and provided with the corresponding informed consent form. A descriptive and analytical statistical study was carried out to compare the responses to the questions concerning different factors (Mann-Whitney U test). Of the 182 surveys completed 75.3% corresponded to diagnostic procedures and the remaining 24.7% to therapeutic procedures. When the responses to closed-ended questions were analyzed, 90.1% of respondents considered the amount of information provided by the document to be sufficient 75.3% declared that they found the form easy to comprehend and 34.1% responded that reading it had calmed their nerves. Statistically significant differences were observed, depending on whether the form corresponded to diagnostic or therapeutic procedures, concerning the questions related to comprehension of the document and to the feeling upon reading it, with those used for diagnostic procedures obtaining better scores. There was a statistically significant difference between the responses of the patients to the question concerning their feeling upon reading the document and the responses of family members, with the patients responding more favorably than their relatives. The consent forms prepared for angiography and interventional radiology procedures are acceptable to the patients concerned with respect to both the quantity and the quality of the information. (Author) 22 refs

  12. Disclosure of information and informed consent: ethical and practical considerations.

    Science.gov (United States)

    Steinberg, Avraham

    2009-12-01

    Disclosure of information and informed consent are relatively new concepts in the patient-physician relationship. They are based primarily on the principle of autonomy and they have many favorable practical advantages. However, the practical implementation of these requirements is fraught with difficulties, some of which can cause harm to the patient or be obstacles in fulfilling the moral obligation of beneficence. This is particularly true when disclosure of information and informed consent are done by physicians in a defensive way for fear of malpractice suits. The most ethically defensible approach is to tailor and navigate the information according to the needs and desires of each individual patient in a sensitive and empathic manner. The informed consent should be a process of mutually shared responsibility by the patient and the physician, ensuring adequate and relevant information that is well comprehended by the individual patient, and is used correctly for his or her decision making.

  13. Informed consent - Providing information about prenatal examinations

    DEFF Research Database (Denmark)

    Dahl, Katja; Kesmodel, Ulrik; Hvidman, Lone

    as well.The review is based on systematic search strategy in the electronic databases Medline and Science Citation. Additional studies were identified through reference lists of individual papers obtained. Improving knowledge scores and reducing decisional conflict can be obtained by group counselling...... pregnant women about prenatal examinations. Women's knowledge, decisional conflict, satisfaction and anxiety will be explored as compared with different ways and different groups of health professionals providing information. To what extent information empowers informed decision making will be explored...

  14. Informed Consent in Clinical Trials Using Stem Cells: Suggestions and Points of Attention from Informed Consent Training Workshops in Japan

    Directory of Open Access Journals (Sweden)

    M Kusunose

    2015-09-01

    Full Text Available Informed consent (IC is an essential requirement of ethical research involving human participants, and usually is achieved by providing prospective research participants (PRPs with a document that explains the study and its procedures. However, results of a series of IC workshops held in Tokyo during 2014 indicate that consent forms alone are not enough to achieve full IC in regenerative medicine research due to the necessity of long-term patient-safety observations to meet the ethical challenges of such research. Adequate training of the people who are responsible for obtaining IC (elucidators is also necessary to ensure full IC. Elucidators must be able to provide PRPs with sufficient information to assure adequate comprehension of the study and its potential aftereffects; judge PRPs’ voluntariness and eligibility; and establish/maintain partnerships with PRPs. The workshops used role-playing simulations to demonstrate how to effectively obtain fuller IC to members of several Japanese research groups preparing for clinical stem cell trials. Workshop results were correlated with the results of a 2013 workshop on what information is patients want when considering participation in iPSC research. The correlated results showed the need for continuous training and education of elucidators in order to have them acquire and maintain IC competency. 

  15. Informed consent: Enforcing pharmaceutical companies' obligations abroad.

    Science.gov (United States)

    Lee, Stacey B

    2010-06-15

    The past several years have seen an evolution in the obligations of pharmaceutical companies conducting clinical trials abroad. Key players, such as international human rights organizations, multinational pharmaceutical companies, the United States government and courts, and the media, have played a significant role in defining these obligations. This article examines how such obligations have developed through the lens of past, present, and future recommendations for informed consent protections. In doing so, this article suggests that, no matter how robust obligations appear, they will continue to fall short of providing meaningful protection until they are accompanied by a substantive enforcement mechanism that holds multinational pharmaceutical companies accountable for their conduct. Issues of national sovereignty, particularly in the United States, will continue to prevent meaningful enforcement by an international tribunal or through one universally adopted code of ethics. This article argues that, rather than continuing to pursue an untenable international approach, the Alien Torts Statute (ATS) offers a viable enforcement mechanism, at least for US-based pharmaceutical companies. Recent federal appellate court precedent interpreting the ATS provides the mechanism for granting victims redress and enforcing accountability of sponsors (usually pharmaceutical companies and research and academic institutions) for informed consent misconduct. Substantive human rights protections are vital in order to ensure that every person can realize the "right to health." This article concludes that by building on the federal appellate court's ATS analysis, which grants foreign trial participants the right to pursue claims of human rights violations in US courts, a mechanism can be created for enforcing not only substantive informed consent, but also human rights protections.

  16. Role of informed consent for intravascular contrast media

    International Nuclear Information System (INIS)

    Hopper, K.D.; Tyler, H.N. Jr.

    1988-01-01

    To evaluate the usefulness of different degrees of informed consent for intravascular contrast media, the authors divided 100 patients into four groups: (1) informed consent with no information on intravascular contrast media, (2) simple written informed consent that detailed common risks, (3) detailed written informed consent that detailed all known risks, and (4) MD informed consent, during which a radiologist discussed all known risks of intravascular contrast media. Physician counseling time for group 4 averaged 11.4 minutes. On a postprocedure test about the common complications and risk factors of intravascular contrast media, the average scores were: group 1, 38.4%; group 2, 68.2%; group 3, 63.2%; and group 4, 69.8%. There was no statistical difference between groups 2-4 on the postprocedure test. If informed consent is to be used prior to intravascular contrast media administration, a simple written consent detailing the common risks and risk factors appears to be the best method

  17. Informed consent: a socio-legal study.

    Science.gov (United States)

    Rathor, M Y; Rani, Mohammad Fauzi Abdul; Shah, Azarisman Mohammad; Akter, Sheikh Fariuddin

    2011-12-01

    Informed consent [IC] is a recognized socio-legal obligation for the medical profession. The doctrine of IC involves the law, which aims to ensure the lawfulness of health assistance and tends to reflect the concept of autonomy of the person requiring and requesting medical and/or surgical treatment. Recent changes in the health care delivery system and the complex sociological settings, in which it is practiced, have resulted in an increase in judicial activity and medical negligence lawsuits for physicians. While IC is a well-established practice, it often fails to meet its stated purpose. In the common law, the standard of medical care to disclose risks has been laid down by the Bolam test- a familiar concept to most physicians, but it has been challenged recently in many jurisdictions. This paper aims to discuss some important judgments in cases of alleged medical negligence so as to familiarize doctors regarding their socio-legal obligations. We also propose to discuss some factors that influence the quality of IC in clinical practice. Literature review. The law of medical consent has been undergoing changes in recent years. Case law appears to be evolving towards a more patient centered standard of disclosure. Patient's expectations are higher and they are aware of the power of exercising their rights. Failure to obtain IC is one of the common allegations in medical malpractice suits. The medical professionals need to change their mindset and avoid claims of negligence by providing information that is "reasonable" in the eyes of the court.

  18. [The informed consent in international clinical trials including developing countries].

    Science.gov (United States)

    Montenegro Surís, Alexander; Monreal Agüero, Magda Elaine

    2008-01-01

    The informed consent procedure has been one of the most important controversies of ethical debates about clinical trials in developing countries. In this essay we present our recommendations about important aspects to consider in the informed consent procedure for clinical trials in developing countries. We performed a full publications review identified by MEDLINE using these terms combinations: informed consent, developing countries, less developed countries and clinical trials. To protect volunteers in less developed countries should be valuated the importance of the community in the informed consent proceeding. The signing and dating of the informed consent form is not always the best procedure to document the informed consent. The informed consent form should be written by local translators. Alternative medias of communications could be needed for communicatios of the information to volunteers. Comparing with developed countries the informed consent proceeding in clinical trials in developing countries frequently require additional efforts. The developing of pragmatic researches is needed to implement informed consent proceedings assuring subjects voluntarily in each developing country. The main aspects to define in each clinical trial for each country are the influence of the community, the effective communication of the information, the documentation of the informed consent and local authority's control.

  19. Informed Consent in Pediatric Oncology: A Systematic Review of Qualitative Literature.

    Science.gov (United States)

    Alahmad, Ghiath

    2018-01-01

    Obtaining informed consent in pediatric cancer research can be subject to important ethical challenges because of the difficulty in distinguishing between care and research, which are interrelated. Pediatric oncologists also often conduct research, such as clinical trials, on their own patients, which may influence voluntary informed consent. This review aims to determine the ethical issues encountered in obtaining informed consent in pediatric oncology by identifying and summarizing the findings of existing qualitative studies on this topic. A systematic review of qualitative studies was conducted. Medline, Embase, CINAHL, and PubMed were searched using the following terms: (oncolog* or cancer or hematol* or haematol* or leuk* or malign* or neoplasm*) and (child* or adolescent* or minor* or young people or pediatr* or paediatr*) and ethic* or moral*) and (qualitative or interview). Other sources were also mined to identify all relevant studies. The data analysis method used was thematic analysis. At the end of the search process, 2361 studies were identified. Duplicates were removed and irrelevant studies were excluded. After screening the full text of the remaining studies against our inclusion and exclusion criteria, 13 studies were included in the qualitative analysis. All studies were qualitative studies using semistructured and structured interviews, qualitative analysis of open-ended questions, and observation of informed consent conferences. Four themes were identified: parental comprehension of the trial and medical terms, influence of parental distress on decision-making, no offer of an alternative treatment, and influence of the doctor-parent relationship. Many ethical challenges affect the informed consent process. These challenges may include a lack of parental understanding, the potential influence of treating doctors, and vulnerability because of psychological status. All of these result in parents being unable to give well-informed and voluntary

  20. 77 FR 36566 - Agency Information Collection Activities: Voluntary Customer Survey

    Science.gov (United States)

    2012-06-19

    ... Activities: Voluntary Customer Survey AGENCY: U.S. Customs and Border Protection (CBP), Department of... requirement concerning a Voluntary Customer Survey. This request for comment is being made pursuant to the... following information collection: Title: Voluntary Customer Survey. OMB Number: 1651-0135. Abstract: Customs...

  1. 77 FR 55487 - Agency Information Collection Activities; Voluntary Customer Survey

    Science.gov (United States)

    2012-09-10

    ... Activities; Voluntary Customer Survey AGENCY: U.S. Customs and Border Protection, Department of Homeland... (OMB) for review and approval in accordance with the Paperwork Reduction Act: Voluntary Customer Survey... forms of information. Title: Voluntary Customer Survey. OMB Number: 1651-0135. Abstract: Customs and...

  2. 75 FR 27563 - Agency Information Collection Activities: Voluntary Customer Survey

    Science.gov (United States)

    2010-05-17

    ... Activities: Voluntary Customer Survey AGENCY: U.S. Customs and Border Protection (CBP), Department of... collection requirement concerning a Voluntary Customer Survey. This request for comment is being made... soliciting comments concerning the following information collection: Title: Voluntary Customer Survey. OMB...

  3. Informed consent in paediatric critical care research--a South African perspective.

    Science.gov (United States)

    Morrow, Brenda M; Argent, Andrew C; Kling, Sharon

    2015-09-09

    Medical care of critically ill and injured infants and children globally should be based on best research evidence to ensure safe, efficacious treatment. In South Africa and other low and middle-income countries, research is needed to optimise care and ensure rational, equitable allocation of scare paediatric critical care resources. Ethical oversight is essential for safe, appropriate research conduct. Informed consent by the parent or legal guardian is usually required for child research participation, but obtaining consent may be challenging in paediatric critical care research. Local regulations may also impede important research if overly restrictive. By narratively synthesising and contextualising the results of a comprehensive literature review, this paper describes ethical principles and regulations; potential barriers to obtaining prospective informed consent; and consent options in the context of paediatric critical care research in South Africa. Voluntary prospective informed consent from a parent or legal guardian is a statutory requirement for child research participation in South Africa. However, parents of critically ill or injured children might be incapable of or unwilling to provide the level of consent required to uphold the ethical principle of autonomy. In emergency care research it may not be practical to obtain consent when urgent action is required. Therapeutic misconceptions and sociocultural and language issues are also barriers to obtaining valid consent. Alternative consent options for paediatric critical care research include a waiver or deferred consent for minimal risk and/or emergency research, whilst prospective informed consent is appropriate for randomised trials of novel therapies or devices. We propose that parents or legal guardians of critically ill or injured children should only be approached to consent for their child's participation in clinical research when it is ethically justifiable and in the best interests of both

  4. Informed Consent for Inclusion into Clinical Trials: A Serious Subject ...

    African Journals Online (AJOL)

    Informed Consent for Inclusion into Clinical Trials: A Serious Subject to Note in the Developing World Morteza. ... Review: The process of taking informed consent is wellunderstood in developed countries, with every effort taken to enhance and maintain the autonomy of patients and their right to make an informed choice of ...

  5. Informed consent for radiotherapy: Our responsibility

    International Nuclear Information System (INIS)

    Colyer, Hazel

    2007-01-01

    This article describes and contextualises the findings from an email survey of cancer centres in the United Kingdom (UK) conducted early in 2005. It sought to discover how widely the model consent policy and process, published in 2001 [Department of Health. Good practice in consent. Achieving the NHS Plan commitment to patient-centred consent practice. HSC 2001/023. NHS Executive; November 2001], had been implemented and, more controversially, which professional groups gained the consent of patients to radiotherapy. The survey was sent on the author's behalf by the Society and College of Radiographers (SCoR) to all cancer centres in the UK, including five private sector facilities (n = 63). Forty-eight responses were received (76%). A majority of cancer centres have implemented the new procedures and these are undertaken most commonly by consultant oncologists and trained specialist registrars. In 10 centres, therapeutic radiographers (radiographers) are among the team gaining consent to radiotherapy and other centres have radiographers in training. There is widespread adherence to government guidance for obtaining consent and a growing number of centres are implementing radiographer-led consent. However, this is controversial from both medical and radiographic professional perspectives despite guidance indicating that the person who is actually treating the patients should seek their consent [Department of Health. 12 Key points on consent: the law in England. March 2001]. In the context of creating person-centred services, the significance for the development of the profession of therapeutic radiography is evaluated. In particular, the implications of radiographers both capitalising on and failing to assume this professional responsibility were explored

  6. [Readability of surgical informed consent in Spain].

    Science.gov (United States)

    San Norberto, Enrique María; Gómez-Alonso, Daniel; Trigueros, José M; Quiroga, Jorge; Gualis, Javier; Vaquero, Carlos

    2014-03-01

    To assess the readability of informed consent documents (IC) of the different national surgical societies. During January 2012 we collected 504 IC protocols of different specialties. To calculate readability parameters the following criteria were assessed: number of words, syllables and phrases, syllables/word and word/phrase averages, Word correlation index, Flesch-Szigriszt index, Huerta Fernández index, Inflesz scale degree and the Gunning-Fog index. The mean Flesch-Szigriszt index was 50.65 ± 6,72, so readability is considered normal. There are significant differences between specialties such as Urology (43.00 ± 4.17) and Angiology and Vascular Surgery (63.00 ± 3.26, P<.001). No IC would be appropriate for adult readability according to the Fernández-Huerta index (total mean 55.77 ± 6.57); the IC of Angiology and Vascular Surgery were the closest ones (67.85 ± 3.20). Considering the Inflesz scale degree (total mean of 2.84 ± 3,23), IC can be described as «somewhat difficult». There are significant differences between the IC of Angiology and Vascular Surgery (3.23 ± 0.47) that could be qualified as normal, or Cardiovascular Surgery (2.79 ± 0.43) as «nearly normal readability»; and others such as Urology (1, 70 ± 0.46, P<.001) and Thoracic Surgery (1.90 ± 0.30, P<.001), with a readability between «very» and «somewhat» difficult. The Gunning-Fog indexes are far from the readability for a general audience (total mean of 26.29 ± 10,89). IC developed by scientific societies of different surgical specialties do not have an adequate readability for patients. We recommend the use of readability indexes during the writing of these consent forms. Copyright © 2012 AEC. Published by Elsevier Espana. All rights reserved.

  7. Anesthesiological ethics: can informed consent be implied?

    Science.gov (United States)

    Spike, Jeffrey R

    2012-01-01

    Surgical ethics is a well-recognized field in clinical ethics, distinct from medical ethics. It includes at least a dozen important issues common to surgery that do not exist in internal medicine simply because of the differences in their practices. But until now there has been a tendency to include ethical issues of anesthesiology as a part of surgical ethics. This may mask the importance of ethical issues in anesthesiology, and even help perpetuate an unfortunate view that surgeons are "captain of the ship" in the operating theater (leaving anesthesiologists in a subservient role). We will have a better ethical understanding if we see surgery and anesthesia as two equal partners, ethically as well as in terms of patient care. Informed consent is one such issue, but it is not limited to that. Even on the topic of what type of anesthesia to use, anesthesiologists have often felt subsumed to the surgeon's preferences. This commentary takes the case study and uses it as a exemplar for this very claim: it is time to give due recognition for a new field in clinical ethics, ethics in anesthesia.

  8. Readability of Informed Consent Documents at University Counseling Centers

    Science.gov (United States)

    Lustgarten, Samuel D.; Elchert, Daniel M.; Cederberg, Charles; Garrison, Yunkyoung L.; Ho, Y. C. S.

    2017-01-01

    The extent to which clients understand the nature and anticipated course of therapy is referred to as informed consent. Counseling psychologists often provide informed consent documents to enhance the education of services and for liability purposes. Professionals in numerous health care settings have evaluated the readability of their informed…

  9. 21 CFR 50.25 - Elements of informed consent.

    Science.gov (United States)

    2010-04-01

    ... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.25 Elements of informed consent. (a) Basic... pertinent questions about the research and research subjects' rights, and whom to contact in the event of a...

  10. Informed Consent in Research on Second Language Acquisition

    Science.gov (United States)

    Thomas, Margaret; Pettitt, Nicole

    2017-01-01

    The practice of securing informed consent from research participants has a relatively low profile in second language (L2) acquisition research, despite its prominence in the biomedical and social sciences. This review article analyses the role that informed consent now typically plays in L2 research; discusses an example of an L2 study where…

  11. 40 CFR 26.1117 - Documentation of informed consent.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Documentation of informed consent. 26.1117 Section 26.1117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF... Intentional Exposure of Non-pregnant, Non-nursing Adults § 26.1117 Documentation of informed consent. (a...

  12. Applying a sociolinguistic model to the analysis of informed consent documents.

    Science.gov (United States)

    Granero-Molina, José; Fernández-Sola, Cayetano; Aguilera-Manrique, Gabriel

    2009-11-01

    Information on the risks and benefits related to surgical procedures is essential for patients in order to obtain their informed consent. Some disciplines, such as sociolinguistics, offer insights that are helpful for patient-professional communication in both written and oral consent. Communication difficulties become more acute when patients make decisions through an informed consent document because they may sign this with a lack of understanding and information, and consequently feel deprived of their freedom to make their choice about different treatments or surgery. This article discusses findings from documentary analysis using the sociolinguistic SPEAKING model, which was applied to the general and specific informed consent documents required for laparoscopic surgery of the bile duct at Torrecárdenas Hospital, Almería, Spain. The objective of this procedure was to identify flaws when information was provided, together with its readability, its voluntary basis, and patients' consent. The results suggest potential linguistic communication difficulties, different languages being used, cultural clashes, asymmetry of communication between professionals and patients, assignment of rights on the part of patients, and overprotection of professionals and institutions.

  13. The informed consent process in randomised controlled trials: a nurse-led process.

    Science.gov (United States)

    Cresswell, Pip; Gilmour, Jean

    2014-03-01

    Clinical trials are carried out with human participants to answer questions about the best way to diagnose, treat and prevent illness. Participants must give informed consent to take part in clinical trials that requires understanding of how clinical trials work and their purpose. Randomised controlled trials provide strong evidence but their complex design is difficult for both clinicians and participants to understand. Increasingly, ensuring informed consent in randomised controlled trials has become part of the clinical research nurse role. The aim of this study was to explore in depth the clinical research nurse role in the informed consent process using a qualitative descriptive approach. Three clinical research nurses were interviewed and data analysed using a thematic analysis approach. Three themes were identified to describe the process of ensuring informed consent. The first theme, Preparatory partnerships, canvassed the relationships required prior to initiation of the informed consent process. The second theme, Partnering the participant, emphasises the need for ensuring voluntariness and understanding, along with patient advocacy. The third theme, Partnership with the project, highlights the clinical research nurse contribution to the capacity of the trial to answer the research question through appropriate recruiting and follow up of participants. Gaining informed consent in randomised controlled trials was complex and required multiple partnerships. A wide variety of skills was used to protect the safety of trial participants and promote quality research. The information from this study contributes to a greater understanding of the clinical research nurse role, and suggests the informed consent process in trials can be a nurse-led one. In order to gain collegial, employer and industry recognition it is important this aspect of the nursing role is acknowledged.

  14. Readability and comprehensibility of informed consent forms for clinical trials

    Directory of Open Access Journals (Sweden)

    Anvita Pandiya

    2010-01-01

    A shortened Informed Consent Form, with information that a reasonable person would want to understand along with specific information that the person wants in particular would be a good option to improve understanding or comprehensibility. Additional informational meetings with a qualified person like a counselor could help in comprehension. Questionnaires designed to test comprehension of patient, peer review, patient writing the salient features could help evaluate the comprehensibility of the Informed Consent Form.

  15. Informed Consent - Attitudes, knowledge and information concerning prenatal examination

    DEFF Research Database (Denmark)

    Dahl, Katja; Kesmodel, Ulrik; Hvidman, Lone

    estimates is low and possible consequences if the test reveals a problem is seldom considered beforehand. A woman's attitude to prenatal examinations is found decisive for up-take of prenatal tests, with no association between a woman's attitude towards prenatal examinations and her knowledge of those tests....... Most women consider their doctor an important source of information, and state that information has influenced their decision.      Conclusions: Pregnant women favor prenatal examinations, but participation does not seem to be based on an informed consent....

  16. Epidural analgesia for labour: maternal knowledge, preferences and informed consent.

    LENUS (Irish Health Repository)

    2012-02-29

    Epidural analgesia has become increasingly popular as a form of labour analgesia in Ireland. However obtaining true inform consent has always been difficult. Our study recruited 100 parturients who had undergone epidural analgesia for labour, aimed to determine the information they received prior to regional analgesia, and to ascertain their preferences regarding informed consent. Only 65 (65%) of patients planned to have an epidural. Knowledge of potential complications was variable and inaccurate, with less than 30 (30%) of women aware of the most common complications. Most women 79 (79%) believed that discomfort during labour affected their ability to provide informed consent, and believe consent should be taken prior to onset of labour (96, 96%). The results of this study helps define the standards of consent Irish patients expect for epidural analgesia during labour.

  17. Informed consent and collaborative research: perspectives from the developing world.

    Science.gov (United States)

    Hyder, Adnan A; Wali, Salman A

    2006-03-01

    Informed consent has been recognized as an important component of research protocols and procedures of disclosure and consent in collaborative research have been criticized, as they may not be in keeping with cultural norms of developing countries. This study, which is part of a larger project funded by the United States National Bioethics Advisory Commission, explores the opinions of developing country researchers regarding informed consent in collaborative research. A survey of developing country researchers, involved in human subject research, was conducted by distributing a questionnaire with 169 questions, which included questions relating to informed consent. In addition, six focus group discussions, eight in-depth interviews and 78 responses to open-ended questions in the questionnaire provided qualitative data. 203 surveys were considered complete and were included in the analysis. Written consent was not used by nearly 40% of the researchers in their most recent studies. A large proportion of respondents recommended that human subject regulations should allow more flexibility in ways of documenting informed consent. 84% of researchers agreed that a mechanism to measure understanding should be incorporated in research studies as part of the process of informed consent. This paper is an empirical step in highlighting the ethical issues concerning disclosure. Health researchers in developing countries are well aware of the importance of consent in health research, and equally value the significance of educating human subjects regarding study protocols and associated risks and benefits. However, respondents emphasize the need for modifying ethical regulations in collaborative research.

  18. Orthodontic informed consent considering information load and serial position effect.

    Science.gov (United States)

    Pawlak, Caroline E; Fields, Henry W; Beck, F Michael; Firestone, Allen R

    2015-03-01

    Previous research has demonstrated that current methods of informed consent are relatively ineffective as shown by poor recall and comprehension by adolescent patients and their parents. The purpose of this study was to determine whether adding a short videotape presentation reiterating the issues related to informed consent to a modified informed consent document that emphasizes a limited number of core and patient-specific custom "chunks" at the beginning of an informed consent presentation improved the recall and comprehension of the risks, benefits, and alternatives of orthodontic treatment. A second objective was to evaluate the current related data for recommendable practices. Seventy patient-parent pairs were randomly divided into 2 groups. The intervention group (group A) patients and parents together reviewed a customized slide show and a short videotape presentation describing the key risks of orthodontic treatment. Group B followed the same protocol without viewing the videotape. All patients and parents were interviewed independently by research assistants using an established measurement tool with open-ended questions. Interviews were transcribed and scored for the appropriateness of responses using a previously established codebook. Lastly, the patients and parents were given 2 reading literacy tests, 1 related to health and 1 with general content followed by the self-administered demographic and psychological state questionnaires. There were no significant differences between the groups for sociodemographic variables. There were no significant differences between the groups for overall recall and comprehension; recall and comprehension for the domains of treatment, risk, and responsibility; and recall and comprehension for core, general, and custom items. The positional effects were limited in impact. When compared with previous studies, these data further demonstrate the benefit of improved readability and audiovisual supplementation with the

  19. Informed consent for medical photography in Nigerian surgical ...

    African Journals Online (AJOL)

    Background: The aim of this study is to assess the current practice of informed consent for medical photography in the Nigerian surgical practice and how it compares to international best practices. Methods: Self-administered questionnaires were distributed to consenting surgeons attending two major surgical conferences.

  20. Informed consent for telemedicine in South Africa: A survey of ...

    African Journals Online (AJOL)

    Informed consent for telemedicine in South Africa: A survey of consent practices among healthcare professionals in Durban, KwaZulu-Natal. C Jack, M Mars. Abstract. Background. The Health Professions Council of South Africa is drafting guidelines to regulate the practice of telemedicine. These emphasise the need for ...

  1. Language, cultural brokerage and informed consent – will ...

    African Journals Online (AJOL)

    2014-05-14

    May 14, 2014 ... focus of recent debate around ethical issues relating to the standard of care and ... Forty-one key words relevant to computer terminology and concepts required to gain informed consent for a .... patients did not understand the meaning of the word 'consent' and .... [24] Lindegger and Richter[25] looked at.

  2. Impact of verbal explanation and modified consent materials on orthodontic informed consent.

    Science.gov (United States)

    Carr, Kelly M; Fields, Henry W; Beck, F Michael; Kang, Edith Y; Kiyak, H Asuman; Pawlak, Caroline E; Firestone, Allen R

    2012-02-01

    Comprehension of informed consent information has been problematic. The purposes of this study were to evaluate the effectiveness of a shortened explanation of an established consent method and whether customized slide shows improve the understanding of the risks and limitations of orthodontic treatment. Slide shows for each of the 80 subject-parent pairs included the most common core elements, up to 4 patient-specific custom elements, and other general elements. Group A heard a presentation of the treatment plan and the informed consent. Group B did not hear the presentation of the informed consent. All subjects read the consent form, viewed the customized slide show, and completed an interview with structured questions, 2 literacy tests, and a questionnaire. The interviews were scored for the percentages of correct recall and comprehension responses. Three informed consent domains were examined: treatment, risk, and responsibility. These groups were compared with a previous study group, group C, which received the modified consent and the standard slide show. No significant differences existed between groups A, B, and C for any sociodemographic variables. Children in group A scored significantly higher than did those in group B on risk recall and in group C on overall comprehension, risk recall and comprehension, and general risks and limitations questions. Children in group B scored significantly higher than did those in group C on overall comprehension, treatment recall, and risk recall. Elements presented first in the slide show scored better than those presented later. This study suggested little advantage of a verbal review of the consent (except for patients for risk) when other means of review such as the customized slide show were included. Regression analysis suggested that patients understood best the elements presented first in the informed consent slide show. Consequently, the most important information should be presented first to patients, and any

  3. Ethical Issues Regarding Informed Consent for Minors for Space Tourism

    Science.gov (United States)

    Marsh, Melvin S.

    2010-01-01

    This paper describes the difficulty with informed consent and debates whether or not whether adults should be able to ethically, morally, and legally consent for their children during the high-risk activity of space tourism. The experimental nature of space vehicles combined with the high likelihood of medical complications and the destination places space tourism legally in the category of "adventure activities," which include adventure travel to exotic locations as well as adventure sports, such as mountain climbing, rafting, etc. which carry a high risk of danger (http://rescommunis.wordpress.com/2008/02/14/interview-tracey-l-knutson-adventure-sports-defense-attorney-on-space-tourism-risk-and-informed-consente/). However, unlike other adventure sports, adults currently cannot consent for their minor children. Other topics also receive attention, such as a "mature minors" clause, radiation exposure of potential future children, and other difficulties preventing adults from legally consenting to space travel.

  4. A randomized controlled trial of an electronic informed consent process.

    Science.gov (United States)

    Rothwell, Erin; Wong, Bob; Rose, Nancy C; Anderson, Rebecca; Fedor, Beth; Stark, Louisa A; Botkin, Jeffrey R

    2014-12-01

    A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study. © The Author(s) 2014.

  5. Evaluating nurse understanding and participation in the informed consent process.

    Science.gov (United States)

    Axson, Sydney A; Giordano, Nicholas A; Hermann, Robin M; Ulrich, Connie M

    2017-01-01

    Informed consent is fundamental to the autonomous decision-making of patients, yet much is still unknown about the process in the clinical setting. In an evolving healthcare landscape, nurses must be prepared to address patient understanding and participate in the informed consent process to better fulfill their well-established role as patient advocates. This study examines hospital-based nurses' experiences and understandings of the informed consent process. This qualitative descriptive study utilized a semi-structured interview approach identifying thematic concerns, experiences, and knowledge of informed consent across a selected population of clinically practicing nurses. Participants and research context: In all, 20 baccalaureate prepared registered nurses practicing in various clinical settings (i.e. critical care, oncology, medical/surgical) at a large northeastern academic medical center in the United States completed semi-structured interviews and a demographic survey. The mean age of participants was 36.6 years old, with a mean of 12.2 years of clinical experience. Ethical considerations: Participation in this study involved minimal risk and no invasive measures. This study received Institutional Review Board approval from the University of Pennsylvania. All participants voluntarily consented. The majority of participants (N = 19) believe patient safety is directly linked to patient comprehension of the informed consent process. However, when asked if nurses have a defined role in the informed consent process, nearly half did not agree (N = 9). Through this qualitative approach, three major nursing roles emerged: the nurse as a communicator, the nurse as an advocate, and the clerical role of the nurse. This investigation contributes to the foundation of ethical research that will better prepare nurses for patient engagement, advance current understanding of informed consent, and allow for future development of solutions. Nurses are at the forefront of

  6. Multimedia Informed Consent Tool for a Low Literacy African Research Population: Development and Pilot-Testing

    Science.gov (United States)

    Afolabi, Muhammed Olanrewaju; Bojang, Kalifa; D’Alessandro, Umberto; Imoukhuede, Egeruan Babatunde; Ravinetto, Raffaella M; Larson, Heidi Jane; McGrath, Nuala; Chandramohan, Daniel

    2014-01-01

    Background International guidelines recommend the use of appropriate informed consent procedures in low literacy research settings because written information is not known to guarantee comprehension of study information. Objectives This study developed and evaluated a multimedia informed consent tool for people with low literacy in an area where a malaria treatment trial was being planned in The Gambia. Methods We developed the informed consent document of the malaria treatment trial into a multimedia tool integrating video, animations and audio narrations in three major Gambian languages. Acceptability and ease of use of the multimedia tool were assessed using quantitative and qualitative methods. In two separate visits, the participants’ comprehension of the study information was measured by using a validated digitised audio questionnaire. Results The majority of participants (70%) reported that the multimedia tool was clear and easy to understand. Participants had high scores on the domains of adverse events/risk, voluntary participation, study procedures while lowest scores were recorded on the question items on randomisation. The differences in mean scores for participants’ ‘recall’ and ‘understanding’ between first and second visits were statistically significant (F (1,41)=25.38, pmultimedia tool was acceptable and easy to administer among low literacy participants in The Gambia. It also proved to be effective in delivering and sustaining comprehension of study information across a diverse group of participants. Additional research is needed to compare the tool to the traditional consent interview, both in The Gambia and in other sub-Saharan settings. PMID:25133065

  7. Should informed consent be based on rational beliefs?

    OpenAIRE

    Savulescu, J; Momeyer, R W

    1997-01-01

    Our aim is to expand the regulative ideal governing consent. We argue that consent should not only be informed but also based on rational beliefs. We argue that holding true beliefs promotes autonomy. Information is important insofar as it helps a person to hold the relevant true beliefs. But in order to hold the relevant true beliefs, competent people must also think rationally. Insofar as information is important, rational deliberation is important. Just as physicians should aim to provide ...

  8. Multimedia Informed Consent Tool for a Low Literacy African Research Population: Development and Pilot-Testing.

    Science.gov (United States)

    Afolabi, Muhammed Olanrewaju; Bojang, Kalifa; D'Alessandro, Umberto; Imoukhuede, Egeruan Babatunde; Ravinetto, Raffaella M; Larson, Heidi Jane; McGrath, Nuala; Chandramohan, Daniel

    2014-04-05

    International guidelines recommend the use of appropriate informed consent procedures in low literacy research settings because written information is not known to guarantee comprehension of study information. This study developed and evaluated a multimedia informed consent tool for people with low literacy in an area where a malaria treatment trial was being planned in The Gambia. We developed the informed consent document of the malaria treatment trial into a multimedia tool integrating video, animations and audio narrations in three major Gambian languages. Acceptability and ease of use of the multimedia tool were assessed using quantitative and qualitative methods. In two separate visits, the participants' comprehension of the study information was measured by using a validated digitised audio questionnaire. The majority of participants (70%) reported that the multimedia tool was clear and easy to understand. Participants had high scores on the domains of adverse events/risk, voluntary participation, study procedures while lowest scores were recorded on the question items on randomisation. The differences in mean scores for participants' 'recall' and 'understanding' between first and second visits were statistically significant (F (1,41)=25.38, presearch is needed to compare the tool to the traditional consent interview, both in The Gambia and in other sub-Saharan settings.

  9. "Informed" Consent: An Audit of Informed Consent of Cesarean Section Evaluating Patient Education and Awareness.

    Science.gov (United States)

    Kirane, Akhilesh G; Gaikwad, Nandkishor B; Bhingare, Prashant E; Mule, Vidya D

    2015-12-01

    Better diagnosis and early referral due to increased health care coverage have increased the cesarean deliveries at tertiary-care hospitals of India. Improvements in the health care system raise many concerns and need of cross-checking system in place to counter the problems pertaining to patient education and participation of patient. While most of the cesarean sections are done in good faith for the patient, it does not escape the purview of consumer awareness and protection. This cross-sectional study was undertaken at a tertiary level government institution to understand the level of awareness of 220 patients regarding the various aspects of cesarean delivery which are essential for women to know before giving an informed consent. 71 % of the women had knowledge about the indication and need to do cesarean delivery. Of these, only one-third (25 % of total women) were properly explained about procedure and complications. Other demographic and social characteristics were also evaluated. While the health care schemes have had their improved results, the onus lies upon the caregivers to improve and maintain the quality of health care in these tertiary-care government hospitals in proportion to the increase in patient load. The results of this study highlight the need for proper counseling of patients regarding complications of cesarean section. The fact that only 25 % of total cases were explained proper procedure and complication as opposed to 71 % of patients having proper knowledge about the indication of cesarean section points out the lack of information in seemingly "informed" consent. To bring about awareness about the risks and complications of cesarean section, there is a need that patients be counseled during the antenatal visits, specifically when patients visit near term for antenatal check up.

  10. Autonomy, consent and responsibility. Part II. Informed consent in medical care and in the law.

    Science.gov (United States)

    Mellado, J M

    Legal recognition of patient's rights aspired to change clinical relationship and medical lex artis. However, its implementation has been hampered by the scarcity of resources and the abundance of regulations. For several years, autonomy, consent, and responsibility have formed one of the backbones of the medical profession. However, they have sparked controversy and professional discomfort. In the first part of this article, we examine the conceptual and regulatory limitations of the principle of autonomy as the basis of informed consent. We approach the subject from philosophical, historical, legal, bioethical, deontological, and professional standpoints. In the second part, we cover the viability of informed consent in health care and its relationship with legal responsibility. Copyright © 2016 SERAM. Publicado por Elsevier España, S.L.U. All rights reserved.

  11. Simplification improves understanding of informed consent information in clinical trials regardless of health literacy level.

    Science.gov (United States)

    Kim, Eun Jin; Kim, Su Hyun

    2015-06-01

    This study evaluated the effect of a simplified informed consent form for clinical trials on the understanding and efficacy of informed consent information across health literacy levels. A total of 150 participants were randomly assigned to one of two groups and provided with either standard or simplified consent forms for a cancer clinical trial. The features of the simplified informed consent form included plain language, short sentences, diagrams, pictures, and bullet points. Levels of objective and subjective understanding were significantly higher in participants provided with simplified informed consent forms relative to those provided with standard informed consent forms. The interaction effects between type of consent form and health literacy level on objective and subjective understanding were nonsignificant. Simplified informed consent was effective in enhancing participant's subjective and objective understanding regardless of health literacy. © The Author(s) 2015.

  12. Pharmacogenetic testing, informed consent and the problem of secondary information.

    Science.gov (United States)

    Netzer, Christian; Biller-Andorno, Nikola

    2004-08-01

    Numerous benefits for patients have been predicted if prescribing decisions were routinely accompanied by pharmacogenetic testing. So far, little attention has been paid to the possibility that the routine application of this new technology could result in considerable harm to patients. This article emphasises that pharmacogenetic testing shares both the opportunities and the pitfalls with 'conventional' disease-genetic testing. It demonstrates that performing pharmacogenetic tests as well as interpreting the results are extraordinarily complex issues requiring a high level of expertise. It further argues that pharmacogenetic testing can have a huge impact on clinical decisions and may influence the therapeutic strategy as well as the clinical monitoring of a patient. This view challenges the predominant paradigm that pharmacogenetic testing will predict patients' responses to medicines, but that it will not provide any other significant disease-specific predictive information about the patient or family members. The article also questions published proposals to reduce the consent procedure for pharmacogenetic testing to a simple statement that the physician wishes to test a sample of the patient's DNA to see if a drug will be safe or whether it will work, and presents an alternative model that is better suited to protect patient's interests and to obtain meaningful informed consent. The paper concludes by outlining conditions for the application of pharmacogenetic testing in clinical practice in a way that can make full use of its potential benefits while minimising possible harm to patients and their families.

  13. [Informed consent and neuromodulation techniques for psychiatric purposes: an introduction].

    Science.gov (United States)

    Mandarelli, Gabriele; Moscati, Filippo Maria; Venturini, Paola; Ferracuti, Stefano

    2013-01-01

    The aim of this review was to investigate informed consent-related issues concerning vagus nerve stimulation and deep brain stimulation in the treatment of psychiatric disorders. We searched the principal medical databases for studies concerning informed consent, as well as ethical and deontological issues in psychosurgery. Data were critically analysed. We also provided guidelines for the evaluation of accuracy of the informed consent in such treatments. Despite major deontological and ethical implications, there is substantial lack of information pertaining informed consent decision-making in psychiatric patients with an indication for psychosurgery. In clinical research studies, deep brain stimulation and vagus nerve stimulation have been mainly used in drug-resistant major depressive disorder, Tourette syndrome and obsessive-compulsive disorder. Existing data on efficacy and tolerability, as well as those studies indicating the risk for incapacity in drug-resistant severe mental disorders, suggest the need to achieve a better understanding of the capacity to consent to psychosurgery in patients affected by mental disorders. Informed consent decision-making in clinical trials of deep brain stimulation and vagus nerve stimulation in psychiatric patients is largely unknown and deserves further investigation.

  14. Informed consent in neurosurgery--translating ethical theory into action.

    Science.gov (United States)

    Schmitz, Dagmar; Reinacher, Peter C

    2006-09-01

    Although a main principle of medical ethics and law since the 1970s, standards of informed consent are regarded with great scepticism by many clinicans. By reviewing the reactions to and adoption of this principle of medical ethics in neurosurgery, the characteristic conflicts that emerge between theory and everyday clinical experience are emphasised and a modified conception of informed consent is proposed. The adoption and debate of informed consent in neurosurgery took place in two steps. Firstly, respect for patient autonomy was included into the ethical codes of the professional organisations. Secondly, the legal demands of the principle were questioned by clinicians. Informed consent is mainly interpreted in terms of freedom from interference and absolute autonomy. It lacks a constructive notion of physician-patient interaction in its effort to promote the best interest of the patient, which, however, potentially emerges from a reconsideration of the principle of beneficence. To avoid insufficient legal interpretations, informed consent should be understood in terms of autonomy and beneficence. A continuous interaction between the patient and the given physician is considered as an essential prerequisite for the realisation of the standards of informed consent.

  15. Informed consent in neurosurgery—translating ethical theory into action

    Science.gov (United States)

    Schmitz, Dagmar; Reinacher, Peter C

    2006-01-01

    Objective Although a main principle of medical ethics and law since the 1970s, standards of informed consent are regarded with great scepticism by many clinicans. Methods By reviewing the reactions to and adoption of this principle of medical ethics in neurosurgery, the characteristic conflicts that emerge between theory and everyday clinical experience are emphasised and a modified conception of informed consent is proposed. Results The adoption and debate of informed consent in neurosurgery took place in two steps. Firstly, respect for patient autonomy was included into the ethical codes of the professional organisations. Secondly, the legal demands of the principle were questioned by clinicians. Informed consent is mainly interpreted in terms of freedom from interference and absolute autonomy. It lacks a constructive notion of physician–patient interaction in its effort to promote the best interest of the patient, which, however, potentially emerges from a reconsideration of the principle of beneficence. Conclusion To avoid insufficient legal interpretations, informed consent should be understood in terms of autonomy and beneficence. A continuous interaction between the patient and the given physician is considered as an essential prerequisite for the realisation of the standards of informed consent. PMID:16943326

  16. Customising informed consent procedures for people with schizophrenia in India.

    Science.gov (United States)

    Chatterjee, Sudipto; Kieselbach, Berit; Naik, Smita; Kumar, Shuba; John, Sujit; Balaji, Madhumitha; Koschorke, Mirja; Dabholkar, Hamid; Varghese, Mathew; Patel, Vikram; Thornicroft, Graham; Thara, Rangaswamy

    2015-10-01

    There is little information on how the ethical and procedural challenges involved in the informed participation of people with schizophrenia in clinical trials are addressed in low- and middle-income countries (LMICs). The informed consent procedure used in the collaborative community care for people with schizophrenia in India (COPSI) RCT was developed keeping these challenges in mind. We describe the feasibility of conducting the procedure from the trial, researcher and participants perspectives and describe the reasons for people consenting to participate in the trial or refusing to do so. Three sources of information were used to describe the feasibility of the COPSI consent procedure: key process indicators for the trial perspective, data from a specially designed post-interview form for participant's observations and focus group discussion (FGD) with the research interviewers. Categorical data were analysed by calculating frequencies and proportions, while the qualitative data from the FGD, and the reasons for participation or refusal were analysed using a thematic content analysis approach. 434 people with schizophrenia and their primary caregiver(s) were approached for participation in the trial. Consent interviews were conducted with 332, of whom 303 (91%) agreed to participate in the trial. Expectation of improvement was the most common reason for agreeing to participate in the trial, while concerns related to the potential disclosure of the illness, especially for women, were an important reason for refusing consent. The COPSI consent procedure demonstrates preliminary, observational information about the feasibility of customising informed consent procedures for people with schizophrenia LMIC contexts. This and other similar innovations need to be refined and rigorously tested to develop evidence-based guidelines for informed consent procedures in such settings.

  17. Informed consent and the law--an English legal perspective.

    Science.gov (United States)

    Hassan, Majid

    2008-01-01

    'Informed consent' is a widely used term, but its application in a legal perspective can be varied. American and Commonwealth jurisdictions have developed a 'patient-based' true informed consent approach, whereas in the English legal system a 'doctor-based' approach has traditionally been applied in relation to disclosure of risk. This article will seek to compare these approaches and give a brief overview of some of the key legal rulings which have shaped the requirement of consent. The decision in the English case of Chester vs. Afshar is considered as showing the significance the court attached to the principle of autonomy and using ethical and policy considerations to depart from established principles of English law relating to consent to treatment and disclosure of risk. This review is intended as general information and not as legal advice which should be sought from defence organisation and specialist health care lawyers. Copyright 2008 S. Karger AG, Basel.

  18. Radiation information and informed consent for clinical trials

    Energy Technology Data Exchange (ETDEWEB)

    Caon, Martin [School of Nursing and Midwifery, Flinders University, Adelaide (Australia)], E-mail: martin.caon@flinders.edu.au

    2008-09-01

    Examples of the statements about the radiation from medical imaging in the information for participants provided to the Human Research Ethics Committee (HREC) for approval are presented and discussed. There is considerable scope for improvement in the information about radiation that is presented to potential participants in clinical trials. Many radiation statements seem only intended to allay fear and anxiety about radiation rather than providing accurate information. This situation cannot be said to be conducive to allowing the participant to give informed consent to their involvement in a clinical trial in which ionising radiation is used. As many clinical trials are international and conducted at many sites (sometimes over 100), we would expect the same statements to have been seen by members of HRECs in many countries. Few HRECs include a member who is an expert in radiation. Hence, to ensure that the information is sound, those sections of the participant information that refer to radiation should be written or reviewed by a specialist in radiation protection such as a medical physicist, a health physicist or a radiation safety officer. (opinion)

  19. Radiation information and informed consent for clinical trials

    International Nuclear Information System (INIS)

    Caon, Martin

    2008-01-01

    Examples of the statements about the radiation from medical imaging in the information for participants provided to the Human Research Ethics Committee (HREC) for approval are presented and discussed. There is considerable scope for improvement in the information about radiation that is presented to potential participants in clinical trials. Many radiation statements seem only intended to allay fear and anxiety about radiation rather than providing accurate information. This situation cannot be said to be conducive to allowing the participant to give informed consent to their involvement in a clinical trial in which ionising radiation is used. As many clinical trials are international and conducted at many sites (sometimes over 100), we would expect the same statements to have been seen by members of HRECs in many countries. Few HRECs include a member who is an expert in radiation. Hence, to ensure that the information is sound, those sections of the participant information that refer to radiation should be written or reviewed by a specialist in radiation protection such as a medical physicist, a health physicist or a radiation safety officer. (opinion)

  20. Informed consent and medical ordeal: a qualitative study.

    Science.gov (United States)

    Little, M; Jordens, C F C; McGrath, C; Montgomery, K; Lipworth, W; Kerridge, I

    2008-08-01

    Informed consent is a mainstay of clinical practice, with both moral and legal forces. Material disclosure about extreme treatments, however, is unlikely to convey the full impact of the experience of treatment. Informed consent may be flawed under such circumstances. The aims of this study were to compare expressed satisfaction with pretreatment information to satisfaction after experiencing autologous stem cell transplantation for recurrent lymphoma. A qualitative, narrative-based cohort study was conducted in a bone-marrow transplant unit of a teaching hospital at Westmead Hospital, Sydney, Australia. The cohort consisted of 10 transplant recipients and 9 of their nominated lay carers. The outcome measure was satisfaction expressed in narrative interviews at the time of transplantation and 3 months later. We used discourse-analytic techniques to examine the narratives. Both patients and carers expressed high satisfaction with the information given by individual clinicians and by speakers at a formal Information Day held before transplantation. At the first interview, neither patients nor carers commented much on the forthcoming ordeal of chemotherapy and bone marrow ablation, although all patients had undergone previous chemotherapy. At the second interview, the ordeal dominated the narratives and retrospective dissatisfaction with information was common. This study suggests that information about treatment theories and protocols can be satisfactorily communicated, but personal experience of suffering defies communication. This finding has serious implications for the practices involved in obtaining informed consent and for the very notion of informed consent.

  1. Parental And Clinician Views Of Consent In Neonatal Research

    LENUS (Irish Health Repository)

    O’Shea, N

    2018-03-01

    Informed consent is an obligatory requirement for research participation1. The process of informed consent states that certain measures must be followed to ensure a research participant has made an informed decision about their participation in a research study2,3. Consent for research should be voluntary, informed, and understood by the consenting individual who must also be competent to do so. In the case of neonatal research informed consent is acquired from parent(s)\\/guardian(s) of a patient.

  2. Negligence in securing informed consent and medical malpractice.

    Science.gov (United States)

    Perry, C

    1988-01-01

    The doctrine of informed consent requires that the patient must act voluntarily and in the light of adequate information in order to give legally valid consent to medical care. Different models have been developed by various courts to determine whether the informational requirement, what the physician must disclose to the patient about the potential risks of the proposed treatment, has been met under the tort theory of negligence. To prevail, the patient plaintiff must show that a particular jurisdiction's disclosure standard has been breached, that harm has resulted, and that the defendant physician's negligent failure to discuss certain risks was causally responsible for the patient's failure to withhold consent. Perry discusses possible problems of redundancy or inconsistency concerning the relationship between different models for disclosure and causality, and notes that these problems may have serious implications for patient autonomy.

  3. Informed Consent for Inclusion into Clinical Trials: A Serious Subject ...

    African Journals Online (AJOL)

    Informed Consent for Inclusion into Clinical Trials: A Serious Subject to Note in the Developing World Morteza. ... Arab Journal of Nephrology and Transplantation ... in developed countries, with every effort taken to enhance and maintain the autonomy of patients and their right to make an informed choice of whether to ...

  4. Influence of Visual Information on Consent for Invasive Procedures ...

    African Journals Online (AJOL)

    2018-05-22

    May 22, 2018 ... decision-making of the physician-patient-relative” as a period of transition. ..... recall of informed consent information by low-income parents: A comparison of ... Media and memory: The efficacy of video and print materials for ...

  5. Informed consent in oral health care | Tsotsi | East African Medical ...

    African Journals Online (AJOL)

    Background: Informed consent and autonomy are the major ethical principles that define the relationship between health workers and the patient. ... Objectives: To investigate what and how much information dental patients perceived to had been given by oral health workers about treatment, benefits, risks and management ...

  6. Time to Improve Informed Consent for Dialysis: An International Perspective.

    Science.gov (United States)

    Brennan, Frank; Stewart, Cameron; Burgess, Hannah; Davison, Sara N; Moss, Alvin H; Murtagh, Fliss E M; Germain, Michael; Tranter, Shelley; Brown, Mark

    2017-06-07

    The literature reveals that current nephrology practice in obtaining informed consent for dialysis falls short of ethical and legal requirements. Meeting these requirements represents a significant challenge, especially because the benefits and risks of dialysis have shifted significantly with the growing number of older, comorbid patients. The importance of informed consent for dialysis is heightened by several concerns, including: ( 1 ) the proportion of predialysis patients and patients on dialysis who lack capacity in decision making and ( 2 ) whether older, comorbid, and frail patients understand their poor prognosis and the full implications to their independence and functional status of being on dialysis. This article outlines the ethical and legal requirements for a valid informed consent to dialysis: ( 1 ) the patient was competent, ( 2 ) the consent was made voluntarily, and ( 3 ) the patient was given sufficient information in an understandable manner to make the decision. It then considers the application of these requirements to practice across different countries. In the process of informed consent, the law requires a discussion by the physician of the material risks associated with dialysis and alternative options. We argue that, legally and ethically, this discussion should include both the anticipated trajectory of the illness and the effect on the life of the patient with particular regard to the outcomes most important to the individual. In addition, a discussion should occur about the option of a conservative, nondialysis pathway. These requirements ensure that the ethical principle of respect for patient autonomy is honored in the context of dialysis. Nephrologists need to be open to, comfortable with, and skillful in communicating this information. From these clear, open, ethically, and legally valid consent discussions, a significant dividend will hopefully flow for patients, families, and nephrologists alike. Copyright © 2017 by the

  7. Relational autonomy in informed consent (RAIC) as an ethics of care approach to the concept of informed consent.

    Science.gov (United States)

    Osuji, Peter I

    2018-03-01

    The perspectives of the dominant Western ethical theories, have dominated the concepts of autonomy and informed consent for many years. Recently this dominant understanding has been challenged by ethics of care which, although, also emanates from the West presents a more nuanced concept: relational autonomy, which is more faithful to our human experience. By paying particular attention to relational autonomy, particularity and Process approach to ethical deliberations in ethics of care, this paper seeks to construct a concept of informed consent from the perspective of ethics of care which is here called relational autonomy-in-informed consent (RAIC). Thus, providing a broader theoretical basis for informed consent beyond the usual theoretical perspectives that are particularly Western. Care ethics provides such a broader basis because it appeals to a global perspective that encompasses lessons from other cultures, and this will help to enrich the current ideas of bioethics principles of autonomy and informed consent. This objective will be achieved by exploring the ethics of care emphasis on relationships based on a universal experience of caring; and by contrasting its concept of autonomy as relational with the understanding of autonomy in the approaches of the dominant moral theories that reflect rational, individualistic, and rights-oriented autonomy of the American liberalism.

  8. Should informed consent be based on rational beliefs?

    Science.gov (United States)

    Savulescu, J; Momeyer, R W

    1997-10-01

    Our aim is to expand the regulative ideal governing consent. We argue that consent should not only be informed but also based on rational beliefs. We argue that holding true beliefs promotes autonomy. Information is important insofar as it helps a person to hold the relevant true beliefs. But in order to hold the relevant true beliefs, competent people must also think rationally. Insofar as information is important, rational deliberation is important. Just as physicians should aim to provide relevant information regarding the medical procedures prior to patients consenting to have those procedures, they should also assist patients to think more rationally. We distinguish between rational choice/action and rational belief. While autonomous choice need not necessarily be rational, it should be based on rational belief. The implication for the doctrine of informed consent and the practice of medicine is that, if physicians are to respect patient autonomy and help patients to choose and act more rationally, not only must they provide information, but they should care more about the theoretical rationality of their patients. They should not abandon their patients to irrationality. They should help their patients to deliberate more effectively and to care more about thinking rationally. We illustrate these arguments in the context of Jehovah's Witnesses refusing life-saving blood transfusions. Insofar as Jehovah's Witnesses should be informed of the consequences of their actions, they should also deliberate rationally about these consequences.

  9. Patient Recall of Informed Consent at 4 Weeks After Total Hip Replacement With Standardized Versus Procedure-Specific Consent Forms.

