Sample records for strengthened informed consent

  1. [Informed consent].

    Medina Castellano, Carmen Delia


    At present times, numerous complaints claiming defects produced at some point in the process of obtaining informed consent are filed in courts of justice; in these complaints there is an underlying comment element which is the roles that health professionals have in these processes. In obtaining this consent, one can see this more as a means to obtain judicial protection for professional practices rather than this process being a respectful exercise for the dignity and freedom which health service patients have. This article reflects on two basic rights related to informed consent: adequately obtaining this consent and the need to protect those people who lack, either partially or totally, the capacity to make this decision by themselves. Afterwards, the author makes some considerations about the necessity to obtain informed consent for nursing practices and treatment.

  2. Informed Consent

    Jean-Pierre CLÉRO


    Full Text Available Informed consent is one pillar of the nowadays’ medical relation; it is a main element of the Copernican revolution of the care ethics: where the doctor was at the centre of the system, the patient has now taken the place at the focus of the care’s process. The new deal with the doctor goes through the informed consent. The change is not always easily accepted. French people which just have a quiet revolution in endowing the patient with a large autonomy in the medical act – nevertheless speak of refus de soin (word for word: refusal of treatment when the patient wants his treatment to be stopped; whereas English-speaking people rightly draw a distinction between to waive and to refuse. There is no a slight difference between to waive and to refuse, between a waiver and a refusal even though a quick translation can take a word for another. A patient may decide to stop the treatment prescribed by the doctor, a treatment that he so far followed, without his waiver be a refusal. He is not necessarily somebody who is spoiling to a fight with the nursing staff. Even when they are Republican, the States are not at ease with the consent they try to restrain by all possible means. Caught between liberalism and republicanism, ethics seem, on the field of consent, prevented by the politics to take its autonomy.

  3. Informed Consent and Routinisation

    Ploug, Thomas; Holm, Søren


    This article introduces the notion of ‘routinisation’ into discussions of informed consent. It is argued that the routinisation of informed consent poses a threat to the protection of the personal autonomy of a patient through the negotiation of informed consent. On the basis of a large survey, we...... on the character of the information exchanged, and we uncover a range of causes of routinisation. Finally, the article discusses possible ways of countering the problem of routinisation of informed consent....

  4. Informed Consent and Routinisation

    Ploug, Thomas; Holm, Søren


    This article introduces the notion of ‘routinisation’ into discussions of informed consent. It is argued that the routinisation of informed consent poses a threat to the protection of the personal autonomy of a patient through the negotiation of informed consent. On the basis of a large survey, we...

  5. Visual informed consent

    Lie, Rico; Witteveen, Loes


    The notion of visual informed consent (VIC) is developed in the context of capturing on film the clarification of the purpose of data collection, the use of information obtained, and the rights, risks and benefits of participation on the one hand, and the registration of the participant’s underst

  6. [Informed consent in emergency medicine].

    Ersoy, Nermin; Ozcan Senses, Müesser; Aydin Er, Rahime


    Informed consent is a prerequisite for the ethical and legal validity of the emergency intervention in emergency medicine, since it protects the fiduciary relationship between the physician and patient; the principle of honesty that grounds this relationship; the principle of autonomy that necessitates right of self-determination; and the principle of respect for persons. Informed consent in emergency medicine, which is supposed to include the nature, benefits and risks of emergency medical intervention, differentiates with respect to definite groups of patients: (1) conscious patients, (2) unconscious patients, and (3) children and mature minors. In addition, informed consent differentiates between medical, psychological and even social circumstances of the patients, referred to as valid consent, expressed-explicit consent, blanket consent, presumed consent, tacit consent, proxy consent, and parental consent. There are a few exceptions in which emergency medical intervention is administered without informed consent. In addition to the exceptions of life-saving interventions, when a patient can not decide for herself/himself, intervention of the physician in the best interest of the patient or children is based on the "therapeutic privilege" of the physician. As an ethically defensible right, since therapeutic privilege may open a door to hard paternalistic approaches, in those situations, emergency physicians should be cautious not to violate a patient's autonomy.

  7. Informed Consent in Adult Psychiatry

    Ahmed Bait Amer


    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.

  8. [Informed consent in clinical practice: persistent doubts].

    Kottow, Miguel


    Informed consent is the core aspect of the patient-physician relationship. Since its beginnings, clinical bioethics was opposed to the authoritarian paternalism characteristic of medicine since the 19th century. The informed consent was developed to provide patients with sufficient information to allow autonomous decisions when faced with medical diagnostic and therapeutic alternatives. In spite of bioethics’ effort to perfect informed consent, the discipline has been unable to avoid informed consent from becoming an impersonal and administrative procedure. Even though the major goal of this procedure is to provide sufficient information to allow patients an objective weighting of benefits and risks of medical practice, the uncertainties of medicine make full disclosure unattainable. Collecting more information finally leads to indecision and ultimate trust in medical advice. The clinical encounter is fundamentally a fiduciary relationship, and bioethics ought to accept that its main objective is to strengthen the trust bond that is essential to the clinical encounter. This goal may become incompatible with the quest for unlimited autonomy. Patients often will only require information as long as they distrust that medical institutions and their professionals are considering their interests and needs. The main proposal of this article is to temper bioethics’ insistence on autonomy, and accept that patients essentially seek to be protected and cared for. Informed consent ought to relent its efforts at full autonomy to the benefit of trustworthiness in medicine, and trust in clinical practice.

  9. Clinical research before informed consent.

    Miller, Franklin G


    Clinical research with patient-subjects was routinely conducted without informed consent for research participation prior to 1966. The aim of this article is to illuminate the moral climate of clinical research at this time, with particular attention to placebo-controlled trials in which patient-subjects often were not informed that they were participating in research or that they might receive a placebo intervention rather than standard medical treatment or an experimental treatment for their condition. An especially valuable window into the thinking of clinical investigators about their relationship with patient-subjects in the era before informed consent is afforded by reflection on two articles published by psychiatric researchers in 1966 and 1967, at the point of transition between clinical research conducted under the guise of medical care and clinical research based on consent following an invitation to participate and disclosure of material information about the study. Historical inquiry relating to the practice of clinical research without informed consent helps to put into perspective the moral progress associated with soliciting consent following disclosure of pertinent information; it also helps to shed light on an important issue in contemporary research ethics: the conditions under which it is ethical to conduct clinical research without informed consent.

  10. Informed consent in dental extractions.

    José Luis Capote Femenías


    Full Text Available When performing any oral intervention, particularly dental extractions, the specialist should have the oral or written consent of the patient. This consent includes the explanation of all possible complications, whether typical, very serious or personalized associated with the previous health condition, age, profession, religion or any other characteristic of the patient, as well as the possi.ble benefits of the intervention. This article is related with the bioethical aspects related with dental extractions, in order to determine the main elements that the informed consent should include.

  11. Changing trends in informed consent

    Victor Lim


    Full Text Available 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 decision making. The paternalistic approach by doctors is no longer acceptable. Today the patient has the right to receive and the doctor the obligation to give sufficient and appropriate information so that the patient can make an informed decision to accept or refuse a treatment option. This has led to higher standards of practice in the process of informed consent taking. Consent taking is both a legal and moral requirement. Failure to comply with standards of practice can result in criminal prosecution, civil litigation or disciplinary action by the relevant professional authority. Consent taking is a process and not merely a one-off affixation of the patient’s signature on a consent form. It involves a continuous discussion to reflect the evolving nature of treatment from before the treatment is given to the post-operative or discharge period. The regulatory authorities in many countries have established standards for consent taking which would include the capacity of the patient, the person who should seek consent, the information to be provided and the necessary documentation.

  12. Informed consent in pediatric research.

    Leibson, Tom; Koren, Gideon


    Pediatric drug research is gradually becoming more and more accepted as the norm for assessing whether a drug is safe and efficacious for infants and children. The process of informed consent and assent for these trials presents a major challenge. The aim of this review is to map historical, ethical and legal aspects relevant to the challenges of informed consent in the setting of pediatric drug research. The impact of age, level of maturity and life circumstances on the process of obtaining informed consent as well as the relations between consent and assent are discussed. There appears to be a lack of regulatory clarity in the area of pediatric clinical trials; while numerous statements have been made regarding children's rights to autonomy and their ability to care for themselves and for younger ones, the ever changing status of adolescence is still difficult to translate to informed consent. This may delay scientific and clinical advancement for children who are at the very junction of being independent and not needing parental permission. Obtaining consent and assent for pediatric clinical trials is a delicate matter, as both parent and child need to agree to participate. The appropriate transfer of information to guardians and the children, especially concerning potential risks and benefits, is at the heart of informed consent, as it serves to protect both patient and physician. As many adults lack health literacy, one must ensure that guardians receive relevant information at a level and in forms they can understand regarding the trials their children are asked to participate in.

  13. Informed Consent (Clinical Trials)

    ... Research Cancer Treatment Types of Treatment Side Effects Clinical Trials Information A to Z List of Cancer Drugs ... Staging Prognosis Treatment Types of Treatment Side Effects Clinical Trials Cancer Drugs Complementary & Alternative Medicine Coping Feelings & Cancer ...

  14. Personal autonomy and informed consent.

    Ursin, Lars Oystein


    Two ways of understanding the notion of autonomy are outlined and discussed in this article, in order to clarify how and if informed consent requirements in biotechnological research are to be justified by the promotion of personal autonomy: A proceduralist conception linking autonomy with authenticity, and a substantivist conception linking autonomy with control. The importance of distinguishing autonomy from liberty is emphasised, which opens for a possible conflict between respecting the freedom and the autonomy of research participants. It is argued that this has implications for how consent requirements based on different criteria of specificity and understanding should be viewed and justified.

  15. [Informed consent in psychosomatic medicine].

    Satohisa, E


    Obtaining informed consent perfectly is very difficult from the view of psychosomatic medicine. Medical education regarding informed consent is generally of a low level. However as it is important to defend patients' human rights, we must educate them as to the precise meaning of both "informed" and "consent". In this report I have tried to demonstrate that both the education of medical students and their social consciousness are very important. I examined students' opinions regarding the care of a sudden case of hysterectomy (Porro's emergent operation). The following students were involved: 1st year medical students (N = 73), 4th year (N = 85) and 6th year (N = 119), and 3rd year nursing students (N = 42) and midwife students (N = 27). I examined their answers by transactional analysis. The answers of the 1st year medical students reflecting the view of the child ego state were significantly greater than those of the other students (P students altered to reflect the view of the adult ego more (P Japan" in our clinic two years ago. Since then we have talked every month to people in general about various women's diseases, and also discussed various problems of the doctor-patient relationships during these talks. I feel that public awareness concerning informed consent has increased gradually recently in Japan.

  16. [The origin of informed consent].

    Mallardi, V


    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

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

    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.

  18. Value of informed consent in surgical orthodontics.

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


    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, atten

  19. Value of informed consent in surgical orthodontics

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


    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, atten

  20. Value of informed consent in surgical orthodontics

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


    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, atten

  1. Medical ghostwriting and informed consent.

    Almassi, Ben


    Ghostwriting in its various forms has received critical scrutiny from medical ethicists, journal editors, and science studies scholars trying to explain where ghostwriting goes wrong and ascertain how to counter it. Recent analyses have characterized ghostwriting as plagiarism or fraud, and have urged that it be deterred through stricter compliance with journal submission requirements, conflict of interest disclosures, author-institutional censure, legal remedies, and journals' refusal to publish commercially sponsored articles. As a supplement to such efforts, this paper offers a critical assessment of medical ghostwriting as contrary to good patient care, on the grounds that it contradicts established general principles guiding clinical ethics. Specifically, I argue that ghostwriting undermines trust relationships between authors and their readers, and between these readers and their trusting patients, and in so doing contradicts the duty of respect for patient autonomy by obstructing informed consent. For this reason, complicity in ghostwriting practices should be understood as a violation of the professional ethical duties of physicians and other healthcare workers.

  2. Collective informed consent and decision power.

    Varelius, Jukka


    It has been suggested that, in addition to individual level decision-making, informed consent procedures could be used in collective decision-making too. One of the main criticisms directed at this suggestion concerns decision-making power. It is maintained that consent is a veto power concept and that, as such, it is not appropriate for collective decision-making. This paper examines this objection to collective informed consent. It argues that veto power informed consent can have some uses in the collective level and that when it is not appropriate the decision power a concerned party ought to have in connection with an arrangement should be made relative to the interest she has at stake in it. It concludes that the objection examined does not undermine collective informed consent.

  3. Informed Consent in Complementary and Alternative Medicine

    Opher Caspi


    Full Text Available The objective of this study was to examine complementary and alternative medicine (CAM practitioners’ (i attitudes toward informed consent and (ii to assess whether standards of practice exist with respect to informed consent, and what these standards look like. The design and setting of the study constituted face-to-face qualitative interviews with 28 non-MD, community-based providers representing 11 different CAM therapeutic modalities. It was found that there is great deal of variability with respect to the informed consent process in CAM across providers and modalities. No unique profession-based patterns were identified. The content analysis yielded five major categories related to (i general attitude towards the informed consent process, (ii type and amount of information exchange during that process, (iii disclosure of risks, (iv discussions of alternatives, and (v potential benefits. There is a widespread lack of standards with respect to the practice of informed consent across a broad range of CAM modalities. Addressing this problem requires concerted and systematic educational, ethical and judicial remedial actions. Informed consent, which is often viewed as a pervasive obligation is medicine, must be reshaped to have therapeutic value. Acknowledging current conceptions and misconception surrounding the practice of informed consent may help to bring about this change. More translational research is needed to guide this process.

  4. Informed Consent for Reconstructive Pelvic Surgery.

    Alam, Pakeeza; Iglesia, Cheryl B


    Informed consent is the process in which a patient makes a decision about a surgical procedure or medical intervention after adequate information is relayed by the physician and understood by the patient. This process is critical for reconstructive pelvic surgeries, particularly with the advent of vaginal mesh procedures. In this article, we review the principles of informed consent, the pros and cons of different approaches in reconstructive pelvic surgery, the current legal issues surrounding mesh use for vaginal surgery, and tips on how to incorporate this information when consenting patients for pelvic floor surgery.

  5. The changing face of informed surgical consent.

    Oosthuizen, J C


    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.

  6. Discussion on Approach of Strengthening Informed Consent in the Implementation Process of ART%加强ART实施过程中知情同意及其方式探讨

    艾海权; 李霞; 腊晓琳; 毛新敏; 蔡霞


    Through analyzed the process of informed consent for more than 400 infertile couples received Assisted Reproductive Technology (ART) treatment in the department of reproductive center of the first affiliated hospital of Xinjiang Medical Univesity, and observed the satisfaction of infertile couples informed consent. The survey found that eight ways taken by the hospital can greatly improve the satisfaction of infertile couples informed consent,The gradual, repeated informing combined with individualized counseling, answering are the basis of informed consent, and they are the better ways of informed consent in the process of the ART implementation.%通过分析新疆医科大学第一附属医院生殖助孕中心400余对接受辅助生殖技术治疗不育夫妇知情同意过程,观察不育夫妇知情同意满意度,发现采取的8种方式可以提高不育夫妇的知情同意满意度,分阶段、反复的信息告知同时结合个体化的咨询、答疑是知情同意的基础,也是辅助生殖技术实施过程中知情同意实施的较好的方式.

  7. Informed consent comprehension in African research settings.

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


    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

  8. A linguistic model of informed consent.

    Marta, J


    The current disclosure model of informed consent ignores the linguistic complexity of any act of communication, and the increased risk of difficulties in the special circumstances of informed consent. This article explores, through linguistic analysis, the specificity of informed consent as a speech act, a communication act, and a form of dialogue, following on the theories of J.L. Austin, Roman Jakobson, and Mikhail Bakhtin, respectively. In the proposed model, informed consent is a performative speech act resulting from a series of communication acts which together constitute a dialogic, polyphonic, heteroglossial discourse. It is an act of speech that results in action being taken after a conversation has happened where distinct individuals, multiple voices, and multiple perspectives have been respected, and convention observed and recognized. It is more meaningful and more ethical for both patient and physician, in all their human facets including their interconnectedness.

  9. Informed consent & ethical issues in paediatric psychopharmacology.

    Malhotra, Savita; Subodh, B N


    Issues relating to informed consent and ethics in paediatric psychopharmacology limit research in this population. Children vary in their levels of cognitive development, and presence of psychiatric disorder may further impair their ability to give informed consent. In decisional impairment subjects, various methods used for consent are assent/dissent; inclusion of advance directives; and/or alternative decision-makers. India is emerging as a new market for clinical trials in recent years. Moreover, in India the sociocultural realities are different from those in the western countries making it necessary for professionals to be cautious in conducting drug trials. In this review, issues regarding informed consent in children and adolescent with psychiatric diagnosis are discussed for information, discussion and debate by professionals, parents, society and legal experts to create awareness and to facilitate development of guidelines that are appropriate and applicable to the Indian system.

  10. Informed consent: an international researchers' perspective.

    Rivera, Roberto; Borasky, David; Rice, Robert; Carayon, Florence; Wong, Emelita


    We reported 164 researchers' recommendations for information that should be included in the informed consent process. These recommendations were obtained during training workshops conducted in Africa, Europe, and the United States. The 8 elements of informed consent of the US Code of Federal Regulations were used to identify 95 items of information ("points"), most related to benefits and research description. Limited consensus was found among the 3 workshops: of the 95 points, only 27 (28%) were identified as useful by all groups. These points serve as a springboard for identifying information applicable in different geographic areas and indicate the need for involving a variety of individuals and stakeholders, with different research and cultural perspectives, in the development of informed consent, particularly for research undertaken in international settings.

  11. Medical informed consent: general considerations for physicians.

    Paterick, Timothy J; Carson, Geoff V; Allen, Marjorie C; Paterick, Timothy E


    Medical informed consent is essential to the physician's ability to diagnose and treat patients as well as the patient's right to accept or reject clinical evaluation, treatment, or both. Medical informed consent should be an exchange of ideas that buttresses the patient-physician relationship. The consent process should be the foundation of the fiduciary relationship between a patient and a physician. Physicians must recognize that informed medical choice is an educational process and has the potential to affect the patient-physician alliance to their mutual benefit. Physicians must give patients equality in the covenant by educating them to make informed choices. When physicians and patients take medical informed consent seriously, the patient-physician relationship becomes a true partnership with shared decision-making authority and responsibility for outcomes. Physicians need to understand informed medical consent from an ethical foundation, as codified by statutory law in many states, and from a generalized common-law perspective requiring medical practice consistent with the standard of care. It is fundamental to the patient-physician relationship that each partner understands and accepts the degree of autonomy the patient desires in the decision-making process.

  12. Dimensions of informed consent to treatment.

    Dickens, B M; Cook, R J


    Modern law approaches patients' consent to treatment not only through liability for unauthorized touching, namely criminal assault and/or civil (non-criminal) battery, but also through liability for negligence. Physicians must exercise appropriate skill in conducting procedures, and in providing patients with information material to the choices that patients have to make. The doctrine of informed consent serves the ethical goal of respecting patients' rights of self-determination. Information is initially pitched at the reasonable, prudent person in the patient's circumstances, and then fine-tuned to what is actually known about the particular patient's needs for information. Elements to be disclosed include the patient's prognosis if untreated, alternative treatment goals and options, the success rate of each option, and its known effects and material risks. Risks include medical risks, but also risks to general well-being such as economic and similar reasonable interests. Consent is a continuing process, not an event or signed form.

  13. [Parental Information and Consent in Neonatology].

    Ehlen, M; Budde, A


    Careful analysis of current adjudication reveals increasing demand of adequate record-keeping as well as meticulously documented informed consent forms regarding all aspects of medicine. Although standardized informed consent forms or explicit guidelines for obtaining procedural consent already exist in surgical disciplines there is strong evidence that, however, in neonatology (and paediatric intensive care) these processes are still incomplete and qualitatively insufficiently implemented. Therefore the author discussed all existing information prescriptions with the legal department and quality management of a large German clinic group especially in terms of relevant legislation, recent case law and specialist literature in order to obtain potential for improvement. Based on the results of this audit of expert opinions improved recommendations could be implemented in the daily practise of a department of neonatology and paediatric intensive care on a tertiary level.

  14. The nocebo effect of informed consent.

    Cohen, Shlomo


    The nocebo effect, the mirror-phenomenon to the placebo effect, is when the expectation of a negative outcome precipitates the corresponding symptom or leads to its exacerbation. One of the basic ethical duties in health care is to obtain informed consent from patients before treatment; however, the disclosure of information regarding potential complications or side effects that this involves may precipitate a nocebo effect. While dilemmas between the principles of respect for patient autonomy and of nonmaleficence are recognized in medical ethics, there has not yet been an ethical discussion focused on the potential dilemma raised by the nocebo effect of informed consent (NEIC). This dilemma is especially pernicious, since it involves a direct causality of harm by the caregiver that is unparalleled by other potential harmful effects of information disclosure. This paper articulates the dilemma of the NEIC and offers a seminal ethical analysis.

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

    Dahl, Katja; Kesmodel, Ulrik; hvidman, lone


    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...

  16. Is informed consent effective in trauma patients?

    Bhangu, A; Hood, E; Datta, A; Mangaleshkar, S


    Informed consent in the modern era is a common and important topic both for the well-informed patient and to prevent unnecessary litigation. However, the effectiveness of informed consent in trauma patients is an under-researched area. This paper aims to assess the differences in patient recall of the consent process and desire for information by performing a comparative analysis between orthopaedic trauma and elective patients. Information from 41 consecutive elective operations and 40 consecutive trauma operations was collected on the first post-operative day. 100% of elective patients and 90% of trauma patients knew what operation they had received (p = 0.06). Overall recall of complications was poor, but was significantly lower in trauma patients compared with elective patients (62% vs 22%, p<0.001). 30% of trauma patients desired more information about their operation compared to 12% of elective patients (p = 0.049), although only 35% of trauma patients wanted written as well as verbal explanations, compared to 85% of elective patients p<0.001). Overall 100% of elective and 90% of trauma patients were happy with the consent process (p = 0.06). Subset analysis of neck of femur compared to other trauma patients showed that the above factors were not significantly different between the two groups. Recall of complications in the trauma patients is significantly lower than in elective patients, although both groups scored poorly overall. Repeated verbal explanations should be reinforced with the option of additional information leaflets for trauma operations. Further research into the usefulness of DVDs for commonly performed operations is warranted, although official internet resources may be more cost-effective.

  17. Informed consent: Do not be afraid.

    Sprumont, Dominique


    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. Copyright © 2015. Published by Elsevier B.V.

  18. Informed consent: Do not be afraid

    Dominique Sprumont


    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.

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

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


    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...

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

    To examine doctors' practices with regard to informed consent. ... difficulties inherent in the concept of informed consent.'2 ... A systematic analysis of findings was undertaken to ..... this issue.20 However, the SAMDC21 supports a policy of.

  1. Vulnerable Subjects: Why Does Informed Consent Matter?

    Goodwin, Michele


    This special issue of the Journal Law, Medicine & Ethics takes up the concern of informed consent, particularly in times of controversy. The dominant moral dilemmas that frame traditional bioethical concerns address medical experimentation on vulnerable subjects; physicians assisting their patients in suicide or euthanasia; scarce resource allocation and medical futility; human trials to develop drugs; organ and tissue donation; cloning; xenotransplantation; abortion; human enhancement; mandatory vaccination; and much more. The term "bioethics" provides a lens, language, and guideposts to the study of medical ethics. It is worth noting, however, that medical experimentation is neither new nor exclusive to one country. Authors in this issue address thorny subjects that span borders and patients: from matters dealing with children and vaccination to the language and perception of consent.

  2. Communication and informed consent in elderly people.

    Giampieri, M


    Physician-patient relationship is the key-point for an optimal management of any medical procedure. Before performing any diagnostic or therapeutic procedure, clinical communication with patients is necessary. It should regard the nature and purpose of a proposed procedure including potential risks and benefits. During physician-patient communication, alternatives, as well as the risks and benefits of not receiving or undergoing a procedure should also be disclosed. Thus, a complete physician-patient clinical communication is the basis of "shared decision-making" and plays a clinical-therapeutic role in the informed consent process in order to improve patient care. Informed consent is a delicate process of communication between a patient and physician necessary for patient authorization for any medical intervention. The success of achieving good informed consent procedure depends on the strength of the relationship between the doctor and the patient. For this reason, the traditional paternalistic relationship, in which decisions were made by the doctor, is no longer appropriate. Therefore, the use of a model which allows for a greater patient involvement in the decision making process is fundamental. This approach allows for a clearer impact on patient values. The aspects of the procedure related to these values, combined with the technical and scientific considerations of the doctor, are the basis of a shared decision making process, in which the patient is actively involved. Therefore, an informed consent is not simply the acquisition of the patient's signature, but a real process based on the dialogue between doctor and patient. This dialogue is particularly delicate in some circumstances, such as geriatric medicine and anesthesiology. Seeking consent is part of a respectful relationship with an older person. Adults are almost always considered capable of making personal healthcare decisions. Older adults should also be considered capable of handling their own

  3. 7 CFR 1c.117 - Documentation of informed consent.


    ... 7 Agriculture 1 2010-01-01 2010-01-01 false Documentation of informed consent. 1c.117 Section 1c... Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent... wants documentation linking the subject with the research, and the subject's wishes will govern; or...

  4. Informed consent - Providing information about prenatal examinations

    Dahl, Katja; Kesmodel, Ulrik; Hvidman, Lone

    Prenatal care has gradually moved away from paternalism, to a state where patient autonomy and information is vital. It is known from other health care settings that the way information is presented affects understanding.The objective is to summarize current knowledge on aspects of informing...... 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......, individual sessions and by way of written materials. None of the interventions leads to a raise in anxiety scores or influence up-take rates. Satisfaction with information provided is found unrelated to level of knowledge, but associated with having expectations for information met. Information does not seem...

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

    Lee, Stacey B


    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.

  6. [Informed consent in aesthetic plastic surgery].

    Fenger, H


    The informed consent plays a very decisive part in aesthetic plastic surgery. As there is often no medical indication in plastic surgery, the patient has to be informed about all the facts of an operation, especially about the possible risks. The legal requests for therapeutic and economic clarification gain in importance. The jurisdiction in Germany demands a merciless clarification for the patient. The patient needs to be clarified about all facts early enough so that he has a sufficient amount of time to weigh-up the pros und cons of the operation and if necessary to take advice from someone else. The sufficient documentation is very important at the sight of the extensive burden of proof at the expense of the physician.

  7. Adherence to informed consent standards in Shiraz hospitals: matrons' perspective

    Mohsenian Sisakht, Alireza; Karamzade Ziarati, Najme; Kouchak, Farideh; Askarian, Mehrdad

    ...) to informed consent standards defined by Joint Commission International (JCI) Accreditation, USA. The questionnaire was designed using the Delphi method and then filled out by hospital matrons...

  8. Who is the patient? Disclosure of information and consent in anesthesia and intensive care (informed consent).

    Korusić, Andelko; Merc, Vlasta; Duzel, Viktor; Tudorić-Djeno, Ivana; Zidak, Davorka; Brundula, Ana; Sojcić, Natasa; Milanović, Rudolf; Barić, Ada; Beslić, Gabrijela


    Physicians have always strived to uphold all the ethical postulates of the medical profession in all aspects of the practice, however with the vast advances in science and technology, numerous ethical dilemmas regarding all aspects of life and ultimately death have emerged. Medical decisions however, are no longer in the sole jurisdiction of traditional Hippocratic medicine but are now deliberated and delivered by the patient and they are comprised of a number of additional determining aspects such as psychological, social, legal, religious, esthetic, administrative etc., which all together represent the complete best interest of the patient. This is the basic goal of the "Informed Consent". The widening of legal boundaries regarding professional liability may consequentially lead to a "defensive medicine" and a deterioration in the quality of healthcare. In the Republic of Croatia there a four types of liability and the hyperproduction of laws which regulate healthcare geometrically increase the hazards to which physicians are exposed to on a daily basis. When evaluating the Croatian informed consent for anesthesia, we can come to the conclusion that it is completely impractical and as such entirely unnecessary. Anesthesiologists should concentrate on an informed consent which would in brief explain all the necessary information a "reasonable" anesthesiologist would disclose to a "reasonable" patient so that a patient could undertake a diagnostic or therapeutic procedure unburdened and with complete confidence in the physicians who are involved in the treatment of the respective patient.

  9. Informed consent process: Foundation of the researcher–participant bond

    Amrita Sil


    Full Text Available Consenting to participate in a clinical research study after being properly and correctly informed upholds the basic ethical principle of “autonomy” in human research. The informed consent is a process by which the physician sensitizes the patient about the nature, procedures, risks benefits, treatment schedules, etc of the study in a language that is non-technical and understandable by the study participant. Informed consent document (ICD has got two parts: the 'Subject Information Sheet' and the 'Informed Consent Form' (ICF; and they have to be approved by the Institutional Ethics Committee (IEC before administration. Consent should be obtained without any coercion. In case of a situation where a participant is not able to give informed consent (e.g. unconscious, minor or those suffering from severe mental illness or disability or is illiterate, it has be obtained from a legally acceptable representative (LAR. If the participant or LAR is unable to read/write, then an impartial witness should be present during the entire informed consent process and must append his/her signatures to the consent form. For children < 7 years, verbal consent is essential and for mature minors (age group 7 to 18 years informed assent should be obtained.

  10. [Informed consent in the patients' rights law].

    Figueroa G, Rodolfo


    The new regulation of patients' rights creates the right to informed consent, which allows accepting or refusing any medical treatment. Also, the patient has the right to be appropriately informed about a variety of aspects determined by the law. Patient's autonomy has limits. Artificial acceleration of death, euthanasia or assisted suicide are not permitted. The problem is that the law does not define those situations. The law provides the intervention of Ethics Committees when the doctor considers that the patient exposes himself to severe harm or the risk of death which would be avoided. This intervention impinges on patient's autonomy. Patients have the right to request discharge and medical facilities could discharge patients against their will if they do not accept medical recommendations. These limitations on autonomy should be explained because the law apparently makes the distinction between killing, letting die and the Double Effect Doctrine. There is plenty of literature questioning the validity of both. The law fails to regulate part of the medical practice, regarding life and death decisions. A lack of consensus could explain this omission. Doctors have a right to conscientious objection to some patient's requests.

  11. Informed consent for radiotherapy: Our responsibility

    Colyer, Hazel [Canterbury Christ Church University College, North Holmes Road, Canterbury, Kent CT1 1QU (United Kingdom)]. E-mail:


    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.

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

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


    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.

  13. Anesthesiological ethics: can informed consent be implied?

    Spike, Jeffrey R


    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.

  14. Consent, Informal Organization and Job Rewards: A Mixed Methods Analysis

    Laubach, Marty


    This study uses a mixed methods approach to workplace dynamics. Ethnographic observations show that the consent deal underlies an informal stratification that divides the workplace into an "informal periphery," a "conventional core" and an "administrative clan." The "consent deal" is defined as an exchange of autonomy, voice and schedule…

  15. 40 CFR 26.1117 - Documentation of informed consent.


    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Documentation of informed consent. 26... HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-pregnant, Non-nursing Adults § 26.1117 Documentation of informed consent....

  16. Informed Consent in Research on Second Language Acquisition

    Thomas, Margaret; Pettitt, Nicole


    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…

  17. [Patient information and obtaining informed consent in laparoscopic surgery].

    Rougé, C; Tuesch, J J; Casa, C; Ludes, B; Arnaud, J P


    Since the advent of laparoscopic surgery, the number of suits against surgeons has risen. One of the most frequent complaints is the lack of sufficient information. Physicians in France have a formal obligation to provide information in the contractual legal context established since 1936. This notion has been confirmed in several court cases. The requirement for patient informed consent has been confirmed by several decisions of the Appeals Court and is stated in the code of deontology. The value of classical oral information has been recently questioned in certain court cases. We analyse the current legal situation in France and try to define the content of information required in the case of laparoscopic surgery in addition to the way this information is provided and the means of obtaining informed consent. The information provided must be personalised. The patient must informed that laparoscopy remains a surgical operation. It is licit to warn the patient of predictable risks according to statistical probabilities, of the team's experience and of the patients own status including past history and psychological factors. A written statement may be prepared but must remain a document complementary to personalised oral information. The surgeon must obtain and assure good patient comprehension. The surgical community should publish risk rates in order for surgeons to have reliable references which can be used to define the notion of exceptional risk.

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

    Anvita Pandiya


    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.

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


    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.

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


    Jun 22, 2015 ... The Amsterdam Preoperative Anxiety and Information. Scale and ... Key words: Anxiety, informed consent, third molar extraction ..... Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative. Anxiety and ...

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

    Marsh, Melvin S.


    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 ( 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.

  2. Relevance of information in informed consent to digestive endoscopy.

    Stroppa, I


    In the field of instrumental methodologies, digestive endoscopy is widely applied diagnostic and therapeutic investigation, involving ethical and medico-legal problems connected with its performance. So, in the light of the present doctor-patient relationship, we therefore wished to reconsider the relevant meaning of preventive information which is indispensable for obtaining the patient's consent to the doctor's action. The aim of this present paper is to provide adequate knowledge, for who ever is about to undergo endoscopic examination, by introducing new informative forms and a new system for their distribution, without negatively affecting the patient's state of anxiety. We have tried to attribute greater responsibility to the person of the doctor requesting the examination, in providing information for the patient, and to underline, in the case of complications, the important conduct of the endoscopic specialist, who must not fail to obtain new informed consent before submitting the patient to any action directed towards treatment of the specific complication. If ignored, these medico-legal aspects can formulate the responsibility of the doctor both in clinical or penal context.

  3. Teleconsent: A novel approach to obtain informed consent for research

    Brandon M. Welch


    Full Text Available Lack of recruitment of qualified research participants continues to be a significant bottleneck in clinical trials, often resulting in costly time extensions, underpowered results, and in some cases early termination. Some of the reasons for suboptimal recruitment include laborious consent processes and access to participants at remote locations. While new electronic consents technologies (eConsent help overcome challenges related to readability and consent management, they do not adequately address challenges related to remote access. To address this, we have developed an innovative solution called “teleconsent”, which embeds the informed consent process into a telemedicine session. Teleconsent allows a researcher to remotely video conference with a prospective research participant, display and interactively guide participants in real-time through a consent form. When finished, the researcher and participant can electronically sign the consent form and print or download the signed document for archiving. This process can eliminate challenges related to travel and management of personnel at remote sites. Teleconsent has been successfully implemented in several clinical trials. Teleconsent can improve research recruitment by reducing the barriers related to informed consent, while preserving human interaction.

  4. Informed Consent Documentation for Lumbar Puncture in the Emergency Department

    Pankaj B. Patel


    Full Text Available Introduction: Informed consent is a required process for procedures performed in the emergency department (ED, though it is not clear how often or adequately it is obtained by emergency physicians. Incomplete performance and documentation of informed consent can lead to patient complaints, medico-legal risk, and inadequate education for the patient/guardian about the procedure. We undertook this study to quantify the incidence of informed consent documentation in the ED setting for lumbar puncture (LP and to compare rates between pediatric (<18 years and adult patients. Methods: In this retrospective cohort study, we reviewed the ED electronic health records (EHR for all patients who underwent successful LPs in three EDs between April 2010 and June 2012. Specific elements of informed consent documentation were reviewed. These elements included the presence of general ED and LP-specific consent forms, signatures of patient/guardian, witness, and physician, documentation of purpose, risks, benefits, alternatives, and explanation of the LP. We also reviewed the use of educational material about the LP and LP-specific discharge information. Results: Our cohort included 937 patients; 179 (19.1% were pediatric. A signed general ED consent form was present in the EHR for 809 (86% patients. A consent form for the LP was present for 524 (56% patients, with signatures from 519 (99% patients/guardians, 327 (62% witnesses, and 349 (67% physicians. Documentation rates in the EHR were as follows: purpose (698; 74%, risks (742; 79%, benefits (605; 65%, alternatives (635; 68%, and explanation for the LP (57; 6%. Educational material about the LP was not documented as having been given to any of the patients and LP-specific discharge information was documented as given to 21 (2% patients. No significant differences were observed in the documentation of informed consent elements between pediatric and adult patients. Conclusion: General ED consent was obtained in

  5. On the Ottoman consent documents for medical interventions and the modern concept of informed consent.

    Kara, Mahmut A; Aksoy, Sahin


    Information for patients prior to medical intervention is one of the principles of modern medical practice. In this study, we looked at an earlier practice of this principle. Ottoman judges had record books called sicil. One of the categories in sicils was the consent documents called riza senedi, which was a patient-physician contract approved by the courts. These contracts were especially for the protection of physicians from punishment if the patient dies. It is not clear whether patients were informed properly or not. Consent for minors was obtained from parents. However, a situation where an adult does not have the capacity to consent, was not clear in these documents. Any sign of free withdrawal of consent was not found in these records. Due to the legal system of Ottoman State, these contracts were related to Islamic law rather than modern civil law. We aim, in this paper, to present a legal practice, which is possible to consider as an early example of the informed consent practice.

  6. Informed Consent in Lumbar Puncture: ¿a Systematic Practice?

    Ivonne Martín Hernández


    Full Text Available Background: the lumbar puncture is an invasive procedure doesn't exempt of risks and for its realization it is necessary to request the patient or family's informed consent. However, this practice is even controversial among our physicians. Objective: to identify how the process of informed consent works for the lumbar puncture in our means and its importance for our professionals. Methods: this study involved 90 physicians who were underwent a validated questionnaire. For the processing of numerical data was used frequency analysis and relative percent. SPSS 11.5 on Windows was employed as statistical system. Results: it was found that informed consent doesn't constitute a systematic practice in our means and was evidenced the deficiencies that even exist in its quality and application. This has been only carried out oral and the informative interest prevails above the respect to the patient's will. The physicians offer insufficient information in aspects like the explanation of the procedure, the contraindications and the complications of proceeding. For most of those interviewed the informed consent is important, but regrettably still some fear that it becomes obstacle for the realization of this to proceed. Conclusions: although most of our physicians value the importance positively of offering the informed consent when they execute the lumbar puncture, many carry out it improperly or they don't still carry out it. Lack of knowledge on the informed consent's ethical foundation and practical aspects is denoted among the physicians interviewed.

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

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


    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.

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

    ... that patients and parents were fully informed about diagnostic and therapeutic interventions. ... Language, inadequate communication skills and lack of time were, ... Doctors who treat children were significantly less likely to obtain consent for

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

    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.

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

    Dahl, Katja; Kesmodel, Ulrik; Hvidman, Lone

      Background:Prenatal screening has become an ever increasing part of antenatal care in the western part of the world. Providing women with information enabling an informed consent to prenatal examinations has been widely recommended, with women accepting or declining the screening tests offered...... in full understanding of pros and contra.Objective and hypothesis:To summarize current knowledge of women's expectations and attitudes concerning prenatal examinations as well as the amount of knowledge possessed by pregnant women undergoing prenatal examinations. Reasons for accepting or declining...... a screening test offered, as well as the influence of information in the decision-making process is also explored. Methods: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...

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

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


    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.

  12. Adherence to Informed Consent Standards in Shiraz Hospitals: Matrons Perspective

    Alireza Mohsenian Sisakht


    Full Text Available Background Informed consent is an important part of the patients’ rights and hospitals are assigned to obtain informed consent before any diagnostic or therapeutic procedures. Obtaining an informed consent enables patients to accept or reject their care or treatments and prevent future contentions among patients and medical staff. Methods This survey was carried out during 2011-2. We assessed adherence of 33 Shiraz hospitals (governmental and non-governmental to informed consent standards defined by Joint Commission International (JCI Accreditation, USA. The questionnaire was designed using the Delphi method and then filled out by hospital matrons. We calculated valid percent frequency for each part of the questionnaire and compared these frequencies in governmental and nongovernmental hospitals using analytical statistics. Results Considering 63% of the hospitals that filled out the questionnaire, no statistically significant difference was observed between the governmental and non-governmental hospitals in adherence to informed consent standards. Conclusion This study shows a relatively acceptable adherence to standards about informed consent in Shiraz hospitals but the implementation seems not to be as satisfactory.

  13. Optimizing the HIV/AIDS informed consent process in India

    Shrotri A


    Full Text Available Abstract Background While the basic ethical issues regarding consent may be universal to all countries, the consent procedures required by international review boards which include detailed scientific and legal information, may not be optimal when administered within certain populations. The time and the technicalities of the process itself intimidate individuals in societies where literacy and awareness about medical and legal rights is low. Methods In this study, we examined pregnant women's understanding of group education and counseling (GEC about HIV/AIDS provided within an antenatal clinic in Maharashtra, India. We then enhanced the GEC process with the use of culturally appropriate visual aids and assessed the subsequent changes in women's understanding of informed consent issues. Results We found the use of visual aids during group counseling sessions increased women's overall understanding of key issues regarding informed consent from 38% to 72%. Moreover, if these same visuals were reinforced during individual counseling, improvements in women's overall comprehension rose to 96%. Conclusions This study demonstrates that complex constructs such as informed consent can be conveyed in populations with little education and within busy government hospital settings, and that the standard model may not be sufficient to ensure true informed consent.

  14. Surgical informed consent in children: a systematic review.

    Chotai, Pranit N; Nollan, Richard; Huang, Eunice Y; Gosain, Ankush


    The purpose of the article was to analyze current literature on surgeon and parents' understanding and role in the informed consent process for children undergoing surgery. A systematic database search (MEDLINE, EMBASE, PsycINFO, and EBM Reviews) was performed to identify articles concerning any aspect of the surgical informed consent for children undergoing an invasive procedure. Articles analyzing informed consent in research studies, non-English-language articles, review articles, case reports and/or series, letters-commentaries, and dentistry and/or nursing-related articles were excluded. Articles meeting inclusion criteria were analyzed to identify common themes related to the process of informed consent. One hundred seventy-eight articles were identified on primary search, after removing duplicates and screening titles for relevance, 83 abstracts were reviewed. Thirty-two additional abstracts were identified by secondary search. Twelve of 115 articles met inclusion criteria. Analysis identified five different study themes. Information delivered during consent (Content) was studied in five articles (42%), three (25%) studied the mechanics or delivery of the information (Delivery), three (25%) studied parent participation and discussion (Interchange), six articles (50%) discussed surgeons' perceptions or the parents' ability to understand or recall the information (Comprehension), and five articles (42%) evaluated surgeon or parent satisfaction or anxiety (Satisfaction). None of the articles studied all five categories. Studies of the surgical informed consent process in children are scarce. Prospective studies evaluating surgeon and parent perception regarding the Content, Delivery, and Interchange of information as well as Comprehension and Satisfaction are needed to understand barriers to the surgeon-patient relationship and to optimize the informed consent process in children undergoing surgery. Copyright © 2017 Elsevier Inc. All rights reserved.

  15. Informed consent and nurses' roles: a survey of Indonesian practitioners.

    Susilo, Astrid P; van Dalen, Jan; Chenault, Michelene N; Scherpbier, Albert


    In Southeast Asia, the process of obtaining informed consent is influenced by both culture and policy at the hospital and national level. Both physicians and nurses play vital roles in this process, but physicians influence the roles of nurses. Since the physicians and nurses often have different perspectives, it is important to investigate their views about the informed consent process and nurses' roles therein and whether there is a difference between ideal and experienced practice (reality), and whether this differs across hospitals. A questionnaire was developed and a survey was conducted among physicians and nurses. Using exploratory factor analysis a three factor structure was determined: 'nurses' roles', 'barriers in informed consent', and 'adequacy of information'. Non-parametric tests were applied to compare nurses and physicians, and hospital setting. Responses were obtained from 129 physicians and 616 nurses from two Indonesian hospitals. Those hospitals differ in ownership, location, and size. The study was reviewed by the hospital ethical committee. Participation was voluntary and confidentiality was ensured by keeping the responses anonymous. Physicians and nurses differ significantly on all three factors. The scores reflecting disparity between ideal and reality regarding nurses' roles varied across professions, while barriers in informed consent differed between hospitals. The differences between ideal and reality indicated that improvement in the informed consent process and nurses' roles therein is called for. Varying views between physicians and nurses on nurses' roles may hinder collaboration. The differences between hospital settings showed interventions may have to be customized for different settings. Views on nurses' roles vary across professions. Views on barriers in informed consent vary across hospitals. Therefore interprofessional education is needed to promote interprofessional collaboration and intervention to improve informed consent

  16. Radiation information and informed consent for clinical trials

    Caon, Martin [School of Nursing and Midwifery, Flinders University, Adelaide (Australia)], E-mail:


    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)

  17. Informed or Misinformed Consent? Abortion Policy in the United States.

    Daniels, Cynthia R; Ferguson, Janna; Howard, Grace; Roberti, Amanda


    Since 2010, the United States has witnessed a dramatic expansion of state-based restrictions on abortion. The most common of these are informed consent statutes, which require that a woman seeking an abortion receive a state-authored informational packet before the abortion procedure can be performed. These laws, in addition to requiring the provision of information about alternatives to and risks of abortion, all also require details of embryological and fetal development. This article presents the findings of a comprehensive study of state-authored informed consent materials regarding embryological and fetal development. To conduct this study, we recruited a panel of experts in human anatomy to assess the accuracy of these materials in the context of the constitutional standard established inPlanned Parenthood of Southeastern Pennsylvania et al. v. Robert P. Casey et al.(505 U.S. 833 (1992)): that such information must be "truthful" and "nonmisleading." We find that nearly one-third of the informed consent information is medically inaccurate, that inaccurate information is concentrated primarily in the earlier weeks of pregnancy and is clustered around particular body systems. We discuss the implications of our findings for the question of the constitutionality of informed consent laws as they have been implemented in practice. Copyright © 2016 by Duke University Press.

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

    Carlo Petrini


    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 subje...

  19. Consenting to uncertainty: challenges for informed consent to disease screening--a case study.

    Greene, Mark; Smith, Suzanne M


    This paper uses chronic beryllium disease as a case study to explore some of the challenges for decision-making and some of the problems for obtaining meaningful informed consent when the interpretation of screening results is complicated by their probabilistic nature and is clouded by empirical uncertainty. Although avoidance of further beryllium exposure might seem prudent for any individual whose test results suggest heightened disease risk, we will argue that such a clinical precautionary approach is likely to be a mistake. Instead, advice on the interpretation of screening results must focus not on risk per se, but on avoidable risk, and must be carefully tailored to the individual. These points are of importance for individual decision-making, for informed consent, and for occupational health.

  20. Should informed consent be based on rational beliefs?

    Savulescu, J; Momeyer, R W


    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. PMID:9358347

  1. Ethics and Bioethics. Bases for Informed Consent in Orthodontics

    Virginia Pentón García


    Full Text Available The quality and scientific development of health assistance in Cuba are reflected in its health index which is an expression of respect for all those who give and receive health services in the country. Thus human dignity, which is widely represented in the informed consent should be a premise while practicing a high quality health service according to the principles of Bioethics, constituting it an ethical challenge for all the health staff. This paper reviews the principles of Bioethics with regards to informed consent in Orthodontics.

  2. Hypothetical contractarianism and the disclosure requirement problem in informed consent.

    Cust, Kenneth F T


    Two of the more deeply problematic issues surrounding the doctrine of informed consent are providing a justification for the practice of informed consent and providing an account of the nature and amount of information that must be disclosed in order for informed consent to take place. This paper is concerned with the latter problem, the problem of disclosure requirements, but it deals with this problem in a novel way; it approaches the problem by asking what fully informed and fully rational agents would agree to under certain hypothetical conditions. In general terms I juxtapose the hypothetical contractarianism found in Rawls' A Theory of Justice with that found in Gauthier's Morals By Agreement and ask what their respective hypothetical contractors would agree to with respect to choosing a particular standard of disclosure to govern the practice of informed consent. In more specific terms a contrast is made between what a Rawlsian agent behind a veil of ignorance would choose as compared to what, in Gauthier's terms, an ideal actor making an Archimedean choice would choose. The idea of an Archimedean point, and the subsequent choice made from that point, although technically identified by Rawls, originated with Archimedes of Syracuse.

