WorldWideScience

Sample records for providing informed consent

  1. Informed consent - Providing information about prenatal examinations

    DEFF Research Database (Denmark)

    Dahl, Katja; Kesmodel, Ulrik; Hvidman, Lone

    to empower women making an informed consent. Information on Down syndrome is often confined and limitations of screenings tests rarely mentioned.  Understanding is better achieved by presenting the risk estimate as a numerical probability compared to a verbal explanation. Rates are better understood than......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...

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

    Science.gov (United States)

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

    2016-01-01

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

  3. Telemedicine Provides Noninferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial.

    Science.gov (United States)

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

    2016-07-01

    Telemedicine networks are beginning to provide an avenue for conducting emergency medicine research, but using telemedicine to recruit participants for clinical trials has not been validated. The goal of this consent study was to determine whether patient comprehension of telemedicine-enabled research informed consent is noninferior to standard face-to-face (F2F) research informed consent. A prospective, open-label randomized controlled trial was performed in a 60,000-visit Midwestern academic emergency department (ED) to test whether telemedicine-enabled research informed consent provided noninferior comprehension compared with standard consent. This study was conducted as part of a parent clinical trial evaluating the effectiveness of 0.12% oral chlorhexidine gluconate in preventing hospital-acquired pneumonia among adult ED patients with expected hospital admission. Prior to being recruited into the study, potential participants were randomized in a 1:1 allocation ratio to consent by telemedicine versus standard F2F consent. Telemedicine connectivity was provided using a commercially available interface (REACH platform, Vidyo Inc.) to an emergency physician located in another part of the ED. Comprehension of research consent (primary outcome) was measured using the modified quality of informed consent (QuIC) instrument, a validated tool for measuring research informed consent comprehension. Parent trial accrual rate and qualitative survey data were secondary outcomes. A total of 131 patients were randomized (n = 64, telemedicine), and 101 QuIC surveys were completed. Comprehension of research informed consent using telemedicine was not inferior to F2F consent (QuIC scores 74.4 ± 8.1 vs. 74.4 ± 6.9 on a 100-point scale, p = 0.999). Subjective understanding of consent (p = 0.194) and parent trial study accrual rates (56% vs. 69%, p = 0.142) were similar. Telemedicine is noninferior to F2F consent for delivering research informed consent, with no detected

  4. Predictors of providing informed consent or assent for research participation in assisted living residents.

    Science.gov (United States)

    Black, Betty S; Brandt, Jason; Rabins, Peter V; Samus, Quincy M; Steele, Cynthia D; Lyketsos, Constantine G; Rosenblatt, Adam

    2008-01-01

    This study's goal was to identify factors associated with providing either informed consent or assent for research in individuals at high risk for cognitive impairment. Cross-sectional baseline data were used to identify predictors of consent or assent status. The study was conducted at 22 assisted living facilities in Maryland. A stratified random sample of 198 assisted living residents participated in the study. Residents' consent or assent status was documented as providing informed consent, written assent, or verbal assent/no objection. Potential predictors included residents' demographic characteristics, measures of physical and mental health status, and neuropsychological test performance. Most participants provided written assent (32.8%) or verbal assent/no objection (30.3%) rather than informed consent (36.9%). Although many resident characteristics correlated with consent or assent status based on bivariate analyses, few variables distinguished those who provided written assent from those in the verbal assent/no objection group. On the basis of multiple discriminant analysis, the best predictors of consent or assent status were Mini-Mental State Exam scores, impairments in instrumental activities of daily living, and dementia diagnosis, which together classified correctly 63.6% of residents. The relatively small proportion of participants who could provide informed consent highlights the importance of assessing decisional capacity for research in a high-risk population and identifying an appropriate surrogate decision maker to provide proxy consent if needed. Consensus on how to define assent is lacking, and specific measures of assent capabilities are needed to better characterize the assent capacity continuum.

  5. Informed Consent and Routinisation

    DEFF Research Database (Denmark)

    Ploug, Thomas; Holm, Søren

    2013-01-01

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

  6. Informed consent - adults

    Science.gov (United States)

    ... this page: //medlineplus.gov/ency/patientinstructions/000445.htm Informed consent - adults To use the sharing features on this ... treatments require written informed consent. What Treatments Need Informed Consent? Medical procedures that may require you to give ...

  7. Informed Consent in Dentistry.

    Science.gov (United States)

    Reid, Kevin I

    2017-03-01

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

  8. Education and informed consent about increased risk donor kidneys: a national survey of non-physician transplant providers.

    Science.gov (United States)

    Gordon, E J; Mullee, J; Beauvais, N; Warren, E; Theodoropoulos, N; McNatt, G; Rassiwala, J; Ison, M G

    2014-04-01

    Transplant providers must understand the definition of increased risk donor (IRD) organs to effectively educate transplant candidates and obtain informed consent. This study surveyed non-physician providers from 20 transplant centers about their educational and informed consent practices of IRD kidneys. An anonymous, web-based survey about the content and timing of education and informed consent for potential recipients of IRD kidneys, providers' knowledge of IRD kidneys, and provider and center characteristics was completed by most (67%; 90 of 135) of those invited to participate; 87 responses were included in analysis. Most (80%) reported understanding the concept of IRD kidneys. However, few reported sufficient knowledge of the Organ Procurement and Transplantation Network definition of IRDs, risk factors, screening tests, window periods, and infection transmission rates. Most (56%) felt uncomfortable with obtaining specific informed consent for IRD kidneys. Most respondents received informal education about IRD kidneys (78%), and recognized the need for (98%) and were interested in receiving (99%) further education on this topic. Non-physician transplant providers need and are interested in better education about IRD kidneys to effectively educate patients and obtain patients' informed consent. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  9. Informed consent for clinical treatment

    National Research Council Canada - National Science Library

    Hall, Daniel E; Prochazka, Allan V; Fink, Aaron S

    2012-01-01

    ... used in this review is available in Box 1. (1) Although we had hoped to identify high-quality studies that would provide a strong quantitative base of evidence for recommendations around informed consent, much of the quantitative literature on this topic is descriptive in nature. Informed consent is primarily a legal and ethical concept; althou...

  10. Informed consent in pediatric anesthesiology.

    Science.gov (United States)

    Gentry, Katherine R; Lepere, Katherine; Opel, Douglas J

    2017-12-01

    Informed consent for pediatric anesthesia is unique because it is (1) obtained from surrogates (ie, parents) rather than from the patient and (2) sought after parents have authorized the surgical intervention. There are limited data on how pediatric anesthesia informed and consent discussions are conducted. The purpose of this study was to characterize the content of preanesthesia informed consent discussions and assess their impact on parent recall and understanding. We conducted a cross-sectional observational study at a tertiary pediatric hospital. We audio-recorded and transcribed preanesthesia consent discussions between pediatric anesthesia providers and parents of children undergoing elective surgery. Parents were recruited on the day of surgery and completed a survey postdiscussion to assess their recall and perceived understanding. We used directed content analysis to identify 7 informed consent elements: (i) description of the plan; mention of (ii) alternatives, (iii) risks, and (iv) benefits; (v) discussion of uncertainties; (vi) assessment of comprehension; and (vii) solicitation of a decision. We used multivariable logistic regression to explore the association between discussions that included 3 informed consent elements (description of plan, mention of risks, and mention of benefits) and parent recall and understanding of these elements. We analyzed 97 discussions involving 41 different anesthesia providers. The element most frequently included in preanesthesia discussions was a description of the plan (100%); the least frequently included was decision solicitation (18%). Seventy-one percent of discussions included ≥5 informed consent elements and 70% included a description of the plan, mention of risks, and mention of benefits. Parental recall of these 3 informed consent elements was associated with their inclusion in the preanesthesia discussion (75% vs 34%), and more parents understood all 3 elements if they had reported (vs not reported) recall

  11. 7 CFR 1c.117 - Documentation of informed consent.

    Science.gov (United States)

    2010-01-01

    ... 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... following: (1) A written consent document that embodies the elements of informed consent required by § 1c...

  12. 21 CFR 50.27 - Documentation of informed consent.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Documentation of informed consent. 50.27 Section... PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.27 Documentation of informed consent. (a) Except as provided in § 56.109(c), informed consent shall be documented by the use of a written consent...

  13. 45 CFR 46.117 - Documentation of informed consent.

    Science.gov (United States)

    2010-10-01

    ... 45 Public Welfare 1 2010-10-01 2010-10-01 false Documentation of informed consent. 46.117 Section... informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be...) A written consent document that embodies the elements of informed consent required by § 46.116. This...

  14. 49 CFR 11.117 - Documentation of informed consent.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 1 2010-10-01 2010-10-01 false Documentation of informed consent. 11.117 Section... Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent... following: (1) A written consent document that embodies the elements of informed consent required by § 11...

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

    Science.gov (United States)

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

    2017-11-01

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

  16. [Informed consent in emergency medicine].

    Science.gov (United States)

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

    2010-01-01

    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.

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

    Directory of Open Access Journals (Sweden)

    Zeynep Mackali

    2014-09-01

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

  18. Informed Consent in Adult Psychiatry

    Directory of Open Access Journals (Sweden)

    Ahmed Bait Amer

    2013-07-01

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

  19. Identity change and informed consent

    Science.gov (United States)

    Witt, Karsten

    2017-01-01

    In this paper, I focus on a kind of medical intervention that is at the same time fascinating and disturbing: identity-changing interventions. My guiding question is how such interventions can be ethically justified within the bounds of contemporary bioethical mainstream that places great weight on the patient's informed consent. The answer that is standardly given today is that patients should be informed about the identity effects, thus suggesting that changes in identity can be treated like ‘normal’ side effects. In the paper, I argue that this approach is seriously lacking because it misses important complexities going along with decisions involving identity changes and consequently runs into mistakes. As a remedy I propose a new approach, the ‘perspective-sensitive account’, which avoids these mistakes and thus provides the conceptual resources to systematically reflect on and give a valid consent to identity-changing interventions. PMID:28320773

  20. Dare we rethink informed consent?

    African Journals Online (AJOL)

    2017-06-26

    Jun 26, 2017 ... (flawed but 'good-enough' or 'minimalist' informed consent). This is unsatisfactory and poses several questions, for example, how reflective should choices be? How do we define acceptable informed consent? Why should limited autonomy be honoured and override other important principles?[6] Manson ...

  1. informed consent in clinical trials

    African Journals Online (AJOL)

    2009-08-27

    Aug 27, 2009 ... ondersteuning ontvang en dat daar beter oor hulle toesig gehou word. INFORMED CONSENT IN CLINICAL TRIALS: PERCEPTIONS AND. EXPERIENCES OF A SAMPLE OF SOUTH AFRICAN RESEARCHERS. INTRODUCTION. First articulated in the Nuremberg Code in 1947, informed consent (IC) has ...

  2. Is Consent Based on Trust Morally Inferior to Consent Based on Information?

    Science.gov (United States)

    Kongsholm, Nana Cecilie Halmsted; Kappel, Klemens

    2017-07-01

    Informed consent is considered by many to be a moral imperative in medical research. However, it is increasingly acknowledged that in many actual instances of consent to participation in medical research, participants do not employ the provided information in their decision to consent, but rather consent based on the trust they hold in the researcher or research enterprise. In this article we explore whether trust-based consent is morally inferior to information-based consent. We analyse the moral values essential to valid consent - autonomy, voluntariness, non-manipulation, and non-exploitation - and assess whether these values are less protected and promoted by consent based on trust than they are by consent based on information. We find that this is not the case, and thus conclude that trust-based consent if not morally inferior to information-based consent. © 2017 John Wiley & Sons Ltd.

  3. 34 CFR 97.117 - Documentation of informed consent.

    Science.gov (United States)

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false Documentation of informed consent. 97.117 Section 97...) § 97.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed by...

  4. 16 CFR 1028.117 - Documentation of informed consent.

    Science.gov (United States)

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Documentation of informed consent. 1028.117... SUBJECTS § 1028.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and...

  5. 15 CFR 27.117 - Documentation of informed consent.

    Science.gov (United States)

    2010-01-01

    ... 15 Commerce and Foreign Trade 1 2010-01-01 2010-01-01 false Documentation of informed consent. 27... SUBJECTS § 27.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and...

  6. 45 CFR 690.117 - Documentation of informed consent.

    Science.gov (United States)

    2010-10-01

    ... 45 Public Welfare 3 2010-10-01 2010-10-01 false Documentation of informed consent. 690.117 Section... PROTECTION OF HUMAN SUBJECTS § 690.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form...

  7. 28 CFR 46.117 - Documentation of informed consent.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Documentation of informed consent. 46.117....117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed by...

  8. 40 CFR 26.117 - Documentation of informed consent.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Documentation of informed consent. 26... EPA § 26.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and...

  9. 22 CFR 225.117 - Documentation of informed consent.

    Science.gov (United States)

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Documentation of informed consent. 225.117....117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed by...

  10. 14 CFR 1230.117 - Documentation of informed consent.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Documentation of informed consent. 1230.117... SUBJECTS § 1230.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and...

  11. 38 CFR 16.117 - Documentation of informed consent.

    Science.gov (United States)

    2010-07-01

    ... PROTECTION OF HUMAN SUBJECTS § 16.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form... elements of informed consent required by § 16.116. This form may be read to the subject or the subject's...

  12. Informed Consent in Complementary and Alternative Medicine

    Directory of Open Access Journals (Sweden)

    Opher Caspi

    2011-01-01

    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.

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

    Directory of Open Access Journals (Sweden)

    Bart Custers

    2016-01-01

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

  14. The quality of obtaining surgical informed consent.

    Science.gov (United States)

    Joolaee, Soodabeh; Faghanipour, Somayeh; Hajibabaee, Fatemeh

    2017-03-01

    Informed consent goes beyond signing a form; it is a process of providing necessary information, helping patients make an informed decision, and actively participate in their treatment. This study aimed to assess the quality of obtaining surgical informed consent in hospitals affiliated with Tehran University of Medical Sciences. Research design/participants/context: In a cross-sectional, descriptive-analytical study, 300 patients were chosen through stratified sampling from seven hospitals affiliated with Tehran University of Medical Sciences. Data were collected using a questionnaire developed by the researchers and analyzed using descriptive and analytical statistics on SPSS software. Ethical considerations: Ethical approval of this study was granted by Tehran University of Medical Sciences research ethics committee. Written informed consent for participation was obtained. The participants were reassured that their information will be used anonymously and their answers will not affect their treatment and care. The mean score of quality of acquisition of informed consent was 17.13 out of 35, indicating that the quality falls in the inappropriate category. The results indicate that 48% of the signatories do not even read the form before signing it. Among the 52% who did read the consent form, 61.3% mentioned varying degrees of incomprehensibility of the consent form and 94.2% mentioned the presence of incomprehensible technical, medical and legal vocabulary. Only 12% and 18% of respondents reported that they were not in hurry and they had no fear or anxiety, respectively, when signing the form. The quality of obtaining informed consent was higher in women, younger patients, patients with higher education, and those who had special surgeries. This study shows a poor practice in obtaining surgical informed consent in Iran. It seems necessary to consider fundamental changes in the process of acquiring consent based on the temporal and local conditions of the patients.

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

    Science.gov (United States)

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

    2013-06-01

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

  16. 42 CFR 441.257 - Informed consent.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false Informed consent. 441.257 Section 441.257 Public... Sterilizations § 441.257 Informed consent. (a) Informing the individual. For purposes of this subpart, an individual has given informed consent only if— (1) The person who obtained consent for the sterilization...

  17. Informed Consent (Clinical Trials)

    Science.gov (United States)

    ... Cancer Treatment Types of Cancer 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 ...

  18. Understanding of informed consent by demented individuals.

    Science.gov (United States)

    Buckles, V D; Powlishta, K K; Palmer, J L; Coats, M; Hosto, T; Buckley, A; Morris, J C

    2003-12-23

    The informed consent process is central to the conduct of research but may be difficult for cognitively impaired participants to understand. The authors developed a brief test addressing the elements of informed consent for a specific minimum-risk nontreatment research protocol. To evaluate and document understanding of informed consent by elderly research participants across a range of dementia severity. The elements of informed consent regarding participation in a longitudinal study of healthy aging and dementia were reviewed with both demented (n = 250) and nondemented (n = 165) participants who then completed a short test requiring yes-no responses to assess understanding of these elements. Demented participants had very mild, mild, or moderate dementia as staged by the Clinical Dementia Rating. After adjusting for education, performance on the test varied with dementia severity in mean differences and by correlation. All nondemented and very mildly demented participants and 92% of mildly demented participants provided correct answers for at least 8 of 10 true-false items, whereas only 67% of the moderately demented participants achieved this level of accuracy. Demented individuals, very mild and mild, understood informed consent information for this nontreatment research study. Understanding notably declined in the moderate stage of dementia. Brief tests may be useful as one method to assess understanding of the consent process for specific studies.

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

    Science.gov (United States)

    Kottow, Miguel

    2016-11-01

    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.

  20. [The origin of informed consent].

    Science.gov (United States)

    Mallardi, V

    2005-10-01

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

  1. Evaluating informed consent for colonoscopy.

    Science.gov (United States)

    Gett, Rohan M; Cooray, Anuk R; Gold, Darren; Danta, Mark

    2014-08-01

    This study aimed to collect and analyze data on patient knowledge of colonoscopy and their preferences regarding the provision of information about the procedure. Specifically, how much detail patients know about different aspects of the procedure and through which methods they best understand risk are evaluated and demographic correlations identified. The study sample consisted of colonoscopy patients from 2 colorectal surgeons and a gastroenterologist at St Vincent's Public Hospital, Sydney for the period August 1 to November 1, 2010. A voluntary questionnaire was performed in the waiting room before colonoscopy. The questionnaire collected data on patient demographics; patient-perceived knowledge of the procedure; and understanding and preferences of various communication formats. Measures of patient-perceived knowledge about colonoscopy were significantly lower than those that would be preferred by patients (P=0.002). Those with higher levels of education preferred communication of colonoscopy-related information via a leaflet form, whereas those with lower levels preferred verbal information from a doctor or nurse (P=0.049). The most preferred format for explaining the risk of perforation was the pie graph, followed by both the 1000-person pictograph and absolute risk ratios. Patients received suboptimal levels of information about colonoscopy compared with their preferences. Key areas for improvement include providing more understandable information about the risks of colonoscopy. A combination of written information, diagrams and graphs, and then a discussion of this information to check the understanding is likely to be most effective. Further research into the communication of risk, with larger groups of patients, is likely to help clinicians in gaining fully informed consent in all patients.

  2. 16 CFR 1028.116 - General requirements for informed consent.

    Science.gov (United States)

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false General requirements for informed consent... HUMAN SUBJECTS § 1028.116 General requirements for informed consent. Except as provided elsewhere in... unless the investigator has obtained the legally effective informed consent of the subject or the subject...

  3. 14 CFR 1230.116 - General requirements for informed consent.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false General requirements for informed consent... PROTECTION OF HUMAN SUBJECTS § 1230.116 General requirements for informed consent. Except as provided... policy unless the investigator has obtained the legally effective informed consent of the subject or the...

  4. 22 CFR 225.116 - General requirements for informed consent.

    Science.gov (United States)

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false General requirements for informed consent. 225... SUBJECTS § 225.116 General requirements for informed consent. Except as provided elsewhere in this policy... investigator has obtained the legally effective informed consent of the subject or the subject's legally...

  5. 28 CFR 46.116 - General requirements for informed consent.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false General requirements for informed consent... SUBJECTS § 46.116 General requirements for informed consent. Except as provided elsewhere in this policy... investigator has obtained the legally effective informed consent of the subject or the subject's legally...

  6. 15 CFR 27.116 - General requirements for informed consent.

    Science.gov (United States)

    2010-01-01

    ... OF HUMAN SUBJECTS § 27.116 General requirements for informed consent. Except as provided elsewhere in... unless the investigator has obtained the legally effective informed consent of the subject or the subject... subject or the representative. No informed consent, whether oral or written, may include any exculpatory...

  7. 10 CFR 745.117 - Documentation of informed consent.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Documentation of informed consent. 745.117 Section 745.117 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a...

  8. 45 CFR 46.116 - General requirements for informed consent.

    Science.gov (United States)

    2010-10-01

    ... 45 Public Welfare 1 2010-10-01 2010-10-01 false General requirements for informed consent. 46.116... for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human... effective informed consent of the subject or the subject's legally authorized representative. An...

  9. 34 CFR 97.116 - General requirements for informed consent.

    Science.gov (United States)

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false General requirements for informed consent. 97.116... Subjects) § 97.116 General requirements for informed consent. Except as provided elsewhere in this policy... investigator has obtained the legally effective informed consent of the subject or the subject's legally...

  10. 40 CFR 26.116 - General requirements for informed consent.

    Science.gov (United States)

    2010-07-01

    ... Supported by EPA § 26.116 General requirements for informed consent. Except as provided elsewhere in this... the investigator has obtained the legally effective informed consent of the subject or the subject's... representative. No informed consent, whether oral or written, may include any exculpatory language through which...

  11. 32 CFR 219.117 - Documentation of informed consent.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 2 2010-07-01 2010-07-01 false Documentation of informed consent. 219.117... (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a...

  12. 49 CFR 11.116 - General requirements for informed consent.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 1 2010-10-01 2010-10-01 false General requirements for informed consent. 11.116....116 General requirements for informed consent. Except as provided elsewhere in this policy, no... has obtained the legally effective informed consent of the subject or the subject's legally authorized...

  13. Improving communication when seeking informed consent: a randomised controlled study of a computer-based method for providing information to prospective clinical trial participants.

    Science.gov (United States)

    Karunaratne, Asuntha S; Korenman, Stanley G; Thomas, Samantha L; Myles, Paul S; Komesaroff, Paul A

    2010-04-05

    To assess the efficacy, with respect to participant understanding of information, of a computer-based approach to communication about complex, technical issues that commonly arise when seeking informed consent for clinical research trials. An open, randomised controlled study of 60 patients with diabetes mellitus, aged 27-70 years, recruited between August 2006 and October 2007 from the Department of Diabetes and Endocrinology at the Alfred Hospital and Baker IDI Heart and Diabetes Institute, Melbourne. Participants were asked to read information about a mock study via a computer-based presentation (n = 30) or a conventional paper-based information statement (n = 30). The computer-based presentation contained visual aids, including diagrams, video, hyperlinks and quiz pages. Understanding of information as assessed by quantitative and qualitative means. Assessment scores used to measure level of understanding were significantly higher in the group that completed the computer-based task than the group that completed the paper-based task (82% v 73%; P = 0.005). More participants in the group that completed the computer-based task expressed interest in taking part in the mock study (23 v 17 participants; P = 0.01). Most participants from both groups preferred the idea of a computer-based presentation to the paper-based statement (21 in the computer-based task group, 18 in the paper-based task group). A computer-based method of providing information may help overcome existing deficiencies in communication about clinical research, and may reduce costs and improve efficiency in recruiting participants for clinical trials.

  14. [Informed consent in gynecology and obstetrics].