    Science.gov (United States)

    Pomeroy, Eoghan; Shaarani, Shahril; Kenyon, Robert; Cashman, James

    2017-08-25

    Informed consent plays a pivotal role in the operative process, and surgeons have an ethical and legal obligation to provide patients with information to allow for shared decision-making. Unfortunately, patient recall after the consent process is frequently poor. This study aims to evaluate the effect of procedure-specific consent forms on patient's recall four weeks after total hip replacement (THR). This is a prospective study using a posttest-only control group design. Sixty adult patients undergoing total hip replacement were allocated to be consented using either the generic or the surgery-specific consent form. Four weeks after surgery, a phone interview was conducted to assess patient's recall of risk of surgical complications. Patient demographic characteristics and educational attainment were similar in both groups. There was a statistically significant increase in the mean number of risks recalled in the study group at 1.43 compared with 0.67 in the control group (P = 0.0131). Consent is a complex process, and obtaining informed consent is far from straightforward. A statistically significant improvement in patient's recall with the use of procedure-specific consent forms was identified, and based on this, we would advocate their use. However, overall patient recall in both groups was poor. We believe that improving the quality of informed consent may require the sum of small gains, and the use of procedure-specific consent forms may aid in this regard.

  10. Fiberoptic endoscopic evaluation of swallowing (FEES): proposal for informed consent.

    Science.gov (United States)

    Nacci, A; Ursino, F; La Vela, R; Matteucci, F; Mallardi, V; Fattori, B

    2008-08-01

    Fiberoptic endoscopic evaluation of swallowing (FEES) is now a first choice method for studying swallowing disorders on account of the various advantages it offers: easy to use, very well tolerated, allows bedside examination and is economic. Nevertheless, this diagnostic procedure is not without risks, the most probable consequences of which include discomfort, gagging and/or vomiting, vasovagal syncope, epistaxis, mucosal perforation, adverse reactions to topical anaesthetics and laryngospasm. The risks involved with FEES stress the importance of informing the patient of these; this is an important aspect in medicine that necessarily and immediately implies receiving the patient's so-called "informed consent". Informed consent should be obtained not only by means of specific printed forms but also after the patient has had an interview with the physician who will be performing the procedure and who will offer information according to the personal clinical, psychological, cultural and linguistic situation of the patient and in keeping with the type of procedure proposed. In the case of FEES, as with other invasive or non-invasive diagnostic procedures, therefore, routine written and signed consent, together with a patient/physician interview should fulfil what is known as "complete information". In this report, a specific form for informed consent to FEES procedures, is proposed.

  11. Consent information leaflets - readable or unreadable?

    Science.gov (United States)

    Graham, Caroline; Reynard, John M; Turney, Benjamin W

    2015-05-01

    The objective of this article is to assess the readability of leaflets about urological procedures provided by the British Association of Urological Surgeons (BAUS) to evaluate their suitability for providing information. Information leaflets were assessed using three measures of readability: Flesch Reading Ease, Flesch-Kincaid and Simple Measure of Gobbledygook (SMOG) grade formulae. The scores were compared with national literacy statistics. Relatively good readability was demonstrated using the Flesch Reading Ease (53.4-60.1) and Flesch-Kincaid Grade Level (6.5-7.6) methods. However, the average SMOG index (14.0-15.0) for each category suggests that the majority of the leaflets are written above the reading level of an 18-year-old. Using national literacy statistics, at least 43% of the population will have significant difficultly understanding the majority of these leaflets. The results suggest that comprehension of the leaflets provided by the BAUS is likely to be poor. These leaflets may be used as an adjunct to discussion but it is essential to ensure that all the information necessary to make an informed decision has been conveyed in a way that can be understood by the patient.

  12. Consent information leaflets – readable or unreadable?

    Science.gov (United States)

    Graham, Caroline; Reynard, John M; Turney, Benjamin W

    2016-01-01

    Objective The objective of this article is to assess the readability of leaflets about urological procedures provided by the British Association of Urological Surgeons (BAUS) to evaluate their suitability for providing information. Methods Information leaflets were assessed using three measures of readability: Flesch Reading Ease, Flesch-Kincaid and Simple Measure of Gobbledygook (SMOG) grade formulae. The scores were compared with national literacy statistics. Results Relatively good readability was demonstrated using the Flesch Reading Ease (53.4–60.1) and Flesch-Kincaid Grade Level (6.5–7.6) methods. However, the average SMOG index (14.0–15.0) for each category suggests that the majority of the leaflets are written above the reading level of an 18-year-old. Using national literacy statistics, at least 43% of the population will have significant difficultly understanding the majority of these leaflets. Conclusions The results suggest that comprehension of the leaflets provided by the BAUS is likely to be poor. These leaflets may be used as an adjunct to discussion but it is essential to ensure that all the information necessary to make an informed decision has been conveyed in a way that can be understood by the patient. PMID:27867520

  13. Avoiding malpractice suits through the use of informed consent.

    Science.gov (United States)

    Annas, G J

    1976-03-01

    The doctrine of informed consent is based on a long tradition of promoting self-autonomy and rational decision-making. The amount of information required to be disclosed by the doctor to the patient is that which permits the patient to decide for himself whether or not to undergo the recommended treatment. It includes information about risks of death or serious bodily harm, probability of success, problems of recuperation, and alternative modes of treatment. Disclosing such information contributes to the doctor-patient relationship and therefore makes recourse to malpractice litigation in the face of an unsatisfactory or untoward result less likely. Attempts to abolish the doctrine are potentially counterproductive and could lead to widespread mistrust of the medical profession on the part of a society that increasingly demands more information in all areas. Physicians will best serve both themselves and their patients by fully disclosing all relevant information before asking patients to consent to specific therapies.

  14. 40 CFR 26.1116 - General requirements for informed consent.

    Science.gov (United States)

    2010-07-01

    ... PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides... informed consent. No investigator may involve a human being as a subject in research covered by this... subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution...

  15. Informed consent in Croatia. A work in progress.

    Science.gov (United States)

    Vučemilo, Luka; Borovečki, Ana

    2014-07-01

    As Croatia makes the transition from one political system and type of economy to another, there are inevitable social and political changes that have a profound affect on the healthcare system. This article charts some of the progress of change with respect to patients' rights and informed consent.

  16. The regulation of informed consent to participation in clinical ...

    African Journals Online (AJOL)

    participation in clinical research by mentally ill persons – the discussion on informed consent .... usually lay persons without scientific and medical knowledge. It is .... is not defined by the Mental Health Care Act; nor is it stated anywhere in the ...

  17. Ethical reasoning and informed consent in occupational therapy.

    Science.gov (United States)

    Kyler-Hutchison, P

    1988-05-01

    Two major ethical theories, the teleological and the deontological, are defined and briefly discussed. A subsequent discussion explores how the ethical principles of informed consent and patient autonomy operate in medical decisions. The application to occupational therapy is left for the reader's judgment.

  18. Impact of informed consent on patient decisions regarding third ...

    African Journals Online (AJOL)

    2015-06-22

    Jun 22, 2015 ... patient is central to the ability to grant informed consent. A verbal ... Access this article online .... which only the relationship with the level of the second .... is the best way to relieve the patient's anxiety, but the doctor.

  19. 42 CFR 50.204 - Informed consent requirement.

    Science.gov (United States)

    2010-10-01

    ... APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.204 Informed consent... available alternative methods of family planning and birth control; (3) Advice that the sterilization... effectively communicated to any individual to be sterilized who is blind, deaf or otherwise handicapped. (d) A...

  20. Use of altered informed consent in pragmatic clinical research.

    Science.gov (United States)

    McKinney, Ross E; Beskow, Laura M; Ford, Daniel E; Lantos, John D; McCall, Jonathan; Patrick-Lake, Bray; Pletcher, Mark J; Rath, Brian; Schmidt, Hollie; Weinfurt, Kevin

    2015-10-01

    There are situations in which the requirement to obtain conventional written informed consent can impose significant or even insurmountable barriers to conducting pragmatic clinical research, including some comparative effectiveness studies and cluster-randomized trials. Although certain federal regulations governing research in the United States (45 CFR 46) define circumstances in which any of the required elements may be waived, the same standards apply regardless of whether any single element is to be waived or whether consent is to be waived in its entirety. Using the same threshold for a partial or complete waiver limits the options available to institutional review boards as they seek to optimize a consent process. In this article, we argue that new standards are necessary in order to enable important pragmatic clinical research while at the same time protecting patients' rights and interests. © The Author(s) 2015.

  1. Improving participant comprehension in the informed consent process.

    Science.gov (United States)

    Cohn, Elizabeth; Larson, Elaine

    2007-01-01

    To critically analyze studies published within the past decade about participants' comprehension of informed consent in clinical research and to identify promising intervention strategies. Integrative review of literature. The Cumulative Index of Nursing and Allied Health Literature (CINAHL), PubMed, and the Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials were searched. Inclusion criteria included studies (a) published between January 1, 1996 and January 1, 2007, (b) designed as descriptive or interventional studies of comprehension of informed consent for clinical research, (c) conducted in nonpsychiatric adult populations who were either patients or volunteer participants, (d) written in English, and (e) published in peer-reviewed journals. Of the 980 studies identified, 319 abstracts were screened, 154 studies were reviewed, and 23 met the inclusion criteria. Thirteen studies (57%) were descriptive, and 10 (43%) were interventional. Interventions tested included simplified written consent documents, multimedia approaches, and the use of a trained professional (consent educator) to assist in the consent process. Collectively, no single intervention strategy was consistently associated with improved comprehension. Studies also varied in regard to the definition of comprehension and the tools used to measure it. Despite increasing regulatory scrutiny, deficiencies still exist in participant comprehension of the research in which they participate, as well as differences in how comprehension is measured and assessed. No single intervention was identified as consistently successful for improving participant comprehension, and results indicated that any successful consent process should at a minimum include various communication modes and is likely to require one-to-one interaction with someone knowledgeable about the study.

  2. Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent substudy): a prospective observational study.

    Science.gov (United States)

    Williams, Barbara F; French, John K; White, Harvey D

    2003-03-15

    Anxiety, fear, pain, and treatment with morphine might compromise the ability of patients to comprehend information about, and give informed consent for, participation in clinical trials. We aimed to assess whether patients with acute myocardial infarction could understand written and verbal information and whether they were competent to give autonomous informed consent to participate in a clinical trial. We prospectively studied 399 patients with acute myocardial infarction in 16 hospitals in New Zealand and Australia who were eligible for participation in the Hirulog and Early Reperfusion or Occlusion (HERO)-2 trial. We assessed readability of patient information sheets, patients' educational status, their views of the consent process, comprehension of verbal and written information, and competence to give consent. The patient information sheet needed a year 13 (age 18) educational level for comprehension, although only 75 of 345 patients (22%) had been educated beyond secondary school. Only 63 of 346 (18%) read the patient information sheet before giving or refusing consent to participate. Patients who gave consent were more likely to report good or partial comprehension of the information provided than were those who refused consent (272 [89%] vs 14 [70%], respectively; p=0.009). In an assessment of competence to make an autonomous decision, 75 of 145 (52%) were ranked at the lowest grade and 26 (18%) were not competent to consent. Although the consent process for HERO-2 met regulatory requirements for clinical trials, it was inappropriate for the needs of most patients. The patients' comprehension of the information provided and their competence to autonomously give consent was less than optimum.

  3. Disclosure of Individual Surgeon's Performance Rates During Informed Consent

    Science.gov (United States)

    Burger, Ingrid; Schill, Kathryn; Goodman, Steven

    2007-01-01

    Objective: The purpose of the paper is to examine the ethical arguments for and against disclosing surgeon-specific performance rates to patients during informed consent, and to examine the challenges that generating and using performance rates entail. Methods: Ethical, legal, and statistical theory is explored to approach the question of whether, when, and how surgeons should disclosure their personal performance rates to patients. The main ethical question addressed is what type of information surgeons owe their patients during informed consent. This question comprises 3 related, ethically relevant considerations that are explored in detail: 1) Does surgeon-specific performance information enhance patient decision-making? 2) Do patients want this type of information? 3) How do the potential benefits of disclosure balance against the risks? Results: Calculating individual performance measures requires tradeoffs and involves inherent uncertainty. There is a lack of evidence regarding whether patients want this information, whether it facilitates their decision-making for surgery, and how it is best communicated to them. Disclosure of personal performance rates during informed consent has the potential benefits of enhancing patient autonomy, improving patient decision-making, and improving quality of care. The major risks of disclosure include inaccurate and misleading performance rates, avoidance of high-risk cases, unjust damage to surgeon's reputations, and jeopardized patient trust. Conclusion: At this time, we think that, for most conditions, surgical procedures, and outcomes, the accuracy of surgeon- and patient-specific performance rates is illusory, obviating the ethical obligation to communicate them as part of the informed consent process. Nonetheless, the surgical profession has the duty to develop information systems that allow for performance to be evaluated to a high degree of accuracy. In the meantime, patients should be informed of the quantity of

  4. Optimization of informed consent for umbilical cord blood banking.

    Science.gov (United States)

    Sugarman, Jeremy; Kurtzberg, Joanne; Box, Tamara L; Horner, Ronnie D

    2002-12-01

    The purpose of this project was to evaluate the informed consent process for donation to a public umbilical cord blood bank. Telephone interviews were conducted with 170 women who had given consent to donate their newborn infants' umbilical cord blood. Of the 170 women who were contacted, 96.8% of the women reported that all their questions had been answered. Nevertheless, approximately one third of the respondents did not consider themselves to be in research, and almost one quarter of the respondents did not know how to contact the umbilical cord blood bank if they or their infant became seriously ill. Further, a substantial proportion of the respondents did not understand the full range of alternatives to donation and incorrectly endorsed potential benefits. Informed consent could be optimized by (1) having those personnel who obtain consent emphasize that banking involves research and to explain the true benefits of donation, (2) ensuring that parents know how and when to contact the umbilical cord blood bank after donation, and (3) using phone surveys to continue assessments and to monitor changes in the process.

  5. Patient privacy, consent, and identity management in health information exchange

    CERN Document Server

    Hosek, Susan D

    2013-01-01

    As a step toward improving its health information technology (IT) interoperability, the Military Health System is seeking to develop a research roadmap to better coordinate health IT research efforts, address IT capability gaps, and reduce programmatic risk for its enterprise projects. This report identifies gaps in research, policy, and practice involving patient privacy, consent, and identity management that need to be addressed to improve the quality and efficiency of care through health information exchange.

  6. Informed consent to medical treatment--the Israeli experience.

    Science.gov (United States)

    Weil, Z

    1998-01-01

    The ideological foundation of the doctrine of "informed consent" is rooted in the concept of personal freedom and freedom of choice. The concept of individual autonomy is represented by the "reasonable patient" standard which requires the disclosure of all information which a reasonable person in the position of the patient would need in order to make a rational decision regarding a proposed medical treatment. This attitude, however, conflicts with the traditional paternalism which is reflected in the "reasonable physician" standard, that is that a doctor must disclose that medical information which a rational doctor would relate to a patient in order to receive his consent. The enactment of the Patients' Rights Law in Israel in 1996 was an essential turning point in Israeli medical law. Section 13 of the new law explicitly establishes the requirement of informed consent and the details which a doctor must relate to a patient in order to reach the said agreement. Nevertheless, the law does not state the standard according to which it should be assessed whether the disclosure was proper. In a recent decision (C.A. 434/94 Shai Berman et al. v. Mor--the Institute for Medical Information, Ltd.) the Israeli Supreme Court took a step forward and determined that the duty to inform a patient will be judged by recognised criteria of negligence as they apply to the merits of each case.

  7. Informed consent in colonoscopy: A comparative analysis of 2 methods.

    Science.gov (United States)

    Sanguinetti, J M; Lotero Polesel, J C; Iriarte, S M; Ledesma, C; Canseco Fuentes, S E; Caro, L E

    2015-01-01

    The manner in which informed consent is obtained varies. The aim of this study is to evaluate the level of knowledge about colonoscopy and comparing 2 methods of obtaining informed consent. A comparative, cross-sectional, observational study was conducted on patients that underwent colonoscopy in a public hospital (Group A) and in a private hospital (Group B). Group A received information verbally from a physician, as well as in the form of printed material, and Group B only received printed material. A telephone survey was carried out one or 2 weeks later. The study included a total of 176 subjects (group A [n=55] and group B [n=121]). As regards education level, 69.88% (n=123) of the patients had completed university education, 23.29% (n= 41) secondary level, 5.68% (n=10) primary level, and the remaining subjects (n=2) had not completed any level of education. All (100%) of the subjects knew the characteristics of the procedure, and 99.43% were aware of its benefits. A total of 97.7% received information about complications, 93.7% named some of them, and 25% (n=44) remembered major complications. All the subjects received, read, and signed the informed consent statement before the study. There were no differences between the groups with respect to knowledge of the characteristics and benefits of the procedure, or the receipt and reading of the consent form. Group B responded better in relation to complications (P=.0027) and group A had a better recollection of the major complications (P<.0001). Group A had a higher number of affirmative answers (P<.0001). The combination of verbal and written information provides the patient with a more comprehensive level of knowledge about the procedure. Copyright © 2014 Asociación Mexicana de Gastroenterología. Published by Masson Doyma México S.A. All rights reserved.

  8. Readability of patient information and consent documents in rheumatological studies

    DEFF Research Database (Denmark)

    Hamnes, Bente; van Eijk-Hustings, Yvonne; Primdahl, Jette

    2016-01-01

    BACKGROUND: Before participation in medical research an informed consent must be obtained. This study investigates whether the readability of patient information and consent documents (PICDs) corresponds to the average educational level of participants in rheumatological studies in the Netherlands......, Denmark, and Norway. METHODS: 24 PICDs from studies were collected and readability was assessed independently using the Gunning's Fog Index (FOG) and Simple Measure of Gobbledygook (SMOG) grading. RESULTS: The mean score for the FOG and SMOG grades were 14.2 (9.0-19.0) and 14.2 (12-17) respectively....... The mean FOG and SMOG grades were 12.7 and 13.3 in the Dutch studies, 15.0 and 14.9 in the Danish studies, and 14.6 and 14.3 in the Norwegian studies, respectively. Out of the 2865 participants, more than 57 % had a lower educational level than the highest readability score calculated in the individual...

  9. Informed consent in experimentation involving mentally impaired persons: ethical issues

    Directory of Open Access Journals (Sweden)

    Carlo Petrini

    2010-12-01

    Full Text Available The problem of experimentation involving subjects whose mental condition prevents them from understanding information and providing proper informed consent has been addressed in various codes, declarations, conventions, treaties and regulations adopted by national, international and supranational institutions and authorities. This article summarizes the basic ethical criteria these documents provide and stresses the historical development from the nearly total exclusion of incapacitated subjects, established in the mid-twentieth century, to their contemporary inclusion in clinical trials on certain ethical conditions. The problem of proxy consent by legal representatives for participation in clinical trials is addressed particularly in reference to current Italian regulations. Exceptions to human experimentation requirements in emergency situations are also briefly discussed.

  10. Informed Consent in the Field of Language and Sexuality

    DEFF Research Database (Denmark)

    Mortensen, Kristine Køhler

    2015-01-01

    In order to understand how sexual and romantic relations are established and negotiated in discourse, the field of language and sexuality is dependent upon empirical data from naturally occurring spontaneous interaction. However, detailed discussions of research methods are lacking in the field...... argue that institutionalized informed consent procedures may undercut participant agency and expose symbolic violence towards their carefully built interactional framework. The analysis demonstrates participants’ ability to negotiate ethical issues and to turn such issues into a contribution...

  11. The History and Current Status of Informed Consent

    OpenAIRE

    Abimbola Farinde

    2014-01-01

    The purpose of this article is to examine the process of informed consent as it relates to the practice of psychology and as a part of Human relations Standards (3.10) of the American Psychological Association Ethical Principles of Psychologists and Code of Conduct. Before a psychologist provides any type of psychological service to a client/patient, whether it involves conducting research, administering a test or assessment/ therapy, counseling, clinical supervision, or providing consulting ...

  12. Audit of the informed consent process as a part of a clinical research quality assurance program.

    Science.gov (United States)

    Lad, Pramod M; Dahl, Rebecca

    2014-06-01

    Audits of the informed consent process are a key element of a clinical research quality assurance program. A systematic approach to such audits has not been described in the literature. In this paper we describe two components of the audit. The first is the audit of the informed consent document to verify adherence with federal regulations. The second component is comprised of the audit of the informed consent conference, with emphasis on a real time review of the appropriate communication of the key elements of the informed consent. Quality measures may include preparation of an informed consent history log, notes to accompany the informed consent, the use of an informed consent feedback tool, and the use of institutional surveys to assess comprehension of the informed consent process.

  13. Efficacy of a separate informed consent for anesthesia services: A prospective study from the Caribbean

    Directory of Open Access Journals (Sweden)

    Kavi Rampersad

    2016-01-01

    Conclusions: A separate written consent for anesthesia improved the efficacy of the informed consent process with respect to better information about the nature and purpose of anesthesia, common side effects, and rare but serious complications.

  14. Description of a Mobile-based Electronic Informed Consent System Development.

    Science.gov (United States)

    Hwang, Min-A; Kwak, In Ja

    2015-01-01

    Seoul National University Hospital constructed and implemented a computer-based informed consent system in December 2011. As of 2013, 30% of the informed consents were still filled out manually on paper. Patients and medical staff continuously suggested the implementation of a system for electronic informed consent using portable devices. Therefore, a mobile-based system for electronic informed consent was developed in 2013 to prevent the issues that arise with computer-based systems and paper informed consent. The rate of filling out electronic informed consent increased from 69% to 95% following the implementation of the mobile-based electronic informed consent. This construction of a mobile-based electronic informed consent system would be a good reference point for the development of a mobile-based Electronic Medical Record and for various mobile system environments in medical institutions.

  15. Involving Medical Students in Informed Consent: A Pilot Study.

    Science.gov (United States)

    Chiapponi, Costanza; Meyer, Frank; Jannasch, Olof; Arndt, Stephan; Stübs, Patrick; Bruns, Christiane J

    2015-09-01

    Studies have reported that patients often sign consent documents without understanding the content. Written paperwork, audio-visual materials, and decision aids have shown to consistently improve patients' knowledge. How informed consent should be taken is not properly taught at most universities in Germany. In this cross-sectional study, we investigated how much information about their procedure our patients retain. In particular, it should be elucidated whether an additional conversation between patients and properly prepared medical students shortly before surgery as an adjunct to informed consent can be introduced as a new teaching unit aimed to increase the understanding of surgery by patients and students. Informed consent of all patients had been previously obtained by three surgical residents 1-3 days in advance. All patients had received a copy of their consent form. The same residents developed assessment forms for thyroidectomy, laparoscopic cholecystectomy, umbilical hernia repair, and Lichtenstein procedure for inguinal hernia, respectively, containing 3-4 major common complications (e.g., bile duct injury, hepatic artery injury, stone spillage, and retained stones for laparoscopic cholecystectomy) and briefed the medical students before seeing the patients. Structured one-to-one interviews between students (n = 9) and patients (n = 55) based on four different assessment forms were performed and recorded by students. Both patients and students were asked to assess the new teaching unit using a short structured questionnaire. Although 100% of patients said at the beginning of their interview to have understood and memorized the risks of their imminent procedure, 5.8% (3/55) were not even able to indicate the correct part of the body where the incision would take place. Only 18.2% (10/55) of the patients were able to mention 2 or more complications, and 45.3% (25/55) could not even recall a single one. 96.4% (53/55) of the patients and 100% (9/9) of the

  16. Informed Consent Decision-Making in Deep Brain Stimulation.

    Science.gov (United States)

    Mandarelli, Gabriele; Moretti, Germana; Pasquini, Massimo; Nicolò, Giuseppe; Ferracuti, Stefano

    2018-05-11

    Deep brain stimulation (DBS) has proved useful for several movement disorders (Parkinson’s disease, essential tremor, dystonia), in which first and/or second line pharmacological treatments were inefficacious. Initial evidence of DBS efficacy exists for refractory obsessive-compulsive disorder, treatment-resistant major depressive disorder, and impulse control disorders. Ethical concerns have been raised about the use of an invasive surgical approach involving the central nervous system in patients with possible impairment in cognitive functioning and decision-making capacity. Most of the disorders in which DBS has been used might present with alterations in memory, attention, and executive functioning, which may have an impact on the mental capacity to give informed consent to neurosurgery. Depression, anxiety, and compulsivity are also common in DBS candidate disorders, and could also be associated with an impaired capacity to consent to treatment or clinical research. Despite these issues, there is limited empirical knowledge on the decision-making levels of these patients. The possible informed consent issues of DBS will be discussed by focusing on the specific treatable diseases.

  17. Informed Consent Decision-Making in Deep Brain Stimulation

    Directory of Open Access Journals (Sweden)

    Gabriele Mandarelli

    2018-05-01

    Full Text Available Deep brain stimulation (DBS has proved useful for several movement disorders (Parkinson’s disease, essential tremor, dystonia, in which first and/or second line pharmacological treatments were inefficacious. Initial evidence of DBS efficacy exists for refractory obsessive-compulsive disorder, treatment-resistant major depressive disorder, and impulse control disorders. Ethical concerns have been raised about the use of an invasive surgical approach involving the central nervous system in patients with possible impairment in cognitive functioning and decision-making capacity. Most of the disorders in which DBS has been used might present with alterations in memory, attention, and executive functioning, which may have an impact on the mental capacity to give informed consent to neurosurgery. Depression, anxiety, and compulsivity are also common in DBS candidate disorders, and could also be associated with an impaired capacity to consent to treatment or clinical research. Despite these issues, there is limited empirical knowledge on the decision-making levels of these patients. The possible informed consent issues of DBS will be discussed by focusing on the specific treatable diseases.

  18. Readability of patient information and consent documents in rheumatological studies.

    Science.gov (United States)

    Hamnes, Bente; van Eijk-Hustings, Yvonne; Primdahl, Jette

    2016-07-16

    Before participation in medical research an informed consent must be obtained. This study investigates whether the readability of patient information and consent documents (PICDs) corresponds to the average educational level of participants in rheumatological studies in the Netherlands, Denmark, and Norway. 24 PICDs from studies were collected and readability was assessed independently using the Gunning's Fog Index (FOG) and Simple Measure of Gobbledygook (SMOG) grading. The mean score for the FOG and SMOG grades were 14.2 (9.0-19.0) and 14.2 (12-17) respectively. The mean FOG and SMOG grades were 12.7 and 13.3 in the Dutch studies, 15.0 and 14.9 in the Danish studies, and 14.6 and 14.3 in the Norwegian studies, respectively. Out of the 2865 participants, more than 57 % had a lower educational level than the highest readability score calculated in the individual study. As the readability level of the PICDs did not match the participants' educational level, consent may not have been valid, as the participants may have had a limited understanding of what they agreed to participate in. There should be more focus on the readability of PICDs. National guidelines for how to write clear and unambiguous PICDs in simple and easily understandable language could increase the focus on the readability of PICD.

  19. Patient autonomy and informed consent in critically lll

    Directory of Open Access Journals (Sweden)

    Todorović Zoran M.

    2017-01-01

    Full Text Available Patient autonomy has been a cornerstone of contemporary clinical ethics since the Nuremberg trial, especially in American school of bioethics. Topic: Patient autonomy has been defined in the Nuremberg Code, and re-defined in the Declaration of Helsinki, Belmont Report and Barcelona Declaration. Founders and followers of the rights-oriented bioethics (for example, Hellegers, Beauchamp and Childers have established and promoted the patient autonomy as the main principle of bio(medical ethics since 1970s. However, there is a lot of controversy surrounding such a principle, especially in vulnerable patients. We aimed at evaluating the real meaning and value of patient autonomy in critical care settings regarding the communication between health workers and their patients and families. Conclusion: Protection of patients autonomy in critically ill is a complex issue. Careful benefit-risk assessment is needed in order to find the most appropriate way of obtaining the informed consent, proxy consent or to omit or delay it.

  20. Improving readability of informed consents for research at an academic medical institution.

    Science.gov (United States)

    Hadden, Kristie B; Prince, Latrina Y; Moore, Tina D; James, Laura P; Holland, Jennifer R; Trudeau, Christopher R

    2017-12-01

    The final rule for the protection of human subjects requires that informed consent be "in language understandable to the subject" and mandates that "the informed consent must be organized in such a way that facilitates comprehension." This study assessed the readability of Institutional Review Board-approved informed consent forms at our institution, implemented an intervention to improve the readability of consent forms, and measured the first year impact of the intervention. Readability assessment was conducted on a sample of 217 Institutional Review Board-approved informed consents from 2013 to 2015. A plain language informed consent template was developed and implemented and readability was assessed again after 1 year. The mean readability of the baseline sample was 10th grade. The mean readability of the post-intervention sample (n=82) was seventh grade. Providing investigators with a plain language informed consent template and training can promote improved readability of informed consents for research.

  1. Organ procurement organizations Internet enrollment for organ donation: Abandoning informed consent

    Directory of Open Access Journals (Sweden)

    Verheijde Joseph L

    2006-12-01

    Full Text Available Abstract Background Requirements for organ donation after cardiac or imminent death have been introduced to address the transplantable organs shortage in the United States. Organ procurement organizations (OPOs increasingly use the Internet for organ donation consent. Methods An analysis of OPO Web sites available to the public for enrollment and consent for organ donation. The Web sites and consent forms were examined for the minimal information recommended by the United States Department of Health and Human Services for informed consent. Content scores were calculated as percentages of data elements in four information categories: donor knowledge, donor consent reinforcement, donation promotion, and informed consent. Results There were 60 Web sites for organ donation enrollment serving the 52 states. The median percent (10 percentile-90 percentile content scores of the Web sites for donor knowledge, donor consent reinforcement, and donation promotion were 33% (20–47, 79% (57–86, and 75% (50–100, respectively. The informed consent score was 0% (0–33. The content scores for donor knowledge and informed consent were significantly lower than donor consent reinforcement and donation promotion for all Web sites (P Conclusion The Web sites and consent forms for public enrollment in organ donation do not fulfill the necessary requirements for informed consent. The Web sites predominantly provide positive reinforcement and promotional information rather than the transparent disclosure of organ donation process. Independent regulatory oversight is essential to ensure that Internet enrollment for organ donation complies with legal and ethical standards for informed consent.

  2. Pharmaceutical information systems and possible implementations of informed consent - developing an heuristic

    DEFF Research Database (Denmark)

    Ploug, Thomas; Holm, Søren

    2012-01-01

    Background Denmark has implemented a comprehensive, nationwide pharmaceutical information system, and this system has been evaluated by the Danish Council of Ethics. The system can be seen as an exemplar of a comprehensive health information system for clinical use. Analysis The paper analyses 1......) how informed consent can be implemented in the system and how different implementations create different impacts on autonomy and control of information, and 2) arguments directed towards justifying not seeking informed consent in this context. Results and Conclusion Based on the analysis a heuristic...... is provided which enables a ranking and estimation of the impact on autonomy and control of information of different options for consent to entry of data into the system and use of data from the system. The danger of routinisation of consent is identified. The Danish pharmaceutical information system raises...

  3. HIV vaccine trials: critical issues in informed consent.

    Science.gov (United States)

    Lindegger, G; Richter, L M

    2000-06-01

    Informed consent (IC), a fundamental principle of ethics in medical research, is recognized as a vital component of HIV vaccine trials. There are different notions of IC, some legally based and others based on ethics. It is argued that, though legal indemnity is necessary, vaccine trials should be founded on fully ethical considerations. Various contentious aspects of IC are examined, especially the problem of social desirability and of adequate comprehension. The need for sensitivity to cultural norms in implementing IC procedures is critically reviewed, and some of the potential conflict between ethos and ethics is considered. The transmission of information is examined as a particular aspect of IC in HIV vaccine trials.

  4. Informed consent in direct-to-consumer personal genome testing: the outline of a model between specific and generic consent.

    Science.gov (United States)

    Bunnik, Eline M; Janssens, A Cecile J W; Schermer, Maartje H N

    2014-09-01

    Broad genome-wide testing is increasingly finding its way to the public through the online direct-to-consumer marketing of so-called personal genome tests. Personal genome tests estimate genetic susceptibilities to multiple diseases and other phenotypic traits simultaneously. Providers commonly make use of Terms of Service agreements rather than informed consent procedures. However, to protect consumers from the potential physical, psychological and social harms associated with personal genome testing and to promote autonomous decision-making with regard to the testing offer, we argue that current practices of information provision are insufficient and that there is a place--and a need--for informed consent in personal genome testing, also when it is offered commercially. The increasing quantity, complexity and diversity of most testing offers, however, pose challenges for information provision and informed consent. Both specific and generic models for informed consent fail to meet its moral aims when applied to personal genome testing. Consumers should be enabled to know the limitations, risks and implications of personal genome testing and should be given control over the genetic information they do or do not wish to obtain. We present the outline of a new model for informed consent which can meet both the norm of providing sufficient information and the norm of providing understandable information. The model can be used for personal genome testing, but will also be applicable to other, future forms of broad genetic testing or screening in commercial and clinical settings. © 2012 John Wiley & Sons Ltd.

  5. HWMA/RCRA Closure Plan for the Basin Facility Basin Water Treatment System - Voluntary Consent Order NEW-CPP-016 Action Plan

    International Nuclear Information System (INIS)

    Evans, S. K.

    2007-01-01

    This Hazardous Waste Management Act/Resource Conservation and Recovery Act closure plan for the Basin Water Treatment System located in the Basin Facility (CPP-603), Idaho Nuclear Technology and Engineering Center (INTEC), Idaho National Laboratory Site, was developed to meet future milestones established under the Voluntary Consent Order. The system to be closed includes units and associated ancillary equipment included in the Voluntary Consent Order NEW-CPP-016 Action Plan and Voluntary Consent Order SITE-TANK-005 Tank Systems INTEC-077 and INTEC-078 that were determined to have managed hazardous waste. The Basin Water Treatment System will be closed in accordance with the requirements of the Hazardous Waste Management Act/Resource Conservation and Recovery Act, as implemented by the Idaho Administrative Procedures Act 58.01.05.009 and 40 Code of Federal Regulations 265, to achieve 'clean closure' of the tank system. This closure plan presents the closure performance standards and methods of achieving those standards for the Basin Water Treatment Systems

  6. HWMA/RCRA Closure Plan for the Basin Facility Basin Water Treatment System - Voluntary Consent Order NEW-CPP-016 Action Plan

    Energy Technology Data Exchange (ETDEWEB)

    Evans, S. K.

    2007-11-07

    This Hazardous Waste Management Act/Resource Conservation and Recovery Act closure plan for the Basin Water Treatment System located in the Basin Facility (CPP-603), Idaho Nuclear Technology and Engineering Center (INTEC), Idaho National Laboratory Site, was developed to meet future milestones established under the Voluntary Consent Order. The system to be closed includes units and associated ancillary equipment included in the Voluntary Consent Order NEW-CPP-016 Action Plan and Voluntary Consent Order SITE-TANK-005 Tank Systems INTEC-077 and INTEC-078 that were determined to have managed hazardous waste. The Basin Water Treatment System will be closed in accordance with the requirements of the Hazardous Waste Management Act/Resource Conservation and Recovery Act, as implemented by the Idaho Administrative Procedures Act 58.01.05.009 and 40 Code of Federal Regulations 265, to achieve "clean closure" of the tank system. This closure plan presents the closure performance standards and methods of achieving those standards for the Basin Water Treatment Systems.

  7. Towards a standardised informed consent procedure for live donor nephrectomy: the PRINCE (Process of Informed Consent Evaluation) project-study protocol for a nationwide prospective cohort study

    NARCIS (Netherlands)

    Kortram, Kirsten; Spoon, Emerentia Q. W.; Ismail, Sohal Y.; d'Ancona, Frank C. H.; Christiaans, Maarten H. L.; van Heurn, L. W. Ernest; Hofker, H. Sijbrand; Hoksbergen, Arjan W. J.; Homan van der Heide, Jaap J.; Idu, Mirza M.; Looman, Caspar W. N.; Nurmohamed, S. Azam; Ringers, Jan; Toorop, Raechel J.; van de Wetering, Jacqueline; Ijzermans, Jan N. M.; Dor, Frank J. M. F.

    2016-01-01

    Introduction: Informed consent is mandatory for all (surgical) procedures, but it is even more important when it comes to living kidney donors undergoing surgery for the benefit of others. Donor education, leading to informed consent, needs to be carried out according to certain standards. Informed

  8. Issues of informed consent for intrapartum trials: a suggested consent pathway from the experience of the Release trial [ISRCTN13204258

    Directory of Open Access Journals (Sweden)

    Weeks Andrew

    2006-05-01

    Full Text Available Abstract Service users within the NHS are increasingly being asked to participate in clinical research. In Liverpool Women's NHS Foundation Trust, approximately 35% of women take part in research during their pregnancy. For many studies the consent process is simple; information is provided and signed consent is given. There is a difficulty, however, with obtaining informed consent from women in pregnancy who become eligible only when they develop unforeseen complications, especially when they occur acutely. The problem is compounded with women in labour who may be frightened, vulnerable, in pain, under the effect of opiate analgesia, or all of the above. If research to improve the care of these women is to continue, then special consent procedures are needed. These procedures must ensure that the woman's autonomy is protected whilst recognising that women under these circumstances vary enormously, both in their desire for information and their ability to comprehend it. This paper will discuss the obtaining of consent in this situation, and describe an information and consent pathway for intrapartum research which has been developed in collaboration with consumer groups as a way in which these issues can be tackled.

  9. [Informed consent right of the appraised individuals in forensic clinical examination].

    Science.gov (United States)

    Li, Ju-Ping; Han, Wei; Gu, Shan-Zhi; Chen, Teng

    2015-02-01

    Informed consent right is not just for basic ethical consideration, but is important for protecting patient's right by law, which is expressed through informed consent contract. The appraised individuals of forensic clinical examination have the similar legal status as the patients in medical system. However, the law does not require informed consent right for the appraised individuals. I recommend giving certain informed consent right to the appraised individuals in the forensic clinical examination. Under the contracted relationship with the institution, the appraised individuals could participate in the examination process, know the necessary information, and make a selected consent on the examination results, which can assure the justice and fairness of judicial examination procedure.

  10. Knowledge, mistakes, communication with patients and informed consent

    Directory of Open Access Journals (Sweden)

    Alessandra De Palma

    2013-04-01

    Full Text Available BACKGROUND Communication is very important in medical activity, particularly to maintain or re-establish trust-based relationships between patients, doctors, nurses and all the people who work in Hospital or for the Italian National Health Service. Health services include the relationship between doctors and patients: the partnership is important as much as the technical ability in Medicine. But it is difficult to learn empathy: doctors are not taught about that at University, nor afterwards, at least not sufficiently. CONCLUSIONS The informed consent form, even if it is very detailed, is not the real answer to that problem.

  11. The student and the ovum: The lack of autonomy and informed consent in trading genes for tuition

    Directory of Open Access Journals (Sweden)

    Papadimos Alexa T

    2004-07-01

    Full Text Available Abstract Rising tuition costs have forced university students to become creative in finding ways to fund their education. Some female university students have decided that ova donation may be an acceptable alternative in which to pay for their tuition. This alternative presents itself because of the insufficient number of ova available for assisted reproduction and emerging stem cell technologies. Young female university students are encouraged by Internet sources and respectable electronic and print media to donate their ova in the cause of assisted reproduction for monetary compensation. While university students generally exhibit autonomy, the constraining influence of their financial predicament compromises the elements of informed consent (voluntariness, competence, capacity, understanding, and disclosure as to their making an autonomous decision in regard to egg donation. Thus, any moral possibility of giving informed consent is negated. Informed consent can only occur through autonomy. A female university student in need of financial resources to pay for her education cannot make an autonomous choice to trade her genes for tuition. Donated ova are not only needed for assisted reproduction, but for stem cell technologies. While the long-term health of women who donate their ova is of concern (a potential risk of cancer after long term use of ovulation induction, of equal concern is the possibility of a growth in the trade of ova targeting third world and Eastern European women where the precedence for autonomy and informed consent is not well established.

  12. Obtaining subjects' consent to publish identifying personal information: current practices and identifying potential issues.

    Science.gov (United States)

    Yoshida, Akiko; Dowa, Yuri; Murakami, Hiromi; Kosugi, Shinji

    2013-11-25

    In studies publishing identifying personal information, obtaining consent is regarded as necessary, as it is impossible to ensure complete anonymity. However, current journal practices around specific points to consider when obtaining consent, the contents of consent forms and how consent forms are managed have not yet been fully examined. This study was conducted to identify potential issues surrounding consent to publish identifying personal information. Content analysis was carried out on instructions for authors and consent forms developed by academic journals in four fields (as classified by Journal Citation Reports): medicine general and internal, genetics and heredity, pediatrics, and psychiatry. An online questionnaire survey of editors working for journals that require the submission of consent forms was also conducted. Instructions for authors were reviewed for 491 academic journals (132 for medicine general and internal, 147 for genetics and heredity, 100 for pediatrics, and 112 for psychiatry). Approximately 40% (203: 74 for medicine general and internal, 31 for genetics and heredity, 58 for pediatrics, and 40 for psychiatry) stated that subject consent was necessary. The submission of consent forms was required by 30% (154) of the journals studied, and 10% (50) provided their own consent forms for authors to use. Two journals mentioned that the possible effects of publication on subjects should be considered. Many journal consent forms mentioned the difficulties in ensuring complete anonymity of subjects, but few addressed the study objective, the subjects' right to refuse consent and the withdrawal of consent. The main reason for requiring the submission of consent forms was to confirm that consent had been obtained. Approximately 40% of journals required subject consent to be obtained. However, differences were observed depending on the fields. Specific considerations were not always documented. There is a need to address issues around the study

  13. Obtaining subjects’ consent to publish identifying personal information: current practices and identifying potential issues

    Science.gov (United States)

    2013-01-01

    Background In studies publishing identifying personal information, obtaining consent is regarded as necessary, as it is impossible to ensure complete anonymity. However, current journal practices around specific points to consider when obtaining consent, the contents of consent forms and how consent forms are managed have not yet been fully examined. This study was conducted to identify potential issues surrounding consent to publish identifying personal information. Methods Content analysis was carried out on instructions for authors and consent forms developed by academic journals in four fields (as classified by Journal Citation Reports): medicine general and internal, genetics and heredity, pediatrics, and psychiatry. An online questionnaire survey of editors working for journals that require the submission of consent forms was also conducted. Results Instructions for authors were reviewed for 491 academic journals (132 for medicine general and internal, 147 for genetics and heredity, 100 for pediatrics, and 112 for psychiatry). Approximately 40% (203: 74 for medicine general and internal, 31 for genetics and heredity, 58 for pediatrics, and 40 for psychiatry) stated that subject consent was necessary. The submission of consent forms was required by 30% (154) of the journals studied, and 10% (50) provided their own consent forms for authors to use. Two journals mentioned that the possible effects of publication on subjects should be considered. Many journal consent forms mentioned the difficulties in ensuring complete anonymity of subjects, but few addressed the study objective, the subjects’ right to refuse consent and the withdrawal of consent. The main reason for requiring the submission of consent forms was to confirm that consent had been obtained. Conclusion Approximately 40% of journals required subject consent to be obtained. However, differences were observed depending on the fields. Specific considerations were not always documented. There is a need

  14. Readability of informed consent forms in vascular and interventional radiology

    International Nuclear Information System (INIS)

    Pinto, I.; Vigil, D.

    1998-01-01

    To evaluate the readability of the informed consent forms prepared for vascular and interventional radiology. The 18 informed consent forms were analyzed using the Gramatica tool employed in Microsoft Word 97 For Windows which combines the statistics on legibility in terms of three sections: scores, averages and legibility (Flech index, passive voice, sentence complexity and vocabulary complexity). For each, the integrated readability index was also manually calculated. All the documents present a Flesch index of over 10; the sentence complexity indexes are less than or equal to 20, demonstrating that the sentences are not long or complicated in structure. Finally, the integrated readability index of all of them is well over 70. The forms posses acceptable legibility indexes, but their evaluation should be completed by an opinion poll of the patients for whom they are written. Moreover, it must be kept in mind that these documents, like the procedures performed, are changing continually. Thus, it is necessary to update and modify the information to be provided to the patients. (Author) 11 refs

  15. Cross-cultural perspectives on research participation and informed consent.

    Science.gov (United States)

    Barata, Paula C; Gucciardi, Enza; Ahmad, Farah; Stewart, Donna E

    2006-01-01

    This study examined Portuguese Canadian and Caribbean Canadian immigrants' perceptions of health research and informed consent procedures. Six focus groups (three in each cultural group) involving 42 participants and two individual interviews were conducted. The focus groups began with a general question about health research. This was followed by three short role-plays between the moderator and the assistant. The role-plays involved a fictional health research study in which a patient is approached for recruitment, is read a consent form, and is asked to sign. The role-plays stopped at key moments at which time focus group participants were asked questions about their understanding and their perceptions. Focus group transcripts were coded in QSR NUDIST software using open coding and then compared across cultural groups. Six overriding themes emerged: two were common in both the Portuguese and Caribbean transcripts, one emphasized the importance of trust and mistrust, and the other highlighted the need and desire for more information about health research. However, these themes were expressed somewhat differently in the two groups. In addition, there were four overriding themes that were specific to only one cultural group. In the Portuguese groups, there was an overwhelming positive regard for the research process and an emphasis on verbal as opposed to written information. The Caribbean participants qualified their participation in research studies and repeatedly raised images of invasive research.

  16. Hope and persuasion by physicians during informed consent.

    Science.gov (United States)

    Miller, Victoria A; Cousino, Melissa; Leek, Angela C; Kodish, Eric D

    2014-10-10

    To describe hopeful and persuasive messages communicated by physicians during informed consent for phase I trials and examine whether such communication is associated with physician and parent ratings of the likelihood of benefit, physician and parent ratings of the strength of the physician's recommendation to enroll, parent ratings of control, and parent ratings of perceived pressure. Participants were children with cancer (n = 85) who were offered a phase I trial along with their parents and physicians. Informed consent conferences (ICCs) were audiotaped and coded for physician communication of hope and persuasion. Parents completed an interview (n = 60), and physicians completed a case-specific questionnaire. The most frequent hopeful statements related to expectations of positive outcomes and provision of options. Physicians failed to mention no treatment and/or palliative care as options in 68% of ICCs and that the disease was incurable in 85% of ICCs. When physicians mentioned no treatment and/or palliative care as options, both physicians and parents rated the physician's strength of recommendation to enroll in the trial lower. Hopes and goals other than cure or longer life were infrequently mentioned, and a minority of physicians communicated that the disease was incurable and that no treatment and/or palliative care were options. These findings are of concern, given the low likelihood of medical benefit from phase I trials. Physicians have an important role to play in helping families develop alternative goals when no curative options remain. © 2014 by American Society of Clinical Oncology.

  17. [Informed consent and experimental treatments: the case of mesotherapy].

    Science.gov (United States)

    Mammucari, Massimo; Gatti, Antonio; Maggiori, Enrica; Vergari, Benedetto; Gafforio, Paolo; Tufaro, Giuseppe; Maggiori, Sergio

    2013-05-01

    Mesotherapy is a minimally invasive technique based on the introduction of pharmacologically active compounds in the surface layer of the skin. The intradermal route has been known for many years and it has the aim of reducing the dose and slowing the diffusion into the underlying tissues. Mesotherapy requires a clinical diagnosis and informed consent. Patient should be well informed about potential benefits, limitations, and risks (even mild). The process of doctor-patient interaction in mesotherapy is an example of compliance with the basic concept: "first do no harm" and, at the same time, the advantage for the patient to conclude a "therapeutic alliance". We propose a draft form to facilitate the decision-making process.

  18. Human genome and genetic sequencing research and informed consent

    International Nuclear Information System (INIS)

    Iwakawa, Mayumi

    2003-01-01

    On March 29, 2001, the Ethical Guidelines for Human Genome and Genetic Sequencing Research were established. They have intended to serve as ethical guidelines for all human genome and genetic sequencing research practice, for the purpose of upholding respect for human dignity and rights and enforcing use of proper methods in the pursuit of human genome and genetic sequencing research, with the understanding and cooperation of the public. The RadGenomics Project has prepared a research protocol and informed consent document that follow these ethical guidelines. We have endeavored to protect the privacy of individual information, and have established a procedure for examination of research practices by an ethics committee. Here we report our procedure in order to offer this concept to the patients. (authors)

  19. Multimedia Informed Consent Tool for a Low Literacy African Research Population: Development and Pilot-Testing

    OpenAIRE

    Afolabi, Muhammed Olanrewaju; Bojang, Kalifa; D’Alessandro, Umberto; Imoukhuede, Egeruan Babatunde; Ravinetto, Raffaella; Larson, Heidi Jane; McGrath, Nuala; Chandramohan, Daniel

    2014-01-01

    Background International guidelines recommend the use of appropriate informed consent procedures in low literacy research settings because written information is not known to guarantee comprehension of study information. Objectives This study developed and evaluated a multimedia informed consent tool for people with low literacy in an area where a malaria treatment trial was being planned in The Gambia. Methods We developed the informed consent document of the malaria treatment trial into a m...

  20. Non-Informed Consent Cultures: Privacy policies and app contracts on Facebook

    DEFF Research Database (Denmark)

    Bechmann, Anja

    2014-01-01

    of consent practices on Facebook, the article argues that with the growing importance and use of these services the consent culture of the internet has turned into a blind non-informed consent culture, heavily relying on social incentives and group dynamics in decision-making that are not adequately...

  1. Autonomy, consent and responsability. Part 1: limitations of the principle of autonomy as a foundation of informed consent.

    Science.gov (United States)

    Mellado, J M

    2016-01-01

    Legal recognition of patient's rights aspired to change clinical relationship and medical lex artis. However, its implementation has been hampered by the scarcity of resources and the abundance of regulations. For several years, autonomy, consent, and responsibility have formed one of the backbones of the medical profession. However, they have sparked controversy and professional discomfort. In the first part of this article, we examine the conceptual and regulatory limitations of the principle of autonomy as the basis of informed consent. We approach the subject from philosophical, historical, legal, bioethical, deontological, and professional standpoints. In the second part, we cover the viability of informed consent in health care and its relationship with legal responsibility. Copyright © 2016 SERAM. Publicado por Elsevier España, S.L.U. All rights reserved.

  2. 75 FR 47607 - Agency Information Collection Activities: Voluntary Customer Survey

    Science.gov (United States)

    2010-08-06

    ... Activities: Voluntary Customer Survey AGENCY: U.S. Customs and Border Protection, Department of Homeland... review and approval in accordance with the Paperwork Reduction Act: Voluntary Customer Survey. This is a.... Title: Voluntary Customer Survey. OMB Number: Will be assigned upon approval. Form Number: None...

  3. Informed consent to healthcare interventions in people with learning disabilities--an integrative review.

    Science.gov (United States)

    Goldsmith, Lesley; Skirton, Heather; Webb, Christine

    2008-12-01

    This paper is a report of an integrative review of informed consent to healthcare interventions in people with learning disabilities. Consent to treatment lies at the heart of the relationship between patient and healthcare professional. In order for people with learning disabilities to have equity of access to health care, they need to be able to give informed consent to health interventions--or be assessed as incompetent to give consent. The British Nursing Index (BNI), CINAHL, MEDLINE, Social Care Online, ERIC and ASSIA and PsycINFO databases were searched using the search terms: Consent or informed choice or capacity or consent to treat* or consent to examin* AND Learning disab* or intellectual* disab* or mental* retard* or learning difficult* or mental* handicap*. The search was limited to papers published in English from January 1990 to March 2007. An integrative review was conducted and the data analysed thematically. Twenty-two studies were reviewed. The main themes identified were: life experience, interaction between healthcare professionals and participants, ability to consent, and psychometric variables. A consensus seemed to emerge that capacity to consent is greater in people with higher cognitive ability and verbal skills, but that the attitudes and behaviour of healthcare professionals was also a crucial factor. The findings support use of the functional approach to assessing mental capacity for the purpose of obtaining informed consent. Future research into informed consent in people with learning disabilities is needed using real life situations rather than hypothetical vignettes.

  4. A Republican Argument Against Nudging and Informed Consent.

    Science.gov (United States)

    Hamilton, Paul

    2017-12-30

    I argue that it is impermissible to use nudges as a tool to influence patients in the context of informed consent. The motivation for such nudges is that their use can help reconcile potential conflicts between a physician's duty of beneficence and duty to respect patient autonomy. I argue that their use places physicians in a position of domination over patients. That is, it violates the republican freedom of patients because it grants physicians the power to arbitrarily interfere. I also argue that if one tries to adjust the duty of beneficence to avoid this conclusion, then the republican freedom of patients is still threatened under conditions of clinical equipoise. As ways to avoid the inevitability of nudging, I suggest the alternative of boosting or the pairing of patients with physicians who share their deep values. This latter option achieves the benefits nudging patients is supposed to provide without violating the republican freedom of those patients.

  5. Making a difference: incorporating theories of autonomy into models of informed consent.

    Science.gov (United States)

    Delany, C

    2008-09-01

    Obtaining patients' informed consent is an ethical and legal obligation in healthcare practice. Whilst the law provides prescriptive rules and guidelines, ethical theories of autonomy provide moral foundations. Models of practice of consent, have been developed in the bioethical literature to assist in understanding and integrating the ethical theory of autonomy and legal obligations into the clinical process of obtaining a patient's informed consent to treatment. To review four models of consent and analyse the way each model incorporates the ethical meaning of autonomy and how, as a consequence, they might change the actual communicative process of obtaining informed consent within clinical contexts. An iceberg framework of consent is used to conceptualise how ethical theories of autonomy are positioned and underpin the above surface, and visible clinical communication, including associated legal guidelines and ethical rules. Each model of consent is critically reviewed from the perspective of how it might shape the process of informed consent. All four models would alter the process of obtaining consent. Two models provide structure and guidelines for the content and timing of obtaining patients' consent. The two other models rely on an attitudinal shift in clinicians. They provide ideas for consent by focusing on underlying values, attitudes and meaning associated with the ethical meaning of autonomy. The paper concludes that models of practice that explicitly incorporate the underlying ethical meaning of autonomy as their basis, provide less prescriptive, but more theoretically rich guidance for healthcare communicative practices.

  6. Communicating Risks and Benefits in Informed Consent for Research: A Qualitative Study

    Science.gov (United States)

    Nusbaum, Lika; Douglas, Brenda; Damus, Karla; Paasche-Orlow, Michael; Estrella-Luna, Neenah

    2017-01-01

    Multiple studies have documented major limitations in the informed consent process for the recruitment of clinical research participants. One challenging aspect of this process is successful communication of risks and benefits to potential research participants. This study explored the opinions and attitudes of informed consent experts about conveying risks and benefits to inform the development of a survey about the perspectives of research nurses who are responsible for obtaining informed consent for clinical trials. The major themes identified were strategies for risks and benefits communication, ensuring comprehension, and preparation for the role of the consent administrator. From the experts’ perspective, inadequate education and training of the research staff responsible for informed consent process contribute to deficiencies in the informed consent process and risks and benefits communication. Inconsistencies in experts’ opinions and critique of certain widely used communication practices require further consideration and additional research. PMID:28975139

  7. Dignity and informed consent in the treatment of mature minors.

    Science.gov (United States)

    Bello, Bidemi Ademola

    2010-12-01

    In today's world, as evinced in various human rights provisions, emphasis is placed on the assertion and protection of the entrenched rights of every human and particularly the dignity of humans and respect of human autonomy. Medical/health workers are concerned about protecting every patient's right to the dignity of his or her person. This led to the formulation of the concept of self determination and informed consent in medical diagnosis and treatments. However, serious concern is placed on these principles especially as it affects mature minors, a group of individuals who by conduct demand a level of respect but may at the same time be viewed as not capable of making the "best" informed decisions, especially about health. The following issues may arise as a result of the aforementioned concerns: --are mature young ones entitled to right of self determination and informed consent despite the alleged fear that they may lack capacity to make informed decisions? --if no, who should decide on their behalf--their parents, their medical/health provider or the society/government (especially since the 3 (three) interested groups may have different and conflicting stands on what is best for the child); --if the answer to the initial question is yes, to what extent should mature minors be informed of their medical choices and be allowed to exercise their right of self determination? --should they be guided? --and who should so guide them? In resolving the above issue, due consideration has been given not only to legal and bio-ethical provisions of some countries but also to international conventions which several countries are party to. Thereafter, it became clear that most authorities are of the view that mature minors should be fully informed and be allowed to have a say in health decisions, coaching them with few exceptions. Ultimately, because of the importance of respect for human dignity, autonomy and self determination along with medical disclosure in today

  8. Informed consent for clinical trials of deep brain stimulation in psychiatric disease: challenges and implications for trial design.