  3. Open consent, biobanking and data protection law: can open consent be 'informed' under the forthcoming data protection regulation?

    Hallinan, Dara; Friedewald, Michael


    This article focuses on whether a certain form of consent used by biobanks--open consent--is compatible with the Proposed Data Protection Regulation. In an open consent procedure, the biobank requests consent once from the data subject for all future research uses of genetic material and data. However, as biobanks process personal data, they must comply with data protection law. Data protection law is currently undergoing reform. The Proposed Data Protection Regulation is the culmination of this reform and, if voted into law, will constitute a new legal framework for biobanking. The Regulation puts strict conditions on consent--in particular relating to information which must be given to the data subject. It seems clear that open consent cannot meet these requirements. 4 categories of information cannot be provided with adequate specificity: purpose, recipient, possible third country transfers, data collected. However, whilst open consent cannot meet the formal requirements laid out by the Regulation, this is not to say that these requirements are substantially undebateable. Two arguments could be put forward suggesting the applicable consent requirements should be rethought. First, from policy documents regarding the drafting process, it seems that the informational requirements in the Regulation are so strict in order to protect the data subject from risks inherent in the use of the consent mechanism in a certain context--exemplified by the online context. There are substantial differences between this context and the biobanking context. Arguably, a consent transaction in the biobanking does not present the same type of risk to the data subject. If the risks are different, then perhaps there are also grounds for a reconsideration of consent requirements? Second, an argument can be made that the legislator drafted the Regulation based on certain assumptions as to the nature of 'data'. The authors argue that these assumptions are difficult to apply to genetic data

  4. Written informed consent in health research is outdated

    Broekstra, R.; Maeckelberghe, E. L. M.; Stolk, R. P.


    Reference to the Declaration of Helsinki as assurance for ethical principles for medical research involving human subjects has become a meaningless mantra. The participants’ relationship with researchers has been distrusted-based with Written Informed Consent (WIC) hereinafter referred to as WIC)

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


    ... 15 Commerce and Foreign Trade 1 2010-01-01 2010-01-01 false General requirements for informed consent. 27.116 Section 27.116 Commerce and Foreign Trade Office of the Secretary of Commerce PROTECTION... description of any reasonably foreseeable risks or discomforts to the subject; (3) A description of...

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

    Hosek, Susan D


    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.

  7. [Formal quality assessment of informed consent documents in 9 hospitals].

    Calle-Urra, J E; Parra-Hidalgo, P; Saturno-Hernández, P J; Martínez-Martínez, M J; Navarro-Moya, F J


    Informed consent forms are very important in the process of medical information. The aim of this study is to design reliable formal quality criteria of these documents and their application in the evaluation of those used in the hospitals of a regional health service. Criteria have been designed from the analysis of existing regulations, previous studies and consultation with key experts. The interobserver concordance was assessed using the kappa index. Criteria evaluation was performed on 1425 documents of 9 hospitals. A total of 19 criteria used in the evaluation of the quality of informed consent forms have been obtained. Kappa values were higher than 0,60 in 17 of them and higher than 0,52 in the other 2. The average number of defects per document was 7.6, with a high-low ratio among hospitals of 1.84. More than 90% of the documents had defects in the information on consequences and contraindications, and in about 90% it did not mention the copy to the patient. More than 60% did not comply with stating the purpose of the procedure, a statement of having understood and clarified doubts, and the treatment options. A tool has been obtained to reliably assess the formal quality of the informed consent forms. The documents assessed have a wide margin for improvement related to giving a copy to the patient, and some aspects of the specific information that patients should receive. Copyright © 2012 SECA. Published by Elsevier Espana. All rights reserved.

  8. Epidural analgesia during labour - maternal understanding and experience - informed consent.

    Mahomed, K; Chin, D; Drew, A


    Women obtain information on epidural analgesia from various sources. For epidural for pain relief in labour this is provided by the anaesthetist as part of the consenting process. There is much discussion about the inadequacy of this consenting process; we report on women's knowledge, experience and recall of this process at a regional hospital with a 24-h epidural service. Fifty-four women were interviewed within 72 h of a vaginal birth. 91% of the women had acquired information from friends, relatives and antenatal classes. Lack of recall of benefits of epidural analgesia accounted for 26 (38%) and 25 (26%) of the responses, respectively. Similarly in terms of amount of pain relief they could expect, 13 (21%) could not remember and 13 (21%) thought that it may not work. We suggest use of varying methods of disseminating information and wider utilisation of anaesthetists in the antenatal educational programmes.

  9. [Informed consent and risk management: medico-legal aspects].

    Moreschi, C; Leone, E; Sabot, A


    In every relief run, both to the goals of medical performance quality and in the optics of a therapeutic alliance, it is fundamental to create a relationship of trust among the physician and the patient, in which communication assumes a fundamental role. The informed consent is set as an integral part of the sanitary action as conclusive moment of that "therapeutic alliance" fundamental to face in a correct way every illness, and it legitimates the same sanitary action, as it is the demonstration of the constitutionally guaranteed right of patient's autodetermination. The A.O.U.D. of Udine has undertaken a run of accreditation to the Joint Commission International that it foresees a revision of the informative runs and an updating of the forms of informed consent, with the purpose to overcome the traditional physician-patient relationship, recognizing to all the patients an active role in the exercise of the medical action and in the care process. In fact the information must be lived as integral part of the sanitary action, with the awareness that this, private of such a part, would result incomplete and inaccurate, independently from the result. In such optics, the consent form, created absorbing legislative, ethical and deontological principles and jurisprudential orientations, will be illustrated and particular considerations about the type of information that must be given to the patient for treatments effected in day-surgery, will be formulated.

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

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


    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.

  11. Informed consent in robotic surgery: quality of information and patient perception

    Ferrarese Alessia


    Full Text Available Obtaining a valid informed consent in the medical and surgical field is a long debated issue in the literature. In robotic surgery we believe in the necessity to follow three arrangements to make the informed consent more complete.

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

    Petrini, Carlo


    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.

  13. Language use in the informed consent discussion for emergency procedures.

    McCarthy, Danielle M; Leone, Katrina A; Salzman, David H; Vozenilek, John A; Cameron, Kenzie A


    The field of health literacy has closely examined the readability of written health materials to optimize patient comprehension. Few studies have examined spoken communication in a way that is comparable to analyses of written communication. The study objective was to characterize the structural elements of residents' spoken words while obtaining informed consent. Twenty-six resident physicians participated in a simulated informed consent discussion with a standardized patient. Audio recordings of the discussions were transcribed and analyzed to assess grammar statistics for evaluating language complexity (e.g., reading grade level). Transcripts and time values were used to assess structural characteristics of the dialogue (e.g., interactivity). Discussions were characterized by physician verbal dominance. The discussions were interactive but showed significant differences between the physician and patient speech patterns for all language complexity metrics. In this study, physicians spoke significantly more and used more complex language than the patients.

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

    Carlo Petrini


    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.

  15. Informed consent in human experimentation before the Nuremberg code.

    Vollmann, J; Winau, R


    The issue of ethics with respect to medical experimentation in Germany during the 1930s and 1940s was crucial at the Nuremberg trials and related trials of doctors and public health officials. Those involved in horrible crimes attempted to excuse themselves by arguing that there were no explicit rules governing medical research on human beings in Germany during the period and that research practices in Germany were not different from those in allied countries. In this context the Nuremberg code of 1947 is generally regarded as the first document to set out ethical regulations in human experimentation based on informed consent. New research, however, indicates that ethical issues of informed consent in guidelines for human experimentation were recognised as early as the nineteenth century. These guidelines shed light on the still contentious issue of when the concepts of autonomy, informed consent, and therapeutic and non-therapeutic research first emerged. This issue assumes renewed importance in the context of current attempts to assess liability and responsibility for the abuse of people in various experiments conducted since the second world war in the United States, Canada, Russia, and other nations.

  16. Informed Consent, Body Property, and Self-Sovereignty.

    Rao, Radhika


    Recent cases involving biosamples taken from indigenous tribes and newborn babies reveal the emptiness of informed consent. This venerable doctrine often functions as a charade, a collective fiction which thinly masks the uncomfortable fact that the subjects of human research are not actually afforded full information regarding the types of research that may be contemplated, nor do they provide meaningful consent. But if informed consent fails to provide adequate protection to the donors of biological materials, why not turn to principles of property law? Property is power, yet current law permits everyone except for those who donate biological materials to possess property rights. The reluctance to invoke property probably stems from fears of resurrecting slavery and the commodification of human beings. But ironically, avoidance of property transforms the subjects of human research into objects that can be owned only by others, resulting in new forms of oppression and exploitation. Human research subjects are autonomous individuals who should not only possess the power to contribute their biological materials, but also the right to help control the course of research, and to share in the resulting benefits or profits. Conferring body property might enable research subjects to regain power and a measure of self-sovereignty.

  17. Understanding the informed consent process in HIV clinical trials in Uganda: a case study

    Ssali, Agnes


    The regulatory guidelines on obtaining informed consent require that all protocols be reviewed by an ethics review committee; in addition study information must be presented to volunteers by the research teams in simple and understandable language, to ensure they are able to give informed consent for their participation. Despite the innovative methods that have been developed over the years to improve informed consent, the informed consent process is still a difficult subject and not fully un...

  18. Towards better-informed consent: Research with livestock-keepers and informal traders in East Africa.

    Cooper, Tarni Louisa; Kirino, Yumi; Alonso, Silvia; Lindahl, Johanna; Grace, Delia


    With the rise of the One Health paradigm, ethicists have called for new research approaches, considering the interdependent relationships of humans, animals, and their environment. These relationships can be particularly complex within resource-poor, smallholder livestock systems, necessitating a rigorous informed-consent process. Little has been published on informed consent beyond human-subject research. This paper outlines two studies on informed consent, for research identifying diseases of animal and human importance, within smallholder livestock value chains. Firstly, a randomized independent-group study compared three communication tools (written, cartoons, and photographs) for informing 22 Tanzanian livestock-keepers before seeking their consent. A significant difference in comprehension and engagement in the informed-consent process was found between tools, and cartoons had the highest (i.e. best combined comprehension and engagement) scores. Most (21 out of 22) farmers answered half or more the questions correctly, but none were able to answer all questions. Comprehension testing allowed identification of common misunderstandings, such as immediate benefits the farmers would receive and the process to be used for relaying research results. Dialogue stimulated by cartoons and photographs allowed researchers to determine and respond to participants' varied relationships with their livestock. The second study assessed preferred methods for indicating consent among informal-sector milk vendors in Nairobi, Kenya. Of consenting participants, 61% (140/230) indicated consent verbally, 39% (90/230) signed consent and none chose thumbprint. There was a significant enumerator-effect on both overall consent and the methods chosen. Several of these findings echo those published in human-medical research. Additionally, highlighted here is the importance of facilitating dialogue during the informed-consent process in One Health research, for a more nuanced understanding

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

    Verheijde Joseph L


    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.

  20. Informed consent, dementia and oral health care provision.

    Ting, Graeme


    Managing patients with dementia requires a practitioner to exercise diverse skills. Communicating with the patient (as their dementia allows), relatives, caregivers and medical personnel are essential elements in the care process. Diagnosis of oral health problems may not be straightforward, clinical examination and treatment planning may be hampered by poor cooperation from the person with dementia. Practitioners must view any treatment from the patient's perspective and balance this with the requirements for sound clinical care. The consent process must be approached in a manner that fulfils the ethical responsibilities that acknowledge patient rights. This can be difficult when managing a patient with dementia. This paper will explore issues surrounding the consent process and the provision of oral health care to people suffering from dementia. It is hoped that readers will be stimulated to review their practice; especially related to informed consent, whether they routinely manage patients with dementia or not. Such practice evaluation should consider the wants and needs of patients and families on a broader than clinical basis and thus enhance the care that is brought to this group of interesting and often challenging patients.

  1. Informed consent for special procedures: electroconvulsive therapy and psychosurgery.

    Beloucif, Sadek


    Informed consent has become the cornerstone of the expression of patient's autonomy for ethical and sound patient-physician relationships. However, some severe psychiatric diseases markedly hinder the ability of selected patients to ensure a proper consent. Confronted with mentally disabled individuals whose condition may lead to violence or inflicting it on others, society must carry out its duty of protecting those who are particularly vulnerable, while respecting and protecting these disabled individuals. The recent update in the indications and more detailed understanding of electroconvulsive therapy, and the technical ability of obtaining less invasive or reversible techniques of psychosurgery, has renewed interest in these impressive and efficient techniques. Specifically, the emergence of new and promising cerebral neurostimulation techniques for treating Parkinson's disease have led to considering their extension to severe psychiatric disorders. This method can mimic the effects of 'conventional' psychosurgery, but in a potentially reversible and adaptable way, thus avoiding many undesirable side-effects of lesional surgery. Ensuring an ethical decision-making process and the appropriateness of consent becomes of paramount importance. Consent can be relatively easy to secure in selected patients who are often fully aware of their torments (such as those suffering from severe refractory depression of obsessive-compulsive disorders) whose suffering may be such that they are ready to accept, or for that matter demand, such actions. However, the duty of physicians is to realize that pains should always be taken to do as much good (and as little harm) as possible, while respecting the freedom of decision of those who seek to help.

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

    Weeks Andrew


    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.

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

    Alessandra De Palma


    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.

  4. Informed Consent in the Field of Language and Sexuality

    Mortensen, Kristine Køhler


    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....... In this article, I explore ways of accessing intimate spontaneous data in a heterosexual online dating context. Through interactional analysis of three types of online dating interaction, I examine the multi-faceted context for securing informed consent while at the same time preserving participants’ intimacy. I...

  5. Why does informed consent fail? A discourse analytic approach.

    Ness, David E; Kiesling, Scott F; Lidz, Charles W


    Informed consent often fails to meet the intended goals that a prospective subject should understand fully and choose autonomously to participate in research. The current study is an attempt to understand such failures by applying linguistic methods of discourse analysis to the transcripts of informed consent interviews. Elements of conversation and of the frame of discourse were analyzed to understand how the participants shaped their spoken interaction during the interview. We looked at the degree to which the subject appeared to be fully informed, at the problem of therapeutic misconception, and at the degree to which the subject was helped to explore concerns relevant to the choice at hand. We found that lapses or miscommunications could be understood specifically in terms of conversational elements and framing. This kind of detailed, language-based analysis is an alternative to approaches that are more abstract and inferential, such as those that are based upon the attitudes or the cognitive performance of speakers. We discuss possible educational and research implications of this approach.

  6. Marriage of professional and technical tasks: a strategy to improve obtaining informed consent.

    Steinemann, Susan; Furoy, Daniel; Yost, Fredrick; Furumoto, Nancy; Lam, Geoffrey; Murayama, Kenric


    Education in obtaining informed consent, combined with technical training using a stepwise approach, may improve resident knowledge of, confidence in, and frequency of obtaining consent for bedside procedures. Surgical trainees were randomized to receive a lecture on obtaining informed consent. Knowledge of, confidence in, and frequency of obtaining consent were assessed. Subsequent first-year residents received combined technical and consent training using a stepwise approach. Residents listed key steps for procedures before and after training, were observed for consent and technical competency on patients, and were assessed on frequency of obtaining consent by follow-up chart review. Knowledge and confidence improved after lecture instruction, but consent rate (21%) did not. Stepwise training increased resident awareness of obtaining informed consent as a key step (19% to 77%) and increased frequency of obtaining consent (89% for proctored procedures and 79% in follow-up). Education alone improves knowledge but not practice of obtaining consent. Teaching the consent process concomitantly with technical training may increase awareness and performance of obtaining informed consent for bedside procedures.

  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

    K. Kortram (Kirsten); E.Q.W. Spoon (Emerentia Q.W.); S.Y. Ismail (Sohal); F.C. D'Ancona (Frank); M.H. Christiaans (Maarten); L.W.E. van Heurn (Ernest); H.S. Hofker (Sijbrand); A.W.J. Hoksbergen (Arjan); J.J.H. Van Der Heide (Jaap J. Homan); M.M. Idu (Mirza); C.W.N. Looman (Caspar); S.A. Nurmohamed (Shaikh Azam); J. Ringers (Jan); R.J. Toorop (Raechel J.); J. van de Wetering (Jacqueline); J.N.M. IJzermans (Jan); F.J.M.F. Dor (Frank)


    textabstractIntroduction: 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 standard

  8. The doctrine of informed consent in surgical practice

    had acted reasonably by asking the doctor to disclose his HIV status.[9] .... Conclusion. The concept of consent is continuously evolving, ... A citizen's right cannot be abridged with the intention of ... Consent A guide for Canadian. Physicians.

  9. [Introduction of an accreditation system for hospital informed consent forms].

    López-Picazo, J J; Tomás-Garcia, N; Calle-Urra, J E; Parra-Hidalgo, P; Valverde-Iniesta, J J


    To describe an accreditation system for informed consent forms (ICF) in a tertiary hospital, as an intervention to improve their quality, and to check the improvements achieved. Following an external evaluation of the ICF quality in a public hospital in Murcia (Spain), an accreditation committee set the ICF requirements and associated procedures. Effectiveness is assessed by comparing two external evaluations carried out by the EMCA Program (2011 and 2013) and based on 19 criteria and a sample of 60 ICF for every public hospital in Murcia Region. To be accredited, every ICF must meet the 19 external criteria plus 5 based on legibility, readability and scientific and technical validity. A form to fill in the contents of every ICF was agreed, which would be reviewed, approved and validated for five years. Before the implementation, 8.2 defects/ICF were detected. The accreditation system obtained an 89% improvement (0.9 defects/ICF) and achieved significant improvements in 18 criteria, 16 of which are benchmarked. The accreditation system achieved a substantial improvement in the ICF (obtaining a better result in external evaluations) and guarantees their contents, legibility and readability. This system needs to be extended to other hospitals, since it is not clear whether common ICFs would be suitable. However, this improvement is structural and does not guarantee that the overall information/consent procedure is done properly, thus complementary strategies for measurement and improvement are required. Copyright © 2014 SECA. Published by Elsevier Espana. All rights reserved.

  10. Hope and persuasion by physicians during informed consent.

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


    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.

  11. Informed consent under the European Convention on Biomedicine and the UNESCO Declaration on Bioethics.

    Salako, Solomon E


    The desirability of obtaining freely given consent is universally accepted. The point, however, is that there is no unanimity on the definition of informed consent or its application in bioethics. Whether informed consent is based on principalism or casuistry or the virtue theory, the problem is how to handle the ethically complex situation created in the interface between informed consent and social justice under international biomedical instruments. This article will proceed by offering detailed historical and critical analyses of informed consent under the European Convention on Human Rights and Biomedicine 1997 and The UNESCO Universal Declaration on Bioethics and Human Rights 2005. Three conceptions of justice will be utilised to show that the doctrine of informed consent has driven the ethos of research on human beings and shaped the physician-patient relationship; and that casuistry and virtue theory are consistent with and not rivals of a principle-based account of informed consent.

  12. Informed consent with suicidal patients: Rethinking risks in (and out of) treatment.

    Rudd, M David; Joiner, Thomas; Brown, Gregory K; Cukrowicz, Kelly; Jobes, David A; Silverman, Morton; Cordero, Liliana


    Informed consent is uniformly accepted as essential to the treatment process. However, the relevant literature has not discussed issues of risk specific to suicidal patients, nor has such information routinely been included in the informed consent process. The implications of including suicide-specific risk information in the informed consent process is discussed and examples provided. (PsycINFO Database Record (c) 2010 APA, all rights reserved).

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

    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.

  14. The writing of informed consent in accessible language: difficulties.

    Fernandes, Nurimar C


    In order to assess the adequacy of informed consent terminology of research projects developed at the Clementino Fraga Filho University Hospital (Federal University of Rio de Janeiro) , we conducted a review study on the terminology found in 55 projects (2008-20013) . Such projects belonged to different medical specialties and were all registered in the hospital's Ethics in Research Committee. Patients had difficulty in understanding the meanings of 76 medical terms and expressions; only 12 of them could be replaced. On the other hand, the present study reached the conclusion that, in most cases, the writing with scientific terms is essential in items such as justification/objectives and procedures, being insurmountable obstacles to the participants of this research and patients' understanding.

  15. Improved understanding and satisfaction with a modified informed consent document: a randomized study

    Raich PC


    Full Text Available Peter C Raich1,2, Ralph L Kennedy1, Chris Vanoni1, William Thorland2, Naamon Owens1, Charles L Bennett31AMC Cancer Research Center, University of Colorado Comprehensive Cancer Center, Denver, 2Denver Health Medical Center, Denver, Colorado, USA; 3Center for Management of Complex Chronic Care, Hines Veterans Administration Hospital, Hines, IL, USABackground: Informed consent documents need to convey crucial information to prospective study participants. We assessed the impact of an informed consent process designed to be understood by persons with low health literacy skills.Methods: We conducted a randomized controlled trial with ethnically and racially diverse male veterans. Participants were randomly assigned to receive and read the standard consent document for the Selenium and Vitamin E Cancer Prevention Trial prostate cancer prevention trial or a culturally tailored, easy-to-read consent document. Telephone interviews were conducted 2 weeks following consent, assessing comprehension, satisfaction, consent anxiety, state anxiety, decisional conflict, and cultural sensitivity.Results: Of 162 male veterans completing the initial telephone interview, 49.7% were African American, 44.1% were Caucasian, and 6.2% were Hispanic. The mean comprehension score for the consent document and process was significantly increased in the intervention arm participants (17.08 versus the standard consent arm (15.06, P < 0.0001. The satisfaction score with the consent information was higher in participants in the intervention arm (3.67 vs 3.42, P = 0.0009, while the consent anxiety score was reduced (1.31 vs 1.56, P = 0.0067.Conclusion: Modifications in the reading level, format, appearance, interactivity, and cultural sensitivity of an informed consent document in the cancer prevention setting significantly improved comprehension of and satisfaction with the consent document, while decreasing consent anxiety.Keywords: health literacy, informed consent, clinical

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

    H Miller MacSween


    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.

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

    Madeira, Jody Lyneé; Andraka-Christou, Barbara


    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

  18. Status of informed consent in the original articles published in a medical journal of Bangladesh.

    Mollah, As


    Informed consent and other ethical issues are included in every guideline of research ethics. Taking informed consent from the participants is essential in human health research. The health researchers are not addressing adequately the issues of informed consent and other relevant issues. In many of the published articles in our country, there is no mention of informed consent and other relevant ethical issues. In this study, a 5-years retrospective review was performed on the original articles that described research involving human subjects, and published in the "Journal of Bangladesh College of Physicians and Surgeons" in the period of 1999 to 2003. The objectives of this review were: i) to document whether the author has mentioned about informed consent in the published original article; and ii) to document whether the author has addressed the informed consent procedure in appropriate details. Fifty three original articles were reviewed, only in 7(13.2%) articles the author has mentioned that informed consent was taken from the participants. In 19 (63%) articles, where the subjects were minors or incompetent, there was no mention from whom informed consent was taken. Only in 2(3.7%) articles, the authors have mentioned about the approval of Ethical Review Committee, and in 4(7.5%) articles about the funding agency. Other ethical issues were also ignored. The study documents deficiencies in informed consent and relevant ethical issues in the published articles. This finding demands greater attention to ethical standards on the part of investigators and the editors.

  19. Strengthening informal healthcare deliver: gender perspectives

    Mashiri, M


    Full Text Available in rural areas in fighting disease, poverty, isolation and deprivation. It will profile the importance of transportation infrastructure and services as well as communication in facilitating informal healthcare service delivery. One strand of thought...

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

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


    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.

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

    Siriwardhana Chesmal


    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

  2. Electroconvulsive therapy, the placebo effect and informed consent.

    Blease, Charlotte Rosalind


    Major depressive disorder is not only the most widespread mental disorder in the world, it is a disorder on the rise. In cases of particularly severe forms of depression, when all other treatment options have failed, the use of electroconvulsive therapy (ECT) is a recommended treatment option for patients. ECT has been in use in psychiatric practice for over 70 years and is now undergoing something of a restricted renaissance following a sharp decline in its use in the 1970s. Despite its success in treating severe depression there is continued debate as to the effectiveness of ECT: in some studies, it is argued that ECT is marginally more effective than sham ECT. In addition, there is still no clear explanation of how ECT works; among the range of hypotheses proposed it is claimed that ECT may work by harnessing placebo effects. In light of the uncertainties over the mechanism of action of ECT and given the risk of serious side effects that ECT may produce, I contend that the process of informed consent must include comprehensive accounts of these uncertainties. I examine the possible consequences of providing adequate information to potential ECT patients, including the consideration that ECT may still prove to be effective even if physicians are open about the possibility of it working as a placebo. I conclude that if we value patient autonomy as well as the professional reputation of medical practitioners, a fuller description of ECT must be provided to patients and their carers.

  3. [Intracerebral aneurysm--treatment options, informed consent, and legal aspects].

    Burkhardt, Jan-Karl; Burkhardt, Werner Friedrich; Zinn, Pascal Olivier; Bozinov, Oliver; Bertalanffy, Helmut


    All medical subspecialties and, in particular, high-tech field neurosurgery are subject to continuous change in therapeutic concepts due to novel treatment options emerging through research and evolution in the field. Hence, the question arises if the patient's informed consent needs to be adjusted in the face of multiple therapeutic options with different configurations of risk/benefit relationships. In this paper we discuss different therapeutic scenarios with regard to ruptured intracerebral aneurysms (RIA) and unruptured intracerebral aneurysms (UIA), and we advise the medical doctor involved in the process. Indeed, experienced neurosurgeons and endovascular interventionalists are very familiar with the management of these scenarios; likewise, interns, residents, and otherwise affiliated physicians may be faced with these situations. In general, asymptomatic and mentally capacitated patients as well as legal guardians of minor patients and of mentally incapacitated patients with incidental aneurysms and more than one therapeutic option need to be accurately informed about the advantages and disadvantages of the treatment options available to them. In case of emergency or when treating a mentally disabled patient who is incapable of making a sound judgment and has no legal guardian, the attending doctor will have to choose the best possible treatment option. Copyright © 2010. Published by Elsevier GmbH.

  4. Informed consent for MRI and fMRI research: Analysis of a sample of Canadian consent documents

    Pike Bruce


    Full Text Available Abstract Background Research ethics and the measures deployed to ensure ethical oversight of research (e.g., informed consent forms, ethics review are vested with extremely important ethical and practical goals. Accordingly, these measures need to function effectively in real-world research and to follow high level standards. Methods We examined approved consent forms for Magnetic Resonance Imaging (MRI and functional Magnetic Resonance Imaging (fMRI studies approved by Canadian research ethics boards (REBs. Results We found evidence of variability in consent forms in matters of physical and psychological risk reporting. Approaches used to tackle the emerging issue of incidental findings exposed extensive variability between and within research sites. Conclusion The causes of variability in approved consent forms and studies need to be better understood. However, mounting evidence of administrative and practical hurdles within current ethics governance systems combined with potential sub-optimal provision of information to and protection of research subjects support other calls for more scrutiny of research ethics practices and applicable revisions.

  5. Monetary incentives improve recall of research consent information: it pays to remember.

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


    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, the authors randomly assigned 31 drug court clients participating in a clinical research trial to a control group that received a standard informed consent procedure or to a group that received 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 control group (65% vs. 42%, p<.01). Findings from this study have important implications for the ethical conduct of human subject research. The incentivized consent procedure may be useful for improving consent recall in research studies, particularly those involving potentially serious side effects. The results also provide an important "proof of concept" regarding the utility of motivational procedures for improving recall of consent information.

  6. The right of minors to confidentiality and informed consent.

    Weisleder, Pedro


    Doctor-patient confidentiality is a precept of adolescent medicine. In general, physicians honor the privacy of adolescents unless there is evidence that the youngster is engaging in dangerous activities. An otherwise healthy 16 year old was referred for headache evaluation. During the portion of the interview conducted outside the presence of his mother, the patient revealed using marijuana and cocaine regularly and LSD (lysergic acid diethylamide), hallucinogenic mushrooms, and "Ecstasy" (3,4-methylenedioxymethamphetamine) occasionally. Given this information, and as allowed by North Carolina's General Statutes, the patient was offered confidential treatment for illegal substance abuse; he declined the offer. He also turned down the request to forgo his right to privacy so that his parents could be made aware of his addiction. As a result of the patient's drug use and disregard of its consequences, it was determined that notification of a parent was essential to his life or health; thus, confidentiality was breached. Although substance abuse is a behavior that threatens the abuser's health and life, state and federal laws vary regarding the rights of minors to confidential evaluation and treatment. For this article, laws that govern minors' rights to consent to confidential treatment for illegal substance abuse were reviewed. The aforementioned case is used as a catalyst for discussion.

  7. When is informed consent required in cluster randomized trials in health research?

    Boruch Robert


    Full Text Available Abstract This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the second of the questions posed, namely, from whom, when, and how must informed consent be obtained in CRTs in health research? The ethical principle of respect for persons implies that researchers are generally obligated to obtain the informed consent of research subjects. Aspects of CRT design, including cluster randomization, cluster level interventions, and cluster size, present challenges to obtaining informed consent. Here we address five questions related to consent and CRTs: How can a study proceed if informed consent is not possible? Is consent to randomization always required? What information must be disclosed to potential subjects if their cluster has already been randomized? Is passive consent a valid substitute for informed consent? Do health professionals have a moral obligation to participate as subjects in CRTs designed to improve professional practice? We set out a framework based on the moral foundations of informed consent and international regulatory provisions to address each of these questions. First, when informed consent is not possible, a study may proceed if a research ethics committee is satisfied that conditions for a waiver of consent are satisfied. Second, informed consent to randomization may not be required if it is not possible to approach subjects at the time of randomization. Third, when potential subjects are approached after cluster randomization, they must be provided with a detailed description of the interventions in the trial arm to which their cluster has been randomized; detailed information on interventions in other trial arms need not be provided. Fourth, while passive consent may serve a

  8. Meaningful Informed Consent with Young Children: Looking Forward through an Interactive Narrative Approach

    Mayne, Fiona; Howitt, Christine; Rennie, Léonie


    Ideas about ethical research with young children are evolving at a rapid rate. Not only can young children participate in the informed consent process, but researchers now also recognize that the process must be meaningful for them. As part of a larger study, this article reviews children's rights and informed consent literature as the foundation…

  9. 76 FR 55390 - Guidance on Exculpatory Language in Informed Consent, Draft


    ... HUMAN SERVICES Guidance on Exculpatory Language in Informed Consent, Draft AGENCY: Office for Human... the availability of a draft guidance entitled, ``Guidance on Exculpatory Language in Informed Consent.'' The draft guidance, when finalized, will represent OHRP's and FDA's current thinking on this topic...

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

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


    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

  11. Negotiating Informed Consent with Children in School-Based Research: A Critical Review

    Gallagher, Michael; Haywood, Sarah L.; Jones, Manon W.; Milne, Sue


    The methods literature on research with children recognises the challenges of negotiating informed consent with this group. Special "child-friendly" techniques are advocated to overcome these challenges. We argue that, upon closer inspection, research with children foregrounds more fundamental problems with informed consent that are not easily…

  12. Meaningful Informed Consent with Young Children: Looking Forward through an Interactive Narrative Approach

    Mayne, Fiona; Howitt, Christine; Rennie, Léonie


    Ideas about ethical research with young children are evolving at a rapid rate. Not only can young children participate in the informed consent process, but researchers now also recognize that the process must be meaningful for them. As part of a larger study, this article reviews children's rights and informed consent literature as the foundation…

  13. Health literacy predicts participant understanding of orally-presented informed consent information.

    Ownby, Raymond L; Acevedo, Amarilis; Goodman, Kenneth; Caballero, Joshua; Waldrop-Valverde, Drenna

    Informed consent for participation in studies with human subjects is a critically important aspect of clinical research, but research has shown that many potential subjects do not understand information relevant to their participation. A better understanding of factors related to participant understanding of study-related information is thus important. As part of a study to develop a new measure of health literacy, participants viewed a 50 second video in their preferred language (Spanish or English) of a clinician presenting informed consent information. They then responded to six questions about it. In progressively more complicated regression models, we evaluated the relation of demographic variables, general cognitive ability, and health literacy to participants' recall of the information. In a model that only included demographic variables, Spanish language, black race and older age were associated with poorer performance. In a model that included the effects of general cognitive ability and health literacy as well as demographics, education and health literacy were related to performance. Informed consent interventions that take potential research subjects' levels of health literacy into account may result in better understanding of research-related information that can inform their decision to participate.

  14. Health literacy predicts participant understanding of orally-presented informed consent information

    Ownby, Raymond L; Acevedo, Amarilis; Goodman, Kenneth; Caballero, Joshua; Waldrop-Valverde, Drenna


    Informed consent for participation in studies with human subjects is a critically important aspect of clinical research, but research has shown that many potential subjects do not understand information relevant to their participation. A better understanding of factors related to participant understanding of study-related information is thus important. As part of a study to develop a new measure of health literacy, participants viewed a 50 second video in their preferred language (Spanish or English) of a clinician presenting informed consent information. They then responded to six questions about it. In progressively more complicated regression models, we evaluated the relation of demographic variables, general cognitive ability, and health literacy to participants’ recall of the information. In a model that only included demographic variables, Spanish language, black race and older age were associated with poorer performance. In a model that included the effects of general cognitive ability and health literacy as well as demographics, education and health literacy were related to performance. Informed consent interventions that take potential research subjects’ levels of health literacy into account may result in better understanding of research-related information that can inform their decision to participate. PMID:26767117

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

    Agnes Ssali


    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.

  16. Predictors of ethical approval and informed consent in orthodontic RCTs.

    Fitzgerald, Rhian C; Burnside, Girvan; Harrison, Jayne E


    Determine the number of orthodontic randomized controlled trials (RCTs) published in four key orthodontic journals from 1 January 2001 to 31 December 2010, whether details about ethical approval (EA) and/or informed consent (IC) were reported and identify predictors for reporting EA and IC in orthodontic RCTs. Retrospective observational study. American Journal of Orthodontics and Dentofacial Orthopedics (AJODO), Angle Orthodontist (AO), European Journal of Orthodontics (EJO) and Journal of Orthodontics (JO) from 2001 to 2010. AJODO, AO, EJO and JO were handsearched to identify all RCTs published from 1 January 2001 to 31 December 2010. The RCTs were assessed to identify: inclusion of details about EA and IC, publication journal, number of authors, number and location of centres involved, perceived statistician involvement, publication year and inclusion of random* in either the title, abstract or body of the text. 218 RCTs were published. 109 (48·6%) had reported both EA and IC, 59 (27·1%) neither and 53 (12·9%) either EA or IC. Factors associated with an RCT reporting obtaining EA and IC: number of authors (Pjournal of publication (P = 0·004) and number of centres (P = 0·008). Logistic regression suggested the most significant indicators of reporting EA and IC were: publication in the JO (P = 0·018), >6 authors (P<0·001), random* in the abstract but not title (P = 0·004) and publication after 2004 (P = 0·001). RCTs were most likely to have reported EA and IC when published in the JO, after 2004 while having more than six authors and random* in the abstract but not title.

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

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


    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.

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

    Ramos, S Raquel; Bakken, Suzanne


    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.

  19. Why we should not seek individual informed consent for participation in health services research.

    Cassell, J; Young, A


    Ethics committees now require that individuals give informed consent to much health services research, in the same way as for clinical research. This is misguided. Existing ethical guidelines do not help us decide how to seek consent in these cases, and have allowed managerial experimentation to remain largely unchecked. Inappropriate requirements for individual consent can institutionalise health inequalities and reduce access to services for vulnerable groups. This undermines the fundamental purpose of the National Health Service (NHS), and ignores our rights and duties as its members, explored here. Alternative forms of community consent should be actively pursued.

  20. Changing constructions of informed consent: qualitative research and complex social worlds.

    Miller, Tina; Boulton, Mary


    Informed consent is a concept which attempts to capture and convey what is regarded as the appropriate relationship between researcher and research participant. Definitions have traditionally emphasised respect for autonomy and the right to self-determination of the individual. However, the meaning of informed consent and the values on which it is based are grounded in society and the practicalities of social relationships. As society changes, so too do the meaning and practice of informed consent. In this paper, we trace the ways in which the meaning and practice of informed consent has changed over the last 35 years with reference to four qualitative studies of parenting and children in the UK which we have undertaken at different points in our research careers. We focus in particular on the shifting boundaries between the professional and personal, and changing expressions of agency and power in a context of heightened perceptions of risk in everyday life. We also discuss developments in information and communication technologies as a factor in changing both the formal requirements for and the situated practicalities of obtaining informed consent. We conclude by considering the implications for informed consent of both increasing bureaucratic regulation and increasingly sophisticated information and communication technologies and suggest strategies for rethinking and managing 'consent' in qualitative research practice.

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

    Pick, Andrew; Gilbert, Kayleigh; McCaul, James


    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.

  2. Video-Assisted Informed Consent for Cataract Surgery: A Randomized Controlled Trial

    Ruan, Xiangcai; Tang, Haoying; Yang, Weizhong; Xian, Zhuanhua; Lu, Min


    Purpose. To investigate whether adding video assistance to traditional verbal informed consent advisement improved satisfaction among cataract surgery patients. Methods. This trial enrolled 80 Chinese patients with age-related cataracts scheduled to undergo unilateral phacoemulsification surgery. Patients were randomized into two groups: the video group watched video explaining cataract-related consent information and rewatched specific segments of the video at their own discretion, before receiving traditional verbal consent advisement; the control group did not watch the video. Outcomes included patient satisfaction, refusal to consent, time to complete the consent process, and comprehension measured by a ten-item questionnaire. Results. All 80 enrolled patients signed informed consent forms. Compared with the control group, members of the video group exhibited greater satisfaction (65% versus 86%, p = 0.035) and required less time to complete the consent process (12.3 ± 6.7 min versus 5.6 ± 5.4 min, p < 0.001), while also evincing levels of comprehension commensurate with those reported for patients who did not watch the video (accuracy rate, 77.5% versus 80.2%, p = 0.386). Conclusion. The video-assisted informed consent process had a positive impact on patients' cataract surgery experiences. Additional research is needed to optimize patients' comprehension of the video. PMID:28191349

  3. On the paradoxes of informed consent: strictness with unlikely risks, tolerance with certain harm

    Carlo Petrini


    Full Text Available The different approaches of two nations to the issues surrounding informed consent by persons with no or limited capacity of understanding are compared. It is important that efforts to ensure formal compliance with consent procedures should not be allowed to distract attention from the risks of harm to individuals.

  4. The Effects of Enhanced Informed Consent in a Pro-Life Pregnancy Counseling Center.

    Mardirosian, Kathryn; And Others


    Investigated effects of enhanced informed consent condition on attitudes of female clients (n=60) toward a counselor, counseling situation, and decision making in a pro-life pregnancy center. Results suggest enhanced consent did not lead to increased or decreased decisions to abort nor to differential attitudes toward counselor or setting.…

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


    Aug 2, 2015 ... research is daunting to the expert and non-expert. We review the ... Without a continuous audit of the study .... You may wish to include a clause about financial ... or -out system that allows participants to tailor their consent, but.

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

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


    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

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

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


    Background 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. Objective 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. Methods 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. Results 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

  8. Informed consent procedures with cognitively impaired patients: A review of ethics and best practices.

    Fields, Lindy Marie; Calvert, James Douglas


    The objectives of this article are to discuss ethical issues of informed consent in cognitively impaired patients and review considerations for capacity determination. We will also discuss how to evaluate capacity, determine competence, and obtain informed consent when a patient is deemed incompetent. This review emphasizes how to carry out informed consent procedures when capacity is questionable and discusses measures supported for use when determining cognitively impaired patients' ability to consent. Information was gathered from medical and psychological codes of ethics, peer-reviewed journals, published guidelines from health-care organizations (e.g., American Medical Association), and scholarly books. Google Scholar and PsycINFO were searched for articles related to 'informed consent' and 'cognitive impairment' published in English between 1975 and 2014. Relevant sources referenced in retrieved publications were subsequently searched and reviewed. We selected 49 sources generated by our search. Sources were included in our review if they presented information related to at least one of our focus areas. These areas included: review of informed consent ethics and procedures, review of cognitive impairment evaluations, recommendations for measuring cognitive capacity, and alternative forms of informed consent. Patients' cognitive impairments can hinder the ability of patients to understand treatment options. Evaluating the capacity of patients with cognitive impairment to understand treatment options is vital for valid informed consent and should be guided by best practices. Thus, proper identification of patients with questionable capacity, capacity evaluation, and determination of competence, as well as reliance upon appropriate alternative consent procedures, are paramount. © 2015 The Authors. Psychiatry and Clinical Neurosciences © 2015 Japanese Society of Psychiatry and Neurology.

  9. The Problem to Consent to the Collection, Use, and Disclosure of Personal Information in Cyberspace

    Thilla Rajaretnam


    Full Text Available 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 transactions. It will argue that consent should not necessarily be sufficient to waive privacy interests, and that the collection, use and/or disclosure of personal information should be subject to regulation.

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

    Roy Tapash


    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.

  11. A computer-based education intervention to enhance surrogates' informed consent for genomics research.

    Shelton, Ann K; Freeman, Bradley D; Fish, Anne F; Bachman, Jean A; Richardson, Lloyd I


    Many research studies conducted today in critical care have a genomics component. Patients' surrogates asked to authorize participation in genomics research for a loved one in the intensive care unit may not be prepared to make informed decisions about a patient's participation in the research. To examine the effectiveness of a new, computer-based education module on surrogates' understanding of the process of informed consent for genomics research. A pilot study was conducted with visitors in the waiting rooms of 2 intensive care units in a Midwestern tertiary care medical center. Visitors were randomly assigned to the experimental (education module plus a sample genomics consent form; n = 65) or the control (sample genomics consent form only; n = 69) group. Participants later completed a test on informed genomics consent. Understanding the process of informed consent was greater (P = .001) in the experimental group than in the control group. Specifically, compared with the control group, the experimental group had a greater understanding of 8 of 13 elements of informed consent: intended benefits of research (P = .02), definition of surrogate consenter (P= .001), withdrawal from the study (P = .001), explanation of risk (P = .002), purpose of the institutional review board (P = .001), definition of substituted judgment (P = .03), compensation for harm (P = .001), and alternative treatments (P = .004). Computer-based education modules may be an important addition to conventional approaches for obtaining informed consent in the intensive care unit. Preparing patients' family members who may consider serving as surrogate consenters is critical to facilitating genomics research in critical care. ©2015 American Association of Critical-Care Nurses.

  12. The role of nonverbal and verbal communication in a multimedia informed consent process.

    Plasek, Joseph M; Pieczkiewicz, David S; Mahnke, Andrea N; McCarty, Catherine A; Starren, Justin B; Westra, Bonnie L


    Nonverbal and verbal communication elements enhance and reinforce the consent form in the informed consent process and need to be transferred appropriately to multimedia formats using interaction design when re-designing the process. Observational, question asking behavior, and content analyses were used to analyze nonverbal and verbal elements of an informed consent process. A variety of gestures, interruptions, and communication styles were observed. In converting a verbal conversation about a textual document to multimedia formats, all aspects of the original process including verbal and nonverbal variation should be one part of an interaction community-centered design approach.

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

    Rodhouse, Toyah; Vanclay, Frank


    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

  14. Informed consent in clinical trials using stem cells: Sugges tions and ...


    Aug 1, 2015 ... Informed consent is an essential requirement of ethical research involving human .... is face with the prospect of closing her business. Therefore, she .... misconceptions), and participants' rights and duties, the patients and.

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

    Vučemilo, Luka; Borovečki, Ana


    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

  16. Impact of informed consent on patient decisions regarding third molar removal.

    Göcmen, G; Atalı, O; Gonul, O; Goker, K


    We investigated whether the order in which patients learned about complication risks affected their anxiety about and willingness to undergo the removal of their third molar. In total, 171 patients (65 males, 106 females) were included in the study. The distributions of gender and the position of mandibular third molars were recorded. The Amsterdam Preoperative Anxiety and Information Scale and Spielberger's State-Trait Anxiety Inventory were used to evaluate anxiety. Associations of anxiety with timing (pre/post), gender, and the order in which the information was presented in the consent form were analyzed. The most common angulations were horizontal (26.3%) and mesioangular (60.2%), and these were more common in women. All patients obtained significantly higher anxiety scores after reading the consent form. There was no significant difference in anxiety scores, according to the order of information. In total, 88 patients underwent surgery, whereas 83 postponed the extraction after reading the consent form. Women were significantly more anxious than men before the procedure. Patients showed lower anxiety levels after the procedure (P anxiety was not associated with the order in which information was presented in the informed consent form. However, the informed consent form itself was a major contributor to increased patient anxiety. Further studies regarding the contents of consent forms and their effects on patient anxiety and decisions regarding third molar removal are needed.

  17. Living Organ Donation and Informed Consent in the United States: Strategies to Improve the Process.

    Henderson, Macey L; Gross, Jed Adam


    About 6,000 individuals participate in the U.S. transplant system as a living organ donor each year. Organ donation (most commonly a kidney or part of liver) by living individuals is a unique procedure, where healthy patients undergo a major surgical operation without any direct functional benefit to themselves. In this article, the authors explore how the ideal of informed consent guides education and evaluation for living organ donation. The authors posit that informed consent for living organ donation is a process. Though the steps in this process are partially standardized through national health policy, they can be improved through institutional structures at the local, transplant center-level. Effective structures and practices aimed at supporting and promoting comprehensive informed consent provide more opportunities for candidates to ask questions about the risks and benefits of living donation and to opt out voluntarily Additionally, these practices could enable new ways of measuring knowledge and improving the consent process.

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

    Lebech, Anne Mette


    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...... to the legal and moral consequences of their anonymity. The child resulting from the artificial procreation, on the contrary, cannot consent to, nor be informed before being conceived, of the secrecy laid on the identity of its genetic parents. Some countries resolve this problem by allowing the children, when...... be regarded as invalid. The paper will argue that a law ensuring the complete anonymity of the parents is disregarding the informed consent and the interests of the children resulting from artificial procreation, and is thus doing more damage to society than good....

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

    Hondras Maria A


    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.

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

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


    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.

  1. The Importance of Purpose: Moving beyond Consent in the Societal Use of Personal Health Information

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


    Background Adoption of electronic health record systems has increased the availability of patient-level electronic health information. Objective Examine public support for secondary uses of electronic health information under different consent arrangements. Design National experimental survey to examine perceptions of uses of electronic health information when varying along three dimensions: patient consent (obtained vs. not obtained), use (research vs. marketing), and framing of the findings (abstract description without results vs. specific results). Setting Nationally representative survey. Participants 3,064 African American, Hispanic, and non-Hispanic White individuals representing a response rate of 65%. Measurements Appropriateness of health information use described in vignettes on a 1-10 scale (1=not at all appropriate; 10=very appropriate). Results 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 where consent was obtained as more appropriate compared to when consent was not obtained (+1.01; 95% CI 0.69, 1.34, P<0.001). Participants rated scenarios where the use was marketing as less appropriate compared to when the use was research (−2.03; 95% CI −2.27, −1.78, P<0.001). Unconsented research uses were seen as more appropriate than consented marketing uses (5.65 vs. 4.52; difference = 1.13; 95% CI 0.87, 1.39).. Limitations Participants rated hypothetical scenarios and results could be vulnerable to non-response bias despite the high response rate. Conclusions Although approaches to health information sharing emphasize consent, public opinion also emphasizes purpose suggesting a need to focus more attention on the social value of information use. Primary Funding Source National Human Genome Research Institute PMID:25506854

  2. Obstetrics and gynaecology residents' knowledge of the informed consent process and its practice in their training institutions.