    Science.gov (United States)

    Krepelka, P

    2006-01-01

    A systematic review of recent available literature on the topic of informed consent, evaluation of the terminus a quo and the creation of theoretical basis for execution of the process of informed consent in clinical practice with attention to specific aspects in gynecology and obstetrics. Review of literature. Mother and Child Care Institute Prague, Chair of Gynecology and Obstetrics, IPVZ, Prague. Review of publications on the given topic and implementation of general principles of medical ethics in the area of gynecology and obstetrics. The branch of gynecology and obstetrics brings about various controversial clinical situations, which arise from specific features of the branch. The informed consent is an integral part of the diagnostic-therapeutic process and precondition of the correct (lege artis) procedure. The adequate agreement with the therapy should be informed, free and competent. It prevents ethical crisis in conditions of an ethical conflict. The paper defines the content and structure of the informed consent and draws attention to its technical prerequisites so as to fulfill the truthfulness and legal validity. The informed consent is an important part of communication between the physician and the patient. The physician provides a complex, qualified, truthful and complete information. A competent patient accepts this kind of information and decides, based on full understanding, when and in what form, undergoes the recommended procedure or refuses it.

  15. Voluntary Informed Consent in Paediatric Oncology Research.

    Science.gov (United States)

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

    2016-07-01

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

  16. 21 CFR 640.61 - Informed consent.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Informed consent. 640.61 Section 640.61 Food and... ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.61 Informed consent. The written... and informed consent be given and that a clear opportunity to refuse is presented. ...

  17. 28 CFR 512.16 - Informed consent.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Informed consent. 512.16 Section 512.16... RESEARCH Research § 512.16 Informed consent. (a) Before commencing a research project requiring participation by staff or inmates, the researcher shall give each participant a written informed consent...

  18. 28 CFR 549.52 - Informed consent.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Informed consent. 549.52 Section 549.52... Plastic Surgery § 549.52 Informed consent. Approved plastic surgery procedures may not be performed without the informed consent of the inmate involved. ...

  19. Informed consent: the nurse's dilemma.

    Science.gov (United States)

    Tabak, N

    1996-01-01

    The author builds upon the concept of informed consent whereby the patient agrees to undergo experimental medical procedures. Ideally, the doctor will inform the patient fully on the proposed treatment so as to assure the patient's right to participate intelligently and freely in the decisions regarding his treatment. The nurse is drawn into the doctor-patient relationship in cases where the patient seeks her counsel because he feels insufficiently informed by the doctor, or because the nurse becomes aware of inadequacies in the information-giving process. She is then faced by the nurse's dilemma: a conflict between the loyalties she owes to her patient and to her physician team mate. A work sheet is presented which can help the nurse decide upon the proper course of action in solving this dilemma, guided by her personal and professional beliefs and by specific ethical concepts in the Code for Nurses. Solution of the dilemma and attainment of informed consent requires willing cooperation between doctor and nurse. Both can develop the skills for imparting information to the patient under difficult conditions and for verifying its comprehension by the patient. Both must learn to respect the patient's decision and to temper their professional skills with sensitivity, a strong moral sense and a deep respect for their fellow human beings.

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

    African Journals Online (AJOL)

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

  1. Informed Consent In Research | Nnebue | Afrimedic Journal

    African Journals Online (AJOL)

    Literature search was done using Google search engine as well as international and local journals. Result: Informed consent as an aspect of medical ethics, balances autonomy and beneficence, and provides adequate assurance of voluntary and autonomous participation without negative repercussions on access to study ...

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

    DEFF Research Database (Denmark)

    Dahl, Katja; Kesmodel, Ulrik; hvidman, lone

    2006-01-01

    Background: Providing women with information enabling an informed consent to prenatal examinations has been widely recommended. Objective: The primary purpose of this review is to summarise current knowledge of the pregnant woman's expectations and attitudes concerning prenatal examinations...... of information, and 57 % stated that this information has influenced their decision.  Conclusions: Pregnant women favor prenatal examinations, but the choice of participation does not seem to be based on insight to enable full informed consent. Health care providers are perceived as an essential source...... of information. ...

  3. Acute pain and narcotic use does not impair the ability to provide informed consent: evaluation of a competency assessment tool in the acute pain patient.

    Science.gov (United States)

    Lucha, Paul A; Kropcho, Luisa; Schneider, James J; Francis, Michael

    2006-02-01

    Patients evaluated in acute pain will often have narcotics withheld until after the patient has been evaluated by a surgeon and has given informed consent. Concern that the patient would have impaired judgment due to narcotic effects often prevents the administration of timely pain relief. The Hopkins Competency Assessment Tool (HCAT) is a validated instrument for both psychiatric and medical patients; it has not been validated to evaluate drug effects on judgment. Thirty consecutive patients agreed to participate in the trial over a 12-month period. The HCAT was administered prior to the planned major elective procedure and repeated on each postoperative day up to and including postoperative day 5. Narcotic use (as morphine equivalents), HCAT scores, demographic data, and surgical procedures were recorded. The average age of our patients was 53 years. Twenty-seven patients passed the initial HCAT, and one patient failed subsequent exams. No correlation was seen between HCAT score and narcotic dose. Narcotic administration sufficient for pain control does not impair the ability to provide informed consent. The only patient who failed the HCAT after an initial passing score was somnolent on the narcotic dose.

  4. Standardized Consent: The Effect of Information Sheets on Information Retention.

    Science.gov (United States)

    Clarke, Keara; OʼLoughlin, Padhraig; Cashman, James

    2015-11-10

    Informed consent embodies the ethical principle of autonomy of the surgical patient. Effective communication is essential to this decision-making process. Variability in consent can lead to confusion among patients and can expose the surgeon to risk in an increasingly litigious environment. This study aimed to evaluate the use of a standardized consenting process and assess the pattern of information recall following provision of patient information sheets. One hundred orthopedic clinic patients were randomly selected to participate in this prospective audit. Mean age was 41 years. Each participant was consented to undergo wrist manipulation under anaesthesia and K-wiring using a standardized British Orthopaedic Association consent form. A 22-item questionnaire was completed based on the information provided. Half of the cohort received additional printed take-home material. Each questionnaire was repeated 1 day later to determine which aspects of consent were best retained. Baseline scores were low on initial questioning for each section. There was a significant decrease in information retained over 24-hour interval (mean, 8.94 versus 7.98, P ≤ 0.000). Where standardized forms were provided, individual baseline scores rose significantly 24 hours after initial questioning. In particular, arthritis, neurovascular injury, and infection were more likely to be remembered with provision of written information (P = 0.01). Significantly lower scores were seen in those who had not received written information (mean, 9.542 versus 6.449; P ≤ 0.00). Consent remains challenging even with a standardized process. Information retention improves significantly with the use of information sheets. We advocate the use of standard consent and provision of patient information sheets for commonly performed procedures.

  5. Informed Consent For Ablative Operations: Environmental Peculiarities

    African Journals Online (AJOL)

    BACKGROUND: Consenting for ablative surgery in our environment is very difficult. The fact that the concept of informed consent is based on patient's autonomy makes it even more frustrating in this environment. BODY: In this paper we have presented five patients in whom obtaining consent was particularly frustrating for ...

  6. Value of informed consent in surgical orthodontics

    NARCIS (Netherlands)

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

    2009-01-01

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

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

    Science.gov (United States)

    Kim, Eun Jin; Kim, Su Hyun

    2015-06-01

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

  8. Implementation of Informed Consent in Obstetrics and Gynecology ...

    African Journals Online (AJOL)

    Objectives: - This is a descriptive, cross-sectional study, done in Khartoum state to assess patients and providers' knowledge and practice on informed consent in obstetrics and gynecology operations during year 2009. Methodology:- After an informed consent from patients and hospital directorate, data was collected by ...

  9. Readability of Informed Consent Documents at University Counseling Centers

    Science.gov (United States)

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

    2017-01-01

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

  10. Using informed consent to save trust.

    Science.gov (United States)

    Eyal, Nir

    2014-07-01

    Increasingly, bioethicists defend informed consent as a safeguard for trust in caretakers and medical institutions.This paper discusses an ‘ideal type’ of that move. What I call the trust-promotion argument for informed consent states:1. Social trust, especially trust in caretakers and medical institutions, is necessary so that, for example,people seek medical advice, comply with it, and participate in medical research.2. Therefore, it is usually wrong to jeopardise that trust.3. Coercion, deception, manipulation and other violations of standard informed consent requirements seriously jeopardise that trust.4. Thus, standard informed consent requirements are justified.This article describes the initial promise of this argument, then identifies challenges to it. As I show, the value of trust fails to account for some common sense intuitions about informed consent. We should revise the argument, common sense morality, or both.

  11. The changing face of informed surgical consent.

    LENUS (Irish Health Repository)

    Oosthuizen, J C

    2012-03-01

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

  12. HIV testing and informed consent - ethical considerations

    African Journals Online (AJOL)

    against his will, even where the patient suffers as a consequence; and the need for informed consent for an HIV test performed for the patient's own sake is simply one instance of that general duty to respect the patient's autonomy. The general duty to gain ir-lformed consent for a medical procedure is subject to exceptions, ...

  13. Providing an intelligible explanation to pet owners by using three-dimensional CT images: use of clinical imaging for better informed consent.

    Science.gov (United States)

    Kishimoto, Miori; Yamada, Kazutaka; Shimizu, Junichiro; Lee, Ki-Ja; Watarai, Hirokazu; Hassan, Hany Y; Iwasaki, Toshiroh; Miyake, Yoh-Ichi

    2009-04-01

    The purpose of the study reported here was to discuss the level of intelligibility of three-dimensional computed tomography (3D-CT) images of clinical patients for persons who are lacking veterinary knowledge. 143 undergraduate students were participated in this study. They were entirely unfamiliar with veterinary anatomy. A survey was conducted using the visual analog scale method with a focus on the level of intelligibility of the 3D-CT images compared to that of the two-dimensional CT images or radiographs. As a result, the mean value of the intelligibility of the 3D-CT image was 88.4 +/- 17.8 points out of 100 points. In clinical cases, it is very difficult for pet owners lacking veterinary knowledge to understand the clinical status of their pets even with explanations using illustrations, radiographs, and transverse CT images. It is considered that better informed consent and patient satisfaction will be obtained provided veterinarians make an effort towards intelligible patient education by using 3D-CT images.

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

    LENUS (Irish Health Repository)

    2012-02-29

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

  15. Informed consent comprehension in African research settings.

    Science.gov (United States)

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

    2014-06-01

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

  16. Communication and informed consent in elderly people

    National Research Council Canada - National Science Library

    Giampieri, M

    2012-01-01

    .... 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...

  17. A linguistic model of informed consent.

    Science.gov (United States)

    Marta, J

    1996-02-01

    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.

  18. Re-engineering the process of surgical informed consent

    National Research Council Canada - National Science Library

    Dierks, M M; Sands, D Z; Safran, C

    1999-01-01

    We have created a clinical performance support system that transforms surgical informed consent into an interactive process capable of evolving in response to institution-specified, provider-specified...

  19. Medical informed consent: general considerations for physicians.

    Science.gov (United States)

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

    2008-03-01

    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.

  20. Autonomy and informed consent: a mistaken association?

    Science.gov (United States)

    Kristinsson, Sigurdur

    2007-09-01

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

  1. [Informed consent in congenital defect heart surgery].

    Science.gov (United States)

    Oka, Norihiko; Miyaji, Kagami

    2014-09-01

    In pediatric cardiac surgery, informed consent is often obtained from the patient's parents. The parents are commonly under great stress due to being in a situation where they have to make the important decision of whether their child will undergo cardiac surgery. Cardiac surgery does not necessarily determine the patient's prognosis if he or she has other organ anomalies or systemic diseases. In such cases, communication among the cardiac surgeon, pediatrician, and family becomes even more crucial. In pediatric cardiac surgery, it is important to obtain informed consent with adequate explanations, an understanding of the parents' stressful situation, and knowledge of the patient's background. In this article, we introduce two examples of obtaining informed consent for two common pediatric cardiac operations, atrial septal defect closure and ventricular septal defect closure.

  2. Cataract Surgery Informed Consent Survey | Omolase | Nigerian ...

    African Journals Online (AJOL)

    To evaluate the importance patients attach to informed consent and the information they are given during counselling for cataract surgery. A total number of sixty one patients who came for cataract surgery during the eye camp in Owo in August, 2006 were randomly selected using simple random sampling and interviewed.

  3. [Human rights and informed consent].

    Science.gov (United States)

    Navarro-Reynoso, Francisco P; Argüelles-Mier, Miguel; Cicero-Sabido, Raúl

    2004-01-01

    The right to information is a right that all human beings have; it is unrenounceable and confers to the human being the Rights to the Political Constitution of the United States of Mexico, the Universal Declaration of Human Rights, the Declaration of Geneva, and the Code of Behavior for Health Personnel. Information given to a sick person should suffice so that he/she can make a decision on management and treatment. Information is related directly with medical ethics and is obligatory not only for health workers but for all professionals in general.

  4. 40 CFR 26.1117 - Documentation of informed consent.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Documentation of informed consent. 26... Intentional Exposure of Non-pregnant, Non-nursing Adults § 26.1117 Documentation of informed consent. (a) Informed consent shall be documented by the use of a written consent form approved by the IRB and signed by...

  5. 42 CFR 50.204 - Informed consent requirement.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Informed consent requirement. 50.204 Section 50.204... APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.204 Informed consent requirement. Informed consent does not exist unless a consent form is completed voluntarily and in accordance...

  6. Informed consent: an essential element of safe anesthesia practice.

    Science.gov (United States)

    McDonough, J P; McMullen, P; Philipsen, N

    1995-05-01

    Generally, health care providers have viewed safety in terms of prevention of patient accidents. However, with the growth of patient consumerism and stress on quality improvement, the concept of "safety" has been expanded. This article examines the legal concept of informed consent and offers practical suggestions on increasing both patient and provider safety and improving quality of care. For reasons dictated by statute, case law, and professional ethics, informed consent should be part of the practice of every CRNA. With proper informed consent, misinformation, dissatisfaction, and subsequent legal action can be diminished. Information should be offered to the patient and family and reinforced with written educational materials and instructions. These procedures should be documented in the medical record to provide verification that the patient was informed of the risks and benefits and agreed to the procedure contemplated. Failure to do so could expose the CRNA to legal actions under legal theories that include not only negligence, but battery, and contract as well.

  7. Informed Consent for Antenatal Serum Screening for Down Syndrome

    Directory of Open Access Journals (Sweden)

    Hsiao-Lin Hwa

    2010-03-01

    Conclusion: Pregnant women should be offered more information to allow them to make an informed decision before they undergo antenatal serum screening for Down syndrome. Comprehensive genetic counseling improved pregnant women's autonomy in deciding whether to participate in serum screening. Health service providers should make effort to fulfill the ethical requirements of informed consent.

  8. Tandheelkunde en gezondheidsrecht 3: informed consent

    NARCIS (Netherlands)

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

    2013-01-01

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

  9. Communication and Informed Consent in Clinical Geriatrics.

    Science.gov (United States)

    Ratzan, Richard M.

    1986-01-01

    Obtaining a valid informed consent from an elderly person, especially with possible senile dementia of the Alzheimer's type, first may involve solving the practical problems of effective communication. Impediments to effective communication with these individuals is discussed and suggestions for how to obviate them are given. (Author/BL)

  10. Learning Ethics through Everyday Problems: Informed Consent

    Science.gov (United States)

    Verdu, Fernando; Frances, Francesc; Castello, Ana

    2012-01-01

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

  11. Patient satisfaction and informed consent for surgery.

    Science.gov (United States)

    Hallock, Jennifer L; Rios, Rebeca; Handa, Victoria L

    2017-08-01

    Informed consent is a process that necessitates time and effort. Underlying this investment is the belief that informing patients about the surgery promotes patient satisfaction with the decision for surgery and potentially satisfaction more broadly. The objective of the study was to investigate the extent to which preoperative satisfaction with a decision to pursue surgery is associated with understanding after an informed consent discussion. We performed an observational study of adult women seeking surgical treatment for pelvic floor disorders. Study participants were recruited after routine preoperative counseling by board-certified or board-eligible urogynecologists. In our practice, the preoperative informed consent process typically includes a discussion of the indications, risks, benefits, alternatives, and chance of success of the procedures. Participants completed a 35 question survey preoperatively at one setting. The primary outcome, satisfaction with decision, was measured with a validated 6 item Satisfaction with Decision Scale-Pelvic Floor Disorder. Participants were classified as highly satisfied if they indicated the highest level of satisfaction for all items. The primary exposure was patient knowledge of the planned surgery, measured using a newly adapted 20 item Informed Consent Questionnaire including 15 yes/no questions and 5 free-text questions. Additionally, the survey included a validated 3 item tool for health literacy, a single-item anxiety measure, and demographic data. Analyses were performed with a χ2 test, a Student t test, and a multivariable logistic regression using the binary outcome variable, highly satisfied or not highly satisfied. A total of 150 participants were enrolled, with a mean age of 57.5 years. The majority were non-Hispanic (97.3%) or white (87.3%), with at least some college education (51.0%). The median number of days between the informed consent discussion and the survey was 35. The mean total Satisfaction with

  12. Informed consent for paediatric clinical trials in Europe.

    Science.gov (United States)

    Lepola, Pirkko; Needham, Allison; Mendum, Jo; Sallabank, Peter; Neubauer, David; de Wildt, Saskia

    2016-11-01

    Paediatric clinical trials are often conducted as multinational trials. Informed consent or assent is part of the ethics committee approval for clinical trials. The consent requirements vary between countries due to national laws and regulations, which are not harmonised in Europe. These discrepancies can present challenges for paediatric clinical trials. The aim of this study was to assemble these consent and assent requirements across the European Economic Area. The collated national requirements have not been publicly available before, despite a real need for this data. National consent and assent requirements for paediatric clinical trials were analysed and collated for 25 European Union Member States and 2 European Free Trade Association countries until the end of 2014. The data were retrieved from existing databases and through communication with the competent authorities and selected ethics committees. Results from a literature search for international or national guidelines, declarations and conventions and academic societies' publications served as comparison material. Consent and assent requirements are heterogeneous across these countries. We compiled our findings in 'The Informed Consent and Assent Tool Kit', a table including 27 national consent and assent requirements listed by individual country. Wide variation in paediatric consents and assents presents challenges for multinational paediatric trials in Europe. The toolkit is available for all those involved in paediatric clinical trials and ethics committees, providing a new platform for proactive feedback on informed consent requirements, and may finally lead to a needed harmonisation process, including uniform standards accepted across Europe. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  13. Comparison of Informed Consent Preferences for Multiplex Genetic Carrier Screening among a Diverse Population.

    Science.gov (United States)

    Reeves, Ashley; Trepanier, Angela

    2016-02-01

    Multiplex genetic carrier screening is increasingly being integrated into reproductive care. Obtaining informed consent becomes more challenging as the number of screened conditions increases. Implementing a model of generic informed consent may facilitate informed decision-making. Current Wayne State University students and staff were invited to complete a web-based survey by blast email solicitation. Participants were asked to determine which of two generic informed consent scenarios they preferred: a brief versus a detailed consent. They were asked to rank the importance of different informational components in making an informed decision and to provide demographic information. Comparisons between informational preferences, demographic variables and scenario preferences were made. Six hundred ninety three participants completed the survey. When evaluating these generic consents, the majority preferred the more detailed consent (74.5%), and agreed that it provided enough information to make an informed decision (89.5%). Those who thought it would be more important to know the severity of the conditions being screened (p = .002) and range of symptoms (p = .000) were more likely to prefer the more detailed consent. There were no significant associations between scenario preferences and demographic variables. A generic consent was perceived to provide sufficient information for informed decision making regarding multiplex carrier screening with most preferring a more detailed version of the consent. Individual attitudes rather than demographic variables influenced preferences regarding the amount of information that should be included in the generic consent. The findings have implications for how clinicians approach providing tailored informed consent.

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

    Science.gov (United States)

    Figueroa G, Rodolfo

    2012-10-01

    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.

  15. INFORMED CONSENT – RIGHT OR BURDEN

    Directory of Open Access Journals (Sweden)

    Borut Stražišar

    2016-07-01

    Full Text Available Informed consent is legal institute that was introduced in the research area to prevent possible abuses in human research. Almost a century later it was introduced also in general medicine outside the research area. It’s a basic human right to decide about own body and thus also about possible interventions in such body. Fore decisions the quality information is necessary. Co-deciding on the type of medical treatment would result also in better result of such treatment (the patient would be more interested to cooperate in the treatment process. The present practice is that informed consent is mere a part of bureaucratic doctor-patient relation as a mode to prevent possible lawsuits.  Taking into account other negative impacts on the patient (sc. nocebo effect there is a serious question whether informed consent is adequate and fruitful. The submission posts some proposals that improve doctor-patient relationship and give patient real possibility to decide alone how and to what extent he/she would execute his/hers rights as a patient regarding medical treatments.

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

    Science.gov (United States)

    Hallinan, Dara; Friedewald, Michael

    2015-01-01

    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

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

    Directory of Open Access Journals (Sweden)

    Verheijde Joseph L

    2006-12-01

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

  18. 21 CFR 50.20 - General requirements for informed consent.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false General requirements for informed consent. 50.20... PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.20 General requirements for informed... informed consent of the subject or the subject's legally authorized representative. An investigator shall...

  19. Ensuring that informed consent is really an informed consent: Role of videography

    Directory of Open Access Journals (Sweden)

    Ravindra B Ghooi

    2014-01-01

    Full Text Available The voluntary consent of a subject participating in research is fundamental to the principle of autonomy. This consent must be free from any coercion, intimidation, falsehood, physical, psychological, or economic pressure. It is in the interest of the subject, the investigator and the sponsor to ensure that informed consent processes conform to the guidelines and regulations, both in the letter and spirit. However, ignorance on the part of investigating team causes deviation from these norms. Videography of the entire process has been suggested as a means to ensure the compliance, and draft rules for the same published. The present article examines how best videography can be introduced in the informed consent procedure without violating other protective mechanisms.

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

    Science.gov (United States)

    Osuji, Peter I

    2017-07-28

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

  1. 40 CFR 26.1116 - General requirements for informed consent.

    Science.gov (United States)

    2010-07-01

    ... informed consent. No investigator may involve a human being as a subject in research covered by this subpart unless the investigator has obtained the legally effective informed consent of the subject or the... subject or the representative. No informed consent, whether oral or written, may include any exculpatory...

  2. 32 CFR 219.116 - General requirements for informed consent.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 2 2010-07-01 2010-07-01 false General requirements for informed consent. 219... informed consent of the subject or the subject's legally authorized representative. An investigator shall... language understandable to the subject or the representative. No informed consent, whether oral or written...

  3. 38 CFR 16.116 - General requirements for informed consent.

    Science.gov (United States)

    2010-07-01

    ... informed consent. 16.116 Section 16.116 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS PROTECTION OF HUMAN SUBJECTS § 16.116 General requirements for informed consent. Except as... covered by this policy unless the investigator has obtained the legally effective informed consent of the...

  4. 45 CFR 690.116 - General requirements for informed consent.