    Science.gov (United States)

    Lipsman, Nir; Giacobbe, Peter; Bernstein, Mark; Lozano, Andres M

    2012-02-01

    Advances in neuromodulation and an improved understanding of the anatomy and circuitry of psychopathology have led to a resurgence of interest in surgery for psychiatric disease. Clinical trials exploring deep brain stimulation (DBS), a focally targeted, adjustable and reversible form of neurosurgery, are being developed to address the use of this technology in highly selected patient populations. Psychiatric patients deemed eligible for surgical intervention, such as DBS, typically meet stringent inclusion criteria, including demonstrated severity, chronicity and a failure of conventional therapy. Although a humanitarian device exemption by the US Food and Drug Administration exists for its use in obsessive-compulsive disorder, DBS remains a largely experimental treatment in the psychiatric context, with its use currently limited to clinical trials and investigative studies. The combination of a patient population at the limits of conventional therapy and a novel technology in a new indication poses interesting challenges to the informed consent process as it relates to clinical trial enrollment. These challenges can be divided into those that relate to the patient, their disease and the technology, with each illustrating how traditional conceptualisations of research consent may be inadequate in the surgical psychiatry context. With specific reference to risk analysis, patient autonomy, voluntariness and the duty of the clinician-researcher, this paper will discuss the unique challenges that clinical trials of surgery for refractory psychiatric disease present to the consent process. Recommendations are also made for an ethical approach to clinical trial consent acquisition in this unique patient population.

  9. Canadian Association of Gastroenterology Practice Guideline for Informed Consent – Gastrointestinal Endoscopy

    Directory of Open Access Journals (Sweden)

    H Miller MacSween

    1997-01-01

    Full Text Available Informed consent has undergone a transformation from an ethical concept to a legal doctrine. It is based on the ethical principles of self-determination and autonomy. Over the past several years, courts have established physician liability based on the failure to obtain adequate informed consent. It is the duty of all gastrointestinal endoscopists to obtain legally adequate informed consent before performing any endoscopic procedure.

  10. Analysis of Informed Consent Document Utilization in a Minimal-Risk Genetic Study

    Science.gov (United States)

    Desch, Karl; Li, Jun; Kim, Scott; Laventhal, Naomi; Metzger, Kristen; Siemieniak, David; Ginsburg, David

    2012-01-01

    Background The signed informed consent document certifies that the process of informed consent has taken place and provides research participants with comprehensive information about their role in the study. Despite efforts to optimize the informed consent document, only limited data are available about the actual use of consent documents by participants in biomedical research. Objective To examine the use of online consent documents in a minimal-risk genetic study. Design Prospective sibling cohort enrolled as part of a genetic study of hematologic and common human traits. Setting University of Michigan Campus, Ann Arbor, Michigan. Participants Volunteer sample of healthy persons with 1 or more eligible siblings aged 14 to 35 years. Enrollment was through targeted e-mail to student lists. A total of 1209 persons completed the study. Measurements Time taken by participants to review a 2833-word online consent document before indicating consent and identification of a masked hyperlink near the end of the document. Results The minimum predicted reading time was 566 seconds. The median time to consent was 53 seconds. A total of 23% of participants consented within 10 seconds, and 93% of participants consented in less than the minimum predicted reading time. A total of 2.5% of participants identified the masked hyperlink. Limitation The online consent process was not observed directly by study investigators, and some participants may have viewed the consent document more than once. Conclusion Few research participants thoroughly read the consent document before agreeing to participate in this genetic study. These data suggest that current informed consent documents, particularly for low-risk studies, may no longer serve the intended purpose of protecting human participants, and the role of these documents should be reassessed. Primary Funding Source National Institutes of Health. PMID:21893624

  11. Paper trails, trailing behind: improving informed consent to IVF through multimedia applications

    Science.gov (United States)

    Madeira, Jody Lyneé; Andraka-Christou, Barbara

    2016-01-01

    Though intended to educate patients on the risks, benefits, side effects and alternatives within medical treatment, informed consent documents may have unanticipated consequences for patients. Patients may regard these forms as little more than a ritual to access treatment. Or patients may perceive that these forms exist to protect doctors rather than to contribute to a meaningful, patient-protective educational interaction. To rehabilitate the informed consent project, this essay considers the baggage that informed consent documents have acquired through practical use, explores patients' and providers' lived experience of informed consent, and considers whether a multimedia consent application would be a viable solution to the various difficulties that currently erode perceptions of and confidence in the informed consent process. PMID:27774231

  12. Perception on Informed Consent Regarding Nursing Care Practices in a Tertiary Care Center.

    Science.gov (United States)

    Paudel, B; Shrestha, G K

    Background Consent for care procedures is mandatory after receipt of adequate information. It maintains patient's rights and autonomy to make thoughtful decisions. Poor communication often leads to poor health quality. Objective To assess hospitalized patients' perception on informed consent regarding nursing care practices in a tertiary care center. Method This is a descriptive cross-sectional study among 113 admitted patients conducted in February 2012 at Dhulikhel Hospital, Nepal. Patients of various wards were selected using purposive non-probability sampling with at least 3 days of hospitalization. Close ended structured questionnaire was used to assess patients' perception on three different areas of informed consent (information giving, opportunity to make decision and taking prior consent). Result Among the participants 71.6% perceived positively regarding informed consent towards nursing care practices with a mean score of 3.32 ± 1.28. Patients' perception on various areas of informed consent viz. information giving, opportunities to make specific decision and taking prior consent were all positive with mean values of 3.43±1.12, 2.88±1.23, 3.65±1.49 respectively. Comparison of mean perception of informed consent with various variables revealed insignificant correlation (p-value >0.05) for age, educational level and previous hospitalization while it was significant (p-value perception on informed consent towards nursing care practices. Communication skills of nurses affect the perception of patients' regardless of age, education level and past experiences.

  13. Informed consent for caesarean section at a Nigerian university ...

    African Journals Online (AJOL)

    Results: The mean age of the respondents was 32±1.8 yearswith 118(79%) of the surgeries being emergency Cesarean sections. The consent for CS were mostly given by the patients (96, 64.0%) and husbands (43, 28.6%). Majority of the respondents 123(81.5%) had the consent obtained in the labour ward with profuse ...

  14. [Quality of information in the process of informed consent for anesthesia].

    Science.gov (United States)

    Guillén-Perales, José; Luna-Maldonado, Aurelio; Fernández-Prada, María; Guillén-Solvas, José Francisco; Bueno-Cavanillas, Aurora

    2013-11-01

    To assess the quality of the information that patients receive in the informed consent document signed prior to surgery. Cross-sectional study of a sample of cancer patients admitted for surgery at the University Hospital San Cecilio of Granada in 2011. After checking the inclusion criteria and obtaining their consent, demographic data were collected and procedure data, and a questionnaire «ad hoc» to assess the quality and comprehensiveness of the information provided in the informed consent. 150 patients were studied. The majority (109 over 150) said they had received sufficient information, in appropriate language, and had the opportunity to ask questions, but only 44.7% correctly answered three or more issues related to anesthesia. University education level, knowledge of the intervention, information about the anesthesia problems and appropriate language were associated. Although systematic informed consent was performed, half of the patients did not comprehend the anesthesia risks. Variables primarily related to the information received were associated with the quality of the response, but not with patient characteristics. Copyright © 2013 AEC. Published by Elsevier Espana. All rights reserved.

  15. Utilization of a Smartphone Platform for Electronic Informed Consent in Acute Stroke Trials.

    Science.gov (United States)

    Haussen, Diogo C; Doppelheuer, Shannon; Schindler, Kiva; Grossberg, Jonathan A; Bouslama, Mehdi; Schultz, Meagan; Perez, Hilarie; Hall, Alex; Frankel, Michael; Nogueira, Raul G

    2017-11-01

    The informed consent process is a major limitation for enrollment in acute stroke clinical investigations. We aim to describe the novel application of smartphone electronic informed consenting (e-Consent) in trials of cerebral thrombectomy. The e-Consent tool consists of a secure/Health Insurance Portability and Accountability Act compliant smartphone platform based on REDCap (Research Electronic Data Capture; Vanderbilt University, TN) that uses a survey project located on a static webpage. A link to the webpage is sent via text message or email to the legally authorized representative. The e-Consent form is filled and a freehand electronic signature added in the smartphone browser; a record ID and an e-Consent Process Attestation form are automatically generated. The e-Consent application was piloted in a randomized trial comparing endovascular versus medical therapy in late presenting patients (DAWN [Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention With Trevo]). Trial enrollment began in January 2015; e-Consent was approved by the local institutional review board in December 2016, and the study was stopped in February 2017. During the trial period, Grady Memorial Hospital performed 273 thrombectomies with 47 patients being consented and 38 patients enrolled in the DAWN trial. Of the randomized patients, 29 (76%) were transferred from outside hospitals. A total of 6 surrogates were e-Consented, with 2 patients being screen failures. Enrolled e-Consented patients (n=4) had similar age (73±14 versus 69±12 years; P =0.65) and National Institutes of Health Stroke Scale (16±5 versus 16±5; P =0.88) as compared with conventionally consented (n=25). Time from door-to-randomization was decreased with e-Consenting (28±9 versus 57±24 minutes; P =0.002). e-Consenting streamlined the consenting process in a randomized trial of patients with emergent large vessel occlusion strokes. © 2017 American Heart Association, Inc.

  16. Informed consent in Sri Lanka: a survey among ethics committee members.

    Science.gov (United States)

    Sumathipala, Athula; Siribaddana, Sisira; Hewage, Suwin; Lekamwattage, Manura; Athukorale, Manjula; Siriwardhana, Chesmal; Murray, Joanna; Prince, Martin

    2008-05-20

    Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research.However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form. We obtained ethical approval from UK and Sri Lanka. A series of consensus generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important. Twenty-nine members from ethics committees participated. Majority of participants (23), believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form. The majority, 20 (69%), believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52%) believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important. The number of themes generated for the consent form (N = 18) is as many as for the information leaflet (N = 19) and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and consent forms proved to be similar with WHO checklist on informed

  17. Informed consent in Sri Lanka: A survey among ethics committee members

    Directory of Open Access Journals (Sweden)

    Siriwardhana Chesmal

    2008-05-01

    Full Text Available Abstract Background Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research. However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form. Methods We obtained ethical approval from UK and Sri Lanka. A series of consensus generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important. Results Twenty-nine members from ethics committees participated. Majority of participants (23, believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form. The majority, 20 (69%, believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52% believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important. Conclusion The number of themes generated for the consent form (N = 18 is as many as for the information leaflet (N = 19 and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and

  18. 49 CFR 11.116 - General requirements for informed consent.

    Science.gov (United States)

    2010-10-01

    ... is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject... authority of a physician to provide emergency medical care, to the extent the physician is permitted to do...

  19. 28 CFR 46.116 - General requirements for informed consent.

    Science.gov (United States)

    2010-07-01

    ... is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject... authority of a physician to provide emergency medical care, to the extent the physician is permitted to do...

  20. 22 CFR 225.116 - General requirements for informed consent.

    Science.gov (United States)

    2010-04-01

    ... is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject... authority of a physician to provide emergency medical care, to the extent the physician is permitted to do...

  1. 45 CFR 690.116 - General requirements for informed consent.

    Science.gov (United States)

    2010-10-01

    ... statement that participation is voluntary, refusal to participate will involve no penalty or loss of...) Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care...

  2. 10 CFR 745.116 - General requirements for informed consent.

    Science.gov (United States)

    2010-01-01

    ...-related injury to the subject; and (8) A statement that participation is voluntary, refusal to participate... physician to provide emergency medical care, to the extent the physician is permitted to do so under...

  3. 45 CFR 46.116 - General requirements for informed consent.

    Science.gov (United States)

    2010-10-01

    ...-related injury to the subject; and (8) A statement that participation is voluntary, refusal to participate... physician to provide emergency medical care, to the extent the physician is permitted to do so under...

  4. 38 CFR 16.116 - General requirements for informed consent.

    Science.gov (United States)

    2010-07-01

    ... statement that participation is voluntary, refusal to participate will involve no penalty or loss of...) Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care...

  5. 15 CFR 27.116 - General requirements for informed consent.

    Science.gov (United States)

    2010-01-01

    ... statement that participation is voluntary, refusal to participate will involve no penalty or loss of...) Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care...

  6. 32 CFR 219.116 - General requirements for informed consent.

    Science.gov (United States)

    2010-07-01

    ... statement that participation is voluntary, refusal to participate will involve no penalty or loss of...) Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care...

  7. 14 CFR 1230.116 - General requirements for informed consent.

    Science.gov (United States)

    2010-01-01

    ... statement that participation is voluntary, refusal to participate will involve no penalty or loss of...) Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care...

  8. 16 CFR 1028.116 - General requirements for informed consent.

    Science.gov (United States)

    2010-01-01

    ... statement that participation is voluntary, refusal to participate will involve no penalty or loss of...) Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care...

  9. 7 CFR 1c.116 - General requirements for informed consent.

    Science.gov (United States)

    2010-01-01

    ... is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject... authority of a physician to provide emergency medical care, to the extent the physician is permitted to do...

  10. Informed consent for anaesthesiological and intensive care unit ...

    African Journals Online (AJOL)

    2013-03-04

    Mar 4, 2013 ... care unit research: a South African perspective. De Roubaix JAM, MBChB, .... (g) the development of new applications of health technology. The last two items .... Consent in emergency and ICU care: SA regulatory guidelines.

  11. Doctors' perspectives of informed consent for non-emergency surgical procedures: a qualitative interview study.

    Science.gov (United States)

    Wood, Fiona; Martin, Sean Michael; Carson-Stevens, Andrew; Elwyn, Glyn; Precious, Elizabeth; Kinnersley, Paul

    2016-06-01

    The need to involve patients more in decisions about their care, the ethical imperative and concerns about ligation and complaints has highlighted the issue of informed consent and how it is obtained. In order for a patient to make an informed decision about their treatment, they need appropriate discussion of the risks and benefits of the treatment. To explore doctors' perspectives of gaining informed consent for routine surgical procedures. Qualitative study using semi-structured interviews selected by purposive sampling. Data were analysed thematically. Twenty doctors in two teaching hospitals in the UK. Doctors described that while consent could be taken over a series of consultations, it was common for consent to be taken immediately prior to surgery. Juniors were often taking consent when they were unfamiliar with the procedure. Doctors used a range of communication techniques to inform patients about the procedure and its risks including quantifying risks, personalizing risk, simplification of language and use of drawings. Barriers to effective consent taking were reported to be shortage of time, clinician inexperience and patients' reluctance to be involved. Current consent processes do not appear to be ideal for many doctors. In particular, junior doctors are often not confident taking consent for surgical procedures and require more support to undertake this task. This might include written information for junior staff, observation by senior colleagues when undertaking the task and ward-based communication skills teaching on consent taking. © 2014 John Wiley & Sons Ltd.

  12. Telemedicine Provides Non-Inferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial

    Science.gov (United States)

    Bobb, Morgan R.; Van Heukelom, Paul G.; Faine, Brett A.; Ahmed, Azeemuddin; Messerly, Jeffrey T.; Bell, Gregory; Harland, Karisa K.; Simon, Christian; Mohr, Nicholas M.

    2016-01-01

    Objective Telemedicine networks are beginning to provide an avenue for conducting emergency medicine research, but using telemedicine to recruit participants for clinical trials has not been validated. The goal of this consent study is to determine whether patient comprehension of telemedicine-enabled research informed consent is non-inferior to standard face-to-face research informed consent. Methods A prospective, open-label randomized controlled trial was performed in a 60,000-visit Midwestern academic Emergency Department (ED) to test whether telemedicine-enabled research informed consent provided non-inferior comprehension compared with standard consent. This study was conducted as part of a parent clinical trial evaluating the effectiveness of oral chlorhexidine gluconate 0.12% in preventing hospital-acquired pneumonia among adult ED patients with expected hospital admission. Prior to being recruited into the study, potential participants were randomized in a 1:1 allocation ratio to consent by telemedicine versus standard face-to-face consent. Telemedicine connectivity was provided using a commercially available interface (REACH platform, Vidyo Inc., Hackensack, NJ) to an emergency physician located in another part of the ED. Comprehension of research consent (primary outcome) was measured using the modified Quality of Informed Consent (QuIC) instrument, a validated tool for measuring research informed consent comprehension. Parent trial accrual rate and qualitative survey data were secondary outcomes. Results One-hundred thirty-one patients were randomized (n = 64, telemedicine), and 101 QuIC surveys were completed. Comprehension of research informed consent using telemedicine was not inferior to face-to-face consent (QuIC scores 74.4 ± 8.1 vs. 74.4 ± 6.9 on a 100-point scale, p = 0.999). Subjective understanding of consent (p=0.194) and parent trial study accrual rates (56% vs. 69%, p = 0.142) were similar. Conclusion Telemedicine is non-inferior to face

  13. 78 FR 27243 - Proposed Collection; 60-Day Comment Request: Interactive Informed Consent for Pediatric Clinical...

    Science.gov (United States)

    2013-05-09

    ... consent or the interactive computer-based program, will be assessed by face-to-face interview. In addition... Comment Request: Interactive Informed Consent for Pediatric Clinical Trials SUMMARY: In compliance with... other technological collection techniques or other forms of information technology. To Submit Comments...

  14. Readability and Content Assessment of Informed Consent Forms for Medical Procedures in Croatia.

    Science.gov (United States)

    Vučemilo, Luka; Borovečki, Ana

    2015-01-01

    High quality of informed consent form is essential for adequate information transfer between physicians and patients. Current status of medical procedure consent forms in clinical practice in Croatia specifically in terms of the readability and the content is unknown. The aim of this study was to assess the readability and the content of informed consent forms for diagnostic and therapeutic procedures used with patients in Croatia. 52 informed consent forms from six Croatian hospitals on the secondary and tertiary health-care level were tested for reading difficulty using Simple Measure of Gobbledygook (SMOG) formula adjusted for Croatian language and for qualitative analysis of the content. The averaged SMOG grade of analyzed informed consent forms was 13.25 (SD 1.59, range 10-19). Content analysis revealed that informed consent forms included description of risks in 96% of the cases, benefits in 81%, description of procedures in 78%, alternatives in 52%, risks and benefits of alternatives in 17% and risks and benefits of not receiving treatment or undergoing procedures in 13%. Readability of evaluated informed consent forms is not appropriate for the general population in Croatia. The content of the forms failed to include in high proportion of the cases description of alternatives, risks and benefits of alternatives, as well as risks and benefits of not receiving treatments or undergoing procedures. Data obtained from this research could help in development and improvement of informed consent forms in Croatia especially now when Croatian hospitals are undergoing the process of accreditation.

  15. Informed consent in blood transfusion : Knowledge and administrative issues in Uganda hospitals

    NARCIS (Netherlands)

    Kajja, Isaac; Bimenya, Gabriel S.; Smit Sibinga, Cees Th.

    Blood as a transplant is not free of risks. Clinicians and patients ought to know the parameters of a transfusion informed consent. A mixed methodology to explore patients' and clinicians' knowledge and opinions of administration and strategies to improve the transfusion informed consent process was

  16. Ethics in clinical research: need for assessing comprehension of informed consent form?

    Science.gov (United States)

    Shafiq, Nusrat; Malhotra, Samir

    2011-03-01

    Comprehension of informed consent form has not achieved the attention it deserves. We made a 24-item questionnaire to assess clinical research participants' comprehension of informed consent form (Contemp Clin Trials 2009;30:427-30). Due to repeated requests by clinical researchers in our country and abroad, we are publishing the questionnaire in this article. Copyright © 2010 Elsevier Inc. All rights reserved.

  17. Informed consent, parental awareness, and reasons for participating in a randomised controlled study

    NARCIS (Netherlands)

    M. van Stuijvenberg (Margriet); M.H. Suur (Marja); S. de Vos (Sandra); G.C.H. Tjiang (Gilbert); E.W. Steyerberg (Ewout); G. Derksen-Lubsen (Gerarda); H.A. Moll (Henriëtte)

    1998-01-01

    textabstractBACKGROUND: The informed consent procedure plays a central role in randomised controlled trials but has only been explored in a few studies on children. AIM: To assess the quality of the informed consent process in a paediatric setting. METHODS: A

  18. Enhancing the informed consent process for critical care research: strategies from a thromboprophylaxis trial.

    Science.gov (United States)

    Smith, Orla M; McDonald, Ellen; Zytaruk, Nicole; Foster, Denise; Matte, Andrea; Clarke, France; Fleury, Suzie; Krause, Katie; McArdle, Tracey; Skrobik, Yoanna; Cook, Deborah J

    2013-12-01

    Critically ill patients lack capacity for decisions about research participation. Consent to enrol these patients in studies is typically obtained from substitute decision-makers. To present strategies that may optimise the process of obtaining informed consent from substitute decision-makers for participation of critically ill patients in trials. We use examples from a randomised trial of heparin thromboprophylaxis in the intensive care unit (PROTECT, clinicaltrials.gov NCT00182143). 3764 patients were randomised, with an informed consent rate of 82%; 90% of consents were obtained from substitute decision-makers. North American PROTECT research coordinators attended three meetings to discuss enrolment: (1) Trial start-up (January 2006); (2) Near trial closure (January 2010); and (3) Post-publication (April 2011). Data were derived from slide presentations, field notes from break-out groups and plenary discussions, then analysed inductively. We derived three phases for the informed consent process: (1) Preparation for the Consent Encounter; (2) The Consent Encounter; and (3) Follow-up to the Consent Encounter. Specific strategies emerged for each phase: Phase 1 (four strategies); Phase 2 (six strategies); and Phase 3 (three strategies). We identified 13 strategies that may improve the process of obtaining informed consent from substitute decision-makers and be generalisable to other settings and studies. Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

  19. The effectiveness of health literacy interventions on the informed consent process of health care users: a systematic review protocol.

    Science.gov (United States)

    Perrenoud, Beatrice; Velonaki, Venetia-Sofia; Bodenmann, Patrick; Ramelet, Anne-Sylvie

    2015-10-01

    The aim of this systematic review is to establish the best available evidence of the effectiveness of health literacy interventions on the informed consent process for health care users. The specific review question is:What is the effectiveness of health literacy interventions on health care users' informed consent to health procedures processes? Informed consent is a fundamental principal in the health care context which nowadays includes the patient's capacity to judge and to be involved in the decision making concerning their care that ensures that the care received reflects their goals, preferences and values. The importance of obtaining a valid consent before any medical procedure is well-established. In a US court case in 1914, it was stated that it is the right of any adult with the capability of making decisions concerning his own body, and that any surgical operation without the patient's consent could be considered as an assault. In another US court case, the court stated that it is a doctor's duty to make a reasonable disclosure to his patient of the nature, probable consequences and dangers of the proposed treatment to the patient. The application of the doctrine of informed consent as a legal procedure may slightly differ from country to country or from state to state, and may have different forms even within the same country. For example in the UK, consent can be written, verbal or non-verbal/implied, and a written consent form is not the actual consent itself but merely serves as evidence that consent has been given. If the elements of voluntariness, appropriate information and capacity have not been satisfied, a signed informed consent form will not make the consent valid. Nowadays it is widely accepted that prior to the application of any medical procedure, its benefits, risks and alternatives must have been explained to the patient, and the competent patient should have voluntarily and understandingly consented. Hence, the informed consent refers

  20. Social and Communicative Functions of Informed Consent Forms in East Asia and Beyond

    Directory of Open Access Journals (Sweden)

    Go Yoshizawa

    2017-07-01

    Full Text Available The recent research and technology development in medical genomics has raised new issues that are profoundly different from those encountered in traditional clinical research for which informed consent was developed. Global initiatives for international collaboration and public participation in genomics research now face an increasing demand for new forms of informed consent which reflect local contexts. This article analyzes informed consent forms (ICFs for genomic research formulated by four selected research programs and institutes in East Asia – the Medical Genome Science Program in Japan, Universiti Sains Malaysia Human Research Ethics Committee in Malaysia, and the Taiwan Biobank and the Taipei Medical University- Joint Institutional Review Board in Taiwan. The comparative text analysis highlights East Asian contexts as distinct from other regions by identifying communicative and social functions of consent forms. The communicative functions include re-contact options and offering interactive support for research participants, and setting opportunities for family or community engagement in the consent process. This implies that informed consent cannot be validated solely with the completion of a consent form at the initial stage of the research, and informed consent templates can facilitate interactions between researchers and participants through (even before and after the research process. The social functions consist of informing participants of possible social risks that include genetic discrimination, sample and data sharing, and highlighting the role of ethics committees. Although international ethics harmonization and the subsequent coordination of consent forms may be necessary to maintain the quality and consistency of consent process for data-intensive international research, it is also worth paying more attention to the local values and different settings that exist where research participants are situated for research in

  1. Social and Communicative Functions of Informed Consent Forms in East Asia and Beyond.

    Science.gov (United States)

    Yoshizawa, Go; Sasongko, Teguh H; Ho, Chih-Hsing; Kato, Kazuto

    2017-01-01

    The recent research and technology development in medical genomics has raised new issues that are profoundly different from those encountered in traditional clinical research for which informed consent was developed. Global initiatives for international collaboration and public participation in genomics research now face an increasing demand for new forms of informed consent which reflect local contexts. This article analyzes informed consent forms (ICFs) for genomic research formulated by four selected research programs and institutes in East Asia - the Medical Genome Science Program in Japan, Universiti Sains Malaysia Human Research Ethics Committee in Malaysia, and the Taiwan Biobank and the Taipei Medical University- Joint Institutional Review Board in Taiwan. The comparative text analysis highlights East Asian contexts as distinct from other regions by identifying communicative and social functions of consent forms. The communicative functions include re-contact options and offering interactive support for research participants, and setting opportunities for family or community engagement in the consent process. This implies that informed consent cannot be validated solely with the completion of a consent form at the initial stage of the research, and informed consent templates can facilitate interactions between researchers and participants through (even before and after) the research process. The social functions consist of informing participants of possible social risks that include genetic discrimination, sample and data sharing, and highlighting the role of ethics committees. Although international ethics harmonization and the subsequent coordination of consent forms may be necessary to maintain the quality and consistency of consent process for data-intensive international research, it is also worth paying more attention to the local values and different settings that exist where research participants are situated for research in medical genomics. More

  2. Informed consent for and regulation of critical care research.

    Science.gov (United States)

    Lemaire, François

    2008-12-01

    Critical care is a special area in which research needs to take place, because of the severity of the diseases which are treated there, but it is also a place where research faces a lot of hurdles and difficulties. The main cause of difficulties is the consent issue, as most patients cannot consent for themselves. Recently, all national legislations in the countries of the European Union have been modified to include the provisions of directive 2001/20. This review article provides a summary of the recent literature concerning the issue of consent for clinical care research such as how the surrogate consent reflects the view of the patient and how time consuming and inaccurate can be the consultation of a community before the start of a trial with a waiver of consent. Another hurdle to research is the rigidity of our legislations concerning clinical research, especially the absence of a simplified way for low or no-risk research. This article shows how this situation is potentially deleterious and how it could ultimately forbid low-risk research. Critical research remains a domain in which research on patients is difficult and controversial. Regulation can be difficult to implement, largely inadequate or uselessly complicated. Intensive care physicians need to keep pressure on politicians and lawmakers to constantly explain the necessity and specificities of critical care research.

  3. Monetary Incentives Improve Recall of Research Consent Information: A Randomized Pilot Study

    Science.gov (United States)

    Festinger, David S.; Marlowe, Douglas B.; Croft, Jason R.; Dugosh, Karen L.; Arabia, Patricia L.; Benasutti, Kathleen M.

    2011-01-01

    Research participants often fail to recall substantial amounts of informed consent information after delays of only a few days. Numerous interventions have proven effective at improving consent recall; however, virtually all have focused on compensating for potential cognitive deficits and have ignored motivational factors. In this pilot study, we randomly assigned 31 drug court clients participating in a clinical research trial to a standard consent procedure or to the same procedure plus incentives for correctly recalling consent information. The incentive group was told they would receive $5 for each of the 15 consent items they could answer correctly 1-week later. At the follow-up, the incentive group recalled a significantly greater percentage of consent information overall than the standard group (65% vs. 42%; p < .01). Similar findings were observed for specific categories of consent information, including study purpose and design, risks and benefits, and human subject protections. Effect sizes were all large (d = 0.89 to 1.25). Findings suggest that motivation plays a key role in recall of consent information and should be considered in the development of future interventions. PMID:19331486

  4. Exploring informed consent in HIV clinical trials: A case study in Uganda

    Directory of Open Access Journals (Sweden)

    Agnes Ssali

    2016-11-01

    Conclusion: This study’s findings indicated that obtaining a volunteer’s signature or thumbprint on a consent form did not necessarily mean that the participant was fully-informed about the information relevant to their taking part nor that they understood all the information shared with them. Informed consent requires sufficient time in the research process to have staff trained well enough before research begins. Ensuring and gaining informed consent should be understood and treated as a relation-centred, dynamic supportive process throughout the duration of a research study.

  5. Using a Multimedia Presentation to Enhance Informed Consent in a Pediatric Emergency Department.

    Science.gov (United States)

    Spencer, Sandra P; Stoner, Michael J; Kelleher, Kelly; Cohen, Daniel M

    2015-08-01

    Informed consent is an ethical process for ensuring patient autonomy. Multimedia presentations (MMPs) often aid the informed consent process for research studies. Thus, it follows that MMPs would improve informed consent in clinical settings. The aim of this study was to determine if an MMP for the informed consent process for ketamine sedation improves parental satisfaction and comprehension as compared with standard practice. This 2-phase study compared 2 methods of informed consent for ketamine sedation of pediatric patients. Phase 1 was a randomized, prospective study that compared the standard verbal consent to an MMP. Phase 2 implemented the MMP into daily work flow to validate the previous year's results. Parents completed a survey evaluating their satisfaction of the informed consent process and assessing their knowledge of ketamine sedation. Primary outcome measures were parental overall satisfaction with the informed consent process and knowledge of ketamine sedation. One hundred eighty-four families from a free-standing, urban, tertiary pediatric emergency department with over 85,000 annual visits were enrolled. Different demographics were not associated with a preference for the MMP or improved scores on the content quiz. Intervention families were more likely "to feel involved in the decision to use ketamine" and to understand that "they had the right to refuse the ketamine" as compared with control families. The intervention group scored significantly higher overall on the content section than the control group. Implementation and intervention families responded similarly to all survey sections. Multimedia presentation improves parental understanding of ketamine sedation, whereas parental satisfaction with the informed consent process remains unchanged. Use of MMP in the emergency department for informed consent shows potential for both patients and providers.

  6. [Analysis of informed consent readibility in intensive care].

    Science.gov (United States)

    Ramírez-Puerta, M R; Fernández-Fernández, R; Frías-Pareja, J C; Yuste-Ossorio, M E; Narbona-Galdó, S; Peñas-Maldonado, L

    2013-11-01

    To analyze the readability of informed consent documents (IC) used in an intensive care department and in the Andalusian Healthcare System (AHS). A descriptive study was carried out. The Intensive Care Unit of a tertiary Hospital, and the AHS. A review and analysis was made of the existing 14 IC models in the Intensive Care Unit and of another 14 IC models offered by the AHS, using the following readability scores: Flesch, Sentence complexity, LEGIN, Fernández-Huerta, Szigriszt and INFLESZ. Twenty-four IC (85.7%) failed to satisfy some of the indexes, while three (10.7%) did not satisfy any of them. Four documents (14.3%) satisfied all the indexes analyzed, and therefore are easy to understand. Flesch score: satisfied by one of the ICU IC (7.1%) and by three of the AHS documents (21.4%). Sentence complexity score: satisfied by 11 of the ICU IC (78.6%) and by 13 of the AHS documents (92.8%). Fernández-Huerta score: satisfied by four of the ICU IC (28.6%) and by 13 of the AHS documents (92.8%). Szigriszt score: satisfied by two of the ICU IC (14.3%) and by 11 of the AHS documents (64.3%). INFLESZ score: satisfied by two of the ICU IC (14.3%) and by 10 of the AHS documents (71.4%). The documents analyzed are generally difficult to read and understand by most people, and do not satisfy the basic purpose for which they were drafted. Copyright © 2012 Elsevier España, S.L. and SEMICYUC. All rights reserved.

  7. Qualitative study of patient consent for health information exchange in an HIV clinic.

    Science.gov (United States)

    Ramos, S Raquel; Bakken, Suzanne

    2014-01-01

    Health information exchange (HIE) is the secure, electronic transfer and/or accessibility of clinical data among healthcare providers. In the United States (US), the consent process for participation varies state to state. New York State (NYS) mandates written patient consent. The purpose of this study was to examine workflow and perceptions related to obtaining HIE consent in an HIV clinic. We used contextual inquiry to observe the HIE consent-related workflow of four registration clerks for a total of 4 hours on two weekdays and subsequently created a flow chart and sequence model diagram. Clerks were also interviewed and the resulting narrative data were coded into themes. Observational and interview data suggested that patient privacy/confidentiality/trust, high volume workflow, and multiple competing demands affect the patient HIE consent process. Additional qualitative data needs to be gathered from the perspectives of patients and clinicians about the HIE consent process.

  8. Using and Disclosing Confidential Patient Information and The English Common Law: What are the Information Requirements of a Valid Consent?

    Science.gov (United States)

    Chico, Victoria; Taylor, Mark J

    2018-02-01

    The National Health Service in England and Wales is dependent upon the flow of confidential patient data. In the context of consent to the use of patient health data, insistence on the requirements of an 'informed' consent that are difficult to achieve will drive reliance on alternatives to consent. Here we argue that one can obtain a valid consent to the disclosure of confidential patient data, such that this disclosure would not amount to a breach of the common law duty of confidentiality, having provided less information than would typically be associated with an 'informed consent'. This position protects consent as a practicable legal basis for disclosure from debilitating uncertainty or impracticability and, perhaps counter-intuitively, promotes patient autonomy.

  9. The doctrine of informed consent in surgical practice

    African Journals Online (AJOL)

    Sociocultural factors have strong influence on the sick role. These factors influence ... point of view as a 'voluntary, uncoerced decision made by a .... On the other hand, a young child of 7 years with the emotional .... [14] The people of Southern ...

  10. The role of effective communication in achieving informed consent for clinical trials.

    Science.gov (United States)

    Pick, Andrew; Gilbert, Kayleigh; McCaul, James

    2014-11-11

    Informed consent is fundamental to the protection of the rights, safety and wellbeing of patients in clinical research. For consent to be valid, patients must first be given all the information they need about the proposed research to be able to decide whether they would like to take part. This material should be presented in a way that is easy for them to understand. This article explores the importance of communication in clinical research, and how more effective communication with patients during the informed consent process can ensure they are fully informed.

  11. Anonymity and informed consent in artificial procreation: a report from Denmark

    DEFF Research Database (Denmark)

    Lebech, Anne Mette

    1997-01-01

    a problem concerning its application when dealing with people having a serious mental, social or even physical disability. Within the field of artificial procreation there are even more problems. Informed written consent is often demanded from anonymous donors of gametes in order to ensure their consent...

  12. Towards guidelines for informed consent for prospective stem cell ...

    African Journals Online (AJOL)

    2015-08-02

    Aug 2, 2015 ... of genes that reactivate the embryonic genetic programme.[5,6]. We, and many ... ever more complex and multifaceted ethical issues, many of which require new guidelines, consent protocols and even change in legislation, since they do not ..... Progress and prospects in stem cells therapy. Acta. Pharmacol ...

  13. 77 FR 29983 - Federal Acquisition Regulation; Information Collection; Subcontract Consent

    Science.gov (United States)

    2012-05-21

    ... performance of functions of the Federal Acquisition Regulation (FAR), and whether it will have practical... The objective of consent to subcontract, as discussed in FAR Part 44, is to evaluate the efficiency and effectiveness with which the contractor spends Government funds, and complies with Government...

  14. Internet based patient education improves informed consent for elective orthopaedic surgery: a randomized controlled trial.

    Science.gov (United States)

    Fraval, Andrew; Chandrananth, Janan; Chong, Yew M; Coventry, Lillian S; Tran, Phong

    2015-02-07

    Obtaining informed consent is an essential step in the surgical pathway. Providing adequate patient education to enable informed decision making is a continued challenge of contemporary surgical practice. This study investigates whether the use of a patient information website, to augment patient education and informed consent for elective orthopaedic procedures is an effective measure. A randomised controlled trial was conducted comparing the quality of informed consent provided by a standard discussion with the treating surgeon compared to augmentation of this discussion with an online education resource (www.orthoanswer.org). Participants were recruited from orthopaedic outpatient clinics. Patients undergoing five common orthopaedic procedures were eligible to participate in the trial. The primary outcome measure was knowledge about their operation. Satisfaction with their informed consent and anxiety relating to their operation were the secondary outcome measures. There was a statistically significant increase in patient knowledge for the intervention arm as compared to the control arm (p education website as an augment to informed consent improves patient knowledge about their planned operation as well as satisfaction with the consent process whilst not increasing their anxiety levels. We recommend that all patients be directed to web based education tools to augment their consent. Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12614001058662 .

  15. Social Annotation Valence: The Impact on Online Informed Consent Beliefs and Behavior.

    Science.gov (United States)

    Balestra, Martina; Shaer, Orit; Okerlund, Johanna; Westendorf, Lauren; Ball, Madeleine; Nov, Oded

    2016-07-20

    Social media, mobile and wearable technology, and connected devices have significantly expanded the opportunities for conducting biomedical research online. Electronic consent to collecting such data, however, poses new challenges when contrasted to traditional consent processes. It reduces the participant-researcher dialogue but provides an opportunity for the consent deliberation process to move from solitary to social settings. In this research, we propose that social annotations, embedded in the consent form, can help prospective participants deliberate on the research and the organization behind it in ways that traditional consent forms cannot. Furthermore, we examine the role of the comments' valence on prospective participants' beliefs and behavior. This study focuses specifically on the influence of annotations' valence on participants' perceptions and behaviors surrounding online consent for biomedical research. We hope to shed light on how social annotation can be incorporated into digitally mediated consent forms responsibly and effectively. In this controlled between-subjects experiment, participants were presented with an online consent form for a personal genomics study that contained social annotations embedded in its margins. Individuals were randomly assigned to view the consent form with positive-, negative-, or mixed-valence comments beside the text of the consent form. We compared participants' perceptions of being informed and having understood the material, their trust in the organization seeking the consent, and their actual consent across conditions. We find that comment valence has a marginally significant main effect on participants' perception of being informed (F2=2.40, P=.07); specifically, participants in the positive condition (mean 4.17, SD 0.94) felt less informed than those in the mixed condition (mean 4.50, SD 0.69, P=.09). Comment valence also had a marginal main effect on the extent to which participants reported trusting the

  16. Architecture of a consent management suite and integration into IHE-based Regional Health Information Networks.

    Science.gov (United States)

    Heinze, Oliver; Birkle, Markus; Köster, Lennart; Bergh, Björn

    2011-10-04

    The University Hospital Heidelberg is implementing a Regional Health Information Network (RHIN) in the Rhine-Neckar-Region in order to establish a shared-care environment, which is based on established Health IT standards and in particular Integrating the Healthcare Enterprise (IHE). Similar to all other Electronic Health Record (EHR) and Personal Health Record (PHR) approaches the chosen Personal Electronic Health Record (PEHR) architecture relies on the patient's consent in order to share documents and medical data with other care delivery organizations, with the additional requirement that the German legislation explicitly demands a patients' opt-in and does not allow opt-out solutions. This creates two issues: firstly the current IHE consent profile does not address this approach properly and secondly none of the employed intra- and inter-institutional information systems, like almost all systems on the market, offers consent management solutions at all. Hence, the objective of our work is to develop and introduce an extensible architecture for creating, managing and querying patient consents in an IHE-based environment. Based on the features offered by the IHE profile Basic Patient Privacy Consent (BPPC) and literature, the functionalities and components to meet the requirements of a centralized opt-in consent management solution compliant with German legislation have been analyzed. Two services have been developed and integrated into the Heidelberg PEHR. The standard-based Consent Management Suite consists of two services. The Consent Management Service is able to receive and store consent documents. It can receive queries concerning a dedicated patient consent, process it and return an answer. It represents a centralized policy enforcement point. The Consent Creator Service allows patients to create their consents electronically. Interfaces to a Master Patient Index (MPI) and a provider index allow to dynamically generate XACML-based policies which are

  17. Cardiac imaging modalities with ionizing radiation: the role of informed consent.

    Science.gov (United States)

    Paterick, Timothy E; Jan, M Fuad; Paterick, Zachary R; Tajik, A Jamil; Gerber, Thomas C

    2012-06-01

    Informed consent ideally results in patient autonomy and rational health care decisions. Frequently, patients face complex medical decisions that require a delicate balancing of anticipated benefits and potential risks, which is the concept of informed consent. This balancing process requires an understanding of available medical evidence and alternative medical options, and input from experienced physicians. The informed consent doctrine places a positive obligation on physicians to partner with patients as they try to make the best decision for their specific medical situation. The high prevalence and mortality related to heart disease in our society has led to increased cardiac imaging with modalities that use ionizing radiation. This paper reviews how physicians can meet the ideals of informed consent when considering cardiac imaging with ionizing radiation, given the limited evidence for risks and benefits. The goal is an informed patient making rational choices based on available medical information. Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  18. Securing recruitment and obtaining informed consent in minority ethnic groups in the UK

    Directory of Open Access Journals (Sweden)

    Roy Tapash

    2008-03-01

    Full Text Available Abstract Background Previous health research has often explicitly excluded individuals from minority ethnic backgrounds due to perceived cultural and communication difficulties, including studies where there might be language/literacy problems in obtaining informed consent. This study addressed these difficulties by developing audio-recorded methods of obtaining informed consent and recording data. This report outlines 1 our experiences with securing recruitment to a qualitative study investigating alternative methods of data collection, and 2 the development of a standardised process for obtaining informed consent from individuals from minority ethnic backgrounds whose main language does not have an agreed written form. Methods Two researchers from South Asian backgrounds recruited adults with Type 2 diabetes whose main language was spoken and not written, to attend a series of focus groups. A screening tool was used at recruitment in order to assess literacy skills in potential participants. Informed consent was obtained using audio-recordings of the patient information and recording patients' verbal consent. Participants' perceptions of this method of obtaining consent were recorded. Results Recruitment rates were improved by using telephone compared to face-to-face methods. The screening tool was found to be acceptable by all potential participants. Audio-recorded methods of obtaining informed consent were easy to implement and accepted by all participants. Attrition rates differed according to ethnic group. Snowballing techniques only partly improved participation rates. Conclusion Audio-recorded methods of obtaining informed consent are an acceptable alternative to written consent in study populations where literacy skills are variable. Further exploration of issues relating to attrition is required, and a range of methods may be necessary in order to maximise response and participation rates.

  19. I had no other option: Women, electroconvulsive therapy, and informed consent.

    Science.gov (United States)

    Clarke, Karen-Ann; Barnes, Margaret; Ross, Dyann

    2018-06-01

    Electroconvulsive therapy (ECT) is a controversial procedure used in the management of depression. Whilst it may be administered under mental health legislation, it is usually given to people who voluntarily consent. At the practice level, the consent process for ECT requires a detailed explanation of the procedure. The person consenting must have capacity to make this decision, and consent must be given freely and without coercion. Research using a feminist narrative approach unexpectedly highlighted the issue of potential coercion in the context of explaining the procedure. In-depth interviews were used to understand seven women's accounts of deciding to receive ECT. A thematic analysis of their narratives uncovered a shared concern with how they consented to the treatment. Four subthemes were identified that related to the way in which they provided their consent: (i) 'Not enough information'; (ii) 'I had no other choice'; (iii) 'Just go along with it'; and (iv) 'Lacking capacity'. A consent process that includes elements of passive coercion and a lack of timely and appropriate information influences the way some women make decisions. These factors can disempower women at the point of decision-making. A practice shift is needed where women are enabled to have control over decisions. Further, there is a need to adhere more rigorously to noncoercive practice when obtaining consent. © 2017 Australian College of Mental Health Nurses Inc.

  20. The regulation of informed consent to participation in clinical research by mentally ill persons: An overview

    Directory of Open Access Journals (Sweden)

    A Nienaber

    2010-12-01

    Full Text Available The article examines the legal requirements relating to the informed consent of mentally ill persons to participation in clinical research in South Africa. First, the juridical basis of informed consent in South African law is outlined; and second, the requirements for lawful consent developed in South African common law and case law are presented. Finally, the article deliberates upon the requirements for the participation of mentally ill persons in research as laid down by the Mental Health Care Act and its regulations, the National Health Act and its (draft regulations, and the South African Constitution.

  1. Towards a standardised informed consent procedure for live donor nephrectomy: the PRINCE (Process of Informed Consent Evaluation) project-study protocol for a nationwide prospective cohort study.

    Science.gov (United States)

    Kortram, Kirsten; Spoon, Emerentia Q W; Ismail, Sohal Y; d'Ancona, Frank C H; Christiaans, Maarten H L; van Heurn, L W Ernest; Hofker, H Sijbrand; Hoksbergen, Arjan W J; Homan van der Heide, Jaap J; Idu, Mirza M; Looman, Caspar W N; Nurmohamed, S Azam; Ringers, Jan; Toorop, Raechel J; van de Wetering, Jacqueline; Ijzermans, Jan N M; Dor, Frank J M F

    2016-04-01

    Informed consent is mandatory for all (surgical) procedures, but it is even more important when it comes to living kidney donors undergoing surgery for the benefit of others. Donor education, leading to informed consent, needs to be carried out according to certain standards. Informed consent procedures for live donor nephrectomy vary per centre, and even per individual healthcare professional. The basis for a standardised, uniform surgical informed consent procedure for live donor nephrectomy can be created by assessing what information donors need to hear to prepare them for the operation and convalescence. The PRINCE (Process of Informed Consent Evaluation) project is a prospective, multicentre cohort study, to be carried out in all eight Dutch kidney transplant centres. Donor knowledge of the procedure and postoperative course will be evaluated by means of pop quizzes. A baseline cohort (prior to receiving any information from a member of the transplant team in one of the transplant centres) will be compared with a control group, the members of which receive the pop quiz on the day of admission for donor nephrectomy. Donor satisfaction will be evaluated for all donors who completed the admission pop-quiz. The primary end point is donor knowledge. In addition, those elements that have to be included in the standardised format informed consent procedure will be identified. Secondary end points are donor satisfaction, current informed consent practices in the different centres (eg, how many visits, which personnel, what kind of information is disclosed, in which format, etc) and correlation of donor knowledge with surgeons' estimation thereof. Approval for this study was obtained from the medical ethical committee of the Erasmus MC, University Medical Center, Rotterdam, on 18 February 2015. Secondary approval has been obtained from the local ethics committees in six participating centres. Approval in the last centre has been sought. Outcome will be published in a

  2. Human subject research: reporting ethics approval and informed consent in 3 chiropractic journals.

    Science.gov (United States)

    Lawrence, Dana J

    2011-11-01

    To date, there have been no reports of ethics board approval or informed consent within the chiropractic literature or within chiropractic research. The purpose of this study was to assess the reporting of ethics approval and informed consent in articles published during the 2008 volume year of 3 chiropractic research journals included in PubMed. A quantitative assessment of the articles published in each journal for the 2008 volume year was performed. Information collected included if the article involved human subject research, if it reported ethics board approval, and if informed consent was given to subjects. Data were collected as descriptive statistics (frequency counts and percentages). In aggregate, 50 articles of a total of 143 published involved human subject research (35%). 44 reported ethics board approval (88%), and 28 reported that informed consent had been obtained (56%). Forty-five percent of articles published in the Journal of Manipulative and Physiological Therapeutics involved human subject research (39/87), of which 95% reported ethics board approval (37/39) and 64% reported informed consent (25/39); 12.5% of articles from the Journal of the Canadian Chiropractic Association involved human subject research (5/40), of which 80% reported ethics board approval (4/5) and 40% reported informed consent (2/5); and 37.5% of articles published in Chiropractic and Osteopathy involved human subject research (6/16), of which 50% reported ethics board approval (3/6) and 17% reported informed consent (1/6). Overall, most articles reported ethics approval, and more than half reported consent. This was harmonious with research on this topic from other disciplines. This situation indicates a need for continued quality improvement and for better instruction and dissemination of information on these issues to researchers, to manuscript reviewers, to journal editors, and to the readers. Copyright © 2011 National University of Health Sciences. Published by Mosby

  3. Is free, prior and informed consent a form of corporate social responsibility?

    NARCIS (Netherlands)

    Rodhouse, Toyah; Vanclay, Frank

    2016-01-01

    International organizations are increasingly including Indigenous peoples' rights and the concept of Free, Prior and Informed Consent (FPIC) in their guidance documents, codes of conduct, and performance standards. Leading companies are adjusting their Corporate Social Responsibility (CSR) and

  4. Patient Perception of Disclosure Performance of Informed Consent Elements in the Preanesthesia Interview

    National Research Council Canada - National Science Library

    Hartgerink, Bradley

    1997-01-01

    ...) were discussed in the preanesthesia interview. A survey composed of 21 questions pertaining to demography and informed consent elements was devised and administered to 53 patients immediately following their preanesthesia interview...

  5. Rates and determinants of informed consent: a case study of an international thromboprophylaxis trial.

    Science.gov (United States)

    Smith, Orla M; McDonald, Ellen; Zytaruk, Nicole; Foster, Denise; Matte, Andrea; Clarke, France; Meade, Laurie; O'Callaghan, Nicole; Vallance, Shirley; Galt, Pauline; Rajbhandari, Dorrilyn; Rocha, Marcelo; Mehta, Sangeeta; Ferguson, Niall D; Hall, Richard; Fowler, Robert; Burns, Karen; Qushmaq, Ismael; Ostermann, Marlies; Heels-Ansdell, Diane; Cook, Deborah

    2013-02-01

    Successful completion of randomized trials depends upon efficiently and ethically screening patients and obtaining informed consent. Awareness of modifiable barriers to obtaining consent may inform ongoing and future trials. The objective of this study is to describe and examine determinants of consent rates in an international heparin thromboprophylaxis trial (Prophylaxis for ThromboEmbolism in Critical Care Trial, clinicaltrials.gov NCT00182143). Throughout the 4-year trial, research personnel approached eligible critically ill patients or their substitute decision makers for informed consent. Whether consent was obtained or declined was documented daily. The trial was conducted in 67 centers in 6 countries. A total of 3764 patients were randomized. The overall consent rate was 82.2% (range, 50%-100%) across participating centers. Consent was obtained from substitute decision makers and patients in 90.1% and 9.9% of cases, respectively. Five factors were independently associated with consent rates. Research coordinators with more experience achieved higher consent rates (odds ratio [OR], 3.43; 95% confidence interval, 2.42-4.86; P 10 years of experience). Consent rates were higher in smaller intensive care units with less than 15 beds compared with intensive care units with 15 to 20 beds, 21 to 25 beds, and greater than 25 beds (all ORs, <0.5; P < .001) and were higher in centers with more than 1 full-time research staff (OR, 1.95; 95% confidence interval, 1.28-2.99; P < .001). Consent rates were lower in centers affiliated with the Canadian Critical Care Trials Group or the Australian and New Zealand Intensive Care Society Clinical Trials Group compared with other centers (OR, 0.57; 95% confidence interval, 0.42-0.77; P < .001). Finally, consent rates were highest during the pilot trial, lowest during the initiation of the full trial, and increased over years of recruitment (P < .001). Characteristics of study centers, research infrastructure, and experience

  6. The Right to Consent and Control Personal Information Processing in Cyberspace

    OpenAIRE

    Thilla Rajaretnam

    2015-01-01

    Consumer concerns over the safety of their personal information and the violation of their privacy rights are described as being the single overwhelming barrier to rapid growth of e- commerce. This paper explores the problems for e-commerce users when there is collection, use, and disclosure of personal information that are based on implied consent in e- commerce transactions. It questions the assumption that consent is sufficient to waive privacy interests in relation to e-commerce transacti...

  7. Informed consent in Sri Lanka: A survey among ethics committee members

    OpenAIRE

    Sumathipala, Athula; Siribaddana, Sisira; Hewage, Suwin; Lekamwattage, Manura; Athukorale, Manjula; Siriwardhana, Chesmal; Murray, Joanna; Prince, Martin

    2008-01-01

    Abstract Background Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research. However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form. Methods We obtained ethical ap...

  8. Readability and Content Assessment of Informed Consent Forms for Medical Procedures in Croatia

    Science.gov (United States)

    Vučemilo, Luka; Borovečki, Ana

    2015-01-01

    Background High quality of informed consent form is essential for adequate information transfer between physicians and patients. Current status of medical procedure consent forms in clinical practice in Croatia specifically in terms of the readability and the content is unknown. The aim of this study was to assess the readability and the content of informed consent forms for diagnostic and therapeutic procedures used with patients in Croatia. Methods 52 informed consent forms from six Croatian hospitals on the secondary and tertiary health-care level were tested for reading difficulty using Simple Measure of Gobbledygook (SMOG) formula adjusted for Croatian language and for qualitative analysis of the content. Results The averaged SMOG grade of analyzed informed consent forms was 13.25 (SD 1.59, range 10–19). Content analysis revealed that informed consent forms included description of risks in 96% of the cases, benefits in 81%, description of procedures in 78%, alternatives in 52%, risks and benefits of alternatives in 17% and risks and benefits of not receiving treatment or undergoing procedures in 13%. Conclusions Readability of evaluated informed consent forms is not appropriate for the general population in Croatia. The content of the forms failed to include in high proportion of the cases description of alternatives, risks and benefits of alternatives, as well as risks and benefits of not receiving treatments or undergoing procedures. Data obtained from this research could help in development and improvement of informed consent forms in Croatia especially now when Croatian hospitals are undergoing the process of accreditation. PMID:26376183

  9. I’m shocked: informed consent in ECT and the phenomenological-self

    OpenAIRE

    Seniuk, Patrick

    2018-01-01

    This paper argues that phenomenological insights regarding selfhood are relevant to the informed consent process in the treatment of depression using electro-convulsive therapy (ECT). One of the most significant side-effects associated with ECT is retrograde amnesia. Unfortunately, the current informed consent model does not adequately appreciate the full extent in which memory loss disturbs lived-experience. Through the philosophy of Merleau-Ponty, it is possible to appreciate the way in whi...

  10. A Development of Automatic Audit System for Written Informed Consent using Machine Learning.

    Science.gov (United States)

    Yamada, Hitomi; Takemura, Tadamasa; Asai, Takahiro; Okamoto, Kazuya; Kuroda, Tomohiro; Kuwata, Shigeki

    2015-01-01

    In Japan, most of all the university and advanced hospitals have implemented both electronic order entry systems and electronic charting. In addition, all medical records are subjected to inspector audit for quality assurance. The record of informed consent (IC) is very important as this provides evidence of consent from the patient or patient's family and health care provider. Therefore, we developed an automatic audit system for a hospital information system (HIS) that is able to evaluate IC automatically using machine learning.