    Okonta, P I


    The ethical principle of autonomy as expressed in the practice of informed consent is a core tenet of clinical practice and good patient physician relationship. The aim was to identify specific gaps in the knowledge of trainee obstetricians and gynecologists in Nigeria about the informed consent process and its content. It also sought to describe the practice of informed consent in their respective institutions. A survey of Residents in obstetrics and gynecology attending the revision course of the Faculty of obstetrics and gynecology of the national postgraduate medical college was done to determine their knowledge of the informed consent process and its practice in their institutions. None of the residents was able to give responses that contained all five conditions for informed consent to be valid. Furthermore, only 3 (2.22%) Residents mentioned that the name of the surgeon to perform the surgery should be part of the information provided to patients during the informed consent process. Similarly, only 8 (5.93%) mentioned that consequences of not having the surgery should be part of the informed consent process. The concept of the 'emancipated minor' being competent to give consent was known by 38% of the residents. Although Residents in obstetrics and gynecology in Nigeria have some knowledge of the informed consent process, this knowledge is deficient in key areas such as competence to give consent, content and scope of information to be disclosed to patients for surgery. There is a need to teach residents the rudiments of informed consent and bioethics in general.

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

    Cresswell, Pip; Gilmour, Jean


    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.

  4. Paving the way to a more effective informed consent process: Recommendations from the Clinical Trials Transformation Initiative.

    Lentz, Jennifer; Kennett, Michele; Perlmutter, Jane; Forrest, Annemarie


    Ethically sound clinical research requires that prospective study participants provide voluntary informed consent before any study procedures begin. The original intent was to provide the participant with clear, accurate information about study specifics (e.g., risks/benefits) to aid in the decision to participate. Broad consensus among sponsors, research staff, study participants, and advocates indicate that the current process could be improved to enhance participants' understanding of study-related information and meet the needs of individuals. The Clinical Trials Transformation Initiative (CTTI) convened a project to identify problems in the current process and to formulate recommendations for improvement. A literature review, expert interviews, and multi-stakeholder meeting were conducted to identify barriers and develop solutions for a more effective informed consent process. Four key topics were the foundation of the recommendations: 1) defining an effective informed consent process, 2) training research staff, 3) improving the informed consent document, and 4) exploring the use of electronic consent. The ideal informed consent process involves an ongoing, interactive conversation between the participant and knowledgeable, responsive research staff who were trained in best practices. The informed consent process should be supported by a tiered informed consent document that provides critically relevant information to aid in the decision to participate in a study. Adoption of the CTTI informed consent recommendations should lead to a more participant-centric informed consent process. Participant involvement better meets the needs of participants and benefits the clinical trial enterprise by promoting a research culture that encourages informed participation in clinical studies.

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

    Siriwardhana Chesmal


    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.

  6. Informed consent of the critically ill patient and drug therapy: legal aspects

    Riccardo Fresa


    Full Text Available Legal issues concerning the doctor-patient relationship are numerous, and belong to the wider field of professional liability in health care. This article will be dealt with the issues related to informed consent in patients temporarily unable to express consent, or patients who are in a state of temporary incapacity. If the patients are temporarily incapable, and therefore are not able to receive the information nor to express consent to treatment, the physicians’ duty to provide medical treatment and the patients’ self-determination should be considered: the patients can consent or refuse treatment only if able to understand the significance of their decision. If a patient is temporarily unable to give consent and the practitioner doesn’t have at his/her disposal a valid document reporting the patient’s wishes, it’s necessary to rely on the so called “amministratore di sostegno” (introduced in the Italian legal system by Law n. 6 of January 9th, 2004. But in the case of not deferrable treatment, as a lifesaving intervention, the rule is in dubio pro life meaning that a doctor is always legitimized by this situation of urgent need, regardless of the informed consent of the patient and/or third parties.

  7. Informed Consent in Otolaryngologic Surgery: Case Scenario from a Nigerian Specialist Hospital

    O. A. Afolabi


    Full Text Available Informed consent is a foundational concept necessary for ethical conduct of clinical research and practice. It is a technical tool that shifts the autonomy to decide whether a medical procedure should be performed—from the doctor to the patient. However there is an ongoing discussion in bioethical circles on the level of comprehension of the informed consent process by the patients and research participants. We present this case vignette and the discussion afterwards to explore the question of to what extent a patient comprehends the information given to him/her before a surgical procedure is carried out. In other words, the question being asked here is how informed is informed consent in the context of oto-laryngological practice.

  8. Informed consent in physical medicine and rehabilitation. The physician/patient relationship--the doctor as a fiduciary.

    Carlisle, John R


    This article reviews the principle of informed consent and the ethical and legal bases upon which it rests. The process of obtaining an appropriate informed consent is explored, and the elements that make a consent valid are delineated. The principles of substitute decision-making and the special rules applied to circumstances such as emergency, therapeutic privilege, refusal of consent, and medical necessity are discussed. The concept of the relationship between physician and patient as a fiduciary relationship is explored as the fundamental basis for the modern doctrine of informed consent.

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

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


    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.

  10. The informed consent aftermath of the genetic revolution. An Italian example of implementation.

    Artizzu, Federica


    A great part of human genetics research is carried out collecting data and building large databases of biological samples that are in a non-anonymous format. These constitute a valuable resource for future research. The construction of such databases and tissue banks facilitates important scientific progress. However, biobanks have been recognized as ethically problematic because they contain thousands of data that could expose individuals and populations to discrimination, stigmatization and psychological stress if misused. Informed consent is regarded as a cornerstone in the protection of personal autonomy in research involving human subjects. Yet in recent years this fundamental concept has been overwhelmed by the genomic revolution. From a general overview of international literature, it seems evident that informed consent issues have come into sharp focus, in particular in relation to the twin issues of time extension (blanket versus specific/repeated consent) and personal extension (group consent). After an introduction on obtaining informed consent in the context of genetic research, this paper addresses the apparent lack of a single, universal model of obtaining informed consent among populations involved in genetic research and it argues for the need to develop an ethical framework tailored to the specific features of each project. In order to support this theory of contextualizing, the case of a private biotechnology company, SharDNA is presented. The present paper explores the management of its biobank, developed from a genetic research project carried out on isolated populations living on the Italian island of Sardinia. In particular, the paper highlights how the company is tackling the problem of informed consent and other ethical requirements for genetic research, such as the respect of individual privacy, the population approach and the existing Italian legal regulatory framework.

  11. [Informed consent in cardiology. The Committee on Informed Consent of the Commission on Professional Matters of the Sociedad Española de Cardiología].

    de los Reyes López, M; Iñíguez Romo, A; Goicolea de Oro, A; Funes López, B; Castro Beiras, A


    In the last thirty years, the clinical relationship between physicians and patients has been rather modified. There are several factors that have contributed to this change: a) New ways to execute medical practises, specially referred to the development of new techniques; b) Cultural changes in our western society, mainly in the mediterranean area, where there has been progress in the recognition of patients' autonomy to decide about their own lives, health and their own bodies; c) The increasing number of lawsuits, complaints and judgements about the problems that clinical information involves, particularly the informed consent in clinical practise. We consider it necessary to make an extensive and deep discussion from all of the areas in Medicine and Law, to analyze the different ethical and legal parts of the informed consent. For that reason the Spanish Society of Cardiology offers their members a basic document in order to reflect about these facts, developing arguments, justifications and supports. This document has also considered models, conditions to their applicability according to Spanish law, and the experience we have had. Finally, there is a list of diagnostic procedures and interventional practises in cardiology that might be preceded by a written informed consent document. We considered them by the name of Spanish Society of Cardiology recommendations.

  12. Collecting informed consent with juvenile justice populations: issues and implications for research.

    Wolbransky, Melinda; Goldstein, Naomi E S; Giallella, Christy; Heilbrun, Kirk


    Researchers must provide participants with opportunities to make informed decisions about whether to participate in research studies. Investigators conducting research with youth in the juvenile justice system face unique ethical, legal, and practical challenges to obtaining informed consent. Juvenile justice researchers must navigate multiple legal and ethical standards for collecting informed consent, take into account youths' dual vulnerabilities as children and prisoners, and overcome practical limitations to obtaining parental/guardian permission. Given the challenges and complexity of obtaining standard informed consent of youth in juvenile justice facilities, this paper provides suggestions for overcoming obstacles to recruiting these youth for research participation. It offers guidance for fostering the enrollment of juvenile justice youth in research studies using procedures that comply with ethical and legal standards for research with this dually vulnerable population. Copyright © 2013 John Wiley & Sons, Ltd.

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

    Carlo Petrini


    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.

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

    Gitanjali B


    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.

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

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


    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.

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

    Wilson, Maria C I


    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.

  17. Understanding of Essential Elements Required in Informed Consent Form among Researchers and Institutional Review Board Members.

    Koonrungsesomboon, Nut; Laothavorn, Junjira; Karbwang, Juntra


    The process of informed consent remains a constant challenge in clinical research. The aim of the present study was to evaluate the understanding of researchers and members of Institutional Review Boards (IRBs) regarding the essential elements of an Informed Consent Form (ICF) as required by internationally recognized regulations. Using eight case studies to illustrate basic ethical elements, the study involved 107 participants, mainly from the Asia Pacific and African regions. The results showed that most of the participants had general knowledge regarding the essential elements required in an ICF. However, the issues of confidentiality of data and payment for study participation proved to be problematic for some participants, accounting for 35% and 28% of all incorrect answers respectively. This suggests that participants' understanding of the underlying concepts of the required ICF elements is limited. Ethical training of researchers and IRB members, particularly in the Asia Pacific and African regions, concerning valid informed consent is still needed.

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

    Melissa Upjohn


    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.

  19. Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures

    Kinnersley, P.; Phillips, K.; Savage, K.; Kelly, M.J.; Farrell, E.; Morgan, B.; Whistance, R.; Lewis, V.; Mann, M.K.; Stephens, B.L.; Blazeby, J.; Elwyn, G.; Edwards, A.G.


    BACKGROUND: Achieving informed consent is a core clinical procedure and is required before any surgical or invasive procedure is undertaken. However, it is a complex process which requires patients be provided with information which they can understand and retain, opportunity to consider their optio

  20. Innovation, informed consent, health research and the Supreme Court: Montgomery v Lanarkshire - a brave new world?

    Mchale, Jean V


    The Supreme Court decision in Montgomery v Lanarkshire ([2015] UKSC11) has been hailed as a landmark not least because the Court enshrines the doctrine of informed consent formally into English law for the first time in relation to medical treatment. This paper explores the decision in Montgomery. It examines what its implications may be in the future for the consent process in relation to health research and innovative treatment and whether it may prove a watershed moment leading to changing dialogues and expectations in relation to consent. First, the paper explores the concept of 'informed consent' in clinical research as seen through international, Council of Europe and EU instruments. Second, it considers how English law currently governs the provision of information to research participants in the context of clinical research. It questions whether such an approach will be sustainable in the future. Third, it discusses the decision of the UK Supreme Court in Montgomery v Lanarkshire and asks what might be the impact of this Supreme Court decision in the health research context. It asks whether Montgomery may result in new approaches to consent in health research and innovative treatment.


    Milinkovic, Igor; Majstorovic, Biljana


    The principle of informed consent, which requires a patient's fully-informed consent prior to the medical treatment, is closely connected with the value of human dignity. The realization and protection of a patient's dignity is not possible without his/her right to choose the character and scope of medical treatment. This goal cannot be adequately achieved within the traditional model of medical paternalism characterized by the physician's authoritative position. The first part of the article deals with the content and ethical significance of the informed consent doctrine. The legal framework of informed consent in Republic Srpska (RS), one of the two Bosnia and Herzegovina (BH)entities, is analyzed. Special reference is made to the relevance of the informed consent principle within the physical rehabilitation process. Although ethical aspects of physical rehabilitation are often overlooked, this medical field possesses a strong ethical dimension (including an appropriate realization of the patient's right to informed consent).

  2. 10 CFR 727.5 - What acknowledgment and consent is required for access to information on DOE computers?


    ... information on DOE computers? 727.5 Section 727.5 Energy DEPARTMENT OF ENERGY CONSENT FOR ACCESS TO INFORMATION ON DEPARTMENT OF ENERGY COMPUTERS § 727.5 What acknowledgment and consent is required for access to information on DOE computers? An individual may not be granted access to information on a DOE...

  3. Agency and communication challenges in discussions of informed consent in pediatric cancer research.

    Young, Amanda J; Kim, Loel; Shu Li; Baker, Justin N; Schmidt, Michael; Camp, Jonathan W; Barfield, Raymond C


    In this article we examine the discourse of four focus groups we conducted at a pediatric research hospital in which we queried teenage patients, parents, nurses, and physicians about their perceptions of the informed consent process in research. Autonomy, as the goal of informed consent, is a murky concept, with some ethicists questioning the possibility that it can ever be attained. We argue that it might be more productive to consider agency, which we define as language and action that are constructed, negotiated, and maintained through effective communication. Our goal was to understand how individuals rhetorically constructed agency in discussions of informed consent experiences. After transcribing and coding the focus group interviews, we identified six aspects of agency in participants' discourse: (a) defining roles, (b) seeking information, (c) providing information, (d) supporting others, (e) making decisions, and (f) claiming agency for self. Examining these aspects of agency indicated that efforts to improve the informed consent process must address: (a) status differentials, (b) role definitions, (c) information flow, and (d) relationships.

  4. Informed Consent in Research with Children: A Piagetian Approach.

    Nichols, Irene A.; Shauffer, Carole B.

    The ethical codes for experimentation adopted by most professional organizations include references to the requirement that subjects be given at least minimal information about their involvement in research, but are generally silent on the necessity of ascertaining whether or not subjects sufficiently comprehend the information given. For moral,…

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

    丸山, 久美子


    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...

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

    Facio Flavia M


    Full Text Available Abstract Background 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. Discussion 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. Summary 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.

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

    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


    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 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 improve participant knowledge more effectively than text alone. However, the

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

    Eccles Martin P


    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

  9. Obligation of the radiologist to obtain informed consent

    Narr, H.


    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.

  10. An Information Technology Framework for Strengthening Telehealthcare Service Delivery

    Chen, Chi-Wen; Weng, Yung-Ching; Shang, Rung-Ji; Yu, Hui-Chu; Chung, Yufang; Lai, Feipei


    Abstract Objective: Telehealthcare has been used to provide healthcare service, and information technology infrastructure appears to be essential while providing telehealthcare service. Insufficiencies have been identified, such as lack of integration, need of accommodation of diverse biometric sensors, and accessing diverse networks as different houses have varying facilities, which challenge the promotion of telehealthcare. This study designs an information technology framework to strengthen telehealthcare delivery. Materials and Methods: The proposed framework consists of a system architecture design and a network transmission design. The aim of the framework is to integrate data from existing information systems, to adopt medical informatics standards, to integrate diverse biometric sensors, and to provide different data transmission networks to support a patient's house network despite the facilities. The proposed framework has been evaluated with a case study of two telehealthcare programs, with and without the adoption of the framework. Results: The proposed framework facilitates the functionality of the program and enables steady patient enrollments. The overall patient participations are increased, and the patient outcomes appear positive. The attitudes toward the service and self-improvement also are positive. Conclusions: The findings of this study add up to the construction of a telehealthcare system. Implementing the proposed framework further assists the functionality of the service and enhances the availability of the service and patient acceptances. PMID:23061641

  11. Responsible research for the construction of maximally humanlike automata : the paradox of unattainable informed consent

    Miller, Lantz E.


    Since the Nuremberg Code and the first Declaration of Helsinki, globally there has been increasing adoption and adherence to procedures for ensuring that human subjects in research are as well informed as possible of the study’s reasons and risks and voluntarily consent to serving as subject. To do

  12. 10 CFR Appendix A to Part 850 - Chronic Beryllium Disease Prevention Program Informed Consent Form


    ... 10 Energy 4 2010-01-01 2010-01-01 false Chronic Beryllium Disease Prevention Program Informed Consent Form A Appendix A to Part 850 Energy DEPARTMENT OF ENERGY CHRONIC BERYLLIUM DISEASE PREVENTION PROGRAM Pt. 850, App. A Appendix A to Part 850—Chronic Beryllium Disease Prevention Program...

  13. [Ethical issues of human experimentation with special reference to informed consent].

    Saso, L; Silvestrini, B


    Human experimentation in order to develop new medical therapies creates very complex ethical problems: when is it possible to test a new therapy on a human subject? Is it always necessary his/her consent? Which information should be given to the subject before requesting his/her consent? How to behave in the case of minors, psychiatric patients and other subjects not perfectly free or able to understand the information provided? Is it right to subject a person to an experimentation from which he/she will not get any direct advantage? Which results can be published? In other words, which are the ethical limits of human experimentation? These are difficult questions, to which the authors tried to answer referring to some ethically significant human experimentations, such as those performed by Lind and Jenner in the XVIII century, and those carried out by the nazi doctors, from whose trial derived the Nuremberg Code, which introduced for the first time, at an international level, the principle of the informed consent. Some of the limits of this document, including the impossibility of doing research on subjects not able to give their informed consent, such as minors and psychiatric patients, were overcome by the Declaration of Helsinki, whose current version resulted from several subsequent revisions. According to this document, a major role is played by the Institutional Review Boards or Institutional Ethical Committees that have the heavy responsibility of evaluating the ethical connotations of human experimentations.

  14. Dutch dental patients on informed consent: Knowledge, attitudes, self-efficacy and behaviour.

    Schouten, B.; Hoogstraten, J.; Eijkman, M.


    Examined knowledge, attitudes, self-efficacy, and behavior concerning informed consent regarding dental patients. 128 dental patients (mean age 41.7 yrs) completed questionnaires concerning knowledge of and attitudes and behavior toward present status, purpose and risks of treatment, treatment costs

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

    Robeson, Richard; King, Nancy M P


    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.

  16. Information sheets and informed consent forms for clinical study participants: towards standardised recommendations?

    Chassany, Olivier; Bernard-Harlaut, Micheline; Guy, Gilles; Billon, Nathalie


    Subjects taking part in biomedical research must be provided with legible and intelligible information enabling them to freely give their informed consent. At present, sponsors tend to provide many different types of information, not all of which is directly connected with or indeed really informative about studies for those taking part.As a result of this observation, a round table was convened during the Clinical Pharmacology meetings to deliberate on the creation of a charter concerning the drafting of information documents for biomedical research participants as well as a code of good practice for the preparation of such documents.Recommendations were made based on the efforts of the various working groups concerned, such as the French National Conference of Ethics Committees (CNCP), users' representatives, patients associations and the French industrial and institutional sponsors association (CPI), together with proposals contained in the literature.The deliberations of the round table may be subsumed under the following 3 categories and 14 points: 1) Format: design, drafting rules, layout, table of contents, glossary. 2) CONTENT: introductory page, description of the study, risks, benefits. 3) Regulatory aspects: legal aspects, CNIL message (data protection), financial aspects, conflict of interests, model and varied signatures. This document should help make research in France more attractive and it was decided after the Clinical Pharmacology meeting to submit the charter and related documents for approval by the various actors involved: DGS (Direction Générale de la Santé), Afssaps (Agence Française de Sécurité Sanitaire des Produits de Santé), CNCP, CPI and LEEM (Les entreprises du médicament). Once the charter has been validated, it will be made available to Sponsors and Ethics Committees in order to ensure greater uniformity and legibility regarding information given to study subjects.

  17. Informed Consent in Genome-Scale Research: What Do Prospective Participants Think?

    Trinidad, Susan Brown; Fullerton, Stephanie M.; Bares, Julie M.; Jarvik, Gail P.; Larson, Eric B.; Burke, Wylie


    Background To promote effective genome-scale research, genomic and clinical data for large population samples must be collected, stored, and shared. Methods We conducted focus groups with 45 members of a Seattle-based integrated healthcare delivery system to learn about their views and expectations for informed consent in genome-scale studies. Results Participants viewed information about study purpose, aims, and how and by whom study data could be used to be at least as important as information about risks and possible harms. They generally supported a tiered consent approach for specific issues, including research purpose, data sharing, and access to individual research results. Participants expressed a continuum of opinions with respect to the acceptability of broad consent, ranging from completely acceptable to completely unacceptable. Older participants were more likely to view the consent process in relational – rather than contractual – terms, compared with younger participants. The majority of participants endorsed seeking study subjects’ permission regarding material changes in study purpose and data sharing. Conclusions Although this study sample was limited in terms of racial and socioeconomic diversity, our results suggest a strong positive interest in genomic research on the part of at least some prospective participants and indicate a need for increased public engagement, as well as strategies for ongoing communication with study participants. PMID:23493836

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

    Sinoff, Gary


    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.

  19. Informed Consent for Vaginal Delivery: Is It Time to Revisit the Shared Decision-Making Process?.

    Malik, Mokerrum F; Awonuga, Awoniyi O; Iglesia, Cheryl B


    Vaginal delivery as we know it today has evolved, with increasing recognition of trauma to the pelvic floor and perineum. Evolutionary adaptation of the human female pelvis to vaginal deliveries brings with it many benefits, but risks still exist. These benefits and risks should be discussed with patients prior to delivery. Currently, no consensus exists on a standard informed consent process prior to normal vaginal delivery. To synopsize the current literature regarding the ethics of informed consent in the setting of obstetric and gynecological practice, and to make the case for informed consent for vaginal delivery prior to labor. Vaginal birth is still viewed as the default method of delivery. The reason for this is not unrelated to the direct connection between the uterus that holds the fetus before labor, and the vagina, for which the term birth canal was given even before modern obstetrics. Although there are known benefits for advocating vaginal births, there are also attendant risks. It is incumbent on obstetricians and midwives to discuss those risk and benefits with their patient prior to labor. Verbal discussion without documentation may no longer be appropriate due to medical advancements and the litigious health care climate. For this reason, we argue for and advocate that a consent process be included as an educational measure and as part of our ethical obligation to provide care.

  20. Between personal and relational privacy: understanding the work of informed consent in cancer genetics in Brazil.

    Goldim, José Roberto; Gibbon, Sahra


    Drawing from perspectives of both bioethics and anthropology, this article explores how the boundaries between personal and relational privacy are negotiated by patients and practitioners in the context of an emerging domain of cancer genetics in Brazil. It reflects on the place of informed consent in the history of bioethics in North America in contrast to the development of bioethics in Brazil and the particular social cultural context in which consent is sought in Brazilian public health care. Making use of empirical research with families and individuals receiving genetic counselling related to increased genetic risk for cancer, in genetic clinics in southern Brazil, it examines how informed consent is linked to the necessary movement between personal and relational privacy. The paper illustrates the value of a particular tool known as a 'sociogram' to examine the complex interpersonal dynamics that arise in negotiating informed consent at the interface between the family and the individual in Brazil. The paper, therefore, points to the scope of further interdisciplinary exchanges between anthropology and bioethics, confronting the new challenges that arise in the context of medical genetics in developing country.

  1. Effect of a study map intended to support informed consent in transplant research.

    Foradori, Megan A; Nolan, Marie T


    Research participants' informed consent is integral to the protection of human subjects; studies exploring the enhancement of standard informed consent processes have had mixed success in increasing patients' understanding of complex research protocols. To determine the effect of a "study map," a flow diagram of a research protocol, on research participants' understanding of research purpose and procedures. This study was an experimental posttest-only design using 30 research participants enrolling in a study of decision making and recovery among living kidney donors. Participants were randomly assigned to the standard care group (verbal description with consent documents) or the experimental group (standard of care plus study map). An instrument measured perceived and objective understanding, and the differences between groups were determined by an independent t test. The high level of comprehension in the control group made detecting improvements in understanding difficult. Objective knowledge and perceived understanding were positively related, suggesting the importance of periodically confirming comprehension with research participants during the informed consent process. Future research should examine the effect of study maps in patients with lower educational levels. Knowledge levels were high in all participants (mean objective = 3.7 on a 5-point scale, SD = 1.02; mean subjective = 9.3 on a 10-point scale, SD = 1.29). There was a significant relationship between objective knowledge and perceived understanding (r = 0.56, P = .001); however, the study map itself had no significant effect on objective or perceived understanding.

  2. Medical Treatment and Human Experimentation: Introducing Illegality, Fraud, Duress and Incapacity to the Doctrine of Informed Consent

    Foster, Constance B.


    The court held in Kaimowitz v. Department of Mental Health that "involuntarily detained mental patients cannot give informed and adequate consent to experimental psychosurgical procedures on the brain." This note argues that the present theory of informed consent is inadequate for such cases and proposes a new theory. (JT)

  3. Click yes to consent: Acceptability of incorporating informed consent into an internet-based testing program for sexually transmitted and blood-borne infections.

    Gilbert, Mark; Bonnell, Amanda; Farrell, Janine; Haag, Devon; Bondyra, Mark; Unger, David; Elliot, Elizabeth


    Autonomous use of online health care services without interaction with a health care provider challenges existing models for achieving informed consent (IC); current examinations of this issue have focused on commercial direct-to-consumer genetic testing. As IC is integral to publicly funded clinical testing services, we incorporated pre-test concepts necessary for IC in GetCheckedOnline (GCO), British Columbia's online sexually transmitted and blood-borne infection (STBBI) testing service. We assessed the acceptability of this IC step and its design options among potential users during usability testing of GCO. English-speaking participants≥19years were recruited from Craigslist and among provincial STI clinic clients for usability testing of an early version of GCO, which included a consent webpage presenting 8 pre-test statements for review prior to completing testing. Participants were interviewed regarding their acceptability, perceptions, and understanding of the consent page; transcripts were analyzed thematically. We conducted 13 interviews (9 males, 4 females; 9 self-identified as heterosexual; all had previously tested for STBBI). We identified three main themes: i) the meaning of IC (consent page viewed as important and for protection of individual and organization; participants demonstrated varying understandings of specific components); ii) the impact of previous experience on understanding IC (participants understood difference between online and in-person testing; IC concepts were better understood by participants with more testing experience); iii) the role of website design on achieving IC (design of page to disrupt speedy click-throughs was valued and demonstrated seriousness of the consent page). Our careful attention to both content and design of the consent page of GCO was highly valued by potential users of the service, and effective in disrupting routinization of consent on websites. We argue that principles of IC apply equally in online

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

    Loré Cosimo


    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

  5. Informed Consent

    ... Surgery Resident Skills Curriculum ACS/APDS/ASE Resident Prep Curriculum ACS/ASE Medical Student Core Curriculum ACS/ ... Registry Trauma Education Trauma Education Trauma Education Achieving Zero Preventable Deaths Trauma Systems Conference Advanced Surgical Skills ...

  6. Difficult decisions: are intellectually disabled patients given enough information to consent to medical treatment?

    Huneke, Nathan T M; Gupta, Rupa; Halder, Neel; Chaudhry, Nasim


    Patients with learning disabilities are not always involved in decision-making about their medications. This may mean that some patients are unfairly denied of their autonomy. We carried out an audit of current practice concerning consent to treatment in patients with learning disabilities against best practice guidelines. Data were collected via a questionnaire given to a sample of 70 patients with learning disabilities within the Salford catchment area. This questionnaire assessed whether patients were involved in decision-making regarding their medications and whether they were being given enough information to give informed consent. A total of 45 patients completed questionnaires. Overall, the patients' knowledge of their medications was poor, particularly of the proposed duration, possible disadvantages and name of the treatment. It appears that doctors are engaging these patients during consultations and discussing their medications. However, the delivery of this information needs to be improved, and patients' understanding and recall need to be checked more thoroughly.

  7. Use of Multimedia Technology in the Doctor-Patient Relationship for Obtaining Patient Informed Consent.

    Michalski, Andrzej; Stopa, Marcin; Miśkowiak, Bogdan


    Patient informed consent for surgery or for high-risk methods of treatment or diagnosis means that unlawful breach of the patient's personal interests is avoided and the patient accepts the risk of surgery and takes the brunt of it. Patient awareness - their knowledge of the condition and circumstances of continued therapeutic procedure, including offered and available methods of treatment and their possible complications - constitutes a particular aspect of the informed-consent process. The rapid development of technologies and methods of treatment may cause communication problems between the doctor and the patient regarding the scope and method of patient education prior to surgery. The use of multimedia technology (e.g., videos of surgical procedures, computer animation, and graphics), in addition to media used in preoperative patient education, may be a factor in improving the quality of the informed consent process. Studies conducted in clinical centers show that with use of multimedia technology, patients remember more of the information presented. The use of new technology also makes it possible to reduce the difference in the amount of information assimilated by patients with different levels of education. The use of media is a way to improve the quality of preoperative patient education and, at the same time, a step towards their further empowerment in the healing process.

  8. Understanding informed consent and its relationship to the incidence of adverse treatment events in conventional endodontic therapy.

    Selbst, A G


    Forty-three endodontic specialists recorded the occurrence of all adverse treatment events in 3308 consecutive conventional endodontic cases. Statistical analysis confirmed that retreatment cases and mid-treatment referral cases have a greater incidence of adverse treatment events. Since the doctrine of informed consent requires that the doctor inform the patient of reasonably foreseeable consequences of treatment, it is therefore important that the endodontist be cognizant of such events and decide what information is appropriate for disclosure. Since jurisdictional differences exist in the interpretation of what constitutes sufficient informed consent, it is important that local groups investigate the statutes in their state and construct reasonable informed consent documents.

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

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


    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

  10. Simple genetics language as source of miscommunication between genetics researchers and potential research participants in informed consent documents.

    Morgenstern, Justin; Hegele, Robert A; Nisker, Jeff


    Informed consent is based on communication, requiring language to convey meanings and ensure understandings. The purpose of this study was to investigate the use of language in informed consent documents used in the genetics research funded by Canadian Institutes of Health Research and Genome Canada. Consent documents were requested from the principal investigators in a recent round of funding. A qualitative content analysis was performed, supported by NVivo7™. Potential barriers to informed consent were identified, including language that was vague and variable, words with both technical and common meanings, novel phrases without clear meaning, a lack of definitions, and common concepts that assume new definitions in genetics research. However, we noted that difficulties in comprehension were often obscured because the words used were generally simple and familiar. We conclude that language gaps between researcher and potential research participants may unintentionally impair comprehension and ultimately impair informed consent in genomics research. © The Author(s) 2014.

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

    Riden Heather E


    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.

  12. Informed consent for exome sequencing in diagnostics: exploring first experiences and views of professionals and patients.

    Rigter, T; van Aart, C J A; Elting, M W; Waisfisz, Q; Cornel, M C; Henneman, L


    Next-generation sequencing is increasingly being chosen as a diagnostic tool for cases of expected genetic, but unresolved origin. The consequential increased need for decisions on disclosure of unsolicited findings poses a challenge for the informed consent procedure. This study explored the first experiences with, and needs for, the informed consent procedure in diagnostic exome sequencing, with the stakeholders involved. Semi-structured interviews were conducted with 11 professional experts and one professional gave a written response. Furthermore, the counseling process was observed in three cases where exome sequencing was offered, followed by interviews with the patient (representative) and the genetic counselor. The respondents not only preferred an opt-out for unsolicited findings but also identified many challenges and therefore more experiences with exome sequencing was considered needed. Context-dependent decision-making was observed and an Advisory Board for unsolicited findings was considered helpful while doubts were raised about the feasibility and the possibility of undermining patients' autonomy. Finally, respondents brought up the complexity of information provision, and division of responsibilities between clinicians and the lab. These challenges and needs, raised by stakeholders involved, provide more insight in the next steps needed for an optimal informed consent procedure for exome sequencing in diagnostics.

  13. Interpreter accuracy and informed consent among Spanish-speaking families with cancer.

    Simon, Christian M; Zyzanski, Stephen J; Durand, Ellen; Jimenez, Xavier F; Jimenez, Xavier; Kodish, Eric D


    Language interpreters mediate a growing number of health care communication events, including the informed consent process, which underlies the ethical conduct of clinical research. This article explores a key interpretive outcome, accuracy, in 21 Spanish/English informed consent consultations. Discussions were transcribed, translated, and coded according to established techniques. Most (74%) discussion was accurately interpreted (range: 47%-98%; std. deviation: .137). Accuracy was lower in the more technical portions of the discussion when compared with nontechnical portions such as discussion of coping and quality-of-life issues (p = .024). The concept of "randomization" often was poorly communicated and interpreted. These differences may be due in part to the use of long, uninterrupted, and jargon-filled sentences by clinicians explaining research, among other factors. The article concludes that accuracy may be promoted if clinicians used less technical language and shorter sentences, and are more "process driven." Interpreters may need to be better informed about research-related concepts such as randomization. Further research is needed to determine the effects of interpretive accuracy on the informed consent process, the decision to participate in research, and other outcomes.

  14. The Informed Consent in Allergology from a Scientific, Technological and Social Perspective

    Marisela Luisa Pérez Pacaréu


    Full Text Available This paper reviews the application of the informed consent within the specialty of allergology in procedures (skin tests, therapeutic interventions (immunotherapy and research (clinical trials from a scientific, technological and social perspective, based on the advances achieved in Cuba in recent years to obtain better allergenic extracts for testing, high-quality vaccines and new drugs to benefit the allergic patient. It is demonstrated that when applying the informed consent in this specialty, the humanistic social precepts are respected by directing health actions to respect the integrity of the patients against possible risks, offering the option to use immunotherapy and respecting their autonomy in research. It benefits the patients by improving their lifestyles to control the allergic disease, improve their health and quality of life. Furthermore, it promotes social justice by making available these services to the entire population.

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

    Lisa Elizabeth Thomas


    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.

  16. Personal autonomy, good care, informed consent and human dignity--some reflections from a European perspective.

    Hendriks, Aart


    Respecting and protecting personal autonomy requires that autonomy is interpreted in conjunction with the principle of good care in a way consistent with (the aspirations enshrined in) human dignity. This leads to a principled and relational approach towards personal autonomy. This implies an active role of health care providers, as councillors of patients, and a personalised way of obtaining informed consent, to maximally ensure the enjoying personal autonomy.

  17. Perception of the informed consent form by participants in clinical trials

    Meneguin, Silmara [UNESP; Ayres, Jairo Aparecido


    To understand the perception of the participants in controlled clinical trials (CCTs) about the informed consent and describe the meaning of their participation in the research. Qualitative study using the focus group technique. The sample was composed of 19 patients who participated in clinical trials about hypertension and coronary disease in a specialized cardiologic hospital located in the city of Sao Paulo. The methodological framework used was the content analysis. Some of the participa...

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



    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.

  19. Talking more about talking cures: cognitive behavioural therapy and informed consent.

    Blease, C R


    Cognitive behavioural therapy (CBT) has risen to prominence as an orthodox treatment option which is commonly recommended to patients with anxiety and depressive disorders. Mainstream healthcare institutions (including the National Health Service in the UK (NHS) and National Institute for Mental Health (NIMH)) assume that CBT works by helping patients to challenge and overcome 'faulty cognition'. Even if we accept the empirical evidence which shows that CBT (like other forms of psychotherapy) is a beneficial treatment there are still problems with this therapy: mainstream medicine and psychotherapy are continuing to ignore established research that CBT does not work according to its core theoretical tenets. This paper presents evidence that psychotherapy is entrenched in such conventional 'wisdom' and that practitioners are failing to meet their own codified requirement of informed consent. I examine ethical arguments for and against upholding current informed consent procedures and focus, in particular, on the relationship between respect for patient autonomy and the duty of beneficence. I argue that (so far) there are no strong grounds for the claim that patient autonomy undermines therapeutic outcome. The modest conclusion of this paper is that psychotherapy (including CBT) needs to begin to adapt informed consent procedures to comply with ongoing scientific research into its efficacy.

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

    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

  1. Development of an electronic research permissions management system to enhance informed consents and capture research authorizations data.

    Obeid, Jihad S; Gerken, Katherine; Madathil, Kapil Chalil; Rugg, Daniel; Alstad, Colin E; Fryar, Katrina; Alexander, Randall; Gramopadhye, Anand K; Moskowitz, Jay; Sanderson, Iain C


    Informed consents are a critical and essential component of the clinical research process. Currently, most consents and research privacy authorizations are being captured on paper. In this paper we describe a novel method of capturing this information electronically. The objective is to allow easier tracking of research participants' intent for current and future research involvement, enhance consent comprehension and facilitate the research workflow. After multidisciplinary analysis in key hospital registration areas and research participant enrollment, an open source software product was designed to capture this data through a user-friendly touch screen interface. The data may then be fed into a clinical data warehouse for use in cohort discovery or consent tracking. Despite ethical, legal and informatics challenges in clinical and research environments, we propose that this technology opens new avenues for significantly enhancing the consent process and positively impacting recruitment.

  2. Educational and interactive informed consent process for treatment of unruptured intracranial aneurysms.

    Park, Jaechan; Son, Wonsoo; Park, Ki-Su; Kang, Dong-Hun; Lee, Joomi; Oh, Chang Wan; Kwon, O-Ki; Kim, Taesun; Kim, Chang-Hyun


    OBJECTIVE For patients with unruptured intracranial aneurysms (UIAs), the information transfer that precedes informed consent needs to be in-depth and detailed, as most patients with a UIA have no symptoms, yet the risks related to treatment are relatively high. Thus, in this study an educational and interactive program was proposed for patients with UIAs to improve the informed consent process and assess the level of comprehension. METHODS A total of 110 patients with UIAs underwent the proposed educational and interactive informed consent (EIIC) process and were enrolled in this study. The EIIC process combines patient education using information booklets, a cartoon book, a video, an initial physician-patient interview, answering a questionnaire, a second physician-patient interview based on the questionnaire results, and finally consent. After the first physician-patient interview that provides the patient with specific information, including his or her angiographic characteristics, medical condition, and recommended treatment, the patient is requested to answer a questionnaire composed of 3 parts: demographic information, including the patient's age, sex, and years of education; 13 medical questions to assess the patient's knowledge about his or her UIA; and an evaluation of the usefulness of the educational resources. The control group consisted of 65 patients from 3 other tertiary university hospitals where the EIIC process was not used. RESULTS The questionnaire scores of the EIIC group ranged from 7 to 13 (mean ± SD: 11.9 ± 1.3) and were significantly higher than those for the controls (10.2 ± 1.9, p education and the questionnaire score (p = 0.015 for the EIIC group, p educational method, while the most effective reinforcement of this verbal communication was the video (n = 86; 78.2%), information booklets (n = 16; 14.5%), the Internet (n = 7; 6.4%), and the cartoon book (n = 1; 0.9%). CONCLUSIONS The proposed standardized EIIC process resulted in good

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

    Satish Chandrasekhar Nair


    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.

  4. Informed consent for emergency surgery--how much do parents truly remember?

    Li, Fay Xiangzhen; Nah, Shireen Anne; Low, Yee


    The purpose of this study was to evaluate parental retention of possible surgical complications in children undergoing emergency laparoscopic appendectomy. A prospective pilot study involving parents whose children had emergency laparoscopic appendectomy was performed. Parents were counseled regarding 7 potential complications of laparoscopic appendectomy. They were asked to recall this list immediately after the consent process (immediate recall, IR) and before discharge from inpatient stay (delayed recall, DR). A score (0-7) was awarded indicating the number of correct answers. For each recall, parents were also reminded on complications they omitted (prompted recall). One surgeon administered all consents in person. Demographic data were collected. Data were reported as median (range). Twenty-one mothers and 10 fathers were recruited, aged 42 years (30-54). Nine (29%) had university or post-graduate education. Score for IR was 2 (0-6). Five (16%) parents scored 0. Upon prompting after IR, 20 (65%) parents had no impression of at least 1 complication. Score for DR was 2 (0-7), while 7 (23%) parents scored 0. At prompting after DR, 25 (81%) had no memory of at least one complication. Eight (26%) demonstrated improved DR scores. Scores were not affected by patient demographics or time between interviews. There is poor parental retention of information provided during operative consent. Hence, proper documentation of this process is essential. Copyright © 2014 Elsevier Inc. All rights reserved.

  5. Event-based versus process-based informed consent to address scientific evidence and uncertainties in ionising medical imaging.

    Recchia, Virginia; Dodaro, Antonio; Braga, Larissa


    Inappropriate ionising medical imaging has been escalating in the last decades. This trend leads to potential damage to health and has been associated to bioethical and legal issues of patient autonomy. While the doctrine underlines the importance of using informed consent to improve patient autonomy and physician-patient communication, some researchers have argued that it often falls short of this aim. There are basically two different informed consent practices. The first - the so-called "event-based model" - regards informed consent as a passive signature of a standard unreadable template, performed only once in each medical pathway. The second - the so-called "process-based model" - integrates information into the continuing dialogue between physician and patient, vital for diagnosis and treatment. Current medical behaviour often embraces the event-based model, which is considered ineffective and contributes to inappropriateness. We sought, in this review, to analyse from juridical and communication standpoints whether process-based informed consent can deal with scientific uncertainties in radiological decision-making. The informed consent is still a distinctive process in defence of both patients' and physicians' health and dignity in rule-of-law states and consequently in curtailing the abuse of ionising medical radiation. • Inappropriate ionising medical imaging is widespread and increasing worldwide. • This trend leads to noteworthy damage to health and is linked to the issue of patient autonomy. • Some authors have argued that informed consent often falls short of improving patient autonomy. • Process-based informed consent can deal with scientific uncertainties to contrast inappropriateness. • Informed consent is still a distinctive process in defence of both patients and physicians.

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

    Abraar Karan


    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.

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

    Tanderup, Malene; Reddy, Sunita; Patel, Tulsi;


    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...

  8. Informed consent in implantable BCI research: identification of research risks and recommendations for development of best practices

    Klein, Eran; Ojemann, Jeffrey


    Objective. Implantable brain-computer interface (BCI) research promises improvements in human health and enhancements in quality of life. Informed consent of subjects is a central tenet of this research. Rapid advances in neuroscience, and the intimate connection between functioning of the brain and conceptions of the self, make informed consent particularly challenging in BCI research. Identification of safety and research-related risks associated with BCI devices is an important step in ensuring meaningful informed consent. Approach. This paper highlights a number of BCI research risks, including safety concerns, cognitive and communicative impairments, inappropriate subject expectations, group vulnerabilities, privacy and security, and disruptions of identity. Main results. Based on identified BCI research risks, best practices are needed for understanding and incorporating BCI-related risks into informed consent protocols. Significance. Development of best practices should be guided by processes that are: multidisciplinary, systematic and transparent, iterative, relational and exploratory.

  9. The readability of information and consent forms in clinical research in France.

    Véronique Ménoni

    Full Text Available BACKGROUND: Quantitative tools have been developed to evaluate the readability of written documents and have been used in several studies to evaluate information and consent forms. These studies all showed that such documents had a low level of readability. Our objective is to evaluate the readability of Information and Consent Forms (ICFs used in clinical research. METHODS AND FINDINGS: Clinical research protocols were collected from four public clinical research centers in France. Readability was evaluated based on three criteria: the presence of an illustration, the length of the text and its Flesch score. Potential effects of protocol characteristics on the length and readability of the ICFs were determined. Medical and statutory parts of the ICF form were analyzed separately. The readability of these documents was compared with that of everyday contracts, press articles, literary extracts and political speeches. We included 209 protocols and the corresponding 275 ICFs. The median length was 1304 words. Their Flesch readability scores were low (median: 24, and only about half that of selected press articles. ICF s for industrially sponsored and randomized protocols were the longest and had the highest readability scores. More than half (52% of the text in ICFs concerned medical information, and this information was statistically (p<0.05 more readable (Flesch: 28 than statutory information (Flesch: 21. CONCLUSION: Regardless of the field of research, the ICFs for protocols included had poor readability scores. However, a prospective analysis of this test in French should be carried out before it is put into general use.

  10. Confidence in outcome estimates from systematic reviews used in informed consent.

    Fritz, Robert; Bauer, Janet G; Spackman, Sue S; Bains, Amanjyot K; Jetton-Rangel, Jeanette


    Evidence-based dentistry now guides informed consent in which clinicians are obliged to provide patients with the most current, best evidence, or best estimates of outcomes, of regimens, therapies, treatments, procedures, materials, and equipment or devices when developing personal oral health care, treatment plans. Yet, clinicians require that the estimates provided from systematic reviews be verified to their validity, reliability, and contextualized as to performance competency so that clinicians may have confidence in explaining outcomes to patients in clinical practice. The purpose of this paper was to describe types of informed estimates from which clinicians may have confidence in their capacity to assist patients in competent decision-making, one of the most important concepts of informed consent. Using systematic review methodology, researchers provide clinicians with valid best estimates of outcomes regarding a subject of interest from best evidence. Best evidence is verified through critical appraisals using acceptable sampling methodology either by scoring instruments (Timmer analysis) or checklist (grade), a Cochrane Collaboration standard that allows transparency in open reviews. These valid best estimates are then tested for reliability using large databases. Finally, valid and reliable best estimates are assessed for meaning using quantification of margins and uncertainties. Through manufacturer and researcher specifications, quantification of margins and uncertainties develops a performance competency continuum by which valid, reliable best estimates may be contextualized for their performance competency: at a lowest margin performance competency (structural failure), high margin performance competency (estimated true value of success), or clinically determined critical values (clinical failure). Informed consent may be achieved when clinicians are confident of their ability to provide useful and accurate best estimates of outcomes regarding

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

    Carpeggiani, Clara; Picano, Eugenio


    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.

  12. Integrating Information and Communication Technology for Health Information System Strengthening: A Policy Analysis.

    Marzuki, Nuraidah; Ismail, Saimy; Al-Sadat, Nabilla; Ehsan, Fauziah Z; Chan, Chee-Khoon; Ng, Chiu-Wan


    Despite the high costs involved and the lack of definitive evidence of sustained effectiveness, many low- and middle-income countries had begun to strengthen their health information system using information and communication technology in the past few decades. Following this international trend, the Malaysian Ministry of Health had been incorporating Telehealth (National Telehealth initiatives) into national health policies since the 1990s. Employing qualitative approaches, including key informant interviews and document review, this study examines the agenda-setting processes of the Telehealth policy using Kingdon's framework. The findings suggested that Telehealth policies emerged through actions of policy entrepreneurs within the Ministry of Health, who took advantage of several simultaneously occurring opportunities--official recognition of problems within the existing health information system, availability of information and communication technology to strengthen health information system and political interests surrounding the national Multimedia Super Corridor initiative being developed at the time. The last was achieved by the inclusion of Telehealth as a component of the Multimedia Super Corridor.

  13. Factors associated with nurses' opinions and practices regarding information and consent.

    Ingravallo, Francesca; Gilmore, Emma; Vignatelli, Luca; Dormi, Ada; Carosielli, Grazia; Lanni, Luigia; Taddia, Patrizia


    This cross-sectional survey aimed to investigate nurses' opinions and practices regarding information and consent in the context of a large Italian teaching hospital and to explore potential influences of gender, age, university education, length of professional experience, and care setting. A questionnaire was administered to 282 nurses from six different care settings (Emergency Room, Emergency Medicine, Surgery, Hematology-Oncology, Geriatrics, and Internal Medicine). Overall, 84% (n = 237) of nurses returned the questionnaire (men: 24%; mean age: 36.2 ± 8 years; university degree: 35%; mean length of professional experience: 12 ± 8.2 years). Most respondents regularly informed patients about medications and nursing procedures and asked for consent prior to invasive procedures, but some provided information to relatives instead of patients. Lack of time or opportunity was the main difficulty in informing patients. The work setting was the foremost factor significantly associated with participants' opinions and practices. Further investigations are needed to confirm these findings in similar and other care settings.