    Science.gov (United States)

    2010-10-01

    ... 45 Public Welfare 3 2010-10-01 2010-10-01 false General requirements for informed consent. 690.116... FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.116 General requirements for informed consent. Except as... covered by this policy unless the investigator has obtained the legally effective informed consent of the...

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

    African Journals Online (AJOL)

    requirements for informed consent. The findings question whether informed consent as envisioned by the law exists in reality. Cross-cultural research is needed to clarify patients' and parents' expectations of informed consent. S Atr Med J 1995; 85: 1273-1278. Department of Paediatrics and Child Health, Bioethics Centre,.

  6. Obtaining informed consent for genomics research in Africa: analysis of H3Africa consent documents.

    Science.gov (United States)

    Munung, Nchangwi Syntia; Marshall, Patricia; Campbell, Megan; Littler, Katherine; Masiye, Francis; Ouwe-Missi-Oukem-Boyer, Odile; Seeley, Janet; Stein, D J; Tindana, Paulina; de Vries, Jantina

    2016-02-01

    The rise in genomic and biobanking research worldwide has led to the development of different informed consent models for use in such research. This study analyses consent documents used by investigators in the H3Africa (Human Heredity and Health in Africa) Consortium. A qualitative method for text analysis was used to analyse consent documents used in the collection of samples and data in H3Africa projects. Thematic domains included type of consent model, explanations of genetics/genomics, data sharing and feedback of test results. Informed consent documents for 13 of the 19 H3Africa projects were analysed. Seven projects used broad consent, five projects used tiered consent and one used specific consent. Genetics was mostly explained in terms of inherited characteristics, heredity and health, genes and disease causation, or disease susceptibility. Only one project made provisions for the feedback of individual genetic results. H3Africa research makes use of three consent models-specific, tiered and broad consent. We outlined different strategies used by H3Africa investigators to explain concepts in genomics to potential research participants. To further ensure that the decision to participate in genomic research is informed and meaningful, we recommend that innovative approaches to the informed consent process be developed, preferably in consultation with research participants, research ethics committees and researchers in Africa. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  7. Informed choice and consent for cervical spine manipulation.

    Science.gov (United States)

    Haswell, Kate

    1996-01-01

    Informed consent is essential in ethical health care practice. Information and advice regarding choices is a precondition of informed consent. Autonomy, truthfulness and ethical decision making are all relevant to the informed choice and consent process. The purpose of this paper is firstly to discuss these topics. Following this, a case of informed choice and consent for cervical spine manipulation is examined. This case illustrates ethical problems that can arise in the informed choice and consent process. The moral reasoning in the case is clarified with the assistance of an ethical grid. The conclusion is that autonomy, a patient's right to self determination, is paramount in the informed choice and consent process. Autonomy enhancing informed consent requires more than a mechanical recitation of procedures, hazards and options. In order to uphold a patient's right to self determination, patients need to be included in the decision making process by allowing them to make treatment choices based on accurate information and advice from the physiotherapist.

  8. Sociocultural limits in informed consent in dementia research.

    Science.gov (United States)

    Guerrero, Martin; Heller, Peter L

    2003-01-01

    Ethical considerations in obtaining informed consent for dementia research have remained a largely neglected issue with respect to recruiting members of ethnic minorities and low-income groups. After briefly sketching the development of informed consent guidelines in the United States, this article focuses on the complex interactions between minority culture and low socioeconomic status as inhibiting factors in the informed consent process. We note that, at a minimum, freely given informed consent rests on the potential participant's belief that he or she is totally free to say "no." Suggestions are presented for making the informed consent more ethically constructive for members of socially underpowered populations.

  9. Informed consent conversations and documents: A quantitative comparison.

    Science.gov (United States)

    Koyfman, Shlomo A; Reddy, Chandana A; Hizlan, Sabahat; Leek, Angela C; Kodish, And Eric D

    2016-02-01

    Informed consent for clinical research includes 2 components: informed consent documents (ICDs) and informed consent conversations (ICCs). Readability software has been used to help simplify the language of the ICD, but to the authors' knowledge is rarely used to assess the language used during the ICC, which may influence the quality of informed consent. The current analysis was performed to determine whether length and reading levels of transcribed ICCs are lower than their corresponding ICDs for selected clinical trials, and to assess whether investigator experience affected the use of simpler language and comprehensiveness. The current study was a prospective study in which ICCs were audiorecorded at 6 institutions when families were offered participation in pediatric phase I oncology trials. Word count, Flesch-Kincaid Grade Level (FKGL), and Flesch Reading Ease score (FRES) of the ICCs were compared with corresponding ICDs, including the frequency with which investigators addressed 8 prespecified critical consent elements during the ICC. Sixty-nine unique physician/protocol pairs were identified. Overall, ICCs contained fewer words (4677 vs 6364 words; P = .0016) and had a lower FKGL (6 vs 9.7; P ≤ .0001) and a higher FRES (77.8 vs 56.7; Pconsent elements, such as voluntariness (55%) and dose-limiting toxicities (26%). Years of investigator experience was not correlated with reliably covering critical elements or decreased linguistic complexity. Clinicians use more understandable language during ICCs than the corresponding ICD, but appear to less reliably cover elements critical to fully informed consent. Efforts focused at providing communication training for clinician-investigators should be made to optimize the synergy between the ICD and the ICC. © 2015 American Cancer Society.

  10. Informed consent: what does it mean?

    OpenAIRE

    Kirby, M D

    1983-01-01

    The editorial in the September 1982 issue of this journal and many articles before and since have addressed the problem of informed consent. Is it possible? Is it a useful concept? Is there anything new to be said about it? In this article the basic rationale of the rule (patient autonomy) is explained and the extent of the rule explored. Various exceptions have been offered by the law and an attempt is made to catalogue the chief of these. A number of specially vulnerable groups are then ide...

  11. [The Use of Informed Consent in Clinical Nursing Practice].

    Science.gov (United States)

    Cheng, Chun-Ting; Lin, Chiu-Chu

    2017-02-01

    Obtaining informed consent and ensuring patient autonomy are critical to implementing a patient-centered model of healthcare. Informed consent is a complex process of communication that includes three elements: disclosure, competence in making decisions, and voluntariness. However, individual patient factors, doctor-patient interaction, and cultural issues are known to influence the process of obtaining informed consent. Individual patient factors include the ability of patients to understand and determine their intent; doctor-patient interaction includes communication skills; and cultural issues include the expectations of patients with regard to family involvement in medical decision-making and in decision-making motives. After assessing the relevant influencing factors, healthcare providers typically provide patients with comprehensive information on the benefits and risks of treatment as well as related alternatives. Moreover, healthcare providers typically provide patients with audio/video, Internet, and written information with illustrations based on individual patient needs. In addition to the above, we suggest that healthcare providers proactively adopt the perspective of patients in order to better encourage patients to address questions, to engage with patients in more productive discussions, and to take the initiative to explain and clarify patients' questions in order to minimize anxiety. This approach will help ensure that patients are adequately informed and free from coercion so that they make appropriate healthcare-related decisions. However, even under this optimal situation, healthcare providers must emphasize the needs of their patients and respect their decisions.

  12. Radiation information and informed consent for clinical trials

    Energy Technology Data Exchange (ETDEWEB)

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

    2008-09-01

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

  13. Informed Consent for Intravenous Tissue Plasminogen Activator in New York State Designated Stroke Centers.

    Science.gov (United States)

    Weintraub, Michael I; Colello, Anna D; Johnson, Samantha A; McClellan, Fabienne; Cole, Steven P; Benesch, Curtis; Rudolph, Steven H; Levine, Steven R

    2017-06-01

    Our objective was to assess informed consent procedures for intravenous tissue plasminogen activator in acute stroke among New York State (NYS) Department of Health (DOH) designated stroke centers. A 13-question survey stratified by 0- to 3-hour and 3.0- to 4.5-hour treatment windows was used to determine the type of consent or if no consent was required. Of the 117 hospitals, 111 responded (95%). All 111 hospitals provided treatment within the 3-hour window, whereas 97 (87%) provided treatment beyond the 3-hour window (P consent (verbal or written) within 3 hours (82%) and beyond 3 hours (92%) (P = .04). Of the hospitals requiring consent, there was a difference in the type of consent: 31 of 91 (34%) required written consent within the 3-hour window, whereas 57 of 89 (64%) required written consent beyond the 3-hour window (P consent within the 3-hour treatment window, compared to hospitals with 500 or more beds where 9 of 30 (30%) did not require consent within the 3-hour treatment window (P consent-2-fold increase "compared to less than 3 hour window" (P consent in either window. Significant variability exists in the types of informed consent based on hospital bed size and treatment windows across NYS DOH designated stroke centers. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  14. Effect of informed consent on patient characteristics in a stroke thrombolysis trial.

    Science.gov (United States)

    Thomalla, Götz; Boutitie, Florent; Fiebach, Jochen B; Simonsen, Claus Z; Nighoghossian, Norbert; Pedraza, Salvador; Lemmens, Robin; Roy, Pascal; Muir, Keith W; Heesen, Christoph; Ebinger, Martin; Ford, Ian; Cheng, Bastian; Cho, Tae-Hee; Puig, Josep; Thijs, Vincent; Endres, Matthias; Fiehler, Jens; Gerloff, Christian

    2017-09-26

    To determine whether the manner of consent, i.e., informed consent by patients themselves or informed consent by proxy, affects clinical characteristics of samples of acute stroke patients enrolled in clinical trials. We analyzed the manner of obtaining informed consent in the first 1,005 patients from WAKE-UP, an investigator-initiated, randomized, placebo-controlled trial of MRI-based thrombolysis in stroke patients with unknown time of symptom onset running in 6 European countries. Patients providing informed consent by themselves were compared with patients enrolled by proxy consent. Baseline clinical measures were compared between groups. In 359 (35.7%) patients, informed consent was by proxy. Patients with proxy consent were older (median 71 vs 66 years, p consent varied among countries (p consent were older, had more severe strokes, and had higher prevalence of aphasia than those with capacity to give personal consent. Variations in the manner of consent across countries may influence trial results. NCT01525290 (clinicaltrials.gov); 2011-005906-32 (clinicaltrialsregister.eu). Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

  15. Understanding informed consent for participation in international health research.

    Science.gov (United States)

    Jegede, Ayodele S

    2009-08-01

    To participate in health research, there is a need for well-administered informed consent. Understanding of informed consent, especially in international health research, is influenced by the participants' understanding of information and the meaning attached to the information communicated to them regarding the purpose and procedure of the research. Incorrect information and the power differential between researcher and participants may lead to participants becoming victims of harmful research procedures. Meningitis epidemics in Kano in early 1996 led to a response from drug companies, especially Pfizer, as well as humanitarian workers from Médecins Sans Frontiers, which resulted in an unethical trial. Pfizer's drug trial during the epidemics has left a lasting controversy, which has yet to be resolved. This paper examines the key issues surrounding the controversy, discusses the context of informed decision-making, the ethical issues and implications of the incident, and concludes with some recommendations. Relevant texts, journals, Internet materials, newspaper articles and documentary materials on the conduct of the Pfizer's Trovan trial have been consulted. Four types of action (act intuitively, act rationally, act ignorantly, and act contextually - based on information provided) are identified as possible options for decision making. Participants most likely acted in ignorance due to poor understanding of the information contained in the verbal informed consent administered, thereby raising ethical issues. It is concluded that health research ethics committees have an important role to play nationally and locally in overseeing research, and in avoiding future occurrences.

  16. The History and Current Status of Informed Consent

    OpenAIRE

    Abimbola Farinde

    2014-01-01

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

  17. Informed Consent in the Changing Landscape of Research.

    Science.gov (United States)

    Hammer, Marilyn J

    2016-09-01

    The history of informed consent dates back as early as the 16th century (Selek, 2010). The current tenets of informed consent pertaining to the ethical conduct of research on human participants predominately stems from the 1947 Nuremberg Code (National Institutes of Health, 2016), which was created following the Nuremberg trials at the end of World War II. The unethical conduct of research on human participants during the Holocaust, coupled with experiments (e.g., the Tuskegee syphilis study), prompted a more formalized structure for ensuring the well-being and autonomy of human participants in research studies. The World Medical Association (2013) created the Declaration of Geneva in 1948 (Fischer, 2006), followed by the Declaration of Helsinki in 1964, to apply ethical principles to medical research involving human participants (Fischer, 2006; Rickham, 1964). A decade later, on July 12, 1974, the National Research Act was signed into law (U.S. Department of Health and Human Services [HHS], 1979). Through this act, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was formed and charged with developing guidelines for the conduct of biomedical and behavioral research. The guidelines were established in the Belmont Report (HHS, 1979; U.S. Department of Health, Education, and Welfare, 1979), which continues to be periodically updated. The Belmont Report describes the general principles of respect for persons, beneficence, and justice, and it outlines the process of obtaining informed consent to ensure that these principles are followed (HHS, 1979). In 1998, an informed consent checklist was instituted (HHS, 1998). Although clearly outlined, defined, and described in consent forms, it is beneficial to revisit how informed participants are when they enter research studies, particularly for patients undergoing treatment for cancer. This article will provide an overview of several areas for consideration. 
.

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

    Directory of Open Access Journals (Sweden)

    Carlo Petrini

    2010-12-01

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

  19. Improving the Quality of Informed Consent in Clinical Research with Information Technology.

    Science.gov (United States)

    Taber, Celia; Warren, Jim; Day, Karen

    2016-01-01

    The clinical research industry has yet to fully embrace information technology (IT) for informed consent purposes, even though it is used indispensably in our everyday lives and in other areas of clinical research and healthcare. This paper presents findings of a meta-narrative literature review to discuss the potential for IT to improve the quality of clinical research informed consent. The review reveals three main rationales for including IT in research consent. First, in the current context consent documents frequently fail to be effective decision aids for patients, and the lack of patient centricity in the process. Second, social media provides opportunities for patients to consult with a broader community during research consent to seek broader support, and potential to participate in creating a more patient centric process. Third, multimedia tools provide opportunities for improved patient education, engagement and decision making during research consent. IT offers opportunities to achieve more meaningful research consent, but more research is needed to create an evidence base, policies and economic analyses on the return on investment of using IT in the process.

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

    Science.gov (United States)

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

    2013-09-01

    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.

  1. ANAESTHETISTS' ATTITUDES AND PRACTICE OF INFORMED CONSENT IN NIGERIA.

    Science.gov (United States)

    Olatosi, J O; Adekola, O O; Anaegbu, N C; Adesida, A; Rotimi, M K

    2016-01-01

    Informed consent is an integral part of a surgical and anaesthetic procedure, failure to obtain it may result in grave medico-legal implications. To determine the attitudes of Nigerian anaesthetists to informed consent. The study population included physician anaesthetists who attended a continuous medical education programme in November 2015. The target was to cover over 50% of anaesthetists by convenience sampling. The responses to the questions were recorded and descriptive statistics were employed to calculate the various qualitative variables under study. Fifty-six respondents were analysed, the majority were in the age group 31-40 years (37.5%), consultants were 51.79%, and males constituted 75%. The respondents agreed that the main purposes of informed consent included a need to improve the doctor/patient relationship in 36(64.29%), inform the patient about the desired benefits of the procedure in 32(57.14%), provide the doctor with greater protection against medical litigation in 32(57.14%), and to respect the patient's right of autonomy in 30(53.57%). The general consensus among the respondents was that the anaesthetist should explain to the patient what the procedure entails 40(71.43%), what the procedure aims to achieve and additional procedures that are likely to be necessary to the patient 41(73.21%). It was also agreed that there should be disclosure of all major risks/complications with incidence >1/20 in 29(51.79%) respondents, incidence >1/100 in 20(35.71%), incidence >1/1000, and incidence >1/10000 were 17(30.36%). The respondents who agreed that it is necessary to take consent before performing surgery or anaesthesia on patients and explained the procedure to patients were 48(85.71%). We determined that informed consent was an integral part of a surgical procedure. which helped to improve doctor/patient relationship, respected the patient's right of autonomy and provided the surgeon and anaesthetists with greater protection against medical

  2. How well informed is the informed consent for cancer clinical trials?

    Science.gov (United States)

    Malik, Laeeq; Kuo, James; Yip, Desmond; Mejia, Alex

    2014-12-01

    The purpose of this study was to analyze the content of informed consent forms for clinical trials in medical oncology to assess readability, determine their completeness, and identify any shortcomings. Informed consent forms for Phase I-III studies that were conducted at two tertiary care cancer centers over a 3-year period were reviewed. Information pertaining to length of the informed consent form, research regimen/methods, treatment agent, potential risks, and benefits was extracted. The reading level was assessed by Flesch-Kincaid and Gunning-Fog index readability tests. All of the 112 informed consent forms clearly stated the voluntary nature of participation. Nearly one half of the forms (51.8%) were of Phase I studies. The median length of informed consent form was 20 pages (range: 8-28). A detailed estimation of the frequency or intensity of risks (range: 3-8 pages) was provided. The average reading level of the informed consent forms was high (Flesch-Kincaid Grade Level of 9.8), which corresponds roughly to 10th-grade reading level. Less than 15% of all consent forms were written at the recommended eighth-grade reading level. A substantial number of forms did not report a potential risk to pregnant/lactating women (16.9%), mechanism of action of the investigational agent (34.8%), study schema (77.6%), a possibility of receiving sub-therapeutic dose (37%), or death (12.5%). Nearly one half of the forms (49.1%) stated clearly that individual participants may not benefit. Overall, these informed consent forms provided a detailed description of the trials in accordance to international guidelines. However, there remains room for improvement, particularly in areas of readability and document length. © The Author(s) 2014.

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

    Science.gov (United States)

    Madeira, Jody Lyneé; Andraka-Christou, Barbara

    2016-01-01

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

  4. VICO: Ontology-based representation and integrative analysis of Vaccination Informed Consent forms.

    Science.gov (United States)

    Lin, Yu; Zheng, Jie; He, Yongqun

    2016-01-01

    Although signing a vaccination (or immunization) informed consent form is not a federal requirement in the US and Canada, such a practice is required by many states and pharmacies. The content and structures of these informed consent forms vary, which makes it hard to compare and analyze without standardization. To facilitate vaccination informed consent data standardization and integration, it is important to examine various vaccination informed consent forms, patient answers, and consent results. In this study, we report a Vaccination Informed Consent Ontology (VICO) that extends the Informed Consent Ontology and integrates related OBO foundry ontologies, such as the Vaccine Ontology, with a focus on vaccination screening questionnaire in the vaccination informed consent domain. Current VICO contains 993 terms, including 248 VICO specific terms and 709 terms imported from 17 OBO Foundry ontologies. VICO ontologically represents and integrates 12 vaccination informed consent forms from the Walgreens, Costco pharmacies, Rite AID, University of Maryland College Park, and the government of Manitoba, Canada. VICO extends Informed Consent Ontology (ICO) with vaccination screening questionnaires and questions. Our use cases and examples demonstrate five usages of VICO. First, VICO provides standard, robust and consistent representation and organization of the knowledge in different vaccination informed consent forms, questionnaires, and questions. Second, VICO integrates prior knowledge, e.g., the knowledge of vaccine contraindications imported from the Vaccine Ontology (VO). Third, VICO helps manage the complexity of the domain knowledge using logically defined ontological hierarchies and axioms. VICO glues multiple schemas that represent complex vaccination informed consent contents defined in different organizations. Fourth, VICO supports efficient query and comparison, e.g., through the Description Language (DL)-Query and SPARQL. Fifth, VICO helps discover new

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

    Directory of Open Access Journals (Sweden)

    Weeks Andrew

    2006-05-01

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

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

    Science.gov (United States)

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

    2015-01-01

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

  7. Exceptions to the rule of informed consent for research with an intervention

    OpenAIRE

    Rebers, Susanne; Aaronson, Neil K.; van Leeuwen, Flora E.; Schmidt, Marjanka K.

    2016-01-01

    Background In specific situations it may be necessary to make an exception to the general rule of informed consent for scientific research with an intervention. Earlier reviews only described subsets of arguments for exceptions to waive consent. Methods Here, we provide a more extensive literature review of possible exceptions to the rule of informed consent and the accompanying arguments based on literature from 1997 onwards, using both Pubmed and PsycINFO in our search strategy. Results We ...

  8. Is Informed Consent Necessary for Research on Stored Human Samples?

    Directory of Open Access Journals (Sweden)

    Lawrence Fred Sembajwe

    2016-06-01

    Full Text Available Informed consent is always required before patients can be treated in health centers as well as participating in any kind of research. This requirement often poses a serious challenge to researchers in situations where existing guidelines are not clear about the ownership of donated or discarded human biological samples in hospital archives. The current regulations demand that when doing research, the major bioethical principles of autonomy, beneficence, non-maleficence and justice should always be respected and adhered to. There is increased value of stored biomaterials due to advancement in biotechnology which has also contributed to increased debate on whether researchers should seek informed consent from the individual donors before such materials can be used for research. In enforcing these bioethical principles, most guidelines focus on research involving direct contact with human beings, and no much attention is given to stored or discarded body parts and biomaterials that end up being used for research in later years. There are some hypotheses that can be tested by doing research on the stored biological samples, especially by students or scientists attached to various University hospitals, research-centers and laboratories. We attempt to provide some scenarios and reviewed guidelines that can help provide a consensus as to whether it is strictly necessary to have informed consent for research on stored or discarded human body parts and who should claim ownership of collected human biomaterials for research or potential commercial purposes. [Archives Medical Review Journal 2016; 25(2.000: 119-128

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

    Science.gov (United States)

    2012-01-01

    Background Denmark has implemented a comprehensive, nationwide pharmaceutical information system, and this system has been evaluated by the Danish Council of Ethics. The system can be seen as an exemplar of a comprehensive health information system for clinical use. Analysis The paper analyses 1) how informed consent can be implemented in the system and how different implementations create different impacts on autonomy and control of information, and 2) arguments directed towards justifying not seeking informed consent in this context. Results and Conclusion Based on the analysis a heuristic is provided which enables a ranking and estimation of the impact on autonomy and control of information of different options for consent to entry of data into the system and use of data from the system. The danger of routinisation of consent is identified. The Danish pharmaceutical information system raises issues in relation to autonomy and control of information, issues that will also occur in relation to other similar comprehensive health information systems. Some of these issues are well understood and their impact can be judged using the heuristic which is provided. More research is, however needed in relation to routinisation of consent. PMID:23157854

  10. Informed Consent Documents Used in Critical Care Trials Often Do Not Implement Recommendations.

    Science.gov (United States)

    Atwere, Pearl; McIntyre, Lauralyn; Carroll, Kelly; Hayes, Tavis; Brehaut, Jamie C

    2018-02-01

    Informed consent documents are often poorly understood by research participants. In critical care, issues such as time pressure, patient capacity, and surrogate decision making complicate the consent process further. Recommendations exist for addressing critical care-specific consent issues; we examined how well existing practice implements these recommendations. We conducted a systematic search of the literature for recommendations specific to critical care informed consent and rated existing informed consent documents on their implementation of 1) 18 of these critical care recommendations and 2) 36 previously developed general informed consent recommendations. Four hundred twelve registered critical care trials were identified and a request sent to the principal investigators for an example of the informed consent document associated with the trial. Each consent document was rated on both set of recommendations. We evaluated informed consent documents for trials conducted in English or French registered with clinicaltrials.gov. Not applicable. Not applicable. Independent coders rated implementation of each recommendation on a four-point scale. Of 412 requests, 137 informed consent documents were returned, for a response rate of 34.1%. Of these, 86 met inclusion criteria and were assessed. Overall agreement between raters was 90.6% (weighted κ = 0.79; 0.77-0.81). Implementation of the 18 critical care recommendations was highly variable, ranging between 2% and 96.5%. Critical care studies often do not provide the information recommended for those providing consent for research. These clear recommendations provide testable hypotheses about how to improve the consent process for patients and family members considering trial participation in the critical care setting.