  11. Doctors, Patients, and Nudging in the Clinical Context--Four Views on Nudging and Informed Consent.

    Science.gov (United States)

    Ploug, Thomas; Holm, Søren

    2015-01-01

    In an analysis of recent work on nudging we distinguish three positions on the relationship between nudging founded in libertarian paternalism and the protection of personal autonomy through informed consent. We argue that all three positions fail to provide adequate protection of personal autonomy in the clinical context. Acknowledging that nudging may be beneficial, we suggest a fourth position according to which nudging and informed consent are valuable in different domains of interaction.

  12. Do chiropractic college faculty understand informed consent: a pilot study

    Directory of Open Access Journals (Sweden)

    Hondras Maria A

    2006-12-01

    Full Text Available Abstract Background The purpose of this study was to survey full-time faculty at a single chiropractic college concerning their knowledge of Institutional Review Board (IRB policies in their institution as they pertain to educational research. Methods All full-time faculty were invited to participate in an anonymous survey. Four scenarios involving educational research were described and respondents were asked to select from three possible courses of action for each. In addition, respondents were queried about their knowledge of IRB policies, how they learned of these policies and about their years of service and departmental assignments. Results The response rate was 55%. In no scenario did the level of correct answers by all respondents score higher than 41% and in most, the scores were closer to just under 1 in 3. Sixty-five percent of respondents indicated they were unsure whether Palmer had any policies in place at all, while 4% felt that no such policies were in place. Just over one-quarter (27% were correct in noting that students can decline consent, while more than half (54% did not know whether there were any procedures governing student consent. Conclusion Palmer faculty have only modest understanding about institutional policies regarding the IRB and human subject research, especially pertaining to educational research. The institution needs to develop methods to provide knowledge and training to faculty. The results from this pilot study will be instrumental in developing better protocols for a study designed to survey the entire chiropractic academic community.

  13. 78 FR 48413 - Proposed Information Collection; Comment Request; Voluntary Self-Disclosure of Antiboycott...

    Science.gov (United States)

    2013-08-08

    ... DEPARTMENT OF COMMERCE Bureau of Industry and Security Proposed Information Collection; Comment Request; Voluntary Self- Disclosure of Antiboycott Violations AGENCY: Bureau of Industry and Security... Administration Regulations by providing a method for industry to voluntarily self-disclose Antiboycott violations...

  14. Informed consent for phase I studies: evaluation of quantity and quality of information provided to patients.

    Science.gov (United States)

    Tomamichel, M; Sessa, C; Herzig, S; de Jong, J; Pagani, O; Willems, Y; Cavalli, F

    1995-04-01

    The process by which patients are informed and their consent is obtained in phase I trials has thus far been only marginally studied. Since 1986 we have followed an oral procedure, consisting of three consecutive conversations in which the investigator responsible for phase I studies, the research nurse and the patients' relatives and/or friends also participate, followed by the patients signing of a written consent form. It is required that six items of information considered essential by our staff be conveyed to patients by the responsible investigator. Meerwein's model, which defines three main dimensions of the informing process (the information itself, the emotional and interactive aspects), has been studied to ascertain whether it can be applied to evaluate the quality of the information proffered. Thirty-two conversations were taped, transcribed and evaluated by one psychiatrist and one psychologist. A quantitative analysis of information was performed by calculating the number of patients to whom the essential items of information had been conveyed. The qualitative analysis was performed by rating on a five-point scoring system, from 1 (very bad) to 5 (excellent), the three dimensions of the informing process for each patient and by calculating for each dimension the mean score of the constituent items. Complete information about the characteristics of the phase I drug and the modalities of the treatment and follow up was given to almost 80% of the patients. All but one of the items of the information dimension scored 3.5 or higher, with the one related to the assessment by the doctor of the patient's understanding at the end of the consultation scoring less than 3 in 53% of the patients. All items of the emotional dimension scored higher than 3.5. Greater difficulty was encountered by the physician with the interactive dimension, the lowest mean scores being reported on the items related to the doctor's awareness of the indirectly expressed anxieties of

  15. [Evaluation and improvement of the management of informed consent in the emergency department].

    Science.gov (United States)

    del Pozo, P; García, J A; Escribano, M; Soria, V; Campillo-Soto, A; Aguayo-Albasini, J L

    2009-01-01

    To assess the preoperative management in our emergency surgical service and to improve the quality of the care provided to patients. In order to find the causes of non-compliance, the Ishikawa Fishbone diagram was used and eight assessment criteria were chosen. The first assessment includes 120 patients operated on from January to April 2007. Corrective measures were implemented, which consisted of meetings and conferences with doctors and nurses, insisting on the importance of the informed consent as a legal document which must be signed by patients, and the obligation of giving a copy to patients or relatives. The second assessment includes the period from July to October 2007 (n=120). We observed a high non-compliance of C1 signing of surgical consent (CRITERION 1: all patients or relatives have to sign the surgical informed consent for the operation to be performed [27.5%]) and C2 giving a copy of the surgical consent (CRITERION 2: all patients or relatives must have received a copy of the surgical informed consent for the Surgery to be performed [72.5%]) and C4 anaesthetic consent copy (CRITERION 4: all patients or relatives must have received a copy of the Anaesthesia informed consent corresponding to the operation performed [90%]). After implementing corrective measures a significant improvement was observed in the compliance of C2 and C4. In C1 there was an improvement without statistical significance. The carrying out of an improvement cycle enabled the main objective of this paper to be achieved: to improve the management of informed consent and the quality of the care and information provided to our patients.

  16. Language cultural brokerage and informed consent will technological terms impede telemedicine use

    Directory of Open Access Journals (Sweden)

    Caron Jack

    2014-04-01

    Full Text Available Introduction. Telemedicine provides a solution to treatment of economically and geographically compromised patients and enhances the level of care. However, a problem has arisen in safeguarding patients’ rights to informed consent.Objective. To determine the impact of language, translation and interpretation barriers on gaining legally valid informed consent in telemedicine.Design. Forty-one key words relevant to computer terminology and concepts required to gain informed consent for a telemedicine encounter were selected and sent for translation into isiZulu, the local indigenous language of KwaZulu-Natal, South Africa. A questionnaire with the list of words was developed with three domains covering information communication technology (ICT use, ICT terms and ethics terms. This was administered to patients at four outpatient departments in rural KwaZulu-Natal hospitals.Results. Of the 54 participants, 50 (92.6% did not know or understand the term ‘telemedicine’, 49 (90.7% the term ‘video conference’ and 49 (90.7% the term ‘electronic records’. Words such as ‘consent’ and ‘autonomy’ were understood by less than a third of the participants. Only 19 individuals (35.2% understood the word ‘consent’, and only 4 (7.4% understood both the words ‘consent’ and ‘telemedicine’.Conclusions. The results of this study show that obtaining informed consent for a telemedicine consultation is problematic. Alternative ways of gaining informed consent need to be investigated.

  17. Just-in-time consent: The ethical case for an alternative to traditional informed consent in randomized trials comparing an experimental intervention with usual care.

    Science.gov (United States)

    Vickers, Andrew J; Young-Afat, Danny A; Ehdaie, Behfar; Kim, Scott Yh

    2018-02-01

    Informed consent for randomized trials often causes significant and persistent anxiety, distress and confusion to patients. Where an experimental treatment is compared to a standard care control, much of this burden is potentially avoidable in the control group. We propose a "just-in-time" consent in which consent discussions take place in two stages: an initial consent to research from all participants and a later specific consent to randomized treatment only from those assigned to the experimental intervention. All patients are first approached and informed about research procedures, such as questionnaires or tests. They are also informed that they might be randomly selected to receive an experimental treatment and that, if selected, they can learn more about the treatment and decide whether or not to accept it at that time. After randomization, control patients undergo standard clinical consent whereas patients randomized to the experimental procedure undergo a second consent discussion. Analysis would be by intent-to-treat, which protects the trial from selection bias, although not from poor acceptance of experimental treatment. The advantages of just-in-time consent stem from the fact that only patients randomized to the experimental treatment are subject to a discussion of that intervention. We hypothesize that this will reduce much of the patient's burden associated with the consent process, such as decisional anxiety, confusion and information overload. We recommend well-controlled studies to compare just-in-time and traditional consent, with endpoints to include characteristics of participants, distress and anxiety and participants' understanding of research procedures.

  18. Informed consent in physiotherapy practice: it is not what is said but how it is said.

    Science.gov (United States)

    Copnell, G

    2018-03-01

    This paper discusses the concept of informed consent in the context of contemporary biomedical ethics. A change in UK law regarding what information should be provided to patients has brought to the fore the role of physiotherapists in the process of gaining informed consent. It is important that physiotherapists are aware of how this change in the law will affect their practice. For an individual to consent, they need to have both the capacity and freedom to exercise rational thought. These concepts are challenged in contemporary biomedical ethics. An individual's ability to make rational decisions has been increasingly questioned by empirical evidence from behavioural psychology. In addition, the concept of freedom in contemporary neoliberal societies has also been critically examined. Liberal paternalism has been advocated by some as a means of helping patients to make better decisions about their care. Actualised as a 'nudge', liberal paternalism has been influential in a number of health policies, and has recently been discussed as a means of gaining consent from patients for assessments and treatments. Physiotherapists engage directly with patients and, through this engagement, construct a therapeutic environment that aims to build mutual trust. This paper questions the legitimacy of informed consent, and presents the argument that, through communicative actions, physiotherapists nudge patients into consenting to assessments and treatments. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

  19. Modified informed consent in a viral seroprevalence study in the Caribbean.

    Science.gov (United States)

    Cox, Cheryl; Macpherson, CNL

    1996-07-01

    An unlinked seroprevalence study of HIV and other viruses was conducted on pregnant women on the Caribbean island of Grenada in 1994. Investigators were from both the developed world and the Grenadian Ministry of Health (MOH). There was then no board on Grenada to protect research subjects or review ethical aspects of studies. Nurses from the MOH were asked to verbally inform their patients about the study, and request that patients become subjects of the study and give blood for screening. If consent was given nurses took blood and administered a survey about each subjects' knowledge of HIV transmission routes. Nurses shared a spoken dialect and cultural heritage with prospective subjects and were probably more effective than foreign researchers at informing subjects. Informed consent was obtained with a simplified consent form supplemented with conversation with each prospective research subject. Facilitating discussion between people with common cultural backgrounds helps apply the Western approach to informed consent to communites in the developing world. Researchers must disclose all information to nurses or other mediators, and ensure that nurses disclose as much information as possible to prospective subjects. So modified, informed consent maintains respect for persons and becomes applicable and relevant to various cultures.

  20. Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka

    Directory of Open Access Journals (Sweden)

    Siriwardhana Chesmal

    2008-02-01

    Full Text Available Abstract Background International guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are documented in locally and internationally published human subject research carried out in Sri Lanka. Methods We obtained ERC approval in Sri Lanka and the United Kingdom. Theses from 1985 to 2005 available at the Postgraduate Institute of Medicine (PGIM library affiliated to the University of Colombo were scrutinised using checklists agreed in consultation with senior research collaborators. A Medline search was carried out with MeSH major and minor heading 'Sri Lanka' as the search term for international publications originating in Sri Lanka during 1999 to 2004. All research publications from CMJ during 1999 to 2005 were also scrutinized. Results Of 291 theses, 34% documented ERC approvals and 61% documented obtaining consent. From the international journal survey, 250 publications originated from Sri Lanka of which only 79 full text original research publications could be accessed electronically. Of these 38% documented ERC approval and 39% documented obtaining consent. In the Ceylon Medical Journal 36% documented ERC approval and 37% documented obtaining consent. Conclusion Only one third of the publications scrutinized recorded ERC approval and procurement of informed consent. However, there is a positive trend in documenting these ethical requirements in local postgraduate research and in the local medical journal.

  1. The effect of informed consent on stress levels associated with extraction of impacted mandibular third molars.

    Science.gov (United States)

    Casap, Nardy; Alterman, Michael; Sharon, Guy; Samuni, Yuval

    2008-05-01

    To evaluate the effect of informed consent on stress levels associated with removal of impacted mandibular third molars. A total of 60 patients scheduled for extraction of impacted mandibular third molars participated in this study. The patients were unaware of the study's objectives. Data from 20 patients established the baseline levels of electrodermal activity (EDA). The remaining 40 patients were randomly assigned into 2 equal groups receiving either a detailed document of informed consent, disclosing the possible risks involved with the surgery, or a simplified version. Pulse, blood pressure, and EDA were monitored before, during, and after completion of the consent document. Changes in EDA, but not in blood pressure, were measured on completion of either version of the consent document. A greater increase in EDA was associated with the detailed version of the consent document (P = .004). A similar concomitant increase (although nonsignificant) in pulse values was monitored on completion of both versions. Completion of overdisclosed document of informed consent is associated with changes in physiological parameters. The results suggest that overdetailed listing and disclosure before extraction of impacted mandibular third molars can increase patient stress.

  2. Ethical issues in bipolar disorders pedigree research: privacy concerns, informed consent, and grounds for waiver.

    Science.gov (United States)

    Parker, Lisa S

    2002-02-01

    Focusing on bipolar disorders research, this article considers ethical issues of informed consent and privacy arising in genetic pedigree research at two stages: the construction of tentative pedigrees to determine family eligibility for study and, subsequently, the enrollment of subjects in and conduct of the family study. Increasing concern to protect the privacy of family members of primary subjects or probands, following ethical controversy over a survey study at Virginia Commonwealth University, has led some researchers and Institutional Review Boards (IRBs) to apply informed consent requirements to those represented on a tentative pedigree at the initial stage of research. This article analyzes the possible benefits, risks, and burdens to prospective subjects of seeking prospective consent for pedigree construction at this initial stage. It argues that the likely risk-benefit ratio favors granting a waiver of consent requirements for this stage of pedigree research and presents grounds for IRBs to grant such a waiver. The article closes by considering particular ethical concerns that should be addressed in the informed consent discussion when enrolling subjects in pedigree studies of bipolar disorder, including concerns about subjects' competence to consent, management of interim and incidental findings, and issues particular to psychiatric research.

  3. Relevant Information and Informed Consent in Research: In Defense of the Subjective Standard of Disclosure.

    Science.gov (United States)

    Dranseika, Vilius; Piasecki, Jan; Waligora, Marcin

    2017-02-01

    In this article, we seek to contribute to the debate on the requirement of disclosure in the context of informed consent for research. We defend the subjective standard of disclosure and describe ways to implement this standard in research practice. We claim that the researcher should make an effort to find out what kinds of information are likely to be relevant for those consenting to research. This invites researchers to take empirical survey information seriously, attempt to understand the cultural context, talk to patients to be better able to understand what can be potentially different concerns and interests prevalent in the target population. The subjective standard of disclosure should be seen as a moral ideal that perhaps can never be perfectly implemented but still can and should be used as a normative ideal guiding research practice. In the light of these discussions, we call for more empirical research on what considerations are likely to be perceived as relevant by potential research participants recruited from different socio-economic and cultural groups.

  4. Electronic processing of informed consents in a global pharmaceutical company environment.

    Science.gov (United States)

    Vishnyakova, Dina; Gobeill, Julien; Oezdemir-Zaech, Fatma; Kreim, Olivier; Vachon, Therese; Clade, Thierry; Haenning, Xavier; Mikhailov, Dmitri; Ruch, Patrick

    2014-01-01

    We present an electronic capture tool to process informed consents, which are mandatory recorded when running a clinical trial. This tool aims at the extraction of information expressing the duration of the consent given by the patient to authorize the exploitation of biomarker-related information collected during clinical trials. The system integrates a language detection module (LDM) to route a document into the appropriate information extraction module (IEM). The IEM is based on language-specific sets of linguistic rules for the identification of relevant textual facts. The achieved accuracy of both the LDM and IEM is 99%. The architecture of the system is described in detail.

  5. The importance of purpose: moving beyond consent in the societal use of personal health information.

    Science.gov (United States)

    Grande, David; Mitra, Nandita; Shah, Anand; Wan, Fei; Asch, David A

    2014-12-16

    Adoption of electronic health record systems has increased the availability of patient-level electronic health information. To examine public support for secondary uses of electronic health information under different consent arrangements. National experimental survey to examine perceptions of uses of electronic health information according to patient consent (obtained vs. not obtained), use (research vs. marketing), and framing of the findings (abstract description without results vs. specific results). Nationally representative survey. 3064 African American, Hispanic, and non-Hispanic white persons (response rate, 65%). Appropriateness of health information use described in vignettes on a scale of 1 (not at all appropriate) to 10 (very appropriate). Mean ratings ranged from a low of 3.81 for a marketing use when consent was not obtained and specific results were presented to a high of 7.06 for a research use when consent was obtained and specific results were presented. Participants rated scenarios in which consent was obtained as more appropriate than when consent was not obtained (difference, 1.01 [95% CI, 0.69 to 1.34]; Pmarketing as less appropriate than when the use was research (difference, -2.03 [CI, -2.27 to -1.78]; Pmarketing uses (5.65 vs. 4.52; difference, 1.13 [CI, 0.87 to 1.39]). Participants rated hypothetical scenarios. Results could be vulnerable to nonresponse bias despite the high response rate. Although approaches to health information sharing emphasize consent, public opinion also emphasizes purpose, which suggests a need to focus more attention on the social value of information use. National Human Genome Research Institute.

  6. Informed consent for the administration of an intravenous contrast agent: importance and determinants of patient refusal

    International Nuclear Information System (INIS)

    Martel, J.; Garcia-Diaz, J. D.

    1999-01-01

    We proposed to determine the proportion of patients who refuse to undergo intravenous contrast administration and the factors that influence their refusal. Our series consisted of 442 patients who were supposed to undergo imaging studies involving the intravenous injection of an iodine contrast. In a personal interview, the patients were issued a questionnaire specifically designed for this study. The following parameters were recorded: sex, age, inpatient or outpatient status, medical history available, person who informed them about the procedure, person signing the informed consent (patient or other) , highest academic degree, attitude toward receiving the information and degree of concern after reading and signing the consent form. In our series 8.6% of the patients (95% confidence interval: 6-11.2) refused to sign the informed consent form. In addition, there were a number of patients who delayed the procedure or hindered the daily work schedule by some other means. When the relationship between each of the variables studied and refusal to sign the consent form was assessed, significant associations were observed between the latter and the academic level of the patient, his or her degree of concern and having received the information from a trained person. There was also a nearly significant trend toward the association between refusal and the patient's background. Relatively few patients refuse to sign the informed consent to receive intravenous contrast administration but this negative decision interferes with the health care practice. It is possible to identify certain correctable factors that influence the patient in this respect. (Author) 13 refs

  7. A randomized study of multimedia informational aids for research on medical practices: implications for informed consent

    Science.gov (United States)

    Kraft, Stephanie A; Constantine, Melissa; Magnus, David; Porter, Kathryn M.; Lee, Sandra Soo-Jin; Green, Michael; Kass, Nancy E; Wilfond, Benjamin S.; Cho, Mildred K

    2016-01-01

    Background/aims Participant understanding is a key element of informed consent for enrollment in research. However, participants often do not understand the nature, risks, benefits, or design of the studies in which they take part. Research on medical practices, which studies standard interventions rather than new treatments, has the potential to be especially confusing to participants because it is embedded within usual clinical care. Our objective in this randomized study was to compare the ability of a range of multimedia informational aids to improve participant understanding in the context of research on medical practices. Methods We administered a Web-based survey to members of a proprietary online panel sample selected to match national U.S. demographics. Respondents were randomized to one of five arms: four content-equivalent informational aids (animated videos, slideshows with voiceover, comics, and text), and one no-intervention control. We measured knowledge of research on medical practices using a summary knowledge score from 10 questions based on the content of the informational aids. We used ANOVA and paired t-tests to compare knowledge scores between arms. Results There were 1500 completed surveys (300 in each arm). Mean knowledge scores were highest for the slideshows with voiceover (65.7%), followed by the animated videos (62.7%), comics (60.7%), text (57.2%), and control (50.3%). Differences between arms were statistically significant except between the slideshows with voiceover and animated videos and between the animated videos and comics. Informational aids that included an audio component (animated videos and slideshows with voiceover) had higher knowledge scores than those without an audio component (64.2% versus 59.0%, peffectively than text alone. However, the relatively low knowledge scores suggest that targeted informational aids may be needed to teach some particularly challenging concepts. Nonetheless, our results demonstrate the

  8. National Comparative Audit of Blood Transfusion: report on the 2014 audit of patient information and consent.

    Science.gov (United States)

    Booth, C; Grant-Casey, J; Lowe, D; Court, E L; Allard, S

    2017-11-28

    The aim of this study was to assess current practices around obtaining consent for blood transfusion and provision of patient information in hospitals across the UK and identify areas for improvement. Recommendations from the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) (2011) state that valid consent should be obtained for blood transfusion and documented in clinical records. A standardised source of information should be available to patients. Practices in relation to this have historically been inconsistent. The consent process was studied in hospitals across the UK over a 3-month period in 2014 by means of an audit of case notes and simultaneous surveys of patients and staff. In total, 2784 transfusion episodes were reviewed across 164 hospital sites. 85% of sites had a policy on consent for transfusion. Consent was documented in 43% of case notes. 68% of patients recalled being given information on benefits of transfusion, 38% on risks and 8% on alternatives and 28% reported receiving an information leaflet. In total, 85% of staff stated they had explained the reason for transfusion, but only 65% had documented this. 41% of staff had received training specifically on transfusion consent in the last 2 years. There is a need to improve clinical practice in obtaining valid consent for transfusion in line with existing national guidelines and local Trust policies, with emphasis on documentation within clinical records. Provision of patient information is an area particularly highlighted for action, and transfusion training for clinicians should be strengthened. © 2017 British Blood Transfusion Society.

  9. Nurses' roles in informed consent in a hierarchical and communal context.

    Science.gov (United States)

    Susilo, Astrid P; Van Dalen, Jan; Scherpbier, Albert; Tanto, Sugiharto; Yuhanti, Patricia; Ekawati, Nora

    2013-06-01

    Although the main responsibility for informed consent of medical procedures rests with doctors, nurses' roles are also important, especially as patient advocates. Nurses' preparation for this role in settings with a hierarchical and communal culture has received little attention. We explored the views of hospital managers and nurses regarding the roles of nurses in informed consent and factors influencing these roles. We conducted a qualitative study in a private, multispecialty hospital in Indonesia. Semi-structured interviews were conducted with seven managers. Two rounds of focus group discussions with nurses (n = 27) were conducted. Constant comparative approach was used in the analysis. Nurses can act as manager, witness, information giver, and advocate in the informed consent process. These roles are influenced by nurses' preparedness, hospital culture and policy, patients' understanding, family involvement, and cost-related issues. In preparation for these tasks, nurses should acquire communication skills, clinical knowledge, and legal and ethical knowledge.

  10. Informed consent from cognitively impaired persons participating in research trials: comparative law observations.

    Science.gov (United States)

    Petrini, Carlo

    2011-01-01

    This article addresses the ethical requirements to be considered when conducting clinical trials involving human subjects whose mental condition limits their ability to understand the information and to express fully autonomous and informed consent. It does not address other categories of vulnerable persons, such as children, or advanced directives concerning end-of-life care. There are many ethical issues entailed in clinical trials involving subjects with mental disabilities: how to obtain informed consent, balancing risks and benefits, balancing individual benefits with collective scientific and social interests, legal representation and many more. This article focuses on the issues surrounding the concept of minimal risk and the relationship between informed consent and risk. These issues are addressed with particular emphasis on the regulations adopted by the European Union and the federal government of the United States of America. The conclusion proposes a list of working criteria.

  11. Informed consent from cognitively impaired persons participating in research trials: comparative law observations

    Directory of Open Access Journals (Sweden)

    Carlo Petrini

    2011-12-01

    Full Text Available This article addresses the ethical requirements to be considered when conducting clinical trials involving human subjects whose mental condition limits their ability to understand the information and to express fully autonomous and informed consent. It does not address other categories of vulnerable persons, such as children, or advanced directives concerning end-of-life care. There are many ethical issues entailed in clinical trials involving subjects with mental disabilities: how to obtain informed consent, balancing risks and benefits, balancing individual benefits with collective scientific and social interests, legal representation and many more. This article focuses on the issues surrounding the concept of minimal risk and the relationship between informed consent and risk. These issues are addressed with particular emphasis on the regulations adopted by the European Union and the federal government of the United States of America. The conclusion proposes a list of working criteria.

  12. Recruitment of subjects for clinical trials after informed consent: does gender and educational status make a difference?

    Directory of Open Access Journals (Sweden)

    Gitanjali B

    2003-01-01

    Full Text Available CONTEXT: Researchers and investigators have argued that getting fully informed written consent may not be possible in the developing countries where illiteracy is widespread. AIMS: To determine the percentage of patients who agree to participate in a trial after receiving either complete or partial information regarding a trial and to find out whether there were gender or educational status-related differences. To assess reasons for consenting or refusing and their depth of understanding of informed consent. SETTINGS AND DESIGN: A simulated clinical trial in two tertiary health care facilities on in-patients. METHODS AND MATERIAL: An informed consent form for a mock clinical trial of a drug was prepared. The detailed / partial procedure was explained to a purposive sample of selected in-patients and their consent was asked for. Patients were asked to free list the reasons for giving or withholding consent. Their depth of understanding was assessed using a questionnaire. Chi-square test was used for statistical analyses. RESULTS: The percentages of those consenting after full disclosure 29/102 (30% and after partial disclosure 15/50 (30% were the same. There was a significant (p=0.043 gender difference with a lesser percentage of females (30% consenting to participation in a trial. Educational status did not alter this percentage. Most patients withheld consent because they did not want to give blood or take a new drug. Understanding of informed consent was poor in those who consented. CONCLUSIONS: The fact that only one-third of subjects are likely to give consent to participate in a trial needs to be considered while planning clinical trials with a large sample size. Gender but not educational status influences the number of subjects consenting for a study. Poor understanding of the elements of informed consent in patients necessitates evolving better methods of implementing consent procedures in India.

  13. Doctors’ perspectives of informed consent for non-emergency surgical procedures: a qualitative interview study

    OpenAIRE

    Wood, Fiona; Martin, Sean Michael; Carson-Stevens, Andrew; Elwyn, Glyn; Precious, Elizabeth; Kinnersley, Paul Richard

    2016-01-01

    Background\\ud The need to involve patients more in decisions about their care, the ethical imperative and concerns about ligation and complaints has highlighted the issue of informed consent and how it is obtained. In order for a patient to make an informed decision about their treatment, they need appropriate discussion of the risks and benefits of the treatment.\\ud \\ud Objectives\\ud To explore doctors’ perspectives of gaining informed consent for routine surgical procedures.\\ud \\ud Design\\u...

  14. The quality of informed consent in Croatia-a cross-sectional study and instrument development.

    Science.gov (United States)

    Vučemilo, Luka; Milošević, Milan; Dodig, Doris; Grabušić, Bruno; Đapić, Biljana; Borovečki, Ana

    2016-03-01

    To examine the informed consent process implementation and quality in Croatia using a specially developed instrument. A cross-sectional questionnaire study was conducted in 300 patients (response rate 73%) from six hospitals in Croatia, along with psychometric evaluation of the questionnaire. Signing the informed consent form was a formality for 64% of patients, 54% of patients did not give their written consent, and in 39% of cases physicians made treatment decisions by themselves. The overall informed consent process score was 4.06±0.60 (of 5.00). Physician-patient relationship score was 4.61±0.57, Verbal information 3.99±0.98, Decision making 3.94±0.75, and Written information 3.60±1.42. The overall Cronbach's alpha coefficient was 0.890. Significant correlations were found in relation to Physician-patient relationship and education levels (OR=0.43, 95% CI=0.18-0.99, p=0.048), and Verbal information and duration of health problems (OR=1.83, 95% CI=1.02-3.25, p=0.041). The developed questionnaire is reliable and valid. The informed consent process quality in Croatia was reasonably high, although insufficient and inadequate written materials represent a weak spot that require enhancement. The study contributes to the development of suitable measuring instrument for assessment of the informed consent process quality in clinical practice. The questionnaire could be of use in the hospital accreditation process. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  15. Assault in medical law: revisiting the boundaries of informed consent to medical treatment in South Africa.

    Science.gov (United States)

    Wilson, Maria C I

    2009-05-01

    This article focuses on assault as a cause of action in medical law, with particular emphasis on the requirements for informed consent, both under common law and under the National Health Act 2003 (Sth Africa). In particular, the test for consent, adopted in Castell v De Greef 1994 (4) SA 408 (C), is analysed in detail. It is noted that the wording of this test for informed consent mirrors the wording of the test for negligence laid down in the Australian case of Rogers v Whitaker (1992) 175 CLR 479. Further, the relationship between the delictual elements of wrongfulness and fault in assault is discussed. It is argued that in South African law a valid consent to medical treatment requires knowledge not only of the general nature of medical treatment but also of the consequences of the treatment and, in determining which consequences should be disclosed to a patient, the constitutional rights to equality and self-determination support the application of a subjective patient-centred test for informed consent. However, it is also proposed that the broad right of a patient to information is reined in at the fault element of assault, so that a limited requirement of consciousness of wrongfulness on the part of the defendant negates liability for delictual assault.

  16. [Informed consent process in clinical trials: Insights of researchers, patients and general practitioners].

    Science.gov (United States)

    Giménez, Nuria; Pedrazas, David; Redondo, Susana; Quintana, Salvador

    2016-10-01

    Adequate information for patients and respect for their autonomy are mandatory in research. This article examined insights of researchers, patients and general practitioners (GPs) on the informed consent process in clinical trials, and the role of the GP. A cross-sectional study using three questionnaires, informed consent reviews, medical records, and hospital discharge reports. GPs, researchers and patients involved in clinical trials. Included, 504 GPs, 108 researchers, and 71 patients. Consulting the GP was recommended in 50% of the informed consents. Participation in clinical trials was shown in 33% of the medical records and 3% of the hospital discharge reports. GPs scored 3.54 points (on a 1-10 scale) on the assessment of the information received by the principal investigator. The readability of the informed consent sheet was rated 8.03 points by researchers, and the understanding was rated 7.68 points by patients. Patient satisfaction was positively associated with more time for reflection. GPs were not satisfied with the information received on the participation of patients under their in clinical trials. Researchers were satisfied with the information they offered to patients, and were aware of the need to improve the information GPs received. Patients collaborated greatly towards biomedical research, expressed satisfaction with the overall process, and minimised the difficulties associated with participation. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

  17. Core information sets for informed consent to surgical interventions: baseline information of importance to patients and clinicians.

    Science.gov (United States)

    Main, Barry G; McNair, Angus G K; Huxtable, Richard; Donovan, Jenny L; Thomas, Steven J; Kinnersley, Paul; Blazeby, Jane M

    2017-04-26

    Consent remains a crucial, yet challenging, cornerstone of clinical practice. The ethical, legal and professional understandings of this construct have evolved away from a doctor-centred act to a patient-centred process that encompasses the patient's values, beliefs and goals. This alignment of consent with the philosophy of shared decision-making was affirmed in a recent high-profile Supreme Court ruling in England. The communication of information is central to this model of health care delivery but it can be difficult for doctors to gauge the information needs of the individual patient. The aim of this paper is to describe 'core information sets' which are defined as a minimum set of consensus-derived information about a given procedure to be discussed with all patients. Importantly, they are intended to catalyse discussion of subjective importance to individuals. The model described in this paper applies health services research and Delphi consensus-building methods to an idea orginally proposed 30 years ago. The hypothesis is that, first, large amounts of potentially-important information are distilled down to discrete information domains. These are then, secondly, rated by key stakeholders in multiple iterations, so that core information of agreed importance can be defined. We argue that this scientific approach is key to identifying information important to all stakeholders, which may otherwise be communicated poorly or omitted from discussions entirely. Our methods apply systematic review, qualitative, survey and consensus-building techniques to define this 'core information'. We propose that such information addresses the 'reasonable patient' standard for information disclosure but, more importantly, can serve as a spring board for high-value discussion of importance to the individual patient. The application of established research methods can define information of core importance to informed consent. Further work will establish how best to incorporate

  18. Ophthalmologists' awareness of informed consent and their compliance to its requirements.

    Science.gov (United States)

    Ehteshami, Asghar; Isfahani, Sakineh Saghaeiannejad; Saeedbakhsh, Saeed; Isfahani, Mahtab Kasaei

    2013-01-01

    Healthcare providers' awareness of laws governing medical documents and patients' health-related information is essential in securing the patients' rights. Given the existing legal problems in documentation of medical record of Consent and Acquittal, we decided to perform an investigation examining the levels of ophthalmologists' awareness of legal requirements for medical record of consent and acquittal and how they complied with such requirements at Feiz Teaching Hospital, Isfahan in the year 2011. This research is an applied, descriptive-analytic one. The research population for awareness measurement includes attending ophthalmologists at Feiz Hospital. Filled-in consent record forms recorded in medical document were used to examine the levels of compliance with legal requirements governing medical record of consent and acquittal. Sampling among the attending ophthalmologists was performed using consensus which included 14 ophthalmologists. The files were samples using the statistical formula, resulting in a sample of 303 files. Data collection tools included a questionnaire and a check list. The questionnaire's reliability was estimated through Cronbach's alpha calculation (0.8); and the check list was completed through a survey among professors of Health Information Technology Management department. In a first step, investigators handed a questionnaire containing 12 items to the ophthalmologists in order to assess their levels of awareness from legal Aspects of medical Informed consent and acquittal, and received the completed questionnaire after answering their possible queries on the issue. In the next step the researchers went to the hospital and evaluated the levels of compliance with legal aspects of medical informed consent and acquittal within the files using a check list and by direct observation. Analytic statistics and SPSS software were used to analyze the data; and Pearson test was applied to evaluate the assumed relationship. The findings were

  19. Challenges associated with informed consent in low- and low-middle-income countries

    Directory of Open Access Journals (Sweden)

    Melissa Upjohn

    2016-10-01

    Full Text Available Frontiers in Veterinary Medicine endorse the Helsinki declaration and guidelines of the International Committee of Medical and Journal Editors, including the requirement to obtain informed consent from all research participants. Whilst the concept of informed consent is well understood in western research environments, its components require further consideration when reviewing studies involving humans and owned animals in low- and middle-income countries (LMICs in order to take account of different social, educational and research norms. This piece identifies some of the challenges that need to be considered and how they might affect the process of obtaining informed consent. It explains the approach taken by an animal welfare non-governmental organization working in LMICs to addressing these challenges. It also identifies questions that reviewers might consider when asked to comment on work originating in this context.

  20. I'm shocked: informed consent in ECT and the phenomenological-self.

    Science.gov (United States)

    Seniuk, Patrick

    2018-02-13

    This paper argues that phenomenological insights regarding selfhood are relevant to the informed consent process in the treatment of depression using electro-convulsive therapy (ECT). One of the most significant side-effects associated with ECT is retrograde amnesia. Unfortunately, the current informed consent model does not adequately appreciate the full extent in which memory loss disturbs lived-experience. Through the philosophy of Merleau-Ponty, it is possible to appreciate the way in which memory loss affects a person's self-experience, with emphasis given to one's pre-reflective and embodied, relationship with things in the world. This paper aims to demonstrate that proper informed consent should acknowledge the extent to which repeated ECT treatments affect a patient's sense self.

  1. Truth telling and informed consent: is "primum docere" the new motto of clinical practice?

    Science.gov (United States)

    Byk, Christian

    2007-09-01

    Autonomy has become in many countries a key concept in the patient-physician relationship, leaving the old paternalistic medical attitude out of the realm of common good clinical practice. Consequently, the validity of the informed consent procedure which is related to any medical intervention, should imply that the information given is true. Raising the question as such obliges us to consider the truth not for itself but in regard to the validity of the consent to a medical intervention. Although a clinical approach reveals that loyalty should guide the patient-physician relationship, there are still some situations in which informed consent and truth telling may be controversial: in some circumstances, the physician should or may not tell the truth, in others he can simply forget to tell.

  2. Researcher liability for negligence in human subject research: informed consent and researcher malpractice actions.

    Science.gov (United States)

    Jansson, Roger L

    2003-02-01

    Two sets of federal regulations, the "Common Rule" and Food and Drug Administration (FDA) regulations, govern human subject research that is either federally-funded or involves FDA regulated products. These regulations require, inter alia, that: (1) researchers obtain informed consent from human subjects, and (2) that an Institutional Review Board (IRB) independently review and approve the research protocol. Although the federal regulations do not provide an express cause of action against researchers, research subjects should be able to bring informed consent and malpractice actions against researchers by establishing a duty of care and standard of care. Researchers owe human subjects a duty of care analogous to the special relationship between physicians and patients. The federal regulations should provide the minimum standard of care for informed consent in human subject research, and complying with them should be a partial defense. In contrast, expert testimony should establish the standard of care for researcher malpractice, and IRB approval should be a partial defense.

  3. Doctors' perspectives of informed consent for non-emergency surgical procedures: a qualitative interview study

    NARCIS (Netherlands)

    Wood, F.; Martin, S.M.; Carson-Stevens, A.; Elwyn, G.; Precious, E.; Kinnersley, P.

    2016-01-01

    BACKGROUND: The need to involve patients more in decisions about their care, the ethical imperative and concerns about ligation and complaints has highlighted the issue of informed consent and how it is obtained. In order for a patient to make an informed decision about their treatment, they need

  4. Ethical communication in clinical trials. Issues faced by data managers in obtaining informed consent.

    Science.gov (United States)

    Loh, Winnie Y; Butow, Phyllis N; Brown, Richard F; Boyle, Frances

    2002-12-01

    Informed consent has been proposed as the optimal method for ensuring the ethical entry of patients into clinical trials. However, it is known that problems with informed consent exist from the perspective of both patients and physicians. This has led to the suggestion that a third party, such as a research nurse or data manager, should be responsible for obtaining informed consent. The objective of this study was to explore the views of data managers concerning the nature, challenges, and rewards of their role and the similarities and differences between their role and that of physicians in obtaining informed consent. Four focus groups in three large teaching hospitals were conducted. Twenty-one data managers who were involved in cancer or pain clinical trials participated. The focus groups were audiotaped, transcribed, and subjected to content analysis to identify themes. Data managers identified three primary roles complementary to that of physicians: information provision, quality assurance of the informed consent process, and ongoing support during the trial. Despite expressed concern that medical and drug company interests may lead to subtle coercion of the patient, participants did not support the notion that they may be solely responsible for the consent process. Participants described a range of ethical dilemmas they confronted, including patients asking them for medical details they could not provide and situations in which they felt that informed consent was compromised in some way, for example, dealing with situations in which the patient appeared to be entering the trial for the wrong reasons due to misunderstanding, need, or passivity. Effective functioning of the multidisciplinary team assisted data managers in performing their role. A range of training needs were identified, particularly communication skills training and trial start-up briefing. The issues raised by these data managers have important implications for the successful conduct of

  5. Informed Consent and Cognitive Dysfunction After Noncardiac Surgery in the Elderly.

    Science.gov (United States)

    Hogan, Kirk J; Bratzke, Lisa C; Hogan, Kendra L

    2018-02-01

    Cognitive dysfunction 3 months after noncardiac surgery in the elderly satisfies informed consent thresholds of foreseeability in 10%-15% of patients, and materiality with new deficits observed in memory and executive function in patients with normal test performance beforehand. At present, the only safety step to avoid cognitive dysfunction after surgery is to forego surgery, thereby precluding the benefits of surgery with removal of pain and inflammation, and resumption of normal nutrition, physical activity, and sleep. To assure that consent for surgery is properly informed, risks of both cognitive dysfunction and alternative management strategies must be discussed with patients by the surgery team before a procedure is scheduled.

  6. Contemporary issues concerning informed consent in Japan based on a review of court decisions and characteristics of Japanese culture.

    Science.gov (United States)

    Masaki, Sakiko; Ishimoto, Hiroko; Asai, Atsushi

    2014-02-04

    Since Japan adopted the concept of informed consent from the West, its inappropriate acquisition from patients in the Japanese clinical setting has continued, due in part to cultural aspects. Here, we discuss the current status of and contemporary issues surrounding informed consent in Japan, and how these are influenced by Japanese culture. Current legal norms towards informed consent and information disclosure are obscure in Japan. For instance, physicians in Japan do not have a legal duty to inform patients of a cancer diagnosis. To gain a better understanding of these issues, we present five court decisions related to informed consent and information disclosure. We then discuss Japanese culture through reviews of published opinions and commentaries regarding how culture affects decision making and obtaining informed consent. We focus on two contemporary problems involving informed consent and relevant issues in clinical settings: the misuse of informed consent and persistence in obtaining consent. For the former issue, the phrase "informed consent" is often used to express an opportunity to disclose medical conditions and recommended treatment choices. The casual use of the expression "informed consent" likely reflects deep-rooted cultural influences. For the latter issue, physicians may try to obtain a signature by doing whatever it takes, lacking a deep understanding of important ethical principles, such as protecting human dignity, serving the patient's best interest, and doing no harm in decision-making for patients.There is clearly a misunderstanding of the concept of informed consent and a lack of complete understanding of ethical principles among Japanese healthcare professionals. Although similar in some respects to informed consent as it originated in the United States, our review makes it clear that informed consent in Japan has clear distinguishing features. Japanese healthcare professionals should aim to understand the basic nature of informed

  7. The Legal Nature of Informed Consent from the Perspective of the Spanish and Brasilian Models of Patient Protection

    Directory of Open Access Journals (Sweden)

    Éfren Paulo Porfirio de Sá Lima

    2017-07-01

    Full Text Available The article presented makes a bibliographical and jurisprudential revision about the juridical nature of informed consent and its respective suitability in the selected list of fundamental rights, through the comparative study of the Brazilian and Spanish models of patient protection. The goal is to demonstrate that the informed consent doesn’t directly constitute a fundamental right in both juridical systems analyzed and that the informed consent protects, essentially, freedom and self-determination in health.

  8. Remarks on the Problem of Informed Consent in Japan : The doctor-Patient Relationship and Implicit Personality Theory

    OpenAIRE

    丸山, 久美子

    1998-01-01

    In Japan it is very difficult to investigate the matter of telling the truth to terminally-ill cancer patients or to obtain informed consent from patients. The reason is that there is no consensus about obtaining informed consent from terminally-ill cancer patients or other dying patients. In this study a questionnaire was used regarding cancer notification, informed consent, and the impressions formed of doctors and nurses by various kinds of patients. University students were surveyed regar...

  9. A randomized study of multimedia informational aids for research on medical practices: Implications for informed consent.

    Science.gov (United States)

    Kraft, Stephanie A; Constantine, Melissa; Magnus, David; Porter, Kathryn M; Lee, Sandra Soo-Jin; Green, Michael; Kass, Nancy E; Wilfond, Benjamin S; Cho, Mildred K

    2017-02-01

    Participant understanding is a key element of informed consent for enrollment in research. However, participants often do not understand the nature, risks, benefits, or design of the studies in which they take part. Research on medical practices, which studies standard interventions rather than new treatments, has the potential to be especially confusing to participants because it is embedded within usual clinical care. Our objective in this randomized study was to compare the ability of a range of multimedia informational aids to improve participant understanding in the context of research on medical practices. We administered a web-based survey to members of a proprietary online panel sample selected to match national US demographics. Respondents were randomized to one of five arms: four content-equivalent informational aids (animated videos, slideshows with voice-over, comics, and text) and one no-intervention control. We measured knowledge of research on medical practices using a summary knowledge score from 10 questions based on the content of the informational aids. We used analysis of variance and paired t-tests to compare knowledge scores between arms. There were 1500 completed surveys (300 in each arm). Mean knowledge scores were highest for the slideshows with voice-over (65.7%), followed by the animated videos (62.7%), comics (60.7%), text (57.2%), and control (50.3%). Differences between arms were statistically significant except between the slideshows with voice-over and animated videos and between the animated videos and comics. Informational aids that included an audio component (animated videos and slideshows with voice-over) had higher knowledge scores than those without an audio component (64.2% vs 59.0%, p informational aids with a character-driven story component (animated videos and comics) and those without. Our results show that simple multimedia aids that use a dual-channel approach, such as voice-over with visual reinforcement, can

  10. Informed consent for telemedicine in South Africa: A survey of ...

    African Journals Online (AJOL)

    2013-11-02

    Nov 2, 2013 ... 'the use of information communication technology (ICT) for health'. .... Telemedicine serves the ethical principle of beneficence, in that ..... review of the uses, benefits, and limitations of social media for health communication.

  11. Analisis Penerapan Informed Consent Di Bagian SMF Bedah dan SMF Kandungan RSUD Deli Serdang Lubuk Pakam

    OpenAIRE

    Siahaan, Hetty Erawaty

    2015-01-01

    An Informed consent is individual agreement given by a patient or closed family following get detail information about a medical action or in dental with any option shall be taken upon the patient. The explanation with information given to patient at least including medical diagnosis and the administration, the purpose of action, alternative action and its risks, the other risks and complication may emerge, and prognosis upon the action shall be taken as well as estimation of cost. The inform...

  12. Approaches to informed consent for hypothesis-testing and hypothesis-generating clinical genomics research.

    Science.gov (United States)

    Facio, Flavia M; Sapp, Julie C; Linn, Amy; Biesecker, Leslie G

    2012-10-10

    Massively-parallel sequencing (MPS) technologies create challenges for informed consent of research participants given the enormous scale of the data and the wide range of potential results. We propose that the consent process in these studies be based on whether they use MPS to test a hypothesis or to generate hypotheses. To demonstrate the differences in these approaches to informed consent, we describe the consent processes for two MPS studies. The purpose of our hypothesis-testing study is to elucidate the etiology of rare phenotypes using MPS. The purpose of our hypothesis-generating study is to test the feasibility of using MPS to generate clinical hypotheses, and to approach the return of results as an experimental manipulation. Issues to consider in both designs include: volume and nature of the potential results, primary versus secondary results, return of individual results, duty to warn, length of interaction, target population, and privacy and confidentiality. The categorization of MPS studies as hypothesis-testing versus hypothesis-generating can help to clarify the issue of so-called incidental or secondary results for the consent process, and aid the communication of the research goals to study participants.

  13. Ethical issues in implementation research: a discussion of the problems in achieving informed consent

    Directory of Open Access Journals (Sweden)

    Eccles Martin P

    2008-12-01

    Full Text Available Abstract Background Improved quality of care is a policy objective of health care systems around the world. Implementation research is the scientific study of methods to promote the systematic uptake of clinical research findings into routine clinical practice, and hence to reduce inappropriate care. It includes the study of influences on healthcare professionals' behaviour and methods to enable them to use research findings more effectively. Cluster randomized trials represent the optimal design for evaluating the effectiveness of implementation strategies. Various codes of medical ethics, such as the Nuremberg Code and the Declaration of Helsinki inform medical research, but their relevance to cluster randomised trials in implementation research is unclear. This paper discusses the applicability of various ethical codes to obtaining consent in cluster trials in implementation research. Discussion The appropriate application of biomedical codes to implementation research is not obvious. Discussion of the nature and practice of informed consent in implementation research cluster trials must consider the levels at which consent can be sought, and for what purpose it can be sought. The level at which an intervention is delivered can render the idea of patient level consent meaningless. Careful consideration of the ownership of information, and rights of access to and exploitation of data is required. For health care professionals and organizations, there is a balance between clinical freedom and responsibility to participate in research. Summary While ethical justification for clinical trials relies heavily on individual consent, for implementation research aspects of distributive justice, economics, and political philosophy underlie the debate. Societies may need to trade off decisions on the choice between individualized consent and valid implementation research. We suggest that social sciences codes could usefully inform the consideration of

  14. 76 FR 16000 - Voluntary Protection Programs Information; Extension of the Office of Management and Budget's...

    Science.gov (United States)

    2011-03-22

    ... management programs including how the programs successfully address management leadership and employee...] Voluntary Protection Programs Information; Extension of the Office of Management and Budget's (OMB's... concerning its proposal to extend the Office of Management and Budget's (OMB's) approval of the information...

  15. Effects of informed consent for individual genome sequencing on relevant knowledge.

    Science.gov (United States)

    Kaphingst, K A; Facio, F M; Cheng, M-R; Brooks, S; Eidem, H; Linn, A; Biesecker, B B; Biesecker, L G

    2012-11-01

    Increasing availability of individual genomic information suggests that patients will need knowledge about genome sequencing to make informed decisions, but prior research is limited. In this study, we examined genome sequencing knowledge before and after informed consent among 311 participants enrolled in the ClinSeq™ sequencing study. An exploratory factor analysis of knowledge items yielded two factors (sequencing limitations knowledge; sequencing benefits knowledge). In multivariable analysis, high pre-consent sequencing limitations knowledge scores were significantly related to education [odds ratio (OR): 8.7, 95% confidence interval (CI): 2.45-31.10 for post-graduate education, and OR: 3.9; 95% CI: 1.05, 14.61 for college degree compared with less than college degree] and race/ethnicity (OR: 2.4, 95% CI: 1.09, 5.38 for non-Hispanic Whites compared with other racial/ethnic groups). Mean values increased significantly between pre- and post-consent for the sequencing limitations knowledge subscale (6.9-7.7, p benefits knowledge subscale (7.0-7.5, p < 0.0001); increase in knowledge did not differ by sociodemographic characteristics. This study highlights gaps in genome sequencing knowledge and underscores the need to target educational efforts toward participants with less education or from minority racial/ethnic groups. The informed consent process improved genome sequencing knowledge. Future studies could examine how genome sequencing knowledge influences informed decision making. © 2012 John Wiley & Sons A/S.

  16. Informed consent for clinical trials: a review | Lema | East African ...

    African Journals Online (AJOL)

    Data sources: Published original research findings and reviews in the English literature, together with anecdotal information from our current professional experiences with clinical trials. Design: Review of peer-reviewed articles. Data extraction: Online searches were done and requests for reprints from corresponding ...

  17. Beyond Informed Consent: Ethical Considerations in the Design and ...

    African Journals Online (AJOL)

    AJRH Managing Editor

    people will inevitably be offered services that have only been tested ... capacity to make informed decisions about their long-term best ... autonomy of the adolescent and yet balance this with other .... their own. These children make considerable decisions for themselves. .... essence of their engagement as critical community.

  18. The informed consent process for anaesthesia: perspectives of ...

    African Journals Online (AJOL)

    patient the false impression that anaesthesia and surgery are ... regard to the information divulged by the anaesthetist during ... attitudes of patients with regard to the existing method of obtaining ... any change in how patients view anaesthetists before and ... specific doctors and their specialities, and a belief that all doctors.

  19. Percutaneous coronary intervention patients’ and cardiologists’ experiences of the informed consent process in Northern England: a qualitative study

    Science.gov (United States)

    Probyn, Joy; Greenhalgh, Joanne; Holt, Janet; Conway, Dwayne; Astin, Felicity

    2017-01-01

    Objective Informed consent is central to ethical medical practice, but little is known about how the process takes place in clinical practice. Percutaneous coronary intervention (PCI) is a common revascularisation procedure. Studies report that patients overestimate benefits, forget the risks and are unaware of alternative treatments. The aim of this study was to describe PCI patients’ and cardiologists’ experiences of the informed consent process in acute care settings. Design/setting/participants A qualitative study with a maximum variation sample of elective and acute PCI patients and cardiologists taking their consent, recruited from a district general hospital and tertiary centre. In-depth interviews were conducted, and consent discussions were audio recorded. Data collection, coding and theorising occurred simultaneously. Findings Forty-one (26 male) patients scheduled for elective (20) or urgent (21) PCI and 19 cardiologists (5 female) participated. Despite diversity in patients’ experiences of informed consent, elective and acute patients experienced a common four-stage process of consent. Most patients made the decision to have treatment at PCI referral and took a passive role in the discussions we recorded. They recognised cardiologists as experts, trusted the medical system to ‘fix’ their health problem and were unaware of their role in the informed consent process. Informed consent discussions functioned as a formal ‘event’,enabling cardiologists to check patients’ understanding and enabling patients to access treatment. Conclusions The configuration of services and patients’ perceptions of their role in informed consent underpin a mismatch between legal and ethical principles of informed consent and current practice. The variation in patients’ experiences of the current place of informed consent in service delivery represents a missed opportunity for cardiologists to work in decision-making partnerships with patients. In light of

  20. Percutaneous coronary intervention patients' and cardiologists' experiences of the informed consent process in Northern England: a qualitative study.

    Science.gov (United States)

    Probyn, Joy; Greenhalgh, Joanne; Holt, Janet; Conway, Dwayne; Astin, Felicity

    2017-06-24

    Informed consent is central to ethical medical practice, but little is known about how the process takes place in clinical practice. Percutaneous coronary intervention (PCI) is a common revascularisation procedure. Studies report that patients overestimate benefits, forget the risks and are unaware of alternative treatments. The aim of this study was to describe PCI patients' and cardiologists' experiences of the informed consent process in acute care settings. A qualitative study with a maximum variation sample of elective and acute PCI patients and cardiologists taking their consent, recruited from a district general hospital and tertiary centre. In-depth interviews were conducted, and consent discussions were audio recorded. Data collection, coding and theorising occurred simultaneously. Forty-one (26 male) patients scheduled for elective (20) or urgent (21) PCI and 19 cardiologists (5 female) participated. Despite diversity in patients' experiences of informed consent, elective and acute patients experienced a common four-stage process of consent. Most patients made the decision to have treatment at PCI referral and took a passive role in the discussions we recorded. They recognised cardiologists as experts, trusted the medical system to 'fix' their health problem and were unaware of their role in the informed consent process. Informed consent discussions functioned as a formal 'event',enabling cardiologists to check patients' understanding and enabling patients to access treatment. The configuration of services and patients' perceptions of their role in informed consent underpin a mismatch between legal and ethical principles of informed consent and current practice. The variation in patients' experiences of the current place of informed consent in service delivery represents a missed opportunity for cardiologists to work in decision-making partnerships with patients. In light of recent changes in the law, a new approach to informed consent is required.

  1. Obligation of the radiologist to obtain informed consent

    Energy Technology Data Exchange (ETDEWEB)

    Narr, H

    1983-06-01

    The hazards involved in radiological examinations, especially with contrast media containing iodine, have led to the following postulations: Anamnesis must be thorough and detailed, especially with a view to allergic reactions and other contra-indications. If severe or lethal affections are suspected, preliminary examinations are necessary in those cases where sufficiently reliable findings are not available. Preliminary testing and reaction prophylaxis should be carried out if necessary. The same applies to general premedication. The information talk as well as the operative procedure must be carried out by the responsible attending physician. Only those contrast media should be applied that are commonly used and well-tested. Contrast media must not be injected for test purposes. Special mention must be made of complications that will surprise the non-expert patient, complications that may lead to incidents requiring treatment, and complications that may be fatal. Information is necessary if severe and long-term damage may occur. Information even on hardly possible and infrequent complications is particularly necessary in those cases where the diagnostic intervention does not justify hopes of healing or even saving the patient. As far as particularly hazardous methods of examination are concerned, it may be better, especially with patients of advanced age, not to carry out any such examination unless there is a vital or absolute indication.

  2. Informed consent recall and comprehension in orthodontics: traditional vs improved readability and processability methods.

    Science.gov (United States)

    Kang, Edith Y; Fields, Henry W; Kiyak, Asuman; Beck, F Michael; Firestone, Allen R

    2009-10-01

    Low general and health literacy in the United States means informed consent documents are not well understood by most adults. Methods to improve recall and comprehension of informed consent have not been tested in orthodontics. The purposes of this study were to evaluate (1) recall and comprehension among patients and parents by using the American Association of Orthodontists' (AAO) informed consent form and new forms incorporating improved readability and processability; (2) the association between reading ability, anxiety, and sociodemographic variables and recall and comprehension; and (3) how various domains (treatment, risk, and responsibility) of information are affected by the forms. Three treatment groups (30 patient-parent pairs in each) received an orthodontic case presentation and either the AAO form, an improved readability form (MIC), or an improved readability and processability (pairing audio and visual cues) form (MIC + SS). Structured interviews were transcribed and coded to evaluate recall and comprehension. Significant relationships among patient-related variables and recall and comprehension explained little of the variance. The MIC + SS form significantly improved patient recall and parent recall and comprehension. Recall was better than comprehension, and parents performed better than patients. The MIC + SS form significantly improved patient treatment comprehension and risk recall and parent treatment recall and comprehension. Patients and parents both overestimated their understanding of the materials. Improving the readability of consent materials made little difference, but combining improved readability and processability benefited both patients' recall and parents' recall and comprehension compared with the AAO form.