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

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


    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

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

    Abelson Julia


    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

  16. Legislation and informed consent brochures for dental patients receiving amalgam restorations.

    Edlich, Richard F; Cochran, Amy A; Cross, Catherine L; Wack, Courtney A; Long, William B; Newkirk, Anthony T


    In 2008, Norway banned the use of mercury for amalgam restorations. Four states in the United States have developed Informed Consent Brochures for amalgam restorations that must be given to their dental patients. The authors describe a patient who had a large cavity in his left lower molar tooth no.18 that had to be removed by an oral surgeon. When the patient went to the oral surgeon, the surgeon told the patient that he would replace the carious tooth with a gold implant. He was not given an Informed Consent Brochure regarding dental restorative materials. The oral surgeon extracted the carious tooth, replacing the tooth with a supposed gold crown implant. On his yearly dental examination, his dentist took an x-ray of his dental implant and explained that the x-ray could not distinguish whether the implant contained either gold or mercury. Consequently, the dentist referred him to a dental clinic in which the dental implant could be removed without mercury contamination of the patient's neurologic system during the extraction of the implant from the root canal. During the removal of the dental restoration, the dentist found build up expanding into the root canal that had a black color. The crown and underlying tooth were sent to ALT BioScience for analysis. Elemental analysis of the crown and underlying tooth confirmed the presence of mercury in the restoration. The patient should have been given an Informed Consent Brochure by the dentist that described the dental restoration that was used in the dental implant.

  17. Patients' perception of quality of pre-operative informed consent in athens, Greece: a pilot study.

    Matthew E Falagas

    Full Text Available BACKGROUND: We sought to perform a study to record and evaluate patients' views of the way surgeons communicate informed consent (IC in Greece. METHODOLOGY/PRINCIPAL FINDINGS: A prospective pilot study was carried out in Athens from 9/2007 to 4/2008. The study sample was extracted from patients, operated by eight different surgeons, who volunteered to fill in a post-surgery self-report questionnaire on IC. A composite delivered information index and a patient-physician relationship index were constructed for the purposes of the analysis. In total, 77 patients (42 males volunteered to respond to the questionnaire. The delivered information index scores ranged from 3 to 10, the mean score was 8, and the standard deviation (SD was 1.9. All patients were aware of their underlying diagnosis and reason for surgery. However, a considerable proportion of the respondents (14.3% achieved a score below or equal to 5. The patient-physician relationship scores ranged from 0 to 20, the mean score was 16 and the standard deviation (SD was 4.3. The better the patient-physician relationship, the more information was finally delivered to the patient from the physician (Spearman's rank-order correlation coefficient was 0.4 and p<0.001. Delivered information index was significantly higher among participants who comprehended the right to informed consent, compared to participants who did not (p<0.001, and among participants who were given information regarding other possible therapeutic options (p = 0.001. 43% of the respondents answered that less than 10 minutes were spent on the consent process, 58.4% of patients stated that they had not been informed about other possible therapeutic choices and 28.6% did not really comprehend their legal rights to IC. CONCLUSIONS: Despite the inherent limitations and the small sample size that do not permit to draw any firm conclusions, results indicate that a successful IC process may be associated with specific elements such as

  18. Informed consent in the ethics of responsibility as stated by Emmanuel Levinas.

    Benito, Javier Jiménez; García, Sonia Ester Rodríguez


    In this paper we analyze some of the major difficulties of informed consent (IC). We consider insufficient to base IC on the principle of autonomy. We must not forget that the patient may be in a situation of extreme vulnerability and the good doctor should assume a degree of commitment and responsibility with his/her decisions. Our aim is to introduce the ethics of responsibility of Levinas in practice and theory of IC in order to generate a beneficent medical practice in which the supervision and overseeing of the patient do not undermine his/her autonomy.

  19. Joint Information Environment: DOD Needs to Strengthen Governance and Management


    implementing JRSS to enable the single security architecture. The effort, which is managed by the Defense Information Systems Agency (DISA), involves...18Defense Information Systems Agency, Information Services Acquisition Oversight and Management , DISA Instruction 610-225-2 (Feb. 19, 2015) and...24Defense Information Systems Agency, Information Services Acquisition Oversight and Management , DISA Instruction

  20. Using media to improve the informed consent process for youth undergoing pediatric endoscopy and their parents

    Yeh, Debra M.; Chun, Stanford; Terrones, Laura; Huang, Jeannie S.


    Background and study aims Youth undergoing pediatric endoscopic procedures and their parents demonstrate suboptimal comprehension of the informed consent (IC) process. We developed informational videos discussing key IC elements for pediatric endoscopy and evaluated their effects on youth and parental comprehension of the IC process. Patients and methods A randomized controlled trial of the video intervention was performed among youth undergoing endoscopy and their parents at an academic children’s hospital. Randomization occurred at the time of enrollment using permutated blocks. Following the IC process with the proceduralist, subjects underwent structured interviews to assess IC comprehension. An Informed Consent Overall Score (ICOS: range 0 – 4) for comprehension was calculated. Results Seventy-seven pairs of children and their parents participated. Intervention recipients (N = 37 pairs) demonstrated higher ICOS scores as compared to control counterparts (mean (standard deviation): 3.6 (0.7) v. 2.9 (0.9), intervention v. control parents, P < 0.0001 and 2.7 (1.1) v. 1.7 (1.1), intervention v. control youth, P < 0.0001). Conclusions A media intervention addressing key elements of the IC process for pediatric endoscopy was effective in improving comprehension of IC for youth undergoing endoscopic procedures and their parents. PMID:28191495

  1. Readability of informed consent documents (1987-2007) for clinical trials: a linguistic analysis.

    Sand, K; Eik-Nes, N L; Loge, J H


    We investigated the readability of informed consent documents linguistically and compared old and new ICDs. Twenty ICDs (ten from 1987-1992 and ten from 2006-2007) were included. The Evaluative Linguistic Framework (ELF) was used to analyze the texts. The ELF evaluates the following items: main themes, order of themes, rhetorical functions, the relationship between reader and writer, metadiscourse, headings, expert terminology, and visual aspects. An ICD is considered readable if it achieves the goal of inviting the reader to participate and explaining the implication of participation. The new ICDs were more readable than the old ones, as they were more oriented towards research, contained instructions about how to consent, and provided clear contact information. Aspects that reduced the readability of the new ICDs were the large number of topics, details, and actors presented. The readability of the old ICDs was enhanced by fewer topics, a clear presentation of the involved actors, and brevity. However, their readability was reduced by the inclusion of a vast amount of information about the reader's diagnosis and treatment.


    Iñigo de la Maza Gazmuri


    Full Text Available Como requisito de una actuación médica, el consentimiento informado es un asunto determinante, complejo y fuertemente debatido. En contraste con lo que suele suceder en el derecho comparado, en Chile carecemos de una ley que establezca como requisito de las ctuaciones médicas la obtención del consentimiento informado. Igualmente, no disponemos de una jurisprudencia significativa al respecto. Finalmente, tampoco se trata de un tema que haya llamado particularmente la atención de la doctrina nacional. El objetivo de este trabajo consiste en presentar de una forma sinóptica el consentimiento informado, sus fundamentos y algunas de las principales discusiones que tienen lugar en torno a él.Informed consent is a key complex and strongly debated, issue in medical liability In contrast to many other countries, in the Chilean case we lack a statute that requires health professionals to provide material information to patients in order to allow them to fully exercises their autonomy We also lack a significant corpus of judicial decisions in this regará, and, finally Chilean scholars have not devoted their best efforts to develop the topic. The aim of this work is to provide a synoptic view of informed consent, its justif¡catión and some of the most debated issues about it.

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

    Doudenkova, Victoria; Bélisle Pipon, Jean-Christophe


    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.

  4. Perceptions of Medical Students and Professors Regarding the Free Informed Consent Form and Humanization

    Angela Maria Moreira Canuto


    Full Text Available The aim of this study was to gather information on the perception of the free informed consent form (FICF and humanization among a population of medical students and professors of medicine. A total of 35 professors of medicine and 56 medical students took part in this study by answering an electronic survey. The collected data were subjected to content analysis using ALCESTE software. The analysis revealed the existence of three different classes: Class 1 designated the “FICF as a guarantee of rights in research”; Class 2 designated the “FICF as informative regarding research procedures”; and Class 3 designated “humanization as a necessary process.” The results show a preferential association of the FICF with research, rather than medical care. There was a consensus regarding the importance of humanization; however, a need to increase knowledge of and the possibilities for implementing both the FICF and humanization was also indicated

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

    Galán Gutiérrez, J C; Galán Cortés, J C


    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.

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

    N. Demosthenous


    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.

  7. Increased Access to Professional Interpreters in the Hospital Improves Informed Consent for Patients with Limited English Proficiency.

    Lee, Jonathan S; Pérez-Stable, Eliseo J; Gregorich, Steven E; Crawford, Michael H; Green, Adrienne; Livaudais-Toman, Jennifer; Karliner, Leah S


    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

  8. Medical Comics as Tools to Aid in Obtaining Informed Consent for Stroke Care.

    Furuno, Yuichi; Sasajima, Hiroyasu


    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.

  9. Informed consent in human subject research: a comparison of current international and Nigerian guidelines.

    Fadare, Joseph O; Porteri, Corinna


    Informed consent is a basic requirement for the conduct of ethical research involving human subjects. Currently, the Helsinki Declaration of the World Medical Association and the International Ethical Guidelines for Biomedical Research of the Council for International Organizations of Medical Sciences (CIOMS) are widely accepted as international codes regulating human subject research and the informed consent sections of these documents are quite important. Debates on the applicability of these guidelines in different socio-cultural settings are ongoing and many workers have advocated the need for national or regional guidelines. Nigeria, a developing country, has recently adopted its national guideline regulating human subject research: the National Health Research Ethics Committee (NHREC) code. A content analysis of the three guidelines was done to see if the Nigerian guidelines confer any additional protection for research subjects. The concept of a Community Advisory Committee in the Nigerian guideline is a novel one that emphasizes research as a community burden and should promote a form of "research friendship" to foster the welfare of research participants. There is also the need for a regular update of the NHREC code so as to address some issues that were not considered in its current version.

  10. Informed Consent as a Litigation Strategy in the Field of Aesthetic Surgery: An Analysis Based on Court Precedents


    Background In an increasing number of lawsuits doctors lose, despite providing preoperative patient education, because of failure to prove informed consent. We analyzed judicial precedents associated with insufficient informed consent to identify judicial factors and trends related to aesthetic surgery medical litigation. Methods We collected data from civil trials between 1995 and 2015 that were related to aesthetic surgery and resulted in findings of insufficient informed consent. Based on these data, we analyzed the lawsuits, including the distribution of surgeries, dissatisfactions, litigation expenses, and relationship to informed consent. Results Cases were found involving the following types of surgery: facial rejuvenation (38 cases), facial contouring surgery (27 cases), mammoplasty (16 cases), blepharoplasty (29 cases), rhinoplasty (21 cases), body-contouring surgery (15 cases), and breast reconstruction (2 cases). Common reasons for postoperative dissatisfaction were deformities (22%), scars (17%), asymmetry (14%), and infections (6%). Most of the malpractice lawsuits occurred in Seoul (population 10 million people; 54% of total plastic surgeons) and in primary-level local clinics (113 cases, 82.5%). In cases in which only invalid informed consent was recognized, the average amount of consolation money was KRW 9,107,143 (USD 8438). In cases in which both violation of non-malfeasance and invalid informed consent were recognized, the average amount of consolation money was KRW 12,741,857 (USD 11,806), corresponding to 38.6% of the amount of the judgment. Conclusions Surgeons should pay special attention to obtaining informed consent, because it is a double-edged sword; it has clinical purposes for doctors and patients but may also be a litigation strategy for lawyers. PMID:27689046

  11. The placebo phenomenon and medical ethics: rethinking the relationship between informed consent and risk-benefit assessment.

    Miller, Franklin G; Colloca, Luana


    It has been presumed within bioethics that the benefits and risks of treatments can be assessed independently of information disclosure to patients as part of the informed consent process. Research on placebo and nocebo effects indicates that this is not true for symptomatic treatments. The benefits and risks that patients experience from symptomatic treatments can be shaped powerfully by information about these treatments provided by clinicians. In this paper we discuss the implications of placebo and nocebo research for risk-benefit assessment and informed consent.

  12. What physicians think about the need for informed consent for communicating the risk of cancer from low-dose radiation

    Karsli, Tijen [Children' s Healthcare of Atlanta, Atlanta, GA (United States); University of Tennessee, Pediatric Intensive Care, Memphis, TN (United States); Kalra, Mannudeep K. [Children' s Healthcare of Atlanta, Department of Radiology, Atlanta, GA (United States); Massachusetts General Hospital, Department of Radiology, Boston, MA (United States); Self, Julie L.; Rosenfeld, Jason Anders; Butler, Susan [Emory University, Department of Behavioral Sciences and Health Education, Atlanta, GA (United States); Simoneaux, Stephen [Children' s Healthcare of Atlanta, Department of Radiology, Atlanta, GA (United States)


    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

  13. How informed is consent in vulnerable populations? Experience using a continuous consent process during the MDP301 vaginal microbicide trial in Mwanza, Tanzania

    Kavit Natujwa


    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


    Achmad Djuhamsa


    Full Text Available ENSICNET-Indonesia provides dissemination of information on the field of water supply and sanitation to potential users by using different methods which depend on their own function and duty. Linkage mechanisms are developed to make users aware of the sources, to identify and define user n~eds and to make the contact 'between the user need and the information sources. Several forms of communication which can link information resources to an individual or groups are disscussed.

  15. Strengthening rural information infrastructure through e-Choupals

    Das, Anup Kumar; Dutta, Chaitali


    Apart from government and developmental agencies’ initiatives, rural information infrastructure develops in some parts of India through corporate initiatives. Some electronic information facilitation centers have been established to cater to the information needs of the farmers at their doorsteps in villages. One of them is e-Choupal system, conceived by the ITC Limited. It serves a dual purpose, as an Internet kiosk and as an alternative village mandi system. There are some pros and cons for...

  16. Informed consent in clinical research; Do patients understand what they have signed?

    Elena Villamañán


    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

  17. Informed consent in clinical research; Do patients understand what they have signed?

    Villamañán, Elena; Ruano, Margarita; Fernández-de Uzquiano, Enma; Lavilla, Paz; González, Diana; Freire, Mercedes; Sobrino, Carmen; Herrero, Alicia


    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.

  18. Information, consent and treatment of patients with Morgellons disease: an ethical perspective.

    Söderfeldt, Ylva; Groß, Dominik


    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.

  19. [Global analysis of the readability of the informed consent forms used in public hospitals of Spain].

    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.

  20. Incorporating a quiz into informed consent processes: Qualitative study of participants' reactions

    Marsh Vicki


    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.

  1. Email-Based Informed Consent: Innovative Method for Reaching Large Numbers of Subjects for Data Mining Research

    Lee, Lesley R.; Mason, Sara S.; Babiak-Vazquez, Adriana; Ray, Stacie L.; Van Baalen, Mary


    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

  2. Chronicles of communication and power: informed consent to sterilisation in the Namibian Supreme Court's LM judgment of 2015.

    Chingore-Munazvo, Nyasha; Furman, Katherine; Raw, Annabel; Slabbert, Mariette


    The 2015 judgment of the Namibia Supreme Court in Government of the Republic of Namibia v LM and Others set an important precedent on informed consent in a case involving the coercive sterilisation of HIV-positive women. This article analyses the reasoning and factual narratives of the judgment by applying Neil Manson and Onora O'Neill's approach to informed consent as a communicative process. This is done in an effort to understand the practical import of the judgment in the particular context of resource constrained public healthcare facilities through which many women in southern Africa access reproductive healthcare. While the judgment affirms certain established tenets in informed consent to surgical procedures, aspects of the reasoning in context demand more particularised applications of what it means for a patient to have capacity and to be informed, and to appropriately accommodate the disruptive role of power dynamics in the communicative process.

  3. Information and consent in internet paternity testing: focus on minors' protection in Italy.

    Caenazzo, Luciana; Tozzo, Pamela; Benciolini, Paolo; Rodriguez, Daniele


    Paternity testing in Italy is usually performed by private laboratories and universities having direct contacts with the applicants. Recently, the number of paternity tests offered through laboratory websites has increased in Italy and Europe. The execution of genetic tests, including paternity testing based on DNA analysis, represents a complex act, which contains three main steps. Paternity analyses carried out by laboratories via Internet are performed on samples collected by the applicants and then mailed back to the laboratories without any patient-physician relationship. Information is given to the subjects through the laboratory's website or mailed with the test order form. The execution of "household" DNA analysis without technical precautions may provide an incorrect response with severe consequences on the individual who has undergone testing, on the family involved, and on society in general. The problems connected with this kind of analysis are not technical, but ethical and deontological. In this work, we will discuss the problems related to information and consent by way of outlining the relevant Italian laws and codes of medical ethics. The Italian Privacy's Guarantor is assessing the ethical and legal implications, but regulations are not yet in place. We believe that adequate information related to this practice cannot be given via Internet, and, consequently, the validity of the consent expressed during this kind of procedure can be uncertain. Further, we will analyze issues regarding the importance of minors' protection when a paternity test is performed via Internet. In our opinion, the complexity of the situations and expectations linked to paternity investigations require a special sensitivity in dealing with each case, based on a patient-physician relationship in the decision-making process especially referring to the defense of the minors' well-being.

  4. [eHealth in Peru: implementation of policies to strengthen health information systems].

    Curioso, Walter H


    Health information systems play a key role in enabling high quality, complete health information to be available in a timely fashion for operational and strategic decision-making that makes it possible to save lives and improve the health and quality of life of the population. In many countries, health information systems are weak, incomplete, and fragmented. However, there is broad consensus in the literature of the need to strengthen health information systems in countries around the world. The objective of this paper is to present the essential components of the conceptual framework to strengthen health information systems in Peru. It describes the principal actions and strategies of the Ministry of Health of Peru during the process of strengthening health information systems. These systems make it possible to orient policies for appropriate decision-making in public health.

  5. Are women who are taking Hormone Replacement Therapy doing so with informed consent?

    Mitchell, E.M


    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.

  6. Community engagement and informed consent in the International HapMap project.

    Rotimi, Charles; Leppert, Mark; Matsuda, Ichiro; Zeng, Changqing; Zhang, Houcan; Adebamowo, Clement; Ajayi, Ike; Aniagwu, Toyin; Dixon, Missy; Fukushima, Yoshimitsu; Macer, Darryl; Marshall, Patricia; Nkwodimmah, Chibuzor; Peiffer, Andy; Royal, Charmaine; Suda, Eiko; Zhao, Hui; Wang, Vivian Ota; McEwen, Jean


    The International HapMap Consortium has developed the HapMap, a resource that describes the common patterns of human genetic variation (haplotypes). Processes of community/public consultation and individual informed consent were implemented in each locality where samples were collected to understand and attempt to address both individual and group concerns. Perceptions about the research varied, but we detected no critical opposition to the research. Incorporating community input and responding to concerns raised was challenging. However, the experience suggests that approaching genetic variation research in a spirit of openness can help investigators better appreciate the views of the communities whose samples they seek to study and help communities become more engaged in the science.

  7. Comic strips help children understand medical research: targeting the informed consent procedure to children's needs.

    Grootens-Wiegers, Petronella; de Vries, Martine C; van Beusekom, Mara M; van Dijck, Laura; van den Broek, Jos M


    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.

  8. 浅论国际医疗援助中的患者知情同意权%On the Right of Informed Consent in International Medical Aid



    从国际医疗援助中患者知情同意权遭遇的尴尬入手,剖析了国际医疗援助中医患关系的独特性,即医患关系的复杂多变性、医患关系的临时应急性、患者自主选择权相对弱化、医生和患者的角色在一定条件下可转换.在此基础上,探究了国际医疗援助中落实患者知情同意权应把握的几个问题:人本理念至上;强化时效救治意识;采用人性化的沟通方式;落实患者知情同意权的评价原则.%This article, from the embarrassment of the right of informed consent in international medical aid action , analyzed the uniqueness of the doctor - patient relationship in the international medical aid, namely the complicated variety, the temporary emergency, weak independent option of patients, shifts of the doctors and patients in certain conditions. On this basis, some points of carrying out the informed consent in the international medical aid were proposed and need to paid attention to, that is, human ?based first; strengthening the consciousness of aging treatment; using humanistic communication way; carrying out the evaluation principle of patients'right of informed consent.

  9. Corrected Feedback: A Procedure to Enhance Recall of Informed Consent to Research among Substance Abusing Offenders.

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


    This study examined the efficacy of corrected feedback for improving consent recall throughout the course of an ongoing longitudinal study. Participants (N = 135) were randomly assigned to either a corrected feedback or a no-feedback control condition. Participants completed a consent quiz 2-weeks after consenting to the host study and at months 1, 2, and 3. The corrected feedback group received corrections to erroneous responses and the no-feedback control group did not. The feedback group displayed significantly greater recall overall and in specific content areas (i.e., procedures, protections, risks/benefits). Results support the use of corrected feedback for improving consent recall.

  10. Attitude towards informed consent practice in a developing country: a community-based assessment of the role of educational status.

    Agu, Kenneth Amaechi; Obi, Emmanuel Ikechukwu; Eze, Boniface Ikenna; Okenwa, Wilfred Okwudili


    It has been reported by some studies that the desire to be involved in decisions concerning one's healthcare especially with regard to obtaining informed consent is related to educational status. The purpose of this study, therefore, is to assess the influence of educational status on attitude towards informed consent practice in three south-eastern Nigerian communities. Responses from consenting adult participants from three randomly selected communities in Enugu State, southeast Nigeria were obtained using self-/interviewer-administered questionnaire. There were 2545 respondents (1508 males and 1037 females) with an age range of 18 to 65 years. More than 70% were aged 40 years and below and 28.4% were married. More than 70% of the respondents irrespective of educational status will not leave all decisions about their healthcare to the doctor. A lower proportion of those with no formal education (18.5%) will leave this entire decision-making process in the hands of the doctor compared to those with tertiary education (21.9%). On being informed of all that could go wrong with a procedure, 61.5% of those with no formal education would consider the doctor unsafe and incompetent while 64.2% of those with tertiary education would feel confident about the doctor. More than 85% of those with tertiary education would prefer consent to be obtained by the doctor who will carry out the procedure as against 33.8% of those with no formal education. Approximately 70% of those who had tertiary education indicated that informed consent was necessary for procedures on children, while the greater number of those with primary (64.4%) and no formal education (76.4%) indicated that informed consent was not necessary for procedures on children. Inability to understand the information was the most frequent specific response among those without formal education on why they would leave all the decisions to the doctor. The study showed that knowledge of the informed consent practice

  11. Exceptions and Exclusions: The Right to Informed Consent for Medical Treatment of People with Psychosocial Disabilities in Europe.

    Waddington, Lisa; Mesherry, Bernadette


    This article examines the relevant international law relating to informed consent to treatment for individuals with psychosocial disabilities and reflects on the protection offered in this respect by the European Convention on Human Rights (ECHR) and the Council of Europe Convention on Human Rights and Biomedicine. The article argues that while the UN Convention on the Rights of Persons with Disabilities is beginning to influence case law of the European Court of Human Rights, only 'weak' protection has been afforded to people with psychosocial disabilities by the ECHR and the Court in relation to informed consent for medical treatment.

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

    Tanderup, Malene; Reddy, Sunita; Patel, Tulsi


    in the surrogacy process were coded to identify categories of ethical concern. Numerical and grounded theory-oriented analyses were used. MAIN OUTCOME MEASURES: Informed consent, number of embryos transferred, fetal reduction, conflict of interest among the involved parties. RESULTS: None of the 14 surrogate......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...


    Ida Ayu Sri Kusuma Wardhani


    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

  14. Ethical aspects of informed consent for the collection, preservation and use of cells and tissues in biological banks for research purposes.

    Petrini, Carlo


    This article explores the current and proposed requirements for informed consent for research with biological samples. The establishment of biobanks and the capabilities of collecting, storing, and using cells and tissues for research purposes have noticeably grown. With new abilities come new challenges to ethical questions of consent, specifically concerning genetic information, and unanticipated usage. This paper summarizes these issues in the context of levels of informed consent, subject risk, individual vs. societal benefits, anonymity, legal consensus.

  15. Quantitative aspects of informed consent: considering the dose response curve when estimating quantity of information.

    Lynöe, N; Hoeyer, K


    Information is usually supposed to be a prerequisite for people making decisions on whether or not to participate in a clinical trial. Previously conducted studies and research ethics scandals indicate that participants have sometimes lacked important pieces of information. Over the past few decades the quantity of information believed to be adequate has increased significantly, and in some instances a new maxim seems to be in place: the more information, the better the ethics in terms of respecting a participant's autonomy. The authors hypothesise that the dose-response curve from pharmacology or toxicology serves as a model to illustrate that a large amount of written information does not equal optimality. Using the curve as a pedagogical analogy when teaching ethics to students in clinical sciences, and also in engaging in dialogue with research institutions, may promote reflection on how to adjust information in relation to the preferences of individual participants, thereby transgressing the maxim that more information means better ethics.

  16. Common Problems of Informed Consent in Medical Equipment Clinical Trials and Relevant Solutions%医疗器械临床试验中知情同意常见的问题与对策

    杨春梅; 袁丹江


    This paper analyzed the problems of informed consent during medical equipment clinical trials, including the poor writing, nonstandard signing, formalized content and loss of signed informed consent. Moreover, this paper also discussed relevant solutions to improve the writing of informed consent, ethical reviews and file management, regulate the researchers’ behavior and strengthen the awareness of protecting the right of informed consent.%本文就目前医疗器械临床试验中知情同意存在的:知情同意书撰写质量不高、签署欠规范,告知与知情同意流于形式、签署的知情同意书发生丢失等问题进行分析;就如何提高知情同意书撰写质量、伦理审查质量及档案管理水平,如何规范研究者行为、强化受试者知情同意权的保护意识等措施进行了探讨。

  17. Patient and public attitudes towards informed consent models and levels of awareness of Electronic Health Records in the UK

    Riordan, Fiona; Papoutsi, Chrysanthi; Reed, Julie E.; Marston, Cicely; Bell, Derek; Majeed, Azeem


    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

  18. Reflecting on Earlier Experiences with Unsolicited Findings: Points to Consider for Next-Generation Sequencing and Informed Consent in Diagnostics

    Rigter, Tessel; Henneman, Lidewij; Kristoffersson, Ulf; Hall, Alison; Yntema, Helger G; Borry, Pascal; Tönnies, Holger; Waisfisz, Quinten; Elting, Mariet W; Dondorp, Wybo J; Cornel, Martina C


    High-throughput nucleotide sequencing (often referred to as next-generation sequencing; NGS) is increasingly being chosen as a diagnostic tool for cases of expected but unresolved genetic origin. When exploring a higher number of genetic variants, there is a higher chance of detecting unsolicited findings. The consequential increased need for decisions on disclosure of these unsolicited findings poses a challenge for the informed consent procedure. This article discusses the ethical and practical dilemmas encountered when contemplating informed consent for NGS in diagnostics from a multidisciplinary point of view. By exploring recent similar experiences with unsolicited findings in other settings, an attempt is made to describe what can be learned so far for implementing NGS in standard genetic diagnostics. The article concludes with a set of points to consider in order to guide decision-making on the extent of return of results in relation to the mode of informed consent. We hereby aim to provide a sound basis for developing guidelines for optimizing the informed consent procedure. PMID:23784691

  19. Intervention Research with Youths at Elevated Risk for Suicide: Meeting the Ethical and Regulatory Challenges of Informed Consent and Assent

    King, Cheryl A.; Kramer, Anne C.


    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…

  20. Overcoming language barriers in the informed consent process: regulatory and compliance issues with the use of the "short form".

    Lad, Pramod M; Dahl, Rebecca


    Language barriers in the informed consent process can be a significant impediment when recruiting non-English speaking subjects into clinical research studies. Regulatory guidelines indicate that the short form procedure be utilized in such circumstances. In this paper, we examine some of the ambiguities in the regulatory framework, the resulting need for institutional policy guidelines, and compliance issues with the short form process.

  1. Developing competency in post-graduate students of anaesthesiology for taking informed consent for elective caesarean section

    Kamla Harshad Mehta


    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.

  2. May Stakeholders be Involved in Design Without Informed Consent? The Case of Hidden Design.

    Pols, A J K


    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.

  3. Informed Consent to Research with Cognitively Impaired Adults: Transdisciplinary Challenges and Opportunities.

    Prusaczyk, Beth; Cherney, Steven M; Carpenter, Christopher R; DuBois, James M


    Due to issues related to informed research consent, older adults with cognitive impairments are often excluded from high-quality studies that are not directly related to cognitive impairment, which has led to a dearth of evidence for this population. The challenges to including cognitively impaired older adults in research and the implications of their exclusion are a transdisciplinary issue. The ethical challenges and logistical barriers to conducting research with cognitively impaired older adults are addressed from the perspectives of three different fields-social work, emergency medicine, and orthopaedic surgery. Issues related to funding, study design, intervention components, and outcomes are discussed through the unique experiences of three different providers. A fourth perspective-medical research ethics-provides alternatives to exclusion when conducting research with cognitively impaired older adults such as timing, corrective feedback and plain language, and capacity assessment and proxy appointments. Given the increasing aging population and the lack of evidence on cognitively impaired older adults, it is critical that researchers, funders, and institutional review boards not be dissuaded from including this population in research studies.

  4. [Human rights and informed consent in clinical practice: beyond the right to health].

    Gonzalo, Gianella


    Providing medical care is us a complex process that requires a strict respect for human rights. In countries like Peru, despite of having regulations and specific laws, patient's autonomy is not a common currency and certainly paternalism and beneficence generally overrule in physicians decision making. In this type of reality the requirement to health care professionals for respecting fundamental rights should be considered crucial, far more than in societies where citizens are really empowered. But to achieve the full respect of human rights, especially when providing a health care service, there is the need to go much further than just advocating for appropriate legislation and regulatory frameworks. In this article I argue that the violation of certain rights as the informed consent process by health care providers, is rooted in how these professionals, specially medical doctors trained in the western tradition, establish priorities and arrive to moral judgments. In this scenario I consider the need of a change in the way the Human Rights framework is being used to improve fundamental rights respect in health care.

  5. O processo de consentimento livre e esclarecido em pesquisa: uma nova abordagem Informed consent in research: a new approach

    José Roberto Goldim


    Full Text Available Objetivos: O processo de consentimento livre e esclarecido tem por objetivo permitir que a pessoa que está sendo convidada a participar de um projeto de pesquisa compreenda os procedimentos, riscos, desconfortos, benefícios e direitos envolvidos, visando permitir uma decisão autônoma. O objetivo do presente estudo foi avaliar a possibilidade de fornecer informações de forma coletiva na obtenção do consentimento livre e esclarecido. MÉTODOS: Em um projeto de pesquisa da área da Ginecologia foi utilizada a transmissão coletiva de informações, através de uma palestra, para a obtenção do consentimento livre e esclarecido. Foram entrevistadas 45 participantes deste projeto, verificando a recordação dos procedimentos, riscos e benefícios. RESULTADOS: Todas as participantes (100% recordaram os procedimentos, 54% delas recordaram os riscos e 96% os benefícios prováveis. Comparando os presentes resultados com os obtidos em um estudo similar utilizando o processo de consentimento livre e esclarecido convencional (transmissão individual de informações, verificou-se que os sujeitos de pesquisa recordaram mais informações no atual estudo. CONCLUSÕES: Estes resultados indicam a possibilidade de que as informações necessárias ao consentimento livre e esclarecido possam ser dadas de forma coletiva, nos projetos em que esta alternativa seja adequada.INTRODUCTION: The Informed Consent allows the person invited to participate of a reserch project to understand the procedures, risks, discomforts, benefits and rights involved; determining an autonomic decision. We want to verify in the informed consent process the adequacy of given information to research subjects in a collective way. METHODS: A research project was chosen from the gynecologic area. The collective obtainment consisted of an oral presentation. After that, The Consent form was shown. Forty-five patients were interwied, immediately after the consent obtainment. RESULTS

  6. International variation in policies and practices related to informed consent in acute cardiovascular research: Results from a 44 country survey.

    van Belle, Gerald; Mentzelopoulos, Spyros D; Aufderheide, Tom; May, Susanne; Nichol, Graham


    Research in an emergency setting such as that with an acute cardiovascular event is challenging because the window of opportunity to treat may be short and may preclude time to obtain informed consent from the patient or their representative. Some perceive that requiring informed consent in emergency situations has limited improvements in care. Vulnerable populations including minorities or residents of low-income countries are at greatest risk of need for resuscitation. Lack of enrollment of such patients would increase uncertainties in treatment benefit or harm in those at greater risk of need for resuscitation. We sought to assess international variation in policies and procedures related to exception from informed consent (EFIC) or deferred consent for emergency research. A brief survey instrument was developed and modified by consensus among the investigators. Included were multiple choice and open-ended responses. The survey included an illustrative example of a hypothetical randomized study. Elicited information included the possibility of conducting such a study in the respondent's country, as well as approvals required to conduct the study. The population of interest was emergency physicians or other practitioners of acute cardiovascular event research. Usable responses were obtained from 44 countries (76% of surveyed). Community opposition to EFIC was noted in 6 (14%) countries. Emergency Medical Services (EMS) providers in 8 (20%) countries were judged unable or unwilling to participate. A majority of countries (36, 82%) required approval by a Research Ethics Committee or similar. Government approval was required in 25 (57%) countries. There is international variation in practices and policies related to consent for emergency research. There is an ongoing need to converge regulations based on the usefulness of multinational emergency research to benefit both affluent and disadvantaged populations. Copyright © 2015. Published by Elsevier Ireland Ltd.

  7. Fair Shares and Sharing Fairly: A Survey of Public Views on Open Science, Informed Consent and Participatory Research in Biobanking.

    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

  8. Fair Shares and Sharing Fairly: A Survey of Public Views on Open Science, Informed Consent and Participatory Research in Biobanking

    Joly, Yann; Dalpé, Gratien; So, Derek; Birko, Stanislav


    Context 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. Results 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

  9. Use of Videos Improves Informed Consent Comprehension in Web-Based Surveys Among Internet-Using Men Who Have Sex With Men: A Randomized Controlled Trial.

    Hall, Eric William; Sanchez, Travis H; Stein, Aryeh D; Stephenson, Rob; Zlotorzynska, Maria; Sineath, Robert Craig; Sullivan, Patrick S


    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 (P<.001) in mean consent comprehension scores. A mediation analysis was used to examine the relationship between time spent on consent page and consent comprehension. Of the 665 MSM participants who completed the comprehension questions, 24.2% (161/665) received the standard consent, 27.1% (180/665) received the FAQ consent, 26.8% (178/665) received the professional consent video, 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 (P<.001), age (P=.04), race or ethnicity (P<.001), and highest level of education (P=.001). Compared with those who received the standard consent, comprehension was significantly higher for participants who received the professional video consent (score increase=1.79; 95% CI 1.02-2.55) and

  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

    Sanchez, Travis H; Stein, Aryeh D; Stephenson, Rob; Zlotorzynska, Maria; Sineath, Robert Craig; Sullivan, Patrick S


    Background 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. Objective 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). Methods 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 (Ptype (Peducation (P=.001). Compared with those who received the standard consent, comprehension was significantly higher for participants who received the professional video 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. [Informed Consent in the Humanization of the Cesarean: A Preliminary Study].

    Castaño Molina, M Ángeles; Carrillo Navarro, Francisco; Pastor, Luis Miguel


    The informed consent (IC) is a process based on dialogue between the professional and the patient in which he freely decides on possible interventions in their health. This is applicable to caesarean delivery and if it meets a number of conditions will help to improve the process of ″humanization″ of birth. The overall objective of this study is to analyze preliminarily in several hospitals in the Region of Murcia the IC in caesarean delivery. To this end, we have revised the documents of IC and we studied who, where, when and how the IC process is done. The results show that all hospitals are based on the same document, and although the documents take into account all the elements of a IC, do not indicate the date of their design or subsequent revisions. It does not contemplate the risks and complications that caesarean section can have on the newborn, mother, and mother-child relationship later. It is noted that the document of IC normally is delivers by gynecologist in the consultation, when intervention is programmed, although it are sometimes nurses, who after admission to the hospital give it to sign the patient. In urgent caesarean sections, there are some hospitals that in life-threatening situation, do not offer the document of IC to women. In others, it is offered hastily by the gynecologist or midwife. In conclusion, the IC is a process which used correctly, favors the relationship between women and health professionals in the intervention of cesarean section. Although this process and the documents of IC examined in our study, have presented many positive aspects, the humanization of caesarean could be increased improving with the preparation and updating of these documents and coordinating the various professionals.

  12. Informed consent: cultural and religious issues associated with the use of allogeneic and xenogeneic mesh products.

    Jenkins, Eric D; Yip, Michael; Melman, Lora; Frisella, Margaret M; Matthews, Brent D


    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.

  13. Using social media for community consultation and public disclosure in exception from informed consent trials.

    Stephens, Shannon W; Williams, Carolyn; Gray, Randal; Kerby, Jeffrey D; Wang, Henry E; Bosarge, Patrick L


    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

  14. Utilizing Social Media for Community Consultation and Public Disclosure in Exception from Informed Consent Trials

    Stephens, Shannon W.; Williams, Carolyn; Gray, Randal; Kerby, Jeffrey D.; Wang, Henry E.; Bosarge, Patrick L.


    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

  15. Doctor-patient interaction and informed consent in pediatric surgery: theory and reality in the regional practice

    Sergio Luis González López


    Full Text Available Informed consent is a core element in the doctor-patient interaction. With the objective of reviewing the essentials and legal basis of its procedure and relation with pediatric surgery in the regional context we developed a bibliographic review of national and international biomedical publications. It is widely accepted that the recognition of patient´s autonomy and the informed consent process have led to a change in the doctor-patients interaction, which is closely linked to the pediatric surgical practice in the particular Cuban modern environment. In addition to the study of bioethical principles and their enforcement by those who are to provide medical services, it is also necessary to look for useful answers to bioethical questions affecting the legal tools that support the procedure.

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

    Tanderup, Malene; Reddy, Sunita; Patel, Tulsi


    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......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...... were carried out among 20 doctors in 18 fertility clinics, five agents from four agencies and 14 surrogate mothers. Surrogate mothers were interviewed both individually and in the presence of doctors and agents. Data on socio-economic context and experiences among and between various actors...... in the surrogacy process were coded to identify categories of ethical concern. Numerical and grounded theory-oriented analyses were used. MAIN OUTCOME MEASURES: Informed consent, number of embryos transferred, fetal reduction, conflict of interest among the involved parties. RESULTS: None of the 14 surrogate...

  17. Investigating the informed consent process, therapeutic misconception and motivations of Egyptian research participants: a qualitative pilot study.

    Mansour, H; Zaki, N; Abdelhai, R; Sabry, N; Silverman, H; El-Kamary, S S


    Few studies have explored the informed consent process among research participants in developing countries. This study aimed to evaluate the informed consent process, therapeutic misconception and motivation for participation among Egyptians participating in clinical trials. In a cross-sectional qualitative pilot study 103 participants in 10 clinical trials responded to a questionnaire. Over 90% agreed they had time to ask questions and received adequate information about the risks prior to consenting. All participants thought the research and the drug would improve their condition; only 46.1% were aware of receiving a non-approved experimental drug and 21.3% of being randomized. Reasons for participation included: better treatment (100%), to benefit society & advance science (85.4%), to receive free drugs (42.6%) and medical care (43.6%), to get hospitalized (15.8%) and to receive money or gifts (4.9%). Investigators need to emphasize the distinction between research and clinical care to address the high rate of therapeutic misconception.

  18. [Inappropriateness in ionizing imaging. The central node of the informed consent: from "event" model to "process" model].

    Dodaro, Antonio; Recchia, Virginia


    The phenomenon of inappropriateness in ionizing imaging and medical interventions is large-scale and increasing. This tendency causes noteworthy damages to health and to patient's autonomy. Moreover, this trend causes a huge increment of health expenditures, waiting lists, organizational conflicts, judicial disputes, insurance compensations. The actual passive signature on unreadable templates of informed consent in the Italian hospital context constitutes, by a matter of facts, a central node of inappropriateness problem. This way to manage informed consent - "event" model - mortifies the patient's right to decide freely and deliberately, being him unaware of biological consequences of clinical-therapeutical interventions on himself and his progeny's health. Physician himself can generate arbitrary clinical acts, with heavy deontological and legal consequences. Hence, informed consent in ionizing imaging necessitates a particular "process" management, useful to convey a series of other clinical and organisational processes towards a full realisation of therapeutic alliance among physician and patient. This review aims at highlighting - in a juridical and communicative key - a range of tools which are applicable to contrasting the hospital abuse of ionizing radiations, for defending both patients' health and patients' dignity, being them primarily persons and citizens of a rule-of-law State.

  19. 34 CFR 303.401 - Definitions of consent, native language, and personally identifiable information.


    ... which consent is sought, in the parent's native language or other mode of communication; (2) The parent... proficiency, means the language or mode of communication normally used by the parent of a child eligible under... child's parent, or other family member; (2) The address of the child; (3) A personal identifier, such as...

  20. The Limits of Informed Consent for an Overwhelmed Patient: Clinicians' Role in Protecting Patients and Preventing Overwhelm.

    Bester, Johan; Cole, Cristie M; Kodish, Eric


    In this paper, we examine the limits of informed consent with particular focus on ways in which various factors can overwhelm decision-making capacity. We introduce overwhelm as a phenomenon commonly experienced by patients in clinical settings and distinguish between emotional overwhelm and informational overload. We argue that in these situations, a clinician's primary duty is prevention of harm and suggest ways in which clinicians can discharge this obligation. To illustrate our argument, we consider the clinical application of genetic sequencing testing, which involves scientific and technical information that can compromise the understanding and decisional capacity of most patients. Finally, we consider and rebut objections that this could lead to paternalism.

  1. Participation with a Punch: Community Referenda on Dam Projects and the Right to Free, Prior, and Informed Consent to Development

    Brant McGee


    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.

  2. Strengthening Intelligence Education with Information-Processing and Knowledge- Organization Competencies

    Yejun Wu


    Full Text Available This paper studies the weaknesses of intelligence-education curriculum in the United States from a Library and Information Science perspective. Intelligence information processing is a separate step in the traditional intelligence cycle; however, information-processing competencies are often included in the intelligence collection and analysis competencies in the Intelligence Community. A study of the websites of the intelligence-education programs in the major 27 intelligence-education institutions in the United States reveals that information processing is often implicitly included in an intelligence analysis or collection course; and only three universities offer such courses that include information-processing components. Only one university has been found to offer courses that implicitly include components of the knowledge-organization competency. This paper recommends strengthening intelligence-education curriculum with information-processing and knowledge-organization competencies.

  3. Culture clash on consent.


    All research on human subjects requires their informed consent. Obtaining valid consent from isolated minorities can be particularly challenging, but scientists need to avoid the temptingly easy way out, so as to prevent further exclusion of these vulnerable populations from biomedical research.

  4. Should patients set the agenda for informed, consent? A prospective survey of desire for information and discussion prior to routine cataract surgery

    Lee Teak Tan


    Full Text Available Lee Teak Tan1,2, Huw Jenkins1,2, John Roberts-Harry2, Michael Austin11Singleton Hospital, Swansea, UK; 2West Wales General Hospital, Carmarthen, UKPurpose: To ascertain the level of information relating to specific risks desired by patients prior to cataract surgery.Setting: Dedicated cataract surgery pre-assessment clinics of 2 hospitals in South West Wales, UK.Methods: Consecutive patients (106 were recruited prospectively. Of these, 6 were formally excluded due to deafness or disorientation. Eligible patients (100 were asked a set of preliminary questions to determine their understanding of the nature of cataract, risk perception, and level of information felt necessary prior to giving consent. Those who desired further information were guided through a standardized questionnaire, which included an audio-visual presentation giving information relating to each potential surgical complication, allowing patients to rate them for relevance to their giving of informed consent.Results: Of the entire group of 100, 32 did not wish to know “anything at all” about risks and would prefer to leave decision making to their ophthalmologist; 22 were interested only in knowing their overall chance of visual improvement; and 46 welcomed a general discussion of possible complications, of whom 25 went on to enquire about specific complications. Of these 25, 18 wished to be informed of posterior capsular (PC tearing, 17 of endophthalmitis, 16 each of dropped lens, retinal detachment and corneal clouding, and 15 of bleeding, sympathetic ophthalmia, and PC opacification.Conclusion: Patients differ in their desire for information prior to cataract surgery, with one significant minority favoring little or no discussion of risk and another wishing detailed consideration of specific risks. A system of consent where patients have a choice as to the level of discussion undertaken may better suit patients’ wishes than a doctor-specified agenda.Keywords: cataract

  5. REXIC project: retrospective cross-sectional study of documentation of informed consent for research biobanking in a public research and teaching hospital

    Marta Nobile


    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. How often are ethics approval and informed consent reported in publications on health research in Cameroon? A five-year review.

    Munung, Nchangwi Syntia; Che, Chi Primus; Ouwe-Missi-Oukem-Boyer, Odile; Tangwa, Godfrey B


    We assessed the extent of research ethics approval and informed consent reporting in publications emanating from Cameroon and indexed in PubMed from 2005-2009. In our review of 219 full-length articles, we found that 57.53% reported ethics approval, 70.78% informed consent, and 50.68% both ethics approval and informed consent. Reporting these procedures was more common in randomized clinical trials than in other study designs. Also, 59.52% of the articles on vulnerable populations documented ethics approval and 76.19% documented informed consent. This study also identified some structures for ethics review and recommends some next steps for research on the quality of ethics review in Cameroon.

  7. User-Centered Design, Experience, and Usability of an Electronic Consent User Interface to Facilitate Informed Decision-Making in a HIV Clinic.

    Ramos, S Raquel


    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 medical records. Comprehension is key factor in the ability to make informed decisions.

  8. Informed consent in oncology clinical trials: A Brown University Oncology Research Group prospective cross-sectional pilot study

    Schumacher, Andrew; Sikov, William M.; Quesenberry, Matthew I.; Safran, Howard; Khurshid, Humera; Mitchell, Kristen M.


    Background 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. Methods 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. Results 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). Conclusions 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. Trial registration NCT01772511 PMID:28235011

  9. A Worrying Trend. Ethical considerations of using data collected without informed consent

    Martin Tolich


    Full Text Available There is a worrying trend in the social sciences whereby researchers bypass ethics review. Autoethnographers often exempt themselves from IRBs claiming the stories they tell are their own; even when others written into their story might not consent. A similar condition emerges in ethnography where novice researchers generate data prior to commencing postgraduate studies both evading ethical oversight and without demonstrating basic ethical considerations. Goffman turned her PhD into On the Run based on six years of fieldwork in inner city black neighbourhoods. Venkatesh's Gangleader for a Day, also based on his PhD, describes researching in an inner city high rise without ethical considerations. How will future social science postgraduate students read these best sellers? Author created a short scenario encapsulating these two books asking academics and IRB members to review it. Under what conditions would they supervise or approve data collected prior to enrolling in a PhD that demonstrated no evidence of ethical considerations. Respondents expressed concern for data collected without ethical considerations seeing it as inadmissible, similar to the legal term fruit of the poisonous tree. They recognised attempts to gain retrospective consent as more likely to exacerbate than alleviate harm.

  10. Confidentiality, informed consent, and children's participation in research involving stored tissue samples: interviews with medical professionals from the Middle East.

    Alahmad, Ghiath; Al Jumah, Mohammed; Dierickx, Kris


    Ethical issues regarding research biobanks continue to be a topic of intense debate, especially issues of confidentiality, informed consent, and child participation. Although considerable empirical literature concerning research biobank ethics exists, very little information is available regarding the opinions of medical professionals doing genetics research from the Middle East, especially Arabic speaking countries. Ethical guidelines for research biobanks are critically needed as some countries in the Middle East are starting to establish national research biobanks. Islam is the dominant religion in these countries, and it affects people's behavior and influences their positions. Moreover, communities in these countries enjoy a set of customs, traditions and social norms, and have social and familial structures that must be taken into account when developing research policies. We interviewed 12 medical professionals from the Middle East currently working with stored tissue samples to document their opinions. We found general agreement. Participants' primary concerns were similar to the views of researchers internationally. Since children tend to represent a high percentage of Middle Eastern populations, and because children's bodies are not just small adult bodies, the interviewed professionals strongly believed that it is imperative to include children in biobank research. Participants generally believed that protecting confidentiality is socially very important and that informed consent/assent must be obtained from both adult and child participants. This study provides a starting point for additional studies.