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

    Science.gov (United States)

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

    2014-03-01

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

  12. Counseling Programs' Informed Consent Practices: A Survey of Student Preferences

    Science.gov (United States)

    Pease-Carter, Cheyenne; Minton, Casey A. Barrio

    2012-01-01

    This study examined 115 master's-level counseling students' preferences for content, timing, and method of programmatic informed consent. Students rated the majority of items as moderately or extremely important to receive, and they indicated a desire for the informed consent to be facilitated through a combination of both oral and written methods…

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

    African Journals Online (AJOL)

    2013-11-02

    Nov 2, 2013 ... for written informed consent.[15] Telemedicine is no different, with written informed consent typically being obtained for more complex procedures, such as robotic assisted ultrasonography or even robotic surgery.[16-18] But is this required for all forms of telemedicine? In several specialities, there is enough ...

  14. Informed Consent in Research on Second Language Acquisition

    Science.gov (United States)

    Thomas, Margaret; Pettitt, Nicole

    2017-01-01

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

  15. Balancing law, ethics and reality in informed consent for surgery.

    Science.gov (United States)

    Sarela, A I; Thomson, M

    2014-07-01

    Informed consent has different implications and requirements in law and bioethics, and some irreconcilable disputes with the reality of surgical practice in the National Health Service. This article explores and discusses various aspects of informed consent that are of critical importance for practising surgeons in all specialties.

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

    African Journals Online (AJOL)

    The regulation of informed consent to participation in clinical research by mentally ill persons in South Africa: An overview. A Nienaber. Abstract. The article examines the legal requirements relating to the informed consent of mentally ill persons to participation in clinical research in South Africa. First, the juridical basis of ...

  17. Ethics of Informed Consent for Pragmatic Trials with New Interventions.

    Science.gov (United States)

    Kalkman, Shona; Kim, Scott Y H; van Thiel, Ghislaine J M W; Grobbee, Diederick E; van Delden, Johannes J M

    Pragmatic trials evaluate the comparative benefits, risks, and burdens of health care interventions in real-world conditions. Such studies are now recognized as valuable to the perimarketing stage of drug development and evaluation, with early pragmatic trials (EPTs) being explored as a means to generate real-world evidence at the time of regulatory market approval. In this article, we present an analysis of the ethical issues involved in informed consent for EPTs, in light of the generally recognized concern that traditional ethical rules governing randomized clinical trials, such as lengthy informed consent procedures, could threaten the "real world" nature of such trials. Specifically, we examine to what extent modifications (waivers or alterations) to regulatory consent for EPTs would be ethical. We first identify broadly accepted necessary conditions for modifications of informed consent (namely, the research involves no more than minimal risk of harm, the research is impracticable with regulatory consent, and the alternative to regulatory consent does not violate legitimate patient expectations) and then apply those criteria to the premarket and early postmarket contexts. The analysis shows that neither waivers nor alterations of regulatory consent for premarket EPTs will be ethically permissible. For postmarket EPTs with newly approved interventions, waivers of consent will be ethically problematic, but some studies might be conducted in an ethical manner with alterations to regulatory consent. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Anvita Pandiya

    2010-01-01

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

  19. An Informed Consent Program Enhances Surgery Resident Education.

    Science.gov (United States)

    Koller, Sarah E; Moore, Ryan F; Goldberg, Michael B; Zhang, Jeanette; Yu, Daohai; Conklin, Charles B; Milner, Richard E; Goldberg, Amy J

    First-year residents often obtain informed consent from patients. However, they typically receive no formal training in this area before residency. We wished to determine whether an educational program would improve residents' comfort with this process. Our institution created an informed consent educational program, which included a didactic component, a role-play about informed consent, and a simulation exercise using standardized patients. Residents completed surveys before and after the intervention, and responses to survey questions were compared using the signed-rank test. This study took place at Temple University Hospital, a tertiary care institution in Philadelphia, PA. First-year surgery and emergency medicine residents at Temple University Hospital in 2014 participated in this study. Thirty-two residents completed the preintervention survey and 27 residents completed the educational program and postintervention survey. Only 37.5% had ever received formal training in informed consent before residency. After participating in the educational program, residents were significantly more confident that they could correctly describe the process of informed consent, properly fill out a procedure consent form, and properly obtain informed consent from a patient. Their comfort level in obtaining informed consent significantly increased. They found the educational program to be very effective in improving their knowledge and comfort level in obtaining informed consent. In all, 100% (N = 27) of residents said they would recommend the use of the program with other first-year residents. Residents became more confident in their ability to obtain informed consent after participating in an educational program that included didactic, role-play, and patient simulation elements. Copyright © 2017. Published by Elsevier Inc.

  20. Series: Pragmatic trials and real world evidence: Paper 4. Informed consent.

    Science.gov (United States)

    Kalkman, Shona; van Thiel, Ghislaine J M W; Zuidgeest, Mira G P; Goetz, Iris; Pfeiffer, Boris M; Grobbee, Diederick E; van Delden, Johannes J M

    2017-09-01

    The GetReal consortium of the Innovative Medicines Initiative aims to develop strategies to incorporate real-world evidence earlier into the drug life cycle to better inform health care decision makers on the comparative risks and benefits of new drugs. Pragmatic trials are currently explored as a means to generate such evidence in routine care settings. The traditional informed consent model for randomized clinical trials has been argued to pose substantial hurdles to the practicability of pragmatic trials: it would lead to recruitment difficulties, reduced generalizability of the results, and selection bias. The present article analyzes these challenges and discusses four proposed alternative informed consent models: integrated consent, targeted consent, broadcast consent, and a waiver of consent. These alternative consent models each aim at overcoming operational and methodological challenges, while still providing patients all the relevant information they need to make informed decisions. Each consent model, however, relies on different attitudes toward the principle of respect for persons and the related duty to inform patients as well as represents different views on whether the common good demands moral duties from patients. Such normative consequences of modifying consent requirements should be at least acknowledged and ought to be assessed in light of the validity of empirical claims. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

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

    2009-04-01

    Research participants often fail to recall substantial amounts of informed consent information after delays of only a few days. Numerous interventions have proven effective at improving consent recall; however, virtually all have focused on compensating for potential cognitive deficits and have ignored motivational factors. In this pilot study, 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. Copyright (c) 2009 APA, all rights reserved.

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

    African Journals Online (AJOL)

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

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

    African Journals Online (AJOL)

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

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

    Science.gov (United States)

    2011-01-01

    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 variety of practical ends, it

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

    African Journals Online (AJOL)

    Language issues can affect HIV and AIDS research trial enrolment, but little is understood about variables in this process. Some evidence indicates barriers exist even when the trial enrollers are linguistically and culturally matched to the participants and when consent forms are translated into a local language. Counsellors ...

  6. HIV testing and informed consent - ethical considerations

    African Journals Online (AJOL)

    In the case of a cadaver donor, relatives, before granting consent, must be ... Exposures carrying a significant risk - the high-risk exposures, as they are called - are hollow needle-stick injuries, or injuries that are more traumatic still. The ground for this ... and health care workers from exposure to HIV-infective material (blood ...

  7. Recruiting for Epigenetic Research: Facilitating the Informed Consent Process

    Directory of Open Access Journals (Sweden)

    Nancy Jallo

    2013-01-01

    Full Text Available Because the effects of epigenetic (gene-environment interaction changes have been associated with numerous adverse health states, the study of epigenetic measures provides exciting research opportunities for biobehavioral scientists. However, recruitment for studies focusing on any aspect of genetics poses challenges. Multiple factors, including lack of knowledge regarding a research study, have been identified as barriers to recruitment. Strengthening the informed consent process through extended discussion has been found to be effective in recruiting for research studies in general, yet there is a paucity of information that focused on such a recruitment strategy for epigenetic studies. In this paper, we share our experiences with strategies to strengthen the informed consent process as well as provide samples of materials developed to heighten potential participants’ understanding of epigenetics, in 4 epigenetic research studies with women from diverse backgrounds experiencing a range of health issues. The combined enrollment success rate for epigenetic studies using the process was 89% with participants representing a diverse population. We posit that carefully developed recruitment scripts provided a foundation for improving potential participants’ understanding of the research project. Easy to understand illustrations of the epigenetic process provided a basis for active engagement and encouraged individual questions.

  8. Informed consent training improves surgery resident performance in simulated encounters with standardized patients.

    Science.gov (United States)

    Thompson, Britta M; Sparks, Rhonda A; Seavey, Jonathan; Wallace, Michelle D; Irvan, Jeremy; Raines, Alexander R; McClure, Heather; Nihira, Mikio A; Lees, Jason S

    2015-09-01

    Although informed consent is vital to patient-physician communication, little training is provided to surgical trainees. We hypothesized that highlighting critical aspects of informed consent would improve resident performance. Eighty (out of 88) surgical postgraduate year 1 surgical residents were randomly assigned to one of the 2 cases (laparoscopic cholecystectomy or ventral herniorrhaphy) and instructed to obtain and document informed consent with a standardized patient (SP) followed by a didactic training session. The residents then obtained and documented informed consent with the other case with the other SP. SPs graded encounters ("Checklist"); trained raters graded notes. Repeated measures multivariate analysis of variance (MANOVA) was used to determine differences between pre- and post-training and Checklist versus "Note" scores. Statistically significant pre- to post differences for Note (P informed consent. Despite this improvement, significant differences between discussion and documentation persisted. Documentation training is a future area for improvement. Copyright © 2015 Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

    Marsh, Melvin S.

    2010-01-01

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

  10. Informed Consent Challenges in Frail, Delirious, Demented, and Do-Not-Resuscitate Adult Patients.

    Science.gov (United States)

    Requarth, Jay A

    2015-11-01

    Without informed consent, any invasive procedure becomes an assault. The prevailing legal and ethical standard is that the physician has a fiduciary duty to give enough information to the patient so that a reasonable person can make an informed decision to accept or refuse the proposed treatment. The patient's frailty, delirium and/or dementia, and end-of-life concerns and expectations can make informed consent a difficult task. This review examines informed consent requirements for adults and provides communication tools to enable shared decision making while engendering patient-physician trust. Copyright © 2015 SIR. Published by Elsevier Inc. All rights reserved.

  11. CTEPP STANDARD OPERATING PROCEDURE FOR OBTAINING INFORMED CONSENT (SOP-1.13)

    Science.gov (United States)

    The CTEPP informed consent procedures are described in the SOP. After an eligible subject provides verbal consent, staff schedule a visit to meet with the subject in person to explain study activities and answer questions about the study. During the visit, staff demonstrate how...

  12. Exceptions to the rule of informed consent for research with an intervention

    NARCIS (Netherlands)

    Rebers, S.; Aaronson, N.K.; van Leeuwen, F.E.; Schmidt, M.K.

    2016-01-01

    Background In specific situations it may be necessary to make an exception to the general rule of informed consent for scientific research with an intervention. Earlier reviews only described subsets of arguments for exceptions to waive consent. Methods Here, we provide a more extensive literature

  13. Pragmatic Randomized Trials Without Standard Informed Consent?: A National Survey.

    Science.gov (United States)

    Nayak, Rahul K; Wendler, David; Miller, Franklin G; Kim, Scott Y H

    2015-09-01

    Significant debate surrounds the issue of whether written consent is necessary for pragmatic randomized, controlled trials (RCTs) with low risk. To assess the U.S. public's views on alternatives to written consent for low-risk pragmatic RCTs. National experimental survey (2 × 2 factorial design) examining support for written consent versus general notification or verbal consent in 2 research scenarios. Web-based survey conducted in December 2014. 2130 U.S. adults sampled from a nationally representative, probability-based online panel (response rate, 64.0%). Respondent's recommendation to an ethics review board and personal preference as a potential participant on how to obtain consent or notification in the 2 research scenarios. Most respondents in each of the 4 groups (range, 60.3% to 71.5%) recommended written informed consent, and personal preferences were generally in accord with that advice. Most (78.9%) believed that the pragmatic RCTs did not pose additional risks, but 62.5% of these respondents would still recommend written consent. In contrast, a substantial minority in all groups (28.5% to 39.7%) recommended the alternative option (general notification or verbal consent) over written consent. Framing effects could have affected respondents' attitudes, and nonrespondents may have differed in levels of trust toward research or health care institutions. Most of the public favored written informed consent over the most widely advocated alternatives for low-risk pragmatic RCTs; however, a substantial minority favored general notification or verbal consent. Time-sharing Experiments for the Social Sciences and Intramural Research Program of the National Institutes of Health Clinical Center.

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

    Directory of Open Access Journals (Sweden)

    Brandon M. Welch

    2016-08-01

    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.

  15. Therapy Provider Phase Information

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Therapy Provider Phase Information dataset is a tool for providers to search by their National Provider Identifier (NPI) number to determine their phase for...

  16. Informed consent. Communication problems: a patient's view.

    Science.gov (United States)

    Jarman, F

    In this paper, the author gives a personal account of how healthcare professionals' communication skills can contribute to confusion and fear in patients undergoing major treatment. She discusses why it is important for nursing staff to act as patient advocates and provide consistent information that is easily understood and that the patient can share with a relative or carer.

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

    Science.gov (United States)

    Kara, Mahmut A; Aksoy, Sahin

    2006-09-01

    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.

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

    DEFF Research Database (Denmark)

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

    2016-01-01

    BACKGROUND: Before participation in medical research an informed consent must be obtained. This study investigates whether the readability of patient information and consent documents (PICDs) corresponds to the average educational level of participants in rheumatological studies in the Netherlands...... study. CONCLUSIONS: As the readability level of the PICDs did not match the participants' educational level, consent may not have been valid, as the participants may have had a limited understanding of what they agreed to participate in. There should be more focus on the readability of PICDs. National...

  19. Informed Consent: We Can Do Better to Defend Privacy

    NARCIS (Netherlands)

    Zuiderveen Borgesius, F.

    2015-01-01

    Informed consent as a means to protect privacy is flawed, especially when considering the privacy problems of behavioral targeting. Policymakers should pay more attention to a combined approach that both protects and empowers individuals.

  20. Informed consent for research participation in frail older persons.

    Science.gov (United States)

    Barron, Jeremy S; Duffey, Patricia L; Byrd, Linda Jo; Campbell, Robin; Ferrucci, Luigi

    2004-02-01

    Informed consent has been the most scrutinized and controversial aspect of clinical research ethics. Institutional review boards (IRBs), government regulatory agencies, and the threat of litigation have all contributed to increasingly detailed consent documents that hope to ensure that subjects are not misled or coerced. Unfortunately, the growing regulatory burden on researchers has not succeeded in protecting subjects, but has rather made the consent process less effective and has discouraged research on vulnerable populations. As a matter of fact, investigators and ethicists continue to identify failures of the consenting process, particularly concerning participation in research of older individuals. The challenges involved in ensuring appropriate consent from the elderly include physical frailty, reduced autonomy and privacy, and impaired decision-making capacity due to dementia, delirium, or other neuropsychiatric illnesses. Ageism among investigators also contributes to failure of informed consent. The evaluation and continuing re-evaluation of an individual's decision-making capacity is critical but difficult. In the most extreme cases, the older adult's ability to participate in the consent process is clearly impaired. However, in many instances, the decision-making capacity is only partially impaired but declines during the course of a research project. Implementing methods of effective communication may enable many frail elderly individuals to make informed decisions. Special challenges are posed by research on end-of-life care, which typically involves frail, older subjects who are uniquely vulnerable, and research is conducted in institutional settings where subtle violations of autonomy are routine. Clearly, the frail elderly represent a vulnerable population that deserves special attention when developing and evaluating an informed consent process. Two important ethical conflicts should be kept in mind. First, although vulnerable older patients must

  1. Patient Recall of Information on a Third Molar Informed Consent Video.

    Science.gov (United States)

    Olsen, Brennen T; Sherwood, Connor J; Carrico, Caroline K; Priest, James H; Laskin, Daniel M

    2017-12-01

    Experience has shown that in malpractice cases patients often claim certain information was not provided during the informed consent process. The purposes of this study were to determine how much of an informed consent video patients initially remember and how much is recalled when there is a hiatus from viewing the video to the surgery. In this prospective cohort study, patients presenting for impacted third molar removal in an academic setting (n = 50) or a private office (n = 50) viewed an informed consent video and then met with the treating doctor for further discussion and signing of an informed consent form. Then, they were given a 10-item test containing questions relating to the information provided on the video. At the subsequent time of surgery, they were again given the same test. The number of correct answers at the 2 points was compared. There was a significant difference in the number of correct responses between the 2 time points (P = .0212) and between patients from the 2 practice settings (P = .0076). However, these differences were less than 0.5 of a possible 10. The number of correct responses was not associated with age (P = .1203), gender (P = .6647), or number of days between testing (P = .7272). Patients have good recall of the information provided by the informed consent video. However, because some information was forgotten, a presurgical review of the information is advisable. Copyright © 2017 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  2. Informed consent and the Facebook emotional manipulation study

    OpenAIRE

    Flick, Catherine

    2015-01-01

    This article argues that the study conducted by Facebook in conjunction with Cornell University did not have sufficient ethical oversight, and neglected in particular to obtain necessary informed consent from the participants in the study. It establishes the importance of informed consent in Internet research ethics and suggests that in Facebook’s case (and other, similar cases), a reasonable shift could be made from traditional medical ethics ‘effective consent’ to a ‘waiver of normative exp...

  3. Understanding, interests and informed consent: a reply to Sreenivasan.

    Science.gov (United States)

    Bromwich, Danielle

    2015-04-01

    It is widely agreed that the view of informed consent found in the regulations and guidelines struggles to keep pace with the ever-advancing enterprise of human subjects research. Over the last 10 years, there have been serious attempts to rethink informed consent so that it conforms to our considered judgments about cases where we are confident valid consent has been given. These arguments are influenced by an argument from Gopal Sreenivasan, which apparently shows that a potential participant's consent to research participation can be perfectly valid even if she fails to understand the risk-benefit profile of the study. I argue that Sreenivasan's argument fails. The set of clinical trials that is supposed to be ethical in the face of this kind of ignorance is empty. However, I argue that his argument is nonetheless instructive in allowing us to identify three important but neglected areas for future conceptual research on informed consent. I close by arguing that research on these identified questions promises to yield a defensible view of consent, lessen the burden of ambiguity on researchers attempting to obtain consent to research participation, and facilitate socially valuable research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

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

    Science.gov (United States)

    Mellado, J M

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

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

    Science.gov (United States)

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

    2015-08-01

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

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

    Science.gov (United States)

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

    2013-11-01

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

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

    Directory of Open Access Journals (Sweden)

    Alireza Mohsenian Sisakht

    2015-01-01

    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.

  8. Dr. Google and Premature Consent: Patients Who Trust the Internet More Than They Trust Their Provider.

    Science.gov (United States)

    Davis, John K

    2017-10-24

    A growing number of patients make up their minds about some medical issue before they see their provider, either by googling their symptoms or asking a friend. They've made up their minds before coming in, and they resist their provider's recommendations even after receiving information and advice from their provider. This is a new kind of medical autonomy problem; it differs from cases of standard consent, futility, or conscientious refusal. Providers sometimes call this problem "Dr. Google." I call it premature consent. Providers may wonder whether these patient decisions command the same deference and respect as other patient decisions. The answer is "no," for these patients are neither fully competent nor properly informed. They typically appear to be competent, but competence includes the ability to deliberate, and they are not deliberating well when they make up their minds before consulting a qualified provider. They seem informed, especially after talking to their provider, but they are misinformed about what sources of medical advice to trust. Moreover, being informed requires believing the information one has received, and these patients sometimes don't believe the information their provider gives them.

  9. Informed consent for live liver donors: A qualitative, prospective study.

    Science.gov (United States)

    Gordon, Elisa J; Rodde, Jillian; Skaro, Anton; Baker, Talia

    2015-10-01

    Adult-to-adult live donor liver transplantation (LDLT) poses serious health risks and no direct health benefits to donors. Ensuring live donors' autonomy through informed consent is critical. We assessed live liver donors' (LD) comprehension, information needs, risk perceptions, and demographics. Semi-structured interviews were prospectively conducted with LDs after completing donor evaluation and informed consent at our transplant center. Likert scales measured informed consent domains. Open-ended responses underwent thematic analysis. Thirty LDs participated (100% participation rate). Although 90% of LDs reported being informed about donation 'a great deal', only 66% reported understanding information about donation 'a great deal.' Many (40%) reported difficulty understanding medical terminology. Information LDs most desired to feel comfortable with their decision included: incidence and type of donor complications (67%), description of donation procedure (57%), and the process of donor preparation (43%). Most (83%) LDs rated risks to themselves as 'not at all' to 'somewhat' risky, and minimized these risks. Although LDs perceived that they were adequately informed, their actual comprehension about donation was inadequate. Findings suggest the value of informed consent for preparation for the procedure and potential periprocedural risks rather than for decision-making. More comprehensible information disclosure may optimize informed consent. Copyright © 2015 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

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

    Science.gov (United States)

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

    2015-10-01

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

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

    Science.gov (United States)

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

    2017-06-01

    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.

  12. Informed consent in clinical research: Consensus recommendations for reform identified by an expert interview panel.

    Science.gov (United States)

    Lorell, Beverly H; Mikita, J Stephen; Anderson, Annick; Hallinan, Zachary P; Forrest, Annemarie

    2015-12-01

    Informed consent is the cornerstone for protection of human subjects in clinical trials. However, a growing body of evidence suggests that reform of the informed consent process in the United States is needed. The Clinical Trials Transformation Initiative conducted interviews with 25 experienced observers of the informed consent process to identify limitations and actionable recommendations for change. There was broad consensus that current practices often fail to meet the ethical obligation to inform potential research participants during the informed consent process. The most frequent single recommendation, which would affect all participants in federally regulated clinical research, was reform of the informed consent document. The interviews also identified the need for reform of clinical research review by institutional review boards, including transitioning to a single institutional review board for multi-site trials. The consensus recommendations from the interviewees provide a framework for meaningful change in the informed consent process. Although some proposed changes are feasible for rapid implementation, others such as substantive reform of the informed consent document may require change in federal regulations. © The Author(s) 2015.