  3. REALIZATION OF INFORMED CONSENT AS ONE OF PATIENT'S RIGHTS: CURRENT SITUATION IN AZERBAIJAN.

    Science.gov (United States)

    Rustamova, F A; Mammadov, V G; Munir, K M

    Azerbaijan is a country in which the law is based on democratic principles. The mentioned principles underlie the national health care law. Democratic values, such as respect for human rights and freedoms, human dignity, as well as universal bioethical principles that are widely implemented in the national law, create conditions for the implementation of the patient's rights. The basic law governing the doctor-patient relationship, Law on Protection of Health of Population in Azerbaijan, reflects the basic patients' rights and obligations of doctors and medical institutions. Informed consent, which is a key component of patient rights, is also reflected, however, to date, a significant drawback of the Azerbaijan medical legislation is described in the article in this field. For example, at the moment there is no single standardized informed consent form in the country's different medical institutions. Due to the absence of any legally approved standards for informed consent forms, public and private health care institutions individually develop such forms, which sometimes can differ significantly. At the moment, one of the important directions in the field of healthcare is its improvement in accordance with international standards. The research made it possible to make conclusions about the necessary measures to improve and unify the informed consent form. The authors also analyzed the main provisions of the medical law of Azerbaijan and identified the main trends of its further development.

  4. 38 CFR 17.32 - Informed consent and advance care planning.

    Science.gov (United States)

    2010-07-01

    ...) Definitions: Advance Directive. Specific written statements made by a patient who has decision-making capacity.... Decision-making capacity. The ability to understand and appreciate the nature and consequences of health... informed consent on behalf of a patient who lacks decision-making capacity. (b) Policy. Except as otherwise...

  5. Responsibility and intersubjectivity as challenge to informed consent

    DEFF Research Database (Denmark)

    Andersen, Anne Mette Fruelund

    2006-01-01

    rådgivning i Danmark. Gennem interviews med patienter kommer der gode eksempler på, hvilke ansvarsrelationer, der er på spil mellem læge og patient, indenfor familien og for den enkelte person, der søger rådgivning og testning. Udover selve beslutningen om test, skal patienten tage stilling til, hvem der...... vanskeligheden ved at håndtere videnskabelig information og usikkerhed at tage hensyn til i vurderingen af de konkrete ansvarsrelationer. Det informerede samtykke problematiseres ud fra analysen af ansvar og intersubjektivitet. Det globale perspektiv ved ansvar og bioteknologi berøres kort i form af en...

  6. Considerations of informed consent and decision-making competence in older adults with cognitive impairment.

    Science.gov (United States)

    Mayo, Ann M; Wallhagen, Margaret I

    2009-04-01

    Including older adults with cognitive impairment in research studies is necessary to ensure that interventions designed to improve care are effective for all older adults. However, issues related to capacity to consent raise many difficult questions that nurse researchers must address. Protecting vulnerable participants while simultaneously maintaining autonomy and moving important research forward can be challenging. Assessing the decision-making abilities of understanding, appreciation, reasoning, and expressing a choice is an important aspect of determining decision-making capacity. Yet although this is the prominent rational method for judging decision-making competence, it does not take into consideration the importance of culture, values, and emotions. This article focuses on the assessment of decision-making capacity to consent, recommendations for obtaining informed consent in older adults with cognitive impairment, the use of surrogate decision makers, strategies to maximize research participation, and directions for future research. Copyright 2009, SLACK Incorporated.

  7. Quality and extent of informed consent for invasive procedures: a pilot study at the institutional level in Turkey.

    Science.gov (United States)

    Dogan, H Hanzade; Işik, Elif; Vural, Ezgi; Vehid, Hayriye; Brezis, Mayer

    2015-02-01

    To assess the quality of informed consent for patients undergoing invasive procedures and to reveal patient preferences for being informed about the potential risks of treatment and alternatives to treatment. This study was planned as a pilot study. Hospitalized patients' perceptions and expectations about the informed-consent process were explored in a general surgery department. The prepared questionnaire was completed by patients via interview. Inpatient services of the general surgery department of a large academic hospital in Istanbul, Turkey. The study population consisted of hospitalized patients in a general surgery department who underwent invasive procedures in March 2013. Recognition of consent forms by the patients, rate of patients' recall of risks, rate of patients who were willing to be involved in decision making, and rate of patients who were satisfied with the whole decision-making process were measured. All patients signed consent forms. Most patients did not properly read the consent form since they trusted their physician. Potential exposure to risk seemed to be important for patient expectations. Paternalism seemed to dominate our clinical setting. The informed-consent process was definitely a separate issue from signing the consent forms. We conclude that the informed-consent process should be modified to be more functional and appropriate to human psychology. We suggest that education is necessary for informed consent to promote better quality and safety in health care. © The Author 2014. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

  8. Loss of possession: concussions, informed consent, and autonomy.

    Science.gov (United States)

    Robeson, Richard; King, Nancy M P

    2014-01-01

    The recent explosion of publicity about the dangers of concussion in contact sports - particularly in football - represents the unraveling of a disinformation campaign by the NFL amid growing public and professional concern about the game's long-term risks of harm. The persistence of controversy and denial reflects a cultural view of football players as serving the needs of the team, a resulting evidentiary skepticism, and resistance to rule changes as excessive or unenforceable. This article considers the cultural context of informed decision making by parents of youth football players and suggests that policy changes designed to lower (although they cannot eliminate) risks of brain injury have the potential to change both the culture of football and the way the benefits and harms of the game are regarded for its players, without loss of its essential excitement and appeal. © 2014 American Society of Law, Medicine & Ethics, Inc.

  9. [The meaning of autonomy in Chinese culture: obtaining informed consent for operation].

    Science.gov (United States)

    Lin, Mei-Ling; Wu, Jo Yung-Wei; Huang, Mei-Chih

    2008-10-01

    The purpose of gaining the patient's informed consent is ethical, lying in respect for his or her autonomy, and such consent forms the foundation for the performance of clinical medical treatment. In order to respect the patient's autonomy, for example, during decisions about operations, doctors have the obligation to clearly explain that patient's medical condition to him/her. A thorough briefing should be given prior to the obtaining of the patients' consent. In fulfillment of their duties as medical professionals, both doctors and nurses should be involved in clinically informing patients as well as in obtaining their signature for operation and anesthesia. Although informing patients about their physical state is not the responsibility of nurses, it remains absolutely necessary for nurses to understand how people in Asian cultures understand autonomy. This paper begins with a discussion of autonomy in ethics, and then outlines the differences between the Eastern and Western concepts of autonomy, before discussing the obtaining of the signature of consent, a process performed by the nursing staff during clinical treatment, and resulting in the provision of such signatures by patients with the legal capacity to provide them.

  10. [Ethical dilemma in research: informed consent in clinical studies on persons with dementia].

    Science.gov (United States)

    Sinoff, Gary

    2012-09-01

    With the world's population aging, there is an increase in the number of demented elderly. It is vital to study this phenomenon in epidemiological and clinical studies, particularly the effects on the increasing numbers of demented elderly. Researchers need to understand the factors predicting the general decline in the demented elderly. However, before any research is undertaken, it is necessary to obtain approval from the Local Internal Review Board. This committee is responsible to maintain accepted national and international ethical standards. The basis for recruitment to a study is the signature on the informed consent form, where the patient is required to understand the study, internalize the study's aim, to consider all options and finally, to express an opinion. Potential elderly participants need to have their judgment evaluated before signing the form. In cases where the subject is incapable, some countries, including Israel, require that there be a legal guardianship. This is a long and complicated process that causes researchers not to recruit demented patients into a study which may actually be beneficial to all. Some countries allow a proxy to sign informed consent forms to permit the demented subject to participate in the study. Often the threshold may depend on the invasiveness of the intervention. The problem of proxies to sign informed consent form troubles researchers worldwide. This article addresses the history and development of ethics in research, and raises the issue to promote an official policy for proxy consent signing.

  11. Improved participants' understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials.

    Science.gov (United States)

    Koonrungsesomboon, Nut; Tharavanij, Thipaporn; Phiphatpatthamaamphan, Kittichet; Vilaichone, Ratha-Korn; Manuwong, Sudsayam; Curry, Parichat; Siramolpiwat, Sith; Punchaipornpon, Thanachai; Kanitnate, Supakit; Tammachote, Nattapol; Yamprasert, Rodsarin; Chanvimalueng, Waipoj; Kaewkumpai, Ruchirat; Netanong, Soiphet; Kitipawong, Peerapong; Sritipsukho, Paskorn; Karbwang, Juntra

    2017-02-01

    This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions. A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing the questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥80%, and the secondary endpoint was the total score of the post-test. The proportion of the participants in the SIDCER ICF group who achieved the primary endpoint was significantly higher than that of the conventional ICF group (60.8 vs. 41.4%, p = 0.002). The total score of the post-test was also significantly higher among the participants who read the SIDCER ICF than those who read the conventional ICF (83.3 vs. 76.0%, p study demonstrated that the SIDCER ICF was applicable and effective to improve Thai research participants' understanding of research information in diverse clinical trials. Using the SIDCER ICF methodology, clinical researchers can improve the quality of ICFs for their trials.

  12. 31 CFR 103.110 - Voluntary information sharing among financial institutions.

    Science.gov (United States)

    2010-07-01

    ... Information Sharing Procedures To Deter Money Laundering and Terrorist Activity § 103.110 Voluntary.... 5312(a)(2) that is required under this part to establish and maintain an anti-money laundering program... suspects may involve possible terrorist activity or money laundering. (2) Notice requirement. A financial...

  13. 75 FR 43486 - Proposed Information Collection; Comment Request; Voluntary Self-Disclosure of Antiboycott...

    Science.gov (United States)

    2010-07-26

    ... Request; Voluntary Self- Disclosure of Antiboycott Violations AGENCY: Bureau of Industry and Security... Administration Regulations (EAR) by providing a method for industry to voluntarily self-disclose antiboycott violations. Companies wishing to voluntarily self-disclose antiboycott may submit pertinent information, as...

  14. Probing the Issue of Informed Consent in Health Care in Korea–Concept Analysis and Guideline Development

    Directory of Open Access Journals (Sweden)

    Won-Hee Lee, RN, PhD

    2008-06-01

    Conclusion: The guidelines developed in the present study offer empirical parameters for an effective process of obtaining informed consent in Korea by seeking to decrease the gap in perceptions of informed consent among patients, family members, physicians, and nurses. The importance of advocating patients and developing a trusting relationship between health care providers and patients is especially noteworthy.

  15. Specimen collection for induced pluripotent stem cell research: harmonizing the approach to informed consent.

    Science.gov (United States)

    Lowenthal, Justin; Lipnick, Scott; Rao, Mahendra; Hull, Sara Chandros

    2012-05-01

    Induced pluripotent stem cells (iPSCs) have elicited excitement in both the scientific and ethics communities for their potential to advance basic and translational research. They have been hailed as an alternative to derivation from embryos that provides a virtually unlimited source of pluripotent stem cells for research and therapeutic applications. However, research with iPSCs is ethically complex, uniquely encompassing the concerns associated with genomics, immortalized cell lines, transplantation, human reproduction, and biobanking. Prospective donation of tissue specimens for iPSC research thus requires an approach to informed consent that is constructed for this context. Even in the nascent stages of this field, approaches to informed consent have been variable in ways that threaten the simultaneous goals of protecting donors and safeguarding future research and translation, and investigators are seeking guidance. We address this need by providing concrete recommendations for informed consent that balance the perspectives of a variety of stakeholders. Our work combines analysis of consent form language collected from investigators worldwide with a conceptual balancing of normative ethical concerns, policy precedents, and scientific realities. Our framework asks people to consent prospectively to a broad umbrella of foreseeable research, including future therapeutic applications, with recontact possible in limited circumstances. We argue that the long-term goals of regenerative medicine, interest in sharing iPSC lines, and uncertain landscape of future research all would be served by a framework of ongoing communication with donors. Our approach balances the goals of iPSC and regenerative medicine researchers with the interests of individual research participants.

  16. Radiological informed consent in cardiovascular imaging: towards the medico-legal perfect storm?

    Directory of Open Access Journals (Sweden)

    Loré Cosimo

    2007-10-01

    Full Text Available Abstract Use of radiation for medical examinations and tests is the largest manmade source of radiation exposure. No one can doubt the immense clinical and scientific benefits of imaging to the modern practice of medicine. Every radiological and nuclear medicine examination confers a definite (albeit low long-term risk of cancer, but patients undergoing such examinations often receive no or inaccurate information about radiological dose exposure and corresponding risk directly related to the radiological dose received. Too detailed information on radiological dose and risk may result in undue anxiety, but information "economical with the truth" may violate basic patients' rights well embedded in ethics (Oviedo convention 1997 and law (97/43 Euratom Directive 1997. Informed consent is a procedure needed to establish a respectful and ethical relation between doctors and patients. Nevertheless, in an "ideal" consent process, the principle of patient autonomy in current radiological practice might be reinforced by making it mandatory to obtain explicit and transparent informed consent form for radiological examination with high exposure (≥ 500 chest x-rays. The form may spell-out the type of examination, the exposure in effective dose (mSv, derived from reference values in guidelines or – better – from actual values from their department. The dose equivalent might be also expressed in number of chest radiographs and the risk of cancer as number of extra cases in the exposed population, derived from most recent and authorative guidelines (e.g., BEIR VII Committee, release 2006. Common sense, deontological code, patients'rights, medical imaging guidelines, Euratom law, all coherently and concordantly encourage and recommend a justified, optimized, responsible and informed use of testing with ionizing radiation. Although the idea of informed consent for radiation dose does not seem to be on the immediate radar screen at least in the US, the

  17. Informed Consent

    Science.gov (United States)

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  18. [Pitfalls in informed consent: a statistical analysis of malpractice law suits].

    Science.gov (United States)

    Echigo, Junko

    2014-05-01

    In medical malpractice law suits, the notion of informed consent is often relevant in assessing whether negligence can be attributed to the medical practitioner who has caused injury to a patient. Furthermore, it is not rare that courts award damages for a lack of appropriate informed consent alone. In this study, two results were arrived at from a statistical analysis of medical malpractice law suits. One, unexpectedly, was that the severity of a patient's illness made no significant difference to whether damages were awarded. The other was that cases of typical medical treatment that national medical insurance does not cover were involved significantly more often than insured treatment cases. In cases where damages were awarded, the courts required more disclosure and written documents of information by medical practitioners, especially about complications and adverse effects that the patient might suffer.

  19. One step forward, two steps back? The GMC, the common law and 'informed' consent.

    Science.gov (United States)

    Fovargue, Sara; Miola, José

    2010-08-01

    Until 2008, if doctors followed the General Medical Council's (GMC's) guidance on providing information prior to obtaining a patient's consent to treatment, they would be going beyond what was technically required by the law. It was hoped that the common law would catch up with this guidance and encourage respect for patients' autonomy by facilitating informed decision-making. Regrettably, this has not occurred. For once, the law's inability to keep up with changing medical practice and standards is not the problem. The authors argue that while the common law has moved forward and started to recognise the importance of patient autonomy and informed decision-making, the GMC has taken a step back in their 2008 guidance on consent. Indeed, doctors are now required to tell their patients less than they were in 1998 when the last guidance was produced. This is an unfortunate development and the authors urge the GMC to revisit their guidance.

  20. Ethical principles of informed consent: exploring nurses' dual role of care provider and researcher.

    Science.gov (United States)

    Judkins-Cohn, Tanya M; Kielwasser-Withrow, Kiersten; Owen, Melissa; Ward, Jessica

    2014-01-01

    This article describes the ethical principles of autonomy, beneficence, and justice within the nurse researcher-participant relationship as these principles relate to the informed consent process for research. Within this process, the nurse is confronted with a dual role. This article describes how nurses, who are in the dual role of care provider and researcher, can apply these ethical principles to their practice in conjunction with the American Nurses Association's code of ethics for nurses. This article also describes, as an element of ethical practice, the importance of using participant-centered quality measures to aid informed decision making of participants in research. In addition, the article provides strategies for improving the informed consent process in nursing research. Finally, case scenarios are discussed, along with the application of ethical principles within the awareness of the dual role of the nurse as care provider and researcher. Copyright 2014, SLACK Incorporated.

  1. Informed consent instead of assent is appropriate in children from the age of twelve: Policy implications of new findings on children's competence to consent to clinical research

    NARCIS (Netherlands)

    Hein, I.M.; de Vries, M.C.; Troost, P.W.; Meynen, G.; van Goudoever, J.B.; Lindauer, R.J.

    2015-01-01

    Background: For many decades, the debate on children's competence to give informed consent in medical settings concentrated on ethical and legal aspects, with little empirical underpinnings. Recently, data from empirical research became available to advance the discussion. It was shown that

  2. Informed consent instead of assent is appropriate in children from the age of twelve: Policy implications of new findings on children's competence to consent to clinical research

    NARCIS (Netherlands)

    Hein, Irma M.; de Vries, Martine C.; Troost, Pieter W.; Meynen, Gerben; van Goudoever, Johannes B.; Lindauer, Ramón J. L.

    2015-01-01

    For many decades, the debate on children's competence to give informed consent in medical settings concentrated on ethical and legal aspects, with little empirical underpinnings. Recently, data from empirical research became available to advance the discussion. It was shown that children's

  3. Informed consent in contrast-enhanced CT. Understanding of risks and identification of possible prognostic factors

    International Nuclear Information System (INIS)

    Roehrl, S.; Dendl, L.M.; Scharf, G.; Stroszczynski, C.; Schreyer, A.G.; Zeman, F.

    2015-01-01

    Aim of our study was to assess understanding of risks associated with intravascular application of contrast media in patients undergoing CT examination. We wanted to evaluate epidemiologic and socio-economic prognostic factors for a higher understanding of risks. Additionally, we evaluated a possible correlation between an extensive, outcome-oriented oral informed consent and better understanding of risks. 120 patients distributed in 2 study arms participated in this prospective study. In study arm I, the treating physician was not informed that his patients participated in a study whereas the physician in study arm II knew about the survey. After the informed consent we performed a standardized, semi-structured interview to enquire the 3 most frequent risks of intravascular application of contrast agents (anaphylactoid reactions, nephropathy and thyrotoxic crisis) and epidemiologic data. The understanding of the risks was evaluated using a 6 point scale. Patients scored 3.73 points in study arm I and 4.93 points in arm II on average. The statistical difference between both study arms was highly significant (p < 0.001). In a combined logistic regression analysis, only ''higher education'' (p = 0.001) and participation in study arm II (p =0.001) showed a significant connection to a better understanding of risks. Patients profit from an outcome-oriented and individualized informed consent. Due to the significant correlation between educational level and understanding of risks, informed consent should be adjusted to the educational status of the individual patient, e.g. by using didactic aids or individualized information sheets.

  4. A cognitive approach for design of a multimedia informed consent video and website in pediatric research.

    Science.gov (United States)

    Antal, Holly; Bunnell, H Timothy; McCahan, Suzanne M; Pennington, Chris; Wysocki, Tim; Blake, Kathryn V

    2017-02-01

    Poor participant comprehension of research procedures following the conventional face-to-face consent process for biomedical research is common. We describe the development of a multimedia informed consent video and website that incorporates cognitive strategies to enhance comprehension of study related material directed to parents and adolescents. A multidisciplinary team was assembled for development of the video and website that included human subjects professionals; psychologist researchers; institutional video and web developers; bioinformaticians and programmers; and parent and adolescent stakeholders. Five learning strategies that included Sensory-Modality view, Coherence, Signaling, Redundancy, and Personalization were integrated into a 15-min video and website material that describes a clinical research trial. A diverse team collaborated extensively over 15months to design and build a multimedia platform for obtaining parental permission and adolescent assent for participant in as asthma clinical trial. Examples of the learning principles included, having a narrator describe what was being viewed on the video (sensory-modality); eliminating unnecessary text and graphics (coherence); having the initial portion of the video explain the sections of the video to be viewed (signaling); avoiding simultaneous presentation of text and graphics (redundancy); and having a consistent narrator throughout the video (personalization). Existing conventional and multimedia processes for obtaining research informed consent have not actively incorporated basic principles of human cognition and learning in the design and implementation of these processes. The present paper illustrates how this can be achieved, setting the stage for rigorous evaluation of potential benefits such as improved comprehension, satisfaction with the consent process, and completion of research objectives. New consent strategies that have an integrated cognitive approach need to be developed and

  5. Reducing information asymmetry in the power industry: Mandatory and voluntary information disclosure regulations of sulfur dioxide emission

    International Nuclear Information System (INIS)

    Zhu Xufeng; Zhang Chao

    2012-01-01

    This paper focuses on the institutional framework for sulfur dioxide emission information disclosure (SDEID) in power industries. The authors argue that mandatory and voluntary SDEID are two complementary regulatory instruments for emission reduction in the power industry. An analytical framework of SDEID with six facets is suggested in this paper to demonstrate relevant legal provisions and regulatory policies of mandatory and voluntary SDEID of power industries in the US. Empirical research shows that mandatory and voluntary SDEID of the power industry have been regulated simultaneously in the US. The foundation of power companies' willingness to disclose emission information voluntarily is the combination of mandatory scientific monitoring with market regulation in the current SDEID system in the US. In comparison, the SDEID of power industries has yet to be widely implemented in developing countries. Finally, the paper provides some implications to developing countries that plan to learn institutional arrangements from developed countries. - Highlights: ► Mandatory and voluntary SDEID are two complementary regulatory instruments. ► An analytical framework is suggested to demonstrate SDEID of power industry in the US. ► Voluntary disclosure can be attributed to scientific monitoring and market regulation. ► We provide implications to developing countries learning from developed countries.

  6. Readability of informed consent forms in clinical trials conducted in a skin research center

    Science.gov (United States)

    Samadi, Aniseh; Asghari, Fariba

    2016-01-01

    Obtaining informed consents is one of the most fundamental principles in conducting a clinical trial. In order for the consent to be informed, the patient must receive and comprehend the information appropriately. Complexity of the consent form is a common problem that has been shown to be a major barrier to comprehension for many patients. The objective of this study was to assess the readability of different templates of informed consent forms (ICFs) used in clinical trials in the Center for Research and Training in Skin Diseases and Leprosy (CRTSDL), Tehran, Iran. This study was conducted on ICFs of 45 clinical trials of the CRTSDL affiliated with Tehran University of Medical Sciences. ICFs were tested for reading difficulty, using the readability assessments formula adjusted for the Persian language including the Flesch–Kincaid reading ease score, Flesch–Kincaid grade level, and Gunning fog index. Mean readability score of the whole text of ICFs as well as their 7 main information parts were calculated. The mean ± SD Flesch Reading Ease score for all ICFs was 31.96 ± 5.62 that is in the difficult range. The mean ± SD grade level was calculated as 10.71 ± 1.8 (8.23–14.09) using the Flesch–Kincaid formula and 14.64 ± 1.22 (12.67–18.27) using the Gunning fog index. These results indicate that the text is expected to be understandable for an average student in the 11th grade, while the ethics committee recommend grade level 8 as the standard readability level for ICFs. The results showed that the readability scores of ICFs assessed in our study were not in the acceptable range. This means they were too complex to be understood by the general population. Ethics committees must examine the simplicity and readability of ICFs used in clinical trials. PMID:27471590

  7. Lessons learned obtaining informed consent in research with vulnerable populations in community health center settings

    Directory of Open Access Journals (Sweden)

    Riden Heather E

    2012-11-01

    Full Text Available Abstract Background To improve equity in access to medical research, successful strategies are needed to recruit diverse populations. Here, we examine experiences of community health center (CHC staff who guided an informed consent process to overcome recruitment barriers in a medical record review study. Methods We conducted ten semi-structured interviews with CHC staff members. Interviews were audiotaped, transcribed, and structurally and thematically coded. We used NVivo, an ethnographic data management software program, to analyze themes related to recruitment challenges. Results CHC interviewees reported that a key challenge to recruitment included the difficult balance between institutional review board (IRB requirements for informed consent, and conveying an appropriate level of risk to patients. CHC staff perceived that the requirements of IRB certification itself posed a barrier to allowing diverse staff to participate in recruitment efforts. A key barrier to recruitment also included the lack of updated contact information on CHC patients. CHC interviewees reported that the successes they experienced reflected an alignment between study aims and CHC goals, and trusted relationships between CHCs and staff and the patients they recruited. Conclusions Making IRB training more accessible to CHC-based staff, improving consent form clarity for participants, and developing processes for routinely updating patient information would greatly lower recruitment barriers for diverse populations in health services research.

  8. Participants' Understanding of Informed Consent in a Randomized Controlled Trial for Chronic Knee Pain.

    Science.gov (United States)

    Guillemin, Marilys; Barnard, Emma; Walker, Hannah; Bennell, Kim; Hinman, Rana; Gillam, Lynn

    2015-12-01

    This study explored participants' experiences of randomized controlled trial (RCT) participation to examine their understanding of the trial design and whether their consent was indeed informed. A nested qualitative interview study was conducted with 38 participants from a sample of 282 who participated in a complex RCT evaluating the effectiveness of laser compared with needle acupuncture for chronic knee pain. Overall participants had a good understanding of the RCT, and concepts such as randomization and placebo. Their experiences of being in the trial were largely positive, even if they did not experience any knee pain improvement. Their responses to unblinding at the end of the study were accepting. Participants had a good functional understanding of the RCT, sufficient for valid informed consent. © The Author(s) 2015.

  9. Informed consent and registry-based research - the case of the Danish circumcision registry

    DEFF Research Database (Denmark)

    Ploug, Thomas; Holm, Søren

    2017-01-01

    Background: Research into personal health data holds great potential not only for improved treatment but also for economic growth. In these years many countries are developing policies aimed at facilitating such research often under the banner of 'big data'. A central point of debate is whether...... the secondary use of health data requires informed consent if the data is anonymised. In 2013 the Danish Minister of Health established a new register collecting data about all ritual male childhood circumcisions in Denmark. The main purpose of the register was to enable future research into the consequences......) polarised research, and that a person may therefore have a strong and legitimate interest in deciding whether or not such data should be collected and/or used in research. This casts doubt on the claim that the requirement of informed consent could and should be waived for all types of secondary research...

  10. Variability in the Perception of Informed Consent for IV-tPA during TeleStroke Consultation

    Directory of Open Access Journals (Sweden)

    Lisa Elizabeth Thomas

    2012-08-01

    Full Text Available OBJECTIVE: To study the perception of informed consent among various raters for thrombolysis in acute ischemic stroke patients receiving IV-tPA.METHODS: Twenty randomly selected videotaped telestroke consultations of acute stroke patients administered IV-tPA were retrospectively reviewed. Adequacy of informed consent was reviewed by 5 raters: a neurologist and emergency physician who routinely treat stroke, a medical risk management paralegal, a bioethicist, and a lay person. Raters assessed the quality of the informed consent presentation by the treating physician and the degree of understanding demonstrated by the patient/family authorizing consent. Factors associated with adequacy of consent were analyzed. RESULTS: Consent was rated as adequately understood by the patient-family in 78.6% cases. Agreement between all 5 raters with regard to the patient-family understanding of consent was poor and also between the subgroups of non-physician and physician (all k< 0.20. Similarly, the quality of the physician consent process was poor for agreement between all 5 raters (k=0.07 or between the subgroup of the 3 non-physician raters (k=-0.06 and fair between the 2 physician raters (k=0.24. The legal reviewer and the bioethicist rated the physician consent process as being of lower quality than did the two physicians and the layperson. CONCLUSION: Despite high variability in the perception of informed consent among raters in this time-sensitive clinical situation, almost 80% of patients were rated by all reviewers as having adequate understanding of risks and benefits of tPA. This suggests the need for a standardized but brief tPA consent process that includes patient/family demonstration of understanding.

  11. Framing and personalizing informed consent to prevent negative expectations: An experimental pilot study.

    Science.gov (United States)

    Heisig, Sarah R; Shedden-Mora, Meike C; Hidalgo, Pablo; Nestoriuc, Yvonne

    2015-10-01

    Informing patients about medical treatments and their possible side effects is ethically and legally obligatory but may trigger negative expectations and nocebo-related side effects. This pilot study aims to investigate the effect of different informed consent procedures on treatment expectations for adjuvant breast cancer treatments (Study 1: endocrine therapy; Study 2: chemotherapy). Using an experimental 2-factorial design, healthy women were informed about endocrine therapy (n = 60) or chemotherapy (n = 64) within a hypothetical scenario. Information was framed with or without treatment benefit information and delivered in a personalized or standardized interaction. Primary outcomes were necessity-concern beliefs about the treatment and side-effect expectations, secondary outcomes were decisional conflicts. In Study 1, side-effect expectations (η²p= .08) and decisional conflicts (η²p = .07) were lower when framed treatment information was given. Providing personalized information resulted in more functional necessity-concern beliefs (η²p = .06) and lower decisional conflicts (η²p = .07). Personalizing and framing of information resulted in more functional necessity-concern beliefs (η²p = .10) and lower decisional conflicts. In Study 2, necessity-concern beliefs were more functional with framing (η²p = .06). Participants in the personalized groups reported lower decisional conflicts (η²p = .06). No differences in side-effect expectations were revealed. This is the first study to provide evidence for optimized treatment expectations through altered informed consent strategies. The results emphasize that framing and personalizing informed consent can positively influence treatment expectations and reduce decisional conflicts. However, generalizations are impaired by the study's pilot character. The potential to prevent nocebo responses in clinical practice should be analyzed. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

  12. Informed Consent and Psychotherapy : An Interpretative Phenomenological Analysis of Therapists’ Views.

    OpenAIRE

    Goddard, Angela; Murray, Craig; Simpson, Jane

    2008-01-01

    Objectives: To examine the issue of informed consent and how this is translated into clinical psychotherapy practice. Design: A qualitative approach was taken in which interviews were used to produce data. Methods: Nine clinical psychologists with specialist psychodynamic training took part in the research. Participants were interviewed using a semi-structured interview schedule. The interviews were transcribed and the data were analysed using Interpretative Phenomenological Analysis. Results...

  13. Using video-taped examples of standardized patient to teach medical students taking informed consent

    Directory of Open Access Journals (Sweden)

    SHIRIN HABIBI KHORASANI

    2015-04-01

    Full Text Available Introduction: Medical student should be trained in medical ethics and one of the most essential issues in this field is taking informed consents. In this research, we compared the effect of effectiveness of teaching methods on students’ ability in taking informed consent from patients. Methods: This semi-experimental study was carried out on fifty eight subjects from the 4th-year students of Shiraz University of Medical Sciences who attended in medical ethics course before their ‘clinical clerkship’training.Method of sampling was census and students were randomly allocated into two groups of control group (n=28 was trained in traditional lecture-based class and the case groupnamed as A1 (n=22 were taught by video-taped examples of standardized patient.Then A1 group attended in traditional lecture-based classes named as A2. The groups were evaluated in terms the ability of recognition of ethical issues through the scenario based ethical examination before and after each training. Scenarios were related to the topics of informed consent. Data were analyzed by SPSS 14 software using descriptive statistics and anova test. P-value less than 0.05 was considered as significant. Results: The mean scores results of A2, A1 and B group were found to be 7.21, 5.91 and 5.73 out of 8, respectively. Comparison between the groups demonstrated that the ability of taking informed consent was significantly higher in A2 group (p<0.001, followed by A1 group (p<0.05, while was the least in the B group (p=0.875. Conclusion: According to this research, lecture-based teaching is still of great value in teaching medical ethics, but when combined with standardized patient, the outcome will be much better. It should be considered that mixed methods of teaching should be used together for better result.

  14. Free will and psychiatric assessments of criminal responsibility: a parallel with informed consent.

    Science.gov (United States)

    Meynen, Gerben

    2010-11-01

    In some criminal cases a forensic psychiatrist is asked to make an assessment of the state of mind of the defendant at the time of the legally relevant act. A considerable number of people seem to hold that the basis for this assessment is that free will is required for legal responsibility, and that mental disorders can compromise free will. In fact, because of the alleged relationship between the forensic assessment and free will, researchers in forensic psychiatry also consider the complicated metaphysical discussions on free will relevant to the assessment. At the same time, there is concern about the lack of advancement with respect to clarifying the nature of the forensic assessment. In this paper I argue that, even if free will is considered relevant, there may be no need for forensic researchers to engage into metaphysical discussions on free will in order to make significant progress. I will do so, drawing a parallel between the assessment of criminal responsibility on the one hand, and the medical practice of obtaining informed consent on the other. I argue that also with respect to informed consent, free will is considered relevant, or even crucial. This is the parallel. Yet, researchers on informed consent have not entered into metaphysical debates on free will. Meanwhile, research on informed consent has made significant progress. Based on the parallel with respect to free will, and the differences with respect to research, I conclude that researchers on forensic assessment may not have to engage into metaphysical discussions on free will in order to advance our understanding of this psychiatric practice.

  15. How to achieve informed consent for research from Spanish-speaking individuals with low literacy: a qualitative report.

    Science.gov (United States)

    Cortés, Dharma E; Drainoni, Mari-Lynn; Henault, Lori E; Paasche-Orlow, Michael K

    2010-01-01

    Investigators have the responsibility to ensure that prospective participants are fully informed about a research protocol prior to consenting to participate, yet many researchers face challenges when obtaining consent, since the majority of the general population has limited or no familiarity with research studies. These challenges are further magnified when obtaining consent from individuals with low literacy levels and who speak languages other than English. In this article we present findings from a qualitative study conducted with Spanish-speaking individuals with low-literacy designed to refine the Agency for Healthcare Research and Quality's Informed Consent and Authorization Toolkit for Minimal Risk Research. Findings from this study indicate that familiarity with providing informed consent and authorization for research or the experience of being a research participant appear to play key roles in an individual's ability to understand the consent and authorization process. While the text of the consent and authorization documents can be simplified using plain language principles, comprehension of several fundamental ideas such as risk and privacy need to be safeguarded with a consent process that confirms comprehension. Recommendations are provided to address the informational needs of individuals with low literacy levels and limited or no experience with research participation.

  16. Correlates of lower comprehension of informed consent among participants enrolled in a cohort study in Pune, India.

    Science.gov (United States)

    Joglekar, Neelam S; Deshpande, Swapna S; Sahay, Seema; Ghate, Manisha V; Bollinger, Robert C; Mehendale, Sanjay M

    2013-03-01

    Optimum comprehension of informed consent by research participants is essential yet challenging. This study explored correlates of lower comprehension of informed consent among 1334 participants of a cohort study aimed at estimating HIV incidence in Pune, India. As part of the informed consent process, a structured comprehension tool was administered to study participants. Participants scoring ≥90% were categorised into the 'optimal comprehension group', whilst those scoring 80-89% were categorised into the 'lower comprehension group'. Data were analysed to identify sociodemographic and behavioural correlates of lower consent comprehension. The mean ± SD comprehension score was 94.4 ± 5.00%. Information pertaining to study-related risks was not comprehended by 61.7% of participants. HIV-negative men (adjusted OR [AOR] = 4.36, 95% CI 1.71-11.05) or HIV-negative women (AOR = 13.54, 95% CI 6.42-28.55), illiteracy (AOR= 1.65, 95% CI 1.19-2.30), those with a history of multiple partners (AOR = 1.73, 95% CI 1.12-2.66) and those never using condoms (AOR = 1.35, 95% CI 1.01-1.82) were more likely to have lower consent comprehension. We recommend exploration of domains of lower consent comprehension using a validated consent comprehension tool. Improved education in these specific domains would optimise consent comprehension among research participants.

  17. Clinical psychology service users' experiences of confidentiality and informed consent: a qualitative analysis.

    Science.gov (United States)

    Martindale, S J; Chambers, E; Thompson, A R

    2009-12-01

    To explore and describe the experience of clinical psychology service users in relation to the processes associated with confidentiality and the generation of informed consent in individual therapy. A qualitative interview-based study employing interpretative phenomenological analysis was conducted with service users. User researchers were active collaborators in the study. A focus group of four users was convened to explore issues related to confidentiality and consent, which then informed the development of the semi-structured interview schedule. Twelve users of community mental health clinical psychology services were interviewed by user researchers. A user researcher and a clinical psychologist undertook joint analysis of the data. A second clinical psychologist facilitated reflexivity and wider consideration of validity issues. Four main themes were identified from the data: being referred; the participant's feelings, mental health difficulties, and their impact; relationships with workers and carers; and autonomy. The meaningfulness of processes of discussing confidentiality, and generating informed consent, can be improved by psychologists placing a greater emphasis on choice, control, autonomy, individual preferences, and actively involving the user in dialogue on repeated occasions.

  18. Informed consent prior to coronary angiography in a real world scenario: what do patients remember?

    Directory of Open Access Journals (Sweden)

    Aslihan Eran

    Full Text Available BACKGROUND: Patients' informed consent is legally essential before elective invasive cardiac angiography (CA and successive intervention can be done. It is unknown to what extent patients can remember previous detailed information given by a specially trained doctor in an optimal scenario as compared to standard care. METHODOLOGY/PRINCIPAL FINDINGS: In this prospective cohort study 150 consecutive in-patients and 50 out-patients were included before elective CA was initiated. The informed consent was provided and documented in in-patients by trained and instructed physicians the day before CA. In contrast, out-patients received standard information by different not trained physicians, who did not know about this investigation. All patients had to sign a form stating that enough information had been given and all questions had been answered sufficiently. One hour before CA an assessment of the patients' knowledge about CA was performed using a standard point-by-point questionnaire by another independent physician. The supplied information was composed of 12 potential complications, 3 general, 4 periprocedural and 4 procedural aspects. 95% of the patients felt that they had been well and sufficiently informed. Less than half of the potential complications could be remembered by the patients and more patients could remember less serious than life-threatening complications (27.9±8.8% vs. 47.1±11.0%; p<0.001. Even obvious complications like local bleeding could not be remembered by 35% of in-patients and 36% of out-patients (p = 0.87. Surprisingly, there were only a few knowledge differences between in- and out-patients. CONCLUSIONS: The knowledge about CA of patients is vague when they give their informed consent. Even structured information given by a specially trained physician did not increase this knowledge.

  19. HWMA/RCRA Closure Plan for the Fluorinel Dissolution Process Makeup and Cooling and Heating Systems Voluntary Consent Order SITE-TANK-005 Action Plan Tank Systems INTEC-066, INTEC-067, INTEC-068, and INTEC-072

    Energy Technology Data Exchange (ETDEWEB)

    M.E. Davis

    2007-05-01

    This Hazardous Waste Management Act/Resource Conservation and Recovery Act closure plan for the fluorinel dissolution process makeup and cooling and heating systems located in the Fluorinel Dissolution Process and Fuel Storage Facility (CPP-666), Idaho Nuclear Technology and Engineering Center, Idaho National Laboratory Site, was developed to meet milestones established under the Voluntary Consent Order. The systems to be closed include waste piping associated with the fluorinel dissolution process makeup systems. This closure plan presents the closure performance standards and methods of achieving those standards.

  20. HWMA/RCRA Closure Plan for the Fluorinel Dissolution Process Makeup and Cooling and Heating Systems Voluntary Consent Order SITE-TANK-005 Action Plan Tank Systems INTEC-066, INTEC-067, INTEC-068, and INTEC-072

    International Nuclear Information System (INIS)

    M.E. Davis

    2007-01-01

    This Hazardous Waste Management Act/Resource Conservation and Recovery Act closure plan for the fluorinel dissolution process makeup and cooling and heating systems located in the Fluorinel Dissolution Process and Fuel Storage Facility (CPP-666), Idaho Nuclear Technology and Engineering Center, Idaho National Laboratory Site, was developed to meet milestones established under the Voluntary Consent Order. The systems to be closed include waste piping associated with the fluorinel dissolution process makeup systems. This closure plan presents the closure performance standards and methods of achieving those standards

  1. Effect of a multimedia-assisted informed consent procedure on the information gain, satisfaction, and anxiety of cataract surgery patients.

    Science.gov (United States)

    Tipotsch-Maca, Saskia M; Varsits, Ralph M; Ginzel, Christian; Vecsei-Marlovits, Pia V

    2016-01-01

    To assess whether a multimedia-assisted preoperative informed consent procedure has an effect on patients' knowledge concerning cataract surgery, satisfaction with the informed consent process, and reduction in anxiety levels. Hietzing Hospital, Vienna, Austria. Prospective randomized controlled clinical trial. Patients participated in an informed consent procedure for age-related cataract surgery that included the standard approach only (reading the information brochure and having a standardized face-to-face discussion) or supplemented with a computer-animated video. The main outcome was information retention assessed by a questionnaire. Further outcome measures used were the State-Trait Anxiety Inventory, the Visual Function-14 score, and an assessment of satisfaction. The study included 123 patients (64 in standard-only group; 59 in computer-animated video group). Both groups scored well on the questionnaire; however, patients who watched the video performed better (82% retention versus 72%) (P = .002). Scores tended to decrease with increasing age (r = -0.25, P = .005); however, this decrease was smaller in the group that watched the video. Both groups had elevated anxiety levels (means in video group: anxiety concerning the current situation [S-anxiety] = 63.8 ± 9.6 [SD], general tendency toward anxiety [T-anxiety] = 65.5 ± 7.9; means in control group: S-anxiety = 61.9 ± 10.3, T-anxiety = 66.2 ± 7.8). A high level of information retention was achieved using an informed consent procedure consisting of an information brochure and a standardized face-to-face discussion. A further increase in information retention was achieved, even with increasing patient age, by adding a multimedia presentation. No author has a financial or proprietary interest in any material or method mentioned. Copyright © 2016 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

  2. Using video-taped examples of standardized patient to teach medical students taking informed consent.

    Science.gov (United States)

    Habibi Khorasani, Shirin; Ebrahimi, Sedigheh

    2015-04-01

    Medical student should be trained in medical ethics and one of the most essential issues in this field is taking informed consents. In this research, we compared the effect of effectiveness of teaching methods on students' ability intaking informed consent from patients. This semi-experimental study was carried out on fifty eight subjects from the 4th-year students  of Shiraz University of Medical Sciences who attended in medical ethics coursebefore their 'clinical clerkship'training.Method of sampling was census and students were randomly allocated into two groups of control group(n=28) was trained in traditional lecture-based class and the case groupnamed as A1(n=22) were taught by video-taped examples of standardized patient.Then A1 group attended in traditional lecture-based classes named as A2. The groups were evaluated in terms the ability of recognition of ethical issuesthrough the scenario based ethical examination before and after each training. Scenarios were related to the topics ofinformed consent. Data were analyzed by SPSS 14 software using descriptive statistics and anovatest.P-Value less than 0.05 was considered as significant. The mean scores results of A2, A1and B groupwere found to be7.21 , 5.91 and 5.73 out of 8,respectively. Comparison between the groups demonstrated that the ability of taking informed consent was significantly higher in A2 group (plecture-based teaching is still of great value in teaching medical ethics, but when combined with standardized patient, the outcome will be much better.it should be considered that mixed methodsof teaching should be used together for better result.

  3. Rapid Ethical Assessment on Informed Consent Content and Procedure in Hintalo-Wajirat, Northern Ethiopia: A Qualitative Study.

    Directory of Open Access Journals (Sweden)

    Serebe Abay

    Full Text Available Informed consent is a key component of bio-medical research involving human participants. However, obtaining informed consent is challenging in low literacy and resource limited settings. Rapid Ethical Assessment (REA can be used to contextualize and simplify consent information within a given study community. The current study aimed to explore the effects of social, cultural, and religious factors during informed consent process on a proposed HPV-serotype prevalence study.A qualitative community-based REA was conducted in Adigudom and Mynebri Kebeles, Northern Ethiopia, from July to August 2013. Data were collected by a multi-disciplinary team using open ended questions concerning informed consent components in relation to the parent study. The team conducted one-to-one In-Depth Interviews (IDI and Focus Group Discussions (FGDs with key informants and community members to collect data based on the themes of the study. Tape recorded data were transcribed in Tigrigna and then translated into English. Data were categorized and thematically analyzed using open coding and content analysis based on pre-defined themes.The REA study revealed a number of socio-cultural issues relevant to the proposed study. Low community awareness about health research, participant rights and cervical cancer were documented. Giving a vaginal sample for testing was considered to be highly embarrassing, whereas giving a blood sample made participants worry that they might be given a result without the possibility of treatment. Verbal consent was preferred to written consent for the proposed study.This rapid ethical assessment disclosed important socio-cultural issues which might act as barriers to informed decision making. The findings were important for contextual modification of the Information Sheet, and to guide the best consent process for the proposed study. Both are likely to have enabled participants to understand the informed consent better and consequently to

  4. [Informed consent consultation as a part of patient safety in pediatric traumatology].

    Science.gov (United States)

    Kraus, R; Heberer, J

    2013-10-01

    In pediatric traumatology as in any other surgical specialty, every treatment measure has to be protected by an adequate clarification. A legally effective clarification has to cover various aspects, such as diagnosis, treatment, risk and safety clarification and leads to an informed consent consultation. The contents of this informed consent discussion must be documented. The nature and extent of clarification, among other things depend on the urgency of the procedure and in an emergency it can be dispensed with in pediatric traumatology. In the case of minors the conversation must be conducted basically in the presence of both parents as they alone are legally entitled to give approval. General treatment proxies are not allowed. If it is not possible to talk to both parents the physician is allowed to trust that the parent present represents the will of the absent parent. Intervention cannot be carried out against the will of adolescents capable of self-determination even with the consent of the parents. The application of these rules is illustrated by means of practical examples.

  5. A need to simplify informed consent documents in cancer clinical trials. A position paper of the ARCAD Group.

    Science.gov (United States)

    Bleiberg, H; Decoster, G; de Gramont, A; Rougier, P; Sobrero, A; Benson, A; Chibaudel, B; Douillard, J Y; Eng, C; Fuchs, C; Fujii, M; Labianca, R; Larsen, A K; Mitchell, E; Schmoll, H J; Sprumont, D; Zalcberg, J

    2017-05-01

    In respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request investigators and sponsors to revise them in a way to make them understandable for potential participants. The purpose of this work is to focus on the written information in the informed consent documentation for drug development clinical trials and suggests (i) to distinguish between necessary and not essential information, (ii) to define the optimal format allowing the best legibility of those documents. The Aide et Recherche en Cancérologie Digestive (ARCAD) Group, an international scientific committee involving oncologists from all over the world, addressed these issues and developed and uniformly accepted a simplified informed consent documentation for future clinical research. A simplified form of informed consent with the leading part of 1200-1800 words containing all of the key information necessary to meet ethical and regulatory requirements and 'relevant supportive information appendix' of 2000-3000 words is provided. This position paper, on the basis of the ARCAD Group experts discussions, proposes our informed consent model and the rationale for its content. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

  6. Managing information and knowledge within maternity services: Privacy and consent issues.

    Science.gov (United States)

    Baskaran, Vikraman; Davis, Kim; Bali, Rajeev K; Naguib, Raouf N G; Wickramasinghe, Nilmini

    2013-09-01

    Electronic Patient Records have improved vastly the quality and efficiency of care delivered. However, the formation of single demographic database and the ease of electronic information sharing give rise to many concerns including issues of consent, by whom and how data are accessed and used. This paper examines the organizational and socio-technical issues related to privacy, confidentiality and security when employing electronic records within a maternity service hospital in England. A preliminary questionnaire was administered (n  =  52), in total, 24 responses were received. Sixteen responses were from personnel in the information technology department, 5 from health information department and 3 from midwifery managers. This was followed by a semi-structured interview with representatives from the clinical and technological side. A number of issues related to information governance (IG) have been identified, especially breaches on sharing personal information without consent from the patients have been identified as one immediate challenge that needs to be fixed. There is an immediate need for more robust, realistic, built-in accountability both locally and nationally on data sharing. A culture of ownership and strict adherence to IG principles is paramount. Focused training in the area of data, information and knowledge sharing will bring in a balance of legitimate usage against the individual's rights to confidentiality and privacy.

  7. GCP compliance and readability of informed consent forms from an emerging hub for clinical trials

    Directory of Open Access Journals (Sweden)

    Satish Chandrasekhar Nair

    2015-01-01

    Full Text Available Background: The rapid expansion of trials in emerging regions has raised valid concerns about research subject protection, particularly related to informed consent. The purpose of this study is to assess informed consent form (ICF compliance with Good Clinical Practice (GCP guidelines and the readability easeof the ICFs in Abu Dhabi, a potential destination for clinical trials in the UAE. Materials and Methods: A multicenter retrospective cross-sectional analysis of 140 ICFs from industry sponsored and non-sponsored studies was conducted by comparing against a local standard ICF. Flesch-Kincaid Reading Scale was used to assess the readability ease of the forms. Results: Non-sponsored studies had signifi cantly lower overall GCP compliance of 55.8% when compared to 79.5% for industry sponsored studies. Only 33% of sponsored and 16% of non-sponsored studies included basic information on the participants′ rights and responsibilities. Flesch-Kincaid Reading ease score for the informed consent forms from industry sponsored studies was signifi cantly higher 48.9 ± 4.8 as compared to 38.5 ± 8.0 for non-sponsored studies, though both were more complex than recommended. Reading Grade Level score was also higher than expected, but scores for the ICFs from the industry sponsored studies were 9.7 ± 0.7, signifi cantly lower as compared to 12.2 ± 1.3 for non-sponsored studies. Conclusion: In spite of the undisputed benefits of conducting research in emerging markets readability, comprehension issues and the lack of basic essential information call for improvements in the ICFs to protect the rights of future research subjects enrolled in clinical trials in the UAE.

  8. Informing the Uninformed: Optimizing the Consent Message Using a Fractional Factorial Design

    Science.gov (United States)

    Tait, Alan R.; Voepel-Lewis, Terri; Nair, Vijayan N.; Narisetty, Naveen N.; Fagerlin, Angela

    2013-01-01

    Objective Research information should be presented in a manner that promotes understanding. However, many parents and research subjects have difficulty understanding and making informed decisions. This study was designed to examine the effect of different communication strategies on parental understanding of research information. Participants 640 parents of children scheduled for elective surgery Design Observational study using a fractional factorial design Setting Large tertiary care children's hospital Interventions Parents were randomized to receive information about a hypothetical pain trial presented in one of 16 consent documents containing different combinations of 5 selected communication strategies (i.e., length, readability, processability [formatting], graphical display, and supplemental verbal disclosure). Main outcome measures Parents were interviewed to determine their understanding of the study elements (e.g., protocol, alternatives etc.) and their gist (main point) and verbatim (actual) understanding of the risks and benefits. Results Main effects for understanding were found for processability, readability, message length, use of graphics, and verbal discussion. Consent documents with high processability, 8th grade reading level, and graphics resulted in significantly greater gist and verbatim understanding compared with forms without these attributes (mean difference, 95% CI = 0.57, 0.26–0.88, correct responses out of 7 and 0.54, 0.20–0.88 correct responses out of 4 for gist and verbatim, respectively). Conclusions Results identified several communication strategy combinations that improved parents' understanding of research information. Adoption of these active strategies by investigators, clinicians, IRBs, and study sponsors represents a simple, practical, and inexpensive means to optimize the consent message and enhance parental, participant, and patient understanding. PMID:23700028

  9. Informed consent in research to improve the number and quality of deceased donor organs.

    Science.gov (United States)

    Rey, Michael M; Ware, Lorraine B; Matthay, Michael A; Bernard, Gordon R; McGuire, Amy L; Caplan, Arthur L; Halpern, Scott D

    2011-02-01

    Improving the management of potential organ donors in the intensive care unit could meet an important public health goal by increasing the number and quality of transplantable organs. However, randomized clinical trials are needed to quantify the extent to which specific interventions might enhance organ recovery and outcomes among transplant recipients. Among several barriers to conducting such studies are the absence of guidelines for obtaining informed consent for such studies and the fact that deceased organ donors are not covered by extant federal regulations governing oversight of research with human subjects. This article explores the underexamined ethical issues that arise in the context of donor management studies and provides ethical guidelines and suggested regulatory oversight mechanisms to enable such studies to be conducted ethically. We conclude that both the respect that is traditionally accorded to the prior wishes of the dead and the possibility of postmortem harm support a role for surrogate consent of donors in such randomized controlled trials. Furthermore, although recipients will often be considered human subjects under federal regulations, several ethical arguments support waiving requirements for recipient consent in donor management randomized controlled trials. Finally, we suggest that new regulatory mechanisms, perhaps linked to existing regional and national organ donation and transplantation infrastructures, must be established to protect patients in donor management studies while limiting unnecessary barriers to the conduct of this important research.

  10. Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011.

    Science.gov (United States)

    Doshi, Peter; Hur, Peter; Jones, Mark; Albarmawi, Husam; Jefferson, Tom; Morgan, Daniel J; Spears, Patricia A; Powers, John H

    2017-10-01

    Potential research participants may assume that randomized trials comparing new interventions with older interventions always hypothesize greater efficacy for the new intervention, as in superiority trials. However, antibiotic trials frequently use "noninferiority" hypotheses allowing a degree of inferior efficacy deemed "clinically acceptable" compared with an older effective drug, in exchange for nonefficacy benefits (eg, decreased adverse effects). Considering these different benefit-harm trade-offs, proper informed consent necessitates supplying different information on the purposes of superiority and noninferiority trials. To determine the degree to which the study purpose is explained to potential participants in randomized clinical trials of antibiotics and the degree to which study protocols justify their selection of noninferiority hypotheses and amount of "clinically acceptable" inferiority. Cross-sectional analysis of study protocols, statistical analysis plans (SAPs), and informed consent forms (ICFs) from clinical study reports submitted to the European Medicines Agency. The ICFs were read by both methodologists and patient investigators. Protocols and SAPs were used as the reference standard to determine prespecified primary hypothesis and record rationale for selection of noninferiority hypotheses and noninferiority margins. This information was cross-referenced against ICFs to determine whether ICFs explained the study purpose. We obtained trial documents from 78 randomized trials with prespecified efficacy hypotheses (6 superiority, 72 noninferiority) for 17 antibiotics conducted between 1991 and 2011 that enrolled 39 407 patients. Fifty were included in the ICF analysis. All ICFs contained sections describing study purpose; however, none consistently conveyed study hypothesis to both methodologists and patient investigators. Methodologists found that 1 of 50 conveyed a study purpose. Patient investigators found that 11 of 50 conveyed a study

  11. The effect of multimedia interventions on the informed consent process for cataract surgery in rural South India

    Directory of Open Access Journals (Sweden)

    Abraar Karan

    2014-01-01

    Full Text Available Context: The provision of ocular surgical interventions for poorer, less educated populations is increasing as a result of increased globalization and outreach. However, these populations still have trouble understanding surgical concepts and are not always fully informed decision makers. Aims: We aimed to test the effect that a multimedia addition to a traditional verbal informed consent would have on patient comprehension of relatively difficult cataract surgical concepts. Settings and Design: We conducted a randomized controlled trial with relatively uneducated patients reporting to a private surgical hospital in Chennai, India. 47 patients were placed into the intervention group and 50 patients were placed into the control group. Materials and Methods: The intervention group was presented with a scripted verbal informed consent as well as a 3-fold pamphlet and a presentation with a 3-dimensional model of the eye. The control group was only presented with a scripted verbal informed consent. The two groups were tested using an 11 item "True/False/I don′t know" quiz directly before the informed consent, directly after the informed consent, and one-day postoperatively. Statistical Analysis Used: Scores on the quiz were compared across groups and time-points using paired t-tests. Results: Patients in the both groups showed a significant improvement in scores between pre- and post-informed consent quizzes (P value on the order of 10 -6 and the improvement in scores was significantly greater in the intervention group than the control group (P value on the order of 10 -16 . There was no significant difference observed in either group with regards to the change in scores between post-informed consent and post-operative quizzes. Conclusion: Multimedia aids in addition to a standard informed consent process are effective in improving patient comprehension even for patients with low literacy and limited knowledge of surgical interventions.