  11. Decision-making and risk-assessment in living liver donation: how informed is the informed consent of donors? A qualitative study.

    Papachristou, Christina; Walter, Marc; Marc, Walter; Frommer, Joerg; Frommer, Jeorg; Klapp, Burghard F


    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.

  12. Application of ICT in strengthening health information systems in developing countries in the wake of globalisation.

    Simba, Daudi O; Mwangu, Mughwira


    Information Communication Technology (ICT) revolution brought opportunities and challenges to developing countries in their efforts to strengthen the Health Management Information Systems (HMIS). In the wake of globalisation, developing countries have no choice but to take advantage of the opportunities and face the challenges. The last decades saw developing countries taking action to strengthen and modernise their HMIS using the existing ICT. Due to poor economic and communication infrastructure, the process has been limited to national and provincial/region levels leaving behind majority of health workers living in remote/rural areas. Even those with access do not get maximum benefit from ICT advancements due to inadequacies in data quality and lack of data utilisation. Therefore, developing countries need to make deliberate efforts to address constraints threatening to increase technology gap between urban minority and rural majority by setting up favourable policies and appropriate strategies. Concurrently, strategies to improve data quality and utilisation should be instituted to ensure that HMIS has positive impact on people's health. Potential strength from private sector and opportunities for sharing experiences among developing countries should be utilised. Short of this, advancement in ICT will continue to marginalise health workers in developing countries especially those living in remote areas.

  13. [Medical prescription and informed consent for the use of physical restraints in nursing homes in the Canary Islands (Spain)].

    Estévez-Guerra, Gabriel J; Fariña-López, Emilio; Penelo, Eva


    To identify the frequency of completion of informed consent and medical prescription in the clinical records of older patients subject to physical restraint, and to analyse the association between patient characteristics and the absence of such documentation. A cross-sectional and descriptive multicentre study with direct observation and review of clinical records was conducted in nine public nursing homes, comprising 1,058 beds. 274 residents were physically restrained. Informed consent was not included in 82.5% of cases and was incomplete in a further 13.9%. There was no medical prescription in 68.3% of cases and it was incomplete in a further 12.0%. The only statistical association found was between the lack of prescription and the patients' advanced age (PR=1.03; p <0.005). Failure to produce this documentation contravenes the law. Organisational characteristics, ignorance of the legal requirements or the fact that some professionals may consider physical restraint to be a risk-free procedure may explain these results. Copyright © 2016 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

  14. Informed consent/assent in children. Statement of the Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP).

    De Lourdes Levy, Maria; Larcher, Victor; Kurz, Ronald


    Informed consent means approval of the legal representative of the child and/or of the competent child for medical interventions following appropriate information. National legal regulations differ in regard to the question when a child has the full right to give his or her autonomous consent. Informed assent means a child's agreement to medical procedures in circumstances where he or she is not legally authorised or lacks sufficient understanding for giving consent competently. Doctors should carefully listen to the opinion and wishes of children who are not able to give full consent and should strive to obtain their assent. Doctors have the responsibility to determine the ability and competence of the child for giving his or her consent or assent. All children, even those not judged as competent, have a right to receive information given in a way that they can understand and give their assent or dissent. This consent/assent process must promote and protect the dignity, privacy and confidentiality of the child and his or her family. Consent or assent is required for all aspects of medical care, for preventive, diagnostic or therapeutic measures and research. Children may effectively refuse treatment or procedures which are not necessary to save their lives or prevent serious harm. Where treatment is necessary to save a life or prevent serious harm, the doctor has the duty to act in the best interest of the child. However, parents may also refuse to consent and in this case national laws and legal mechanisms for resolving disputes may be used.

  15. Strengthening Rehabilitation in Health Systems Worldwide by Integrating Information on Functioning in National Health Information Systems.

    Stucki, Gerold; Bickenbach, Jerome; Melvin, John


    A complete understanding of the experience of health requires information relevant not merely to the health indicators of mortality and morbidity but also to functioning-that is, information about what it means to live in a health state, "the lived experience of health." Not only is functioning information relevant to healthcare and the overall objectives of person-centered healthcare but to the successful operation of all components of health systems.In light of population aging and major epidemiological trends, the health strategy of rehabilitation, whose aim has always been to optimize functioning and minimize disability, will become a key health strategy. The increasing prominence of the rehabilitative strategy within the health system drives the argument for the integration of functioning information as an essential component in national health information systems.Rehabilitation professionals and researchers have long recognized in WHO's International Classification of Functioning, Disability and Health the best prospect for an internationally recognized, sufficiently complete and powerful information reference for the documentation of functioning information. This paper opens the discussion of the promise of integrating the ICF as an essential component in national health systems to secure access to functioning information for rehabilitation, across health systems and countries.

  16. Experiences with community engagement and informed consent in a genetic cohort study of severe childhood diseases in Kenya

    Mlamba Albert M


    Full Text Available Abstract Background The potential contribution of community engagement to addressing ethical challenges for international biomedical research is well described, but there is relatively little documented experience of community engagement to inform its development in practice. This paper draws on experiences around community engagement and informed consent during a genetic cohort study in Kenya to contribute to understanding the strengths and challenges of community engagement in supporting ethical research practice, focusing on issues of communication, the role of field workers in 'doing ethics' on the ground and the challenges of community consultation. Methods The findings are based on action research methods, including analysis of community engagement documentation and the observations of the authors closely involved in their development and implementation. Qualitative and quantitative content analysis has been used for documentation of staff meetings and trainings, a meeting with 24 community leaders, and 40 large public and 70 small community group meetings. Meeting minutes from a purposive sample of six community representative groups have been analysed using a thematic framework approach. Results Field workers described challenges around misunderstandings about research, perceived pressure for recruitment and challenges in explaining the study. During consultation, leaders expressed support for the study and screening for sickle cell disease. In community meetings, there was a common interpretation of research as medical care. Concerns centred on unfamiliar procedures. After explanations of study procedures to leaders and community members, few questions were asked about export of samples or the archiving of samples for future research. Conclusions Community engagement enabled researchers to take account of staff and community opinions and issues during the study and adapt messages and methods to address emerging ethical challenges. Field

  17. Obtaining informed consent from study participants and results of field studies. Methodological problems caused by the literal treatment of codes of ethics

    Grzyb Tomasz


    Full Text Available The article discusses the issue of the necessity of obtaining informed consent from an individual who is to be a participant in an experiment. Codes of ethics concerning the behaviour of a psychologist fundamentally do not permit conducting experiments without informing their participants in advance that they will be conducted. Meanwhile, the act of obtaining prior consent (and thus of informing the study participant that they will be taking part in an experiment can have a significant impact on results. The article describes an experiment in the field of social influence psychology during which one group was asked for their informed consent to participate in a study, while the second was simply presented with the main request (to sign a letter to the mayor about reducing the number of parking spaces for the disabled. The results demonstrate the strong influence of awareness that a study is being conducted on the decisions taken in the course of the experiment.

  18. Randomised controlled trial of whether erotic material is required for semen collection: impact of informed consent on outcome.

    Handelsman, D J; Sivananathan, T; Andres, L; Bathur, F; Jayadev, V; Conway, A J


    Semen is collected to evaluate male fertility or cryostore sperm preferentially in laboratories but such collection facilities have no standard fit-out. It is widely believed but untested whether providing erotic material (EM) is required to collect semen by masturbation in the unfamiliar environment. To test this assumption, 1520 men (1046 undergoing fertility evaluation, 474 sperm cryostorage, providing 1932 semen collection episodes) consecutively attending the semen laboratory of a major metropolitan teaching hospital for semen analysis were eligible for randomization to be provided or not with printed erotic material EM (X-rated, soft-core magazines) during semen collection. Randomization was performed by providing magazines in the collection rooms (as a variation on non-standard fit-out) on alternate weeks using a schedule concealed from participants. In the pilot study, men were randomized without seeking consent. In the second part of the study, which continued on from the first without interruption, an approved informed consent procedure was added. The primary outcome, the time to collect semen defined as the time from receiving to returning the sample receptacle, was significantly longer (by ~6%, 14.9 ± 0.3 [mean ± standard error of mean] vs. 14.0 ± 0.2 minutes, p = 0.02) among men provided with EM than those randomized to not being provided. There was no significant increase in the failure to collect semen samples (2.6% overall) nor any difference in age, semen volume or sperm concentration, output or motility according to whether EM was provided or not. The significantly longer time to collect was evident in the pilot study and the study overall, but not in the main study where the informed consent procedure was used. This study provides evidence that refutes the assumption that EM needs to be provided for semen collection in a laboratory. It also provides an example of a usually unobservable participation bias influencing study outcome of a

  19. Adapting Free, Prior, and Informed Consent (FPIC to Local Contexts in REDD+: Lessons from Three Experiments in Vietnam

    Thuy Thu Pham


    Full Text Available Free, prior, and informed consent (FPIC is a means of ensuring that people’s rights are respected when reducing emissions from deforestation and forest degradation, and enhancing forest carbon stocks (REDD+ projects are established in developing countries. This paper examines how FPIC has been applied in three projects in Vietnam and highlights two key lessons learnt. First, as human rights and democracy are seen as politically sensitive issues in Vietnam, FPIC is likely to be more accepted by the government if it is built upon the national legal framework on citizen rights. Applying FPIC in this context can ensure that both government and citizen’s interests are achieved within the permitted political space. Second, FPIC activities should be seen as a learning process and designed based on local needs and preferences, with accountability of facilitators, two-way and multiple communication strategies, flexibility, and collective action in mind.

  20. [General and ethical considerations for the informed consent process: Guidelines from the Francophone Society of Bone Marrow Transplantation and Cellular Therapy (SFGM-TC)].

    Thibert, Jean-Baptiste; Polomeni, Alice; Yakoub-Agha, Ibrahim; Bordessoule, Dominique


    Informed consent is not restricted to clinical research and must be applied to high-risk care such as hematopoietic stem cell transplantation. If standardized informed consent might improve inequalities in medical practices between different transplantation centers, it is strongly recommended that it be adapted with an honest dialogue between physicians and patients and physicians and donors. In an attempt to harmonize clinical practices among French hematopoietic stem cell transplantation centers, the Francophone Society of Bone Marrow Transplantation and Cellular Therapy (SFGM-TC) held its sixth annual workshop series in September 2015 in Lille. This event brought together practitioners from across the country. The purpose of this paper is to highlight the French law concerning patients' rights and ethical practices for an informed consent process to be applied to care or research.

  1. "They Take Positive People": An Investigation of Communication in the Informed Consent Process of an HIV/AIDS Vaccine Trial in South Africa

    Watermeyer, Jennifer; Penn, Claire


    South Africa is a multilingual, multicultural context that poses communication challenges to health professionals. In a clinical trial, information must be thoroughly understood by participants in order for consent to be informed. Unfortunately, this is not always the case. This pilot study aimed to identify communication successes and breakdowns…

  2. Risk communication and informed consent in the medical tourism industry: A thematic content analysis of canadian broker websites


    Background Medical tourism, thought of as patients seeking non-emergency medical care outside of their home countries, is a growing industry worldwide. Canadians are amongst those engaging in medical tourism, and many are helped in the process of accessing care abroad by medical tourism brokers - agents who specialize in making international medical care arrangements for patients. As a key source of information for these patients, brokers are likely to play an important role in communicating the risks and benefits of undergoing surgery or other procedures abroad to their clientele. This raises important ethical concerns regarding processes such as informed consent and the liability of brokers in the event that complications arise from procedures. The purpose of this article is to examine the language, information, and online marketing of Canadian medical tourism brokers' websites in light of such ethical concerns. Methods An exhaustive online search using multiple search engines and keywords was performed to compile a comprehensive directory of English-language Canadian medical tourism brokerage websites. These websites were examined using thematic content analysis, which included identifying informational themes, generating frequency counts of these themes, and comparing trends in these counts to the established literature. Results Seventeen websites were identified for inclusion in this study. It was found that Canadian medical tourism broker websites varied widely in scope, content, professionalism and depth of information. Three themes emerged from the thematic content analysis: training and accreditation, risk communication, and business dimensions. Third party accreditation bodies of debatable regulatory value were regularly mentioned on the reviewed websites, and discussion of surgical risk was absent on 47% of the websites reviewed, with limited discussion of risk on the remaining ones. Terminology describing brokers' roles was somewhat inconsistent across

  3. Risk communication and informed consent in the medical tourism industry: A thematic content analysis of canadian broker websites

    Crooks Valorie A


    Full Text Available Abstract Background Medical tourism, thought of as patients seeking non-emergency medical care outside of their home countries, is a growing industry worldwide. Canadians are amongst those engaging in medical tourism, and many are helped in the process of accessing care abroad by medical tourism brokers - agents who specialize in making international medical care arrangements for patients. As a key source of information for these patients, brokers are likely to play an important role in communicating the risks and benefits of undergoing surgery or other procedures abroad to their clientele. This raises important ethical concerns regarding processes such as informed consent and the liability of brokers in the event that complications arise from procedures. The purpose of this article is to examine the language, information, and online marketing of Canadian medical tourism brokers' websites in light of such ethical concerns. Methods An exhaustive online search using multiple search engines and keywords was performed to compile a comprehensive directory of English-language Canadian medical tourism brokerage websites. These websites were examined using thematic content analysis, which included identifying informational themes, generating frequency counts of these themes, and comparing trends in these counts to the established literature. Results Seventeen websites were identified for inclusion in this study. It was found that Canadian medical tourism broker websites varied widely in scope, content, professionalism and depth of information. Three themes emerged from the thematic content analysis: training and accreditation, risk communication, and business dimensions. Third party accreditation bodies of debatable regulatory value were regularly mentioned on the reviewed websites, and discussion of surgical risk was absent on 47% of the websites reviewed, with limited discussion of risk on the remaining ones. Terminology describing brokers' roles was

  4. Risk communication and informed consent in the medical tourism industry: a thematic content analysis of Canadian broker websites.

    Penney, Kali; Snyder, Jeremy; Crooks, Valorie A; Johnston, Rory


    Medical tourism, thought of as patients seeking non-emergency medical care outside of their home countries, is a growing industry worldwide. Canadians are amongst those engaging in medical tourism, and many are helped in the process of accessing care abroad by medical tourism brokers - agents who specialize in making international medical care arrangements for patients. As a key source of information for these patients, brokers are likely to play an important role in communicating the risks and benefits of undergoing surgery or other procedures abroad to their clientele. This raises important ethical concerns regarding processes such as informed consent and the liability of brokers in the event that complications arise from procedures. The purpose of this article is to examine the language, information, and online marketing of Canadian medical tourism brokers' websites in light of such ethical concerns. An exhaustive online search using multiple search engines and keywords was performed to compile a comprehensive directory of English-language Canadian medical tourism brokerage websites. These websites were examined using thematic content analysis, which included identifying informational themes, generating frequency counts of these themes, and comparing trends in these counts to the established literature. Seventeen websites were identified for inclusion in this study. It was found that Canadian medical tourism broker websites varied widely in scope, content, professionalism and depth of information. Three themes emerged from the thematic content analysis: training and accreditation, risk communication, and business dimensions. Third party accreditation bodies of debatable regulatory value were regularly mentioned on the reviewed websites, and discussion of surgical risk was absent on 47% of the websites reviewed, with limited discussion of risk on the remaining ones. Terminology describing brokers' roles was somewhat inconsistent across the websites. Finally

  5. The Trafigura Case and the System of Prior Informed Consent Under the Basel Convention – A Broken System?

    Gary Cox


    Full Text Available The much publicised Trafigura case of the illegal dumping of hazardous petrochemical waste in and around Abidjan in Côte d’Ivoire has reignited the debate about the international trade in hazardous wastes as well as issues of international corporate social responsibility. The incident, which took place in August 2006, highlights major flaws in the existing international regulatory system, particularly around the prior informed consent (PIC procedure. PIC forms the keystone of the 1989 Basel Convention on the Transboundary Movement of Hazardous Wastes. This article focuses on the effectiveness of the PIC procedures under the Basel Convention in the light of the response to the Trafigura incident. The incident exemplifies the failures of the PIC system under the Basel Convention. It reveals confusion on the part of regulatory authorities, failure to take prompt and appropriate action by the authorities involved, a lack of proactive supervisory intervention on the part of the Basel Secretariat, and a more far-reaching lack of developing country support for capacity building and technical assistance. There is a need for a more thorough-going approach to the assessment of environmentally sound management in developing countries. More fundamentally, meaningful consent encompasses the human rights dimension of hazardous wastes on local communities. Efforts aimed at increasing co-operation between the Basel, Rotterdam, Stockholm and MARPOL Conventions should be fully supported but they should be rapidly complemented by addressing deficiencies at ‘the sharp end’ around compliance and the effectiveness of the current system of PIC. A more integrated multilateral environmental regime dealing with all aspects of hazardous chemicals and wastes is warranted based on a wider focus on common concern for the global environment.

  6. Strengthening health information systems for disability-related rehabilitation in LMICs.

    McPherson, Anna; Durham, Jo; Richards, Nicola; Gouda, Hebe; Rampatige, Rasika; Whittaker, Maxine


    The purpose of this study was to describe the state of rehabilitation health information systems (HIS) in different settings, and identify key processes and actions which contribute to the development of HIS which can effectively support low- and middle-income countries (LMICs) allocate resources to health-related rehabilitation to people with disabilities. Nine case studies were conducted across different disability and developmental settings using documentary review and semi-structured key informant interviews (N = 41). Results were analysed against the six building blocks of a HIS, based on the Health Metrics Network Framework and Standards for Country Health Information Systems and existing HIS capacity. Key barriers or enablers to good disability data collection and use, were documented for each HIS component. Research results suggest there is no gold standard HIS for rehabilitation. There was broad consensus however, that effective health related disability planning requires reliable data on disability prevalence, functional status, access to rehabilitation services and functional outcomes of rehabilitation. For low-resource settings, and where routine HIS are already challenged, planning to include disability and rehabilitation foci starting with a minimum dataset on functioning, and progressively improving the system for increased utility and harmonization, is likely to be most effective and minimize the potential for overburdening fragile systems. The recommendations from this study are based on the successes and challenges of countries with established information systems, and will assist LMICs to prioritize strategic measures to strengthen the collection and use of data for rehabilitation, and progressively realize the rights of people with disabilities.

  7. New Law Requiring Adult Consent for a Minor's Abortion (1991 Wisconsin Act 263). Information Memorandum 92-12.

    Wisconsin State Legislative Council, Madison.

    This document describes Wisconsin's new law requiring the consent of a minor's parent or adult relative in order for a physician to perform an abortion on a minor. Part I describes highlights of the new law, including the consent requirement, exemptions, and court bypass procedure. Part II gives the background of the law, including incidence of…

  8. The Informed Consent under the Situation of Information Asymmetry%信息不对称状态下的知情同意权



    Information asymmetry exists in the medical service market. Due to its special features of the combination of personal goods and public goods, the medical service market can not resolve its problem of imformation asymmetry by self - adjustion. Informed consent grants certain rights to patients to get sufficient medical information in the aspect of law, virtue and reality, and further resolves information dissymmetry to some degree. In modern China, the reform in medical system is still at the initial stage, the competition in the medical service market is still limited and disordered. Moreover, the informed consent is still not clearly defined in Chinese law. Therefore, only by requesting doctors to abide by the principle of informed consent in the aspect of ethics, may information asymmetry be resolved in better degree.%医疗卫生服务属于特殊商品,兼具私人物品和公共物品双重属性,在一定程度上存在非竞争性和排他性.市场很难通过自身调节缓解信息不对称.知情同意权从道德、法律、现实层面赋予患者获取足够有效医疗服务信息的权利,能较好地缓解医疗服务市场的信息不对称.在我国现阶段,由于医疗卫生服务体制改革仍处在攻坚阶段,医疗服务市场竞争仍显混乱.知情同意权存在诸多问题.唯有从道德伦理层面,要求规范医生履行知情同意义务,从而更大限度地缓解医疗服务市场的信息不对称.

  9. Patients' perception and actual practice of informed consent, privacy and confidentiality in general medical outpatient departments of two tertiary care hospitals of Lahore

    Rasheed Almas


    Full Text Available Abstract Background The principles of informed consent, confidentiality and privacy are often neglected during patient care in developing countries. We assessed the degree to which doctors in Lahore adhere to these principles during outpatient consultations. Material & Method The study was conducted at medical out-patient departments (OPDs of two tertiary care hospitals (one public and one private hospital of Lahore, selected using multi-stage sampling. 93 patients were selected from each hospital. Doctors' adherence to the principles of informed consent, privacy and confidentiality was observed through client flow analysis performed by trained personnel. Overall patient perception was also assessed regarding these practices and was compared with the assessment made by our data collectors. Results Some degree of informed consent was obtained from only 9.7% patients in the public hospital and 47.8% in the private hospital. 81.4% of patients in the public hospital and 88.4% in the private hospital were accorded at least some degree of privacy. Complete informational confidentiality was maintained only in 10.8% and 35.5% of cases in public & private hospitals respectively. Informed consent and confidentiality were better practiced in the private compared to the public hospital (two-sample t-test > 2, p value Conclusion Observance of medical ethics is inadequate in hospitals of Lahore. Doctors should be imparted formal training in medical ethics and national legislation on medical ethics is needed. Patients should be made aware of their rights to medical ethics.

  10. Researching Real-World Web Use with Roxy: Collecting Observational Web Data with Informed Consent

    E. Menchen-Trevino (Ericka); C. Karr (Chris)


    textabstractOutside of a laboratory environment, it has been difficult for researchers to collect both behavioral and self-reported Web use data from the same participants. To address this challenge, we created Roxy, which is software that collects real-world Web-use data with participants' informed

  11. 78 FR 59943 - Submission for OMB Review; 30-Day Comment Request; Interactive Informed Consent for Pediatric...


    ... Research (NIDCR), National Institutes of Health, may not conduct or sponsor, and the respondent is not...: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding... plans and instruments must be requested in writing. Proposed Collection: Interactive Informed...

  12. Patient Privacy, Consent, and Identity Management in Health Information Exchange: Issues for the Military Health System


    Medical Journal, Vol. 340, 2010, p. c3111. Greenhalgh, Trisha, Gary W. Wood , Tanja Bratan, Katja Stramer, and Susan Hinder, “Patients’ Attitudes to the...Nationwide Health Information Network: Overview, May 20, 2011. Patel, Vaishali N., Rina V. Dhopeshwarkar, Alison Edwards, Yolanda Barrón

  13. Researching Real-World Web Use with Roxy: Collecting Observational Web Data with Informed Consent

    E. Menchen-Trevino (Ericka); C. Karr (Chris)


    textabstractOutside of a laboratory environment, it has been difficult for researchers to collect both behavioral and self-reported Web use data from the same participants. To address this challenge, we created Roxy, which is software that collects real-world Web-use data with participants' informed

  14. 32 CFR 806b.47 - Rules for releasing Privacy Act information without consent of the subject.


    ..., economy and to avoid redundancy. Unless a system notice specifically excludes a system of records from a... 8. (e) Exception 5. A recipient for statistical research or reporting. The recipient must give advanced written assurance that the information is for statistical purposes only. Note: No one may use any...

  15. 76 FR 30199 - Proposed Extension of Information Collection Request Submitted for Public Comment; Consent To...


    ... (Operating and Maintenance): $170,000. Description: The Department established a safe harbor pursuant to... only if a participant who does not have access to the employer's electronic information system in the normal course of his duties, or a beneficiary or other person entitled to documents, has affirmatively...

  16. Risk management for the emergency physician: competency and decision-making capacity, informed consent, and refusal of care against medical advice.

    Magauran, Brendan G


    This article focuses on those times that the emergency physician (EP) and patient do not agree on a treatment option. Attention is placed on the risk management issues relevant to the patient's unexpected choice. Emphasis is placed on determining a patient's competency or capability of making clinical decisions, with particular focus on the EP deciding that patient competency requires a formal evaluation. The EP should have a strategy for assessing clinical decision-making capability and an understanding of what circumstances should act as a trigger for considering such an assessment. Attention to documentation issues around informed consent, common barriers to consent, refusal of care, and ED discharge against medical advice are examined.

  17. [Information and consent forms for hematopoietic stem cell transplantation donors and recipients: Guidelines from the Franchophone society of bone marrow transplantation and cellular therapy (SFGM-TC)].

    Bruno, Bénédicte; Thibert, Jean-Baptiste; Bancillon, Nelly; Desbos, Anna; Fawaz, Abir; Fournier, Isabelle; Genty, Carole; Issarni, Dominique; Leveille, Sandrine; Premel, Christelle; Polomeni, Alice; Renault, Myriam; Tarillon, Sylvie; Wallart, Anne; Yakoub-Agha, Ibrahim; Bordessoule, Dominique


    Within the context of the SFGM-TC's 6th workshop series on the harmonization of clinical practices, our workshop proposes a standardization of the informed consent process for hematopoietic stem cell donors and recipients leading up to an autologous or allogenic transplantation. All informed consent was for bone marrow or peripheral stem cell donors, and mononuclear/lymphocyte donors according to usual procedures. The informed consent for autologous and allogenic related or unrelated adults and pediatric transplantation patients have been included. A first step has been conducted for collecting in advance the informed consent forms used routinely in all francophone transplantation centers. In a second step, a comprehensive version has been re-written by a multidisciplinary team. For the purposes of understanding the risks and advantages, language has been carefully considered and streamlined. In the third step, texts were sent to stem cell transplantation experts, experts at the French biomedical agency (agence de la biomédecine [ABM]), law specialists, members of the ethical committee of the French society of hematology and several transplant recipients to be edited and proofread.

  18. [Adolescents as research subjects and free informed consent: knowledge and opinion of researchers and adolescents].

    Guariglia, Fabiana; Bento, Silvana Ferreira; Hardy, Ellen


    This article presents the results of a study that evaluated the knowledge and opinions of researchers and adolescents that served as their research subjects on the legal norms that regulate the participation of the latter as research subjects, the capacity of adolescents to make autonomous decisions regarding participation, and the adolescent experience after agreeing to take part in a study. This was a qualitative study with a convenience sample, the size of which was defined by the criteria of informational redundancy. Interviews were conducted with three researchers who had used adolescents as research subjects and nine of these subjects. This number of interviews was sufficient to reach informational redundancy. Data was collected through recorded semi-structured interviews, with open questions. All the researchers were familiar with some legal document related to the participation of adolescents as subjects of research. On the other hand, the adolescents were surprised because they were not aware of the existence of such documents. However, they considered them necessary for their own protection. In general, researchers and adolescents believe that adolescents have the capacity to decide autonomously to participate as research subjects. The adolescents affirmed that they had decided to volunteer conscientiously.

  19. Being uninformed on informed consent: a pilot survey of medical education faculty

    Henry Rebecca C


    Full Text Available Abstract Background This paper describes a pilot survey of faculty involved in medical education. The questionnaire focuses on their understanding of IRB policies at their institution, specifically in relation to the use of student assessment and curriculum evaluation information for scholarship. Methods An anonymous survey was distributed to medical educators in a variety of venues. Two brief scenarios of typical student assessment or curriculum evaluation activities were presented and respondents were asked to indicate their likely course of action related to IRB approval. The questionnaire also asked respondents about their knowledge of institutional policies related to IRB approval. Results A total of 121 completed surveys were obtained; 59 (50% respondents identified themselves as from community-based medical schools. For the first scenario, 78 respondents (66% would have contact with the IRB; this increased to 97 respondents (82% for the second scenario. For both scenarios, contact with the IRB was less likely among respondents from research-intensive institutions. Sixty respondents (55% were unsure if their institutions had policies addressing evaluation data used for scholarship. Fifty respondents (41% indicated no prior discussions at their institutions regarding IRB requirements. Conclusion Many faculty members are unaware of IRB policies at their medical schools related to the use of medical student information. To the extent that policies are in place, they are highly variable across schools suggesting little standardization in faculty understanding and/or institutional implementation. Principles to guide faculty decision-making are provided.

  20. Risk of seizures in transcranial magnetic stimulation: a clinical review to inform consent process focused on bupropion

    Dobek CE


    Full Text Available Christine E Dobek,1 Daniel M Blumberger,2 Jonathan Downar,3 Zafiris J Daskalakis,2 Fidel Vila-Rodriguez11Department of Psychiatry, Faculty of Medicine, Non-Invasive Neurostimulation Therapies (NINET Laboratory, University of British Columbia, Vancouver, BC, 2Department of Psychiatry, Centre for Addiction and Mental Health, 3Department of Psychiatry, University Health Network, University of Toronto, Toronto, ON, CanadaObjective: When considering repetitive transcranial magnetic stimulation (rTMS for major depressive disorder, clinicians often face a lack of detailed information on potential interactions between rTMS and pharmacotherapy. This is particularly relevant to patients receiving bupropion, a commonly prescribed antidepressant with lower risk of sexual side effects or weight increase, which has been associated with increased risk of seizure in particular populations. Our aim was to systematically review the information on seizures occurred with rTMS to identify the potential risk factors with attention to concurrent medications, particularly bupropion.Data sources: We conducted a systematic review through the databases PubMed, PsycINFO, and EMBASE between 1980 and June 2015. Additional articles were found using reference lists of relevant articles. Reporting of data follows Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement.Study selection: Two reviewers independently screened articles reporting the occurrence of seizures during rTMS. Articles reporting seizures in epilepsy during rTMS were excluded. A total of 25 rTMS-induced seizures were included in the final review.Data extraction: Data were systematically extracted, and the authors of the applicable studies were contacted when appropriate to provide more detail about the seizure incidents.Results: Twenty-five seizures were identified. Potential risk factors emerged such as sleep deprivation, polypharmacy, and neurological insult. High-frequency-rTMS was

  1. 整形美容手术中知情同意的伦理探讨%The investigation of informed consent in the plastic surgery

    沈慧青; 陆尔奕; 吴正一


    目的 明确知情同意在整形美容行业中的必要性和重要性,探讨其中隐藏的伦理学意蕴,用知情同意这一重要的伦理原则规范医务人员的行为.方法 使用文献检索法、专家咨询法、抽样调查等方法对整形美容手术中的知情同意情况进行调查,分析实施过程中的规范化情况和遇到的难点和伦理困境.结果 整形美容医师牢牢把握了知情同意这一原则,作为术前常规工作执行,但在实际操作过程中还有些难点.结论 整形美容医生应规范履行知情告知义务,尊重患者的知情权;院方须制定一系列的制度来规范知情同意这一原则.%Object To emphasize the necessity and significance of informed consent in the plastic surgery.Further investigating the ethical implication involved in informed consent principles.To standardize the medical treatment action according to the informed consent principles.Methods Through the literature search method,counseling for experts,sampling surveys and other approaches to elucidate the importancy of informed consent in plastic surgery,to survey and analyze the difficulties and ethical dilemma encountered in the process of standardization.Results Plastic surgeons firmly are aware of the principles of informed consent,as a routine preoperative procedure,however there are still some difficulties in practice.Conclusions To respect the patient's right to know,plastic surgery doctors should be standardized to perform the principle of informed consent; meanwhile hospital should develop a series of systems to regulate the principle of informed consent.

  2. Strengthening the Social Information-Processing Skills of Children: A Controlled Test of the "Let's Be Friends" Program in China

    Wu, Fan; Fraser, Mark W.; Guo, Shenyang; Day, Steven H.; Galinsky, Maeda J.


    Objective: The study had two objectives (a) to adapt for Chinese children an intervention designed to strengthen the social information--processing (SIP) skills of children in the United States, and (b) to pilot test the adapted intervention in China. Methods: Adaptation of the "Making Choices" program involved reviewing Chinese…

  3. Are open-Label Placebos Ethical? Informed Consent and Ethical Equivocations.

    Blease, Charlotte; Colloca, Luana; Kaptchuk, Ted J


    The doctor-patient relationship is built on an implicit covenant of trust, yet it was not until the post-World War Two era that respect for patient autonomy emerged as an article of mainstream medical ethics. Unlike their medical forebears, physicians today are expected to furnish patients with adequate information about diagnoses, prognoses and treatments. Against these dicta there has been ongoing debate over whether placebos pose a threat to patient autonomy. A key premise underlying medical ethics discussion is the notion that the placebo effect necessitates patient deception. Indeed, the American Medical Association guidelines imply that placebo treatment necessary entails a form of deception. As a consequence of this assumption, the fulcrum of debate on the use of placebo treatment has hinged on whether that deception is ever justified. Recently performed experiments with open-label transparently prescribed placebos have begun to challenge the notion that deception is necessary in eliciting the placebo effect and such effects necessarily involve a binary distinction between autonomy and beneficence. In this article we focus on the content of disclosures in distinctive open-label, transparently disclosed placebo studies and inquire whether they might be said to invoke deception in clinical contexts, and if so, whether the deception is unethical. We find that open placebos may be said to involve equivocation over how placebos work. However, drawing on surveys of patient attitudes we suggest that this equivocation appears to be acceptable to patients. We conclude that open placebos fulfil current American Medical Association guidelines for placebo use, and propose future research directions for harnessing the placebo effect ethically.

  4. Quality assessment of patient leaflets on misoprostol-induced labour: does written information adhere to international standards for patient involvement and informed consent?

    Clausen, Jette Aaroe; Rydahl, Eva


    Objectives The need for thorough patient information is increasing as maternity care becomes more medicalised. The aim was to assess the quality of written patient information on labour induction. In most Danish hospitals, misoprostol is the first-choice drug for induction in low-risk pregnancies. Misoprostol has been associated with adverse side effects and severe outcomes for mother and child and is not registered for obstetric use in Denmark. Setting Secondary care hospitals in Denmark. Data Patient information leaflets from all hospitals that used misoprostol as an induction agent by June 2015 (N=13). Design Patient leaflets were evaluated according to a validated scoring tool (International Patient Decision Aid Standards instrument, IPDAS), core elements in the Danish Health Act, and items regarding off-label use and non-registered medication. Two of the authors scored all leaflets independently. Outcome measures Women's involvement in decision-making, information on benefits and harms associated with the treatment, other justifiable treatment options, and non-registered treatment. Results Generally, the hospitals scored low on the IPDAS checklist. No hospitals encouraged women to consider their preferences. Information on side effects and adverse outcomes was poorly covered and varied substantially between hospitals. Few hospitals informed about precautions regarding outpatient inductions, and none informed about the lack of evidence on the safety of this procedure. None informed that misoprostol is not registered for induction or explained the meaning of off-label use or use of non-registered medication. Elements such as interprofessional consensus, long-term experience, and health authorities' approval were used to add credibility to the use of misoprostol. Conclusions Central criteria for patient involvement and informed consent were not met, and the patient leaflets did not inform according to current evidence on misoprostol-induced labour. Our findings

  5. Digitised audio questionnaire for assessment of informed consent comprehension in a low-literacy African research population: development and psychometric evaluation.

    Afolabi, Muhammed O; Bojang, Kalifa; D'Alessandro, Umberto; Ota, Martin O C; Imoukhuede, Egeruan B; Ravinetto, Raffaella; Larson, Heidi J; McGrath, Nuala; Chandramohan, Daniel


    To develop and psychometrically evaluate an audio digitised tool for assessment of comprehension of informed consent among low-literacy Gambian research participants. We conducted this study in the Gambia where a high illiteracy rate and absence of standardised writing formats of local languages pose major challenges for research participants to comprehend consent information. We developed a 34-item questionnaire to assess participants' comprehension of key elements of informed consent. The questionnaire was face validated and content validated by experienced researchers. To bypass the challenge of a lack of standardised writing formats, we audiorecorded the questionnaire in three major Gambian languages: Mandinka, Wolof and Fula. The questionnaire was further developed into an audio computer-assisted interview format. The digitised questionnaire was administered to 250 participants enrolled in two clinical trials in the urban and rural areas of the Gambia. One week after first administration, the questionnaire was readministered to half of the participants who were randomly selected. Participants were eligible if enrolled in the parent trials and could speak any of the three major Gambian languages. The primary outcome measure was reliability and validity of the questionnaire. Item reduction by factor analysis showed that 21 of the question items have strong factor loadings. These were retained along with five other items which were fundamental components of informed consent. The 26-item questionnaire has high internal consistency with a Cronbach's α of 0.73-0.79 and an intraclass correlation coefficient of 0.94 (95% CI 0.923 to 0.954). Hypotheses testing also showed that the questionnaire has a positive correlation with a similar questionnaire and discriminates between participants with and without education. We have developed a reliable and valid measure of comprehension of informed consent information for the Gambian context, which might be easily adapted to

  6. Improving Community Understanding of Medical Research: Audience Response Technology for Community Consultation for Exception to Informed Consent

    Taher Vohra


    Full Text Available Introduction: The Department of Health and Human Services and Food and Drug Administration described guidelines for exception from informed consent (EFIC research. These guidelines require community consultation (CC events, which allow members of the community to understand the study, provide feedback and give advice. A real-time gauge of audience understanding would allow the speaker to modify the discussion. The objective of the study is to describe the use of audience response survey (ARS technology in EFIC CCs. Methods: As part of the Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART, 13 CC events were conducted. We prepared a PowerPoint™ presentation with 4 embedded ARS questions,according to specific IRB guidelines to ensure that the pertinent information would reach our targeted audience. During 6 CCs, an ARS was used to gauge audience comprehension. Participants completed paper surveys regarding their opinion of the study following each CC. Results: The ARS was used with minimal explanation and only one ARS was lost. Greater than 80% of the participants correctly answered 3 of the 4 ARS questions with 61% correctly answering the question regarding EFIC. A total of 105 participants answered the paper survey; 80-90% of the responses to the paper survey were either strongly agree or agree. The average scores on the paper survey in the ARS sites compared to the non-ARS sites were significantly more positive. Conclusion: The use of an audience response system during the community consultation aspects of EFIC is feasible and provides a real-time assessment of audience comprehension of the study and EFIC process. It may improve the community’s opinion and support of the study.

  7. Consentimiento informado: algunas consideraciones actuales Consentimento informado: algumas considerações atuais Informed consent: some current considerations

    Roberto Cañete


    Full Text Available El consentimiento informado constituye un eslabón crucial en las investigaciones que involucran seres humanos. Sin embargo, limitaciones del conocimiento que conducen a errores en su confección y/o aplicación han sido frecuentemente identificadas entre los profesionales a escala global. En correspondencia, se expone una breve revisión temática de su concepto y de los elementos relacionados con su adecuada confección y aplicación, lo que, creemos, permitirá clarificar la información que poseen los profesionales que conducen investigaciones con seres humanos.O consentimento informado constitui um obstáculo crucial nas pesquisas que envolvem seres humanos. No entanto, limitações do conhecimento que conduzem a erros em sua confecção e/ou aplicação têm sido frequentemente identificadas entre os profissionais em escala global. Em correspondência, se expõe uma breve revisão temática de seu conceito e dos elementos relacionados com a sua adequada confecção e aplicação, o que cremos permitirá esclarecer a informação que possuem os profissionais que conduzem pesquisas com seres humanos.Informed consent constitutes a crucial link in research involving human beings. Nevertheless, knowledge limitations which lead to errors of its process and application have been frequently identified by professionals globally. Hence, a brief review of the topic is exposed about the concept and the elements related to adequate process and application, which we belief will allow to clarify the information that professionals who do research involving human beings posses.

  8. Strengthening Social Justice in Informal Dispute Resolution Processes Through Cultural Competence

    Gemma Smyth


    Full Text Available Professor Voyvodic’s call for cultural competence as an ethical requirement challenges perceptions of the legal profession as inherently and necessarily morally neutral. While lawyers wrestle with the boundaries of ethical mandates, alternative dispute resolution practitioners have adopted their own codes of ethics following very much in the path of the law. Although expanding dispute resolution options for disputants, many theorists have warned of the potential of informalism to undermine natural justice principals. I will argue that the choice to omit any explicit commitment to a “social justice ethic” leaves the practice of ADR vulnerable to these decades-old arguments that informalism erodes protections for marginalized populations. As such, I will argue that mediators must call for an explicit social justice mandate in their codes of conduct, training and practices to cement the place of informal processes as equitable – not just efficient – options for settlement. In doing so, informal processes, particularly mediation, may increase discourse in civil society about human rights, thus strengthening their congruence with lived realities of citizens. L’appel que fait la professeure Voyvodic en faveur de compétence culturelle comme exigence éthique lance un défi aux avocats de considérer la compétence culturelle comme étant centrale à leur rôle professionnel, et conteste les suppositions de neutralité morale qui sont centrales à la pratique juridique traditionnelle. Pendant que les avocats débattent les frontières de mandats éthiques, ceux et celles qui s’intéressent au règlement extrajudiciaire de conflits (REC ont adopté leurs propres codes de déontologie qui, suivant de près les sentiers du droit, omettent généralement toute mention de justice sociale, de compétence culturelle ou de droits de la personne. À mon avis, le choix d’omettre un engagement explicite envers la compétence culturelle et la

  9. Informed consent in contrast-enhanced CT. Understanding of risks and identification of possible prognostic factors; Patientenaufklaerung bei kontrastmittelgestuetzter CT. Risikoverstaendnis und Identifikation moeglicher Prognosefaktoren

    Roehrl, S.; Dendl, L.M.; Scharf, G.; Stroszczynski, C.; Schreyer, A.G. [University Medical Center Regensburg (Germany). Dept. of Radiology; Zeman, F. [University Medical Center Regensburg (Germany). Center for Clinical Studies


    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.

  10. A Comparison of the Quality of Informed Consent for Clinical Trials of an Experimental Hookworm Vaccine Conducted in Developed and Developing Countries.

    Diemert, David J; Lobato, Lucas; Styczynski, Ashley; Zumer, Maria; Soares, Amanda; Gazzinelli, Maria Flávia


    Informed consent is one of the principal ethical requirements of conducting clinical research, regardless of the study setting. Breaches in the quality of the informed consent process are frequently described in reference to clinical trials conducted in developing countries, due to low levels of formal education, a lack of familiarity with biomedical research, and limited access to health services in these countries. However, few studies have directly compared the quality of the informed consent process in developed and developing countries using the same tool and in similar clinical trials. This study was conducted to compare the quality of the informed consent process of a series of clinical trials of an investigational hookworm vaccine that were performed in Brazil and the United States. A standardized questionnaire was used to assess the ethical quality of the informed consent process in a series of Phase 1 clinical trials of the Na-GST-1/Alhydrogel hookworm vaccine that were conducted in healthy adults in Brazil and the United States. In Brazil, the trial was conducted at two sites, one in the hookworm non-endemic urban area of Belo Horizonte, Minas, and one in the rural, resource-limited town of Americaninhas, both in the state of Minas Gerais; the American trial was conducted in Washington, DC. A 32-question survey was administered after the informed consent document was signed at each of the three trial sites; it assessed participants' understanding of information about the study presented in the document as well as the voluntariness of their decision to participate. 105 participants completed the questionnaire: 63 in Americaninhas, 18 in Belo Horizonte, and 24 in Washington, DC. Overall knowledge about the trial was suboptimal: the mean number of correct answers to questions about study objectives, methods, duration, rights, and potential risks and benefits, was 45.6% in Americaninhas, 65.2% in Belo Horizonte, and 59.1% in Washington, DC. Although there

  11. Donation after cardiocirculatory death: a call for a moratorium pending full public disclosure and fully informed consent


    Many believe that the ethical problems of donation after cardiocirculatory death (DCD) have been "worked out" and that it is unclear why DCD should be resisted. In this paper we will argue that DCD donors may not yet be dead, and therefore that organ donation during DCD may violate the dead donor rule. We first present a description of the process of DCD and the standard ethical rationale for the practice. We then present our concerns with DCD, including the following: irreversibility of absent circulation has not occurred and the many attempts to claim it has have all failed; conflicts of interest at all steps in the DCD process, including the decision to withdraw life support before DCD, are simply unavoidable; potentially harmful premortem interventions to preserve organ utility are not justifiable, even with the help of the principle of double effect; claims that DCD conforms with the intent of the law and current accepted medical standards are misleading and inaccurate; and consensus statements by respected medical groups do not change these arguments due to their low quality including being plagued by conflict of interest. Moreover, some arguments in favor of DCD, while likely true, are "straw-man arguments," such as the great benefit of organ donation. The truth is that honesty and trustworthiness require that we face these problems instead of avoiding them. We believe that DCD is not ethically allowable because it abandons the dead donor rule, has unavoidable conflicts of interests, and implements premortem interventions which can hasten death. These important points have not been, but need to be fully disclosed to the public and incorporated into fully informed consent. These are tall orders, and require open public debate. Until this debate occurs, we call for a moratorium on the practice of DCD. PMID:22206616

  12. Donation after cardiocirculatory death: a call for a moratorium pending full public disclosure and fully informed consent

    Joffe Ari R


    Full Text Available Abstract Many believe that the ethical problems of donation after cardiocirculatory death (DCD have been "worked out" and that it is unclear why DCD should be resisted. In this paper we will argue that DCD donors may not yet be dead, and therefore that organ donation during DCD may violate the dead donor rule. We first present a description of the process of DCD and the standard ethical rationale for the practice. We then present our concerns with DCD, including the following: irreversibility of absent circulation has not occurred and the many attempts to claim it has have all failed; conflicts of interest at all steps in the DCD process, including the decision to withdraw life support before DCD, are simply unavoidable; potentially harmful premortem interventions to preserve organ utility are not justifiable, even with the help of the principle of double effect; claims that DCD conforms with the intent of the law and current accepted medical standards are misleading and inaccurate; and consensus statements by respected medical groups do not change these arguments due to their low quality including being plagued by conflict of interest. Moreover, some arguments in favor of DCD, while likely true, are "straw-man arguments," such as the great benefit of organ donation. The truth is that honesty and trustworthiness require that we face these problems instead of avoiding them. We believe that DCD is not ethically allowable because it abandons the dead donor rule, has unavoidable conflicts of interests, and implements premortem interventions which can hasten death. These important points have not been, but need to be fully disclosed to the public and incorporated into fully informed consent. These are tall orders, and require open public debate. Until this debate occurs, we call for a moratorium on the practice of DCD.

  13. From Dams to Development Justice: Progress with 'Free, Prior and Informed Consent' Since the World Commission on Dams

    Joji Cariño


    Full Text Available The World Commission on Dams (WCD helped establish as development best practice the requirement to respect the right of indigenous peoples to give or withhold their 'free, prior and informed consent' (FPIC to development projects that will affect them. Recognition of this right helps redress the unequal power relations between indigenous peoples and others seeking access to their lands and resources. In this Viewpoint, we examine the evolution of policy in the ten years since the publication of the WCD Report, and how FPIC has been affirmed as a right of indigenous peoples under international human rights law and as industry best practice for extractive industries, logging, forestry plantations, palm oil, protected areas and, most recently, for projects to reduce greenhouse gas (GHG emissions from deforestation and forest degradation. To date, relatively few national legal frameworks explicitly require respect for this right and World Bank standards have yet to be revised in line with these advances in international law. We analyse how international law also needs to clarify how the right to FPIC relates to the State’s power to impose resource exploitation in the 'national interest' and whether 'local communities' more broadly also enjoy the right to FPIC. In practice, as documented in this Viewpoint and in the cases we review, the right to FPIC is widely abused by corporations and State agencies. A growing tendency to reduce implementation of FPIC to a simplified check list of actions for outsiders to follow, risks again removing control over decisions from indigenous peoples. For FPIC to be effective it must respect indigenous peoples’ rights to control their customary lands, represent themselves through their own institutions and make decisions according to procedures and rhythms of their choosing.