  13. Informed consent and the limits of confidentiality.

    Science.gov (United States)

    Haggerty, L A; Hawkins, J

    2000-06-01

    Investigators encounter many legal and ethical issues when they conduct research on partner abuse. Balancing abused women's rights to privacy with legally mandated reporting requirements involves considerable thought and planning. Failure to protect participants may result in escalation of abuse as well as loss of children to protective services. Various perspectives on maintaining participant privacy while conforming to legal mandates to report child abuse, homicidality, and suicidality are discussed. The role of confidentiality certificates in providing legal immunity for researchers and the method of obtaining the certificates are presented. In addition, the authors describe the strategies for participant protection that are implemented in a federally funded study of abuse, women's self-care, and pregnancy outcomes. The decision to clearly and specifically inform abused women of the limits of confidentiality allows participants to make informed decisions about disclosures, but may result in diminished recruitment.

  14. Informed consent and decision making by cataract patients.

    Science.gov (United States)

    Kiss, Christopher G; Richter-Mueksch, Sibylla; Stifter, Eva; Diendorfer-Radner, Gabriela; Velikay-Parel, Michaela; Radner, Wolfgang

    2004-01-01

    To investigate decision making by patients on the day before cataract surgery and to evaluate to what extent the informed consent process influences the patients' decision regarding consent. On the day before surgery, 70 patients (mean +/- SD age, 70.3 +/- 10.3 years) underwent a standardized informed consent procedure. They were also invited to answer 15 questions established in interdisciplinary cooperation among clinical psychologists, lawyers, and ophthalmologists. We assessed presurgical information and personal estimation of risks in cataract surgery; the patient-physician relationship regarding surgery-related decisions; and evaluations of the informed consent procedure and the patients' decision. Questionnaire answers indicated that 28 (40%) of the 70 participating patients arrived for surgery without any information; 16 (23%) believed that there were surgical procedures without risks; and 53 (76%) estimated that there were no risks for their cataract surgery. A physician-dominated decision for surgery was preferred by 31 patients (44%); 16 (26%) wanted to decide together with their ophthalmologist. Possible risks of a sight-threatening complication did not influence 54 patients' (77%) decisions, and 55 patients (78%) said the informed consent process did not influence their decision. The remaining 15 (22%) stated that the informed consent process positively confirmed their decision. Informed consent 1 day preoperatively does not seem to influence the decision for cataract surgery. Cognitive dissonance as part of a decision-making process makes changes in an already chosen option unlikely. The resulting limited decisive potential is very important for credibility in a trial and has to be considered in ophthalmologic surgery.

  15. Participants' Understanding of Informed Consent for Biobanking: A Systematic Review.

    Science.gov (United States)

    Eisenhauer, Elizabeth R; Tait, Alan R; Rieh, Soo Young; Arslanian-Engoren, Cynthia M

    2017-07-01

    Nurses are increasingly asked to obtain consent from participants for biobanking studies. Biobanking has added unique complexities to informed consent. The purpose of this systematic review was to evaluate participants' level of understanding of the information presented during the informed consent process unique to the donation of biological specimens for research. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were utilized to conduct the review. PubMed, EMBASE, CINAHL, PsycINFO, Scopus, Web of Science, and ProQuest bibliographic databases were searched. Results indicated that elements of informed consent unique to biobanking were poorly understood. Most studies had authors or funding associated with a biobank. Only one study disclosed and assessed participants' understanding of moral risks. Increased disclosures, values-clarification, and presenting information via multiple modalities may facilitate understanding. There is a need to improve the quality of informed consent for biobanking studies by utilizing standardized instruments, definitions, and encouraging research about informed choice outside the biobanking industry.

  16. Information preferences of high literacy pregnant women regarding informed consent models for genetic carrier screening.

    Science.gov (United States)

    Ormond, K E; Banuvar, S; Daly, A; Iris, M; Minogue, J; Elias, S

    2009-05-01

    With the increasing carrier screening options being offered to pregnant women, it is critical to consider what information women want in an informed consent process, and how they make decisions regarding screening. We surveyed 201 pregnant women. Subjects prefer "to have as much information as possible" (84%), and valued their physician's recommendations (82%) regarding screening. After reviewing two hypothetical scenarios, 71% of participants preferred more information about genetic carrier screening; however, some participants expressed concern that too much information can also lead to anxiety. When specifically asked about components of a potential informed consent process, the highest preferences were to include: the chance of having a child with the disorder (97%), the options for carriers (93%), the value and purpose of testing (91%), and the prognosis if a child has the disease (94%); preference for "symptoms" information differed based on scenario preference (pinformation desired as part of the informed consent process. Providers should consider ways to ascertain their patients' preferred informational style, and how to provide information in the amount and style that patients find useful in making decisions.

  17. Architecture of a consent management suite and integration into IHE-based regional health information networks

    Science.gov (United States)

    2011-01-01

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

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

    Science.gov (United States)

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

    2011-10-04

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

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

    Science.gov (United States)

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

    2015-09-09

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

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

    Science.gov (United States)

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

    2016-07-20

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

  1. Elements of informed consent and decision quality were poorly correlated in informed consent documents.

    Science.gov (United States)

    Brehaut, Jamie C; Carroll, Kelly; Elwyn, Glyn; Saginur, Raphael; Kimmelman, Jonathan; Shojania, Kaveh; Syrowatka, Ania; Nguyen, Trang; Fergusson, Dean

    2015-12-01

    Although informed consent (IC) documents must contain specific elements, inclusion of these elements may be insufficient to encourage high-quality decision making. We assessed the extent to which documents conform to IC standards and how well conformity to decision quality (DQ) standards can be predicted by IC standards, IC document characteristics, and study characteristics. We obtained 139 IC documents for trials registered with ClinicalTrials.gov from study investigators. Using a four-point scale, two raters independently assessed each IC document on 36 IC standard items and 9 DQ items. Overall agreement between raters across all 45 items was 93%. Across the 36 IC standards items, conformity was generally quite high but variable, with 20 items showing conformity of 80% or more and seven items showing conformity of 50% or lower. IC standards concordance, overall length of the IC document, and country of study were all significant predictors of DQ standards but together accounted for less than 20% of the variance in DQ standards. Conformity to recommendations for improving IC documents was relatively high but variable. The extent to which an IC document conformed to these recommendations was only moderately related to whether it conformed to recommendations for improving DQ. Existing IC regulations may not describe the optimal approach to helping people make good study participation decisions. Copyright © 2015 Elsevier Inc. All rights reserved.

  2. Informed Consent for Radiation in Interventional Radiology Procedures.

    Science.gov (United States)

    Zener, Rebecca; Johnson, Peter; Wiseman, Daniele; Pandey, Sachin; Mujoomdar, Amol

    2017-11-29

    To explore the patient perception on radiation-related cancer risk from interventional radiology (IR) procedures and whether informed radiation consent is warranted. A multiple-choice survey was prospectively administered to 68 adults undergoing a body or neuro-IR procedure with ionizing radiation exposure. Subgroup analysis with chi-square or Fisher exact test was performed based on patient past IR history (P informed if there was a radiation-related 3% increased cancer risk over 5 years. Although 55% considered 3% a small risk, 28% wanted to further discuss the risks and alternate options, and 15% would have only proceeded if it were a life-saving procedure: 89%, 80%, and 67% of patients wanted to be informed with exposure risks of 1 in 100, 1 in 1000, and 1 in 10,000, respectively. Only 53% were aware they were going to be exposed to radiation, irrespective of past IR history (P = .15). Most patients believed radiation consent should include radiation-related cancer risks (85%). No past IR history was significantly associated with wanting consent to include cancer-related risk (100% vs 76%; P = .01) and deterministic risks (70% vs 41%; P = .04). A majority (69%) believed both the referring physician and the interventional radiologist were responsible for obtaining radiation consent, and 65% of patients wanted verbal consent followed by signed written consent, regardless of past IR history. Many patients want to discuss cancer-related radiation risks with both radiologists and physicians. Informed radiation consent should be considered for procedures with high anticipated radiation doses. Copyright © 2017. Published by Elsevier Inc.

  3. Informed consent in randomised controlled trials: development and preliminary evaluation of a measure of Participatory and Informed Consent (PIC).

    Science.gov (United States)

    Wade, Julia; Elliott, Daisy; Avery, Kerry N L; Gaunt, Daisy; Young, Grace J; Barnes, Rebecca; Paramasivan, Sangeetha; Campbell, W Bruce; Blazeby, Jane M; Birtle, Alison J; Stein, Rob C; Beard, David J; Halliday, Alison W; Donovan, Jenny L

    2017-07-17

    Informed consent (IC) is an ethical and legal prerequisite for trial participation, yet current approaches evaluating participant understanding for IC during recruitment lack consistency. No validated measure has been identified that evaluates participant understanding for IC based on their contributions during consent interactions. This paper outlines the development and formative evaluation of the Participatory and Informed Consent (PIC) measure for application to recorded recruitment appointments. The PIC allows the evaluation of recruiter information provision and evidence of participant understanding. Published guidelines for IC were reviewed to identify potential items for inclusion. Seventeen purposively sampled trial recruitment appointments from three diverse trials were reviewed to identify the presence of items relevant to IC. A developmental version of the measure (DevPICv1) was drafted and applied to six further recruitment appointments from three further diverse trials to evaluate feasibility, validity, stability and inter-rater reliability. Findings guided revision of the measure (DevPICv2) which was applied to six further recruitment appointments as above. DevPICv1 assessed recruiter information provision (detail and clarity assessed separately) and participant talk (detail and understanding assessed separately) over 20 parameters (or 23 parameters for three-arm trials). Initial application of the measure to six diverse recruitment appointments demonstrated promising stability and inter-rater reliability but a need to simplify the measure to shorten time for completion. The revised measure (DevPICv2) combined assessment of detail and clarity of recruiter information and detail and evidence of participant understanding into two single scales for application to 22 parameters or 25 parameters for three-arm trials. Application of DevPICv2 to six further diverse recruitment appointments showed considerable improvements in feasibility (e.g. time to

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

    African Journals Online (AJOL)

    Objective: To identify and highlight challenges related to informed consent process for clinical trials in sub-Saharan Africa. Data sources: Published original research findings and reviews in the English literature, together with anecdotal information from our current professional experiences with clinical trials. Design: Review ...

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

    African Journals Online (AJOL)

    Background: Informed consent and autonomy are the major ethical principles that define the relationship between health workers and the patient. A patient should be given adequate information on the risks and benefits of treatment to be undertaken and also alternative treatment options. Objectives: To investigate what and ...

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

    African Journals Online (AJOL)

    role of the anaesthetist in patient care.3−9 These studies have only considered the issue of patient perceptions of informed consent to a small degree. This study aimed to ascertain the knowledge of patients with regard to the information divulged by the anaesthetist during the preoperative interview, focusing specifically on ...

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

    Science.gov (United States)

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

    2017-06-07

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

  8. [Informed consent of the surgical patient].

    Science.gov (United States)

    Kovács, József

    2014-02-01

    The article analyses the consequences of the paradigm shift in the surgical practice in the last fifty years. The earlier, paternalistic physician-patient relationship has been replaced by an equal one, which is based on informing the patient and involving him or her in the treatment decisions. This shift did not happen uniformly in various medical subspecialties. In this respect, surgery is more conservative than general medicine. The article analyses the most frequent problems of informing patients, and examines the major elements of information, together with their technical conditions in surgery. It reflects on specifics of surgical information disclosure and conditions of refusing medical interventions.

  9. Patient satisfaction and informed consent for surgery

    National Research Council Canada - National Science Library

    Hallock, Jennifer L; Handa, Victoria L; Rios, Rebeca

    2017-01-01

    .... Underlying this investment is the belief that informing patients about the surgery promotes patient satisfaction with the decision for surgery and potentially satisfaction more broadly. Author Affiliation...

  10. Evaluation of the Informed Consent Process of a Multicenter Tuberculosis Treatment Trial

    Science.gov (United States)

    Chapman, Kimberley N.; Pevzner, Eric; Mangan, Joan M.; Breese, Peter; Lamunu, Dorcas; Shrestha-Kuwahara, Robin; Nakibali, Joseph G.; Goldberg, Stefan V.

    2016-01-01

    Background Ethical principles obligate researchers to maximize study participants’ comprehension during the informed consent process for clinical trials. A pilot evaluation of the consent process was conducted during an international clinical trial of treatment for pulmonary tuberculosis to assess the feasibility of conducting an evaluation in a larger population and to guide these future efforts. Methods Study staff administered an informed consent assessment tool (ICAT) to a convenience sample of trial participants, measuring comprehension of consent components as derived from the Common Rule and FDA Title 21 Part 50, and satisfaction with the process. Participating site staff completed a consent process questionnaire about consent practices at their respective sites and provided improvement recommendations. ICAT scores and corresponding practices were compared where both were completed. Results ICATs (n = 54) were submitted from one site in Spain (n = 10), one in Uganda (n = 30), and five in the United States (n = 14). Participants were primarily male (76%), born in Africa (n = 31, 57%), and had a median age of 27 years (interquartile range [IQR]: 24–42). Median ICAT scores were 80% (IQR: 67–93) for comprehension and 89% (IQR: 78–100) for satisfaction. Ugandan participants scored higher than participants from other sites on comprehension (87% vs. 64%) and satisfaction (100% vs. 78%). Staff from 14 sites completed consent process questionnaires. Median ICAT scores for comprehension and satisfaction were higher at sites that utilized visual aids. Practice recommendations included shorter forms, simpler documents, and supplementary materials. Conclusions Participants achieved high levels (≥80%) of comprehension and satisfaction with their current consent processes. Higher ICAT scores at one site suggest an additional evaluation may identify approaches to improve comprehension and satisfaction in future trials. Through this pilot evaluation, complexities

  11. Effect of informed consent on patient characteristics in a stroke thrombolysis trial

    DEFF Research Database (Denmark)

    Thomalla, Götz; Boutitie, Florent; Fiebach, Jochen B

    2017-01-01

    OBJECTIVE: To determine whether the manner of consent, i.e., informed consent by patients themselves or informed consent by proxy, affects clinical characteristics of samples of acute stroke patients enrolled in clinical trials. METHODS: We analyzed the manner of obtaining informed consent in the...

  12. 76 FR 256 - Informed Consent Elements

    Science.gov (United States)

    2011-01-04

    ... designed to promote transparency of clinical research to participants and patients. DATES: Effective date... 20993-0002, 301- 796-4830. SUPPLEMENTARY INFORMATION: Table of Contents I. Introduction II. Overview of.... References I. Introduction In the Federal Register of December 29, 2009 (74 FR 68750), FDA issued a notice of...

  13. Personal Autonomy and Informed Consent : Conceptual and Normative Analyses

    OpenAIRE

    Ahlin, Jesper

    2017-01-01

    This licentiate thesis is comprised of a “kappa” and two articles. The kappa includes an account of personal autonomy and informed consent, an explanation of how the concepts and articles relate to each other, and a summary in Swedish. Article 1 treats one problem with the argument that a patient’s consent to treatment is valid only if it is authentic, i.e., if it is “genuine,” “truly her own,” “not out of character,” or similar. As interventions with a patient’s life and liberties must be j...

  14. Expanding newborn screening programmes and strengthening informed consent

    NARCIS (Netherlands)

    Nijsingh, N.M.

    2012-01-01

    Part I offers the context to the claim that informed consent requirements need to be strengthened to the extent that newborn screening conveys more disadvantages relative to the advantages. This includes a discussion of the Dutch debate on expanding newborn screening. From this discussion it becomes

  15. An audit of the informed consent process in postgraduate ...

    African Journals Online (AJOL)

    Background: Informed consent ensures respect for individual autonomy and safeguards against abuses of human participants. However, the high prevalence of poverty, inaccessibility of healthcare services, diseases, social insecurity and low literacy in developing countries such as Kenya increases participants' ...

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

    African Journals Online (AJOL)

    Background: Caesarean section is one of the commonest obstetrics surgery and has become increasingly safer compared with the early 20th century. The practice of informed consent has also become universally adopted for surgical procedures. However, with increasing knowledge about ethics and rights, issues on ...

  17. Informed Consent in Educational Settings and the Novice Researcher

    Science.gov (United States)

    Sanderson, Lara

    2010-01-01

    Research ethics are of fundamental importance to any research. They define and shape the research process from the very beginning as they are the code on which academics rely on as guiding practice in the field (Hopf, 2004). Informed consent is an interesting concept as it is interwoven with other ethical issues that include power, privacy and…

  18. Voluntary informed consent and good clinical practice for clinical ...

    African Journals Online (AJOL)

    Most differences, shortcomings and contradictions regarding voluntary informed consent for participation in clinical research relate to the South African-specific guidance documents, i.e. South African Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa (2006) and Ethics in ...

  19. The doctrine of informed consent in surgical practice | Lawal ...

    African Journals Online (AJOL)

    Physicians and other professionals in the field of medicine have to perform invasive and non-invasive procedures on patients as part of their duties. There is a legal basis upon which these procedures are done; this is called 'informed consent.' Sociocultural factors have strong influence on the sick role. These factors ...

  20. Informed Consent: Over- and Under-interpretation | Knapp van ...

    African Journals Online (AJOL)

    Informed consent is the expression of an individual's autonomy or selfrule. To be autonomous one has to be competent and acting freely. Ethicists make a distinction between a “thin” and a “thick” concept of autonomy. The thin concept of autonomy refers to “a competent person, in possession of the relevant facts making a ...

  1. The doctrine of informed consent in surgical practice

    African Journals Online (AJOL)

    Physicians and other professionals in the field of medicine have to perform invasive and non-invasive procedures on patients as part of their duties. There is a legal basis upon which these procedures are done; this is called 'informed consent.' Sociocultural factors have strong influence on the sick role. These factors ...

  2. Informed consent in clinical trials: Perceptions and experiences of a ...

    African Journals Online (AJOL)

    The implementation of informed consent (IC) in clinical trials presents many challenges, especially in developing countries. This study explored the experiences and reported practices regarding the implementation of IC in clinical trials in South Africa. Data were gathered through semi-structured interviews with a range of ...

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

    African Journals Online (AJOL)

    2014-05-14

    May 14, 2014 ... Language, cultural brokerage and informed consent – will technological terms impede telemedicine use? C Jack, BMedSci (Hons), LLM; Y Singh, PhD; B Hlombe; M Mars, MB ChB, MD. Department of TeleHealth, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa.

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

    African Journals Online (AJOL)

    Beyond Informed Consent: Ethical Considerations in the Design and Implementation of Sexual and Reproductive Health Research Among Adolescents. ... Ces besoins comprennent les questions d'infections sexuellement transmissibles, le VIH, le sida, les résultats défavorables de la grossesse, la communauté, la famille ...

  5. Ethical reasoning and informed consent in occupational therapy.

    Science.gov (United States)

    Kyler-Hutchison, P

    1988-05-01

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

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

    African Journals Online (AJOL)

    Background: Informed consent and autonomy are the major ethical principles that define the relationship between health workers and the patient. ... Results: The majority of the students were treated in the private sector (85.0%) by male oral health workers (61.6%) and dentists (89.5%) as opposed to dental therapists or oral ...

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

    African Journals Online (AJOL)

    Objective. To examine doctors' practices with regard to informed consent. Design. Cross-sectional, descriptive survey. Participants 'and setting. All full-time consultants and registrars in the Departments of Medicine, Obstetrics and Gynaecology, Paediatrics and Child Health, Paediatric Surgery and Surgery at the University ...

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

    African Journals Online (AJOL)

    HIV-related ethics - who should decide? S Afr Med J. 1991; 79: 527-528. 13. Harris L, Boyle JM, Bronstein PJ. Views of informed consent and decisionmaking: Parallel surveys of physicians and the public. In: President's Commission for the. StUdy of Ethical Problems in Medicine and Biomedical and Bahavioral Research.

  9. Heroin addiction and voluntary choice: the case of informed consent.

    Science.gov (United States)

    Henden, Edmund

    2013-09-01

    Does addiction to heroin undermine the voluntariness of heroin addicts' consent to take part in research which involves giving them free and legal heroin? This question has been raised in connection with research into the effectiveness of heroin prescription as a way of treating dependent heroin users. Participants in such research are required to give their informed consent to take part. Louis C. Charland has argued that we should not presume that heroin addicts are competent to do this since heroin addiction by nature involves a loss of ability to resist the desire for heroin. In this article, I argue that Charland is right that we should not presume that heroin addicts are competent to consent, but not for the reason he thinks. In fact, as Charland's critics correctly point out, there is plenty of evidence showing that heroin addicts can resist their desire for heroin. These critics are wrong, however, to conclude from this that we should presume that heroin addicts are competent to give their voluntary consent. There are, I shall argue, other conditions associated with heroin addiction that might constrain heroin addicts' choice in ways likely to undermine the voluntariness of their consent. In order to see this, we need to move beyond the focus on the addicts' desires for heroin and instead consider the wider social and psychological circumstances of heroin addiction, as well as the effects these circumstances may have on the addicts' beliefs about the nature of their options. © 2012 John Wiley & Sons Ltd.

  10. Informed consent - where do we stand in South Africa in 2004?

    African Journals Online (AJOL)

    Adele

    implications, risks and obligations of such refusal. This information must be communicated by the health care provider in a language that the user understands and in a manner which takes into account the user's level of literacy. 2. A health service may not be provided to a user without the user's informed consent. 3.

  11. Informed consent in field trials of gene-drive mosquitoes.

    Science.gov (United States)

    Kolopack, Pamela A; Lavery, James V

    2017-12-11

    The US National Academies' (NAS) recent report 'Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values' examines the requirements of responsible conduct in research involving gene drives in non-human organisms. Many of the complex ethical issues raised by the introduction of gene drive technologies for mosquito population control have been anticipated during the development and field-testing of earlier-generation genetic engineering approaches with mosquitoes. One issue-the requirement for informed consent in field trials-is not addressed explicitly in the NAS' report. Some commentators have presumed that informed consent should play a role as a protection for research participants in studies of genetically modified mosquitoes. Others have argued that there are no human subjects of field trials, so the informed consent requirement does not apply. It is both ethically and practically important that these presumptions are adequately scrutinized to ensure that any applications of informed consent in these trials are properly justified. We argue that informed consent from individual research participants in gene drive trials may be required: (1) when blood and other forms of clinical data are collected from them, as will likely be the case in some studies involving epidemiological endpoints, such as the incidence of new infections with dengue and malaria; (2) when they participate in social science and/or behavioral research involving the completion of surveys and questionnaires; or (3) when their home or property is accessed and the location recorded as a spatial variable for the release or collection of mosquitoes because the precise location of the household is important for entomological reasons and these data constitute identifiable private information at the household level. Importantly, most regulations and guidelines allow these requirements to be waived or modified, to various degrees, according to the

  12. Use of altered informed consent in pragmatic clinical research

    Science.gov (United States)

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

    2015-01-01

    There are situations in which the requirement to obtain conventional written informed consent can impose significant or even insurmountable barriers to conducting pragmatic clinical research, including some comparative effectiveness studies and cluster-randomized trials. Although certain federal regulations governing research in the United States (45 CFR 46) define circumstances in which any of the required elements may be waived, the same standards apply regardless of whether any single element is to be waived or whether consent is to be waived in its entirety. Using the same threshold for a partial or complete waiver limits the options available to IRBs as they seek to optimize a consent process. In this article, we argue that new standards are necessary in order to enable important pragmatic clinical research while at the same time protecting patients’ rights and interests. PMID:26374677

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

    Science.gov (United States)

    Henley, L; Benatar, S R; Robertson, B A; Ensink, K

    1995-12-01

    To examine doctors' practices with regard to informed consent. Cross-sectional, descriptive survey. All full-time consultants and registrars in the Departments of Medicine, Obstetrics and Gynaecology, Paediatrics and Child Health, Paediatric Surgery and Surgery at the University of Cape Town were included. The overall response rate was 63% (160/254). Data were collected by means of self-administered, semi-structured questionnaires. Most doctors (79%) felt it was their responsibility to ensure that patients and parents were fully informed about diagnostic and therapeutic interventions. Many (62%) supported a patient-centred standard for determining the type and amount of information to disclose. Doctors disclose most of the legally required information except for information about alternative forms of treatment and remote serious risks. They almost never provide information on medical costs. The most common reasons for not obtaining informed consent were the doctors' tendency to 'tell' patients/parents what they intend doing and their belief that patients/parents expect doctors to know what is medically best for them. Language, inadequate communication skills and lack of time were, surprisingly, seldom viewed as obstacles to the obtaining of informed consent. Findings were independent of discipline (medical or surgical) and doctors' status (consultant or registrar). Doctors who treat children were significantly less likely to obtain consent for certain interventions. Doctors meet many, but not all, of the legal requirements for informed consent. The findings question whether informed consent as envisioned by the law exists in reality. Cross-cultural research is needed to clarify patients' and parents' expectations of informed consent.