  12. Informed Consent in Medical Decision-Making in Commercial Gestational Surrogacy: A Mixed Methods Study in New Delhi, India

    DEFF Research Database (Denmark)

    Tanderup, Malene; Reddy, Sunita; Patel, Tulsi

    2015-01-01

    OBJECTIVE: To investigate ethical issues in informed consent for decisions regarding embryo transfer and fetal reduction in commercial gestational surrogacy. DESIGN: Mixed methods study employing observations, an interview-guide and semi-structured interviews. SETTING: Fertility clinics and agenc...

  13. A need to simplify informed consent documents in cancer clinical trials. A position paper of the ARCAD Group

    OpenAIRE

    Bleiberg, H.; Decoster, G.; de Gramont, A.; Rougier, P.; Sobrero, A.; Benson, A.; Chibaudel, B.; Douillard, J. Y.; Eng, C.; Fuchs, C.; Fujii, M.; Labianca, R.; Larsen, A. K.; Mitchell, E.; Schmoll, H. J.

    2017-01-01

    Background: In respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request ...

  14. The radiology informed consent form: recommendations from the European Society of Cardiology position paper.

    Science.gov (United States)

    Carpeggiani, Clara; Picano, Eugenio

    2016-06-01

    Every radiological and nuclear medicine examination confers a definite long-term risk of cancer, but most patients undergoing such examinations receive no or inaccurate information about radiation dose and corresponding risk related to the dose received. Informed consent is a procedure to support (not substitute) the physician/patient dialogue and relationship, facilitating a free, informed and aware expression of the patient's will in the principle of patient autonomy. Physicians are responsible for providing patients with all the information on risks, benefits and alternatives useful to the patient to make the decision. In current radiological practice the information on the radiation dose and long-term cancer risks is difficult to find and not easy to understand. The form using plain language should spell-out the type of examination, the effective dose (mSv), the effective dose expressed in number of chest radiographs and the risk of cancer. The current practice clashes against the guidelines and the law.

  15. Using iterative learning to improve understanding during the informed consent process in a South African psychiatric genomics study.

    Science.gov (United States)

    Campbell, Megan M; Susser, Ezra; Mall, Sumaya; Mqulwana, Sibonile G; Mndini, Michael M; Ntola, Odwa A; Nagdee, Mohamed; Zingela, Zukiswa; Van Wyk, Stephanus; Stein, Dan J

    2017-01-01

    Obtaining informed consent is a great challenge in global health research. There is a need for tools that can screen for and improve potential research participants' understanding of the research study at the time of recruitment. Limited empirical research has been conducted in low and middle income countries, evaluating informed consent processes in genomics research. We sought to investigate the quality of informed consent obtained in a South African psychiatric genomics study. A Xhosa language version of the University of California, San Diego Brief Assessment of Capacity to Consent Questionnaire (UBACC) was used to screen for capacity to consent and improve understanding through iterative learning in a sample of 528 Xhosa people with schizophrenia and 528 controls. We address two questions: firstly, whether research participants' understanding of the research study improved through iterative learning; and secondly, what were predictors for better understanding of the research study at the initial screening? During screening 290 (55%) cases and 172 (33%) controls scored below the 14.5 cut-off for acceptable understanding of the research study elements, however after iterative learning only 38 (7%) cases and 13 (2.5%) controls continued to score below this cut-off. Significant variables associated with increased understanding of the consent included the psychiatric nurse recruiter conducting the consent screening, higher participant level of education, and being a control. The UBACC proved an effective tool to improve understanding of research study elements during consent, for both cases and controls. The tool holds utility for complex studies such as those involving genomics, where iterative learning can be used to make significant improvements in understanding of research study elements. The UBACC may be particularly important in groups with severe mental illness and lower education levels. Study recruiters play a significant role in managing the quality of

  16. Using iterative learning to improve understanding during the informed consent process in a South African psychiatric genomics study.

    Directory of Open Access Journals (Sweden)

    Megan M Campbell

    Full Text Available Obtaining informed consent is a great challenge in global health research. There is a need for tools that can screen for and improve potential research participants' understanding of the research study at the time of recruitment. Limited empirical research has been conducted in low and middle income countries, evaluating informed consent processes in genomics research. We sought to investigate the quality of informed consent obtained in a South African psychiatric genomics study. A Xhosa language version of the University of California, San Diego Brief Assessment of Capacity to Consent Questionnaire (UBACC was used to screen for capacity to consent and improve understanding through iterative learning in a sample of 528 Xhosa people with schizophrenia and 528 controls. We address two questions: firstly, whether research participants' understanding of the research study improved through iterative learning; and secondly, what were predictors for better understanding of the research study at the initial screening? During screening 290 (55% cases and 172 (33% controls scored below the 14.5 cut-off for acceptable understanding of the research study elements, however after iterative learning only 38 (7% cases and 13 (2.5% controls continued to score below this cut-off. Significant variables associated with increased understanding of the consent included the psychiatric nurse recruiter conducting the consent screening, higher participant level of education, and being a control. The UBACC proved an effective tool to improve understanding of research study elements during consent, for both cases and controls. The tool holds utility for complex studies such as those involving genomics, where iterative learning can be used to make significant improvements in understanding of research study elements. The UBACC may be particularly important in groups with severe mental illness and lower education levels. Study recruiters play a significant role in managing

  17. Alternatives to project-specific consent for access to personal information for health research: Insights from a public dialogue

    Directory of Open Access Journals (Sweden)

    Abelson Julia

    2008-11-01

    Full Text Available Abstract Background The role of consent for research use of health information is contentious. Most discussion has focused on when project-specific consent may be waived but, recently, a broader range of consent options has been entertained, including broad opt-in for multiple studies with restrictions and notification with opt-out. We sought to elicit public values in this matter and to work toward an agreement about a common approach to consent for use of personal information for health research through deliberative public dialogues. Methods We conducted seven day-long public dialogues, involving 98 participants across Canada. Immediately before and after each dialogue, participants completed a fixed-response questionnaire rating individuals' support for 3 approaches to consent in the abstract and their consent choices for 5 health research scenarios using personal information. They also rated how confident different safeguards made them feel that their information was being used responsibly. Results Broad opt-in consent for use of personal information garnered the greatest support in the abstract. When presented with specific research scenarios, no one approach to consent predominated. When profit was introduced into the scenarios, consent choices shifted toward greater control over use. Despite lively and constructive dialogues, and considerable shifting in opinion at the individual level, at the end of the day, there was no substantive aggregate movement in opinion. Personal controls were among the most commonly cited approaches to improving people's confidence in the responsible use of their information for research. Conclusion Because no one approach to consent satisfied even a simple majority of dialogue participants and the importance placed on personal controls, a mechanism should be developed for documenting consent choice for different types of research, including ways for individuals to check who has accessed their medical record

  18. Alternatives to project-specific consent for access to personal information for health research: insights from a public dialogue.

    Science.gov (United States)

    Willison, Donald J; Swinton, Marilyn; Schwartz, Lisa; Abelson, Julia; Charles, Cathy; Northrup, David; Cheng, Ji; Thabane, Lehana

    2008-11-19

    The role of consent for research use of health information is contentious. Most discussion has focused on when project-specific consent may be waived but, recently, a broader range of consent options has been entertained, including broad opt-in for multiple studies with restrictions and notification with opt-out. We sought to elicit public values in this matter and to work toward an agreement about a common approach to consent for use of personal information for health research through deliberative public dialogues. We conducted seven day-long public dialogues, involving 98 participants across Canada. Immediately before and after each dialogue, participants completed a fixed-response questionnaire rating individuals' support for 3 approaches to consent in the abstract and their consent choices for 5 health research scenarios using personal information. They also rated how confident different safeguards made them feel that their information was being used responsibly. Broad opt-in consent for use of personal information garnered the greatest support in the abstract. When presented with specific research scenarios, no one approach to consent predominated. When profit was introduced into the scenarios, consent choices shifted toward greater control over use. Despite lively and constructive dialogues, and considerable shifting in opinion at the individual level, at the end of the day, there was no substantive aggregate movement in opinion. Personal controls were among the most commonly cited approaches to improving people's confidence in the responsible use of their information for research. Because no one approach to consent satisfied even a simple majority of dialogue participants and the importance placed on personal controls, a mechanism should be developed for documenting consent choice for different types of research, including ways for individuals to check who has accessed their medical record for purposes other than clinical care. This could be done, for

  19. Information disclosure in clinical informed consent: "reasonable" patient's perception of norm in high-context communication culture.

    Science.gov (United States)

    Hammami, Muhammad M; Al-Jawarneh, Yussuf; Hammami, Muhammad B; Al Qadire, Mohammad

    2014-01-10

    The current doctrine of informed consent for clinical care has been developed in cultures characterized by low-context communication and monitoring-style coping. There are scarce empirical data on patients' norm perception of information disclosure in other cultures. We surveyed 470 adults who were planning to undergo or had recently undergone a written informed consent-requiring procedure in a tertiary healthcare hospital in Saudi Arabia. Perceptions of norm and current practice were explored using a 5-point Likert scale (1 = strongly agree with disclosure) and 30 information items in 7 domains: practitioners' details, benefits, risks, complications' management, available alternatives, procedure's description, and post-procedure's issues. Respondents' mean (SD) age was 38.4 (12.5); 50.2% were males, 57.2% had ≥ college education, and 37.9% had undergone a procedure. According to norm perception, strongly agree/agree responses ranged from 98.0% (major benefits) to 50.5% (assistant/trainee's name). Overall, items related to benefits and post-procedure's issues were ranked better (more agreeable) than items related to risks and available alternatives. Ranking scores were better in post-procedure respondents for 4 (13.3%) items (p s name) to 13.9% (lead practitioner's training place), ranking scores were worse for all items compared to norm perception (p norm, 2) the focus of the desired information is closer to benefits and post-procedure's issues than risks and available alternatives, 3) male, post-procedure, and older patients are in favor of more information disclosure, 4) male, older, and more educated patients may be particularly dissatisfied with current information disclosure. The focus and extent of information disclosure for clinical informed consent may need to be adjusted if a "reasonable" patient's standard is to be met.

  20. Informed consent for inclusion into clinical trials: a serious subject to note in the developing world.

    Science.gov (United States)

    Izadi, Morteza; Fazel, Mozhgan; Nasiri-Vanashi, Taha; Saadat, Seyed Hasan; Taheri, Saeed

    2012-05-01

    Informed consent is a critical issue especially in conducting clinical trials that expose human life to medical or surgical interventions. It necessitates a long and complex process through which the participant is presented with all potential favorable and non-favorable consequences upon getting enrolled in the study. The process of taking informed consent is well-understood in developed countries, with every effort taken to enhance and maintain the autonomy of patients and their right to make an informed choice of whether to participate or not. This may not be the case in the developing world.The information given to patients before the trial might not be properly developed and presented, an issue that can result in serious threat to the decision-making process. On the other hand, investigators should remember that enrolling people into a trial with no potential benefit for themselves cannot be considered ethical. In the current debate, we aim to address the issue of how respectfully and ethically clinical research trials can be done on human subjects and what we can do to enhance the practice in an ethical context. Development of a system through which we could warrant all rights of study participants in all cases around the world seems far from view. However, if we are in doubt about the ethics of a clinical trial, we can ask ourselves: "what would we do, if we were in the same position our patients are in now?"

  1. Assessing informed consent in an opioid relapse prevention study with adults under current or recent criminal justice supervision.

    Science.gov (United States)

    Allen, Ashleigh A; Chen, Donna T; Bonnie, Richard J; Ko, Tomohiro M; Suratt, Colleen E; Lee, Joshua D; Friedmann, Peter D; Gordon, Michael; McDonald, Ryan; Murphy, Sean M; Boney, Tamara Y; Nunes, Edward V; O'Brien, Charles P

    2017-10-01

    Concerns persist that individuals with substance use disorders who are under community criminal justice supervision experience circumstances that might compromise their provision of valid, informed consent for research participation. These concerns include the possibilities that desire to obtain access to treatment might lead individuals to ignore important information about research participation, including information about risks, or that cognitive impairment associated with substance use might interfere with attending to important information. We report results from a consent quiz (CQ) administered in a multisite randomized clinical trial of long-acting naltrexone to prevent relapse to opioid use disorder among adults under community criminal justice supervision-a treatment option difficult to access by this population of individuals. Participants were required to answer all 11 items correctly before randomization. On average, participants answered 9.8 items correctly (89%) at baseline first attempt (n=306). At week 21 (n=212), participants scored 87% (9.5 items correct) without review. Performance was equivalent to, or better than, published results from other populations on a basic consent quiz instrument across multiple content domains. The consent quiz is an efficient method to screen for adequate knowledge of consent information as part of the informed consent process. Clinical researchers who are concerned about these issues should consider using a consent quiz with corrected feedback to enhance the informed consent process. Overall, while primarily useful as an educational tool, employing a CQ as part of the gateway to participation in research may be particularly important as the field continues to advance and tests novel experimental treatments with significant risks and uncertain potential for benefit. Copyright © 2017. Published by Elsevier Inc.

  2. Informed consent instead of assent is appropriate in children from the age of twelve: Policy implications of new findings on children's competence to consent to clinical research.

    Science.gov (United States)

    Hein, Irma M; De Vries, Martine C; Troost, Pieter W; Meynen, Gerben; Van Goudoever, Johannes B; Lindauer, Ramón J L

    2015-11-09

    For many decades, the debate on children's competence to give informed consent in medical settings concentrated on ethical and legal aspects, with little empirical underpinnings. Recently, data from empirical research became available to advance the discussion. It was shown that children's competence to consent to clinical research could be accurately assessed by the modified MacArthur Competence Assessment Tool for Clinical Research. Age limits for children to be deemed competent to decide on research participation have been studied: generally children of 11.2 years and above were decision-making competent, while children of 9.6 years and younger were not. Age was pointed out to be the key determining factor in children's competence. In this article we reflect on policy implications of these findings, considering legal, ethical, developmental and clinical perspectives. Although assessment of children's competence has a normative character, ethics, law and clinical practice can benefit from research data. The findings may help to do justice to the capacities children possess and challenges they may face when deciding about treatment and research options. We discuss advantages and drawbacks of standardized competence assessment in children on a case-by-case basis compared to application of a fixed age limit, and conclude that a selective implementation of case-by-case competence assessment in specific populations is preferable. We recommend the implementation of age limits based on empirical evidence. Furthermore, we elaborate on a suitable model for informed consent involving children and parents that would do justice to developmental aspects of children and the specific characteristics of the parent-child dyad. Previous research outcomes showed that children's medical decision-making capacities could be operationalized into a standardized assessment instrument. Recommendations for policies include a dual consent procedure, including both child as well as parents

  3. VOLUNTARY DISCLOSURE OF CASH FLOWS INFORMATION AND COMPANY'S CHARACTERISTICS: EVIDENCE FROM THE CROATIAN CAPITAL MARKET

    Directory of Open Access Journals (Sweden)

    Željana Aljinović Barać

    2012-12-01

    Full Text Available This paper focuses on the voluntary disclosure of cash flows information of Croatian large companies whose shares are listed on the Zagreb Stock Exchange, with the aim to identify characteristics of companies that provide extensive disclosures. In order to conduct the research and test the likelihood that company publicly announces wealth of information about cash flows, three groups of company’s features are defined as variables: accounting data, capital market information and company’s qualitative characteristics. Verification of empirical evidence was provided through the sample of Croatian listed companies using logistic regression analysis. Obtained results indicate that despite the desire of the regulatory authorities that capital market investors receive all relevant information, companies voluntarily disclose information about cash flows very rarely. Those companies are young (i.e. their shares are listed on an organized securities market for a short time and profitable, with growing net income and growing cash flow from operating activities and usually use indirect method for operating cash flow report. The provision of features of Croatian companies that voluntary disclose cash flow information can be found as contribution of our research, because this topic in a cases of macro-oriented accounting system economies, i.e. bank oriented economies with emerging capital market is still unexplored.

  4. A bibliography concerning informed consent and biobanking: documents from national and international bodies.

    Science.gov (United States)

    Petrini, Carlo

    2009-09-01

    The article contains a list of national and international documents addressing the ethical aspects of biobanking, which were drafted by national bioethics committees; national ad hoc commissions; and national and international agencies, organizations, and societies. The greater part of the documents specifically focuses on questions involving the ethics of informed consent for biobanking. The documents are grouped according to the nature of the promulgating body, and are listed alphabetically within each group according to the promulgating body. Special attention is devoted to documents issued by the European Union and the Council of Europe.

  5. Level of knowledge and understanding of informed consent amongst the training grade group orthodontists in England, Wales and Northern Ireland.

    Science.gov (United States)

    Sharma, Pratik K; Chate, Robert A

    2011-06-01

    To assess the level of knowledge and understanding of informed consent in UK orthodontic trainees. A cross-sectional, written questionnaire-based study. Hospital orthodontic departments in England, Wales and Northern Ireland. A one page questionnaire which covered a range of legal issues pertinent to informed consent was circulated to 207 members of the Training Grades Group (TGG) of the British Orthodontic Society (BOS). The questionnaire consisted of four open questions with 11 responses, which the investigators considered to be ideal, seven closed questions requiring yes/no responses and one question requiring a yes/no response followed by two open responses. Following the initial circulation, a second posting to non-responders was conducted. The response rate was 61% (N=126). The mean number of complete answers to the 21 questions was 13 (62%; median 13; mode 14). There were a low number of complete responses to specific questions in the following areas - explanations patients need from clinicians prior to obtaining consent; how to fully judge if a patient is capable of consenting; how to manage a patient incapable of giving consent; the legal status of fathers consenting on behalf of their children; whether consent forms have to be re-signed if the start of treatment is delayed by six months or more and responsibility for obtaining consent for dental treatment under general anaesthesia. There was a disappointingly high proportion of incomplete answers to questions testing the knowledge and understanding of the law as it pertains to informed consent exists amongst members of the TGG of BOS.

  6. A Proposal for a Scientifically-Informed and Instrumentalist Account of Free Will and Voluntary Action

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    Eric Racine

    2017-05-01

    Full Text Available The ability to choose freely is captured under the umbrella concept of “free will,” which designates an ability that plays a crucial role in most understandings of autonomy and responsibility and, thus, bears significance for moral practice and moral theory. Some claim that neuroscience research challenges the existence of free will/voluntary action while some who adopt stronger eliminativist stances have gone as far as describing free will as an illusion. Contrary to that, those relying on realist stances have restated the foundational value and role of folk psychological concepts of voluntary action and free will in, for example, the domains of ethics and law. An emerging body of research in cognitive science and social psychology has generated results suggesting that the phenomena captured by the concepts describing free will and voluntary action are dynamic and responsive to priming and framing effects. We propose that this body of research suggests the existence of dynamic and consequential properties of free will better captured following pragmatist theory and instrumentalist epistemology. This contrasts the simpler static concept of free will and the related metaphysics that was at the basis of earlier debates and structured around the poles of realism and eliminativism. This paper contextualizes ontological and epistemological debates about free will, describes a scientifically-informed and instrumentalist account of the concept of free will and voluntary action consistent with recent research in cognitive science, and discusses its implications for research (e.g., theoretical assumptions of research paradigms, interdisciplinary research and practice (e.g., impact on self-image and social behavior.

  7. Duty to Inform and Informed Consent in Diagnostic Radiology: How Ethics and Law can Better Guide Practice.

    Science.gov (United States)

    Doudenkova, Victoria; Bélisle Pipon, Jean-Christophe

    2016-03-01

    Although there is consensus on the fact that ionizing radiation used in radiological examinations can affect health, the stochastic (random) nature of risk makes it difficult to anticipate and assess specific health implications for patients. The issue of radiation protection is peculiar as any dosage received in life is cumulative, the sensitivity to radiation is highly variable from one person to another, and between 20 % and 50 % of radiological examinations appear not to be necessary. In this context, one might reasonably assume that information and patient consent would play an important role in regulating radiological practice. However, there is to date no clear consensus regarding the nature and content of-or even need for-consent by patients exposed to ionizing radiation. While law and ethics support the same principles for respecting the dignity of the person (inviolability and integrity), in the context of radiology practice, they do not provide a consistent message to guide clinical decision-making. This article analyzes the issue of healthcare professionals' duty to inform and obtain patient consent for radiological examinations. Considering that both law and ethics have as one of their aims to protect vulnerable populations, it is important that they begin to give greater attention to issues raised by the use of ionizing radiation in medicine. While the situation in Canada serves as a backdrop for a reflective analysis of the problem, the conclusions are pertinent for professional practice in other jurisdictions because the principles underlying health law and jurisprudence are fairly general.

  8. Why persons choose to opt out of an exception from informed consent cardiac arrest trial.

    Science.gov (United States)

    Nelson, Maria J; Deiorio, Nicole M; Schmidt, Terri A; Zive, Dana M; Griffiths, Denise; Newgard, Craig D

    2013-06-01

    We sought to characterize persons who requested to opt out of an exception from informed consent (EFIC) cardiac arrest trial and their reasons for opting out. At one site of a multi-site, out-of-hospital, cardiac arrest EFIC trial (September 2007 - June 2009), persons who did not want to participate in the study could request an opt-out "NO STUDY" bracelet to prevent trial enrollment. We surveyed all persons who requested a bracelet by phone interview, web or mail. Opt-out bracelets were advertised in all public communication about the study, including community consultation and public disclosure efforts. Survey questions included demographics, Likert scale items about attitudes toward the trial and research in general, plus open-ended questions. We used descriptive statistics for standardized questions and qualitative analysis to identify common themes from open-ended questions. Sixty bracelets were requested by 50 individuals. Surveys were completed by 46 persons (92% response rate). Seventy percent of respondents agreed emergency research is important, but 87% objected to any research without consent. In the qualitative analysis, 5 overlapping themes emerged: questioning the ethics of EFIC research; concerns about how the study would impact end-of-life preferences; subjective emotions including sarcasm, anger, and allusions to past unethical research; negative reference to unrelated public health controversies; and objections to the study protocol based on misinformation. A primary reason for opting out from this EFIC trial was opposition to all research without informed consent, despite stated support for emergency research. Understanding the demographics and beliefs of persons opting out may aid researchers planning EFIC studies and help provide clarity in future EFIC-related community education efforts. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  9. Cognitive Function in Patients Undergoing Arthroplasty: The Implications for Informed Consent

    Directory of Open Access Journals (Sweden)

    N. Demosthenous

    2011-01-01

    Full Text Available Obtaining informed consent for an operation is a fundamental daily interaction between orthopaedic surgeon and patient. It is based on a patient's capacity to understand and retain information about the proposed procedure, the potential consequences of having it, and the alternative options available. We used validated tests of memory on 59 patients undergoing lower limb arthroplasty to assess how well they learned and recalled information about their planned procedure. All patients showed an ability to learn new material; however, younger age and higher educational achievement correlated with better performance. These results have serious implications for orthopaedic surgeons discussing planned procedures. They identify groups of patients who may require enhanced methods of communicating the objectives, risks, and alternatives to surgery. Further research is necessary to assess interventions to improve communication prior to surgery.

  10. [Informed consent in anaesthesiology: period of notice as a requisite of validity].

    Science.gov (United States)

    Galán Gutiérrez, J C; Galán Cortés, J C

    2014-02-01

    The analysis of one of the requisites of the validity of the informed consent, the notice period, during which the patient should be provided with information, so that he/she can reflect and fully exercise his/her Kantian right of self-determination. National legislation appears to be insufficient when dealing with this issue, which is compensated for in some regional legislations. We conclude by pointing the need to provide the patient with information with sufficient notice prior to operations, so that he/she can ponder over his/her decision. Copyright © 2013 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Published by Elsevier España. All rights reserved.

  11. Increased Access to Professional Interpreters in the Hospital Improves Informed Consent for Patients with Limited English Proficiency.

    Science.gov (United States)

    Lee, Jonathan S; Pérez-Stable, Eliseo J; Gregorich, Steven E; Crawford, Michael H; Green, Adrienne; Livaudais-Toman, Jennifer; Karliner, Leah S

    2017-08-01

    Language barriers disrupt communication and impede informed consent for patients with limited English proficiency (LEP) undergoing healthcare procedures. Effective interventions for this disparity remain unclear. Assess the impact of a bedside interpreter phone system intervention on informed consent for patients with LEP and compare outcomes to those of English speakers. Prospective, pre-post intervention implementation study using propensity analysis. Hospitalized patients undergoing invasive procedures on the cardiovascular, general surgery or orthopedic surgery floors. Installation of dual-handset interpreter phones at every bedside enabling 24-h immediate access to professional interpreters. Primary predictor: pre- vs. post-implementation group; secondary predictor: post-implementation patients with LEP vs. English speakers. Primary outcomes: three central informed consent elements, patient-reported understanding of the (1) reasons for and (2) risks of the procedure and (3) having had all questions answered. We considered consent adequately informed when all three elements were met. We enrolled 152 Chinese- and Spanish-speaking patients with LEP (84 pre- and 68 post-implementation) and 86 English speakers. Post-implementation (vs. pre-implementation) patients with LEP were more likely to meet criteria for adequately informed consent (54% vs. 29%, p = 0.001) and, after propensity score adjustment, had significantly higher odds of adequately informed consent (AOR 2.56; 95% CI, 1.15-5.72) as well as of each consent element individually. However, compared to post-implementation English speakers, post-implementation patients with LEP had significantly lower adjusted odds of adequately informed consent (AOR, 0.38; 95% CI, 0.16-0.91). A bedside interpreter phone system intervention to increase rapid access to professional interpreters was associated with improvements in patient-reported informed consent and should be considered by hospitals seeking to improve

  12. Evaluating the quality of informed consent and contemporary clinical practices by medical doctors in South Africa: an empirical study.

    Science.gov (United States)

    Chima, Sylvester C

    2013-01-01

    Informed consent is a legal and ethical doctrine derived from the principle of respect for autonomy. Generally two rights derived from autonomy are accorded legal protection. The constitutional right to bodily integrity followed by the right to bodily well-being, protected by professional negligence rules. Therefore healthcare professionals treating patients' without valid consent may be guilty of infringing patients' rights. Many challenges are experienced by doctors obtaining informed consent in complex multicultural societies like South Africa. These include different cultural ethos, multilingualism, poverty, education, unfamiliarity with libertarian rights based autonomy, and power asymmetry between doctors and patients. All of which could impact on the ability of doctors to obtain legally valid informed consent. The objective of this study was to evaluate whether the quality of informed consent obtained by doctors practicing in South Africa is consistent with international ethical standards and local regulations. Responses from 946 participants including doctors, nurses and patients was analyzed, using a semi-structured self-administered questionnaire and person triangulation in selected public hospitals in Durban, KwaZulu-Natal, South Africa. The median age of 168 doctors participating was 30 years with 51% females, 28% interns, 16% medical officers, 26% registrars, 30% consultant/specialists. A broad range of clinical specialties were represented. Challenges to informed consent practice include language difficulties, lack of interpreters, workload, and time constraints. Doctors spent 5-10 minutes on consent, disclosed most information required to patients, however knowledge of essential local laws was inadequate. Informed consent aggregate scores (ICAS) showed that interns/registrars scored lower than consultants/specialists. ICAS scores were statistically significant by specialty (p = 0.005), with radiologists and anaesthetists scoring lowest, while

  13. A survey on surgeons' perceived quality of the informed consent process in a Swiss paediatric surgery unit.

    Science.gov (United States)

    Guinand, Julie; Gapany, Christophe; Simon, Jeanne-Pascale; Wasserfallen, Jean-Blaise; Joseph, Jean-Marc

    2015-01-01

    To evaluate the levels of satisfaction and opinions on the usefulness of the informed consent form currently in use in our Paediatric Surgery Department. Qualitative study carried out via interviews of senior paediatric surgeons, based on a questionnaire built up from reference criteria in the literature and public health law. Physicians with between 2 and 35 years experience of paediatric surgery, with a participation rate of 92 %, agreed on the definition of an informed consent form, were satisfied with the form in use and did not wish to modify its structure. The study revealed that signing the form was viewed as mandatory, but meant different things to different participants, who diverged over whom that signature protected. Finally, all respondents were in agreement over what information was necessary for parents of children requiring surgery. Paediatric surgeons seemed to be satisfied with the informed consent form in use. Most of them did not identify that the first aim of the informed consent form is to give the patient adequate information to allow him to base his consent, which is a legal obligation, the protection of physicians by the formalisation and proof of the informed consent being secondary. Few surgeons brought up the fact that the foremost stakeholder in paediatric surgery are the children themselves and that their opinions are not always sought. In the future, moving from informed consent process to shared decision-making, a more active bidirectional exchange may be strongly considered. Involving children in such vital decisions should become the norm while keeping in mind their level of maturity.

  14. Medical Comics as Tools to Aid in Obtaining Informed Consent for Stroke Care.

    Science.gov (United States)

    Furuno, Yuichi; Sasajima, Hiroyasu

    2015-07-01

    Informed consent has now become common in medical practice. However, a gap still exists between doctors and patients in the understanding of clinical conditions. We designed medical comics about "subarachnoid hemorrhage" and "intracerebral hemorrhage" to help doctors obtain informed consent intuitively, quickly, and comprehensively.Between September 2010 and September 2012, we carried out a questionnaire survey about medical comics with the families of patients who had suffered an intracerebral or subarachnoid hemorrhage. The questionnaire consisted of 6 questions inquiring about their mental condition, reading time, usefulness of the comics in understanding brain function and anatomy, pathogenesis, doctor's explanation, and applicability of these comics.The results showed that 93.8% responders would prefer or strongly prefer the use of comics in other medical situations. When considering the level of understanding of brain function and anatomy, pathology of disease, and doctor's explanation, 81.3%, 75.0%, and 68.8% of responders, respectively, rated these comics as very useful or useful.We think that the visual and narrative illustrations in medical comics would be more helpful for patients than a lengthy explanation by a doctor. Most of the responders hoped that medical comics would be applied to other medical cases. Thus, medical comics could work as a new communication tool between doctors and patients.

  15. Understanding of Technical Terms and Contents of Informed Consent Forms for Sedative Gastrointestinal Endoscopy Procedures

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    Ihnsook Jeong, RN, PhD

    2013-03-01

    Conclusion: The understanding of the terms and knowledge about the procedures were disappointing. Therefore, sufficient explanations should be provided to the patients. While the informed consent was taken by doctors, the level of understanding should be monitored by nurses. In particular, subjects who did not have any previous experience with endoscopy procedures showed relatively lower level of understanding. We recommend that medical terms should be replaced with more common and nontechnical words in consent forms.

  16. Ethical frameworks for obtaining informed consent in tumour profiling: an evidence-based case for Singapore.

    Science.gov (United States)

    Bylstra, Yasmin; Lysaght, Tamra; Thrivikraman, Jyothi; Watson, Sangeetha; Tan, Patrick

    2017-12-08

    Genomic profiling of malignant tumours has assisted clinicians in providing targeted therapies for many serious cancer-related illnesses. Although the characterisation of somatic mutations is the primary aim of tumour profiling for treatment, germline mutations may also be detected given the heterogenous origin of mutations observed in tumours. Guidance documents address the return of germline findings that have health implications for patients and their genetic relations. However, the implications of discovering a potential but unconfirmed germline finding from tumour profiling are yet to be fully explored. Moreover, as tumour profiling is increasingly applied in oncology, robust ethical frameworks are required to encourage large-scale data sharing and data aggregation linking molecular data to clinical outcomes, to further understand the role of genetics in oncogenesis and to develop improved cancer therapies. This paper reports on the results of empirical research that is broadly aimed at developing an ethical framework for obtaining informed consent to return results from tumour profiling tests and to share the biomolecular data sourced from tumour tissues of cancer patients. Specifically, qualitative data were gathered from 36 semi-structured interviews with cancer patients and oncology clinicians at a cancer treatment centre in Singapore. The interview data indicated that patients had a limited comprehension of cancer genetics and implications of tumour testing. Furthermore, oncology clinicians stated that they lacked the time to provide in depth explanations of the tumour profile tests. However, it was accepted from both patients and oncologist that the return potential germline variants and the sharing of de-identified tumour profiling data nationally and internationally should be discussed and provided as an option during the consent process. Findings provide support for the return of tumour profiling results provided that they are accompanied with an

  17. Satisfying the needs of Japanese cancer patients: a comparative study of detailed and standard informed consent documents.

    Science.gov (United States)

    Sato, Keiko; Watanabe, Toru; Katsumata, Noriyuki; Sato, Tosiya; Ohashi, Yasuo

    2014-02-01

    Simplified informed consent forms have been successful in improving patient satisfaction and decreasing patient anxiety. However, unsolved problems remain about whether these documents improve comprehension and satisfaction of patients with standard literacy skills. s To investigate whether a detailed consent form explaining the key elements of informed consent, in comparison to a standard consent form, would increase the comprehension and satisfaction of adult cancer patients. Patients who were eligible for the National Surgical Adjuvant Study of Breast Cancer (protocol 01(N-SAS/BC-01)) were randomly selected to receive one of the following four versions: detailed document with graphics, detailed document without graphics, standard document with graphics, and standard document without graphics. The forms were written in plain language from the patients' point of view. A total of 85 patients were administered questionnaires via interview to assess levels of comprehension, satisfaction, and anxiety. Patients demonstrated a strong understanding of information regarding treatment and research. Patient comprehension did not differ significantly between the detailed document arms and the standard document arms. Patient satisfaction level increased according to the amount of information presented in the consent form; most patients preferred the detailed document with graphics. Anxiety and accrual rates in the parent study were not affected by informed consent procedures. Findings were limited to adults who had standard literacy skills and may not be generalizable to a population with lower literacy. Informed consent can be a significant experience for a population with standard literacy skills, as long as the document is easily comprehensible. Such information should be provided in a format that corresponds with patient needs, education levels, and preferences.

  18. An audit of the knowledge and attitudes of doctors towards Surgical Informed Consent (SIC).

    Science.gov (United States)

    Ashraf, Bushra; Tasnim, Nasira; Saaiq, Muhammad; Zaman, Khaleeq-Uz-

    2014-11-01

    The Surgical Informed Consent (SIC) is a comprehensive process that establishes an information-based agreement between the patient and his doctor to undertake a clearly outlined medical or surgical intervention. It is neither a casual formality nor a casually signed piece of paper. The present study was designed to audit the current knowledge and attitudes of doctors towards SIC at a tertiary care teaching hospital in Pakistan. This cross-sectional qualitative investigation was conducted under the auspices of the Department of Medical Education (DME), Pakistan Institute of Medical Sciences (PIMS), Shaheed Zulfiqar Ali Bhutto Medical University (SZABMU), Islamabad over three months period. A 19-item questionnaire was employed for data collection. The participants were selected at random from the list of the surgeons maintained in the hospital and approached face-to-face with the help of a team of junior doctors detailed for questionnaire distribution among them. The target was to cover over 50% of these doctors by convenience sampling. Out of 231 respondents, there were 32 seniors while 199 junior doctors, constituting a ratio of 1:6.22. The respondents variably responded to the questions regarding various attributes of the process of SIC. Overall, the junior doctors performed poorer compared to the seniors. The knowledge and attitudes of our doctors particularly the junior ones, towards the SIC are less than ideal. This results in their failure to avail this golden opportunity of doctor-patient communication to guide their patients through a solidly informative and legally valid SIC. They are often unaware of the essential preconditions of the SIC; provide incomplete information to their patients; and quite often do not ensure direct involvement of their patients in the process. Additionally they lack an understanding of using interactive computer-based programs as well as the concept of nocebo effect of informed consent.

  19. Semantic Web-Based Services for Supporting Voluntary Collaboration among Researchers Using an Information Dissemination Platform

    Directory of Open Access Journals (Sweden)

    Hanmin Jung

    2007-05-01

    Full Text Available Information dissemination platforms for supporting voluntary collaboration among researchers should assure that controllable and verified information is being disseminated. However, previous related studies on this field narrowed their research scopes into information type and information specification. This paper focuses on the verification and the tracing of information using an information dissemination platform and other Semantic Web-based services. Services on our platform include information dissemination services to support reliable information exchange among researchers and knowledge service to provide unrevealed information. The latter is also divided into the two: knowledgization using ontology and inference using a Semantic Web-based inference engine. This paper discusses how this platform supports instant knowledge addition and inference. We demonstrate our approach by constructing an ontology for national R&D reference information using 37,656 RDF triples from about 2,300 KISTI (Korea Institute of Science and Technology Information outcomes. Three knowledge services including 'Communities of Practice', 'Researcher Tracing,' and 'Research Map' were implemented on our platform using a Jena framework. Our study shows that information dissemination platforms will make a meaningful contribution to the possibility of realizing a practical Semantic Web-based information dissemination platform.

  20. A rural community's involvement in the design and usability testing of a computer-based informed consent process for the Personalized Medicine Research Project.

    Science.gov (United States)

    Mahnke, Andrea N; Plasek, Joseph M; Hoffman, David G; Partridge, Nathan S; Foth, Wendy S; Waudby, Carol J; Rasmussen, Luke V; McManus, Valerie D; McCarty, Catherine A

    2014-01-01

    Many informed consent studies demonstrate that research subjects poorly retain and understand information in written consent documents. Previous research in multimedia consent is mixed in terms of success for improving participants' understanding, satisfaction, and retention. This failure may be due to a lack of a community-centered design approach to building the interventions. The goal of this study was to gather information from the community to determine the best way to undertake the consent process. Community perceptions regarding different computer-based consenting approaches were evaluated, and a computer-based consent was developed and tested. A second goal was to evaluate whether participants make truly informed decisions to participate in research. Simulations of an informed consent process were videotaped to document the process. Focus groups were conducted to determine community attitudes towards a computer-based informed consent process. Hybrid focus groups were conducted to determine the most acceptable hardware device. Usability testing was conducted on a computer-based consent prototype using a touch-screen kiosk. Based on feedback, a computer-based consent was developed. Representative study participants were able to easily complete the consent, and all were able to correctly answer the comprehension check questions. Community involvement in developing a computer-based consent proved valuable for a population-based genetic study. These findings may translate to other types of informed consents, including those for trials involving treatment of genetic disorders. A computer-based consent may serve to better communicate consistent, clear, accurate, and complete information regarding the risks and benefits of study participation. Additional analysis is necessary to measure the level of comprehension of the check-question answers by larger numbers of participants. The next step will involve contacting participants to measure whether understanding of

  1. What physicians think about the need for informed consent for communicating the risk of cancer from low-dose radiation

    International Nuclear Information System (INIS)

    Karsli, Tijen; Kalra, Mannudeep K.; Self, Julie L.; Rosenfeld, Jason Anders; Butler, Susan; Simoneaux, Stephen

    2009-01-01

    The National Institute of Environmental Health Sciences, a subsidiary of the Food and Drug Administration, has declared that X-ray radiation at low doses is a human carcinogen. The purpose of our study was to determine if informed consent should be obtained for communicating the risk of radiation-induced cancer from radiation-based imaging. Institutional review board approval was obtained for the prospective survey of 456 physicians affiliated with three tertiary hospitals by means of a written questionnaire. Physicians were asked to state their subspecialty, number of years in practice, frequency of referral for CT scanning, level of awareness about the risk of radiation-induced cancer associated with CT, knowledge of whether such information is provided to patients undergoing CT, and opinions about the need for obtaining informed consent as well as who should provide information about the radiation-induced cancer risk to patients. Physicians were also asked to specify their preference among different formats of informed consent for communicating the potential risk of radiation-induced cancer. Statistical analyses were performed using the chi-squared test. Most physicians stated that informed consent should be obtained from patients undergoing radiation-based imaging (71.3%, 325/456) and the radiology department should provide information about the risk of radiation-induced cancer to these patients (54.6%, 249/456). The informed consent format that most physicians agreed with included modifications to the National Institute of Environmental Health Services report on cancer risk from low-dose radiation (20.2%, 92/456) or included information on the risk of cancer from background radiation compared to that from low-dose radiation (39.5%, 180/456). Most physicians do not know if patients are informed about cancer risk from radiation-based imaging in their institutions. However, they believe that informed consent for communicating the risk of radiation-induced cancer

  2. How informed is consent in vulnerable populations? Experience using a continuous consent process during the MDP301 vaginal microbicide trial in Mwanza, Tanzania

    Directory of Open Access Journals (Sweden)

    Kavit Natujwa

    2010-06-01

    Full Text Available Abstract Background HIV prevention trials conducted among disadvantaged vulnerable at-risk populations in developing countries present unique ethical dilemmas. A key concern in bioethics is the validity of informed consent for trial participation obtained from research subjects in such settings. The purpose of this study was to investigate the effectiveness of a continuous informed consent process adopted during the MDP301 phase III vaginal microbicide trial in Mwanza, Tanzania. Methods A total of 1146 women at increased risk of HIV acquisition working as alcohol and food vendors or in bars, restaurants, hotels and guesthouses have been recruited into the MDP301 phase III efficacy and safety trial in Mwanza. During preparations for the trial, participatory community research methods were used to develop a locally-appropriate pictorial flipchart in order to convey key messages about the trial to potential participants. Pre-recorded audio tapes were also developed to facilitate understanding and compliance with gel-use instructions. A comprehension checklist is administered by clinical staff to all participants at screening, enrolment, 12, 24, 40 and 50 week follow-up visits during the trial. To investigate women's perceptions and experiences of the trial, including how well participants internalize and retain key messages provided through a continuous informed consent process, a random sub-sample of 102 women were invited to participate in in-depth interviews (IDIs conducted immediately after their 4, 24 and 52 week follow-up visits. Results 99 women completed interviews at 4-weeks, 83 at 24-weeks, and 74 at 52 weeks (a total of 256 interviews. In all interviews there was evidence of good comprehension and retention of key trial messages including that the gel is not currently know to be effective against HIV; that this is the key reason for conducting the trial; and that women should stop using gel in the event of pregnancy. Conclusions

  3. A qualitative study of institutional review board members' experience reviewing research proposals using emergency exception from informed consent.

    Science.gov (United States)

    McClure, Katie B; Delorio, Nicole M; Schmidt, Terri A; Chiodo, Gary; Gorman, Paul

    2007-05-01

    Emergency exception to informed consent regulation was introduced to provide a venue to perform research on subjects in emergency situations before obtaining informed consent. For a study to proceed, institutional review boards (IRBs) need to determine if the regulations have been met. To determine IRB members' experience reviewing research protocols using emergency exception to informed consent. This qualitative research used semistructured telephone interviews of 10 selected IRB members from around the US in the fall of 2003. IRB members were chosen as little is known about their views of exception to consent, and part of their mandate is the protection of human subjects in research. Interview questions focused on the length of review process, ethical and legal considerations, training provided to IRB members on the regulations, and experience using community consultation and notification. Content analysis was performed on the transcripts of interviews. To ensure validity, data analysis was performed by individuals with varying backgrounds: three emergency physicians, an IRB member and a layperson. Respondents noted that: (1) emergency exception to informed consent studies require lengthy review; (2) community consultation and notification regulations are vague and hard to implement; (3) current regulations, if applied correctly, protect human subjects; (4) legal counsel is an important aspect of reviewing exception to informed-consent protocols; and (5) IRB members have had little or no formal training in these regulations, but are able to access materials needed to review such protocols. This preliminary study suggests that IRB members find emergency exception to informed consent studies take longer to review than other protocols, and that community consultation and community notification are the most difficult aspect of the regulations with which to comply but that they adequately protect human subjects.

  4. Physician counseling, informed consent and parental decision making for infants with hypoplastic left-heart syndrome.

    Science.gov (United States)

    Paris, J J; Moore, M P; Schreiber, M D

    2012-10-01

    Until the development in 1980 by William Norwood of a staged palliative surgical procedure for hypoplastic left heart syndrome (HPLHS), there was no treatment for that condition. With medical developments in the 1980s, parents had the option of the Norwood procedure, transplantation or comfort care for a child born with HPLHS. With an improvement in the survival rate for the Norwood procedure from an initial 30% to now better than 80%, some physicians believe that comfort care should no longer be an option. If, however, medically sophisticated parents, who know the neurological and motor skills impairments that accompany HPLHS, object to the surgery, they are allowed to opt for comfort care. This two-pronged approach to medical treatment seems to violate the norms on equity and fairness in the care of the patient. Parents need to be informed about long-term neurological and motor skill development as well as survival rates to give informed consent.

  5. Information, consent and treatment of patients with Morgellons disease: an ethical perspective.

    Science.gov (United States)

    Söderfeldt, Ylva; Groß, Dominik

    2014-04-01

    Morgellons is a medically contested diagnosis with foremost dermatological symptoms. Patients experience fibers emerging from the skin, together with a range of other somatic, psychiatric, and neurological complaints. Within the medical community, it is generally held to be a variation of delusional parasitosis/delusional infestation, which is usually treated with antipsychotics. Little attention has been paid in the literature to the ethical aspects of treating patients with Morgellons disease. The communicative strategies suggested in the literature display significant ethical issues, primarily the use of therapeutic privilege, i.e. withholding information from the patient. Since this limits patient autonomy, that approach is ethically problematic. Instead, the physician has an ethical obligation to respect the patient's autonomy, provide full information, and seek consent before initiating a psychiatric referral.

  6. Informed consent in clinical research; Do patients understand what they have signed?

    Directory of Open Access Journals (Sweden)

    Elena Villamañán

    2016-05-01

    Full Text Available Informed consent is an essential element of research, and signing this document is required to conduct most clinical trials. Its aim is to inform patients what their participation in the study will involve. However, increasingly, their complexity and length are making them difficult to understand, which might lead patients to give their authorization without having read them previously or without having understood what is stated. In this sense, the Ethics Committees for Clinical Research, and Pharmacists specialized in Hospital Pharmacy and Primary Care in their capacity as members of said committees, play an important and difficult role in defending the rights of patients. These Committees will review thoroughly these documents to guarantee that all legal requirements have been met and, at the same time, that they are easy to understand by the potential participants in a clinical trial

  7. Email-Based Informed Consent: Innovative Method for Reaching Large Numbers of Subjects for Data Mining Research

    Science.gov (United States)

    Lee, Lesley R.; Mason, Sara S.; Babiak-Vazquez, Adriana; Ray, Stacie L.; Van Baalen, Mary

    2015-01-01

    Since the 2010 NASA authorization to make the Life Sciences Data Archive (LSDA) and Lifetime Surveillance of Astronaut Health (LSAH) data archives more accessible by the research and operational communities, demand for data has greatly increased. Correspondingly, both the number and scope of requests have increased, from 142 requests fulfilled in 2011 to 224 in 2014, and with some datasets comprising up to 1 million data points. To meet the demand, the LSAH and LSDA Repositories project was launched, which allows active and retired astronauts to authorize full, partial, or no access to their data for research without individual, study-specific informed consent. A one-on-one personal informed consent briefing is required to fully communicate the implications of the several tiers of consent. Due to the need for personal contact to conduct Repositories consent meetings, the rate of consenting has not kept up with demand for individualized, possibly attributable data. As a result, other methods had to be implemented to allow the release of large datasets, such as release of only de-identified data. However the compilation of large, de-identified data sets places a significant resource burden on LSAH and LSDA and may result in diminished scientific usefulness of the dataset. As a result, LSAH and LSDA worked with the JSC Institutional Review Board Chair, Astronaut Office physicians, and NASA Office of General Counsel personnel to develop a "Remote Consenting" process for retrospective data mining studies. This is particularly useful since the majority of the astronaut cohort is retired from the agency and living outside the Houston area. Originally planned as a method to send informed consent briefing slides and consent forms only by mail, Remote Consenting has evolved into a means to accept crewmember decisions on individual studies via their method of choice: email or paper copy by mail. To date, 100 emails have been sent to request participation in eight HRP

  8. EMS providers and exception from informed consent research: benefits, ethics, and community consultation.

    Science.gov (United States)

    Ripley, Elizabeth; Ramsey, Cornelia; Prorock-Ernest, Amy; Foco, Rebecca; Luckett, Solomon; Ornato, Joseph P

    2012-01-01

    As attention to, and motivation for, emergency medical services (EMS)-related research continues to grow, particularly exception from informed consent (EFIC) research, it is important to understand the thoughts, beliefs, and experiences of EMS providers who are actively engaged in the research. We explored the attitudes, beliefs, and experiences of EMS providers regarding their involvement in prehospital emergency research, particularly EFIC research. Using a qualitative design, 24 participants were interviewed including nationally registered paramedics and Virginia-certified emergency medical technicians employed at Richmond Ambulance Authority, the participating EMS agency. At the time of our interviews, the EMS agency was involved in an EFIC trial. Transcribed interview data were coded and analyzed for themes. Findings were presented back to the EMS agency for validation. Overall, there appeared to be support for prehospital emergency research. Participants viewed research as necessary for the advancement of the field of EMS. Improvement in patient care was identified as one of the most important benefits. A number of ethical considerations were identified: individual risk versus public good and consent. The EMS providers in our study were open to working with EMS researchers throughout the community consultation and public disclosure process. The EMS providers in our study valued research and were willing to participate in studies. Support for research was balanced with concerns and challenges regarding the role of providers in the research process.

  9. A pilot study of three dimensional color CT images of brain diseases to improve informed consent

    International Nuclear Information System (INIS)

    Tanizaki, Yoshio; Akiyama, Takenori; Hiraga, Kenji; Akaji, Kazunori

    2005-01-01

    We have described brain diseases to patients and their family using monochrome CT images. It is thought that patients have difficulties in giving their consent to our conventional explanation because their understanding of brain diseases is based on three dimensional and color images, however, standard CT images are two dimensional and gray scale images. We have been trying to use three dimensional color CT images to improve the typical patient's comprehension of brain diseases. We also try to simulate surgery using these images. Multi-slice CT accumulates precise isotropic voxel data within a half minute. These two dimensional and monochrome data are converted to three dimensional color CT images by 3D workstation. Three dimensional color CT images of each brain structures (e.g. scalp, skull, brain, ventricles and lesions) are created separately. Then, selected structures are fused together for different purposes. These images are able to rotate around any axis. Because the methods to generate three-dimensional color images have not established, we neurosurgeons must create these images. In particular, when an operation is required, the surgeon should create the images. In this paper, we demonstrate how three-dimensional color CT images can improve informed consent. (author)

  10. Incorporating a quiz into informed consent processes: Qualitative study of participants' reactions

    Directory of Open Access Journals (Sweden)

    Marsh Vicki

    2007-11-01

    Full Text Available Abstract Background Formal checks of participant understanding are now widely recommended to improve informed consent processes. However, the views of the participants these assessments are designed to protect are rarely considered. In this paper the findings of a qualitative study aimed at documenting community reactions to a semi-structured questionnaire ('quiz' are reported. The quiz was administered to 189 mothers after consenting for their children to participate in a malaria vaccine trial on the Kenyan Coast. Methods Once the malaria vaccine trial was underway, focus group discussions were held with some of these mothers (nine groups; 103 mothers, and with community-based field staff attached to the malaria vaccine trial (two groups of five workers. Individual interviews with other trial staff were also held. Results The quiz prompted community members to voice concerns about blood sampling and vaccine side-effects, thereby encouraging additional discussions and interactions between the research team and potential study participants. However, it also caused significant upset and concern. Some of the quiz questions, or the way in which they were asked, appeared to fuel misconceptions and fears, with potentially negative consequences for both the study and community members. Conclusion Formal approaches to checking study understanding should be employed with sensitivity and caution. They are influenced by and impact upon complex social relationships between and among researchers and community members. Adequate consideration of these contexts in assessments of understanding, and in responding to the issues raised, requires strong social science capacity.

  11. An Audit of the Knowledge and Attitudes of Doctors towards Surgical Informed Consent (SIC

    Directory of Open Access Journals (Sweden)

    Bushra Ashraf

    2014-11-01

    Full Text Available Background The Surgical Informed Consent (SIC is a comprehensive process that establishes an informationbased agreement between the patient and his doctor to undertake a clearly outlined medical or surgical intervention. It is neither a casual formality nor a casually signed piece of paper. The present study was designed to audit the current knowledge and attitudes of doctors towards SIC at a tertiary care teaching hospital in Pakistan. Methods This cross-sectional qualitative investigation was conducted under the auspices of the Department of Medical Education (DME, Pakistan Institute of Medical Sciences (PIMS, Shaheed Zulfiqar Ali Bhutto Medical University (SZABMU, Islamabad over three months period. A 19-item questionnaire was employed for data collection. The participants were selected at random from the list of the surgeons maintained in the hospital and approached face-to-face with the help of a team of junior doctors detailed for questionnaire distribution among them. The target was to cover over 50% of these doctors by convenience sampling. Results Out of 231 respondents, there were 32 seniors while 199 junior doctors, constituting a ratio of 1:6.22. The respondents variably responded to the questions regarding various attributes of the process of SIC. Overall, the junior doctors performed poorer compared to the seniors. Conclusion The knowledge and attitudes of our doctors particularly the junior ones, towards the SIC are less than ideal. This results in their failure to avail this golden opportunity of doctor-patient communication to guide their patients through a solidly informative and legally valid SIC. They are often unaware of the essential preconditions of the SIC; provide incomplete information to their patients; and quite often do not ensure direct involvement of their patients in the process. Additionally they lack an understanding of using interactive computer-based programs as well as the concept of nocebo effect of informed

  12. [Global analysis of the readability of the informed consent forms used in public hospitals of Spain].

    Science.gov (United States)

    Mariscal-Crespo, M I; Coronado-Vázquez, M V; Ramirez-Durán, M V

    To analyse the readability of informed consent forms (ICF) used in Public Hospitals throughout Spain, with the aim of checking their function of providing comprehensive information to people who are making any health decision no matter where they are in Spain. A descriptive study was performed on a total of 11,339 ICF received from all over Spanish territory, of which 1617 ICF were collected from 4 web pages of Health Portal and the rest (9722) were received through email and/or telephone contact from March 2012 to February 2013. The readability level was studied using the Inflesz tool. A total of 372 ICF were selected and analysed using simple random sampling. The Inflesz scale and the Flesch-Szigriszt index were used to analyse the readability. The readability results showed that 62.4% of the ICF were rated as a "little difficult", the 23.4% as "normal", and the 13.4% were rated as "very difficult". The highest readability means using the Flesch index were scored in Andalusia with a mean of 56.99 (95% CI; 55.42-58.57) and Valencia with a mean of 51.93 (95% CI; 48.4-55.52). The lowest readability means were in Galicia with a mean of 40.77 (95% CI; 9.83-71.71) and Melilla, mean=41.82 (95% CI; 35.5-48.14). The readability level of Spanish informed consent forms must be improved because their scores using readability tools could not be classified in normal scales. Furthermore, there was very wide variability among Spanish ICF, which showed a lack of equity in information access among Spanish citizens. Copyright © 2017 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

  13. A pilot study of simple interventions to improve informed consent in clinical research: feasibility, approach, and results.