  14. Informed consent and placebo effects: a content analysis of information leaflets to identify what clinical trial participants are told about placebos.

    Felicity L Bishop

    Full Text Available BACKGROUND: Placebo groups are used in randomised clinical trials (RCTs to control for placebo effects, which can be large. Participants in trials can misunderstand written information particularly regarding technical aspects of trial design such as randomisation; the adequacy of written information about placebos has not been explored. We aimed to identify what participants in major RCTs in the UK are told about placebos and their effects. METHODS AND FINDINGS: We conducted a content analysis of 45 Participant Information Leaflets (PILs using quantitative and qualitative methodologies. PILs were obtained from trials on a major registry of current UK clinical trials (the UKCRN database. Eligible leaflets were received from 44 non-commercial trials but only 1 commercial trial. The main limitation is the low response rate (13.5%, but characteristics of included trials were broadly representative of all non-commercial trials on the database. 84% of PILs were for trials with 50:50 randomisation ratios yet in almost every comparison the target treatments were prioritized over the placebos. Placebos were referred to significantly less frequently than target treatments (7 vs. 27 mentions, p<001 and were significantly less likely than target treatments to be described as triggering either beneficial effects (1 vs. 45, p<001 or adverse effects (4 vs. 39, p<001. 8 PILs (18% explicitly stated that the placebo treatment was either undesirable or ineffective. CONCLUSIONS: PILs from recent high quality clinical trials emphasise the benefits and adverse effects of the target treatment, while largely ignoring the possible effects of the placebo. Thus they provide incomplete and at times inaccurate information about placebos. Trial participants should be more fully informed about the health changes that they might experience from a placebo. To do otherwise jeopardises informed consent and is inconsistent with not only the science of placebos but also the

  15. The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--chapter 7: Informed consent and xenotransplantation clinical trials.

    Vanderpool, Harold Y


    This essay explores the meaning and implications of informed consent in xenotransplantation clinical trials from both ethically justifiable and international perspectives. In international and national codes and guidelines involving human subject research and in the laws of many nations, the informed consent of research subjects is obligatory. Its moral foundations include and also extend beyond respect for individual persons as autonomous agents in Western nations. Axioms regarding the value of human life and duties to protect innocent and vulnerable persons from harm, duress, and deceit underlie Western individualism and are broadly shared in many non-Western cultures. Accents on family and/or community consent in China and other nations are compatible with individual consent as long as family and community consent supplement, rather than replace, individual consent. Reflecting its moral foundations, informed consent in medical research is rightly characterized as "voluntary" or "freely given" informed consent because it encompasses researchers' disclosure and subjects' comprehension of all the relevant information about the protocol that reasonable persons would want to know in order to freely and affirmatively enroll in the research. The interplay between these conceptual foundations of informed consent and the realities of xenotransplantation research defines what the nature and functions of consent should be in xenotransplantation clinical trials. Because these trials involve a complex body of medical information, numerous procedures, numerous risks (associated with failure rates, immunosuppression, xenogeneic infections, and so on) and the subject's obligation to abide by extensive national and international precautionary guidelines, informed consent should be enacted as an organized, sequential, thoughtfully paced, jargon-free process of communication. The features and functions of consent forms or consent documents should accord with this process. Rather

  16. Consentimento livre e esclarecido em odontologia nos hospitais públicos do Distrito Federal Informed consent for dentistry in public hospitals, Federal District, Brazil

    Fabiano Maluf


    Full Text Available A individualidade e o poder de decisão dos indivíduos devem ser respeitados. A autonomia manifestada por meio do consentimento livre e esclarecido é a fonte de tal respeito. Este trabalho visou levantar dados sobre a realidade no uso do consentimento livre e esclarecido nos hospitais públicos do Distrito Federal. Um questionário foi encaminhado aos dentistas dos hospitais públicos para ser respondido. Os resultados obtidos demonstram que, no início do tratamento, é utilizado o consentimento livre e esclarecido, de forma verbal, na maioria dos hospitais. Observam-se, ainda, equívocos na utilização e conceituação do consentimento livre e esclarecido. Os documentos misturam autorização do uso de imagem, com consentimento livre e esclarecido. Os documentos apresentam poucas informações e não esclarecem aspectos importantes do tratamento. Portanto, os cirurgiões-dentistas atuantes na rede pública hospitalar necessitam de um aprofundamento nos fundamentos bioéticos com o intuito de congregarem, ao princípio da beneficência, já consolidado e normatizado, o princípio da autonomia.Personal powers of decision and individuality must be respected, grounded on autonomy expressed through informed consent. This paper examines data on the actual use of informed consent in public hospitals in Brazil's Federal District. A questionnaire was completed by dentists in public hospitals, and its findings show that verbal informed consent is obtained at the start of treatment in most of the hospitals. Errors were noted in the use and conceptualization of informed consent. Failing to distinguish between image rights authorization and informed consent, the documents provide little information and do not explain important aspects of the treatment. Dentists practicing in the public hospital network thus need more detailed knowledge of basic bio-ethics in order to merge the long-consolidated and regulated principle of welfare with the principle of

  17. Communications between volunteers and health researchers during recruitment and informed consent: qualitative content analysis of email interactions.

    Townsend, Anne; Amarsi, Zubin; Backman, Catherine L; Cox, Susan M; Li, Linda C


    While use of the Internet is increasingly widespread in research, little is known about the role of routine electronic mail (email) correspondence during recruitment and early volunteer-researcher interactions. To gain insight into the standpoint of volunteers we analyzed email communications in an early rheumatoid arthritis qualitative interview study. The objectives of our study were (1) to understand the perspectives and motivations of individuals who volunteered for an interview study about the experiences of early rheumatoid arthritis, and (2) to investigate the role of emails in volunteer-researcher interactions during recruitment. Between December 2007 and December 2008 we recruited 38 individuals with early rheumatoid arthritis through rheumatologist and family physician offices, arthritis Internet sites, and the Arthritis Research Centre of Canada for a (face-to-face) qualitative interview study. Interested individuals were invited to contact us via email or telephone. In this paper, we report on email communications from 12 of 29 volunteers who used email as their primary communication mode. Emails offered insights into the perspective of study volunteers. They provided evidence prospectively about recruitment and informed consent in the context of early rheumatoid arthritis. First, some individuals anticipated that participating would have mutual benefits, for themselves and the research, suggesting a reciprocal quality to volunteering. Second, volunteering for the study was strongly motivated by a need to access health services and was both a help-seeking and self-managing strategy. Third, volunteers expressed ambivalence around participation, such as how far participating would benefit them, versus more general benefits for research. Fourth, practical difficulties of negotiating symptom impact, medical appointments, and research tasks were revealed. We also reflect on how emails documented volunteer-researcher interactions, illustrating typically

  18. 精神障碍患者知情同意权的研究%Study on the Informed Consent Right of Patients with Mental Disorders

    陈圆方; 李小萍


    Mental Health Law has specify the mental disorder patients’ informed consent right,but in practice, the problems,the mental health status of patients, namely the families’ right of subrogation exercise,“loss of self-control or deny having mental disorder”, have prevented the exercising of informed consent right. Therefore,it is necessary to effectively solve this plight of rebuilding a harmonious relationship between doctors and patients,estab-lishing mentally disordered patients’ right to advance directives, especially choosing the instrument of assessing the individual’ s capacity to consent.%精神障碍患者的知情同意权在《精神卫生法》中有明确的规定,但患者在实现其自身的权益中受自身精神状况、家属的代位行使权及“自制力丧失—否认自己有精神病”等问题的困扰而使其知情同意权得不到切实的保障。在提出上述问题的同时也立足于从和谐的医患关系、患者的预先指示权、尤其是患者知情同意能力的评定的视角来解决上述问题。

  19. 加强卫生信息人才教育研究%Strengthening the Research on Health Information Talents Education



    分析卫生信息人才现状,论述卫生信息人才教育的必要性和重要意义,提出卫生信息人才教育的目标是建立合理的卫生信息人才教育培养机制,为此应加强卫生信息人才教育研究.%The paper analyzes the status of talents in health information field, discusses the necessity and significance of developing health information talents education, puts forward the aim of health information talents education is to build up a reasonable cultivating mechanism of health information talents, for this reason we should strengthen the research in this field.

  20. Mejora de la calidad en el consentimiento informado Melhora da qualidade no consentimento informado Enhancement of informed consent quality

    María Jesús Gómez Ramos

    Full Text Available Objetivo: Aplicar un círculo de mejora al consentimiento informado para la transfusión de hemoderivados. Pacientes y Método: Durante 10 meses se incluyeron 577 pacientes intervenidos en el Hospital General Reina Sofía de Murcia. Seleccionamos 6 criterios relacionados con el cumplimiento de la normativa sobre transfusiones. Tras el análisis de calidad, se aplicaron medidas correctoras y se reevaluaron los criterios. Los datos se compararon con los estándares en ambos periodos y entre periodos. En la primera evaluación se obtuvo un pobre cumplimiento de los criterios. Basándonos en el análisis de factores asociados al incumplimiento y la priorización resultante del diagrama de Pareto, el plan de intervención se dividió en actividad docente y modificaciones organizativas. Resultados: Todos los criterios estaban por debajo del estándar (pObjetivo: Aplicar um círculo de melhora ao consentimento informado para a transfusão de hemoderivados. Pacientes e Método: Durante 10 meses foram incluídos 577 pacientes internados no Hospital General Reina Sofía de Murcia. Selecionamos 6 critérios relacionados com o cumprimento da norma sobre transfusões. Após a análise de qualidade, foram aplicadas medidas corretoras e se reavaliaram os critérios. Os dados foram comparados com os padrões em ambos periodos e entre periodos. Na primeira avaliação se obteve um pobre cumprimento dos critérios. Baseando-nos na análise de fatores associados ao incumprimento e a priorização resultante do diagrama de Pareto, o plano de intervenção se dividiu em atividade docente e modificações organizativas. Resultados: Todos os critérios estavam abaixo do padrão (pAim: To apply an enhancement circle for informed consent for transfusion of blood derivatives. Patients and Method: During 10 months 577 intervened patients were included in General Hospital Reina Sofia of Murcia, Spain. Six criteria were selected related to compliance with transfusion norms

  1. Refinements of the ICF Linking Rules to strengthen their potential for establishing comparability of health information.

    Cieza, Alarcos; Fayed, Nora; Bickenbach, Jerome; Prodinger, Birgit


    Purpose The content of and methods for collecting health information often vary across settings and challenge the comparability of health information across time, individuals or populations. The International Classification of Functioning, Disability and Health (ICF) contains an exhaustive set of categories of information which constitutes a unified and consistent language of human functioning suitable as a reference for comparing health information. Methods and results In two earlier papers, we have proposed rules for linking existing health information to the ICF. Further refinements to these existing ICF Linking Rules are presented in this paper to enhance the transparency of the linking process. The refinements involve preparing information for linking, perspectives from which information is collected and the categorization of response options. Issues regarding the linking of information not covered or unspecified within the ICF are also revisited in this paper. The ICF Linking Rules are valuable for enhancing comparability of health information to ensure that information is available in a consistent manner to serve as a foundation for evidence-based decision-making across all levels of health systems. The refinements presented in this paper enhance transparency in, and ultimately reliability of the process of, linking health information to the ICF. Implications for Rehabilitation The International Classification of Functioning, Disability and Health (ICF) constitutes a unified and consistent language of human functioning suitable as a reference for comparing health information. Comparability of information is essential to ensure that the widest range of information is available in a consistent manner for any decision-maker at all levels of the health system. The refined ICF Linking Rules presented in this article outline the method to establish comparability of health information based on the ICF.

  2. To waiver or not to waiver? The dilemma of informed consent in emergency department suicide prevention research.

    Lynette Joubert


    Full Text Available Ethical issues are inherent in research with vulnerablepopulations; researchers are encouraged to view theseissues as challenges rather than obstacles. This paper detailsthe request of a suicide prevention research collaborationto collect data in specific circumstances involving the waiverof consent. The conflicting multi-ethics committees’responses to this request are examined, with the purpose ofhighlighting the resultant impact of delayed multi-siteethical approvals. Implications of the committees’responses for this research in terms of being able to addressthe original stated project aims of improving future acutehealth service provision to suicidal individuals are discussed.

  3. Shared decision-making: is it time to obtain informed consent before radiologic examinations utilizing ionizing radiation? Legal and ethical implications.

    Berlin, Leonard


    Concerns about the possibility of developing cancer due to diagnostic imaging examinations utilizing ionizing radiation exposure are increasing. Research studies of survivors of atomic bomb explosions, nuclear reactor accidents, and other unanticipated exposures to similar radiation have led to varying conclusions regarding the stochastic effects of radiation exposure. That high doses of ionizing radiation cause cancer in humans is generally accepted, but the question of whether diagnostic levels of radiation cause cancer continues to be hotly debated. It cannot be denied that overexposure to ionizing radiation beyond a certain threshold, which has not been exactly determined, does generate cancer. This causes a dilemma: what should patients be informed about the possibility that a CT or similar examination might cause cancer later in life? At present, there is no consensus in the radiology community as to whether informed consent must be obtained from a patient before the patient undergoes a CT or similar examination. The author analyzes whether there is a legal duty mandating radiologists to obtain such informed consent but also, irrespective of the law, whether there an ethical duty that compels radiologists to inform patients of potential adverse effects of ionizing radiation. Over the past decade, there has been a noticeable shift from a benevolent, paternalistic approach to medical care to an autonomy-based, shared-decision-making approach, whereby patient and physician work as partners in determining what is medically best for the patient. Radiologists should discuss the benefits and hazards of imaging with their patients.

  4. Investigation on knowledge about informed consent by clinicians%临床医师对知情同意相关知识掌握情况的调查

    张利; 魏日胞; 谢院生; 蔡广研; 陈香美


    Objective To investigate on awareness of informed consent related knowledge of medical ethics by clinicians.Methods A survey was conducted by questionnaire in refresher doctors, clinical graduates,and employed residents working in Department of Nephrology,PLA General Hospital from 2012 to 2013.The questionnaire included general questions,and informed consent-related ethical issues in both medical work and research.A total of 44 doctors accepted the survey with a response rate of 100%,and a valid questionnaire rate of 100%.Statistical measurement data were expressed as mean ±standard deviation,and count data expressed as frequency or a percentage.Results The mean working time of the 44 physicians was 5.6 ±3.2 years.43 physicians had been trained on informed consent-related ethical knowledge among whom 37 trained during the university period,4 trained during the master study,and 2 trained in a continuing medical education course.Of the 44 physicians,60%could not fully answered the purpose of informed consent,and 3 1 .8% could not correctly address when informed consent should be carried out in medical activities.None of the 44 physicians answered the content of optional interventions and consequences without treatment which should be addressed to patients among the five elements of informed consent.Only 18 of 44 physicians (40.9%)correctly answered that“Declaration of Helsinki”is the ethical principles for a medical research involving human subjects.Conclusion Clinicians lack in informed consent-related knowledge in medical activities or medical researches,the training about ethical contents should be strengthened in continuing medical education.%目的:了解临床医师对知情同意相关医学伦理知识的知晓情况。方法问卷调查2012~2013年在解放军总医院肾病科工作的进修医师、轮转临床研究生和受聘住院医师。问卷包括一般问题、医疗工作中及医学研究中知情同意相关伦理问题。共有44位

  5. Informed consent, and an ethico-legal framework for paediatric observational research and biobanking: the experience of an Italian birth cohort study.

    Toccaceli, Virgilia; Serino, Laura; Stazi, Maria Antonietta


    Birth cohort studies are important tools for life-course epidemiology, given the spectrum of the environmental, behavioural, and genetic factors that should be considered when making judgements on human health. Biobanks are valuable components of studies designed to investigate the genetic variability of diseases and improve phenotypic characterisation. In studies involving vulnerable populations and biobanks, it is essential to provide ethical reasoning and analyse the legal requirements. We describe the processes and the tools used in the iterative design of an appropriate informed consent model and the ethico-legal framework of the Piccolipiù study. The Piccolipiù study is a prospective population-based study funded by the Italian Ministry of Health that intends to enrol 3,000 newborns and their mothers in five Italian cities, and to store biological samples for future use. To realise these objectives, we performed a thorough evaluation of the literature, of national and international guidelines, and of the impact of the Italian legal requirements for research biobanking. Discussions among stakeholders facilitated the design of the informed consent and the ethico-legal framework. Several topics are addressed, including the suitability of a broad informed consent for paediatric biobanks, infant vulnerability, access to and sharing of data, and the disclosure of individual's genetic results. Discussion of the ethical and legal procedures adopted in epidemiological biobanking might be a fruitful ground for comparison both at the national level, where standardization and homogeneity are lacking, and at the international level, where different regulatory issues are often in the background and might hamper research biobanks networking.

  6. Polycrystalline strengthening

    Hansen, Niels


    . The strength-grain size relationships can be described in a number of empirical equations relating the yield stress and the flow stress in tension to various structural parameters. A number of such equations are reviewed and their predictive capability is discussed. Structural information of importance...... found, and this structural information is correlated with a number of strength structural equations. Finally, the flow stress of fcc and bcc polycrystalline specimens is related to the occurrence of microstructures formed by macroscopic and microscopic strain accommodation processes during plastic...... for the understanding of polycrystalline strengthening is obtained mainly from surface relief patterns and from bulk structures observed by transmission electron microscopy of thin foils. The results obtained by these methods are discussed and correlations are proposed. A number of features characterizing the deformed...

  7. 精神障碍患者知情同意权的伦理审视%Ethical Review of Mental Disorder Patients’ Rights of Informed Consent

    张婷; 沈春明; 刘鹏飞; 胡晓


    精神障碍患者作为社会的弱势群体,其合法权益应当得到保障。在医疗、司法领域中,精神障碍患者在救济渠道和知情同意书问题上依旧得不到有效落实,医生将知情同意书作为规避法律的挡箭牌,法律细化程度依旧不够。对精神障碍患者知情同意权的发展及法律规定予以阐述,通过对伦理学、法理学理论基础予以研究,在论证权利正当性基础上,分析精神障碍患者知情同意权问题涉及的伦理价值冲突,同时针对现实问题提出在多元价值社会中寻求维护精神障碍患者权益的价值平衡。%As one of social vulnerable groups , the legitimate rights and interests of mental disorder patients should be protected .In the medical and judicial field ,mental disorder patients in relief channels and informed consent still cannot get effective implementation .Informed consent is used to shield against law and the refinement degree of law is insufficient . This article analyzed the development and relevant law of informed consent rights of mental disorder patients .In addition , this article analyzed the ethical value conflicts about informed consent rights of mental disorder patients based on research of ethics and jurisprudence ,and the demonstration power legitimacy .Finally ,it suggested that we should seek the balance of value of safeguarding the rights and interests of mental disorder patients in multiple values society aiming at the question of reality .

  8. Strengthening capacity for local evidence to inform local responders to HIV in a remote Solomon Island health service

    David MacLaren


    Full Text Available Background: Documenting specific knowledge and attitudes about HIV in the culturally diverse nation of Solomon Islands is essential to inform locally targeted public health responses. As part of a large capacity-strengthening project at Atoifi Adventist Hospital in East Kwaio, Solomon Islands, researchers, using a ‘learn-by-doing’ process, worked with participants in public health research methods. Methods: Overall, 43 people attended research capacity building workshops in 2011; eight joined the HIV study group. A cross-sectional survey including semi-structured interviews on HIV was conducted by the group. In February 2014, a hospital administrator was interviewed about how the 2011 study informed local HIV responses. Results: Of the 53 survey participants, 64% self-assessed as having little or no HIV knowledge, but 90% knew HIV could be transmitted between men and women during sex. Less than 50% knew HIV could be transmitted between two men having sex, 45% thought HIV could be transmitted by mosquitoes and 55% agreed condoms help protect from HIV. Most participants reported negative attitudes towards people with HIV. Three years later the health administrator reported ad hoc responses to HIV because of low HIV prevalence, increasing noncommunicable diseases, staff turnover and resource shortages. Discussion: This HIV study was used to strengthen research skills in local health professionals and community members in Solomon Islands. It showed that community members require accurate information about HIV transmission and that entrenched stigma is an issue. Although results provided local evidence for local response, ongoing health system challenges and little local HIV transmission meant HIV services remain rudimentary.

  9. Use of deferred consent for severely ill children in a multi-centre phase III trial

    Boga Mwamvua


    Full Text Available Abstract Background Voluntary participation of a subject in research respects a subject's rights, strengthens its ethical conduct, and is formalized by the informed consent process. Clinical trials of life-saving interventions for medical emergencies often necessitate enrolment of patients where prior written individual informed consent is impossible. Although there are regulations and guidelines on protecting subjects in emergency research, these have been criticised for being limited and unnecessarily restrictive. Across Europe and the United States stringent regulations have resulted in a substantial decline of clinical trials involving emergency interventions. Methods We are conducting a trial of fluid resuscitation in children with hypovolaemic shock in six hospitals across three malaria-endemic African countries. The design is pragmatic as children are enrolled on clinical criteria alone and is being conducted in hospitals with facilities typical of many district hospitals across Africa. The trial aims to inform strategy for managing children with febrile illness and features of shock. In order to develop appropriate consent processes for the trial, we conducted a narrative review of current international recommendations for emergency consent. Results Practical or specific guidance was generally sparse or confusing with few examples in the literature to direct our informed consent process. For a sub-group of children who were critically sick or where parents themselves were otherwise too distressed to consider prior written consent, we opted for a modified form of deferred consent. This included verbal assent from guardians at the point of enrolment, with full written consent obtained after stabilising the child. For children who died prior to full written consent, ethical permission was received to waiver full consent. Conclusions In light of the controversy around guidance and regulations in this area we report how and why we have used a

  10. 儿童用药临床试验中的知情同意获得%Informed consent on clinical trail of drug for children

    唐燕; 奚益群


    儿童用药临床试验的开展是儿童用药安全的重要保障,知情同意则是保障受试者权益的关键环节。与成年人相比,处于生长发育期的儿童在生理、心理等方面均有其特殊性。因此,对儿童参与临床试验的知情同意获得有特殊要求。%Clinical trail of drug for children is an important guarantee for the safety of children medication. Informed consent is the key link in the protection of the rights and interests of the subjects. Compared with adults, children in the growth and development are special in physiological, psychological and other aspects. Therefore, there are special requirements in the acquisition of informed consent for children participating in clinical trail.

  11. Building the Partners HealthCare Biobank at Partners Personalized Medicine: Informed Consent, Return of Research Results, Recruitment Lessons and Operational Considerations

    Elizabeth W. Karlson


    Full Text Available The Partners HealthCare Biobank is a Partners HealthCare enterprise-wide initiative whose goal is to provide a foundation for the next generation of translational research studies of genotype, environment, gene-environment interaction, biomarker and family history associations with disease phenotypes. The Biobank has leveraged in-person and electronic recruitment methods to enroll >30,000 subjects as of October 2015 at two academic medical centers in Partners HealthCare since launching in 2010. Through a close collaboration with the Partners Human Research Committee, the Biobank has developed a comprehensive informed consent process that addresses key patient concerns, including privacy and the return of research results. Lessons learned include the need for careful consideration of ethical issues, attention to the educational content of electronic media, the importance of patient authentication in electronic informed consent, the need for highly secure IT infrastructure and management of communications and the importance of flexible recruitment modalities and processes dependent on the clinical setting for recruitment.

  12. 知情同意原则的起源与发展%The Origin and Development of Principle of Informed Consent



    知情同意作为一项基本的医学伦理原则起源于20世纪中叶的西方国家,在医学科研和临床实践中有着不同的产生和发展历程,涉及到一系列的医学伦理规范和法律规定.这一原则的兴起和发展受到西方自由主义思想的影响,并且与20世纪西方社会的权利运动以及医学科学技术的发展相关.%Informed consent is a fundamental principle of medical ethics that originated from the western countries at the middle of the twenty century. It has different origin and development ways between medical research and clinical practice and it is relevant to a lot of ethical codes and laws. The origin and development of informed consent are due mainly to an important effect of liberalistic idea and also relate to the civil right and consumer protection movement and the development of medical science and technology.

  13. Medical Individualism or Medical Familism? A Critical Analysis of China's New Guidelines for Informed Consent: The Basic Norms of the Documentation of the Medical Record.

    Bian, Lin


    Modern Western medical individualism has had a significant impact on health care in China. This essay demonstrates the ways in which such Western-style individualism has been explicitly endorsed in China's 2010 directive: The Basic Norms of the Documentation of the Medical Record. The Norms require that the patient himself, rather than a member of his family, sign each informed consent form. This change in clinical practice indicates a shift toward medical individualism in Chinese healthcare legislation. Such individualism, however, is incompatible with the character of Chinese familism that is deeply rooted in the Chinese ethical tradition. It also contradicts family-based patterns of health care in China. Moreover, the requirement for individual informed consent is incompatible with numerous medical regulations promulgated in the past two decades. This essay argues that while Chinese medical legislation should learn from relevant Western ideas, it should not simply copy such practices by importing medical individualism into Chinese health care. Chinese healthcare policy is properly based on Chinese medical familist resources.

  14. Trauma-Informed Positive Education: Using Positive Psychology to Strengthen Vulnerable Students

    Brunzell, Tom; Stokes, Helen; Waters, Lea


    This paper explores the role of a positive education paradigm in mainstream and specialist classrooms for students who have experienced complex trauma resulting from abuse, neglect, violence, or being witness to violence. Existing trauma-informed education focuses on repairing regulatory abilities and repairing disrupted attachment in students.…

  15. Trauma-Informed Positive Education: Using Positive Psychology to Strengthen Vulnerable Students

    Brunzell, Tom; Stokes, Helen; Waters, Lea


    This paper explores the role of a positive education paradigm in mainstream and specialist classrooms for students who have experienced complex trauma resulting from abuse, neglect, violence, or being witness to violence. Existing trauma-informed education focuses on repairing regulatory abilities and repairing disrupted attachment in students.…

  16. Harmonizing routinely collected health information for strengthening quality management in health systems: requirements and practice.

    Prodinger, Birgit; Tennant, Alan; Stucki, Gerold; Cieza, Alarcos; Üstün, Tevfik Bedirhan


    Our aim was to specify the requirements of an architecture to serve as the foundation for standardized reporting of health information and to provide an exemplary application of this architecture. The World Health Organization's International Classification of Functioning, Disability and Health (ICF) served as the conceptual framework. Methods to establish content comparability were the ICF Linking Rules. The Rasch measurement model, as a special case of additive conjoint measurement, which satisfies the required criteria for fundamental measurement, allowed for the development of a common metric foundation for measurement unit conversion. Secondary analysis of data from the North Yorkshire Survey was used to illustrate these methods. Patients completed three instruments and the items were linked to the ICF. The Rasch measurement model was applied, first to each scale, and then to items across scales which were linked to a common domain. Based on the linking of items to the ICF, the majority of items were grouped into two domains, Mobility and Self-care. Analysis of the individual scales and of items linked to a common domain across scales satisfied the requirements of the Rasch measurement model. The measurement unit conversion between items from the three instruments linked to the Mobility and Self-care domains, respectively, was demonstrated. The realization of an ICF-based architecture for information on patients' functioning enables harmonization of health information while allowing clinicians and researchers to continue using their existing instruments. This architecture will facilitate access to comprehensive and consistently reported health information to serve as the foundation for informed decision-making. © The Author(s) 2016.

  17. Insider Threats: DOD Should Strengthen Management and Guidance to Protect Classified Information and Systems


    examination reports, facility access records, security violation files, travel records, foreign contact reports, and financial disclosure filings. b...suffered grave damage to national security and an increased risk to the lives of U.S. personnel due to unauthorized disclosures of classified information...because this work may contain copyrighted images or other material , permission from the copyright holder may be necessary if you wish to reproduce this

  18. Consenting to Heteronormativity: Assumptions in Biomedical Research

    Cottingham, M.D.; Fisher, J.A.


    The process of informed consent is fundamental to basic scientific research with human subjects. As one aspect of the scientific enterprise, clinical drug trials rely on informed consent documents to safeguard the ethical treatment of trial participants. This paper explores the role of heteronormati

  19. Consenting to Heteronormativity: Assumptions in Biomedical Research

    Cottingham, M.D.; Fisher, J.A.


    The process of informed consent is fundamental to basic scientific research with human subjects. As one aspect of the scientific enterprise, clinical drug trials rely on informed consent documents to safeguard the ethical treatment of trial participants. This paper explores the role of heteronormati

  20. Consentimento informado: o desafio médico-jurídico de nossos dias Informed consent: a medical and legal challenge of our time

    Luiz Carlos Séllos Simões


    Full Text Available OBJETIVOS: Avaliar a real importância de se obter o consentimento informado, em formulário apropriado, e o papel deste no desfecho de ações indenizatórias. MÉTODOS: A letra da lei brasileira e jurisprudência existente atualmente foram comparadas com o decisão judicial do Tribunal de Justiça do Estado do Rio de Janeiro, em 269 casos de ação civil indenizatória contra profissionais de saúde e hospitais. RESULTADOS: Favoráveis (absolvições e desfavoráveis (condenações foram comparadas e possíveis variações em seus resultados foram discutidas quanto à existência, ou não, do termo de consentimento informado. CONCLUSÕES: A obtenção do consentimento informado, em formulários apropriados, ainda não é usual nem na área de saúde nem na jurídica brasileiras. É recomendado que essa prática seja adotada de acordo com os termos descritos neste trabalho, uma vez que este foi escrito nos termos da lei brasileira.OBJECTIVE: To assess the real importance of obtaining informed consent, through an appropriate form, and its role in the outcome of civil liability claims. METHODS: The wording of the existing Brazilian law and jurisprudence were compared with the actual rulings of the State Court of the State of Rio de Janeiro State, in 269 civil liability claims against healthcare professionals and hospitals. Favorable and unfavorable outcomes (i.e. acquittals and convictions were compared, and possible variations in the verdicts were discussed in relation to whether informed consent forms had been filled out or not. CONCLUSIONS: Obtaining informed consent, by means of appropriate forms, is still not a widespread practice in the Brazilian healthcare or judicial systems. It is recommended that this practice be adopted in the manner described in this paper, and as prescribed in Brazilian law.

  1. Design and application of skin care informed consent form in critically ill patient%危重患者皮肤护理知情同意书的设计与应用

    谷红俊; 杨建; 陈迪; 马兴华; 贾艳红


    Objective To discuss the application of informed consent of skin care. Methods The informed consent of skin care was designed by nurses themselves. Informed consent of skin care was applied in the nursing of critically ill patients from October 2013 to August 2014. Comparisons were conducted before and after the use of informed consent of skin care. Results After the application of the informed consent of skin care, there was no complaints while the incidence of complaints was 9. 86% before the application of informed consent of skin care (P<0. 05). Family satisfaction of the skin care was higher than before the application of the informed consent of skin care (98. 4% and 87. 3%) (P <0. 05). Conclusions The application of the informed consent of skin care can improve the quality of skin care in critically ill patients, enhance the relationship between nurse and patient, increase the satisfaction of skin care.%目的 探讨皮肤护理知情同意书在ICU危重症患者中的应用方法 及其效果.方法 自制《皮肤护理知情同意书》,比较应用前后患者皮肤问题不满意事件和患者家属对皮肤护理的满意率.结果 使用皮肤护理知情同意书前,患者家属对皮肤问题不满意事件发生7例,使用后无一例发生,患者家属对皮肤问题的满意率由87.3%提高至98.4%,使用前后比较差异有统计学意义(P<0.05).结论 《皮肤护理知情同意书》的应用有效地提高了危重症患者的皮肤护理质量,增进了护患关系,提高了皮肤护理满意度.

  2. 20 CFR 401.105 - Disclosure of personal information without the consent of the subject of the record.


    ... statute and regulation to provide us with the information in order to establish entitlement for benefits. ... keeps to administer benefit programs under Federal law. (b) We apply different levels of...

  3. Punching strengthen

    Hazem M.F. Elbakry


    Full Text Available An experimental and analytical study on the punching strengthening of reinforced concrete two-way slabs using external steel plates is presented. Five reinforced concrete square slabs of 100 mm thickness were tested over simply supported four sides of 1000 mm span under central square patch load of 100 mm size up to failure. One control slab was tested without strengthening; however, four tested slabs were strengthened using four configurations of square steel plates provided with steel anchor shear studs. Such configurations considered two different plate thickness, two plate side dimensions and different arrangement and diameter of shear studs. The strengthened four slabs showed improved stiffness and punching shear capacity. The magnitude of improvement depended on the plate dimensions and the studs diameter and arrangement. An analytical approach was proposed for predicting the punching shear strength increase due to using the strengthening steel plate. The proposed approach was applied to the tested specimens with the use of the punching shear strength equations adopted by several codes of practice and proved to be in good agreement with the test results. Generally, this research presented a practical strengthening concept that can be used to increase the punching shear capacity of two-way slabs.

  4. The Effects of Training on the Ability of Adults with an Intellectual Disability to Give Informed Consent to Medication

    Ferguson, L.; Murphy, G. H.


    Background: This study had two aims: to investigate the capacity of individuals with intellectual disabilities (ID) to make decisions about their medications, and to evaluate whether the provision of training (information) sessions on medications would increase their capacity. Method: Twenty-eight adults (18 male and 10 female), with a mild to…

  5. 儿童药物临床试验研究知情同意的伦理审查%Ethic review of informed consent in pediatric medicine clinical and trial study

    李艺影; 潘岳松; 任佩娟


    The significant difference between children and adult have been identified in physiology, pharmacology, psychology, recognition and autonomy. There was different characteristics among different children age group. Besides complying with the basic principle of general clinical and trial study, informed consent in clinical and trial study involving children has special requirements in informed information, informed consent procedure, and consent decision. This paper focused on the ethic issues and specificity of informed consent in pediatric clinical and trial study involving children. The paper might provide guidance on the ethic review of informed consent in pediatric clinical and trial study.%由于儿童的生理、药理、心理及认知和自主权与成人有较大的差异,且各年龄段儿童又呈现不同的特点,儿童药物临床试验研究的知情同意除需遵循一般临床试验研究知情同意的基本原则外,在知情告知的信息、知情同意过程和同意的决定等各个环节又有其特殊要求.文章对儿童药物临床试验研究知情同意的伦理学和特殊性进行了辨析,以更好地指导开展儿童药物临床试验研究知情同意的伦理审查.

  6. Informed consent for the administration of an intravenous contrast agent: importance and determinants of patient refusal; Consentimiento informado para la administracion de contraste intravenoso. Importancia y factores determinantes del rechazo por los pacientes

    Martel, J. [Fundacion Hospital Alcorcon. Madrid (Spain); Garcia-Diaz, J. D. [Hospital Universitario Principe de Asturias. Alcala de Henares. Madrid (Spain)


    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. Strengthening district-based health reporting through the district health management information software system: the Ugandan experience


    Background Untimely, incomplete and inaccurate data are common challenges in planning, monitoring and evaluation of health sector performance, and health service delivery in many sub-Saharan African settings. We document Uganda’s experience in strengthening routine health data reporting through the roll-out of the District Health Management Information Software System version 2 (DHIS2). Methods DHIS2 was adopted at the national level in January 2011. The system was initially piloted in 4 districts, before it was rolled out to all the 112 districts by July 2012. As part of the roll-out process, 35 training workshops targeting 972 users were conducted throughout the country. Those trained included Records Assistants (168, 17.3%), District Health Officers (112, 11.5%), Health Management Information System Focal Persons (HMIS-FPs) (112, 11.5%), District Biostatisticians (107, 11%) and other health workers (473, 48.7%). To assess improvements in health reporting, we compared data on completeness and timeliness of outpatient and inpatient reporting for the period before (2011/12) and after (2012/13) the introduction of DHIS2. We reviewed data on the reporting of selected health service coverage indicators as a proxy for improved health reporting, and documented implementation challenges and lessons learned during the DHIS2 roll-out process. Results Completeness of outpatient reporting increased from 36.3% in 2011/12 to 85.3% in 2012/13 while timeliness of outpatient reporting increased from 22.4% to 77.6%. Similarly, completeness of inpatient reporting increased from 20.6% to 57.9% while timeliness of inpatient reporting increased from 22.5% to 75.6%. There was increased reporting on selected health coverage indicators (e.g. the reporting of one-year old children who were immunized with three doses of pentavelent vaccine increased from 57% in 2011/12 to 87% in 2012/13). Implementation challenges included limited access to computers and internet (34%), inadequate

  8. Analysis on the existing problems and present implemental situation of the informed consent%知情同意书实施现状及存在问题分析

    刘乐; 胡蓉


    对某市6家综合医院的650名医患双方进行问卷调查,有84.1%的患者和71.3%的患者家属曾经签署过知情同意书.对医患双方知情同意书的认知情况进行调查,通过8个问题的正确率统计,医方和患方的平均正确率分别为80.1%和65.0%,医患双方对知情同意书的理解还存在一些误区.结合临床实践中知情同意书存在的问题,提出严格书写规范,提高填写质量;结合医院实际修订,完善知情同意书的内容;提高医患双方认知水平,充分发挥其权益保障作用等建议.%To conduct a questionnaire survey to 650 both doctors and patients from six general hospital , 84 .1% patients and 71.3% family members had signed the informed consent. Then investigated on the cognition of doctors and patients who signed the informed consent , by eight issues of the correct rate statistics , the average correct rate of doctors was 80 .1% , while the patients is 65% , and there were still some misunderstandings on their comprehension about informed consent. Combined with clinical practice informed consent problems , we put forward the strict norms of writing to improve filling quality , and at the same time complete the content of informed consent , improve the cognitive level of both sides , fully play its role in protecting the rights and interests .

  9. 儿科诊断性 X线扫描家属知情与接受现状调查%Investigation on family members informed consent and accepting the status quo of children's diagnostic X-ray scanning

    徐筱; 赵志勇; 吴清美; 张华


    was acceptable (P<0. 001). Conclusions:In the primary hospitals, the informed consent about children's di-agnostic X-ray scanning in pediatric departments should be strengthened. The X-ray examination in pediatric departments is much more and should be avoided by reinforcing publicizing and education.

  10. Consent in crisis: the need to reconceptualize consent to tissue banking research.

    Lipworth, W; Ankeny, R; Kerridge, I


    The issues surrounding consent to tissue banking research in Australia are complex and have created a forum of intense debate, thus providing a window of opportunity to critically appraise and challenge standard models of consent for research in general and for tissue banking research in particular. The usual practical difficulties associated with meeting the criteria for valid consent to research (including adequate information provision and voluntariness) are amplified in the case of tissue banking research. A number of models, based on widely accepted ethical principles, have been proposed to improve the process of obtaining consent to tissue banking research, all of which assume that the consent of individual tissue donors is needed to meet the criteria for valid consent. Feminist and communitarian theories use many of the same criteria for valid consent but interpret these criteria differently and de-emphasize the importance of individual autonomy as the central criterion for valid consent. An enriched model of consent incorporating feminist and communitarian ideas could satisfy the currently accepted criteria for valid consent while also furthering a broader range of community values.

  11. Alzheimer disease ethics--informed consent and related issues in clinical trials: results of a survey among the members of the Research Ethics Committees in Sweden.

    Peterson, Gunbrith; Wallin, Anders


    The rapid advances in biomedical sciences have induced special moral and ethical attitudes, which ought to be taken into account. One of the most essential issues is the principles for participation in research of subjects with reduced decision-making capacity. We conducted a questionnaire survey among members of the research ethics committees in Sweden to find out their attitudes to a range of ethical issues related to research on subjects with Alzheimer's disease. One hundred thirty-six of those approached responded (66%), and 117 of the responses (56%) were considered substantially complete. There were 16 questions with fixed reply alternatives. Some central questions concerned the informed consent process. With a few exceptions, there were no significant differences in attitudes between the experts and laypersons, between persons of different ages, and between men and women. However, women and laypersons were in general keener to preserve the patient's integrity and the experts were more willing than the laypersons to allow participation of subjects with dementia in placebo-controlled trials.

  12. [Informed Consent and the Approval by Ethics Committees of Studies Involving the Use of Atypical Antipsychotics in the Management of Delirium].

    Millán-González, Ricardo


    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.

  13. Human dignity and consent in research biobanking


    Dec 2, 2012 ... Research biobanking raises numerous ethical questions.1 This ... ethical and legal reflections on the notion of informed consent in ... Faculty of Theology and Philosophy, Australian Catholic University, Brisbane, Australia.

  14. On the Value Analysis and Improvement of Informed Consent Regulation of Mental Health Law in China%我国精神卫生法知情同意规则的价值分析及完善研究

    王茹; 王兆良


    The Mental Health Law promulgated in 2012 in China makes many new provision of informed consent, it embodies the legislation on the humanistic consent for patients with mental disorders. Mental Health Law scientifically demarcates the general and special inform obligation, embodies the inform obligation applicable objects, details the content of the inform obligation, definitizes the procedures of the inform obligation, determines the professional principle of judging the informed consent ability. However, there is a need of further perfected of the standards of information disclosure, violation of the responsibility of the inform obligation and informed consent relief program.%我国2012年颁布的《精神卫生法》对知情同意作出了许多新的规定,体现了立法上对精神障碍患者的人文关怀。《精神卫生法》对一般告知义务和特殊告知义务进行了科学划界,具体化了告知义务的适用对象,细化了告知义务的内容,严格了告知义务的程序,确定了知情同意能力判断的专业性原则等。但是,在信息披露的标准、违反告知义务的责任、知情同意救济程序等问题的规定上还存在着需要进一步完善的地方。

  15. Consenting options for posthumous organ donation: presumed consent and incentives are not favored


    Background Posthumous organ procurement is hindered by the consenting process. Several consenting systems have been proposed. There is limited information on public relative attitudes towards various consenting systems, especially in Middle Eastern/Islamic countries. Methods We surveyed 698 Saudi Adults attending outpatient clinics at a tertiary care hospital. Preference and perception of norm regarding consenting options for posthumous organ donation were explored. Participants ranked (1, most agreeable) the following, randomly-presented, options from 1 to 11: no-organ-donation, presumed consent, informed consent by donor-only, informed consent by donor-or-surrogate, and mandatory choice; the last three options ± medical or financial incentive. Results Mean(SD) age was 32(9) year, 27% were males, 50% were patients’ companions, 60% had ≥ college education, and 20% and 32%, respectively, knew an organ donor or recipient. Mandated choice was among the top three choices for preference of 54% of respondents, with an overall median[25%,75%] ranking score of 3[2,6], and was preferred over donor-or-surrogate informed consent (4[2,7], p organ donation (11[7,11] vs. 11[6,11], respectively, p = 0.002). Compared to females, males more perceived donor-or-surrogate informed consent as the norm (3[1,6] vs. 5[3,7], p organ donor or recipient. Conclusions We conclude that: 1) most respondents were in favor of posthumous organ donation, 2) mandated choice system was the most preferred and presumed consent system was the least preferred, 3) there was no difference between preference and perception of norm in consenting systems ranking, and 4) financial (especially in females) and medical (especially in males) incentives reduced preference. PMID:23173834

  16. Included or Excluded: An Analysis of the Application of the Free, Prior and Informed Consent Principle in Land Grabbing Cases in Cameroon

    Jean-Claude N Ashukem


    Full Text Available Even though the principle of free, prior and informed consent (FPIC is soft law, the need to respect, protect and fulfil the rights to be informed and to be involved in development projects is strongly backed in international legal instruments including inter alia the ILO Convention 169 Concerning Indigenous and Tribal People in Independent Countries (1998 and the UN Declaration on the Rights of Indigenous and Tribal People (2007. These instruments do not only appear to be the most comprehensive and advanced international legal instruments that deal with indigenous peoples' rights in terms of the FPIC, but also signal an addition to the growing body of international human rights law that serves to ensure the realisation and protection of the substantive environmental and other human rights of indigenous people, particularly in the context of land grabbing activities that have the potential to negatively impact on their rights. Such rights include, for example, the rights to be informed and to participate in decision-making processes with respect to development projects, including land grabbing activities. This implies an obligation on states party to such international agreements to ensure that indigenous people are informed about and are actively involved in both the negotiation and the implementation of land grabbing deals. However, because the latter often takes place against the background of non-transparent transactions which are inimical to the rights and interests of indigenous people, one may wonder why the principle of FPIC is not applicable during land grabbing transactions. Focusing on Cameroon, this article examines instances of land grabbing in the country in order to support this hypothesis. This is done by focusing specifically on the application of the principle of FPIC. The arguments in the article are inspired by international law in which the application of the principle in the context of land grabbing serves not only to

  17. A quality assessment of patient leaflets on misoprostol induced labour – does written information adhere to international standards for patient involvement and informed consent?

    Clausen, Jette Aaroe; Juul, Mette; Rydahl, Eva


    Objectives: The need for thorough patient information is increasing as maternity care becomes more medicalised. The aim was to assess the quality of written patient information on labour induction. In most Danish hospitals misoprostol is the first-choice drug for induction in low-risk pregnancies...... were not met, and the patient leaflets did not inform according to current evidence on misoprostol-induced labour. Our findings indicate that patients receive very different, sometimes contradictory, information with potential ethical implications. Concerns should be given to outpatient inductions...

  18. Strengthening national capacities for researching on Social Determinants of Health (SDH) towards informing and addressing health inequities in Tanzania

    Mtenga, Sally; Masanja, Irene M; Mamdani, Masuma


    Background Tanzania’s socio-economic development is challenged by sharp inequities between and within urban and rural areas, and among different socio-economic groups. This paper discusses the importance of strengthening SDH research, knowledge, relevant capacities and responsive systems towards addressing health inequities in Tanzania. Methods Based on a conceptual framework for building SDH research capacity, a mapping of existing research systems was undertaken between February and June 20...

  19. Consent for organ donation

    Vincent, A; Logan, L


    Summary Improving the consent rate for solid organ donation from deceased donors is a key component of strategies in the UK and other countries to increase the availability of organs for transplantation...

  20. 关于强化学生信息素质教育的一点思考%Consideration on Strengthening Students' Information Literacy Education



    本文主要从激发学生求知欲望,图书馆工作职能,学生信息素质教育的培养,以及建设高素质的教师队伍方面来思考强化学生信息素质教育问题.%This articie discussed how to strengthen student's information literacy education mainly from inspiring students' seeking knowledge desire,library functions, the cultivation of students' information literacy education, and constructing the quality of the teachers.

  1. Electroconvulsive therapy without consent.

    Moksnes, Kjell Martin


    In principle, electroconvulsive therapy (ECT) can only be administered to patients who consent to the treatment. If the patient does not consent, the treatment can be given in exceptional cases, in situations where a plea of necessity can be made. The purpose of this study was to investigate whether the issue of consent was documented in the patient records at Dikemark Hospital in the period 1960-95, and to study the outcomes for patients who were given ECT treatment without having consented. The article is based on a review of the ECT protocols and the records of patients who were given this treatment during the period 1960-95 in three psychiatric wards at Dikemark Hospital. We registered whether the issue of consent had been documented, and if so, whether consent had been provided or not. The material encompasses 241 ECT series administered to 141 patients. The issue of consent had been documented for 107 of a total of the 241 series. Seven patients were given the therapy against their wishes. The median age of these seven was 68 years (range 56-82 years). All of them had been diagnosed with depressive psychosis and were given electroconvulsive therapy on a vital indication under a plea of necessity. Insufficient intake of nourishment was described as the main reason for the vital indication in all the seven patients. According to their records, they showed signs of improvement on the day after the first treatment. Their lifespan after the treatment varied from three to 19 years. On the basis of the records in which it was documented that the patient had not provided consent, electroconvulsive therapy was administered exclusively as a life-saving intervention.

  2. Legal sanctity of consent for surgical procedures in India

    Gauri Sharma


    Full Text Available As surgeons, we are morally committed to respecting the right of self-determination of patients, thus an informed consent is necessary before any operative intervention. Many neurosurgical patients are incapable of giving consent because of impaired consciousness. Moreover, neurosurgical procedures involve high risks and often are time sensitive; therefore obtaining consent is a challenging job. Patients and their family members need immense courage, understanding, and trust before giving consent for a surgical procedure to a doctor. Lawsuits against doctors are on the rise and it is important to understand "what is consent?" in legal parlance.