  14. Re-engineering the process of surgical informed consent.

    Science.gov (United States)

    Dierks, M M; Sands, D Z; Safran, C

    1999-01-01

    We have created a clinical performance support system that transforms surgical informed consent into an interactive process capable of evolving in response to institution-specified, provider-specified and patient-specified needs. The system functions in several capacities, including: (1) a source of standardized and comprehensive content and format the transmission of procedure-related risk and complications; (2) as expert critique, providing cues in an effort to reduce the effects of biased risk appraisal; (3) captures and archives clinician behavior relating to use, modification and disclosure of standardized knowledge sources; (4) provides just-in-time access to procedural descriptions information relating to risks and complications; (5) captures, archives and makes available to the clinician patient use of procedure-related knowledge resources. By design, the system will be used to assess the relationship between clinician perception and heuristics surrounding risk appraisal and disclosure and patient perceptions based on response to the disclosure process. The system prototype is currently being deployed in a breast surgery unit at the Beth Israel Deaconess Medical Center.

  15. Donation of eggs in assisted reproduction and informed consent.

    Science.gov (United States)

    Uroz, Victoria; Guerra, Lucia

    2009-09-01

    In Spain, there exists an increasing amount of advertising for the donation of eggs for assisted reproduction. This study attempts to assess: (1) scientific evidence available about adverse effects of egg donation; (2) characteristics of the information given in the informed consent to donors; and (3) the legality of this advertising. The main results are: (1) Many severe problems are associated with induction of ovulation, as ovarian hyperstimulation (reported frequencies from 5.9 to 15%), thromboembolism, hepatic failure and increased risk of ovarian, breast, endometrial and colon cancer. (2) Informed consent for egg donors is very incomplete, according to the Spanish law 41/2002 on Patient's Information. (3) Current advertising to promote egg donation does not respect, among others, law 14/2006 about Assisted Human Reproduction, as it includes reference to economic compensation or benefits but no information about the risks. Deontological and judicial disciplinary procedures should be initiated to protect donors' rights.

  16. 78 FR 59943 - Submission for OMB Review; 30-Day Comment Request; Interactive Informed Consent for Pediatric...

    Science.gov (United States)

    2013-09-30

    ...; Interactive Informed Consent for Pediatric Clinical Trials SUMMARY: In compliance with the requirement of... plans and instruments must be requested in writing. Proposed Collection: Interactive Informed Consent... standard paper consent document or an interactive computer-based consent program. Parents' and children's...

  17. Exceptions to the rule of informed consent for research with an intervention.

    Science.gov (United States)

    Rebers, Susanne; Aaronson, Neil K; van Leeuwen, Flora E; Schmidt, Marjanka K

    2016-02-06

    In specific situations it may be necessary to make an exception to the general rule of informed consent for scientific research with an intervention. Earlier reviews only described subsets of arguments for exceptions to waive consent. Here, we provide a more extensive literature review of possible exceptions to the rule of informed consent and the accompanying arguments based on literature from 1997 onwards, using both Pubmed and PsycINFO in our search strategy. We identified three main categories of arguments for the acceptability of a consent waiver: data validity and quality, major practical problems, and distress or confusion of participants. Approval by a medical ethical review board always needs to be obtained. Further, we provide examples of specific conditions under which consent waiving might be allowed, such as additional privacy protection measures. The reasons legitimized by the authors of the papers in this overview can be used by researchers to form their own opinion about requesting an exception to the rule of informed consent for their own study. Importantly, rules and guidelines applicable in their country, institute and research field should be followed. Moreover, researchers should also take the conditions under which they feel an exception is legitimized under consideration. After discussions with relevant stakeholders, a formal request should be sent to an IRB.

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

    Directory of Open Access Journals (Sweden)

    Won-Hee Lee, RN, PhD

    2008-06-01

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

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

    CERN Document Server

    Hosek, Susan D

    2013-01-01

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

  20. Informed Consent: Does Anyone Really Understand What Is Contained In The Medical Record?

    Science.gov (United States)

    Fenton, S H; Manion, F; Hsieh, K; Harris, M

    2015-01-01

    Despite efforts to provide standard definitions of terms such as "medical record", "computer-based patient record", "electronic medical record" and "electronic health record", the terms are still used interchangeably. Initiatives like data and information governance, research biorepositories, and learning health systems require availability and reuse of data, as well as common understandings of the scope for specific purposes. Lacking widely shared definitions, utilization of the afore-mentioned terms in research informed consent documents calls to question whether all participants in the research process - patients, information technology and regulatory staff, and the investigative team - fully understand what data and information they are asking to obtain and agreeing to share. This descriptive study explored the terminology used in research informed consent documents when describing patient data and information, asking the question "Does the use of the term "medical record" in the context of a research informed consent document accurately represent the scope of the data involved?" Informed consent document templates found on 17 Institutional Review Board (IRB) websites with Clinical and Translational Science Awards (CTSA) were searched for terms that appeared to be describing the data resources to be accessed. The National Library of Medicine's (NLM) Terminology Services was searched for definitions provided by key standards groups that deposit terminologies with the NLM. The results suggest research consent documents are using outdated terms to describe patient information, health care terminology systems need to consider the context of research for use cases, and that there is significant work to be done to assure the HIPAA Omnibus Rule is applied to contemporary activities such as biorepositories and learning health systems. "Medical record", a term used extensively in research informed consent documents, is ambiguous and does not serve us well in the context

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

    Directory of Open Access Journals (Sweden)

    Riccardo Fresa

    2013-08-01

    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.http://dx.doi.org/10.7175/rhc.v4i2s.874

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

    Science.gov (United States)

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

    2009-11-01

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

  3. [Informed consent in the intragastric balloon supported by SENPE, SEEDO, SEN and SECO: legal aspects].

    Science.gov (United States)

    Abilés, V; Martínez Olmos, M A; Escartí, M A; Bretón, I; Cáncer, E; Pelaez, N; Álvarez, V; Culebras, J M; Mazure, R A

    2012-01-01

    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. The aim was to adapt the informed consent used for bariatric surgery to a method that has especial characteristics. We used the informed consent proposed by ASAC for bariatric surgery and 8 statements related to IGB included in the WESTLAW ES database. 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, the obligations of providing a correct and complete information -which includes the dietary regime- should be observed, as well as the possible therapeutic alternatives and finally, the proceeding used should be in written. The informed consent is a medico-legal document which content should consider the latest jurisprudence on the minimally invasive techniques for the treatment of obesity.

  4. Informed consent: physician inexperience is a material risk for patients.

    Science.gov (United States)

    Veerapen, Richard J

    2007-01-01

    This paper examines the case for an expanded interpretation of the concept of "material risk" such that it necessitates voluntary disclosure of physician inexperience with a specific medical procedure. Informed consent law in the United States, Canada, and most commonwealth jurisdictions has become a driver of standards of risk disclosure by physicians during the informed consent process. The legal standard of risk disclosure expected of a physician hinges on the interpretation of the entity called "material risk." Any impairment of the physician related to drug usage, disease, or alcohol which compounds the risk of a procedure is very likely to be considered material by a patient. This paper argues that physician inexperience is a factor that a reasonable patient would attach significance to and that it should therefore be viewed as a "material risk" requiring disclosure.

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

    Science.gov (United States)

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

    2012-01-01

    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.

  6. Public preferences on written informed consent for low-risk pragmatic clinical trials in Spain.

    Science.gov (United States)

    Dal-Ré, Rafael; Carcas, Antonio J; Carné, Xavier; Wendler, David

    2017-09-01

    Pragmatic randomized clinical trials (pRCTs) collect data that have the potential to improve medical care significantly. However, these trials may be undermined by the requirement to obtain written informed consent, which can decrease accrual and increase selection bias. Recent data suggest that the majority of the US public endorses written consent for low-risk pRCTs. The present study was designed to assess whether this view is specific to the US. The study took the form of a cross-sectional, probability-based survey, with a 2 × 2 factorial design, assessing support for written informed consent vs. verbal consent or general notification for two low-risk pRCTs in hypertension, one comparing two drugs with similar risk/benefit profiles and the other comparing the same drug being taken in the morning or at night. The primary outcome measures were respondents' personal preference and hypothetical recommendation to a research ethics committee regarding the use of written informed consent vs. the alternatives. A total of 2008 adults sampled from a probability-based online panel responded to the web-based survey conducted in May 2016 (response rate: 61%). Overall, 77% of respondents endorsed written consent. In both scenarios, the alternative of general notification received significantly more support (28.7-37.1%) than the alternative of verbal consent (12.7-14.0%) (P = 0.001). Forty per cent of respondents preferred and/or recommended general notification rather than written consent. The results suggested that, rather than attempting to waive written consent, current pRCTs should focus on developing ways to implement written consent that provide sufficient information without undermining recruitment or increasing selection bias. The finding that around 40% of respondents endorsed general notification over written consent raises the possibility that, with educational efforts, the majority of Spaniards might accept general notification for low-risk pRCTs. © 2017 The

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

    Science.gov (United States)

    Vollmann, J; Winau, R

    1996-12-07

    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.

  8. Informed consent for biobanking research: cancer patient recruitment from rural communities in Maine.

    Science.gov (United States)

    Morrison, Deborah G; Farah, Christopher; Hock, Janet M

    2013-04-01

    Biobanking research seeks to improve the diversity, availability, and quality of human specimens critical for translational research, including biospecimen collections from disadvantaged minorities. American rural whites are seldom represented in such initiatives as geographic isolation makes obtaining informed consent challenging. We report a case series of 83 newly diagnosed cancer patients, attending a rural community medical center, who consented to participate in cancer research. To enable pooling with population studies, we created a BioGeoBank using 2007 NCI and ISBER Best Practices, after a protocol approval by Eastern Maine Medical Center (EMMC) IRB and OHP HRPO. Informed consent forms were at Flesch-Kincaid 8th Grade reading level, supplemented by NCI educational brochures. Of 108 patients identified, 85 were eligible. Of these, 83 patients (49 lung cancer, 21 breast cancer, and 13 other cancers) consented to donate data, blood, and tissue specimens for future research, and maintained eligibility. Two years later, we executed a legacy protocol to transfer specimens to NCI's biorepository. Of the 69 surviving patients, 9 patients could not be contacted. All those contacted (60) agreed to provide additional data on environmental risks, and consented to specimen transfer. Self-organizing map analyses showed no evidence that age, education, income, familial susceptibility, or lifestyle factors were associated with consent to donate data or biospecimens. Cancer cases reported 1-3 co-morbid chronic diseases (mostly cardiovascular), near lifetime smoking and/or alcohol consumption; familial cancer risks, and many had a prior cancer history. Anecdotally, willingness to consent was based on altruistic hopes that research would generate knowledge to reduce cancer incidence. Our study shows that cancer patients from disadvantaged white rural communities with health disparities associated with geographic isolation are motivated to consent to participate and support

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

    Science.gov (United States)

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

    2015-09-01

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

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

    Science.gov (United States)

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

    2016-06-01

    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

  11. Case two: A Kantian approach to the morality of blood substitute clinical trials without informed consent.

    Science.gov (United States)

    Fields, Keota

    2008-01-01

    Clinical trials in a number of countries are now underway to evaluate experimental, non-human blood substitute. One scenario calls for the blood substitute to be available on board emergency vehicles. This allows first responders the opportunity to provide transfusion support at an accident site and on the way to the hospital. However, many of the patients who would most benefit from the use of this material may be unconscious and unable to comprehend or sign an informed consent. One possible solution would be to eliminate the need for informed consent.

  12. Patient involvement in informed consent for pediatric phase I cancer research.

    Science.gov (United States)

    Miller, Victoria A; Baker, Justin N; Leek, Angela C; Drotar, Dennis; Kodish, Eric

    2014-11-01

    To examine children's and adolescents' involvement in the informed consent conference for phase I cancer trials and test associations with patient age, ease of understanding, and pressure to participate. Participants included 61 patients aged 7 through 21 years who were offered participation in a phase I trial. Consent conferences were audiotaped, transcribed, and coded for communication between patients and physicians and between patients and parents. On the basis of word counts, the mean proportion of the consent conference in which the physician was talking to the patient was 36%; the vast majority (73%) of this communication consisted of giving information. Physician-patient communication increased with age, but overall levels of patient-to-physician communication were low (3%). After controlling for patient age, greater physician-to-patient communication was associated with greater ease of understanding. The focus on providing information in the context of informed consent may come at the expense of other communication exchanges that are important to patients, especially in the context of end-of-life decisions. Children and adolescents may benefit from the assent process when physicians direct more of their communication to them. Future research should identify the reasons for low patient communication during the consent conference and strategies to enhance their participation in decision making about phase I trial enrollment.

  13. Informed Consent: the Rate-Limiting Step in Acute Stroke Trials

    Directory of Open Access Journals (Sweden)

    David Z Rose

    2011-10-01

    Full Text Available Successful implementation of a randomized clinical trial (RCT for neuro-vascular emergencies such as cerebral infarction, intracerebral hemorrhage (ICH, or subarachnoid hemorrhage (SAH is difficult. Besides establishing an accurate, hyper-expedited diagnosis among many mimics in a person with acute neurological deficits, informed consent must be obtained from this vulnerable group of patients who may be unable to convey their own wishes, grasp the gravity of their situation, or give a complete history or examination. We review the influences, barriers, and factors investigators encounter when providing established and putative stroke therapies, and focus on informed consent, the most important research protector of human subjects, as the rate-limiting step for enrollment into acute stroke RCTs. The informed consent process has received relatively little attention in the stroke literature, but is especially important for stroke victims with acute cognitive, aural, lingual, motor, or visual impairments. Consent by a surrogate may not accurately reflect the patient’s wishes. Further, confusion about trial methodology, negative opinions of placebo-controlled studies, and therapeutic misconception by patients or surrogates may impede trial enrollment and requires further study. Exception From Informed Consent (EFIC offers an opportunity that is rarely if ever utilized for stroke RCTs. Ultimately, advancing the knowledge base and treatment paradigms for acute stroke is essential but autonomy, beneficence (non-malfeasance, and justice must also be carefully interwoven into any well-designed RCT.

  14. 21 CFR 50.24 - Exception from informed consent requirements for emergency research.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Exception from informed consent requirements for... AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.24 Exception from informed consent requirements for emergency research. (a) The IRB responsible for the review...

  15. 76 FR 55390 - Guidance on Exculpatory Language in Informed Consent, Draft

    Science.gov (United States)

    2011-09-07

    ... 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... Language in Informed Consent document to the Division of Policy and Assurances, Office for Human Research...

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

    Science.gov (United States)

    Lindegger, G; Richter, L M

    2000-06-01

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

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

    Science.gov (United States)

    Ting, Graeme

    2012-04-01

    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.

  18. Influence of Written Informed Consent for Methylphenidate on Medicine Persistence Rates in Children with Attention-Deficit Hyperactivity Disorder.

    Science.gov (United States)

    Naenen-Hernani, Kristian; Palazón-Bru, Antonio; Colomina-Climent, Francisco; Gil-Guillén, Vicente F

    2017-10-01

    To assess the influence of written informed consent on nonpersistence with methylphenidate treatment in children with attention-deficit hyperactivity disorder (ADHD). We undertook a cohort study including 141 children with ADHD who started treatment with methylphenidate, with a follow-up of 6 months. The main outcome variable was nonpersistence, defined as discontinuation of treatment by the patient. Two groups were analyzed with and without written informed consent. Use of this consent was the decision of the prescribing physician because the law allows its use on a voluntary basis. The homogeneity of both groups was verified by evaluating sex, type of ADHD, methylphenidate dosage, age, severity, and other psychiatric disorders. To assess the influence of consent on nonpersistence, bootstrapping was used to determine relative risk reduction (RRR) and number needed to treat (NNT). Among the participants who completed follow-up, 67 provided written informed consent and 63 did not. We found the following nonpersistence frequencies in each group: (1) with written informed consent: 5 (7.5%) and (2) without written informed consent: 15 (23.8%). The clinically significant results were RRR, 0.67 ± 0.17; NNT, 7 (5-9). The use of written informed consent yielded higher persistence rates. Further studies are needed to determine whether we can use this procedure routinely in clinical practice.

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

    Science.gov (United States)

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

    2013-01-01

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

  20. EPO or not-EPO? An evidence based informed consent.

    Science.gov (United States)

    Mezza, E; Piccoli, G B; Pacitti, A; Soragna, G; Bermond, F; Burdese, M; Gai, M; Motta, D; Jeantet, A; Merletti, F; Vineis, P; Segoloni, G P

    2004-04-01

    Informed consent is crucial in therapeutic choices; however, the forms presented to patients are often locally developed and information may not be homogeneous. To prepare an evidence-based model for informed consent, applied in the case of erythropoietin therapy (EPO) as a teaching tool for medical students. Methodological tools of Evidence-Based Medicine (EBM) were developed within the EBM Course in the Medical School of Torino, Italy, as problem solving and patient information tools (5th year students work in small groups under the supervision of statisticians, epidemiologists and experts of internal medicine--nephrology in this case). Methodological and ethical problems were identified: in the pre-dialysis field, evidence from randomized clinical trials (RCT) is scant; how to use evidence gathered in dialysis? How to deal with implementation? How with the mass media? Do we need to discuss the drug choice with the patients? How to deal with rare and severe side effects?). The "evidence" was searched for on Medline/Embase, by using key-words and free terms. About 680 papers were retrieved and screened. Forms available on the Internet were retrieved and a general scheme was drawn: it included 5 areas: title, aim and targets (patients and family physicians); search strategies and updating; pros and cons of therapy; alternative options; open questions. EBM may offer valuable tools for systematically approaching patient information; the inclusion of this kind of exercise in the Medical School EBM courses may help enhance the awareness of future physicians of the correct communication with patients.

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

    NARCIS (Netherlands)

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

    2016-01-01

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

  2. Informed Consent: An Ethical Issue in Conducting Research with Male Partner Violent Offenders.

    Science.gov (United States)

    Crane, Cory A; Hawes, Samuel W; Mandel, Dolores; Easton, Caroline J

    Ethical codes help guide the methods of research that involve samples gathered from "at-risk" populations. The current paper reviews general as well as specific ethical principles related to gathering informed consent from partner violent offenders mandated to outpatient treatment, a group that may be at increased risk of unintentional coercion in behavioral sciences research due to court-mandates that require outpatient treatment without the ethical protections imbued upon prison populations. Recommendations are advanced to improve the process of informed consent within this special population and data supporting the utility of the recommendations in a sample 70 partner violent offenders are provided. Data demonstrate that participants were capable of comprehending all essential elements of consent.

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

    Science.gov (United States)

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

    2010-01-01

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

  4. Informed consent in dementia research: Legislation, theoretical concepts and how to assess capacity to consent

    NARCIS (Netherlands)

    Meulenbroek, O.V.; Vernooij-Dassen, M.J.F.J.; Kessels, R.P.C.; Graff, M.J.L.; Sjogren, J.M.C.; Schalk, B.W.M; Hoogsteen-Ossewaarde, M.E.; Claassen, J.A.H.R.; Melis, R.J.F.; Olde Rikkert, M.G.M.

    2010-01-01

    The diagnosis of dementia does not mean that a person is by definition incompetent to consent. Although the legislation has been modified to allow for research on incompetent persons, still, it becomes increasingly important to be able to judge the capacity to consent on an individual basis.

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

    Directory of Open Access Journals (Sweden)

    Alessandra De Palma

    2013-04-01

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

  6. The informed consent: a study of the efficacy of informed consents and the associated role of language barriers.

    Science.gov (United States)

    Clark, Steven; Mangram, Alicia; Ernest, Dunn; Lebron, Ricardo; Peralta, Lauren

    2011-01-01

    Obtaining informed consent before performing invasive procedures and operations has become a standard practice at all medical institutions in the United States. All agree that patients should be both conscious of and in agreement with their medical care. Though patients routinely sign consent forms with numerous risks and complications detailed, there are only a limited amount of reports that study if these patients have a thorough understanding of those risks and complications. Confounding the issue of the efficacy of informed consents is the growing population of patients who do not speak English. To obtain objective data on the efficacy of informed consents and the role of language barriers we looked at how well patients who consented to have a laparoscopic cholecystectomy understood the complications associated with this procedure. We conducted a randomized prospective study of all patients seen in the General Surgery Resident Outpatient Clinic who presented for an elective cholecystectomy. Fifty patients agreed to participate in our study. Participants were split into two groups. In the first group (the control group) surgical benefits, risks and complications were explained in the usual fashion. In the second group, after hearing the standard explanation of surgical risks, complications and benefits, patients watched a PowerPoint presentation with illustrations on laparoscopic cholecystectomy. Patients from both groups then took a ten question assessment based on the presentations that they encountered. Spanish speaking patients were addressed with an interpreter and given a Spanish PowerPoint presentation with a Spanish assessment. The patients' age, education level, income, and birth country were also studied. Fifty-two percent of the patients in the study were born outside of the United States. All of the non-US born patients were Hispanic and their primary language was Spanish. The average age of the studied patients was 38. Sixty-eight percent of the

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

    OpenAIRE

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

    2012-01-01

    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...

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

    Science.gov (United States)

    Salako, Solomon E

    2011-03-01

    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.

  9. Hope and persuasion by physicians during informed consent.

    Science.gov (United States)

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

    2014-10-10

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

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

    Science.gov (United States)

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

    2015-01-01

    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.