    Science.gov (United States)

    Kass, Nancy E; Taylor, Holly A; Ali, Joseph; Hallez, Kristina; Chaisson, Lelia

    2015-02-01

    Research suggests that participants do not always adequately understand studies. While some consent interventions increase understanding, methodologic challenges have been raised in studying consent outside of actual trial settings. This study examined the feasibility of testing two consent interventions in actual studies and measured effectiveness of interventions in improving understanding. Participants enrolling in any of eight ongoing clinical trials were sequentially assigned to one of three different informed consent strategies for enrollment in their clinical trial. Control participants received standard consent procedures for their trial. Participants in the first intervention arm received a bulleted fact sheet summarizing key study information. Participants in the second intervention arm received the bulleted fact sheet and also engaged in a feedback Q&A session. Later, patients answered closed- and open-ended questions to assess patient understanding and literacy. Descriptive statistics, Wilcoxon -Mann -Whitney and Kruskal-Wallis tests were generated to assess correlations; regression analysis determined predictors of understanding. 144 participants enrolled. Using regression analysis, participants receiving the second intervention scored 7.6 percentage points higher (p = .02) on open-ended questions about understanding than participants in the control, although unadjusted comparisons did not reach statistical significance. Our study supports the hypothesis that patients receiving both bulleted fact sheets and a Q&A session had higher understanding compared to standard consent. Fact sheets and short structured dialog are quick to administer and easy to replicate across studies and should be tested in larger samples. © The Author(s) 2014.

  14. Failure to report and provide commentary on research ethics board approval and informed consent in medical journals.

    Science.gov (United States)

    Finlay, K A; Fernandez, C V

    2008-10-01

    The Declaration of Helsinki prohibits the publication of articles that do not meet defined ethical standards for reporting of research ethics board (REB) approval and informed consent. Despite this prohibition and a call to highlight the deficiency for the reader, articles with potential ethical shortcomings continue to be published. To determine what proportion of articles in major medical journals lack statements confirming REB approval and informed consent, and whether accompanying commentary alerts readers to this deficiency. Retrospective, observational study. Online review of five major medical journals. All clinical research articles published online between 1 January 2005 and 31 December 2006 in the BMJ, Lancet, Annals of Internal Medicine, JAMA and the New England Journal of Medicine. Statement of REB approval and informed consent. Of 1780 articles reviewed, 1133 (63.7%) met inclusion criteria (manuscripts reporting human subjects, human tissue or identifiable personal data research), 36 (3.2%) articles lacked a statement of REB approval, 62 (5.5%) lacked disclosure of informed consent and 15 (1.3%) articles lacked both. Articles that did not state REB approval were associated with not stating informed consent (pjournals without editorial statements to alert the reader to this deficiency.

  15. State or nature? Endogenous formal versus informal sanctions in the voluntary provision of public goods

    DEFF Research Database (Denmark)

    Kamei, Kenju; Putterman, Louis; Tyran, Jean-Robert Karl

    2015-01-01

    We investigate the endogenous formation of sanctioning institutions supposed to improve efficiency in the voluntary provision of public goods. Our paper parallels Markussen et al. (Rev Econ Stud 81:301–324, 2014) in that our experimental subjects vote over formal versus informal sanctions......, but it goes beyond that paper by endogenizing the formal sanction scheme. We find that self-determined formal sanctions schemes are popular and efficient when they carry no up-front cost, but as in Markussen et al. informal sanctions are more popular and efficient than formal sanctions when adopting...... the latter entails such a cost. Practice improves the performance of sanction schemes: they become more targeted and deterrent with learning. Voters’ characteristics, including their tendency to engage in perverse informal sanctioning, help to predict individual voting....

  16. Genomic research and data-mining technology: implications for personal privacy and informed consent.

    Science.gov (United States)

    Tavani, Herman T

    2004-01-01

    This essay examines issues involving personal privacy and informed consent that arise at the intersection of information and communication technology (ICT) and population genomics research. I begin by briefly examining the ethical, legal, and social implications (ELSI) program requirements that were established to guide researchers working on the Human Genome Project (HGP). Next I consider a case illustration involving deCODE Genetics, a privately owned genetic company in Iceland, which raises some ethical concerns that are not clearly addressed in the current ELSI guidelines. The deCODE case also illustrates some ways in which an ICT technique known as data mining has both aided and posed special challenges for researchers working in the field of population genomics. On the one hand, data-mining tools have greatly assisted researchers in mapping the human genome and in identifying certain "disease genes" common in specific populations (which, in turn, has accelerated the process of finding cures for diseases tha affect those populations). On the other hand, this technology has significantly threatened the privacy of research subjects participating in population genomics studies, who may, unwittingly, contribute to the construction of new groups (based on arbitrary and non-obvious patterns and statistical correlations) that put those subjects at risk for discrimination and stigmatization. In the final section of this paper I examine some ways in which the use of data mining in the context of population genomics research poses a critical challenge for the principle of informed consent, which traditionally has played a central role in protecting the privacy interests of research subjects participating in epidemiological studies.

  17. Are women who are taking Hormone Replacement Therapy doing so with informed consent?

    Energy Technology Data Exchange (ETDEWEB)

    Mitchell, E.M

    2003-11-01

    Just over half the population in Britain today are women, and each is likely to spend over one-third of her life in the post menopausal state. The number of post-war 'Baby Boomers' is having a profound effect on interest in the menopause and increasing awareness of Hormone Replacement Therapy (HRT). Patients are no longer prepared to passively accept the advice of their doctor, and should make an informed decision over its use, after having been given up-to-date information. Some of the claimed benefits of taking HRT are not fully proven and the risks and disadvantages must be considered, notably the increased risk of breast cancer and the effect on the sensitivity and specificity of the mammographic image. The long-term benefits are still uncertain. Available information needs to be comprehensible, credible, and up to date. Whether to initiate the taking of HRT is one of the most important decisions a woman entering mid-life will make, so she needs to be given information she can understand in order to make an informed decision. HRT and informed consent are topics relevant to mammography, which was the rationale in writing this paper as part of a Post Graduate Certificate in Mammographic Studies.

  18. Informed Consent Obtainment, Malpractice Litigation, and the Potential Role of Shared Decision Making Approaches

    DEFF Research Database (Denmark)

    Birkeland, Søren

    2015-01-01

    of the iceberg as lack of patient ‘ownership’ of the DM is not always exposed or may be explicated otherwise (alleged substandard behavior or surgery etc). SDM approaches possibly may sometimes prevent IC duty breaches, assist documenting the DM process, and reduce litigation occurrence.......Internationally, there is increasing recognition of Shared Decision Making (SDM) and Decision Aids (DAs) as measures to increase patient involvement in – and satisfaction with - decision making (DM), improve health care communication, and address bioethical autonomy principles and informed consent...... search term ‘consent’; 15th May 2015). Among 3291 lawsuits, 229 with explicit IC judgments were found. They mostly concerned the hospital sector (179; 78%) and commonly involved surgery (69), gyn/obstetrics (33), and gen. medicine (20; incl, eg, cardiology). 21 affected minor patients and 36 were cancer...

  19. The centennial of the Yellow Fever Commission and the use of informed consent in medical research

    Directory of Open Access Journals (Sweden)

    Güereña-Burgueño Fernando

    2002-01-01

    Full Text Available The year 2000 marked the centennial of the discovery of the mode of transmission of yellow fever. Informed consent was systematically used for the first time in research. This process was the result of a complex social phenomenon involving the American Public Health Association, the US and Spanish Governments, American and Cuban scientists, the media, and civilian and military volunteers. The public health and medical communities face the AIDS pandemic at the beginning of the 21st Century, as they faced the yellow fever epidemic at the beginning of the 20th Century. Current medical research dilemmas have fueled the debate about the ethical conduct of research in human subjects. The AIDS pandemic is imposing enormous new ethical challenges on the conduct of medical research, especially in the developing world. Reflecting on the yellow fever experiments of 1900, lessons can be learned and applied to the current ethical challenges faced by the international public health research community.

  20. Oil exploitation, development justice and the utility of free, prior and informed consent in northwest Kenya

    DEFF Research Database (Denmark)

    Owiso, Michael

    2018-01-01

    manipulation, internal weaknesses of the state in Africa, illiteracy among the local populations and extreme levels of poverty, among others, as significantly contributing to resource conflicts in the region. This contribution is anchored on the free, prior and informed consent framework as a remedy...... for the resource curse. The framework must have a regional, national as well as local strategic and systematic focus and must bring together key actors, amongst them public and private actors and particularly the communities, in thinking and planning for the future.......Policy addressing the governance of natural resources and issues of development justice, though present, is either in its nascent stages or is weak in addressing the challenges that accrue from this relationship within states in Africa and the world in general. This complicates and antagonises...

  1. Conocimiento del consentimiento informado en servicios quirúrgicos Knowledge of informed consent in surgical services

    Directory of Open Access Journals (Sweden)

    Verónica Castillo Pérez

    2013-02-01

    Full Text Available Introducción: el conocimiento informado constituye un elemento esencial de la relación médico paciente actualmente. Objetivo: diagnosticar el conocimiento que sobre el consentimiento informado tienen los miembros de los servicios quirúrgicos así como los pacientes que en esta etapa de la investigación se le practicó alguna intervención quirúrgica. Método: se realizó un estudio en los servicios quirúrgicos del Hospital Clínico Quirúrgico Docente Dr. León Cuervo Rubio de Pinar del Río en el período de Enero a Marzo del 2012, para ello se encuestaron profesionales de los servicios de cirugía y anestesiología así como a pacientes que fueron intervenidos quirúrgicamente en igual período de tiempo. Con un universo de 73 profesionales médicos y 253 pacientes, con una muestra de 45 médicos e igual cantidad de personal de enfermería así como 220 pacientes Resultados: existe un dominio incompleto del consentimiento informado en los pacientes, en la mayoría de los cirujanos y enfermeros no tienen dominio y no aplican correctamente el mismo, sin embargo habían recibido perfeccionamiento sobre dicho tema. Conclusiones: el reconocimiento de la autonomía del paciente y el proceso provocó un cambio en la relación médico paciente en la práctica de la cirugía. Además de la profundización en el estudio de los principios bioéticos y su aplicación, se hace necesaria la búsqueda de respuestas útiles a los problemas bioéticos en estos servicios que afectan la propia relación médico paciente así como la seguridad que les debemos brindar a los pacientes para respaldar el procedimiento quirúrgico.Introduction: current knowledge of informed consent constitutes an essential element of doctor-patient relationship. Objective: to identify knowledge of informed consent in the members of surgical services and in patients who underwent surgeries during the period of investigation. Method: a study was conducted in the surgical services

  2. Provision of Informed Consent towards the Level of Anxiety in Pre-operative Patients at Mamuju District Public Hospital

    Directory of Open Access Journals (Sweden)

    Imelda Appulembang

    2017-08-01

    Tindakan pembedahan merupakan salah satu tindakan medis yang dapat mendatangkan stressor sehingga menimbulkan kecemasan pada pasien. Penelitian ini bertujuan untuk mengetahui pengaruh pemberian informed consent terhadap tingkat kecemasan pada pasien pra-operasi di Rumah Sakit Umum Daerah (RSUD Mamuju. Populasi pada penelitian ini adalah pasien pra-operasi. Sampel ditentukan dengan menggunakan pendekatan accidental sampling sehingga diperoleh sampel sebanyak 32 orang. Jenis penelitian ini adalah penelitian kuantitatif dengan menggunakan metode quasi experimental design melalui pendekatan non-equivalent time sample design yang dianalisis dengan menggunakan uji statistik Wilcoxon. Hasil penelitian menunjukkan bahwa terdapat pengaruh pemberian informed consent terhadap tingkat kecemasan pasien. Dapat disimpulkan pemberian informed consent dapat menurunkan kecemasan pasien pra-operasi di RSUD Kabupaten Mamuju.

  3. Comic strips help children understand medical research: targeting the informed consent procedure to children's needs.

    Science.gov (United States)

    Grootens-Wiegers, Petronella; de Vries, Martine C; van Beusekom, Mara M; van Dijck, Laura; van den Broek, Jos M

    2015-04-01

    Children involved in medical research often fail to comprehend essential research aspects. In order to improve information provision, a participatory approach was used to develop new information material explaining essential concepts of medical research. A draft of a comic strip was developed by a science communicator in collaboration with pediatricians. The draft was presented to children participating in a clinical trial and to two school classes. Children were consulted for further development in surveys and interviews. Subsequently, the material was revised and re-evaluated in four school classes with children of varying ages and educational levels. In the first evaluation, children provided feedback on the storyline, wording and layout. Children thought the comic strip was 'fun' and 'informative'. Understanding of 8 basic research aspects was on average 83% and all above 65%, illustrating that children understood and remembered key messages. A comic strip was developed to support the informed consent process. Children were consulted and provided feedback. The resulting material was well understood and accepted. Involving children in the development of information material can substantially contribute to the quality of the material. Children were excited to participate and to 'be a part of science'. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  4. Pattern of informed consent acquisition in patients undergoing emergent endovascular treatment for acute ischemic stroke

    Science.gov (United States)

    Qureshi, Adnan I; Gilani, Sarwat; Adil, Malik M; Majidi, Shahram; Hassan, Ameer E; Miley, Jefferson T; Rodriguez, Gustavo J

    2014-01-01

    Background Telephone consent and two physician consents based on medical necessity are alternate strategies for time sensitive medical decisions but are not uniformly accepted for clinical practice or recruitment into clinical trials. We determined the rate of and associated outcomes with alternate consenting strategies in consecutive acute ischemic stroke patients receiving emergent endovascular treatment. Methods We divided patients into those treated based on in-person consent and those based on alternate strategies. We identified clinical and procedural differences and differences in hospital outcomes: symptomatic ICH and favorable outcome (defined by modified Rankin Scale of 0–2 at discharge) based on consenting methodology. Results Of a total of 159 patients treated, 119 were treated based on in-person consent (by the patient in 27 and legally authorized representative in 92 procedures). Another 40 patients were treated using alternate strategies (20 telephone consents and 20 two physician consents based on medical necessity). There was no difference in the mean ages and proportion of men among the two groups based on consenting methodology. There was a significantly greater time interval incurred between CT scan and initiation of endovascular procedure in those in whom in-person consent was obtained (117 ± 65 min versus 101 ± 45 min, p = 0.01). There was no significant difference in rates of ICH (9% versus 8%, p = 0.9), or favorable outcome at discharge (28% versus 30%, p = 0.8). Conclusions Consent through alternate strategies does not adversely affect procedural characteristics or outcome of patients and may be more time efficient than in-person consenting process. PMID:25132906

  5. Cognitive Investigation Study of Patients Admitted for Cosmetic Surgery: Information, Expectations, and Consent for Treatment

    Directory of Open Access Journals (Sweden)

    Mauro Barone

    2015-01-01

    Full Text Available BackgroundIn all branches of medicine, it is the surgeon's responsibility to provide the patient with accurate information before surgery. This is especially important in cosmetic surgery because the surgeon must focus on the aesthetic results desired by the patient.MethodsAn experimental protocol was developed based on an original questionnaire given to 72 patients. The nature of the responses, the patients' motivation and expectations, the degree of patient awareness regarding the planned operation, and the patients' perceptions of the purpose of the required consent for cosmetic surgery were all analyzed using Fisher's exact test.ResultsCandidates for abdominal wall surgery had significantly more preoperative psychological problems than their counterparts did (P=0.035. A significantly different percentage of patients under 40 years of age compared to those over 40 years of age searched for additional sources of information prior to the operation (P=0.046. Only 30% of patients with a lower educational background stated that the preoperative information had been adequate, whereas 92% of subjects with secondary schooling or a postsecondary degree felt that the information was sufficient (P=0.001. A statistically significant difference was also present between patients according to their educational background regarding expected improvements in their quality of life postoperatively (P=0.008.ConclusionsThis study suggests that patients require more attention in presurgical consultations and that clear communication should be prioritized to ensure that the surgeon understands the patient's expectations.

  6. IMPLEMENTASI PERSETUJUAN TINDAKAN KEDOKTERAN (INFORMED CONSENT DALAM PERJANJIAN TERAPEUTIK OLEH TENAGA KESEHATAN TERHADAP PASIEN RUMAH SAKIT DI PROVINSI BALI

    Directory of Open Access Journals (Sweden)

    Ida Ayu Sri Kusuma Wardhani

    2014-03-01

    Full Text Available Health is the most important part of human life that can affect productivity and optimal human activity. When a person's health is compromised, then that person will seek treatment in health care facilities in the hospital one of them in order to get action. Measures of medicine containing the high risk should get written consent from patient/family called Informed Consent. The legal relationship between health professionals with patients occurs because of the agreement that causes the therapeutic relationship inspaningverbintenis law (treaty effort. Similarly in the Bali Provincial Hospital in any medical act especially those containing a high risk, which is done by some health professionals are also using the Informed Consent. But if there is negligence actions that cause harm, who will be responsible for the risks in the suffering patient / family? and how the efforts of patient / family to resolve medical disputes against the risk of Informed Consent? The method used in this research is an empirical law derived from primary data and secondary data. The nature of the study is descriptive, with qualitative data analysis. Overall the results of these analyzes are presented in the description which describes the complete problem under study, along with a critical discussion. Based on the Theory of Legal System of L. M. Friedman, legal systems theory described by Soerjono Soekanto be legal efficacy theory, the theory of Hans Kelsen responsibility, and legislation as well as the results of research in the field, it is known that the liability of health professionals based on Informed Consent Agreement Therapeutic Hospital in Bali province is on the doctor who signed the operator of the informed consent form. However, if the patient / family prosecute acts of negligence committed by health professionals, the hospital will be responsible jointly and severally against such negligence. From the result of  research in the hospital in the province of

  7. Improving validity of informed consent for biomedical research in Zambia using a laboratory exposure intervention.

    Science.gov (United States)

    Zulu, Joseph Mumba; Lisulo, Mpala Mwanza; Besa, Ellen; Kaonga, Patrick; Chisenga, Caroline C; Chomba, Mumba; Simuyandi, Michelo; Banda, Rosemary; Kelly, Paul

    2014-01-01

    Complex biomedical research can lead to disquiet in communities with limited exposure to scientific discussions, leading to rumours or to high drop-out rates. We set out to test an intervention designed to address apprehensions commonly encountered in a community where literacy is uncommon, and where complex biomedical research has been conducted for over a decade. We aimed to determine if it could improve the validity of consent. Data were collected using focus group discussions, key informant interviews and observations. We designed an intervention that exposed participants to a detailed demonstration of laboratory processes. Each group was interviewed twice in a day, before and after exposure to the intervention in order to assess changes in their views. Factors that motivated people to participate in invasive biomedical research included a desire to stay healthy because of the screening during the recruitment process, regular advice from doctors, free medical services, and trust in the researchers. Inhibiting factors were limited knowledge about samples taken from their bodies during endoscopic procedures, the impact of endoscopy on the function of internal organs, and concerns about the use of biomedical samples. The belief that blood can be used for Satanic practices also created insecurities about drawing of blood samples. Further inhibiting factors included a fear of being labelled as HIV positive if known to consult heath workers repeatedly, and gender inequality. Concerns about the use and storage of blood and tissue samples were overcome by a laboratory exposure intervention. Selecting a group of members from target community and engaging them in a laboratory exposure intervention could be a useful tool for enhancing specific aspects of consent for biomedical research. Further work is needed to determine the extent to which improved understanding permeates beyond the immediate group participating in the intervention.

  8. Improving validity of informed consent for biomedical research in Zambia using a laboratory exposure intervention.

    Directory of Open Access Journals (Sweden)

    Joseph Mumba Zulu

    Full Text Available Complex biomedical research can lead to disquiet in communities with limited exposure to scientific discussions, leading to rumours or to high drop-out rates. We set out to test an intervention designed to address apprehensions commonly encountered in a community where literacy is uncommon, and where complex biomedical research has been conducted for over a decade. We aimed to determine if it could improve the validity of consent.Data were collected using focus group discussions, key informant interviews and observations. We designed an intervention that exposed participants to a detailed demonstration of laboratory processes. Each group was interviewed twice in a day, before and after exposure to the intervention in order to assess changes in their views.Factors that motivated people to participate in invasive biomedical research included a desire to stay healthy because of the screening during the recruitment process, regular advice from doctors, free medical services, and trust in the researchers. Inhibiting factors were limited knowledge about samples taken from their bodies during endoscopic procedures, the impact of endoscopy on the function of internal organs, and concerns about the use of biomedical samples. The belief that blood can be used for Satanic practices also created insecurities about drawing of blood samples. Further inhibiting factors included a fear of being labelled as HIV positive if known to consult heath workers repeatedly, and gender inequality. Concerns about the use and storage of blood and tissue samples were overcome by a laboratory exposure intervention.Selecting a group of members from target community and engaging them in a laboratory exposure intervention could be a useful tool for enhancing specific aspects of consent for biomedical research. Further work is needed to determine the extent to which improved understanding permeates beyond the immediate group participating in the intervention.

  9. In private practice, informed consent is interpreted as providing explanations rather than offering choices: a qualitative study.

    Science.gov (United States)

    Delany, Clare M

    2007-01-01

    How do physiotherapists working in private practice understand and interpret the meaning and significance of informed consent in everyday clinical practice? Qualitative study using semi-structured interviews. Seventeen physiotherapists purposefully recruited from metropolitan private practices where treatment was on a one-on-one basis. Therapists defined informed consent as an implicit component of their routine clinical explanations, rather than a process of providing explicit patient choices. Therapists' primary concern was to provide information that led to a (therapist-determined) beneficial therapeutic outcome, rather than to enhance autonomous patient choice. Explicit patient choice and explicit informed consent were defined as important only if patients requested information or therapists recognised risks associated with the treatment. Physiotherapists defined informed consent within a context of achieving therapeutic outcomes rather than a context of respect for patient autonomy and autonomous choice. Physiotherapy practice guidelines developed to ensure compliance with ethical and legal obligations may therefore be followed only if they fit with therapists' understanding and interpretation of a desired therapeutic outcome.

  10. Consent and assessment of capacity to decide or refuse treatment.

    Science.gov (United States)

    Simpson, Owena

    Consent protects the right of patients to decide what happens to them. Before any medical intervention, adults must give valid consent, which must be voluntary, informed and given free of undue influence. When consent is being obtained, patients must be informed about the intervention, why it is being done and its risks; information they are given must be recorded. Every effort should be made to explain the issues in terms that the patient can understand and by providing support and aids to communicate. Consent can be expressed, where patients say they consent or put it in writing, or implied, where a healthcare professional infers from their behaviour that they consent. While different types of consent are valid, some are evidence of stronger proof in court that valid consent has been given. Competent adults have the right to refuse treatment, regardless of the reasons they give for refusal and even if the refusal will result in death; clinicians must respect their decision. In some circumstances-such as when an unconscious person is admitted as an emergency-healthcare professionals can make decisions on behalf of patients, and must do so in patients' best interests.

  11. Parental comprehension and satisfaction in informed consent in paediatric clinical trials: a prospective study on childhood leukaemia.

    Science.gov (United States)

    Chappuy, H; Baruchel, A; Leverger, G; Oudot, C; Brethon, B; Haouy, S; Auvrignon, A; Davous, D; Doz, F; Tréluyer, J M

    2010-10-01

    To evaluate the extent to which parents are satisfied with and understand the information they are given when their consent is sought for their child to participate in a phase III randomised clinical trial and the reasons for their decision. The authors carried out a prospective study. The authors included all parents whose consent was sought for their child to participate in the FRALLE 2000A protocol (acute lymphoblastic leukaemia) at two centres. The parents were questioned twice by a qualified psychologist using a semidirected interview, 1 and 6 months after consent was sought. 43 first interviews were carried out. All the parents declared they were satisfied with the explanations provided by the physician. 35 (81%) parents felt that the information provided with the request for consent was appropriate. Eight (19%) parents did not realise that their child had been included in a research protocol. 16 (39%) parents did not understand the concept of randomisation. Half the parents could explain neither the aim of the clinical trial nor the potential benefit of inclusion to their child. Only one third of the parents were aware that they had an alternative. The principal factor underlying their decision, as stated by 29 parents (67%), was confidence in the medical team. The parents signed consent forms without having fully understood all the elements specific to the experimental protocol. Rather, the parents based their decision on their confidence in the medical team, even when their child's life was at risk.

  12. Radon risk information and voluntary protection: evidence from a natural experiment

    International Nuclear Information System (INIS)

    Johnson, F.R.; Luken, R.A.

    1987-01-01

    This study examines the perceived risks and mitigating behavior of Maine households who received new information on their exposures to significant health risks from indoor radon. The observed responses of these households illustrate conceptual issues related to designing an effective risk information program. Despite the involvement of generally well-motivated homeowners and well-intentioned researchers and government officials, we conclude that the risk information approach used in Maine failed to induce appropriate, cost-effective voluntary protection. The results indicate that, after receiving radon test results, information on associated health risks, and suggestions on how to reduce exposures: perceived risks tended to understate objective risks by orders of magnitude, and there was no statistically significant relationship between mitigating behavior and objective risks. These results suggest that the formation of risk perceptions and subsequent behavioral adjustments involve complex interactions among information, contextual, socioeconomic, and psychological variables. Therefore, government programs that seek to reduce health and safety risks with information programs, instead of using more conventional enforced standards, must be crafted very carefully to accommodate this complex process

  13. Rola świadomej zgody pacjenta w procesie diagnostyki i leczenia = The role of patient informed consent in the process of diagnosis and treatment

    Directory of Open Access Journals (Sweden)

    Marta Podgórniak

    2016-05-01

      Keywords: informed consent, medical law, legal liability.   Abstract Patient’s consent is a document defining a range and terms of intervention of medical personnel in the patient's personal sphere, which is protected by the Constitution and other many laws. Obtaining consent to treatment from the patient plays a main role in the diagnosis and treatment. The doctor is obliged to obtain consent to provide health care services aimed at saving lives and preserving, restoring or improving the health with the exception of situations in which the patient requires immediate medical intervention. In the case of many basic health services verbal consent is sufficient. In the case of medical services with increased risk of complications it is necessary to get the written consent to treatment, the text should include a statement of the will of the patient, the term of medical activities and related possible complications, signature and the date of the patient's consent. For undertaking medical services in the group of people under 16 years it is necessary to get consent from patient's legal representative. In cases of a patients who are over 16 years it is needed to obtain the consent known as cumulative, that is the consent of the patient and his legal representative. Performing treatments and diagnostic activities without consent of the patient is permitted in certain exceptional situations. In daily practice of physicians, getting consent is sometimes difficult task due to the limited amount of time or difficulties in collaboration with the patient or assess his state of consciousness.

  14. Understanding and retention of trial-related information among participants in a clinical trial after completing the informed consent process.

    Science.gov (United States)

    Mexas, Fernanda; Efron, Anne; Luiz, Ronir Raggio; Cailleaux-Cezar, Michelle; Chaisson, Richard E; Conde, Marcus B

    2014-02-01

    for assessing the level of understanding of trial-related information during the informed consent (IC) process in developing countries are lacking. To assess the understanding and retention of trial-related information presented in the IC process by administering an informed consent assessment instrument (ICAI) to participants in a clinical trial for a new tuberculosis (TB) regimen being conducted in Rio de Janeiro (Brazil). Methods The format of the ICAI was based on the language and structure of the United States National Cancer Institute's IC comprehension checklist. The ICAI was designed to assess points of the RioMAR study IC process that addressed the principles of research ethics requested by Brazilian Regulatory Authority: autonomy, beneficence, non-maleficence, and justice. Briefly, (1) Is the respondent participating in a clinical trial? (2) Are two different treatments being evaluated? (3) Is the treatment arm chosen by chance? (4) Is an HIV test required? (5) Are liver function tests required? (6) Can participants leave the study at any time? (7) Are the risks and benefits of taking part in the study clear? (8) May pregnant women participate in the study? (9) Can one of the study drugs reduce the effectiveness of contraceptives? (10) Are patients paid to participate in the study? The ICAI was applied at two time points: immediately after enrollment in the clinical trial and 2 months later. A total of 61 patients who enrolled in the RioMAR study participated in this study. The percentage of correct answers to all questions was 82% at the time of the first ICAI; 31 participants (51%) did not recall that an HIV test was required (question 4) and 43 (70%) did not know that they could leave the study (question 6). Other individual questions were answered correctly by at least 76% of participants. There was no association between incorrect answers and age, gender, monthly family income, neighborhood, or level of education (p > 0.07). When the responses to the

  15. Risk perception and decision processes underlying informed consent to research participation.

    Science.gov (United States)

    Reynolds, William W; Nelson, Robert M

    2007-11-01

    According to the rational choice model, informed consent should consist of a systematic, step-by-step evaluation of all information pertinent to the treatment or research participation decision. Research shows that people frequently deviate from this normative model, however, employing decision-making shortcuts, or heuristics. In this paper we report findings from a qualitative study of 32 adolescents and (their) 31 parents who were recruited from two Northeastern US hospitals and asked to consider the risks of and make hypothetical decisions about research participation. The purpose of this study was to increase our understanding of how diabetic and at-risk adolescents (i.e., those who are obese and/or have a family history of diabetes) and their parents perceive risks and make decisions about research participation. Using data collected from adolescents and parents, we identify heuristic decision processes in which participant perceptions of risk magnitude, which are formed quickly and intuitively and appear to be based on affective responses to information, are far more prominent and central to the participation decision than are perceptions of probability. We discuss participants' use of decision-making heuristics in the context of recent research on affect and decision processes, and we consider the implications of these findings for researchers.

  16. An integrated conceptual framework for evaluating and improving 'understanding' in informed consent.

    Science.gov (United States)

    Bossert, Sabine; Strech, Daniel

    2017-10-17

    The development of understandable informed consent (IC) documents has proven to be one of the most important challenges in research with humans as well as in healthcare settings. Therefore, evaluating and improving understanding has been of increasing interest for empirical research on IC. However, several conceptual and practical challenges for the development of understandable IC documents remain unresolved. In this paper, we will outline and systematize some of these challenges. On the basis of our own experiences in empirical user testing of IC documents as well as the relevant literature on understanding in IC, we propose an integrated conceptual model for the development of understandable IC documents. The proposed conceptual model integrates different methods for the participatory improvement of written information, including IC, as well as quantitative methods for measuring understanding in IC. In most IC processes, understandable written information is an important prerequisite for valid IC. To improve the quality of IC documents, a conceptual model for participatory procedures of testing, revising, and retesting can be applied. However, the model presented in this paper needs further theoretical and empirical elaboration and clarification of several conceptual and practical challenges.

  17. [Level of information of students at the University of Regensburg concerning organ donation and transplantation--informed or not informed consent in organ donation?].

    Science.gov (United States)

    Banas, B; Bleyer, B; Eckert, M; Gruber, H; Pfirstinger, J; Schaller, O; Dietl, B

    2013-04-01

    As a result of the actual amendment of the German transplantation law, every citizen will be regularly asked by health insurance companies about his attitude towards post-mortem organ donation--without the obligation to decide. The aim is to increase the willingness of donations as well as the availability of organs. Therefore, we investigated the level of information of students at the University of Regensburg and their agreement to organ transplantation regarding an informed consent. Using an interdisciplinary developed questionnaire (Medicine, Theology, Educational Science) the level of information concerning process and possibilities of organ donation, the possession of an organ donor card, as well as the active or passive consent to donate organs was investigated. Out of 1225 respondents 31.5% had an organ donor card, 49.1% wanted to donate organs, 32.1% were unsure. 98% generally favoured organ donation. However, serious information deficits about brain death were identified: 37.4% did not know that brain death is a prerequisite for a post-mortem organ donation, 18% thought brain death is reversible, 52.7% were not aware of the necessity of intensive medical care. Furthermore, providing information about other potential donor organs including lungs, pancreas, small intestine, and tissue is required. Health insurance companies and responsible authorities need to close the identified gaps in knowledge in order to achieve "informed" consent with organ donation, which might increase the availability and number of donor organs. © Georg Thieme Verlag KG Stuttgart · New York.

  18. Informed consent for exome sequencing research in families with genetic disease: the emerging issue of incidental findings.

    Science.gov (United States)

    Bergner, Amanda L; Bollinger, Juli; Raraigh, Karen S; Tichnell, Crystal; Murray, Brittney; Blout, Carrie Lynn; Telegrafi, Aida Bytyci; James, Cynthia A

    2014-11-01

    Genomic sequencing technology is increasingly used in genetic research. Studies of informed consent for exome and genome sequencing (ES/GS) research have largely involved hypothetical scenarios or healthy individuals enrolling in population-based studies. Studies have yet to explore the consent experiences of adults with inherited disease. We conducted a qualitative interview study of 15 adults recently enrolled in a large-scale ES/GS study (11 affected adults, four parents of affected children). Our study had two goals: (1) to explore three theoretical barriers to consent for ES/GS research (interpretive/technical complexity, possibility of incidental findings, and risks of loss of privacy); and (2) to explore how interviewees experienced the consent process. Interviewees could articulate study goals and processes, describe incidental findings, discuss risks of privacy loss, and reflect on their consent experience. Few expected the study would identify the genetic cause of their condition. All elected to receive incidental findings. Interviewees acknowledged paying little attention to potential implications of incidental findings in light of more pressing goals of supporting research regarding their own medical conditions. Interviewees suggested that experience living with a genetic condition prepared them to adjust to incidental findings. Interviewees also expressed little concern about loss of confidentiality of study data. Some experienced the consent process as very long. None desired reconsent prior to return of study results. Families with inherited disease likely would benefit from a consent process in which study risks and benefits were discussed in the context of prior experiences with genetic research and genetic disease. © 2014 Wiley Periodicals, Inc.

  19. Patient and public attitudes towards informed consent models and levels of awareness of Electronic Health Records in the UK

    Science.gov (United States)

    Riordan, Fiona; Papoutsi, Chrysanthi; Reed, Julie E.; Marston, Cicely; Bell, Derek; Majeed, Azeem

    2015-01-01

    Background The development of Electronic Health Records (EHRs) forms an integral part of the information strategy for the National Health Service (NHS) in the UK, with the aim of facilitating health information exchange for patient care and secondary use, including research and healthcare planning. Implementing EHR systems requires an understanding of patient expectations for consent mechanisms and consideration of public awareness towards information sharing as might be made possible through integrated EHRs across primary and secondary health providers. Objectives To explore levels of public awareness about EHRs and to examine attitudes towards different consent models with respect to sharing identifiable and de-identified records for healthcare provision, research and planning. Methods A cross-sectional questionnaire survey was administered to adult patients and members of the public in primary and secondary care clinics in West London, UK in 2011. In total, 5331 individuals participated in the survey, and 3157 were included in the final analysis. Results The majority (91%) of respondents expected to be explicitly asked for consent for their identifiable records to be accessed for health provision, research or planning. Half the respondents (49%) did not expect to be asked for consent before their de-identified records were accessed. Compared with White British respondents, those from all other ethnic groups were more likely to anticipate their permission would be obtained before their de-identified records were used. Of the study population, 59% reported already being aware of EHRs before the survey. Older respondents and individuals with complex patterns of interaction with healthcare services were more likely to report prior awareness of EHRs. Individuals self-identifying as belonging to ethnic groups other than White British, and those with lower educational qualifications were less likely to report being aware of EHRs than White British respondents and

  20. Procedures of recruiting, obtaining informed consent, and compensating research participants in Qatar: findings from a qualitative investigation.

    Science.gov (United States)

    Killawi, Amal; Khidir, Amal; Elnashar, Maha; Abdelrahim, Huda; Hammoud, Maya; Elliott, Heather; Thurston, Michelle; Asad, Humna; Al-Khal, Abdul Latif; Fetters, Michael D

    2014-02-04

    Very few researchers have reported on procedures of recruiting, obtaining informed consent, and compensating participants in health research in the Arabian Gulf Region. Empirical research can inform the debate about whether to adjust these procedures for culturally diverse settings. Our objective was to delineate procedures related to recruiting, obtaining informed consent, and compensating health research participants in the extremely high-density multicultural setting of Qatar. During a multistage mixed methods project, field observations and qualitative interviews were conducted in a general medicine clinic of a major medical center in Qatar. Participants were chosen based on gender, age, literacy, and preferred language, i.e., Arabic, English, Hindi and Urdu. Qualitative analysis identified themes about recruitment, informed consent, compensation, and other research procedures. A total of 153 individuals were approached and 84 enrolled; the latter showed a diverse age range (18 to 75 years); varied language representation: Arabic (n = 24), English (n = 20), Hindi (n = 20), and Urdu (n = 20); and balanced gender distribution: women (n = 43) and men (n = 41). Primary reasons for 30 declinations included concern about interview length and recording. The study achieved a 74% participation rate. Qualitative analytics revealed key themes about hesitation to participate, decisions about participation with family members as well as discussions with them as "incidental research participants", the informed consent process, privacy and gender rules of the interview environment, reactions to member checking and compensation, and motivation for participating. Vulnerability emerged as a recurring issue throughout the process among a minority of participants. This study from Qatar is the first to provide empirical data on recruitment, informed consent, compensation and other research procedures in a general adult population in the Middle East and Arabian Gulf. This

  1. Practice variation across consent templates for biobank research. A survey of German biobanks

    Directory of Open Access Journals (Sweden)

    Irene eHirschberg

    2013-11-01

    Full Text Available Introduction: Informed, voluntary, and valid consent from biomaterial donors is a precondi-tion for biobank research. Valid consent protects donors’ rights and helps maintain public trust in biobank research. Harmonisation of consent procedures in biobank research is needed, because of the widely shared vision on national and international networking of biobanks in-cluding data and sample sharing. So far, no study has assessed and compared the content of current consent forms for biobank research. The objective of this study was to perform a con-tent analysis of consent forms in German biobanks. Methods: Based on 10 guidelines for biomedical research, we developed an assessment ma-trix with 41 content issues that are potentially relevant for consent forms in biobank research. This assessment matrix was applied in a thematic text analysis to 30 consent documents of German biobanks identified via the German Biobank Registry in July 2012. Results: Coverage of the 41 items in the assessed consent forms varied widely. For example, the items Right to withdraw consent (without disadvantage, Policy for genetic infor-mation / consent to genetic analyses and International cooperation / transborder use were addressed in 97%, 40% and 23% of all 30 consent forms respectively. The number of items covered by a single consent form ranged from 9 to 36 (22% to 88% out of 41 items.Discussion: Our findings serve as a starting point to reflect upon the spectrum of consent is-sues that must be addressed in biobank research. The findings show that the majority of con-sent forms for German biobanks, if not all, should be improved and harmonised to better sup-port an informed and balanced choice of potential donors and to facilitate networking of bi-obanks. Best practice models for consent forms in biobank research should be developed and biobank operators need to be more aware of relevant consent issues.

  2. A stakeholder-driven approach to improve the informed consent process for palliative chemotherapy.

    Science.gov (United States)

    Enzinger, Andrea C; Wind, Jennifer K; Frank, Elizabeth; McCleary, Nadine J; Porter, Laura; Cushing, Heather; Abbott, Caroline; Cronin, Christine; Enzinger, Peter C; Meropol, Neal J; Schrag, Deborah

    2017-08-01

    Patients often anticipate cure from palliative chemotherapy. Better resources are needed to convey its risks and benefits. We describe the stakeholder-driven development and acceptability testing of a prototype video and companion booklet supporting informed consent (IC) for a common palliative chemotherapy regimen. Our multidisciplinary team (researchers, advocates, clinicians) employed a multistep process of content development, production, critical evaluation, and iterative revisions. Patient/clinician stakeholders were engaged throughout using stakeholder advisory panels, featuring their voices within the intervention, conducting surveys and qualitative interviews. A national panel of 57 patient advocates, and 25 oncologists from nine US practices critiqued the intervention and rated its clarity, accuracy, balance, tone, and utility. Participants also reported satisfaction with existing chemotherapy IC materials. Few oncologists (5/25, 20%) or advocates (10/22, 45%) were satisfied with existing IC materials. In contrast, most rated our intervention highly, with 89-96% agreeing it would be useful and promote informed decisions. Patient voices were considered a key strength. Every oncologist indicated they would use the intervention regularly. Our intervention was acceptable to advocates and oncologists. A randomized trial is evaluating its impact on the chemotherapy IC process. Stakeholder-driven methods can be valuable for developing patient educational interventions. Copyright © 2017 Elsevier B.V. All rights reserved.

  3. Navigating the legal and ethical foundations of informed consent and confidentiality in integrated primary care.

    Science.gov (United States)

    Hudgins, Cathy; Rose, Sandra; Fifield, Peter Y; Arnault, Steve

    2013-03-01

    This article describes findings from ongoing research and analysis of current literature in addition to discussions with leaders in the field, communications with lawyers and administrators of advocacy and government agencies pertaining to integrated primary care (IPC). Standards of care are established based on a myriad of factors, including professional codes of ethics, case law, state and federal laws, professional standards, existing best practices, current professional guidelines, administrative rules and regulations, and licensing board regulations. Regulations may differ for behavioral health and medical providers, posing challenges in IPC settings. This article provides a review of these regulations, particularly 42CFR Part 2, a federal law governing confidentiality for substance abuse programs, Health Insurance Portability and Accountability Act (HIPAA), and state laws relevant to patient care in IPC settings. On the basis of findings from the study, the authors make recommendations related to patient care practices concerning informed consent and release of information procedures, treatment and warm hand-off protocols, documentation and electronic record keeping, agreements with other providers, and billing. (PsycINFO Database Record (c) 2013 APA, all rights reserved).

  4. [Nationwide Survey on Informed Consent and Ethical Review at Hospitals Conducting Post-marketing Studies Sponsored by Pharmaceutical Companies].

    Science.gov (United States)

    Urushihara, Hisashi; Murakami, Yuka; Matsui, Kenji; Tashiro, Shimon

    2018-01-01

     Under the Japanese drug regulatory system, post-marketing studies (PMS) must be in compliance with Good Post-marketing Study Practice (GPSP). The GPSP Ordinance lacks standards for the ethical conduct of PMSs; although only post-marketing clinical trials are subject to Good Clinical Practice. We conducted a web-based questionnaire survey on the ethical conduct of PMSs in collaboration with the Japanese Society of Hospital Pharmacists and pharmacists belonging to the Society. 1819 hospitals around Japan answered the questionnaire, of which 503 hospitals had conducted company-sponsored PMSs in 2015. 40.2% of the hospitals had obtained informed consent from participating patients in at least one PMS conducted in 2015, the majority of which was in written form. The first and second most frequent reasons for seeking informed consent in PMSs were to meet protocol requirements, followed by the requirement to meet institutional standard operational procedures and the request of the ethical review board of the hospital. Ethical review of PMSs was conducted in 251 hospitals. Despite a lack of standards for informed consent and ethical review in PMSs, a considerable number of study sites employed informed consent and ethical review for PMSs. While company policies and protocols are likely to be major determinants of the ethical conduct of PMSs, the governmental regulatory agency should also play a significant role in implementing a standardized ethical code for the conduct of PMSs.

  5. Intervention Research with Youths at Elevated Risk for Suicide: Meeting the Ethical and Regulatory Challenges of Informed Consent and Assent

    Science.gov (United States)

    King, Cheryl A.; Kramer, Anne C.

    2008-01-01

    Intervention research with youths at elevated risk for suicidal behavior and suicide--a vulnerable and high risk population--presents investigators with numerous ethical challenges. This report specifically addresses those challenges involving the informed consent and assent process with parents/guardians and youths. The challenges are delineated…

  6. 78 FR 48413 - Proposed Information Collection; Comment Request; Voluntary Self-Disclosure of Violations of the...

    Science.gov (United States)

    2013-08-08

    ... Request; Voluntary Self- Disclosure of Violations of the Export Administration Regulations AGENCY: Bureau... violators. Voluntary self-disclosure of EAR violations strengthens BIS's enforcement efforts by allowing BIS... detect the violations without such disclosures. BIS evaluates the seriousness of the violation and either...

  7. 75 FR 28780 - Proposed Information Collection; Comment Request; Procedure for Voluntary Self-Disclosure of...

    Science.gov (United States)

    2010-05-24

    ... Request; Procedure for Voluntary Self-Disclosure of Violations of the Export Administration Regulations... violators. Voluntary self-disclosure of EAR violations strengthens BIS's enforcement efforts by allowing BIS... detect the violations without such disclosures. BIS evaluates the seriousness of the violation and either...

  8. Developing competency in post-graduate students of anaesthesiology for taking informed consent for elective caesarean section

    Directory of Open Access Journals (Sweden)

    Kamla Harshad Mehta

    2017-01-01

    Full Text Available Background and Aims: Post-graduate medical students (residents generally lack effective communication skills required to obtain informed consent. The aim of this study was to assess role play and group discussion as teaching/learning tools for improving residents' knowledge on informed consent and competency in communicating while taking informed consent. Methods: This prospective, observational study was conducted on 30 anaesthesia residents. They were first observed while obtaining informed consent and their basic knowledge regarding communication skills was checked with a pre-test questionnaire. Then, lecture and group discussion were carried out to increase the knowledge base, and their knowledge gain was checked by the same questionnaire as a post-test. Communication skills were demonstrated by role play and residents were assessed by direct unobtrusive observation using a checklist. Feedback regarding effectiveness of programme was taken from students. Statistical analyses were done using Microsoft Office Excel and SPSS software. Results: Percentage gain was 122.37% for knowledge domain. For communication skills, mean ± standard deviation for checklist was 8.93 ± 1.43 before role play and it improved to 17.96 ± 1.29 after role play. Regarding effectiveness of role play as a teaching/learning tool, 76.66% of residents said they strongly agreed and 23.33% of residents said they agreed. Likert scale for evaluation of programme was graded 4 or 5 by all residents. Conclusion: The knowledge and communication skills required for obtaining informed consent was improved significantly after role playing.

  9. Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials.

    Science.gov (United States)

    Nishimura, Adam; Carey, Jantey; Erwin, Patricia J; Tilburt, Jon C; Murad, M Hassan; McCormick, Jennifer B

    2013-07-23

    Obtaining informed consent is a cornerstone of biomedical research, yet participants comprehension of presented information is often low. The most effective interventions to improve understanding rates have not been identified. To systematically analyze the random controlled trials testing interventions to research informed consent process. The primary outcome of interest was quantitative rates of participant understanding; secondary outcomes were rates of information retention, satisfaction, and accrual. Interventional categories included multimedia, enhanced consent documents, extended discussions, test/feedback quizzes, and miscellaneous methods. The search spanned from database inception through September 2010. It was run on Ovid MEDLINE, Ovid EMBASE, Ovid CINAHL, Ovid PsycInfo and Cochrane CENTRAL, ISI Web of Science and Scopus. Five reviewers working independently and in duplicate screened full abstract text to determine eligibility. We included only RCTs. 39 out of 1523 articles fulfilled review criteria (2.6%), with a total of 54 interventions. A data extraction form was created in Distiller, an online reference management system, through an iterative process. One author collected data on study design, population, demographics, intervention, and analytical technique. Meta-analysis was possible on 22 interventions: multimedia, enhanced form, and extended discussion categories; all 54 interventions were assessed by review. Meta-analysis of multimedia approaches was associated with a non-significant increase in understanding scores (SMD 0.30, 95% CI, -0.23 to 0.84); enhanced consent form, with significant increase (SMD 1.73, 95% CI, 0.99 to 2.47); and extended discussion, with significant increase (SMD 0.53, 95% CI, 0.21 to 0.84). By review, 31% of multimedia interventions showed significant improvement in understanding; 41% for enhanced consent form; 50% for extended discussion; 33% for test/feedback; and 29% for miscellaneous.Multiple sources of variation

  10. Seeking informed consent to Phase I cancer clinical trials: identifying oncologists' communication strategies.

    Science.gov (United States)

    Brown, Richard; Bylund, Carma L; Siminoff, Laura A; Slovin, Susan F

    2011-04-01

    Phase I clinical trials are the gateway to effective new cancer treatments. Many physicians have difficulty when discussing Phase I clinical trials. Research demonstrates evidence of suboptimal communication. Little is known about communication strategies used by oncologists when recruiting patients for Phase I trials. We analyzed audio recorded Phase I consultations to identify oncologists' communication strategies. Subjects were consecutive cancer patients from six medical oncologists attending one of three outpatient clinics at a major Cancer Center in the United States. Sixteen patients signed informed consent for audio recording of their consultations in which a Phase I study was discussed. These were transcribed in full and analyzed to identify communication strategies. Six communication themes emerged from the analysis: (1) orienting, (2) educating patients, (3) describing uncertainty and prognosis, (4) persuading, (5) decision making, and (6) making a treatment recommendation. As expected, although there was some common ground between communication in Phase I and the Phase II and III settings, there were distinct differences. Oncologists used persuasive communication, made explicit recommendations, or implicitly expressed a treatment preference and were choice limiting. This highlights the complexity of discussing Phase I trials and the need to develop strategies to aid oncologists and patients in these difficult conversations. Patient centered communication that values patient preferences while preserving the oncologist's agenda can be a helpful approach to these discussions. Copyright © 2010 John Wiley & Sons, Ltd.

  11. May Stakeholders be Involved in Design Without Informed Consent? The Case of Hidden Design.

    Science.gov (United States)

    Pols, A J K

    2017-06-01

    Stakeholder involvement in design is desirable from both a practical and an ethical point of view. It is difficult to do well, however, and some problems recur again and again, both of a practical nature, e.g. stakeholders acting strategically rather than openly, and of an ethical nature, e.g. power imbalances unduly affecting the outcome of the process. Hidden Design has been proposed as a method to deal with the practical problems of stakeholder involvement. It aims to do so by taking the observation of stakeholder actions, rather than the outcomes of a deliberative process, as its input. Furthermore, it hides from stakeholders the fact that a design process is taking place so that they will not behave differently than they otherwise would. Both aspects of Hidden Design have raised ethical worries. In this paper I make an ethical analysis of what it means for a design process to leave participants uninformed or deceived rather than acquiring their informed consent beforehand, and to use observation of actions rather than deliberation as input for design, using Hidden Design as a case study. This analysis is based on two sets of normative guidelines: the ethical guidelines for psychological research involving deception or uninformed participants from two professional psychological organisations, and Habermasian norms for a fair and just (deliberative) process. It supports the conclusion that stakeholder involvement in design organised in this way can be ethically acceptable, though under a number of conditions and constraints.

  12. The centennial of the Yellow Fever Commission and the use of informed consent in medical research.

    Science.gov (United States)

    Güereña-Burgueño, Fernando

    2002-01-01

    The year 2000 marked the centennial of the discovery of the mode of transmission of yellow fever. Informed consent was systematically used for the first time in research. This process was the result of a complex social phenomenon involving the American Public Health Association, the US and Spanish Governments, American and Cuban scientists, the media, and civilian and military volunteers. The public health and medical communities face the AIDS pandemic at the beginning of the 21st Century, as they faced the yellow fever epidemic at the beginning of the 20th Century. Current medical research dilemmas have fueled the debate about the ethical conduct of research in human subjects. The AIDS pandemic is imposing enormous new ethical challenges on the conduct of medical research, especially in the developing world. Reflecting on the yellow fever experiments of 1900, lessons can be learned and applied to the current ethical challenges faced by the international public health research community. The English version of this paper is available too at: http://www.insp.mx/salud/index.html.

  13. Oncologists’ view of informed consent and shared decision making in paediatric radiation oncology

    International Nuclear Information System (INIS)

    Olson, Robert A.; Bobinski, Mary Ann; Ho, Anita; Goddard, Karen J.

    2012-01-01

    Background and purpose: Cure rates of paediatric malignancies have dramatically improved with therapy intensification, at the cost of late treatment side effects. A survey was developed, centred around medulloblastoma scenarios, in order to explore paediatric oncology physicians’ views on discussing late effects and involving parents in treatment decisions. Materials and methods: Participants were 59 paediatric radiation and medical oncologists or fellows from USA (22), Canada (18), Europe (16), Australia (2), and Asia (1). Results: Ninety-five percent of respondents indicated late effects discussion prior to multimodality treatment was important. Of those who supported it, 100%, 83%, 64%, and 48% thought discussing cognitive impairment, infertility, stroke, and seizures as potential late effects was important, respectively. Only 71% of respondents believed parents should be involved in treatment decisions, which did not significantly vary by respondent age, country, specialty, gender, or years in practice. Conclusions: The majority of oncologists who treat children believe discussing late effects with parents is important. However, there is mixed opinion on which late effects should be discussed and whether parents should be involved in deciding which treatments should be pursued. Research into perceived barriers to shared decision making and effective methods of improving the informed consent process in paediatric malignancies is needed.

  14. Fair Shares and Sharing Fairly: A Survey of Public Views on Open Science, Informed Consent and Participatory Research in Biobanking.

    Directory of Open Access Journals (Sweden)

    Yann Joly

    Full Text Available Biobanks are important resources which enable large-scale genomic research with human samples and data, raising significant ethical concerns about how participants' information is managed and shared. Three previous studies of the Canadian public's opinion about these topics have been conducted. Building on those results, an online survey representing the first study of public perceptions about biobanking spanning all Canadian provinces was conducted. Specifically, this study examined qualitative views about biobank objectives, governance structure, control and ownership of samples and data, benefit sharing, consent practices and data sharing norms, as well as additional questions and ethical concerns expressed by the public.Over half the respondents preferred to give a one-time general consent for the future sharing of their samples among researchers. Most expressed willingness for their data to be shared with the international scientific community rather than used by one or more Canadian institutions. Whereas more respondents indicated a preference for one-time general consent than any other model of consent, they constituted less than half of the total responses, revealing a lack of consensus among survey respondents regarding this question. Respondents identified biobank objectives, governance structure and accountability as the most important information to provide participants. Respondents' concerns about biobanking generally centred around the control and ownership of biological samples and data, especially with respect to potential misuse by insurers, the government and other third parties. Although almost half the respondents suggested that these should be managed by the researchers' institutions, results indicate that the public is interested in being well-informed about these projects and suggest the importance of increased involvement from participants. In conclusion, the study discusses the viability of several proposed models for

  15. Fair Shares and Sharing Fairly: A Survey of Public Views on Open Science, Informed Consent and Participatory Research in Biobanking.

    Science.gov (United States)

    Joly, Yann; Dalpé, Gratien; So, Derek; Birko, Stanislav

    2015-01-01

    Biobanks are important resources which enable large-scale genomic research with human samples and data, raising significant ethical concerns about how participants' information is managed and shared. Three previous studies of the Canadian public's opinion about these topics have been conducted. Building on those results, an online survey representing the first study of public perceptions about biobanking spanning all Canadian provinces was conducted. Specifically, this study examined qualitative views about biobank objectives, governance structure, control and ownership of samples and data, benefit sharing, consent practices and data sharing norms, as well as additional questions and ethical concerns expressed by the public. Over half the respondents preferred to give a one-time general consent for the future sharing of their samples among researchers. Most expressed willingness for their data to be shared with the international scientific community rather than used by one or more Canadian institutions. Whereas more respondents indicated a preference for one-time general consent than any other model of consent, they constituted less than half of the total responses, revealing a lack of consensus among survey respondents regarding this question. Respondents identified biobank objectives, governance structure and accountability as the most important information to provide participants. Respondents' concerns about biobanking generally centred around the control and ownership of biological samples and data, especially with respect to potential misuse by insurers, the government and other third parties. Although almost half the respondents suggested that these should be managed by the researchers' institutions, results indicate that the public is interested in being well-informed about these projects and suggest the importance of increased involvement from participants. In conclusion, the study discusses the viability of several proposed models for informed consent

  16. A voluntary nutrition labeling program in restaurants: Consumer awareness, use of nutrition information, and food selection

    Directory of Open Access Journals (Sweden)

    Christine M. White

    2016-12-01

    Full Text Available Health Check (HC was a voluntary nutrition labeling program developed by the Heart and Stroke Foundation of Canada as a guide to help consumers choose healthy foods. Items meeting nutrient criteria were identified with a HC symbol. This study examined the impact of the program on differences in consumer awareness and use of nutritional information in restaurants. Exit surveys were conducted with 1126 patrons outside four HC and four comparison restaurants in Ontario, Canada (2013. Surveys assessed participant noticing of nutrition information, influence of nutrition information on menu selection, and nutrient intake. Significantly more patrons at HC restaurants noticed nutrition information than at comparison restaurants (34.2% vs. 28.1%; OR = 1.39; p = 0.019; however, only 5% of HC restaurant patrons recalled seeing the HC symbol. HC restaurant patrons were more likely to say that their order was influenced by nutrition information (10.9% vs. 4.5%; OR = 2.96, p < 0.001; and consumed less saturated fat and carbohydrates, and more protein and fibre (p < 0.05. Approximately 15% of HC restaurant patrons ordered HC approved items; however, only 1% ordered a HC item and mentioned seeing the symbol in the restaurant in an unprompted recall task, and only 4% ordered a HC item and reported seeing the symbol on the item when asked directly. The HC program was associated with greater levels of noticing and influence of nutrition information, and more favourable nutrient intake; however, awareness of the HC program was very low and differences most likely reflect the type of restaurants that “self-selected” into the program.