  3. Black Boxing Restraints: The Need for Full Disclosure and Consent

    Mohr, Wanda K.; Nunno, Michael A.


    In this article we discuss the necessity of fully informing patients and their families of what constitutes physical interventions and their attendant risks under the established principles and obligations of informed consent. After a brief review of the elements of informed consent and the nature of the duty to advise patients and their families…

  4. Black Boxing Restraints: The Need for Full Disclosure and Consent

    Mohr, Wanda K.; Nunno, Michael A.


    In this article we discuss the necessity of fully informing patients and their families of what constitutes physical interventions and their attendant risks under the established principles and obligations of informed consent. After a brief review of the elements of informed consent and the nature of the duty to advise patients and their families…

  5. Role of Informed Consent in a Decision-making on Participation in The Clinical Trial: Multicenter study in Russia “Face to Face”

    O. I. Zvonareva


    Full Text Available Introduction. Currently, clinical trials (CT remain the only technology, which provides proof of efficacy and safety of new drugs and their subsequent release to the market. Medical researcher and informed consent (IC are the main (and often the only source of information for the patient about the upcoming clinical trials, and thus have a direct impact on the perception of clinical trials, and on the patient’s decision about participation. However, the degree of influence of these factors on the clinical trials participants still remains unclear.Materials and methods. A multicenter cross-sectional study was conducted in different cities of the Russian Federation. Patients who had previous experience in CTs (or were enrolled in a CT at the time of this study were asked to complete a questionnaire.Results. To assess the impact of researcher, all respondents were divided into 2 groups: patients that acquainted with IC in collaboration with the researcher, and the other group, which reviewed IC form independently. We evaluated the importance of the factors influencing the decision-making process on participation in clinical trials. According to our data, the most important factors were professional monitoring services (3,72 ± 1,00, regular condition monitoring (3,66 ± 0,98, and better medical care (3,62 ± 1,00. These factors were evaluated at significantly lower score by group of patients that acquainted with IC together with the researcher (3,55 ±0,94, vs 4,01 ± 0,90, p = 0,002; 3,52 ± 1,01 vs 3,87 ± 0,90, p = 0,040; 3,49 ± 0,94, vs 3,83 ± 1,06, p = 0,020 respectively. In assessing the factors that had negative impact on the interest in participating in a clinical trial, the most significant were risk of side effects (3,01 ± 1,27, study of new medication (2,68 ± 1,21, and the risk of getting into the placebo group (2,64 ± 1,34 (so-called “objective” risk factors. At the same time, risk of side effects and risk of

  6. Consentimento Informado Normatizado pela Resolução 196/96: Conhecimento e Opinião de Pesquisadores Brasileiros Knowledge and Opinion of Brazilian Researchers About Informed Consent

    Hardy Ellen


    Full Text Available Introdução : a Resolução 196/96, do Conselho Nacional de Saúde (Ministério da Saúde, apresenta as diretrizes regulamentadoras mais abrangentes acerca de pesquisas envolvendo seres humanos no Brasil, incluindo o conteúdo do termo de consentimento. Objetivo: apresentar o conhecimento e opinião de pesquisadores brasileiros sobre o conteúdo da Resolução 196/96 do Conselho Nacional de Saúde em relação ao consentimento informado. Sujeitos e Métodos: 46 responsáveis pela área de ginecologia em universidades, 4 diretores de centros de pesquisa e 31 pesquisadores, que participaram de um estudo sobre regulação da fecundidade nos 12 meses anteriores a setembro de 2000, completaram um questionário auto-respondido. Para a análise dos dados foi utilizado o teste de chi². Resultados: a maioria dos participantes: declarou conhecer a Resolução e que a considerava adequada, embora difícil de ser cumprida; opinou que todas as pesquisas deviam ter um termo de consentimento; sabia que o termo deve assegurar o sigilo. Significativamente mais pesquisadores do que responsáveis/diretores sabiam que o termo tinha que ser elaborado pelo pesquisador principal, em duas vias. Mais responsáveis/diretores do que pesquisadores disseram que os participantes sempre devem assinar ou colocar a impressão digital no termo e consideraram que a forma de ressarcimento das despesas decorrentes de participar no estudo deve sempre constar no documento. Conclusões: apesar da difusão dada à Resolução 196/96, nem todos os sujeitos deste estudo a conheciam, mesmo estando ligados a uma universidade ou centro de pesquisa. A maioria foi favorável aos conteúdos exigidos pela Resolução para o consentimento informado.Introduction: the Resolution 196/96 of the Conselho Nacional de Saúde (National Council of Health/Ministry of Health presents the main Brazilian guidelines on research involving human subjects, including the content of written informed consent

  7. A descriptive study of consent documentation.

    Murphy, K


    The aim of this study was to observe the error rate in the consent process of a university hospital and to illicit the opinions of the consenting doctors on the process. A prospective observational review of theatre consent forms was performed along with an anonymous survey of non-consultant hospital doctors (NCHD\\'s). No potential risks were documented in 95.3% of the 64 scrutinized consents and late alterations were required in 9%. Respondents to the NCHD survey estimated that they were unsure of the procedure or risks involved in an average of 29% of occasions. Interns admitted to being unsure of the details of the procedure in almost a third (32%) of cases, making them less well informed than their senior colleagues (p=0.024). This study highlights the difficulties encountered by consenting doctors, an issue which may lead to patient dissatisfaction, threaten the efficient running of a surgical unit and potentially expose its staff to avoidable litigation. It also recommends the use of multimedia adjuncts to facilitate both patient and doctor education in the consent process.

  8. Strengthening institutional and organizational capacity for social health protection of the informal sector in lesser-developed countries: a study of policy barriers and opportunities in Cambodia.

    Annear, Peter Leslie; Ahmed, Shakil; Ros, Chhun Eang; Ir, Por


    Reaching out to the poor and the informal sector is a major challenge for achieving universal coverage in lesser-developed countries. In Cambodia, extensive coverage by health equity funds for the poor has created the opportunity to consolidate various non-government health financing schemes under the government's proposed social health protection structure. This paper identifies the main policy and operational challenges to strengthening existing arrangements for the poor and the informal sector, and considers policy options to address these barriers. Conducted in conjunction with the Cambodian Ministry of Health in 2011-12, the study reviewed policy documents and collected qualitative data through 18 semi-structured key informant interviews with government, non-government and donor officials. Data were analysed using the Organizational Assessment for Improving and Strengthening Health Financing conceptual framework. We found that a significant shortfall related to institutional, organisational and health financing issues resulted in fragmentation and constrained the implementation of social health protection schemes, including health equity funds, community-based health insurance, vouchers and others. Key documents proposed the establishment of a national structure for the unification of the informal-sector schemes but left unresolved issues related to structure, institutional capacity and the third-party status of the national agency. This study adds to the evidence base on appropriate and effective institutional and organizational arrangements for social health protection in the informal sector in developing countries. Among the key lessons are: the need to expand the fiscal space for health care; a commitment to equity; specific measures to protect the poor; building national capacity for administration of universal coverage; and working within the specific national context.

  9. Consent for Dental Therapy in Severely Ill Patients.

    Litch, C. Scott; Liggett, Martha L.


    Legal standards for informed consent are discussed in the context of dental care for the elderly and severely ill. Variations in state common law and legislation are analyzed, focusing on differences between practitioner-oriented and patient-oriented approaches to informed consent. Implications for educators and practitioners are examined.…

  10. El consentimiento informado en el tratamiento integral del niño con fisura labio-alveolo-palatina Informed consent in the comprehensive treatment of children with labial-alveolar-palatal clefts

    Georgia Garmendia Hernández


    Full Text Available Introducción: el Servicio de Cirugía Maxilofacial del Hospital Pediátrico Universitario "Juan Manuel Márquez" de La Habana adoleció de un proceso estandarizado de consentimiento informado. Se tuvo además como propósito el analizar los criterios de los representantes válidos sobre la información que le brindaría el consentimiento informado. Métodos: se estudió a los 32 integrantes del equipo multidisciplinario y a 9 representantes válidos de los pacientes para así constatar el grado de conocimiento sobre los principios de Ética Médica y Bioética. Resultados: se mostró que la mayoría tuvo un nivel bajo en cuanto a Ética Médica y niveles medio o alto en la Bioética. Los representantes válidos presentaron un nivel bajo. Se confirmó el reconocimiento de la necesidad e importancia del consentimiento informado aunque el equipo de salud refirió que no lo utiliza adecuadamente. Se elaboró una propuesta metodológica del proceso de consentimiento informado. Conclusiones: el nivel de conocimiento sobre los principios de la Ética Médica y la Bioética de los profesionales no se correspondió con la percepción que ellos tuvieron ni con la expresión práctica de dichos elementos.Introduction: the Maxillofacial Surgery Service at Juan Manuel Marquez Children's University Hospital in Havana did not have a standardized informed consent procedure. Another purpose was to analyze the opinions of valid representatives about the information to be provided by such informed consent. Methods: a study was conducted of the 32 members of the multidisciplinary team and 9 valid representatives of the patients to verify their awareness of the principles of medical ethics and bioethics. Results: most showed low awareness of medical ethics, and medium to high awareness of bioethics. Valid representatives showed a low level of awareness. Acknowledgement of the importance of and need for informed consent was confirmed, but the medical team admitted

  11. 未成年人器官捐赠知情同意权的法理基础与制度构建∗%Nomological basis and institution construction of right of informed consent of organ donation of minors



    近年来器官捐赠的行为越来越多,其合法性特别是未成年人器官捐赠的合法性引起了社会的广泛关注。分析未成年人器官捐赠的现状及器官的法律性质,明确捐赠行为的合法性和知情同意权的法理基础,指出未成年人器官捐赠知情同意权的不足,并结合社会各方利益提出对策建议,以期建立合法合理的未成年人器官捐赠知情同意权制度。%More and more organ donation appeared in recent years, whose legitimacy is attracting wide attention of the society, especially the legitimacy of organ donation of minors. The status quo of organ donation of minors and the legal character of organ are analyzed, and the legitimacy of donation and the nomological basis of the right of informed consent is clarified. The shortages of the right of informed consent of organ donation of minors are pointed out, and countermeasures and suggestions are proposed combined with the benefits of different subjects of the society, in order to construct legal and proper institution of the right of informed consent of organ donation of minors.

  12. The accompanying adult: authority to give consent in the UK.

    Lal, Seema Madhur Lata; Parekh, Susan; Mason, Carol; Roberts, Graham


    Children may be accompanied by various people when attending for dental treatment. Before treatment is started, there is a legal requirement that the operator obtain informed consent for the proposed procedure. In the case of minors, the person authorized to give consent (parental responsibility) is usually a parent. To ascertain if accompanying persons of children attending the Department of Paediatric Dentistry at the Eastman Dental Hospital, London were empowered to give consent for the child's dental treatment. A total of 250 accompanying persons of children attending were selected, over a 6-month period. A questionnaire was used to establish whether the accompanying person(s) were authorized to give consent. The study showed that 12% of accompanying persons had no legal authority to give consent for the child's dental treatment. Clinicians need to be aware of the status of persons accompanying children to ensure valid consent is obtained.

  13. Monitoring Lake Victoria Water Quality from Space: Opportunities for Strengthening Trans-boundary Information Sharing for Effective Resource Management

    Mugo, R. M.; Korme, T.; Farah, H.; Nyaga, J. W.; Irwin, D.; Flores, A.; Limaye, A. S.; Artis, G.


    Lake Victoria (LV) is an important freshwater resource in East Africa, covering 68,800 km2, and a catchment that spans 193,000km2. It is an important source of food, energy, drinking and irrigation water, transport and a repository for agricultural, human and industrial wastes generated from its catchment. For such a lake, and a catchment transcending 5 international boundaries, collecting data to guide informed decision making is a hard task. Remote sensing is currently the only tool capable of providing information on environmental changes at high spatio-temporal scales. To address the problem of information availability for LV, we tackled two objectives; (1) we analyzed water quality parameters retrieved from MODIS data, and (2) assessed land cover changes in the catchment area using Landsat data. We used L1A MODIS-Aqua data to retrieve lake surface temperature (LST), total suspended matter (TSM), chlorophyll-a (CHLa) and diffuse attenuation coefficient (KD490) in four temporal periods i.e. daily, weekly, monthly and seasonal scales. An Empirical Orthogonal Function (EOF) analysis was done on monthly data. An analysis of land cover change was done using Landsat data for 3 epochs in order to assess if land degradation contributes to water quality changes. Our results indicate that MODIS-Aqua data provides synoptic views of water quality changes in LV at different temporal scales. The Winam Gulf in Kenya, the shores of Jinja town in Uganda, as well as the Mwanza region in Tanzania represent water quality hotspots due to their relatively high TSM and CHLa concentrations. High levels of KD490 in these areas would also indicate high turbidity and thus low light penetration due to the presence of suspended matter, algal blooms, and/or submerged vegetation. The EOF analysis underscores the areas where LST and water color variability are more significant. The changes can be associated with corresponding land use changes in the catchment, where for instance wetlands are

  14. Adolescents and consent to treatment.

    Dickens, B M; Cook, R J


    Adolescents, defined by WHO as 10 to 19 years old, can give independent consent for reproductive health services if their capacities for understanding have sufficiently evolved. The international Convention on the Rights of the Child, almost universally ratified, limits parental powers, and duties, by adolescents' "evolving capacities" for self-determination. Legal systems may recognize "mature minors" as enjoying adult rights of medical consent, even when consent to sexual relations does not absolve partners of criminal liability; their consent does not make the adolescents offenders. There is usually no chronological "age of consent" for medical care, but a condition of consent, meaning capacity for understanding. Like adults, mature minors enjoy confidentiality and the right to treatment according to their wishes rather than their best interests. Minors incapable of self-determination may grant or deny assent to treatment for which guardians provide consent. Emancipated minors' self-determination may also be recognized, for instance on marriage or default of adults' guardianship.

  15. Inclusion of authorized deception in the informed consent process does not affect the magnitude of the placebo effect for experimentally induced pain.

    Martin, Andrea L; Katz, Joel


    The ethics of placebo research have been of paramount concern since the discovery of the phenomenon. To address these ethical concerns, Miller and colleagues (PLoS Med 2005 Sep;2(9):e262, 0853-0859) propose an alternate approach to placebo research, called "authorized deception", in which participants are alerted of the use of deception in the research prior to study enrollment and thus knowingly permit its use if they decide to participate. The present study sought to investigate the authorized deception methodology in experimentally induced placebo analgesia. The participants were randomly assigned to an authorized deception or non-authorized deception group. A commonly used protocol was employed wherein heat pain stimulation was surreptitiously lowered following the application of a placebo cream during a series of conditioning trials and the magnitude of the placebo effect was subsequently assessed in test trials for which the stimulus intensity was the same for both the placebo and control creams. Authorized deception did not have any negative impact on the magnitude of the placebo effect, recruitment and retention of participants, nor did it result in any significant psychological harm. The majority of participants who received this form of consent preferred it to the traditional approach in which the participants are not alerted to the presence of deception. These findings suggest that the use of authorized deception is a viable and ethically preferable alternative consent process for laboratory-based studies on placebo analgesia. Further studies are needed to examine the effect of authorized deception in clinical trials and other placebo research within a clinical setting.

  16. Consent to tissue banking for research: qualitative study and recommendations.

    Soto, Carmen; Tarrant, Carolyn; Pritchard-Jones, Kathy; Dixon-Woods, Mary


    To explore how families of children with cancer experience giving consent for tissue banking and to produce recommendations on good practice. 79 participants from 42 families (41 mothers, 18 fathers, 20 children and young people with cancer) took part in semistructured interviews to explore their experiences of being approached for consent to tissue banking. Tertiary care facilities for childhood cancer. Families are generally supportive of tissue banking, although they report that it may be difficult for them to consider all the implications when asked for consent. They typically do not want detailed information when consent is sought close to diagnosis, preferring to see tissue banking as part of routine practice. Families often recognise that their consent may not be fully informed, but are content to give consent based on their understanding at the time. Some may want a chance to go over the information and revisit their decision when things have settled. Families' views can inform practical recommendations for optimising the experience of consent for tissue banking. Current guidelines for obtaining consent should be revisited to take account of families' preferences.

  17. Identifying inequities in maternal and child health through risk stratification to inform health systems strengthening in Northern Togo

    McCarthy, Katharine J.; Braganza, Sandra; Fiori, Kevin; Gbeleou, Christophe; Kpakpo, Vivien; Lopez, Andrew; Schechter, Jennifer; Singham Goodwin, Alicia; Jones, Heidi E.


    Objective In Togo, substantial progress in maternal and child health is needed to reach global development goals. To better inform clinic and community-based health services, this study identifies factors associated with maternal and child health care utilization in the Kara region of Northern Togo. Methods We conducted a population-representative household survey of four health clinic catchment areas of 1,075 women of reproductive age in 2015. Multivariable logistic regression was used to model individual and structural factors associated with utilization of four maternal and child health services. Key outcomes were: facility-based delivery, maternal postnatal health check by a health professional within the first six weeks of birth, childhood vaccination, and receipt of malaria medication for febrile children under age five within 72 hours of symptom onset. Results 83 percent of women who gave birth in the last 2 years delivered at a health facility. In adjusted models, the strongest predictor of facility delivery in the rural catchment areas was proximity to a health center, with women living under three kilometers having 3.7 (95% CI 1.7, 7.9) times the odds of a facility birth. Only 11 percent of women received a health check by a health provider at any time in the postnatal period. Postnatal health checks were less likely for women in the poorest households and for women who resided in rural areas. Children of polygamous mothers had half the odds of receiving malaria medication for fever within 72 hours of symptom onset, while children with increased household wealth status had increased odds of childhood vaccination and receiving treatment for malaria. Conclusion Our analysis highlights the importance of risk stratification analysis to inform the delivery and scope of maternal and child health programs needed to reach those with the least access to care. PMID:28301539

  18. Applying Cognitive Interviewing to Inform Measurement of Partnership Readiness: A New Approach to Strengthening Community-Academic Research

    Teal, Randall; Enga, Zoe; Diehl, Sandra J.; Rohweder, Catherine L.; Kim, Mimi; Dave, Gaurav; Durr, April; Wynn, Mysha; Isler, Malika Roman; Corbie-Smith, Giselle; Weiner, Bryan J.


    Background Partnerships between academic and community-based organizations can richly inform the research process and speed translation of findings. While immense potential exists to co-conduct research, a better understanding of how to create and sustain equitable relationships between entities with different organizational goals, structures, resources, and expectations is needed. Objective To engage community leaders in the development of an instrument to assess community-based organizations' interest and capacity to engage with academia in translational research partnerships. Methods Leaders from community-based organizations partnered with our research team in the design of a 50-item instrument to assess organizational experience with applying for federal funding and conducting research studies. Respondents completed a self-administered, paper/pencil survey and a follow-up structured cognitive interview (n=11). A community advisory board (n=8) provided further feedback on the survey through guided discussion. Thematic analysis of the cognitive interviews and a summary of the community advisory board discussion informed survey revisions. Results Cognitive interviews and discussion with community leaders identified language and measurement issues for revision. Importantly, they also revealed an unconscious bias on the part of researchers and offered an opportunity, at an early research stage, to address imbalances in the survey perspective and to develop a more collaborative, equitable approach. Conclusions Engaging community leaders enhanced face and content validity and served as a means to form relationships with potential community co-investigators in the future. Cognitive interviewing can enable a bi-directional approach to partnerships, starting with instrument development. PMID:26639377

  19. 从“牙拔除术知情同意书”的签署中看医患关系%Analyzing the Doctor-patient Relationship via the "Tooth Extraction Informed Consent" Singing

    赵亮; 李洁; 蔡丽萍


    The tooth extraction informed consent should be signed before operation. From the perspective of the singing process of the informed consent, this paper explored the contradiction points between doctors and patients and put forward the harmonious doctor - patient relationship must be established on the basis of the constant optimization of the health care system, the mutual cooperation, trust and benefit. Only through doctors'selfless devotion and patients'respect and understanding can the harmonious relationship be established.%患者在牙拔除术前均应签署“牙拔除术知情同意书”.从医患双方不同的角度探讨知情同意书签署过程中的矛盾点,提出和谐医患关系的建立是在医疗体制不断优化完善的基础上,需要医患双方相互合作、互相信任和互惠互利.通过医方真诚的服务并取得患方的尊重和理解,才能建立和谐的医患关系.


    Leonor Palomer R


    Full Text Available Para conocer acerca de la petición de consentimiento informado en odontología, se realizó una búsqueda de información en las bases de dato de SciELO y PubMed, usando las palabras claves "consentimiento informado", "odontología" y "autonomía". Como complemento, para tener información sobre la situación en Chile, se envió una encuesta a 40 cirujanos dentistas de tres centros de atención dental de la Red de Salud de la Pontificia Universidad Católica de Chile. Se puede observar que aún existe desinformación en odontología en cuanto a la finalidad, implicancia e importancia de un adecuado proceso de consentimiento informado en la relación odontólogo-paciente.Para conhecer a respeito do pedido de consentimento informado em odontologia, realizou-se uma busca de informação na base de dados SciELO e Pub Med, usando as palabras chaves "consentimento informado", "odontologia" e "autonomia". Como complemento, para se ter uma informação sobre a situacão no Chile, foi enviado um questionário para 40 cirurgiões dentistas de trës centros de cuidados dentais da Rede de Saúde da Pontifícia Universidade Católica do Chile. Pode-se observar que ainda existe desinformação em odontologia relacionadas com a finalidade, implicância e importância de um adecuado processo de consentimento informado na relação odontólogo-paciente.In order to know more about the petition of informed consent in odontology, we realized a search of information in the database of SciELO and Pub Med, using the key words "informed consent", "odontology" and "autonomy". As a complement, in order to have information about the situation in Chile, a survey was sent to 40 dental surgeons in 3 dental centers belonging to the health network of the Pontificia Universidad Católica de Chile. It can be observed that there still exists disinformation in odontology in Chile relating to the purpose, implications and importance of an adequate process of informed consent in

  1. Seeking consent for research with indigenous communities: a systematic review.

    Fitzpatrick, Emily F M; Martiniuk, Alexandra L C; D'Antoine, Heather; Oscar, June; Carter, Maureen; Elliott, Elizabeth J


    When conducting research with Indigenous populations consent should be sought from both individual participants and the local community. We aimed to search and summarise the literature about methods for seeking consent for research with Indigenous populations. A systematic literature search was conducted for articles that describe or evaluate the process of seeking informed consent for research with Indigenous participants. Guidelines for ethical research and for seeking consent with Indigenous people are also included in our review. Of 1447 articles found 1391 were excluded (duplicates, irrelevant, not in English); 56 were relevant and included. Articles were categorised into original research that evaluated the consent process (n = 5) or publications detailing the process of seeking consent (n = 13) and guidelines for ethical research (n = 38). Guidelines were categorised into international (n = 8); national (n = 20) and state/regional/local guidelines (n = 10). In five studies based in Australia, Canada and The United States of America the consent process with Indigenous people was objectively evaluated. In 13 other studies interpreters, voice recording, videos, pictures, flipcharts and "plain language" forms were used to assist in seeking consent but these processes were not evaluated. Some Indigenous organisations provide examples of community-designed resources for seeking consent and describe methods of community engagement, but none are evaluated. International, national and local ethical guidelines stress the importance of upholding Indigenous values but fail to specify methods for engaging communities or obtaining individual consent. In the 'Grey literature' concerns about the consent process are identified but no solutions are offered. Consultation with Indigenous communities is needed to determine how consent should be sought from the community and the individual, and how to evaluate this process.

  2. Consentimento livre e esclarecido: experiência de pesquisadores brasileiros na área da regulação da fecundidade Free informed consent: the experience of Brazilian researchers in the area of fertility regulation

    Ellen Hardy


    Full Text Available O objetivo deste estudo foi avaliar a experiência de pesquisadores com a apreciação do protocolo por um Comitê de Ética em Pesquisa (CEP; com a elaboração do Termo de Consentimento Livre e Esclarecido (TCLE e com a obtenção do consentimento, e verificar se o conteúdo do TCLE estava de acordo com as exigências da Resolução 196/96. Trinta e quatro pesquisadores completaram um questionário auto-respondido, enviado por correio eletrônico. Quase todos os participantes (91% relataram que o protocolo desse estudo havia sido avaliado por um CEP. Mais da metade deles referiram que o TCLE utilizado havia sido recebido pronto; que o consentimento do possível sujeito havia sido obtido pelo pesquisador responsável, e que os sujeitos haviam recebido uma cópia do Termo assinada. Cerca da metade dos participantes afirmaram que a forma de ressarcimento das despesas dos sujeitos, decorrentes da participação na pesquisa, e 44% disseram que as formas de indenização, no caso de eventuais danos, constavam no Termo. De acordo com o relato dos participantes, em geral as exigências da Resolução avaliadas haviam sido cumpridas.This study aimed to evaluate the experience of Brazilian researchers in relation to: assessment of the research protocol by a research ethics committee with the elaboration of a free informed term of consent (FITC and the process of obtaining consent, as well as to verify whether the content and wording of the term of consent complies with Federal Ruling 196/96. Thirty-four researchers filled out a questionnaire and returned it by electronic mail. The vast majority of the respondents (91% reported that the respective study protocol had been evaluated by a research ethics committee. More than half reported that they had received a previously prepared FITC; that consent from potential study subjects had been obtained by the researcher in charge; and that the subjects had received a copy of their signed FITC. Approximately one

  3. Strengthening of Indonesia school of management in the 21st century through the implementation of school management system based information technology and communications integrated

    Setiawan, Wawan; Munir, Senen, Syamsul Hadi; Nugroho, Eddy Prasetyo; Wihardi, Yaya; Nugraha, Eki


    Indonesia strengthening school management through the implementation of School Management System Based Information Technology and Communications (SMS-ICT) is intended to improve the performance of schools to accommodate the complexities of management in a computerized system that is simple but comprehensive so that it aligns with the era of the 21st century. School Management System Based Information and Communication Technology-based standards developed 12 education, adapted from 8 national standards into the system components that support the characteristics of 21st century schools. Twelfth system components include curriculum, Personal Development, Recruitment of New Student Services and Student Development, Education Labor and Education, Infrastructure, Leadership, School Management, Financing, Evaluation, and Social Communications. Development of the system is done through the stages of systematically covering Need Assessment, System Design, System Development, Testing Limited, Reveiw and Improvement, Testing Expanded, Finalize, and Packaging. SMS-ICT has gained Copyright and had seminars both nationally and internationally, and have been published by national journals, and in a book chapter. SMS-ICT applied to several schools in districy/city of West Java is based on cooperation with the Education Department of West Java. Implementation of School Management System as strengthening school management Indonesia shows the essential matters of school management. SMS-ICT managed to bring changes not only bring substantial improvements to the school how it should be managed, but also change the mindset of school leaders and teachers in ways of thinking and acting more professional in carrying out their respective duties. SMS-ICT managed as a unified system of governance that is integrated schools overall strategic component in an integrated system that implements ICT that has the capacity to process data and information quickly, accurately and reliably. SMS-ICT as a

  4. Consentimiento informado en el balón intragástrico avalado por SENPE, SEEDO, SEN y SECO: aspectos médico-legales Informed consent in the intragastric balloon supported by SENPE, SEEDO, SEN and SECO: legal aspects

    V. Abilés


    Full Text Available Introducción: El Balón Intragástrico (BIG es una técnica invasiva, no quirúrgica, de carácter temporal, para el tratamiento de la obesidad, cuyos resultados dependen en gran medida de la colaboración del paciente. Objetivo: El objetivo es adaptar el Consentimiento Informado propio de la cirugía bariátrica, a un método que reviste las características especiales descritas. Material y método: Se utiliza el Consentimiento Informado propuesto por la ASAC para cirugía bariátrica, así como 8 sentencias relacionadas con el BIG tal como se hallan en la base de datos WESTLAW ES. Resultado: La revisión de las sentencias define el tratamiento mediante BIB como tratamiento con intención curativa y no satisfactiva, con obligación de medios aunque no de resultados, por parte del médico tratante. Se han de respetar además las obligaciones de una información correcta y completa -incluyendo las pautas dietéticas a seguir-, así como de las alternativas terapéuticas posibles, y por fin, de una constancia del proceso por escrito. Conclusiones: El Consentimiento Informado es un importante documento médico-legal cuyo contenido debe tener en cuenta la jurisprudencia recientemente aparecida en el campo de las técnicas mínimamente invasivas para el tratamiento de la obesidad.Introduction: Intra-gastric balloon (IGB is an invasive, temporary, non-surgical technique for the treatment of obesity. Its outcomes mainly depend on the patient's collaboration. Objective: The aim was to adapt the informed consent used for bariatric surgery to a method that has especial characteristics. Materials and methods: We used the informed consent proposed by ASAC for bariatric surgery and 8 statements related to IGB included in the WESTLAW ES database. Results: The review of the statements defines the IGB treatment as a curative-intended and non-satisfactive therapy with an obligation of the means used, but not the outcomes, by the treating physician. Moreover

  5. Human drugs and biologics; determination that informed consent is NOT feasible or is contrary to the best interests of recipients; revocation of 1990 interim final rule; establishment of new interim final rule. Food and Drug Administration, HHS. Interim final rule; opportunity for public comment.


    The Food and Drug Administration (FDA) is revoking its 1990 interim final regulations that permitted the Commissioner of Food and Drugs (the Commissioner) to determine that obtaining informed consent from military personnel for the use of an investigational drug or biologic is not feasible in certain situations related to military combat. FDA also is issuing a new interim final rule addressing waiver of informed consent in military operations. FDA is taking these actions based on its analysis and consideration of all relevant facts, including its evaluation of the Department of Defense's (DOD) experience during the Persian Gulf War, its evaluation of the comments received by the agency in response to the agency's July 31, 1997, request for comments on whether the agency should revise or revoke the interim regulations, and the enactment of the Strom Thurmond National Defense Authorization Act for Fiscal Year 1999 (the Defense Authorization Act). Under the Defense Authorization Act, the President is authorized to waive the Federal Food, Drug, and Cosmetic Act's (the act) informed consent requirements in military operations if the President finds that obtaining consent is infeasible or contrary to the best interests of recipients and on an additional ground that obtaining consent is contrary to national security interests. In light of the enactment of the Defense Authorization Act, with an immediate effective date, and because the President could be called upon to make a waiver determination for military personnel engaged in a specific military operation at any time, the agency believes that it is critical to have in place adequate criteria and standards for the President to apply in making an informed consent waiver determination. Therefore, FDA is issuing a new interim final regulation with an immediate effective date to establish criteria and standards for the President to apply in making a determination that informed consent is not feasible or is contrary to the

  6. Strengthen the innovation of agricultural information technology and service capacity of public service information%加强农业信息科技创新与公益信息服务能力的思考

    刘 珺


    农业信息科技创新是促进现代农业发展、增加农民收入的重要途径,在农业科技中具有重要的引领和支撑作用。要大力加强农业信息技术的创新,提升农业社会化公共信息服务能力。%The innovation of agricultural information technology which plays an important role on leading and supporting in agricultural science and technology is an important way to promote the development of modem agriculture and to increase farmers' income. We should vigorously strengthen the innovations in agricultal information technology, to enhance capability of public information service for the socialization of agriculture.

  7. On the Legal Effect of AID Informed Consent on Parentage Identification%论AID知情同意书在亲子关系认定中的法律效力

    陈传荣; 杨芳


    The extensive application of AID (artificial insemination by a donor) technology brings both a lot of benefit to the infertile couples and a series of ethical and legal issues, especially in parentage identification of AID-children. Identification of the parentage between the AID-children and the relevant parties is of crucial importance to the interests of the AID-children. According to legal provisions and judicial adjudications in different countries, the principle of informed consent plays an important role in parentage identification of AID-children. Due to legislative deficiency in China, the reply of the Supreme People’s Court serves as the only evidence for parentage identification of AID-children, which cannot serve as an ample evidence. The present paper recommends that the future legislation should further clarify and enhance the status of informed consent in parentage identification of AID-children under the guiding principle of informed consent and respect for party autonomy, making it a factual ground that affirms the husband of natural mother as the legal father of AID-children.%AID 技术的广泛应用,为不育症夫妇带来福音的同时也带来一系列伦理和法律问题,AID 子女亲子关系认定尤其突出。明确AID子女与相关当事人的亲子关系,对保护AID子女利益至为重要。根据各国的法律规定和司法裁判,知情同意原则在认定AID子女亲子关系中发挥了重要作用。我国由于法律缺失,仅以最高人民法院的复函作为AID子女亲子关系的认定依据是不够的。建议以遵循知情同意原则、尊重当事人意思自治原则为指导思想,在未来立法中进一步明确和提升知情同意书在AID子女亲子关系中的地位,将AID知情同意书作为认定生母之夫为AID子女法律父亲的事实依据。

  8. Dibasic Esters; Final Enforceable Consent Agreement and Testing Consent Order

    Under section 4 of the Toxic Substances Control Act (TSCA), EPA has issued a testing consent order (Order) that incorporates an enforceable consent agreement (ECA) with the Aceto Corporation, E.I. du Pont de Nemours and Company, and Solutia Inc.

  9. When "no" might not quite mean "no"; the importance of informed and meaningful non-consent: results from a survey of individuals refusing participation in a health-related research project

    McMurdo Marion ET


    does not necessarily mean that a fully informed evaluation of the pros and cons of participation and non-participation has taken place. The meaningfulness of expressions of non-consent may therefore be a cause for concern and should be subject to further research. Many reasons for non-participation may be specific to a particular research topic or population. Information sheets should reflect this by going beyond standardised guidelines for their design and instead proactively seek out and address areas of concern or potential misunderstanding. The use of established behavioural theory in their design could also be considered.

  10. 论我国知情同意权的缺陷*--以“李丽云案”为视角%On the Defects of Informed Consent Right in China---From the perspective of"Li Liyun Case"

    徐连英; 宋庆


    “李丽云案”中,因患者代理人对知情同意权的错误使用,导致了悲剧的发生。知情同意权所体现的,是患者的医疗自主权,而特定情况下,医疗自主权又存在一些局限:非自愿的自愿性、绝对的不容否认性以及形式与内容的矛盾性。这些局限性使得医疗自主权有可能被滥用;而造成权利滥用最直接的原因,则是自主权运行中权利与义务存在不对等性,以及公权力对自主权的运行规制不够。%In "Li Liyun Case", tragedy happened because of the patient's agent abused informed consent right. Informed consent right reflects the patient's medical autonomy right, but in some specific circumstances, there are some limitations to medical autonomy right: unwilling willingness, absolute undeniability, and the contradiction between form and content. These limitations make it possible for medical autonomy right to be abused, and the most direct reasons for the abuses are: the unequivalence of the rights and obligations in the operation of autonomy right, and the insufficient regulation of the public power in the operation of autonomy right.

  11. A randomized trial comparing concise and standard consent forms in the START trial.

    Grady, Christine; Touloumi, Giota; Walker, A Sarah; Smolskis, Mary; Sharma, Shweta; Babiker, Abdel G; Pantazis, Nikos; Tavel, Jorge; Florence, Eric; Sanchez, Adriana; Hudson, Fleur; Papadopoulos, Antonios; Emanuel, Ezekiel; Clewett, Megan; Munroe, David; Denning, Eileen


    Improving the effectiveness and efficiency of research informed consent is a high priority. Some express concern about longer, more complex, written consent forms creating barriers to participant understanding. A recent meta-analysis concluded that randomized comparisons were needed. We conducted a cluster-randomized non-inferiority comparison of a standard versus concise consent form within a multinational trial studying the timing of starting antiretroviral therapy in HIV+ adults (START). Interested sites were randomized to standard or concise consent forms for all individuals signing START consent. Participants completed a survey measuring comprehension of study information and satisfaction with the consent process. Site personnel reported usual site consent practices. The primary outcome was comprehension of the purpose of randomization (pre-specified 7.5% non-inferiority margin). 77 sites (2429 participants) were randomly allocated to use standard consent and 77 sites (2000 participants) concise consent, for an evaluable cohort of 4229. Site and participant characteristics were similar for the two groups. The concise consent was non-inferior to the standard consent on comprehension of randomization (80.2% versus 82%, site adjusted difference: 0.75% (95% CI -3.8%, +5.2%)); and the two groups did not differ significantly on total comprehension score, satisfaction, or voluntariness (p>0.1). Certain independent factors, such as education, influenced comprehension and satisfaction but not differences between consent groups. An easier to read, more concise consent form neither hindered nor improved comprehension of study information nor satisfaction with the consent process among a large number of participants. This supports continued efforts to make consent forms more efficient. Informed consent substudy was registered as part of START study in #NCT00867048, and EudraCT # 2008-006439-12.

  12. Termo de consentimento informado: a visão dos advogados e tribunais Término de consentimiento informado: la visión de los abogados y tribunales Informed consent: the understanding of lawyers and courts

    Adriano Marteleto Godinho


    visión jurídica acerca del universo del consentimiento informado. CONTENIDO: El texto aborda el historial, los conceptos y los fundamentos del Término de Consentimiento, los requisitos para la validez, a saber: capacidad del paciente, voluntariedad, comprensión y prestación de las informaciones relevantes, como también las circunstancias que no necesitan ese Consentimiento. CONCLUSIONES: A través de la firma del Término de Consentimiento Informado, el paciente declara tener conocimiento de la naturaleza de la intervención médica y de los correspondientes riesgos, y los asume con plenitud de conciencia. Se espera que con este artículo, la clase médica esté más consciente de los aspectos legales que están en torno al tema, para que, a partir de ese momento, se puedan evitar las equivocaciones que a menudo hacen llevar la sagrada relación médico-paciente de los consultorios y hospitales, hasta los tribunales.BACKGROUND AND OBJECTIVES: An increase in malpractice lawsuits has been seen in Brazil over the past several years, mainly due to higher awareness of the population regarding the quality of the medical care provided. According to the 1988 Brazilian Constitution and Consumers' Defense Code, physicians cannot subject patients to any treatment or surgical procedure without proper consent. The objective of this article was to provide medical professionals the legal understanding on informed consent. CONSENTS: This report focuses on the history, concepts, and fundaments of the informed consent, and validity requirements such as: capacity, voluntariness, and understanding by the patient, and providing relevant information, as well as the circumstances in which the informed consent is not necessary. CONCLUSIONS: Signing an informed consent is a statement, by the patient, that he/she is aware of the nature of the medical intervention and corresponding risks, and he/she freely accepts those conditions and risks. With this article, we hope the medical community

  13. Where no consent = death.


    Men must be made to understand the value of family planning - particularly in societies where men hold the power of decision in the family. Dr. Kotha Pannikar, chairman of the Kedah Family Planning Association (FPA) in Malaysia, illustrated this point in discussion which followed the Consultation of Medical and Communication Fieldworkers conference in Kuala Lumpur in August, with a story about 1 of her own patients. When the girl, who had a rheumatic heart, was 16, Dr. Pannikar advised the parents that she needed cardiac surgery if she were to be a healthy wife and mother. But the parents lived some distance from Dr. Pannikar's surgery and did not heed the advice. The girl was married to a carpenter from a traditional Chinese family, in which "the man is lord and master." Her new home had no piped water, and in additional to normal domestic tasks she had to carry water from a source 1 1/2 miles agay. In the 7th month of her 1st pregnancy, she went into cardiac failure. After the 3rd pregnancy and a 3rd cardiac failure, Dr. Pannikar tried to arrange a sterilization "but we could not get consent - her husband refused to turn up at the hospital." When the girl was admitted to hospital 6 months into her 4th pregnancy, Dr. Pannikar got hold of her patient's mother-in-law. "I told her if she wanted a servant in the house, it was easy to get one. But no servant would look after her grandchildren the way their mother would. I told her if she wanted to save the girl's life she had better speak to her son." During the 4th delivery, the girl went into cardiac arrest and spent 2 weeks in intensive care. The mother-in-law prevailed upon her son to at least consent, and the girl was sterilized before she left hospital. But "it was a very near thing," Dr. Pannikar recalls "and it wouldn't have happened if the husband had felt he was responsible in parenthood." The Kedah FPA makes special efforts to reach men. Dr. Pannikar herself talks to men's organizations like the Lions and

  14. Practice variation across consent templates for biobank research. A survey of German biobanks

    Irene eHirschberg


    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.

  15. 34 CFR 303.404 - Parent consent.


    ... DISABILITIES Procedural Safeguards General § 303.404 Parent consent. (a) Written parental consent must be... given. (Authority: 20 U.S.C. 1439) Note 1: In addition to the consent requirements in this section...

  16. Informing egg donors of the potential for embryonic research: a survey of consent forms from U.S. in vitro fertilization clinics

    Schaefer, Gerald Owen; Sinaii, Ninet; Grady, Christine


    To understand whether and to what extent U.S. IVF clinics inform egg donors that resultant embryos initially intended to be implanted for reproductive purposes may in fact be used for research instead...

  17. Consentimento informado e competência em pediatria: opiniões de uma amostra de médicos romenos em treinamento Informed consent and competence in pediatrics: opinions from a sample of Romanian physicians in training

    Sorin Hostiuc


    Full Text Available OBJETIVOS: Analisar o ponto de vista de médicos em treinamento a respeito do consentimento informado como autorização autônoma em pediatria e discutir os efeitos limitantes da norma de competência nesse campo. MÉTODOS: Foi realizado um estudo multi-institucional com 158 residentes de medicina com o intuito de analisar o ponto de vista de médicos em treinamento a respeito do consentimento informado como autorização autônoma em pediatria. A participação no estudo foi voluntária, e os participantes eram provenientes de uma área geográfica limitada (Bucareste e arredores. RESULTADOS: A maioria dos respondentes concordou totalmente que um paciente entre 16 e 18 anos deve tomar decisões médicas informadas sobre qualquer tipo de procedimento (inclusive os referentes a escolhas reprodutivas; enquanto que pacientes entre 14 e 16 anos devem ser autorizados a tomar decisões médicas informadas apenas a respeito de procedimentos menores. A maioria concordou que transplantes de medula óssea devem ser permitidos entre irmãos se aprovados por ambos, enquanto que a maioria não concorda com o transplante de órgãos sólidos. A participação de crianças em estudos clínicos deve ser permitida apenas se a criança concordar. CONCLUSÕES: As respostas obtidas em nosso estudo sobre o consentimento informado aproximam-no mais do sentido de autorização autônoma do que do sentido de autorização efetiva. Portanto, a intuição moral dos participantes é mais bioética e menos jurídica, o que, embora maximize os benefícios do paciente, está associado a um aumento no risco de responsabilidade. No entanto, visto que as gerações mais novas tornam-se cada vez mais precoces, é preciso reavaliar os dogmas tradicionais a respeito da competência.OBJECTIVES: To assess the views of physicians in training regarding the informed consent as autonomous authorization in pediatrics and to discuss the limiting effects of the competence norm in this

  18. Consent to organ donation part 2: alternative modes of consent.

    Griffith, Richard; Tengnah, Cassam


    In the December 2009 issue of British Journal of Community Nursing Richard Griffith and Cassam Tengnah reviewed the system of consent for non-beating heart organ donation at the centre of the Human Tissue Act 2004. This article considers the benefits and risks of alternative systems of consent being proposed to overcome the United Kingdom's poor organ donation rate that is the worst in Western Europe.

  19. Meeting the complex needs of urban youth and their families through the 4Rs 2Ss Family Strengthening Program: The "real world" meets evidence-informed care.

    Small, Latoya; Jackson, Jerrold; Gopalan, Geetha; McKay, Mary McKernan


    Youth living in poverty face compounding familial and environmental challenges in utilizing effective community mental health services. They have ongoing stressors that increase their dropout rate in mental health service use. Difficulties also exist in staying engaged in services when they are involved with the child welfare system. This study examines the 4Rs 2Ss Family Strengthening Program, developed across four broad conceptual categories related to parenting skills and family processes that form a multiple family group service delivery approach. A total of 321 families were enrolled in this randomized intervention study, assigned to either the 4Rs 2Ss Family Strengthening Program or standard care services. Caregivers and their children randomly assigned to the experimental condition received a 16 week multiple family group intervention through their respective outpatient community mental health clinic. Data was collected at baseline, midtest (8 weeks), posttest (16 weeks), and 6 month follow-up. Major findings include high engagement in the 4Rs 2Ss Family Strengthening Program, compared to standard services. Although child welfare status is not related to attendance, family stress and parental depression are also related to participant engagement in this multiple family group intervention. Involvement in the 4Rs 2Ss Family Strengthening Program resulted in improved effects for child behaviors. Lastly, no evidence of moderation effects on family stress, child welfare involvement, or parental needs were found. The 4Rs 2Ss Family Strengthening Program appeared able to engage families with more complex "real world" needs.

  20. Evaluación de la práctica clínica del Consentimiento Informado en los ensayos clínicos Evaluation of the clinical practice of Informed Consent in clinical trials

    J. Gost


    Full Text Available Sobre la base de las publicaciones existentes parece lícito suponer que en un ensayo clínico (EC, las dificultades inherentes al proceso de comunicación investigador-participante son en la práctica mayores que las deseadas. Se asume asimismo la hipótesis de que existen deficiencias en la legibilidad formal de los documentos de consentimiento informado. Se presentan los resultados de un estudio transversal realizado en una muestra aleatoria (n= 160 de los EC aprobados por el CEIC de Navarra durante los años 1995-1999. Los resultados encontrados (en el 69,7% de los casos el investigador archiva la documentación correspondiente al EC, el CI aparece firmado por el investigador en el 56,6% de los EC, y en más del 83% de los casos la información escrita presenta una deficiente legibilidad confirman la bondad de la hipótesis y detectan áreas de mejora a desarrollar.On the basis of existing publications it would seem legitimate to assume that in a clinical test (CT the difficulties inherent in the process of researcher-participant communication are in practice greater than desired. Similarly, the hypothesis is adopted that difficulties exist in the formal legibility of the documents of Informed Consent. We present the results of a transversal study made of a random sample (n=160 of the CTs approved by the Ethical Committee of Clinical Research (CEIC of Navarra during the years 1995-1999. The results found were: in 69.7% of the cases the researcher filed the documents corresponding to the CT, the Informed Consent appears signed by the researcher in 56.6% of the CTs, and in more than 83% of the cases the written information shows shortcomings in legibility, which confirms the correctness of the hypothesis and permits the detection of areas where improvements need to be developed.

  1. The Channels and Methods of Strengthening Information Literacy Education in Traditional Chinese Medicine College and University Libraries%中医院校图书馆加强信息素质教育的途径与方法

    张稚鲲; 李文林


    对中医院校图书馆如何加强信息素质教育进行探讨,指出中医院校图书馆可以通过突出教育职能、创新新生入馆教育模式、加强文献检索课程建设、提高图书馆员整体素质、建立及完善信息素质教育网站、培养院系教师信息素质、为学生创造信息需求环境等途径,增强信息素质教育效果。%The paper discusses how to strengthen information literacy education in traditional Chinese medicine college and university libraries,points out that highlighting educational function,innovating education modes for freshman,strengthening retrieval curriculum construction,improving the overall quality of librarians,constructing and perfecting information literacy education website,cultivating the information literacy of college teachers,creating information demands environment for students would be good ways to strengthen effect on information literacy education.