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

    Science.gov (United States)

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

    2014-01-01

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

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

    Science.gov (United States)

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

    2013-05-01

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

  13. 34 CFR 303.401 - Definitions of consent, native language, and personally identifiable information.

    Science.gov (United States)

    2010-07-01

    ... 34 Education 2 2010-07-01 2010-07-01 false Definitions of consent, native language, and personally... Definitions of consent, native language, and personally identifiable information. As used in this subpart— (a... which consent is sought, in the parent's native language or other mode of communication; (2) The parent...

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

    Science.gov (United States)

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

    2017-05-01

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

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

    Science.gov (United States)

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

    2017-01-01

    Background In respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request investigators and sponsors to revise them in a way to make them understandable for potential participants. The purpose of this work is to focus on the written information in the informed consent documentation for drug development clinical trials and suggests (i) to distinguish between necessary and not essential information, (ii) to define the optimal format allowing the best legibility of those documents. Methods The Aide et Recherche en Cancérologie Digestive (ARCAD) Group, an international scientific committee involving oncologists from all over the world, addressed these issues and developed and uniformly accepted a simplified informed consent documentation for future clinical research. Results A simplified form of informed consent with the leading part of 1200–1800 words containing all of the key information necessary to meet ethical and regulatory requirements and ‘relevant supportive information appendix’ of 2000–3000 words is provided. Conclusions This position paper, on the basis of the ARCAD Group experts discussions, proposes our informed consent model and the rationale for its content. PMID:28453700

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

    Directory of Open Access Journals (Sweden)

    Hondras Maria A

    2006-12-01

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

  17. Informed consent-It's more than a signature on a piece of paper.

    Science.gov (United States)

    Cocanour, Christine S

    2017-12-01

    Informed consent is an ethical concept that is codified in the law and is in daily practice at every health care institution. Three fundamental criteria are needed for clinical informed consent: the patient must be competent, adequately informed and not coerced. Physician-patient interaction is rooted in the ethical concept of beneficence, but over the 19th and 20th centuries, case law and societal changes brought respect for autonomy and with it--informed consent. This article briefly reviews the basics of informed consent, when is it required, how did informed consent evolve into what it is today and what can the surgeon do to truly achieve informed consent. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. Cervical manipulation--how might informed consent be obtained before treatment?

    Science.gov (United States)

    Delany, Clare

    2002-11-01

    This article discusses methods and mediums of obtaining informed consent in physiotherapy clinical practice, specifically in relation to cervical manipulation. Whilst cervical manipulation is a useful method of treatment for spinal joint pain and dysfunction, it has also been shown to be ineffective or even positively harmful. Legal precedents have set boundaries for informing patients of such adverse consequences. However, a degree of uncertainty exists in the physiotherapy profession, as in other health care professions, as to how to obtain informed consent in a busy clinical setting in order to discharge the legal duties owed. Obtaining meaningful informed consent in clinical practice raises issues of patient comprehension, memory and decision-making capacity. A large quantity of research directed at enhancing patient understanding has been undertaken in recent years. The important findings are that a variety of communication methods and mediums need to be employed in both providing information and assessing patient understanding. A combination of verbal, written and audiovisual information provides patients with maximum opportunity to be involved in treatment decisions.

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

    Science.gov (United States)

    Mellado, J M

    2016-01-01

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

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

    Science.gov (United States)

    Fernandes, Nurimar C

    2015-06-01

    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.

  1. Informed consent in China: status quo and its future.

    Science.gov (United States)

    Dai, Qingkang

    2003-01-01

    Informed consent is one of the fundamental rights of a patient. However it used to be ignored in mainland China and was neither academically discussed nor a matter of practical concern until recent years. Paternalism was dominant in the practice of traditional Chinese medicine which was intensely influenced by Confucianism. The historic medical paternalism was reinforced under communism and the planned economy due to the communist beliefs. But is has been frequently challenged in recent years with patients' awakening awareness of rights and the advent of rights-defending litigation culture in the course of the transformation to market economy. Nevertheless, the current Chinese laws lag behind this patients' awakening awareness and litigation culture. The resulting deficiency in Chinese laws governing medical relations has created dilemmas and chaos in the resolution of medical disputes. In conclusion, the author appeals for the amendment of Chinese law and tries to point out how it should be amended.

  2. The politics of information: informed consent in abortion and end-of-life decision making.

    Science.gov (United States)

    Suter, Sonia M

    2013-01-01

    The politics of reproduction dominate the political landscape now more than ever. One area of controversy has been informed consent statutes for abortion, which have been praised by the pro-life movement but derided by the pro-choice movement. More recently, legislatures have begun to enact informed consent statutes with respect to end-of-life decision making, an area almost as politically controversial as abortion. Like many abortion disclosure laws, some of these have been entitled "Right to Know" statutes. Yet, the supporters and opponents of each set of statutes tend not to be the same, aligning to a large extent based on their place in the culture wars over life and death. In this Article, I strive not only to show the remarkably similar critiques each side marshals but also to use these concerns to think in more nuanced ways about the goals of informed consent and whether the disclosure mandates achieve those goals. I first argue in favor of the aspirational goals of informed consent as a process that allows patients to participate in their medical decision making. While conceding the inherently political nature of abortion and end-of-life care, I also contend that the significance of decisions regarding those matters warrants, at least in theory, legislative efforts to ensure that patients have the opportunity to engage in deliberative and informed decision making. In describing and responding to the similar critiques of both sets of laws--the political bias of the statutes; the efforts to persuade, especially with non-medical information; the potential vulnerability of the targeted audience; and the interference with physician discretion--I uncover and challenge some of the presumptions about informed consent inherent in those critiques. Although information that persuades or influences is not per se problematic, I argue that disclosure of information that is inaccurate, untrue, or emotionally inflammatory harms informed consent. Even well-crafted informed

  3. Specimen Collection for Induced Pluripotent Stem Cell Research: Harmonizing the Approach to Informed Consent

    Science.gov (United States)

    Lowenthal, Justin; Lipnick, Scott; Rao, Mahendra

    2012-01-01

    Induced pluripotent stem cells (iPSCs) have elicited excitement in both the scientific and ethics communities for their potential to advance basic and translational research. They have been hailed as an alternative to derivation from embryos that provides a virtually unlimited source of pluripotent stem cells for research and therapeutic applications. However, research with iPSCs is ethically complex, uniquely encompassing the concerns associated with genomics, immortalized cell lines, transplantation, human reproduction, and biobanking. Prospective donation of tissue specimens for iPSC research thus requires an approach to informed consent that is constructed for this context. Even in the nascent stages of this field, approaches to informed consent have been variable in ways that threaten the simultaneous goals of protecting donors and safeguarding future research and translation, and investigators are seeking guidance. We address this need by providing concrete recommendations for informed consent that balance the perspectives of a variety of stakeholders. Our work combines analysis of consent form language collected from investigators worldwide with a conceptual balancing of normative ethical concerns, policy precedents, and scientific realities. Our framework asks people to consent prospectively to a broad umbrella of foreseeable research, including future therapeutic applications, with recontact possible in limited circumstances. We argue that the long-term goals of regenerative medicine, interest in sharing iPSC lines, and uncertain landscape of future research all would be served by a framework of ongoing communication with donors. Our approach balances the goals of iPSC and regenerative medicine researchers with the interests of individual research participants. PMID:23197820

  4. Making a decision about trial participation: the feasibility of measuring deliberation during the informed consent process for clinical trials.

    Science.gov (United States)

    Gillies, Katie; Elwyn, Glyn; Cook, Jonathan

    2014-07-30

    Informed consent of trial participants is both an ethical and a legal requirement. When facing a decision about trial participation, potential participants are provided with information about the trial and have the opportunity to have any questions answered before their degree of 'informed-ness' is assessed, usually subjectively, and before they are asked to sign a consent form. Currently, standardised methods for assessing informed consent have tended to be focused on aspects of understanding and associated outcomes, rather than on the process of consent and the steps associated with decision-making. Potential trial participants who were approached regarding participation in one of three randomised controlled trials were asked to complete a short questionnaire to measure their deliberation about trial participation. A total of 136 participants completed the 10-item questionnaire (DelibeRATE) before they made an explicit decision about trial participation (defined as signing the clinical trial consent form). Overall DelibeRATE scores were compared and investigated for differences between trial consenters and refusers. No differences in overall DelibeRATE scores were identified. In addition, there was no significant difference between overall score and the decision to participate, or not, in the parent trial. To our knowledge, this is the first study to prospectively measure the deliberation stage of the informed consent decision-making process of potential trial participants across different conditions and clinical areas. Although there were no differences detected in overall scores or scores of trial consenters and refusers, we did identify some interesting findings. These findings should be taken into consideration by those designing trials and others interested in developing and implementing measures of potential trial participants decision making during the informed consent process for research. International Standard Randomised Controlled Trial Number (ISRCTN

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

    Directory of Open Access Journals (Sweden)

    Raich PC

    2012-05-01

    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

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

    Science.gov (United States)

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

    2017-09-01

    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

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

    OpenAIRE

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

    2017-01-01

    The recent research and technology development in medical genomics has raised new issues that are profoundly different from those encountered in traditional clinical research for which informed consent was developed. Global initiatives for international collaboration and public participation in genomics research now face an increasing demand for new forms of informed consent which reflect local contexts. This article analyzes informed consent forms (ICFs) for genomic research formulated by fo...

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

    Directory of Open Access Journals (Sweden)

    H Miller MacSween

    1997-01-01

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

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

    Science.gov (United States)

    Paudel, B; Shrestha, G K

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

  10. Informed consent: A study of patients with life-threatening illnesses.

    Science.gov (United States)

    Busquets, Montserrat; Caïs, Jordi

    2017-06-01

    The relationship between healthcare professionals and patients in the Spanish health sector has undergone dramatic change. One aspect of this is that the use of informed consent has become a key factor in the delivery of adequate healthcare. But although a certain period of time has already passed since informed consent started to be used, in Spain there is still doubt about how adequately informed consent is being used. (a) To look at how patients understand the notion and purpose of informed consent, and (b) how the informed consent is applied - the way patients receive such information affects their level of participation and decision making during the time they receive medical care. We use interpretative description of interviews with patients. We developed guiding questions for the interviews with patients in two preliminary and exploratory focus groups. Then, we carried out 20 personal open-ended interviews with 20 purposive selected patients with illnesses that had a serious impact on their lives. Ethical considerations: Permission from ethical committees and institutions involved in the study, and consent and confidentiality were ensured before conducting the research. The findings show that while patients agreed that their consent should be necessary for health professionals to be able to intervene, they had serious difficulty obtaining and then understanding information offered to them at the moment when they were being asked to sign informed consent documents. The participants were critical of the consent documents, which they considered were treated as merely a formality and even some of them had felt coerced to sign. Participants confirmed that the informed consent documents that they signed did not meet their ethical objectives. Their perception of the purpose of consent indicates that informed consent document may still be largely understood as a formality rather an ethical obligation.

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

    Science.gov (United States)

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

    2017-11-01

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

  12. Understanding of Technical Terms and Contents of Informed Consent Forms for Sedative Gastrointestinal Endoscopy Procedures

    Directory of Open Access Journals (Sweden)

    Ihnsook Jeong, RN, PhD

    2013-03-01

    Conclusion: The understanding of the terms and knowledge about the procedures were disappointing. Therefore, sufficient explanations should be provided to the patients. While the informed consent was taken by doctors, the level of understanding should be monitored by nurses. In particular, subjects who did not have any previous experience with endoscopy procedures showed relatively lower level of understanding. We recommend that medical terms should be replaced with more common and nontechnical words in consent forms.

  13. Informed consent in dental care and research for the older adult population: A systematic review.

    Science.gov (United States)

    Mukherjee, Amrita; Livinski, Alicia A; Millum, Joseph; Chamut, Steffany; Boroumand, Shahdokht; Iafolla, Timothy J; Adesanya, Margo R; Dye, Bruce A

    2017-04-01

    Ethics in health care and research is based on the fundamental principle of informed consent. However, informed consent in geriatric dentistry is not well documented. Poor health, cognitive decline, and the passive nature of many geriatric patients complicate this issue. The authors completed this systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The authors searched the PubMed (MEDLINE), Web of Science, PsycINFO, and Cochrane Library databases. The authors included studies if they involved participants 65 years or older and discussed topics related to informed consent beyond obtaining consent for health care. The authors explored informed consent issues in dentistry and other biomedical care and research. The authors included 80 full-text articles on the basis of the inclusion criteria. Of these studies, 33 were conducted in the United States, 29 addressed consent issues in patients with cognitive impairment, 29 were conducted in patients with medical conditions, and only 3 involved consent related to dental care or research. Informed consent is a neglected topic in geriatric dental care and research. Substantial knowledge gaps exist between the understanding and implementation of consent procedures. Additional research in this area could help address contemporary consent issues typically encountered by dental practitioners and to increase active participation from the geriatric population in dental care and research. This review is the first attempt, to the authors' knowledge, to identify informed consent issues comprehensively in geriatric dentistry. There is limited information in the informed consent literature covering key concepts applicable to geriatric dentistry. Addressing these gaps could assist dental health care professionals in managing complex ethical issues associated with geriatric dental patients. Published by Elsevier Inc.

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

    Science.gov (United States)

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

    2011-01-01

    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.

  15. Quality of informed consent for invasive procedures in central Saudi Arabia

    Directory of Open Access Journals (Sweden)

    Abolfotouh MA

    2012-03-01

    Full Text Available Mostafa A Abolfotouh, Abdallah A AdlanKing Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi ArabiaBackground: Informed consent is considered the most important step in clinical interventions. The aims of this study were (1 to assess the quality of informed consent for invasive procedures with regard to consent process and information given about risks and alternative treatments, and (2 to determine patients' attitude toward informed consent at King Abdulaziz Medical City, Riyadh, Saudi Arabia.Methods: A cross-sectional study was conducted of 162 adult patients in different wards after undergoing surgery or invasive procedures within 1–2 days of signing the informed consent, using a previously validated interview questionnaire. Data on patients' characteristics, type of invasive procedure, and some informed consent-related issues were collected. Multiple linear regression analysis was used to identify the predictors of the percentage mean score of quality of informed consent, and significance was considered at P ≤ 0.05.Results: The quality of informed consent was generally poor (% mean score = 50.98 ± 17.49. About two-thirds of patients were told during the informed consent process that they have to sign merely as routine, 48% thought that if they refused the treatment plan they would lose the interest of the treating physician to help them, 42% thought that by saying no they would lose the good relationship with their physician, and 42.6% were not interested in having a copy of the informed consent document. Significantly higher quality was predicted when the physicians were the ones who explained the informed consent (t = 4.15, P < 0.001 and when informed consent was explained to younger patients (t = 2.754, P = 0.007. The overall attitude of the patients toward the process of informed consent was satisfactory (% mean score = 76.31 ± 7.63.Conclusion: The results suggest

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

    Directory of Open Access Journals (Sweden)

    Pike Bruce

    2011-01-01

    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.

  17. Without 'informed consent'? Ethics and ancient mummy research.

    Science.gov (United States)

    Kaufmann, I M; Rühli, F J

    2010-10-01

    Ethical issues are of foremost importance in modern bio-medical science. Ethical guidelines and socio-cultural public awareness exist for modern samples, whereas for ancient mummy studies both are de facto lacking. This is particularly striking considering the fact that examinations are done without informed consent or that the investigations are invasive due to technological aspects and that it affects personality traits. The aim of this study is to show the pro and contra arguments of ancient mummy research from an ethical point of view with a particular focus on the various stakeholders involved in this research. Relevant stakeholders in addition to the examined individual are, for example, a particular researcher, and the science community in general, likely descendents of the mummy or any future generation. Our broad discussion of the moral dilemma of mummy research should help to extract relevant decision-making criteria for any such study in future. We specifically do not make any recommendations about how to rate these decision-factors, since this is highly dependent on temporal and cultural affiliations of the involved researcher. The sustainability of modern mummy research is dependent on ethical orientation, which can only be given and eventually settled in an interdisciplinary approach such as the one we attempt to present here.

  18. Informed Consent in Asymmetrical Relationships: An Investigation into Relational Factors That Influence Room for Reflection

    NARCIS (Netherlands)

    Spruit, S.L.; van de Poel, I.R.; Doorn, N.

    2016-01-01

    In recent years, informed consent has been suggested as a way to deal with risks posed by engineered nanomaterials. We argue that while we can learn from experiences with informed consent in treatment and research contexts, we should be aware that informedconsent traditionally pertains to certain

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

    Science.gov (United States)

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

    2010-01-01

    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…

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

    Science.gov (United States)

    Mayne, Fiona; Howitt, Christine; Rennie, Léonie

    2016-01-01

    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…

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

    NARCIS (Netherlands)

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

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

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

    NARCIS (Netherlands)

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

    1998-01-01

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

  3. Informed consent - where do we stand in South Africa in 2004?

    African Journals Online (AJOL)

    Adele

    The issue of informed consent seems to have re-surfaced re- cently. Perhaps this is as a .... tion constitutes an emergency, (to save life or permanent injury) then the head of ... worded, and is a signed consent form the be all and end all? This issue was ... information on which to base his or her decision, the con- sent may be ...

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

    Science.gov (United States)

    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.

  5. Patient-physician communication: informed consent for imaging-guided spinal injections.

    Science.gov (United States)

    Bennett, D Lee; Dharia, Chiraag V; Ferguson, Kristi J; Okon, Anietie E

    2009-01-01

    Historically, informed-consent forms have been developed for the purpose of educating patients. However, informed-consent forms can be very difficult to understand. The hypothesis of this study was that a method using diagrams would improve patient-physician communication without increasing the time required to obtain informed consent over the teach-the-teacher method, as well as over current standard informed-consent protocol. Ninety-nine of 109 patients undergoing spinal injections agreed to participate and completed this prospective, randomized, controlled study. The patients were randomly assigned to the control group (informed consent obtained in the customary manner at the investigators' institution, with 12 key points of consent and home care discussed conversationally), the teach-the-teacher group (patients had to repeat the 12 key points to the physicians before informed consent was complete), and the diagram group (patients viewed a set of diagrams illustrating the 12 key points before signing the informed-consent form). After the procedure, the patients completed a survey to test knowledge recall, anxiety, and pain during the procedure. Statistically significant results included a lower survey score for the control group, longer time required for the teach-the-teacher group than the control group, and a negative correlation between age and survey score in the teach-the-teacher group. The diagram method required less time than the teach-the-teacher method, had no negative correlation in survey score results with age, and had improved patient-physician communication over the control group.

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

    Directory of Open Access Journals (Sweden)

    Aslihan Eran

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

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

    Directory of Open Access Journals (Sweden)

    Go Yoshizawa

    2017-07-01

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

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

    Science.gov (United States)

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

    2017-01-01

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

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

    Science.gov (United States)

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

    2011-01-01

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

  10. Making a decision about trial participation: the feasibility of measuring deliberation during the informed consent process for clinical trials

    NARCIS (Netherlands)

    Gillies, K.; Elwyn, G.; Cook, J

    2014-01-01

    BACKGROUND: Informed consent of trial participants is both an ethical and a legal requirement. When facing a decision about trial participation, potential participants are provided with information about the trial and have the opportunity to have any questions answered before their degree of

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

    Science.gov (United States)

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

    2013-11-01

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

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

    Science.gov (United States)

    Pick, Andrew; Gilbert, Kayleigh; McCaul, James

    2014-11-11

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

  13. 77 FR 56644 - Federal Acquisition Regulation; Information Collection; Subcontract Consent

    Science.gov (United States)

    2012-09-13

    ... policy when subcontracting. The Government requires a contractor to provide certain information (e.g... of placing a subcontract to ensure that the proposed subcontract is appropriate for the risks...

  14. 77 FR 29983 - Federal Acquisition Regulation; Information Collection; Subcontract Consent

    Science.gov (United States)

    2012-05-21

    ... policy when subcontracting. The Government requires a contractor to provide certain information (e.g... of placing a subcontract to ensure that the proposed subcontract is appropriate for the risks...

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Science.gov (United States)

    Mardirosian, Kathryn; And Others

    1990-01-01

    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.…

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

    African Journals Online (AJOL)

    2015-08-02

    Aug 2, 2015 ... Skin epidermal cells (keratinocytes) are a typical example of adult stem cells; they can be harvested from donor skin samples, cultured in vitro and used for research or for treatment, such as for burns. These unipotent adult cells can only be grown into skin cells and are covered in current consent protocols.

  18. Informed consent and deafness in South Africa: Guidelines for ...

    African Journals Online (AJOL)

    2017-12-01

    Dec 1, 2017 ... years of childhood, will retain such oral language skills in the event of severe or profound hearing loss. ... and lip-reading skills may assist their understanding of others. Of course, the profound trauma of ... analysis to check the reading age and grade level at which the consent forms have been written.

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

    African Journals Online (AJOL)

    Yet, there is increasing need for fundamental clinical ICU research which falls outside this limitation. Health research ethics committees (HRECs) generally apply their minds and may allow surrogate decision making (i.e. consent by a person other that the participant), but this can also be problematic since relatives may not ...

  20. Informed Consent in Asymmetrical Relationships: an Investigation into Relational Factors that Influence Room for Reflection.

    Science.gov (United States)

    Spruit, Shannon Lydia; van de Poel, Ibo; Doorn, Neelke

    In recent years, informed consent has been suggested as a way to deal with risks posed by engineered nanomaterials. We argue that while we can learn from experiences with informed consent in treatment and research contexts, we should be aware that informed consent traditionally pertains to certain features of the relationships between doctors and patients and researchers and research participants, rather than those between producers and consumers and employers and employees, which are more prominent in the case of engineered nanomaterials. To better understand these differences, we identify three major relational factors that influence whether valid informed consent is obtainable, namely dependency, personal proximity, and existence of shared interests. We show that each type of relationship offers different opportunities for reflection and therefore poses distinct challenges for obtaining valid informed consent. Our analysis offers a systematic understanding of the possibilities for attaining informed consent in the context of nanomaterial risks and makes clear that measures or regulations to improve the obtainment of informed consent should be attuned to the specific interpersonal relations to which it is supposed to apply.

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

    Science.gov (United States)

    Fields, Lindy Marie; Calvert, James Douglas

    2015-08-01

    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.

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

    Science.gov (United States)

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

    2017-10-01

    purpose, 7 accurately and 4 inaccurately compared with the reference standard. Seventy-one of 72 noninferiority trial protocols or SAPs provided no rationale for selection of noninferiority hypothesis. None provided a clinical rationale for the chosen amount of decreased efficacy. Patients were not accurately informed of study purpose, which raises questions regarding the ethics of informed consent in antibiotic trials. Noninferiority and superiority trials entail different benefit-harm trade-offs that must be conveyed for ethical informed consent.

  3. Informed consent as an ethical requirement in clinical trials: an old, but still unresolved issue. An observational study to evaluate patient's informed consent comprehension.