  17. A voluntary nutrition labeling program in restaurants: Consumer awareness, use of nutrition information, and food selection.

    Science.gov (United States)

    White, Christine M; Lillico, Heather G; Vanderlee, Lana; Hammond, David

    2016-12-01

    Health Check (HC) was a voluntary nutrition labeling program developed by the Heart and Stroke Foundation of Canada as a guide to help consumers choose healthy foods. Items meeting nutrient criteria were identified with a HC symbol. This study examined the impact of the program on differences in consumer awareness and use of nutritional information in restaurants. Exit surveys were conducted with 1126 patrons outside four HC and four comparison restaurants in Ontario, Canada (2013). Surveys assessed participant noticing of nutrition information, influence of nutrition information on menu selection, and nutrient intake. Significantly more patrons at HC restaurants noticed nutrition information than at comparison restaurants (34.2% vs. 28.1%; OR = 1.39; p = 0.019); however, only 5% of HC restaurant patrons recalled seeing the HC symbol. HC restaurant patrons were more likely to say that their order was influenced by nutrition information (10.9% vs. 4.5%; OR = 2.96, p restaurant patrons ordered HC approved items; however, only 1% ordered a HC item and mentioned seeing the symbol in the restaurant in an unprompted recall task, and only 4% ordered a HC item and reported seeing the symbol on the item when asked directly. The HC program was associated with greater levels of noticing and influence of nutrition information, and more favourable nutrient intake; however, awareness of the HC program was very low and differences most likely reflect the type of restaurants that "self-selected" into the program.

  18. The medically examined applicant for private insurance and his/her right to informed consent: a comparative analysis.

    Science.gov (United States)

    Defloor, Sarah

    2011-05-01

    Within the context of health and insurance law, an important question that arises is "to what extent is an applicant for private insurance truly capable of giving his/her 'free' and informed consent for a medical examination?". It should be borne in mind that it is the private insurer who requires a medical examination in order to gather medical information, and, moreover, that the insurer will not be inclined to conclude or carry out an insurance contract without this medical information. A distinction has to be made between not being free by legal coercion and not being (completely) free by factual circumstances. Exercising the right to informed consent involves exactly weighing up the consequences of the decision. Hence the applicant must be put in a position of being able to weigh up the consequences and take them into consideration.

  19. Patients' experiences of intervention trials on the treatment of myocardial infarction: is it time to adjust the informed consent procedure to the patient's capacity?

    OpenAIRE

    Agard, A; Hermeren, G; Herlitz, J

    2001-01-01

    OBJECTIVE—To investigate how patients included in trials on treatment in the early phase of acute myocardial infarction experience the consent procedure.
DESIGN—A combined qualitative and quantitative interview concerning the patients' knowledge of the trial, their feelings about being asked to participate, and their attitudes towards the consent procedure.
SETTING—Tertiary referral centre.
PATIENTS—31 patients who had given written informed consent for their participation in randomised inter...

  20. Informed consent for clinical trials: a comparative study of standard versus simplified forms.

    Science.gov (United States)

    Davis, T C; Holcombe, R F; Berkel, H J; Pramanik, S; Divers, S G

    1998-05-06

    A high level of reading skill and comprehension is necessary to understand and complete most consent forms that are required for participation in clinical research studies. This study was conducted to test the hypothesis that a simplified consent form would be less intimidating and more easily understood by individuals with low-to-marginal reading skills. During July 1996, 183 adults (53 patients with cancer or another medical condition and 130 apparently healthy participants) were tested for reading ability and then asked to read either the standard Southwestern Oncology Group (SWOG) consent form (16th grade level) or a simplified form (7th grade level) developed at Louisiana State University Medical Center-Shreveport (LSU). Participants were interviewed to assess their attitudes toward and comprehension of the form read. Then they were given the alternate consent form and asked which one they preferred and why. Overall, participants preferred the LSU form (62%; 95% confidence interval [CI] = 54.8%-69.2%) over the SWOG form (38%; 95% CI = 30.8%-45.2%) (P = .0033). Nearly all participants thought that the LSU form was easier to read (97%; 95% CI = 93.1%-99.9%) than the SWOG form (75%; 95% CI = 65.1%-85.7%) (Pinformed consent documents for the substantial proportion of Americans with low-to-marginal literacy skills.

  1. [Informed Consent and the Approval by Ethics Committees of Studies Involving the Use of Atypical Antipsychotics in the Management of Delirium].

    Science.gov (United States)

    Millán-González, Ricardo

    2012-03-01

    Delirium is an acute alteration of consciousness and cognition. Atypical antipsychotics (AA) have recently become a main part of its treatment. Studies in this population generate a series of ethical dilemmas concerning the voluntary participation of patients and their state of vulnerability since their mental faculties are, by definition, compromised. To assess whether studies with AA for the treatment of delirium obtained an approval by an ethics committee on human research (ECHR), if an informed consent (IC) was obtained, whether the IC was verbal or written, and who gave the approval to participate. Systematic review of Medline for studies of delirium where quetiapine and olanzapine were the main treatment, assessing the existence of an ECHR approval and implementation of an IC. 11 studies were identified (6 of quetiapine and 5 of olanzapine). 5 had an ECHR approval. Most studies examining the treatment of delirium with quetiapine or olanzapine were not subject to approval by an ECHR and most of them did not obtain an IC from the patient's legal guardian. It is essential that future studies of antipsychotics and other drugs for the treatment of delirium have the protocol approved by an ECHR and a written IC signed by the patient's legal representative, since by definition delirium is a condition that compromises superior mental processes. Copyright © 2012 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

  2. Discussing sarcoma risks during informed consent for nonhysterectomy management of fibroids: an unmet need.

    Science.gov (United States)

    Seagle, Brandon-Luke L; Alexander, Amy L; Strohl, Anna E; Shahabi, Shohreh

    2018-01-01

    There is no reliable way to distinguish symptomatic uterine fibroids from sarcoma without a surgical specimen. Many women with a uterine sarcoma are initially managed without hysterectomy under a presumed fibroid diagnosis, without understanding sarcoma risks. Currently many alternatives to hysterectomy, including medical and procedural interventions, for treatment of fibroids are promoted. The sarcoma incidence among women with presumed fibroids is 0.29% (1/340) to 0.05% (1/2000). Nonmetastatic leiomyosarcoma has a 63% 5-year survival rate whereas metastatic leiomyosarcoma has a 14% 5-year survival rate. In uterine sarcoma, we often cannot identify who has sarcoma before making a potentially cure-denying decision by delaying surgery. Therefore, women electing an alternative to hysterectomy for fibroids should undergo an informed consent process that specifically includes discussion of uterine sarcoma incidence and mortality. Alternatives to hysterectomy for presumed fibroids remain preferable treatment options for many women with symptomatic fibroids, so long as underlying sarcoma risks are adequately discussed. The challenge for obstetrician- gynecologists then is how to provide better informed consent and maintain the primacy of patient autonomy over our concern to "First, do no harm." Major threats to patient's autonomy are faced in the sarcoma risk discussion. How we should present sarcoma risk information to avoid being dismissive of sarcoma or frightening women toward hysterectomy is unstudied. Research is needed to determine how to provide sarcoma risk information with less bias during informed consent. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. Attitudes of the Japanese public and doctors towards use of archived information and samples without informed consent: Preliminary findings based on focus group interviews

    Directory of Open Access Journals (Sweden)

    Fukuhara Shunichi

    2002-01-01

    Full Text Available Abstract Background The purpose of this study is to explore laypersons' attitudes toward the use of archived (existing materials such as medical records and biological samples and to compare them with the attitudes of physicians who are involved in medical research. Methods Three focus group interviews were conducted, in which seven Japanese male members of the general public, seven female members of the general public and seven physicians participated. Results It was revealed that the lay public expressed diverse attitudes towards the use of archived information and samples without informed consent. Protecting a subject's privacy, maintaining confidentiality, and communicating the outcomes of studies to research subjects were regarded as essential preconditions if researchers were to have access to archived information and samples used for research without the specific informed consent of the subjects who provided the material. Although participating physicians thought that some kind of prior permission from subjects was desirable, they pointed out the difficulties involved in obtaining individual informed consent in each case. Conclusions The present preliminary study indicates that the lay public and medical professionals may have different attitudes towards the use of archived information and samples without specific informed consent. This hypothesis, however, is derived from our focus groups interviews, and requires validation through research using a larger sample.

  4. Informed consent and stimulant medication: adolescents' and parents' ability to understand information about benefits and risks of stimulant medication for the treatment of attention-deficit/hyperactivity disorder.

    Science.gov (United States)

    Schachter, Debbie; Tharmalingam, Sukirtha; Kleinman, Irwin

    2011-04-01

    This study of informed consent examines understanding of information needed to consent to stimulant treatment for attention-deficit/hyperactivity disorder (ADHD). The understanding of adolescents with ADHD, their parents, control adolescents, and their parents is compared. Fifty-eight ADHD and 64 control adolescents between the ages of 12 and 16 and their parents were studied. Baseline understanding of information was determined. Subjects received information relevant to informed consent for stimulation medication and afterward were evaluated on their recall understanding and their final understanding. Knowledge was increased after the information session for all subjects. There was no significant difference between unadjusted baseline, recall, and final knowledge of control adolescents and parents. Although unadjusted baseline, recall, and final knowledge of ADHD adolescents is significantly less than that of parents, 78% of ADHD adolescents had final understanding scores within 2 standard deviations of parents' scores. After controlling for baseline understanding and cognitive variables, there was no significant difference between understanding of ADHD adolescents and ADHD parents, whereas control adolescents understanding scores were higher than that of their parents. Understanding was highly associated with mathematics achievement in all groups. The majority of adolescents with ADHD, both with and without a history of stimulant medication treatment, have understanding that is similar to their parents and their inclusion in the informed consent process should be encouraged. Extra care should be afforded to those adolescents with low numeracy or literacy to ensure their understanding.

  5. Proponent-Indigenous agreements and the implementation of the right to free, prior, and informed consent in Canada

    Energy Technology Data Exchange (ETDEWEB)

    Papillon, Martin, E-mail: martin.papillon@umontreal.ca [Département de science politique, Université de Montréal, Pavillon Lionel-Groulx, C. P. 6128, succ. Centre-ville, Montréal, Québec H3C 3J7 (Canada); Rodon, Thierry, E-mail: thierry.rodon@pol.ulaval.ca [Département de science politique, Pavillon Charles-De Koninck, 1030, avenue des Sciences-Humaines, local 4433, Université Laval, Québec, Québec G1V 0A6 (Canada)

    2017-01-15

    Indigenous peoples have gained considerable agency in shaping decisions regarding resource development on their traditional lands. This growing agency is reflected in the emergence of the right to free, prior, and informed consent (FPIC) when Indigenous rights may be adversely affected by major resource development projects. While many governments remain non-committal toward FPIC, corporate actors are more proactive at engaging with Indigenous peoples in seeking their consent to resource extraction projects through negotiated Impact and Benefit Agreements. Focusing on the Canadian context, this article discusses the roots and implications of a proponent-driven model for seeking Indigenous consent to natural resource extraction on their traditional lands. Building on two case studies, the paper argues that negotiated consent through IBAs offers a truncated version of FPIC from the perspective of the communities involved. The deliberative ethic at the core of FPIC is often undermined in the negotiation process associated with proponent-led IBAs. - Highlights: • FPIC is becoming a norm for resource extraction projects on Indigenous lands. • Proponent-led IBAs have become the main instrument to establish FPIC in Canada. • Case studies show elite-driven IBA negotiations do not always create the conditions for FPIC. • We need to pay attention to community deliberations as an inherent aspect of FPIC.

  6. Proponent-Indigenous agreements and the implementation of the right to free, prior, and informed consent in Canada

    International Nuclear Information System (INIS)

    Papillon, Martin; Rodon, Thierry

    2017-01-01

    Indigenous peoples have gained considerable agency in shaping decisions regarding resource development on their traditional lands. This growing agency is reflected in the emergence of the right to free, prior, and informed consent (FPIC) when Indigenous rights may be adversely affected by major resource development projects. While many governments remain non-committal toward FPIC, corporate actors are more proactive at engaging with Indigenous peoples in seeking their consent to resource extraction projects through negotiated Impact and Benefit Agreements. Focusing on the Canadian context, this article discusses the roots and implications of a proponent-driven model for seeking Indigenous consent to natural resource extraction on their traditional lands. Building on two case studies, the paper argues that negotiated consent through IBAs offers a truncated version of FPIC from the perspective of the communities involved. The deliberative ethic at the core of FPIC is often undermined in the negotiation process associated with proponent-led IBAs. - Highlights: • FPIC is becoming a norm for resource extraction projects on Indigenous lands. • Proponent-led IBAs have become the main instrument to establish FPIC in Canada. • Case studies show elite-driven IBA negotiations do not always create the conditions for FPIC. • We need to pay attention to community deliberations as an inherent aspect of FPIC.

  7. Bioethics and power: Informed consent procedures in post-socialist Latvia.

    Science.gov (United States)

    Putniņa, Aivita

    2013-12-01

    This paper explores two lines of development in the donor consent procedures in post-Soviet Latvia. The paper is based on secondary analysis of interview, focus group discussion data, and media and legal text material collected throughout three previously conducted research projects on organ transplantation, population genome project and xenotransplantation focusing on the historical development of the issues of donor consent across these three fields of medical technologies. The paper argues that the quality of consent depends not as much on political and legal change per se as on the strengthening of the position of both medical specialists and donors, facilitating bonds between the two. Copyright © 2013 Elsevier Ltd. All rights reserved.

  8. Informed consent: cultural and religious issues associated with the use of allogeneic and xenogeneic mesh products.

    Science.gov (United States)

    Jenkins, Eric D; Yip, Michael; Melman, Lora; Frisella, Margaret M; Matthews, Brent D

    2010-04-01

    Our aim was to investigate the views of major religions and cultural groups regarding the use of allogeneic and xenogeneic mesh for soft tissue repair. We contacted representatives from Judaism, Islam, Buddhism, Hinduism, Scientology, and Christianity (Baptists, Methodists, Seventh-Day Adventists, Catholics, Lutherans, Church of Jesus Christ of Latter-Day Saints, Evangelical, and Jehovah's Witnesses). We also contacted American Vegan and People for the Ethical Treatment of Animals (PETA). Standardized questionnaires were distributed to the religious and cultural authorities. Questions solicited views on the consumption of beef and pork products and the acceptability of human-, bovine-, or porcine-derived acellular grafts. Dietary restrictions among Jews and Muslims do not translate to tissue implantation restriction. Approximately 50% of Seventh-day Adventists and 40% of Buddhists practice vegetarianism, which may translate into a refusal of the use of xenogeneic tissue. Some Hindus categorically prohibit the use of human tissue and animal products; others allow the donation and receipt of human organs and tissues. PETA is opposed to all uses of animals, but not to human acellular grafts or organ transplantation. Some vegans prefer allogeneic to xenogeneic tissue. Allogeneic and xenogeneic acellular grafts are acceptable among Scientologists, Baptists, Lutherans, Evangelicals, and Catholics. Methodists, Jehovah's Witnesses, and The Church of Jesus Christ of Latter-Day Saints leave the decision up to the individual. Knowledge of religious and cultural preferences regarding biologic mesh assists the surgeon in obtaining a culturally sensitive informed consent for procedures involving acellular allogeneic or xenogeneic grafts. Copyright (c) 2010 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

  9. Are women getting relevant information about mammography screening for an informed consent: a critical appraisal of information brochures used for screening invitation in Germany, Italy, Spain and France.

    Science.gov (United States)

    Gummersbach, Elisabeth; Piccoliori, Giuliano; Zerbe, Cristina Oriol; Altiner, Attila; Othman, Cecile; Rose, Christine; Abholz, Heinz-Harald

    2010-08-01

    The aim was to find out if information brochures on mammography screening in Germany, Italy, Spain and France contain more information to facilitate informed consent than in similar studies carried out over the last few years in Sweden, Canada, USA and the UK, countries with different medical cultures. We generated a list of essential information items on mammography screening for the purpose of informed consent. We mostly used the same items of information as had been used in previous studies and analysed the information brochures of major national initiatives in Germany and France, and three brochures each from regionalized programmes in Italy and Spain. We cross-checked which of our items were covered in the brochures and if correct numbers were given. We found that the information brochures contained only about half of the information items we defined. Six of the eight brochures mentioned the reduction in breast-cancer fatalities. Four of the eight provided information on false positives, and four of the brochures highlighted the side-effects of radiation. The information on side-effects and risks provided by the brochures was generally of poor quality, and none of them referred to over diagnosis. When numbers were given, they were only indicated in terms of relative numbers. The information brochures currently being used in Germany, Italy, Spain and France are no better than the brochures analysed some years ago. Our results suggest that the providers of mammography screening programmes continue to conceal information from women that is essential when making an informed decision.

  10. Assessing the quality of informed consent in a resource-limited setting: A cross-sectional study

    Directory of Open Access Journals (Sweden)

    Kiguba Ronald

    2012-08-01

    Full Text Available Abstract Background The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University. Methods Data were collected using semi-structured interviewer-administered questionnaires on clinic days after initial or repeat informed consent procedures for the respective clinical studies had been administered to each study participant. Results Of the 600 participants interviewed, two thirds (64.2%, 385/600 were female. Overall mean age of study participants was 37.6 (SD = 7.7 years. Amongst all participants, less than a tenth (5.9%, 35/598 reported that they were not given enough information before making a decision to participate. A similar proportion (5.7%, 34/597 reported that they had not signed a consent form prior to making a decision to participate in the study. A third (33.7%, 201/596 of the participants were not aware that they could, at any time, voluntarily withdraw participation from these studies. Participants in clinical trials were 50% less likely than those in observational studies [clinical trial vs. observational; (odds ratio, OR = 0.5; 95% CI: 0.35-0.78] to perceive that refusal to participate in the parent research project would affect their regular medical care. Conclusions Most of the participants signed informed consent forms and a vast majority felt that they received enough information before deciding to participate. On the contrary, several were not aware that they could voluntarily withdraw their participation. Participants in observational studies were more likely than those in clinical trials to perceive that refusal to participate in the parent study would affect their regular medical care.

  11. Assessing the quality of informed consent in a resource-limited setting: a cross-sectional study.

    Science.gov (United States)

    Kiguba, Ronald; Kutyabami, Paul; Kiwuwa, Stephen; Katabira, Elly; Sewankambo, Nelson K

    2012-08-21

    The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University. Data were collected using semi-structured interviewer-administered questionnaires on clinic days after initial or repeat informed consent procedures for the respective clinical studies had been administered to each study participant. Of the 600 participants interviewed, two thirds (64.2%, 385/600) were female. Overall mean age of study participants was 37.6 (SD = 7.7) years. Amongst all participants, less than a tenth (5.9%, 35/598) reported that they were not given enough information before making a decision to participate. A similar proportion (5.7%, 34/597) reported that they had not signed a consent form prior to making a decision to participate in the study. A third (33.7%, 201/596) of the participants were not aware that they could, at any time, voluntarily withdraw participation from these studies. Participants in clinical trials were 50% less likely than those in observational studies [clinical trial vs. observational; (odds ratio, OR = 0.5; 95% CI: 0.35-0.78)] to perceive that refusal to participate in the parent research project would affect their regular medical care. Most of the participants signed informed consent forms and a vast majority felt that they received enough information before deciding to participate. On the contrary, several were not aware that they could voluntarily withdraw their participation. Participants in observational studies were more likely than those in clinical trials to perceive that refusal to participate in the parent study would affect their regular medical care.

  12. Using social media for community consultation and public disclosure in exception from informed consent trials.

    Science.gov (United States)

    Stephens, Shannon W; Williams, Carolyn; Gray, Randal; Kerby, Jeffrey D; Wang, Henry E; Bosarge, Patrick L

    2016-06-01

    The US Food and Drug Administration and the Department of Health and Human Services outline regulations allowing an exception from informed consent (EFIC) for research conducted in an emergency setting. Acute care clinical trials using EFIC must include community consultation and public disclosure (CC/PD) activities. We describe our experience using social media to facilitate the CC/PD process in two trauma resuscitation clinical trials. We conducted local CC/PD activities for two multicenter trauma clinical trials, Pragmatic, Randomized Optimal Platelet and Plasma Ratios (PROPPR) and Prehospital Tranexamic Acid Use for Traumatic Brain Injury (ROC-TXA). As part of the CC/PD process, we developed research study advertisements using the social media Web site Facebook. The Facebook advertisements directed users to a regional study Web site that contained trial information. We targeted the advertisements to specific demographic users, in specific geographic areas. We analyzed the data using descriptive statistics. During the study periods, the PROPPR Facebook advertisement was displayed 5,001,520 times (12 displays per target population) with 374 individuals selecting the advertisement. The ROC-TXA Facebook advertisement was displayed 3,806,448 times (8 per target population) with 790 individuals selecting the advertisement. Respondents to both Facebook advertisements were mostly male (52.6%), with the highest proportion between the ages 15 years and 24 years (28.2%). Collectively, 26.9% of individuals that clicked on the Facebook advertisement spent more than 3 minutes on the study Web site (3-49 minutes). Commonly accessed Web pages were "contact us" (PROPPR, 5.5%; ROC-TXA, 7.7%), "study-specific FAQs" (PROPPR, 2.4%; ROC-TXA, 6.7%), and "opt out of research" (PROPPR, 2.5%; ROC-TXA, 3.8%). Of 51 total individuals viewing the opt out of research information (PROPPR, 19; ROC-TXA, 32), time spent on that specific page was modest (PROPPR, 62 seconds; ROC-TXA, 55 seconds

  13. Utilizing Social Media for Community Consultation and Public Disclosure in Exception from Informed Consent Trials

    Science.gov (United States)

    Stephens, Shannon W.; Williams, Carolyn; Gray, Randal; Kerby, Jeffrey D.; Wang, Henry E.; Bosarge, Patrick L.

    2016-01-01

    Background The U.S. Food and Drug Administration and Department of Health and Human Services outline regulations allowing an Exception From Informed Consent (EFIC) for research conducted in an emergency settings. Acute care clinical trials utilizing EFIC must include community consultation and public disclosure (CC/PD) activities. We describe our experience using social media to facilitate the CC/PD process in two trauma resuscitation clinical trials. Methods We conducted local CC/PD activities for two multicenter trauma clinical trials, Pragmatic, Randomized Optimal Platelet and Plasma Ratios (PROPPR) and Prehospital Tranexamic Acid Use for Traumatic Brain Injury (ROC TXA). As part of the CC/PD process, we developed research study advertisements using the social media website Facebook. The Facebook advertisements directed users to a regional study website that contained trial information. We targeted the advertisements to specific demographic users, in specific geographic areas. We analyzed the data using descriptive statistics. Results During the study periods, the PROPPR Facebook advertisement was displayed 5,001,520 times, (12 displays per target population) with 374 individuals selected the advertisement. The ROC-TXA Facebook advertisement was displayed 3,806,448 times (8 per target population) with 790 individuals selecting the advertisement. Respondents to both Facebook advertisements were mostly male (52.6%), with the highest proportion between the ages 15-24 (28.2%). Collectively, 26.9% of individuals that clicked on the Facebook advertisement, spent > 3 minutes on the study website [3min – 49 min]. Commonly accessed webpages were “Contact Us” (PROPPR 5.5%, TXA 7.7%), “Study-specific FAQs” (PROPPR 2.4%), ROC-TXA 6.7%) and “Opt-Out of Research” (PROPPR 2.5%, ROC-TXA 3.8%). Of 51 total individuals viewing the opt-out of research information (PROPPR 19, ROC-TXA 32), Time spent on that specific page was modest (PROPPR 62 seconds, ROC-TXA 55

  14. The Potential of Digital Technologies for Transforming Informed Consent Practices with Children and Young People in Social Research

    Directory of Open Access Journals (Sweden)

    Sarah Parsons

    2015-12-01

    Full Text Available How children and young people understand and exercise their autonomy, engagement and decision-making is fundamental to learning how to become active and engaged citizens, and to be socially included. Digital technologies are increasingly an integral part of children’s everyday lives and, therefore, valuable tools for supporting social inclusion. This paper discusses how digital technologies might positively support autonomy, engagement and decision-making through the lens of informed consent practices within social research. Current research practices are dominated by paper-based methods for obtaining informed consent which could be exclusionary for children and young people generally, and children with additional learning and support needs in particular. Digital technologies (laptops, PCs, tablet devices, smartphones offer the potential to support accessibility and understanding of ideas and activities, as well as engagement with and autonomy in decision-making and participation. This paper explores this potential as well as the challenges that researchers may face in this context.

  15. The Challenges of Research Informed Consent in Socio-Economically Vulnerable Populations: A Viewpoint From the Democratic Republic of Congo.

    Science.gov (United States)

    Kalabuanga, Marion; Ravinetto, Raffaella; Maketa, Vivi; Muhindo Mavoko, Hypolite; Fungula, Blaise; Inocêncio da Luz, Raquel; Van Geertruyden, Jean-Pierre; Lutumba, Pascal

    2016-08-01

    In medical research, the ethical principle of respect for persons is operationalized into the process of informed consent. The consent tools should be contextualized and adapted to the different socio-cultural environment, especially when research crosses the traditional boundaries and reaches poor communities. We look at the challenges experienced in the malaria Quinact trial, conducted in the Democratic Republic of Congo, and describe some lessons learned, related to the definition of acceptable representative, the role of independent witness and the impact of socio-economic vulnerability. To ensure children's protection, consent is required by the parents or, in their absence, by a legally mandated representative. In our setting, children's responsibility is often entrusted permanently or temporarily to relatives or friends without a tribunal mandate. Hence, a notion of 'culturally acceptable representative' under supervision of the local Ethics Committee may be more suitable. To ensure protection of illiterate subjects, an independent witness is required to confirm that the consent was freely given. However, in low-literacy contexts, potential witnesses often don't have any previous relationship with patient and there may be power-unbalance in their relationship, rather than genuine dialogue. In poor communities, trial participation may be seen as an opportunity to secure access to healthcare. Poverty may also lead to 'competition' to access the research-related benefits, with a risk of disturbance at societal or household level. Adjusting consent procedures to sociocultural and socioeconomic realities is essential for fulfilling the underlying ethical principles. This requires a collaborative dialogue between researchers, regulators and ethics committees. © 2015 John Wiley & Sons Ltd.

  16. The influence of process and patient factors on the recall of consent information in mentally competent patients undergoing surgery for neck of femur fractures.

    Science.gov (United States)

    Khan, S K; Karuppaiah, K; Bajwa, A S

    2012-07-01

    Informed consent is an ethical and legal prerequisite for major surgical procedures. Recent literature has identified 'poor consent' as a major cause of litigation in trauma cases. We aimed to investigate the patient and process factors that influence consent information recall in mentally competent patients (abbreviated mental test score [AMTS] ≥6) presenting with neck of femur (NOF) fractures. A prospective study was conducted at a tertiary unit. Fifty NOF patients (cases) and fifty total hip replacement (THR) patients (controls) were assessed for process factors (adequacy and validity of consent) as well as patient factors (comprehension and retention) using consent forms and structured interview proformas. The two groups were matched for ASA (American Society of Anesthesiologists) grade and AMTS. The consent forms were adequate in both groups but scored poorly for validity in the NOF group. Only 26% of NOF patients remembered correctly what surgery they had while only 48% recalled the risks and benefits of the procedure. These results were significantly poorer than in THR patients (p = 0.0001). This study confirms that NOF patients are poor at remembering the information conveyed to them at the time of consent when compared with THR patients despite being intellectually and physiologically matched. We suggest using preprinted consent forms (process factors), information sheets and visual aids (patient factors) to improve retention and recall.

  17. Rights Information Infrastructures and Voluntary Stakeholders Agreements in Digital Library Programmes

    Directory of Open Access Journals (Sweden)

    Piero Attanasio

    2010-11-01

    Full Text Available Rights management for digital library programs is affected by high transaction costs and this calls for new schemes of collective management. Voluntary Stakeholders Agreements (VSA is proposed as a solution. However, there is a need to reshape the way of defining the scope of such agreements. In the past, the scope was set by limiting the type of uses licensed in the collective agreement, while other uses, pertaining the primary exploitation of works, remain in the sphere of direct management by the rightholder. In the agreements under discussion in several countries in relation to digital library initiatives, the scope is rather defined through limiting the type of works included in the agreement, while the licensed use is broad, including full making available in the Internet. A key distinction is the commercial status of a work, if it is in-print or out-of-print.Such new VSAs require innovative forms of managing of rights information, i.e. set of metadata referred to rights management. A significant part of transaction costs derives from the search of rightholders, and thus there is a trend to call for reducing or even abolishing the need for this search. However, the identification of the right status (public domain vs. in-copyright and the commercial status (in print vs. out of print requires a title by title management of information, which is inevitable because of the characteristics of the emerging VSAs. The proper rightholder search cost should be assessed as an additional cost to something that is in the nature of the agreements. The paper tries to set the terms and conditions to achieve this assessment, and to figure out practical solutions to the problem.

  18. Discordance in Informed Consent Response on the Basis of Demographic Factors: Brief Report

    Science.gov (United States)

    Nunez-Wallace, Karen R.; Gill, Chandler E.; Harrison, Courtney H.; Taylor, Henry M.; Charles, P. David

    2010-01-01

    During an outcomes study of spasticity treatment at a developmental center for 62 residents with profound intellectual disabilities, either botulinum toxin A (BTX-A), intrathecal baclofen (ITB), or both were recommended with physical and occupational therapy. Conservators consented to BTX-A more than ITB (p = 0.021). Court-appointed conservators…

  19. Routine antenatal HIV testing: the responses and perceptions of pregnant women and the viability of informed consent. A qualitative study.

    Science.gov (United States)

    de Zulueta, Paquita; Boulton, Mary

    2007-06-01

    This qualitative cross-sectional survey, undertaken in the antenatal booking clinics of a hospital in central London, explores pregnant women's responses to routine HIV testing, examines their reasons for declining or accepting the test, and assesses how far their responses fulfil standard criteria for informed consent. Of the 32 women interviewed, only 10 participants were prepared for HIV testing at their booking interview. None of the women viewed themselves as being particularly at risk for HIV infection. The minority (n = 6) of the participants who declined testing differed from those who accepted, by interpreting test acceptance as risky behaviour, privileging the negative outcomes of HIV positivity and expressing an inability to cope with these, should they occur. Troublingly, only a minority of women (n = 9) had a broad understanding of the rationale for the test, and none fulfilled the standard criteria for informed consent. This study suggests that, although routine screening combined with professional recommendation may be successful in increasing uptake, this may be at the cost of eroding informed consent. Protecting third parties (notably fetuses) from a preventable disease may outweigh the moral duty of respecting autonomy, enshrined in Western bioethical tradition. Nevertheless, such a policy should be made transparent, debated in the public domain and negotiated with women seeking antenatal care.

  20. Participation with a Punch: Community Referenda on Dam Projects and the Right to Free, Prior, and Informed Consent to Development

    Directory of Open Access Journals (Sweden)

    Brant McGee

    2010-06-01

    Full Text Available The 2000 Report of the World Commission on Dams (WCD found that dams can threaten the resources that provide the basis for indigenous and other peoples’ culture, religion, subsistence, social and family structure – and their very existence, through forced relocation – and lead to ecosystem impacts harmful to agriculture, animals and fish. The WCD recommended the effective participation of potentially impacted local people in decisions regarding dam construction. The international right to free, prior, and informed consent (FPIC accorded to indigenous peoples promises not only the opportunity to participate in decisions affecting their lands and livelihoods but to stop unwanted development by refusing consent as well. The newly developed concept of community referenda, held in areas potentially impacted by development projects, provides an accurate measure of the position of local voters on the proposed project through a democratic process that discourages violence, promotes fair and informed debate, and provides an avenue for communities to express their consent or refusal of a specific project. The legal basis, practical and political implications, and Latin American examples of community referenda are explored as a means of implementing the critical goal of the principle of FPIC, the expression of community will and its conclusive impact on development decision-making.

  1. The use of multimedia as an adjunct to the informed consent process for ankle ligament reconstruction surgery.

    Science.gov (United States)

    Batuyong, Eldridge; Birks, Christopher; Beischer, Andrew D

    2012-06-01

    Obtaining "informed consent" is an integral aspect of surgery that can be fraught with difficulty. This study assessed the efficacy of a multimedia education tool in improving patients' understanding when used as an adjunct to the traditional verbal consent process regarding ankle lateral ligament reconstruction surgery. A total of 56 patients (28 males and 28 females) were recruited with a mean age of 36 years. A standardized verbal discussion regarding surgical treatment was provided to each patient. Understanding was then assessed using a knowledge questionnaire. Subsequently, each patient observed a multimedia educational program following which the knowledge questionnaire was repeated. Additional supplementary questions were then given regarding the ease of understanding and satisfaction with the 2 methods of education delivery. The patients answered 75% of the questions correctly before the multimedia module compared with 88% after it (P multimedia tool performed as well as the treating surgeon. Multimedia tools used in sequence after a verbal consent resulted in improved patient understanding of pertinent information regarding ankle lateral ligament reconstruction surgery. Therapeutic Level II.

  2. An Observational Study of Children's Involvement in Informed Consent for Exome Sequencing Research.

    Science.gov (United States)

    Miller, Victoria A; Werner-Lin, Allison; Walser, Sarah A; Biswas, Sawona; Bernhardt, Barbara A

    2017-02-01

    The goal of this study was to examine children's involvement in consent sessions for exome sequencing research and associations of involvement with provider and parent communication. Participants included 44 children (8-17 years) from five cohorts who were offered participation in an exome sequencing study. The consent sessions were audiotaped, transcribed, and coded. Providers attempted to facilitate the child's involvement in the majority (73%) of sessions, and most (75%) children also verbally participated. Provider facilitation was strongly associated with likelihood of child participation. These findings underscore that strategies such as asking for children's opinions and soliciting their questions show respect for children and may increase the likelihood that they are engaged and involved in decisions about research participation.

  3. Readability and Understanding of Informed Consent Among Participants With Low Incomes: A Preliminary Report.

    Science.gov (United States)

    Ittenbach, Richard F; Senft, Elizabeth C; Huang, Guixia; Corsmo, Jeremy J; Sieber, Joan E

    2015-12-01

    With passage and implementation of the Affordable Health Care Act, more vulnerable segments of the U.S. population will now have access to regular health care and increased opportunities to participate in biomedical research. Yet, access to new groups brings with it new responsibilities for investigators, most importantly, reducing burdens for participants. Data collected through this small pilot study suggest several preliminary but potentially important findings when working with adults from low-income populations: First, while all participants read some parts of the consent forms (55%), only a minority reported reading the entire form (45%); second, 73% of participants reported understanding the study very well whereas only 27% reported understanding the study "a little"; third, there was a slight reported advantage of the simplified form over the regular form; however, this difference varied by section. Relatedly, other research has shown a high incidence of persons reading none of the consent form, but signing a statement that they have read and understood the study. Why does this occur? What are we teaching people when we request that they sign a consent form they have chosen not to read? What are the ethical and regulatory implications? Embedded ethics studies such as this one, although pilot and preliminary in nature, offer a number of advantages, such as stimulating additional scientific inquiry as well as challenging established institutional practices. © The Author(s) 2015.

  4. Readability and Content Assessment of Informed Consent Forms for Phase II-IV Clinical Trials in China.

    Science.gov (United States)

    Wen, Gaiyan; Liu, Xinchun; Huang, Lihua; Shu, Jingxian; Xu, Nana; Chen, Ruifang; Huang, Zhijun; Yang, Guoping; Wang, Xiaomin; Xiang, Yuxia; Lu, Yao; Yuan, Hong

    2016-01-01

    To explore the readability and content integrity of informed consent forms (ICFs) used in China and to compare the quality of Chinese local ICFs with that of international ICFs. The length, readability and content of 155 consent documents from phase II-IV drug clinical trials from the Third Xiangya Hospital Ethics Committee from November 2009 to January 2015 were evaluated. Reading difficulty was tested using a readability formula adapted for the Chinese language. An ICF checklist containing 27 required elements was successfully constructed to evaluate content integrity. The description of alternatives to participation was assessed. The quality of ICFs from different sponsorships were also compared. Among the 155 evaluable trials, the ICFs had a median length of 5286 words, corresponding to 7 pages. The median readability score was 4.31 (4.02-4.41), with 63.9% at the 2nd level and 36.1% at the 3rd level. Five of the 27 elements were frequently neglected. The average score for the description of alternatives to participation was 1.06, and 27.7% of the ICFs did not mention any alternatives. Compared with Chinese local ICFs, international ICFs were longer, more readable and contained more of the required elements (P readability and content integrity than Chinese local ICFs. More efforts should thus be made to improve the quality of consent documents in China.

  5. REXIC project: retrospective cross-sectional study of documentation of informed consent for research biobanking in a public research and teaching hospital

    Directory of Open Access Journals (Sweden)

    Marta Nobile

    2013-07-01

    Full Text Available Background. The Center for Transfusion Medicine, Cell Therapy and Cryobiology, Milan, Northern Italy, is the headquarter of the POLI-MI biobank. It co-ordinates the biobank activities of the Fondazione Ca’ Granda Ospedale Maggiore Policlinico of Milan. Such activities require specific safeguarding of donors’ rights and protection of sensitive and genetic data. The Fondazione Ca’ Granda Ospedale Maggiore Policlinico has set up a project on informed consent with the aim of developing awareness and understanding of this issue. Within this project, it has been decided to evaluate how consent for biobanking material is expressed. Design and methods. The aim of the study was to evaluate the quality and completeness of consent to biobanking in the POLI-MI biobank. This was a retrospective study carried out in 2012 on samples of consent declarations collected by biobank units in 2011. Some units used a single, standard consent model available from a previous POLI-MI biobank workgroup. Other units used models which had been previouly formulated. Evaluation was made using a form that indicated the essential elements of consent. Results. A total of 48 consent declarations were collected using the single, standard model and 84 were collected using other models. The consent declarations that used the single, standard model were found to be the most complete and were filled in better than other models. Conclusions. Progressive adoption of a simple, standard consent model is expected to improve the quality of consent acquisition. Regular audit of the compliance of consent practices with ethical and legal requirements is mandatory to improve the quality of research biobanking.

  6. Informed consent: do information pamphlets improve post-operative risk-recall in patients undergoing total thyroidectomy: prospective randomized control study

    OpenAIRE

    Alsaffar, Hussain; Wilson, Lindsay; Kamdar, Dev P.; Sultanov, Faizullo; Enepekides, Danny; Higgins, Kevin M.

    2016-01-01

    Background Informed consent consists of basic five elements: voluntarism, capacity, disclosure, understanding, and ultimate decision-making. Physician disclosure, patient understanding, and information retention are all essential in the doctor-patient relationship. This is inclusive of helping patients make and manage their decisions and expectations better and also to deal with any consequences and/or complications that arise. This study investigates whether giving patients procedure-specifi...

  7. Development of a tiered and binned genetic counseling model for informed consent in the era of multiplex testing for cancer susceptibility.

    Science.gov (United States)

    Bradbury, Angela R; Patrick-Miller, Linda; Long, Jessica; Powers, Jacquelyn; Stopfer, Jill; Forman, Andrea; Rybak, Christina; Mattie, Kristin; Brandt, Amanda; Chambers, Rachelle; Chung, Wendy K; Churpek, Jane; Daly, Mary B; Digiovanni, Laura; Farengo-Clark, Dana; Fetzer, Dominique; Ganschow, Pamela; Grana, Generosa; Gulden, Cassandra; Hall, Michael; Kohler, Lynne; Maxwell, Kara; Merrill, Shana; Montgomery, Susan; Mueller, Rebecca; Nielsen, Sarah; Olopade, Olufunmilayo; Rainey, Kimberly; Seelaus, Christina; Nathanson, Katherine L; Domchek, Susan M

    2015-06-01

    Multiplex genetic testing, including both moderate- and high-penetrance genes for cancer susceptibility, is associated with greater uncertainty than traditional testing, presenting challenges to informed consent and genetic counseling. We sought to develop a new model for informed consent and genetic counseling for four ongoing studies. Drawing from professional guidelines, literature, conceptual frameworks, and clinical experience, a multidisciplinary group developed a tiered-binned genetic counseling approach proposed to facilitate informed consent and improve outcomes of cancer susceptibility multiplex testing. In this model, tier 1 "indispensable" information is presented to all patients. More specific tier 2 information is provided to support variable informational needs among diverse patient populations. Clinically relevant information is "binned" into groups to minimize information overload, support informed decision making, and facilitate adaptive responses to testing. Seven essential elements of informed consent are provided to address the unique limitations, risks, and uncertainties of multiplex testing. A tiered-binned model for informed consent and genetic counseling has the potential to address the challenges of multiplex testing for cancer susceptibility and to support informed decision making and adaptive responses to testing. Future prospective studies including patient-reported outcomes are needed to inform how to best incorporate multiplex testing for cancer susceptibility into clinical practice.Genet Med 17 6, 485-492.

  8. User-Centered Design, Experience, and Usability of an Electronic Consent User Interface to Facilitate Informed Decision-Making in an HIV Clinic.

    Science.gov (United States)

    Ramos, S Raquel

    2017-11-01

    Health information exchange is the electronic accessibility and transferability of patient medical records across various healthcare settings and providers. In some states, patients have to formally give consent to allow their medical records to be electronically shared. The purpose of this study was to apply a novel user-centered, multistep, multiframework approach to design and test an electronic consent user interface, so patients with HIV can make more informed decisions about electronically sharing their health information. This study consisted of two steps. Step 1 was a cross-sectional, descriptive, qualitative study that used user-centric design interviews to create the user interface. This informed Step 2. Step 2 consisted of a one group posttest to examine perceptions of usefulness, ease of use, preference, and comprehension of a health information exchange electronic consent user interface. More than half of the study population had college experience, but challenges remained with overall comprehension regarding consent. The user interface was not independently successful, suggesting that in addition to an electronic consent user interface, human interaction may also be necessary to address the complexities associated with consenting to electronically share health information. Comprehension is key factor in the ability to make informed decisions.

  9. The influence of process and patient factors on the recall of consent information in mentally competent patients undergoing surgery for neck of femur fractures

    OpenAIRE

    Khan, SK; Karuppaiah, K; Bajwa, AS

    2012-01-01

    INTRODUCTION Informed consent is an ethical and legal prerequisite for major surgical procedures. Recent literature has identified ‘poor consent’ as a major cause of litigation in trauma cases. We aimed to investigate the patient and process factors that influence consent information recall in mentally competent patients (abbreviated mental test score [AMTS] ≥6) presenting with neck of femur (NOF) fractures. METHODS A prospective study was conducted at a tertiary unit. Fifty NOF patients (cas...

  10. Use of Videos Improves Informed Consent Comprehension in Web-Based Surveys Among Internet-Using Men Who Have Sex With Men: A Randomized Controlled Trial.

    Science.gov (United States)

    Hall, Eric William; Sanchez, Travis H; Stein, Aryeh D; Stephenson, Rob; Zlotorzynska, Maria; Sineath, Robert Craig; Sullivan, Patrick S

    2017-03-06

    Web-based surveys are increasingly used to capture data essential for human immunodeficiency virus (HIV) prevention research. However, there are challenges in ensuring the informed consent of Web-based research participants. The aim of our study was to develop and assess the efficacy of alternative methods of administering informed consent in Web-based HIV research with men who have sex with men (MSM). From July to September 2014, paid advertisements on Facebook were used to recruit adult MSM living in the United States for a Web-based survey about risk and preventive behaviors. Participants were randomized to one of the 4 methods of delivering informed consent: a professionally produced video, a study staff-produced video, a frequently asked questions (FAQs) text page, and a standard informed consent text page. Following the behavior survey, participants answered 15 questions about comprehension of consent information. Correct responses to each question were given a score of 1, for a total possible scale score of 15. General linear regression and post-hoc Tukey comparisons were used to assess difference (Pvideo, and 22.0% (146/665) received the staff video. The overall average consent comprehension score was 6.28 (SD=2.89). The average consent comprehension score differed significantly across consent type (Pvideo consent (score increase=1.79; 95% CI 1.02-2.55) and participants who received the staff video consent (score increase=1.79; 95% CI 0.99-2.59). There was no significant difference in comprehension for those who received the FAQ consent. Participants spent more time on the 2 video consents (staff video median time=117 seconds; professional video median time=115 seconds) than the FAQ (median=21 seconds) and standard consents (median=37 seconds). Mediation analysis showed that though time spent on the consent page was partially responsible for some of the differences in comprehension, the direct effects of the professional video (score increase=0.93; 95% CI 0

  11. How parents and practitioners experience research without prior consent (deferred consent) for emergency research involving children with life threatening conditions: a mixed method study.

    Science.gov (United States)

    Woolfall, Kerry; Frith, Lucy; Gamble, Carrol; Gilbert, Ruth; Mok, Quen; Young, Bridget

    2015-09-18

    Alternatives to prospective informed consent to enable children with life-threatening conditions to be entered into trials of emergency treatments are needed. Across Europe, a process called deferred consent has been developed as an alternative. Little is known about the views and experiences of those with first-hand experience of this controversial consent process. To inform how consent is sought for future paediatric critical care trials, we explored the views and experiences of parents and practitioners involved in the CATheter infections in CHildren (CATCH) trial, which allowed for deferred consent in certain circumstances. Mixed method survey, interview and focus group study. 275 parents completed a questionnaire; 20 families participated in an interview (18 mothers, 5 fathers). 17 CATCH practitioners participated in one of four focus groups (10 nurses, 3 doctors and 4 clinical trial unit staff). 12 UK children's hospitals. Some parents were momentarily shocked or angered to discover that their child had or could have been entered into CATCH without their prior consent. Although these feelings resolved after the reasons why consent needed to be deferred were explained and that the CATCH interventions were already used in clinical care. Prior to seeking deferred consent for the first few times, CATCH practitioners were apprehensive, although their feelings abated with experience of talking to parents about CATCH. Parents reported that their decisions about their child's participation in the trial had been voluntary. However, mistiming the deferred consent discussion had caused distress for some. Practitioners and parents supported the use of deferred consent in CATCH and in future trials of interventions already used in clinical care. Our study provides evidence to support the use of deferred consent in paediatric emergency medicine; it also indicates the crucial importance of practitioner communication and appropriate timing of deferred consent discussions

  12. How parents and practitioners experience research without prior consent (deferred consent) for emergency research involving children with life threatening conditions: a mixed method study

    Science.gov (United States)

    Woolfall, Kerry; Frith, Lucy; Gamble, Carrol; Gilbert, Ruth; Mok, Quen; Young, Bridget

    2015-01-01

    Objective Alternatives to prospective informed consent to enable children with life-threatening conditions to be entered into trials of emergency treatments are needed. Across Europe, a process called deferred consent has been developed as an alternative. Little is known about the views and experiences of those with first-hand experience of this controversial consent process. To inform how consent is sought for future paediatric critical care trials, we explored the views and experiences of parents and practitioners involved in the CATheter infections in CHildren (CATCH) trial, which allowed for deferred consent in certain circumstances. Design Mixed method survey, interview and focus group study. Participants 275 parents completed a questionnaire; 20 families participated in an interview (18 mothers, 5 fathers). 17 CATCH practitioners participated in one of four focus groups (10 nurses, 3 doctors and 4 clinical trial unit staff). Setting 12 UK children's hospitals. Results Some parents were momentarily shocked or angered to discover that their child had or could have been entered into CATCH without their prior consent. Although these feelings resolved after the reasons why consent needed to be deferred were explained and that the CATCH interventions were already used in clinical care. Prior to seeking deferred consent for the first few times, CATCH practitioners were apprehensive, although their feelings abated with experience of talking to parents about CATCH. Parents reported that their decisions about their child's participation in the trial had been voluntary. However, mistiming the deferred consent discussion had caused distress for some. Practitioners and parents supported the use of deferred consent in CATCH and in future trials of interventions already used in clinical care. Conclusions Our study provides evidence to support the use of deferred consent in paediatric emergency medicine; it also indicates the crucial importance of practitioner communication

  13. Informed consent in oncology clinical trials: A Brown University Oncology Research Group prospective cross-sectional pilot study.

    Directory of Open Access Journals (Sweden)

    Andrew Schumacher

    Full Text Available Informed consent forms (ICFs for oncology clinical trials have grown increasingly longer and more complex. We evaluated objective understanding of critical components of informed consent among patients enrolling in contemporary trials of conventional or novel biologic/targeted therapies.We evaluated ICFs for cancer clinical trials for length and readability, and patients registered on those studies were asked to complete a validated 14-question survey assessing their understanding of key characteristics of the trial. Mean scores were compared in groups defined by trial and patient characteristics.Fifty patients, of whom half participated in trials of immunotherapy or biologic/targeted agents and half in trials of conventional therapy, completed the survey. On average, ICFs for industry-originated trials (N = 9 trials were significantly longer (P < .0001 and had lower Flesch ease-of-reading scores (P = .003 than investigator-initiated trials (N = 11. At least 80% of patients incorrectly responded to three key questions which addressed the experimental nature of their trial therapy, its purported efficacy and potential risks relative to alternative treatments. The mean objective understanding score was 76.9±8.8, but it was statistically significantly lower for patients who had not completed high school (P = .011. The scores did not differ significantly by type of cancer therapy (P = .12 or trial sponsor (P = .38.Many participants enrolled on cancer trials had poor understanding of essential elements of their trial. In order to ensure true informed consent, innovative approaches, such as expanded in-person counseling adapted to the patient's education level or cultural characteristics should be evaluated across socio-demographic groups.Clinicaltrials.gov NCT01772511.

  14. Past, Present, and Future of Informed Consent in Pain and Genomics Research: Challenges Facing Global Medical Community.

    Science.gov (United States)

    Compagnone, Christian; Schatman, Michael E; Rauck, Richard L; Van Zundert, Jan; Kraus, Monika; Primorac, Dragan; Williams, Frances; Allegri, Massimo; Saccani Jordi, Gloria; Fanelli, Guido

    2017-01-01

    In recent decades, there has been a revision of the role of institutional review boards with the intention of protecting human subjects from harm and exploitation in research. Informed consent aims to protect the subject by explaining all of the benefits and risks associated with a specific research project. To date, there has not been a review published analyzing issues of informed consent in research in the field of genetic/Omics in subjects with chronic pain, and the current review aims to fill that gap in the ethical aspects of such investigation. Despite the extensive discussion on ethical challenges unique to the field of genetic/Omics, this is the first attempt at addressing ethical challenges regarding Informed Consent Forms for pain research as the primary focus. We see this contribution as an important one, for while ethical issues are too often ignored in pain research in general, the numerous arising ethical issues that are unique to pain genetic/Omics suggest that researchers in the field need to pay even greater attention to the rights of subjects/patients. This article presents the work of the Ethic Committee of the Pain-Omics Group (www.painomics.eu), a consortium of 11 centers that is running the Pain-Omics project funded by the European Community in the 7th Framework Program theme (HEALTH.2013.2.2.1-5-Understanding and controlling pain). The Ethic Committee is composed of 1 member of each group of the consortium as well as key opinion leaders in the field of ethics and pain more generally. © 2016 The Authors. Pain Practice published by Wiley Periodicals, Inc. on behalf of World Institute of Pain.

  15. What do our patients understand about their trial participation? Assessing patients' understanding of their informed consent consultation about randomised clinical trials.

    Science.gov (United States)

    Behrendt, C; Gölz, T; Roesler, C; Bertz, H; Wünsch, A

    2011-02-01

    Ethically, informed consent regarding randomised controlled trials (RCTs) should be understandable to patients. The patients can then give free consent or decline to participate in a RCT. Little is known about what patients really understand in consultations about RCTs. Cancer patients who were asked to participate in a randomised trial were surveyed using a semi-standardised interview developed by the authors. The interview addresses understanding, satisfaction and needs of the patients. The sample included eight patients who participated in a trial and two who declined. The data were analysed on the basis of Mayring's qualitative analysis. Patients' understanding of informed consent was less developed than anticipated, especially concerning key elements such as randomisation, content and procedure of RCTs. Analysing the result about satisfaction of the patients, most of the patients described their consultations as hectic and without advance notice. Health limitations due to cancer played a decisive role. However, most of the patients perceived their physician to be sympathetic. Analysing the needs of patients, they ask for a clear informed consent consultation with enough time and adequate advance notice. This study fills an important empirical research gap of what is ethically demanded in an RCT consultation and what is really understood by patients. The qualitative approach enabled us to obtain new results about cancer patients' understanding of informed consent, to clarify patients' needs and to develop new ideas to optimise the informed consent.

  16. Decision-making and risk-assessment in living liver donation: how informed is the informed consent of donors? A qualitative study.

    Science.gov (United States)

    Papachristou, Christina; Walter, Marc; Marc, Walter; Frommer, Joerg; Frommer, Jeorg; Klapp, Burghard F

    2010-01-01

    The practice of living donor liver transplantation (LDLT) has been increasing over the past 20 years. In LDLT, a healthy individual offers a substantial part of his or her liver (up to 60%) for the benefit of a terminally-ill recipient. The aim of the study was to identify decision-making and risk-assessment patterns of living liver donors and assess whether the principles of informed consent and decision autonomy are being met. The authors conducted semistructured clinical interviews with 28 donors before transplantation. The authors found that a decision was being reached before a decision-making process could take place. Surgery risks were perceived and processed in different ways, including the factors of risk-awareness, denial, limited acceptance, and fatalism. The authors assess concepts of informed consent and decision autonomy in LDLT, and offer suggestions for donor selection.

  17. Informed consent and decision-making about adult-to-adult living donor liver transplantation: a systematic review of empirical research.

    Science.gov (United States)

    Gordon, Elisa J; Daud, Amna; Caicedo, Juan Carlos; Cameron, Kenzie A; Jay, Colleen; Fryer, Jonathan; Beauvais, Nicole; Skaro, Anton; Baker, Talia

    2011-12-27

    Adult-to-adult living donor liver transplantation (LDLT) is a complex procedure that poses serious health risks to and provides no direct health benefit for the donor. Because of this uneven risk-benefit ratio, ensuring donor autonomy through informed consent is critical. To assess the current knowledge pertaining to informed consent for LDLT, we conducted a systematic review of the empirical literature on donors' decision-making process, comprehension about risks and outcomes, and information needs for LDLT. Of the 1423 identified articles, 24 met final review criteria, representing the perspective of approximately 2789 potential and actual donors. As donors' decisions to donate often occur before evaluation, they often make uninformed decisions. The review found that 88% to 95% of donors reported understanding information clinicians disclosed about risks and benefits. However, don