  2. Development of ISRMS for readability of the text of informed consent for tooth extraction%拔牙知情同意书文本易读性ISRMS的开发研究

    王春燕; 虎斌; 马东


    介绍了利用Microsoft Office Access对象、窗体控件、ActiveX控件以及Microsoft Visual Basic for Applications(VBA)等功能优势,以拔牙知情同意为模型,开发主观评价医疗知情同意书文本易读性的信息化系统(ISRMS).指出该系统实现了主观评价操作、实验数据同步收集和实验数据分析的计算机信息化,引入了ActiveX控件形式的视觉模拟评分法量规和临床电子牙位记录工具.%We developed the Information-based Subjective Readability Measuring System (ISRMS) for readability of the text of informed consent for tooth extraction by utilizing the advantages of Microsoft Office Access, window control, ActiveX control, and Microsoft Visual Basic for Applications (VBA). This system has realized subjective evaluation, synchronous collection of experiment data, and analysis of experiment data, introduced the visual analogue scale in the form of ActiveX control and the tool for recording clinical electronic tooth position.

  3. El consentimiento informado; una acción imprescindible en la investigación médic The informed consent is a compulsory action in medical research

    Miguel L. Castellanos Arcís


    Full Text Available Se hace una revisión de los conceptos éticos y bioéticos para adentrarnos en el consentimiento informado. El conocimiento científico ha conducido a notables avances que han sido de gran beneficio para la humanidad. El desarrollo de estas ramas científicas trae consigo serios problemas éticos, por los cuales deben velar los hombres de ciencia y además todos los miembros de la sociedad. La Medicina hoy día, posee una fuerte carga experimental y surgen extrapolaciones desde el laboratorio de investigaciones, al hombre. Las investigaciones que se realizan, cada vez con mayor frecuencia, hacen partícipes a las personas, y un procedimiento imprescindible en las investigaciones con seres humanos, lo constituye el otorgamiento por los sujetos del consentimiento informado para su inclusión en el estudio. Este aspecto no constituye una acción aislada destinada a lograr que el paciente firme un documento autorizando al equipo de salud, a realizar un tratamiento o investigación, sino un proceso donde deben ser explicadas todas las acciones para la salud, en cualquiera de los 3 niveles de atención. En esta revisión se detallan los aspectos fundamentales que deben discutirse con el paciente sobre los principios y elementos que deben estar contenidos en la conversación y planilla para el otorgamiento del consentimiento.We made a review of ethical and bioethical features to enter the heart of informed consent. Scientific knowledge has allows significant advances very beneficial for mankind. Development of these scientific branches give raise many serious ethical problems, by which the scientists and also all the society members must to look after. Present Medicine, has a strong experimental charge and from research laboratories give raise extrapolations for men. Researches performed, each time with a great frequency, allow the involvement of persons, and a compulsory procedure in researches with human beings, is the informed consent for their

  4. Patients' consent to the measure of medical treatment

    Sjeničić Marta Ž.


    Full Text Available Consent to medical treatment is a patient right. The patient right to give or withhold consent to some treatment procedure arises from the principle of free will of each person, that is, the principle of self-determination. The patient consent is valid only in case he/she has previously been provided by the physician with the relevant information on the intended medical measure. The scope of information is generally regulated. However, the physician is obliged to estimate each patient's need and the ability to receive information. Treatment can have desired results only with patients' compliance. Apart from being patient right, giving of consent to medical treatment is also his/her legal duty, the fulfillment of which is expected prior to beginning of treatment. By non-complicance, a patient unable the treatment procedure and damages his/her own health. However, the duty to give the consent is not the real legal obligation. It cannot be the subject of claim, nor can it be coercively enforced. For this reason, consent to medical treatment, as well as the other subsidiary duties of patients, is named duty of the patient in his own interest. Its non full filament does not lead to the liability of the patient. It can, under certain circumstances, reduce or exclude the physicians share in damage and his liability or, under certain circumstances, give the possibility to the physician to cancel further rendering of health care to the patient.

  5. Involving Research Stakeholders in Developing Policy on Sharing Public Health Research Data in Kenya: Views on Fair Process for Informed Consent, Access Oversight, and Community Engagement.

    Jao, Irene; Kombe, Francis; Mwalukore, Salim; Bull, Susan; Parker, Michael; Kamuya, Dorcas; Molyneux, Sassy; Marsh, Vicki


    Increased global sharing of public health research data has potential to advance scientific progress but may present challenges to the interests of research stakeholders, particularly in low-to-middle income countries. Policies for data sharing should be responsive to public views, but there is little evidence of the systematic study of these from low-income countries. This qualitative study explored views on fair data-sharing processes among 60 stakeholders in Kenya with varying research experience, using a deliberative approach. Stakeholders' attitudes were informed by perceptions of benefit and concerns for research data sharing, including risks of stigmatization, loss of privacy, and undermining scientific careers and validity, reported in detail elsewhere. In this article, we discuss institutional trust-building processes seen as central to perceptions of fairness in sharing research data in this setting, including forms of community involvement, individual prior awareness and agreement to data sharing, independence and accountability of governance mechanisms, and operating under a national framework.

  6. The Influence of Age, Health Literacy, and Affluence on Adolescents' Capacity to Consent to Research.

    Nelson, Lance R; Stupiansky, Nathan W; Ott, Mary A


    While adults are assumed to have the capacity to consent to medical research, and young children to have no capacity, adolescents' capacity to consent is not well described. Adapting the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), we describe adolescents' capacity to consent to medical research and factors influencing that capacity. Our pilot study included a community-based sample of 30 adolescents, 14 to 21 years of age, who completed the MacCAT-CR after undergoing a simulated informed consent process. We found that adolescents' capacity to consent to research was associated with age, health literacy, and family affluence. These findings suggest that investigators and institutional review boards should be aware that factors other than age may influence capacity to consent, and, for modifiable factors, such as health literacy, consent processes for medical research with adolescents can be modified.

  7. Consent Processes for Mobile App Mediated Research: Systematic Review.

    Moore, Sarah; Tassé, Anne-Marie; Thorogood, Adrian; Winship, Ingrid; Zawati, Ma'n; Doerr, Megan


    Since the launch of ResearchKit on the iOS platform in March 2015 and ResearchStack on the Android platform in June 2016, many academic and commercial institutions around the world have adapted these frameworks to develop mobile app-based research studies. These studies cover a wide variety of subject areas including melanoma, cardiomyopathy, and autism. Additionally, these app-based studies target a variety of participant populations, including children and pregnant women. The aim of this review was to document the variety of self-administered remote informed consent processes used in app-based research studies available between May and September 2016. Remote consent is defined as any consenting process with zero in-person steps, when a participant is able to join a study without ever seeing a member of the research team. This type of review has not been previously conducted. The research community would benefit from a rigorous interrogation of the types of consent taken as part of the seismic shift to entirely mobile meditated research studies. This review examines both the process of information giving and specific content shared, with special attention to data privacy, aggregation, and sharing. Consistency across some elements of the app-based consent processes was found; for example, informing participants about how data will be curated from the phone. Variations in other elements were identified; for example, where specific information is shared and the level of detail disclosed. Additionally, several novel elements present in eConsent not typically seen in traditional consent for research were highlighted. This review advocates the importance of participant informedness in a novel and largely unregulated research setting.

  8. Consent - a new era begins.

    D'Cruz, L; Kaney, H


    The law in relation to consent has changed following the handing down of the Supreme Court judgement in Montgomery vs Lanarkshire in March this year. Legally, clinicians, including dentists, must now take reasonable care to ensure that patients are aware of any material risks involved in a proposed treatment and of reasonable alternatives. This case now brings the law in relation to the disclosure of risks when obtaining consent to treatment in line with the guidance issued by regulatory bodies such as the GMC and GDC.

  9. 42 CFR 441.257 - Informed consent.


    ... otherwise entitled. (ii) A description of available alternative methods of family planning and birth control... advantages that may be expected as a result of the sterilization. (vii) Advice that the sterilization will...

  10. 76 FR 256 - Informed Consent Elements


    ... elements which align with various ethics codes and apply to all clinical investigations regulated by FDA and clinical investigations that support applications for research or marketing permits for products... ethical research, patient advocacy organizations, health care attorneys, pharmacy and law students,...

  11. Improving Informed Consent for Cleft Palate Repair


    Cleft Palate; Jaw Abnormalities; Maxillofacial Abnormalities; Mouth Abnormalities; Congenital Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Stomatognathic System Abnormalities

  12. 28 CFR 512.16 - Informed consent.


    ... participant's release date or parole eligibility; (11) An offer to answer questions about the research project... confidentiality required by federal or state law. For example, a researcher may not guarantee confidentiality when the subject indicates an intent to commit future criminal conduct or harm himself/herself or...

  13. Transboundary Resources, Consent and Customary Law - Comment

    Graham Dutfield


    Full Text Available This brief commentary focuses on the unresolved access and benefit sharing (ABS challenges of transboundary resources and situations where getting prior informed consent is not possible. In the absence of the global mechanism envisaged by the Nagoya Protocol, satisfactory ABS deals can still be struck but these are unlikely to be either common or effective in generating substantial benefits for the indigenous peoples. The commentary closes by underlining the moral imperative of ensuring that traditional knowledge and genetic resource users comply with the laws and customary practices established by indigenous groups rather than simply impose their own norms. However, there are many legal and conceptual obstacles to be overcome first.

  14. Influenza Vaccination in dutch Nursing Homes: is tacit consent morally justified?

    Verweij, M.F.; Hoven, M.A. van den


    Objectives: Efficient procedures for obtaining informed (proxy) consent may contribute to high influenza vaccination rates in nursing homes. Yet are such procedures justified? This study’s objective was to gain insight in informed consent policies in Dutch nursing homes; to assess how these may affe

  15. Assessing a narrated white board animation as part of the consent process for intravenous fluorescein angiography: a randomized educational study.

    Mednick, Zale; Irrcher, Isabella; Hopman, Wilma M; Sharma, Sanjay


    To determine if a narrated white board animation (nWBA) video as part of the consent process for intravenous fluorescein angiography (IVFA) improves patient comprehension compared with a standard consent process. Prospective, randomized study. Patients undergoing an initial IVFA investigation. Three groups of 26 patients (N = 78) naïve to the IVFA procedure were included. Groups 1 and 2 consisted of patients undergoing IVFA for diagnostic purposes. Group 1 received the IVFA information via standard physician-patient interaction to obtain standard consent. Group 2 received IVFA information by watching an nWBA explaining the purpose, method, and risks of the diagnostic test to obtain informed consent. Group 3 comprised patients who were not scheduled to undergo IVFA. This group was exposed to both the standard and nWBA consent. All groups completed a 6-question knowledge quiz to assess retained information and a survey to reflect on the consent experience. Participants receiving information via standard physician-patient interaction to obtain informed consent had a lower mean knowledge score (4.38 out of 6; 73%) than participants receiving the information to obtain consent via nWBA (5.04 out of 6, 84%; P = 0.023). Of participants receiving both forms of information (group 3) to obtain informed consent, 73% preferred the nWBA to the standard consent process. Participants receiving consent information for an IVFA diagnostic test via nWBA have better knowledge retention regarding the IVFA procedure and preferred this medium compared with participants receiving the standard physician-patient interaction for obtaining consent. Incorporation of multimedia into the informed consent process should be explored for other diagnostic tests. Copyright © 2016 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

  16. Importance of strengthening financial management in information age%信息时代加强财务管理的重要性



    Establishment of a modem financial management system is the fundamental way of the refonn of enterprise. This paper introduces the importance of strengthening financial management, and discusses several aspects should be paid attention to in enterprise managemant. At last, the ultimate goal and the development of financial management is pointed out.%建立建全现代财务管理制度是企业改革的根本出路.文中阐述了企业加强财务管理的重要性,论述了加强企业管理应该注意的几个方面问题,最后指出财务管理的最终目标和发展方向.

  17. 7 CFR 1.420 - Consent recommendation.


    ... 7 Agriculture 1 2010-01-01 2010-01-01 false Consent recommendation. 1.420 Section 1.420... Conservation and Shortage Relief Act of 1990 (16 U.S.C. 620 et seq.) § 1.420 Consent recommendation. Any time before the Judge files the decision, the parties of record may enter a consent recommendation....

  18. [Consent to genetic paternity testing].

    Lach, Arkadiusz; Linkowska, Katarzyna; Grzybowski, Tomasz


    The present article aims at reviewing the legislation in Poland and other countries concerning the consent to DNA sample collection, with the special reference to genetic relatedness analyses (including paternity tests) in anonymous samples of biological materials. The Polish legislator has not regulated this issue in a direct manner. Therefore, in view of progressing commercialization of genetic paternity tests, it is necessary to undertake legislative actions towards regulation of DNA tests admissibility, both in civil proceedings and by commission of private individuals.

  19. Consent for Genetic Research in the Framingham Heart Study

    Levy, Daniel; Splansky, Greta Lee; Strand, Nicolle K.; Atwood, Larry D.; Benjamin, Emelia J.; Blease, Susan; Cupples, L. Adrienne; D’Agostino, Ralph B.; Fox, Caroline S.; Kelly-Hayes, Margaret; Koski, Greg; Larson, Martin G.; Mutalik, Karen M.; Oberacker, Elizabeth; O’Donnell, Christopher J.; Sutherland, Patrice; Valentino, Maureen; Vasan, Ramachandran S.; Wolf, Philip A.; Murabito, Joanne M.


    Extensive efforts have been aimed at understanding the genetic underpinnings of complex diseases that affect humans. Numerous genome-wide association studies have assessed the association of genes with human disease; including the Framingham Heart Study (FHS), which genotyped 550,000 SNPs in 9,000 participants. The success of such efforts requires high rates of consent by participants, which is dependent on ethical oversight, communications, and trust between research participants and investigators. To study this we calculated percentages of participants who consented to collection of DNA and to various uses of their genetic information in two FHS cohorts between 2002 and 2009. The data included rates of consent for providing a DNA sample, creating an immortalized cell line, conducting research on various genetic conditions including those that might be considered sensitive, and for notifying participants of clinically significant genetic findings were above 95%. Only with regard to granting permission to share DNA or genetic findings with for-profit companies was the consent rate below 95%. We concluded that the FHS has maintained high rates of retention and consent for genetic research that has provided the scientific freedom to establish collaborations and address a broad range of research questions. We speculate that our high rates of consent have been achieved by establishing frequent and open communications with participants that highlight extensive oversight procedures. Our approach to maintaining high consent rates via ethical oversight of genetic research and communication with study participants is summarized in this report and should be of help to other studies engaged in similar types of research. PMID:20425830

  20. Strengthening Resilience in Families

    Guild, Diane; Espiner, Deborah


    Rolling with Resilience (RwR) provides a springboard for developing strategies that build strengths and supports to foster developmental assets in children and youth (Benson, Scales, & Roehlkepartain, 2011). In Circle of Courage terms, resilience is strengthened by opportunities for Belonging, Mastery, Independence, and Generosity (Brendtro,…

  1. as the Strengthening Precipitates

    Lu, Qi; Xu, Wei; van der Zwaag, Sybrand


    Generally, Laves phase and M23C6 are regarded as undesirable phases in creep-resistant steels due to their very high-coarsening rates and the resulting depletion of beneficial alloying elements from the matrix. In this study, a computational alloy design approach is presented to develop martensitic steels strengthened by Laves phase and/or M23C6, for which the coarsening rates are tailored such that they are at least one order of magnitude lower than those in existing alloys. Their volume fractions are optimized by tuning the chemical composition in parallel. The composition domain covering 10 alloying elements at realistic levels is searched by a genetic algorithm to explore the full potential of simultaneous maximization of the volume fraction and minimization of the precipitates coarsening rate. The calculations show that Co and W can drastically reduce the coarsening rate of Laves and M23C6 and yield high-volume fractions of precipitates. Mo on the other hand was shown to have a minimal effect on coarsening. The strengthening effects of Laves phase and M23C6 in the newly designed alloys are compared to existing counterparts, showing substantially higher precipitation-strengthening contributions especially after a long service time. New alloys were designed in which both Laves phase and M23C6 precipitates act as strengthening precipitates. Successfully combining MX and M23C6 was found to be impossible.

  2. 29 CFR 801.66 - Consent findings and order.


    ... Administrative Law Judge § 801.66 Consent findings and order. (a) General. At any time after the commencement of... Administrative Law Judge; and (4) A waiver of any right to challenge or contest the validity of the findings and...) Submit the proposed agreement for consideration by the Administrative Law Judge; or (2) Inform...

  3. Forecasting for strengthening technological development

    Aida Mayerly Fúquene Montañez


    Full Text Available Producing technological innovation is currently one of the key items in being more competitive. However, production sectors are facing great challenges, including analysing a large amount of available technological and market information regarding the en- vironment for strategic decision-making and being able to launch themselves onto the market with technological developments bringing the desired economic returns. Several tools for analysing information have emerged for reducing the uncertainty of tech- nological and market changes. This article provides conceptual and reflective elements so that forecasting strengthens technolo- gical development (TD. Forecasting is initially proposed as being one of the future methods of analysis having a significant im- pact on decision-making, mainly within the field of economics but which could be extrapolated to making a contribution to TD. The techniques which have been the recent instrument for collecting information for producing forecasting are described, as is work about the concept of surveillance/monitoring and the processes used for coordinating such approaches. It can thus be sta- ted that they provide an excellent basis for strengthening TD by providing platforms for new or improved developments in pro- cesses or products. Reflection about these aspects provides perspectives for implementing technological forecasting (TF in pro- duction systems so that they obtain efficient and concrete results via deterministic methods as input in decision-making in techno- logy regarding its middle- and long-term competitiveness.

  4. 从维基解密看加强我国信息安全体系建设%Strengthening construction of information security system in China in view of WikiLeaks



    在"维基解密"的背景下,以应对全球信息安全挑战和加强我国信息安全工作为目的,首先分析国外信息安全发展历程和经验成果,在介绍信息安全、军事信息安全等概念基础上,结合我国及我军信息化建设实际情况,提出我军信息安全体系是我国信息安全中的重要组成部分,并指出构建我军信息安全体系的迫切性,最后构造我军信息安全体系.%In view of "WikiLeaks" under the background of global information security Challenges and strengthening our information security, this paper firstly analyzes other countries’ information security development history and experience in the introduction of concepts. such as information security and military information security, put forward that our military information security system is important composition fo our information security. The urgency and the security system is pointed ont.

  5. Strengthening the decentralised healthcare system in rural South Africa through improved service delivery: testing mobility, information and communication technology intervention options

    Chakwizira, J


    Full Text Available of information) become most difficult. In addition, access to information and communication technologies (ICT) and systems is cross-cutting through all challenges. As part of the overarching framework, this paper seeks to provide a platform on which ICT systems...

  6. Informed consent document in gastrointestinal endoscopy: understanding and acceptance by patients Estudio del grado de entendimiento y aceptación por nuestros pacientes de los consentimientos informados utilizados para endoscopia

    J. J. Vila


    Full Text Available Objective: we wanted to know if patients read and understand the informed consent (IC document used for endoscopic procedures, and to evaluate the readability of IC. Method: during two months we gave patients studied in our endoscopy unit an anonymous questionnaire with different items concerning reading degree, knowledge of the technique, complications, sedation used, and information received. We evaluated IC readability using the Flesch index. Results: 309 patients were included (mean age: 53 years, 55% males, 86% outpatients, 50% with basic education; 85% of patients read the IC, 96% considered they understood the exploration technique, 22% were not aware of severe complications, and 82% knew which kind of sedation would be used; 88% of patients received additional information from their doctors. Outpatients read the IC in a greater percentage versus inpatients (p Objetivo: conocer si los pacientes estudiados en nuestra unidad de endoscopia leen y comprenden el documento de consentimiento informado. Conocer la legibilidad de dichos consentimientos informados. Método: entregamos a los pacientes estudiados endoscopicamente en nuestra unidad un cuestionario acerca del grado de lectura del consentimiento informado, conocimiento de la técnica endoscópica, complicaciones, sedación utilizada e información recibida. Valoramos la legibilidad de nuestros consentimientos informados mediante el índice de Flesch. Resultados: 309 pacientes fueron incluidos (edad media: 53 años, 55% varones. El 85% de los pacientes se había leído el consentimiento informado, el 96% conocían la técnica endoscópica, 15,2% no conocían el riesgo de complicaciones graves durante la exploración. El 82% sabía qué tipo de sedación iba a recibir. El 88% recibieron información adicional por sus médicos. Los pacientes con estudios básicos tendieron a desconocer la posibilidad de complicaciones (p < 0,05. Los médicos aportaron más información a los pacientes de

  7. Attitudes toward financial incentives, donor authorization, and presumed consent among next-of-kin who consented vs. refused organ donation.

    Rodrigue, James R; Cornell, Danielle L; Howard, Richard J


    Financial incentives, donor authorization, and presumed consent are strategies designed to increase organ donation rates. Surveys designed to assess attitudes toward these initiatives have been conducted with the general public, transplant patients, and transplant professionals. To assess attitudes toward financial incentives, donor authorization, and presumed consent and to identify multivariate predictors of such attitudes, we conducted telephone interviews with 561 family members who had recently been asked for consent to donate the organs of a deceased family member (348 donors, 213 nondonors). Financial incentives would have made a difference in the donation decision for 54% of nondonors (vs. 46% of donors, P=0.02), and a higher percentage of nondonors would themselves become donors if financial incentives were available (P=0.03). Donors had significantly more favorable attitudes toward donor authorization (Pdonation was unnecessary when the deceased documented their donation intention, and 24% favored a presumed consent law with an opting out provision. Of the three initiatives, donor authorization is likely supported by more donor and nondonor families than either financial incentives or presumed consent. Public education efforts should aim to better inform the public regarding existing and proposed donor authorization legislation and its benefits for registered organ donors and their families.

  8. Tailoring consent to context: designing an appropriate consent process for a biomedical study in a low income setting.

    Fasil Tekola

    Full Text Available BACKGROUND: Currently there is increasing recognition of the need for research in developing countries where disease burden is high. Understanding the role of local factors is important for undertaking ethical research in developing countries. We explored factors relating to information and communication during the process of informed consent, and the approach that should be followed for gaining consent. The study was conducted prior to a family-based genetic study among people with podoconiosis (non-filarial elephantiasis in southern Ethiopia. METHODOLOGY/PRINCIPAL FINDINGS: We adapted a method of rapid assessment validated in The Gambia. The methodology was entirely qualitative, involving focus-group discussions and in-depth interviews. Discussions were conducted with podoconiosis patients and non-patients in the community, fieldworkers, researchers, staff of the local non-governmental organisation (NGO working on prevention and treatment of podoconiosis, and community leaders. We found that the extent of use of everyday language, the degree to which expectations of potential participants were addressed, and the techniques of presentation of information had considerable impact on comprehension of information provided about research. Approaching podoconiosis patients via locally trusted individuals and preceding individual consent with community sensitization were considered the optimal means of communication. Prevailing poverty among podoconiosis patients, the absence of alternative treatment facilities, and participants' trust in the local NGO were identified as potential barriers for obtaining genuine informed consent. CONCLUSIONS: Researchers should evaluate the effectiveness of consent processes in providing appropriate information in a comprehensible manner and in supporting voluntary decision-making on a study-by-study basis.

  9. Foot muscles strengthener

    Boris T. Glavač


    Full Text Available Previous experience in the correction of flat feet consisted of the use of insoles for shoes and exercises with toys, balls, rollers, inclined planes, etc. A device for strengthening foot muscles is designed for the correction of flat feet in children and, as its name suggests, for strengthening foot muscles in adults. The device is made of wood and metal, with a mechanism and technical solutions, enabling the implementation of specific exercises to activate muscles responsible for the formation of the foot arch. It is suitable for home use with controlled load quantities since it has calibrated springs. The device is patented with the Intellectual Property Office, Republic of Serbia, as a petty patent.

  10. A model for consent-based privilege management in personal electronic health records.

    Heinze, Oliver; Bergh, Björn


    One of the biggest issues in the domain of standardized, regional, crossinstitutional, personal, electronic health records is the privilege management. While many health information exchange projects use IHE-based architectures there are still unsolved questions regarding the restricting parameters a patient can use in the electronic consent configuring access control. This work determines these parameters, derives an information model of privilege management, introduces a set representation of the model and shows how to apply them to EHR architectures. The introduced model can serve as framework for health information exchanges using a consent-based privilege management. The set representation can help to understand the complexity of consent representations.

  11. Consulting communities when patients cannot consent: a multicenter study of community consultation for research in emergency settings.

    Dickert, Neal W; Mah, Victoria A; Biros, Michelle H; Harney, Deneil M; Silbergleit, Robert; Sugarman, Jeremy; Veledar, Emir; Weinfurt, Kevin P; Wright, David W; Pentz, Rebecca D


    To assess the range of responses to community consultation efforts conducted within a large network and the impact of different consultation methods on acceptance of exception from informed consent research and understanding of the proposed study. A cognitively pretested survey instrument was administered to 2,612 community consultation participants at 12 U.S. centers participating in a multicenter trial of treatment for acute traumatic brain injury. Survey nested within community consultation for a phase III randomized controlled trial of treatment for acute traumatic brain injury conducted within a multicenter trial network and using exception from informed consent. Adult participants in community consultation events. Community consultation efforts at participating sites. Acceptance of exception from informed consent in general, attitude toward personal exception from informed consent enrollment, and understanding of the study content were assessed. Fifty-four percent of participants agreed exception from informed consent enrollment was acceptable in general in the proposed study; 71% were accepting of personal exception from informed consent enrollment. Participants in interactive versus noninteractive community consultation events were more accepting of exception from informed consent in general (63% vs 49%) and personal exception from informed consent inclusion (77% vs 67%). Interactive community consultation participants had high-level recall of study content significantly more often than noninteractive consultation participants (77% vs 67%). Participants of interactive consultation were more likely to recall possible study benefits (61% vs 45%) but less likely to recall potential risks (56% vs 69%). Interactive community consultation methods were associated with increased acceptance of exception from informed consent and greater overall recall of study information but lower recall of risks. There was also significant variability in exception from informed

  12. 人事信息化加强高校人力资源管理%Personnel Information to Strengthen Human Resources Management in Colleges and Universities



    Personnel management in Colleges and universities is complex and cumbersome, in the rapid development of information technology today, personnel information level affect the college human resources management efficiency and quality. College personnel information raising the level of education services to guarantee the quality of personnel management work, is one of the important measures for sustainable development. In view of the college personnel management information large, complicated characteristic, put forward a kind of college human resource management information platform solutions, implementation of college personnel information standard and unified, data sharing and management, in the implementation of personnel management work, fast development and constantly improve the level of human resource management decision.%高校人事管理工作复杂且繁琐,在信息化高速发展的今天,人事信息化水平影响着高校人力资源管理的效率和质量.高校人事信息化水平的提高是教育服务质量的有力保证,是人事管理工作持续发展的重要举措之一.针对高校人事管理信息庞大、繁琐的特点,提出一种高校人力资源综合管理信息平台解决方案,实现高校人事信息标准规范和统一、数据共享与管理,在实现人事管理工作好、快的发展的同时不断提高人力资源管理决策水平.

  13. Dynamic consent: a patient interface for twenty-first century research networks

    J. Kaye; Whitley, EA; Lund, D; Morrison, M; Teare, H.; Melham, K


    Biomedical research is being transformed through the application of information technologies that allow ever greater amounts of data to be shared on an unprecedented scale. However, the methods for involving participants have not kept pace with changes in research capability. In an era when information is shared digitally at the global level, mechanisms of informed consent remain static, paper-based and organised around national boundaries and legal frameworks. Dynamic consent (DC) is both a ...

  14. 图书情报学专业人员应加强定性研究%Library and Information Science Professionals Should Strengthen Qualitative Study



    图书情报研究人员不重视定性研究的学术现象有许多危害,产生这种现象的原因是多方面的,图书情报学专业人员应坚持学理精神,加强定性研究。%The academic phenomenon that the library and information science research personnel do not pay attention to qualitative study is very harmful.There are many causes led to this phenomenon.The library and information science professionals should insist on s

  15. Impossible, impractical, and non-identifiable? New criteria regarding consent for human tissue research in the Declaration of Helsinki.

    Colledge, Flora; Elger, Bernice S


    The 2008 revision of the Declaration of Helsinki (Declaration) includes a new paragraph dealing specifically with the standards of informed consent required for research involving identifiable human tissue samples and/or data. In cases where obtaining consent would be impossible or unduly burdensome, researchers may now proceed without it, following approval of the project by an ethics committee. This is a significant development in the Declaration, yet so far it has received little attention. We examine the implications of paragraph 25, and assess its role in the debates on proper sample handling. In particular, we question whether the use of the term "identifiable" weakens the paragraph, as its meaning depends on national context. Relying on this term to designate samples that could be traced to the donor, and therefore carry risk for that donor, is impossible if its meaning is not universally accepted. The Declaration of Helsinki is now entering a new revision phase. In order to protect sample donors, paragraph 25 should be enhanced, and the remit of the Declaration strengthened, by a more precise description of which samples and data count as identifiable.

  16. Strengthening the self-care of women working in the informal sector: local fabric weaving in Khon Kaen, Thailand (Phase I).

    Nilvarangkul, Kessarawan; Wongprom, Jaranya; Tumnong, Chuanpit; Supornpun, Ausa; Surit, Pattama; Srithongchai, Niramol


    The first phase of this study was undertaken using Participatory Action Research (PAR) to identify the factual situations of fabric-weaving women working in the informal sector in Thailand. The aims were to enhance the mutual understanding of the women and researchers concerning the problems faced by these women and to establish an action plan to address these problems. The participant group consisted of 107 women working in the informal sector from three local villages who voluntarily took part in the study. Data were collected using quantitative and qualitative methods through structured questionnaires, focus groups, in-depth interviews, participant observations, and field notes. The results of the study revealed that the women learned their health problems were related to work and their labor potentially placed them at a risk for illness. When the women realized the gravity of their situation, they attained a sense of empowerment and took the initiative in establishing action plans to address their problems.

  17. Strengthen the Construction of Information Network and Improve the work Efficiency of Labour Unions%加强网络信息化建设 提升高校工会工作水平



    The paper based on the analysis of current situation in construction of informationize network of labour unions,and put up with such suggestions that the labour unions should make the most of advanced network resources and strengthen the construction of network station and information management platform and network communication platform,so it will improve the work efficiency of labour unions.%本文通过对高校工会面临的形势和网络信息化建设现状的分析,提出了高校工会应充分利用高校先进的网络资源,加强工会网站、网络信息管理和网络交流平台建设,提升高校工会的整体工作水平。

  18. Who is the Patient? Disclosure of Information and Consent in Anesthesia and Intensive Care (Informed Consent)

    Korušić, Anđelko; Merz, Vlasta; Đuzel, Viktor; Tudorić-Djeno, Ivana; ŽIDAK, DAVORKA; Brundula, Ana; Sojčić, Nataša; Milanović, Rudolf; Barić, Ada; Bešlić, Gabrijela


    Physicians have always strived to uphold all the ethical postulates of the medical profession in all aspects of the prac- tice, however with the vast advances in science and technology, numerous ethical dilemmas regarding all aspects of life and ultimately death have emerged. Medical decisions however, are no longer in the sole jurisdiction of traditional Hip- pocratic medicine but are now deliberated and delivered by the patient and they are comprised of a number of additional determining as...

  19. Strengthening of Shear Walls

    Hansen, Christian Skodborg

    -plane loaded walls and disks is however not included in any guidelines, and only a small fraction of scientists have initiated research within this topic. Furthermore, studies of the principal behavior and response of a strengthened disk has not yet been investigated satisfactorily, and this is the principal...... be altered to fit the surrounding boundary conditions. The effective cohesive law will then become a function of the investigated structural geometry. A simplified approach for the latter topic was used to predict the load capacity of concrete beams in shear. Results obtained were acceptable, but the model...

  20. What is presumed when we presume consent?

    Pierscionek Barbara K


    Full Text Available Abstract Background The organ donor shortfall in the UK has prompted calls to introduce legislation to allow for presumed consent: if there is no explicit objection to donation of an organ, consent should be presumed. The current debate has not taken in account accepted meanings of presumption in law and science and the consequences for rights of ownership that would arise should presumed consent become law. In addition, arguments revolve around the rights of the competent autonomous adult but do not always consider the more serious implications for children or the disabled. Discussion Any action or decision made on a presumption is accepted in law and science as one based on judgement of a provisional situation. It should therefore allow the possibility of reversing the action or decision. Presumed consent to organ donation will not permit such reversal. Placing prime importance on the functionality of body organs and their capacity to sustain life rather than on explicit consent of the individual will lead to further debate about rights of ownership and potentially to questions about financial incentives and to whom benefits should accrue. Factors that influence donor rates are not fully understood and attitudes of the public to presumed consent require further investigation. Presuming consent will also necessitate considering how such a measure would be applied in situations involving children and mentally incompetent adults. Summary The presumption of consent to organ donation cannot be understood in the same way as is presumption when applied to science or law. Consideration should be given to the consequences of presuming consent and to the questions of ownership and organ monetary value as these questions are likely to arise should presumed consent be permitted. In addition, the implications of presumed consent on children and adults who are unable to object to organ donation, requires serious contemplation if these most vulnerable


    Ricardo Miguel


    Full Text Available Este trabajo se fundamenta en la necesidad de obtener datos sobre la práctica del consentimiento informado realizado por odontólogos. Los datos pertenecen al Programa de Residencias Odontológicas Universitarias (ROU de la Facultad de Odontología de la Universidad Nacional de La Plata (UNLP. La investigación tiene como intención conocer diferentes aspectos respecto a las fortalezas y debilidades de su utilización actual. A partir de los datos, se puede concluir que, a pesar de que los conocimientos teóricos sobre la práctica del consentimiento informado son escasos, existe una tendencia significativa a destinar tiempo en la consulta dental para su empleo, especialmente en la nueva generación. Se considera imperativo incluir en la malla curricular y en los programas académicos odontológicos principios éticos y legales en relación con el proceso de consentimiento informadoEste trabalho fundamenta a necessidade de se obter dados sobre a prática do consentimento informado realizado por odontólogos. Os dados pertencem ao Programa de Residencias Odontológicas Universitárias (ROU da Faculdade de Odontologia da Universidade Nacional de la Plata (UNLP. A pesquisa tem como objetivo conhecer os diferentes aspectos, a respeito das forças e fraquezas de sua utilzação atual. A partir dos dados, se pode concluir que, apesar de serem escassos os conhecimentos teóricos sobre a prática do consentimento informado, existe uma tendencia significativa a destinar tempo na consulta dental para seu uso, especialmente na nova geração. Considera-se um imperativo incluir no curriculo de formação profissional e nos programas acadêmicos odontológicos, princípios éticos e legais relacionados com o processo do consentimento informadoThis work is based upon the need to obtain data on the practice of informed consent carried out by dentists. Data was generated from the University Residence Program at the Dentistry Faculty, L.P.N.U., Argentina. The

  2. 77 FR 52762 - Notice of Lodging of Consent Decree Pursuant to The Clean Water Act


    .... 42. The Modified Consent Decree requires Gloucester to: (1) Adjust the existing Combined Sewer Overflows schedule to accommodate information collected during construction of currently required projects; (2) more accurately characterize drainage basin overflows and propose mitigation measures; and...

  3. 78 FR 56266 - Consent Based Social Security Number Verification (CBSV) Service


    ...-6401, , for more information about the CBSV service, visit our Internet site, Social Security Online... From the Federal Register Online via the Government Publishing Office SOCIAL SECURITY ADMINISTRATION Consent Based Social Security Number Verification (CBSV) Service AGENCY: Social...

  4. Medical imaging and consent: when is an X-ray assault?

    Lane, Andrea N


    New Zealand patients have rights in relation to their healthcare including the right to consent to medical treatment. Medical imaging is the third largest category of hospital procedure in New Zealand and it constitutes a circumstance where examination without consent could be assault. New Zealand assault law is unique, and medical radiation technologists (MRTs) must be educated about their responsibilities. A literature review was conducted focusing on the medicolegal aspects of consent as it relates to medical imaging. This was compared to the practical realities of practicing radiography as experienced by the author. Finally, the guidance given by the professional bodies for MRTs in New Zealand was examined to determine whether it adequately informs MRTs of the responsibilities and provides them with a framework to guide their practice. Medical imaging is a diverse area presenting a range of challenging circumstances for consent. Currently, the consent framework and guidance provided by professional bodies is insufficient and in need of updating.

  5. 16 CFR 312.5 - Parental consent.


    ... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Parental consent. 312.5 Section 312.5 Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS CHILDREN'S ONLINE... from children, including consent to any material change in the collection, use, and/or...

  6. Optimizing Opt-Out Consent for Record Linkage

    Das Marcel


    Full Text Available This article reports on a study testing the effects of different ways of administering an opt-out consent for record linkage in a probability-based Internet panel. First, we conducted cognitive interviews to explore reactions to a draft version of the opt-out consent text. Second, we conducted a two-factor experiment to test the effects of content manipulations and mode. The results indicate that the way in which respondents were informed did not have much effect on opting out. Results from a follow-up survey on attitudes regarding privacy, confidentiality, and trust, along with knowledge questions about the process of linking, showed no evidence that presenting the opt-out consent statement makes respondents more concerned about privacy. Knowledge about the aspects of record linkage is generally not high. When looking at long-term effects of sending an opt-out consent statement, we found no evidence that this leads to higher attrition or lower participation rates.

  7. [How to make consent forms easier to read?].

    Araujo, Diego Vinicius Pacheco de; Zoboli, Elma Lourdes Campos Pavone; Massad, Eduardo


    Define the literacy level of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCMFUSP) outpatients, for the purpose of identifying recommendations to adapt writing of the informed consent form to the outpatients literacy level, since these can become the subject of research. Quantitative cross sectional study with 399 subjects. The sample was intentional, selected from different outpatient care units of HCFMUSP. Data collection used an instrument that contained a text with prose compatible for assessment of reading skills needed for comprehension of the consent form. More than 46.6% of the interviewees were classified as functionally illiterate, of these, 12.7% were even unable to understand the proposed task in the text they read. Nevertheless, nearly 50% of the interviewees reported having at least started high school. The results and the orientations for the text writing centered on the reader allowed us to make recommendations to render the consent form easier to read. We recommend that the researcher modifies the text to a structural narrative, addressed to the reader, using terms that are familiar. In other words, with terms common to the subjects' and to the medical language. In addition to improving the relationship between the subject and researcher, it is believed that these recommendations may reduce the time taken for the proceeding of research projects, since problems in the wording of consent forms contribute significantly to project delays.

  8. Assessment of children's capacity to consent for research: a descriptive qualitative study of researchers' practices.

    Gibson, Barbara E; Stasiulis, Elaine; Gutfreund, Shawna; McDonald, Maria; Dade, Lauren


    In Canadian jurisdictions without specific legislation pertaining to research consent, the onus is placed on researchers to determine whether a child is capable of independently consenting to participate in a research study. Little, however, is known about how child health researchers are approaching consent and capacity assessment in practice. The aim of this study was to explore and describe researchers' current practices. The study used a qualitative descriptive design consisting of 14 face-to-face interviews with child health researchers and research assistants in Southern Ontario. Transcribed interviews were analysed for common themes. Procedures for assessing capacity varied considerably from the use of age cutoffs to in-depth engagement with each child. Three key issues emerged from the accounts: (1) requirements that consent be provided by a single person thwarted researchers' abilities to support family decision-making; (2) little practical distinction was made between assessing if a child was capable, versus determining if study information had been adequately explained by the researcher; and (3) participants' perceived that review boards' requirements may conflict with what they considered ethical consent practices. The results suggest that researchers' consent and capacity knowledge and skills vary considerably. Perceived discrepancies between ethical practice and ethics boards' requirements suggest the need for dialogue, education and possibly ethics board reforms. Furthermore we propose, where appropriate, a 'family decision-making' model that allows parents and their children to consent together, thereby shifting the focus from separate assent and consent procedures to approaches that appropriately engage the child and family.

  9. Understanding the Public's Reservations about Broad Consent and Study-By-Study Consent for Donations to a Biobank: Results of a National Survey.

    Raymond Gene De Vries

    Full Text Available Researchers and policymakers do not agree about the most appropriate way to get consent for the use of donations to a biobank. The most commonly used method is blanket-or broad-consent where donors allow their donation to be used for any future research approved by the biobank. This approach does not account for the fact that some donors may have moral concerns about the uses of their biospecimens. This problem can be avoided using "real-time"-or study-by-study-consent, but this policy places a significant burden on biobanks. In order to better understand the public's preferences regarding biobank consent policy, we surveyed a sample that was representative of the population of the United States. Respondents were presented with 5 biobank consent policies and were asked to indicate which policies were acceptable/unacceptable and to identify the best/worst policies. They were also given 7 research scenarios that could create moral concern (e.g. research intending to make abortions safer and more effective and asked how likely they would be to provide broad consent knowing that their donation might be used in that research. Substantial minorities found both broad and study-by-study consent to be unacceptable and identified those two options as the worst policies. Furthermore, while the type of moral concern (e.g., regarding abortion, the commercial use of donations, or stem cell research had no effect on policy preferences, an increase in the number of research scenarios generating moral concerns was related to an increased likelihood of finding broad consent to be the worst policy. The rejection of these ethically problematic and costly extremes is good news for biobanks. The challenge now is to design a policy that combines consent with access to information in a way that assures potential donors that their interests and moral concerns are being respected.

  10. Strengthening regional safeguards

    Palhares, L.; Almeida, G.; Mafra, O. [Brazilian-Argentine Agency for Accounting and Control of Nuclear Materials, Rio de Janeiro (Brazil)] [and others


    Nuclear cooperation between Argentina and Brazil has been growing since the early 1980`s and as it grew, so did cooperation with the US Department of Energy (DOE). The Brazilian-Argentine Agency for Accounting and Control of Nuclear Materials (ABACC) was formed in December 1991 to operate the Common System of Accounting and Control of Nuclear Materials (SCCC). In April 1994, ABACC and the DOE signed an Agreement of Cooperation in nuclear material safeguards. This cooperation has included training safeguards inspectors, exchanging nuclear material measurement and containment and surveillance technology, characterizing reference materials, and studying enrichment plant safeguards. The goal of the collaboration is to exchange technology, evaluate new technology in Latin American nuclear facilities, and strengthen regional safeguards. This paper describes the history of the cooperation, its recent activities, and future projects. The cooperation is strongly supported by all three governments: the Republics of Argentina and Brazil and the United States.

  11. Strengthening Aboriginal community wellbeing

    Bronwyn Batten


    Full Text Available Since 2008 the NSW Government has been investigating the concept of ‘wellbeing’ as it relates to Aboriginal communities. Adopting a focus on wellbeing has meant delving into questions about what makes communities strong, and what factors are unique to creating strong Aboriginal communities, as well as considering the government’s role (if any in supporting Aboriginal community wellbeing. This paper seeks to convey the essence of the journey into wellbeing to date. It details the positions and assumptions that this work started with, and analyses why this has shifted over time. It examines what worked and was feasible, and what didn’t. In particular, the paper overviews the creation of the Strengthening Aboriginal Community Wellbeing Framework (the policy context, and the development of a resource in the form of a user friendly software program for communities wishing to holistically assess their wellbeing – the ‘toolkit’ (the practical outcome of the work to date.

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

    Dahl, Katja; Kesmodel, Ulrik; hvidman, lone


    of the possibility of a false negative result. The risk of miscarriage in relation to amniocentesis (AC) is unknown to 11-53%. Uptake rates are associated with attitudes towards prenatal examinations, but not knowledge of the test offered. A total of 88 % concidered their health care provider an important source...

  13. International experience of informed consent and genetic counseling on non-invasive prenatal testing applied in Down syndrome prenatal screening%非侵入性产前检测技术知情同意与遗传咨询的国际经验

    明坚; 许艳; 周萍; 黄葭燕; 陈英耀


    This paper summarized the international experience on the implementation of informed consent and genetic counseling when non-invasive prenatal testing(NIPT) applied in Down syndrome prenatal screening. Then its implications for China were discussed and some policy recommendations were put forward,including enhancing the training to the counselors and doctors,clearly defining the content of genetic counseling,and further standardizing the informed consent implementation.%围绕非侵入性产前检测技术(NIPT)应用于唐氏产前筛查的知情同意与遗传咨询实施,总结分析了国际相关经验与研究,并结合我国国情提出了相关政策建议。建议加强相关人员培训,明确知情告知内容,进一步规范知情同意与遗传咨询的操作实施。

  14. Electrical stimulation and muscle strengthening

    Dehail, P; Duclos, C; Barat, M


    ...: muscular or neuromuscular, electromyostimulation, electrical stimulation, strengthening, strength training, immobilization, muscle dystrophy, bed-rest, bed-bound, knee or hip surgery, postoperative...

  15. Conflicting interests, social justice and proxy consent to research.

    Pullman, Daryl


    Historically the primary role of the Institutional Review Board (IRB) has been "to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in research" (U.S. FDA, 1996). However, there is much to suggest that IRBs have been unable to fulfil this mandate, particularly in regard to the matter of informed consent. Part of the problem in this regard is that the competing interests of other stakeholders often undermine the IRB's capacity to serve the best interests of research subjects. This paper proposes an alternative view of the role of the IRB. It begins by treating the interests of other stakeholders as legitimate matters of concern for IRBs. Hence the process established to review and monitor human research should be treated as an exercise in social justice in which the interests of all legitimate stakeholders must be represented and considered. A variation of Rawls' (1971) heuristic "the veil of ignorance" is employed to explore the dynamic relationship between knowledge and interests that ensues when the role of the IRB is characterized in this manner. Inadequacies in the informed consent process are taken as illustrative of the inability of IRBs as they are presently construed to attend to the interests of research subjects. The major normative implication of the analysis offered here is that the role of the IRB must be expanded to include the granting of a provisional proxy consent on behalf of prospective research subjects. This provision is necessary, it is argued, if the interests of research subjects are to be fairly assessed by IRBs as a matter of social justice. It is necessary as well to ensure that an adequate standard of informed consent is attained. Somewhat paradoxically it is argued that the interests of research subjects are better served when treated as one among a number of competing sets of interests the IRB must serve, rather than as the primary

  16. Framing patient consent for student involvement in pelvic examination: a dual model of autonomy.

    Carson-Stevens, Andrew; Davies, Myfanwy M; Jones, Rhiain; Chik, Aiman D Pawan; Robbé, Iain J; Fiander, Alison N


    Patient consent has been formulated in terms of radical individualism rather than shared benefits. Medical education relies on the provision of patient consent to provide medical students with the training and experience to become competent doctors. Pelvic examination represents an extreme case in which patients may legitimately seek to avoid contact with inexperienced medical students particularly where these are male. However, using this extreme case, this paper will examine practices of framing and obtaining consent as perceived by medical students. This paper reports findings of an exploratory qualitative study of medical students and junior doctors. Participants described a number of barriers to obtaining informed consent. These related to misunderstandings concerning student roles and experiences and insufficient information on the nature of the examination. Participants reported perceptions of the negative framing of decisions on consent by nursing staff where the student was male. Potentially coercive practices of framing of the decision by senior doctors were also reported. Participants outlined strategies they adopted to circumvent patients' reasons for refusal. Practices of framing the information used by students, nurses and senior doctors to enable patients to decide about consent are discussed in the context of good ethical practice. In the absence of a clear ethical model, coercion appears likely. We argue for an expanded model of autonomy in which the potential tension between respecting patients' autonomy and ensuring the societal benefit of well-trained doctors is recognised. Practical recommendations are made concerning information provision and clear delineations of student and patient roles and expectations.

  17. Testing Consent Order for Sodium Cyanide

    This document announces that EPA has signed an enforceable testing Consent Order with E.I. du Pont de Nemours and Company (DuPont), FMC Corporation (FMC), Degussa Corporation (Degussa), ICI Americas Incorporated (ICI), and Cyanco Company (Cyanco).

  18. Testing Consent Order on Refractory Ceramic Fibers

    This notice announces that EPA has signed signed an enforceable testing consent order under the Toxic Substances Control Act (TSCA), 15 U.S.C. section 2601 at seq., with three of the primary producers of refractory ceramic fibers (RCF).

  19. Parents, adolescents, and