    Science.gov (United States)

    Sanchini, Virginia; Reni, Michele; Calori, Giliola; Riva, Elisabetta; Reichlin, Massimo

    2014-04-01

    We explored the comprehension of the informed consent in 77 cancer patients previously enrolled in randomised phase II or phase III clinical trials, between March and July 2011, at the San Raffaele Scientific Institute in Milano. We asked participants to complete an ad hoc questionnaire and analysed their answers. Sixty-two per cent of the patients understood the purpose and nature of the trial they were participating in; 44% understood the study procedures and 40% correctly listed at least one of the major risks or complications related to their participation in the trial. We identified three factors associated with comprehension of the informed consent: age, education and type of tumour/investigator team. We suggest several possible improvements of how to obtain informed consent that will increase patient awareness, as well as the validity and effectiveness of the clinical trials.

  4. Informed consent for the diagnosis of brain death: a conceptual argument

    OpenAIRE

    Muramoto, Osamu

    2016-01-01

    Background This essay provides an ethical and conceptual argument for the use of informed consent prior to the diagnosis of brain death. It is meant to enable the family to make critical end-of-life decisions, particularly withdrawal of life support system and organ donation, before brain death is diagnosed, as opposed to the current practice of making such decisions after the diagnosis of death. The recent tragic case of a 13-year-old brain-dead patient in California who was maintained on a ...

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

    Directory of Open Access Journals (Sweden)

    Roy Tapash

    2008-03-01

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

  6. Informed consent for the diagnosis of brain death: a conceptual argument.

    Science.gov (United States)

    Muramoto, Osamu

    2016-10-13

    This essay provides an ethical and conceptual argument for the use of informed consent prior to the diagnosis of brain death. It is meant to enable the family to make critical end-of-life decisions, particularly withdrawal of life support system and organ donation, before brain death is diagnosed, as opposed to the current practice of making such decisions after the diagnosis of death. The recent tragic case of a 13-year-old brain-dead patient in California who was maintained on a ventilator for over 2 years illustrates how such a consent would have made a crucial difference. Conceptual, philosophical, and ethical analysis. I first consider a conceptual justification for the use of consent for certain non-beneficial and unwanted medical diagnoses. I suggest that the diagnosis of brain death falls into this category for some patients. Because the diagnostic process of brain death lacks the transparency of traditional death determination, has a unique epistemic structure and a complex risk-benefit profile which differs markedly from case to case, and presents conflicts of interest for physicians and society, I argue that pre-diagnostic counseling and informed consent should be part of the diagnostic process. This approach can be termed as "allow cardiac death", whose parallel logic with "allow natural death" is discussed. I also discuss potential negative impacts on organ donation and health care cost from this proposal and offer possible mitigation. I show that the pre-diagnostic counseling can improve the possibility for well-thought-out decisions regarding organ donation and terminating life-support system in cases of hopeless prognosis. This approach differs conceptually from the pluralism of the definition of death, such as those in New Jersey and Japan, and it upholds the Uniform Determination of Death Act. My intention is not to provide an instant panacea for the ongoing impasse of the brain death debate, but to point to a novel conceptual ground for a more

  7. Informed consent for chiropractic care: Comparing patients' perceptions to the legal perspective.

    Science.gov (United States)

    Winterbottom, Melissa; Boon, Heather; Mior, Silvano; Facey, Marcia

    2015-06-01

    This study explored chiropractic patients' perceptions of exchanging risk information during informed consent and compared them with the legal perspective of the informed consent process. Interviews were conducted with 26 participants, recruited from chiropractic clinics. Transcripts were analysed using a constant comparative method of analysis. Participants experienced informed consent as an on-going process where risk information informed their decisions to receive treatment throughout four distinct stages. In the first stage, information acquired prior to arriving at the clinic for treatment shaped perceptions of risk. In stage two, participants assessed the perceived competence of their practitioners. Participants then signed the consent form and discussed the risks with their practitioners. Finally, they communicated with their practitioners during treatment to ensure their pain threshold was not crossed. These findings suggest that chiropractic patients perceive informed consent as a process involving communication with their practitioners, and that it is possible to educate patients about the risks associated with treatment while satisfying the legal requirements of informed consent. Copyright © 2014 Elsevier Ltd. All rights reserved.

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

    Science.gov (United States)

    Doudenkova, Victoria; Bélisle Pipon, Jean-Christophe

    2016-03-01

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

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

    Science.gov (United States)

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

    2015-03-01

    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.

  10. Strengths and weaknesses of guideline approaches to safeguard voluntary informed consent of patients within a dependent relationship.

    Science.gov (United States)

    Dekking, Sara A S; van der Graaf, Rieke; van Delden, Johannes J M

    2014-03-24

    It is thought that a dependent relationship between patients and physicians who enroll their own patients in research compromises voluntary informed consent. Therefore, several ethical guidelines for human subject research provide approaches to mitigate these compromises. Currently, these approaches have not been critically evaluated. In this article, we analyze the approaches of ethical guidelines to manage the influence of a dependent relationship between patients and physicians on voluntary informed consent and discuss the strengths and weaknesses of these approaches. We performed a review of international ethical guidance documents on human subject research, listed in the Oxford Textbook of Clinical Research Ethics and found through cross referencing. We also searched Global Ethics Observatory (GEObs) and the World Health Organization (WHO) website. Guidelines from all years were eligible for inclusion. The date last searched was December 2013. We identified two basic guideline approaches: 1. A process approach, which focuses on the person who obtains informed consent, that is, an independent individual, such as a research nurse or counselor; and 2. A content approach, emphasizing the voluntary nature of participation. Both approaches are valuable, either because the influence of the physician may diminish or because it empowers patients to make voluntary decisions. However, the approaches also face challenges. First, research nurses are not always independent. Second, physician-investigators will be informed about decisions of their patients. Third, involvement of a counselor is sometimes unfeasible. Fourth, the right to withdraw may be difficult to act upon in a dependent relationship. Current guideline approaches to protect voluntary informed consent within a dependent relationship are suboptimal. To prevent compromises to voluntary informed consent, consent should not only be obtained by an independent individual, but this person should also emphasize the

  11. Improving the informed consent process--a booklet on participants' rights in medical research.

    Science.gov (United States)

    Benatar, Jocelyne R; McKibbin, Philip; Stewart, Ralph A H

    2012-09-21

    This paper describes the process undertaken to develop and validate a booklet that informs participants of their rights in clinical studies. A booklet coupled with a shorter study-specific informed consent form may improve informed consent. A booklet was developed in simple clear language, based on information contained in currently used audited informed consent forms and good clinical practice guidelines. 159 people from a broad range of backgrounds with expertise or interest in the consent process were asked to review the booklet and complete a survey. The booklet was modified based on feedback received from 59 respondents. Feedback was used to improve the booklet and ensure it complied with guidelines, was legally accurate and sensitive to tanga te whenua (Māori/indigenous people). The booklet was easier to read and comprehend compared to equivalent information contained in currently used informed consent forms. A broad consultation and revisions improved the booklet and suggested it would be well received if introduced in New Zealand together with shorter study-specific informed consent forms.

  12. Patients' beliefs regarding informed consent for low-risk pragmatic trials.

    Science.gov (United States)

    Dal-Ré, Rafael; Carcas, Antonio J; Carné, Xavier; Wendler, David

    2017-09-18

    The requirement to obtain written informed consent may undermine the potential of pragmatic randomized clinical trials (pRCTs) to improve evidence-based care. This requirement could compromise trials statistical power or even force it to close them down prematurely. However, recent data from the U.S. and Spain suggest that a majority of the public endorses written consent for low-risk pRCTs. The present manuscript assesses whether this view is shared by patients. This was a cross-sectional, probability-based survey, with a 2 × 2 factorial design, assessing support for written informed consent versus verbal consent or general notification for two low-risk pRCTs in hypertension, one comparing 2 drugs with similar risk/benefit profiles and the other comparing the same drug being taken in the morning or at night. This web-based survey was conducted in May 2016. Two-thousand and eight adults who were representative of the Spanish population participated in the survey (response rate: 61%). Of these 2008 respondents, 338 indicated that they had been diagnosed with hypertension and were being treated with prescription medicines for this condition at the time of responding to the survey. The primary outcome measures were respondents' personal preference and recommendation to a research ethics committee regarding the use of written informed consent versus verbal consent or general notification. Overall, 74% of the 338 patient respondents endorsed written consent. In both scenarios, general notification received significantly more support (30.6%-44.7%) than verbal consent (13.3%-17.6%). 43% of respondents preferred and/or recommended general notification rather than written consent. As in the survey of the general public, more patients endorsed written consent than the alternative option. However, two factors suggest that a different approach to written consent should be investigated for low-risk pRCTs: a) a substantial minority of respondents supported general

  13. Patients’ beliefs regarding informed consent for low-risk pragmatic trials

    Directory of Open Access Journals (Sweden)

    Rafael Dal-Ré

    2017-09-01

    Full Text Available Abstract Background The requirement to obtain written informed consent may undermine the potential of pragmatic randomized clinical trials (pRCTs to improve evidence-based care. This requirement could compromise trials statistical power or even force it to close them down prematurely. However, recent data from the U.S. and Spain suggest that a majority of the public endorses written consent for low-risk pRCTs. The present manuscript assesses whether this view is shared by patients. Methods This was a cross-sectional, probability-based survey, with a 2 × 2 factorial design, assessing support for written informed consent versus verbal consent or general notification for two low-risk pRCTs in hypertension, one comparing 2 drugs with similar risk/benefit profiles and the other comparing the same drug being taken in the morning or at night. This web-based survey was conducted in May 2016. Two-thousand and eight adults who were representative of the Spanish population participated in the survey (response rate: 61%. Of these 2008 respondents, 338 indicated that they had been diagnosed with hypertension and were being treated with prescription medicines for this condition at the time of responding to the survey. The primary outcome measures were respondents’ personal preference and recommendation to a research ethics committee regarding the use of written informed consent versus verbal consent or general notification. Results Overall, 74% of the 338 patient respondents endorsed written consent. In both scenarios, general notification received significantly more support (30.6%-44.7% than verbal consent (13.3%-17.6%. 43% of respondents preferred and/or recommended general notification rather than written consent. Conclusions As in the survey of the general public, more patients endorsed written consent than the alternative option. However, two factors suggest that a different approach to written consent should be investigated for low-risk pRCTs: a a

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

    Science.gov (United States)

    Galán Gutiérrez, J C; Galán Cortés, J C

    2014-02-01

    The analysis of one of the requisites of the validity of the informed consent, the notice period, during which the patient should be provided with information, so that he/she can reflect and fully exercise his/her Kantian right of self-determination. National legislation appears to be insufficient when dealing with this issue, which is compensated for in some regional legislations. We conclude by pointing the need to provide the patient with information with sufficient notice prior to operations, so that he/she can ponder over his/her decision. Copyright © 2013 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Published by Elsevier España. All rights reserved.

  15. CONSENTIMIENTO INFORMADO, UNA VISIÓN PANORÁMICA Informed consent, an outlook

    Directory of Open Access Journals (Sweden)

    Iñigo de la Maza Gazmuri

    2010-01-01

    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.

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

    Directory of Open Access Journals (Sweden)

    A Nienaber

    2010-12-01

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

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

    Science.gov (United States)

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

    2014-05-01

    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.

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

    NARCIS (Netherlands)

    Rodhouse, Toyah; Vanclay, Frank

    2016-01-01

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

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

    OpenAIRE

    Thilla Rajaretnam

    2015-01-01

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

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

    OpenAIRE

    Furuno, Yuichi; Sasajima, Hiroyasu

    2015-01-01

    Abstract 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 i...

  1. Patient information, consents and privacy protection scheme for an information system dedicated to pervasive developmental disorders.

    Science.gov (United States)

    Ben Said, Mohamed; Robel, Laurence; Messiaen, Claude; Craus, Yann; Jais, Jean Philippe; Golse, Bernard; Landais, Paul

    2014-01-01

    Patients explicit and unambiguous information, patients consents and privacy protection are reviewed in this article, in the frame of the deployment of the information system TEDIS dedicated to autism spectrum disorders. The role of the Delegate to the Protection of Data is essential at this stage. We developed a privacy protection scheme based on storing encrypted patients personal data on the server database and decrypting it on the Web browser. It tries to respond to the end-users request to manage nominative data in a human readable form and to meet with privacy protection framework.

  2. Informed consent for blood tests in people with a learning disability.

    Science.gov (United States)

    Goldsmith, Lesley; Woodward, Val; Jackson, Leigh; Skirton, Heather

    2013-09-01

    This article is a report of a study of informed consent in people with a learning disability. The aims of the study were to explore the information needs of people with mild-to-moderate learning disabilities with respect to consent for blood tests and to identify ways of facilitating informed consent. The recent political agenda for social change in the UK has emphasized the right of people with a learning disability to have more autonomy and make their own decisions. As in other countries, there has also been a shift towards shared decision-making in healthcare practice. Qualitative study using an ethnographic approach. An ethnographic approach was used for this qualitative study. Phase 1 involved observation of six participants with a learning disability having a routine blood test in general practice, followed by semi-structured interviews with 14 participants with a learning disability in Phase 2. Data were collected between February 2009-February 2010. The data showed that consent procedures were often inadequate and provision of information to patients prior to a blood test was variable. People with a learning disability expressed clearly their information requirements when having a routine blood test; this included not wanting any information in some cases. Healthcare practitioners and people with a learning disability need to be familiar with current consent law in their own country to facilitate valid consent in the healthcare context. This study demonstrated the value of qualitative research in exploring the knowledge and attitudes of people with learning disability. © 2012 Blackwell Publishing Ltd.

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

    Science.gov (United States)

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

    2017-02-01

    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.

  4. Reciprocity and Constructions of Informed Consent: Researching with Indigenous Populations

    Directory of Open Access Journals (Sweden)

    Jason Brent Ellis

    2006-12-01

    Full Text Available In this article, the authors present a discussion of institutional review boards and potential challenges qualitative researchers may face when presenting human subjects research proposals to these boards for approval. In particular, they focus on issues of consent and reciprocity with Indigenous populations, whose culture and traditions might be quite different from those review boards typically see. After presenting these issues, the authors close with a framework that can be used as a guide for ethical considerations in research with Indigenous peoples.

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

    Science.gov (United States)

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

    2015-10-01

    most tasks required to function in the health care setting.Low or inadequate health literacy has been found to have several adverse effects on health and health care use: reduced ability to take medications properly and to interpret labels and health messages, poorer overall health status and higher risk of mortality in seniors, increased emergency department and hospital use, and decreased use of preventive interventions.Most studies examining the relationship between health literacy and informed consent conclude that patients with low health literacy are less likely to participate in decision making concerning their health care. According to a recent literature review, health care users' literacy, together with other factors, were found to be important determinants of a patient's capacity to provide fully informed consent. According to this review, 21 to 86% of the patients were able to recall the potential risks and complications of their medical procedure. This percentage may be even lower because most of the included studies referred to self-reported recall, which may be a flawed measure. According to the literature, much of the written material related to the informed consent is too difficult for health care users to understand. In addition, in their study, McCarthy et al. observed that during consultations, physicians spoke and used significantly more complex language than their patients, which may result in inappropriate communication for the patients, mainly for those with limited literacy. The situations described above may raise a number of critical legal and ethical problems. Health professionals, who shape the conditions of interactions with the patient, are responsible for adapting appropriate interventions, such as communication approaches that take into account patients' health literacy. These interventions could have a major contribution to the improvement of the informed consent process.Sheridan et al. conducted a systematic review on interventions

  6. "Not Tied Up Neatly with a Bow": Professionals' Challenging Cases in Informed Consent for Genomic Sequencing.

    Science.gov (United States)

    Tomlinson, Ashley N; Skinner, Debra; Perry, Denise L; Scollon, Sarah R; Roche, Myra I; Bernhardt, Barbara A

    2016-02-01

    As the use of genomic technology has expanded in research and clinical settings, issues surrounding informed consent for genome and exome sequencing have surfaced. Despite the importance of informed consent, little is known about the specific challenges that professionals encounter when consenting patients or research participants for genomic sequencing. We interviewed 29 genetic counselors and research coordinators with considerable experience obtaining informed consent for genomic sequencing to understand their experiences and perspectives. As part of this interview, 24 interviewees discussed an informed consent case they found particularly memorable or challenging. We analyzed these case examples to determine the primary issue or challenge represented by each case. Challenges fell into two domains: participant understanding, and facilitating decisions about testing or research participation. Challenges related to participant understanding included varying levels of general and genomic literacy, difficulty managing participant expectations, and contextual factors that impeded participant understanding. Challenges related to facilitating decision-making included complicated family dynamics such as disagreement or coercion, situations in which it was unclear whether sequencing research would be a good use of participant time or resources, and situations in which the professional experienced disagreement or discomfort with participant decisions. The issues highlighted in these case examples are instructive in preparing genetics professionals to obtain informed consent for genomic sequencing.

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

    Science.gov (United States)

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

    2017-12-01

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

  8. Decision-making capacity and informed consent to participate in research by cognitively impaired individuals.

    Science.gov (United States)

    Simpson, Cherie

    2010-11-01

    Obtaining informed consent is a fundamental part of conducting research that balances the need for participant autonomy and calls on the principal investigator to exercise beneficence. This is especially true in research involving persons with dementia and mild cognitive impairment where the ability to understand and reason may be compromised. Performing an assessment of decision-making capacity to consent to research should be the first step in helping the researcher decide who signs the consent. This article reviews the current literature available on instrumentation and procedures for capacity assessment, and in the absence of universal guidelines offers implications and suggestions for practice. Copyright © 2010 Elsevier Inc. All rights reserved.

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

    DEFF Research Database (Denmark)

    Bechmann, Anja

    2014-01-01

    Social networking sites collect extensive personal and sensitive user data across a wide range of services and users accept this through a click on the accept-button in their end-user license agreements (EULAs). By comparing existing regulation and discussion on future adjustments with studies...... of consent practices on Facebook, the article argues that with the growing importance and use of these services the consent culture of the internet has turned into a blind non-informed consent culture, heavily relying on social incentives and group dynamics in decision-making that are not adequately...

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

    Science.gov (United States)

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

    2013-06-01

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

  11. Efficacy of a Procedure-Specific Education Module on Informed Consent in Plastic Surgery.

    Science.gov (United States)

    Brandel, Michael G; Reid, Christopher M; Parmeshwar, Nisha; Dobke, Marek K; Gosman, Amanda A

    2017-05-01

    Truly informed consent is an elusive goal, seldom attained in medical or surgical practice. Patients often do not fully understand procedures and therapies they undergo or the associated sequelae. Historically, informed consent and patient education have been limited to physician discussions, sometimes with the addition of simple visual aids. More recently, there is a growing body of decision aids available, including interactive multimedia patient educational modules that review preoperative through postoperative care, risks, benefits, alternatives, different surgical options, as well as commonly asked questions. We hypothesized that the addition of a Web-based educational tool would positively impact attainment of informed consent and satisfaction in plastic surgery patients. We performed a prospective randomized controlled study comparing patients who presented in consultation for breast reconstruction, breast reduction, and abdominoplasty. Patients received standard patient education along with a procedure-specific (study) or general patient safety (control) Web-based educational module. Informed consent was measured using a surgical-focused, modified version of the Shared Decision-making 25 index tool. Patient demographic information as well as surrogate markers of familiarity with technology were recorded preoperatively and postoperatively. Comparisons were made between study and control groups, procedure subgroups, and preoperative and postoperative time points. Demographic factors and consent variables were compared among experimental and procedure groups. Data were collected from 65 patients preoperatively and 48 patients postoperatively. Thirty patients competed both surveys. Overall, no differences in patient characteristics or familiarity with technology were observed between experimental groups. Demographic characteristics were also similar between groups. No meaningful differences were identified in comparisons between experimental groups on either

  12. The Definition of Placebo in the Informed Consent Forms of Clinical Trials

    Science.gov (United States)

    Hernández, Astrid; Baños, Josep-E.; Llop, Cristina; Farré, Magí

    2014-01-01

    Aim Lack of knowledge concerning the nature of placebo and why it is necessary may influence the participation of patients in clinical trials. The objective of the present study is to review how placebo is described in written information for participants in clinical trials to be evaluated by a Human Research Ethics Committee. Methods All research protocols submitted for evaluation in a Spanish hospital during 2007–2013 were reviewed. The main characteristics of the studies using a placebo were collected. Three authors read each of them to determine how the term “placebo” was explained and if there was any comment on its efficacy and safety. Results Two thousand seven-hundred and forty research protocols were evaluated, of which three hundred and fifty-nine used a placebo. Pharmaceutical companies sponsored most placebo-controlled clinical trials (91.9%), and phase III studies were the commonest (59.9%). Oncology (15.0%), cardiology (14.2%), and neurology (13.1%) made the greatest contributions. A review of the informed consent forms showed that placebo was described in a similar manner in most studies: the explanation was limited to between four and eight words. Very few gave information about the risks of its use or adverse reactions from its administration. None of the studies provided details about the placebo effect. And 23 lacked any information about placebo at all. Conclusions Explanations about placebo in informed consent forms is often scarce, and information about the placebo effect and associated risks are absent. This situation may influence a full understanding of placebo by participants in clinical trials and might reduce their informed decision to participate. PMID:25423149

  13. Hearing loss following myringoplasty - implications for informed consent.

    Science.gov (United States)

    Bewick, J; Prinsley, P

    2015-04-01

    There are many reports of operations performed to successfully close ear drum perforations. Hearing deterioration after myringoplasty is not a widely published topic. This paper presents an audit of this complication. A six-year retrospective analysis of a series of myringoplasty operations was performed using electronic patient records. Patients with post-operative hearing loss were identified and those with hearing loss greater than 10 dB were further scrutinised. Out of 187 patients who underwent myringoplasty procedures, 44 (23.53 per cent) experienced a reduction in hearing thresholds. In seven cases (3.74 per cent), the hearing loss was greater than 10 dB. A case note review revealed no obvious predictive factors, although posterior perforations and the possibility of ossicular chain manipulation were considered. Hearing loss following myringoplasty is not rare, and this may alter the consent process for this procedure.

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

    Directory of Open Access Journals (Sweden)

    Kavit Natujwa

    2010-06-01

    Full Text Available Abstract Background HIV prevention trials conducted among disadvantaged vulnerable at-risk populations in developing countries present unique ethical dilemmas. A key concern in bioethics is the validity of informed consent for trial participation obtained from research subjects in such settings. The purpose of this study was to investigate the effectiveness of a continuous informed consent process adopted during the MDP301 phase III vaginal microbicide trial in Mwanza, Tanzania. Methods A total of 1146 women at increased risk of HIV acquisition working as alcohol and food vendors or in bars, restaurants, hotels and guesthouses have been recruited into the MDP301 phase III efficacy and safety trial in Mwanza. During preparations for the trial, participatory community research methods were used to develop a locally-appropriate pictorial flipchart in order to convey key messages about the trial to potential participants. Pre-recorded audio tapes were also developed to facilitate understanding and compliance with gel-use instructions. A comprehension checklist is administered by clinical staff to all participants at screening, enrolment, 12, 24, 40 and 50 week follow-up visits during the trial. To investigate women's perceptions and experiences of the trial, including how well participants internalize and retain key messages provided through a continuous informed consent process, a random sub-sample of 102 women were invited to participate in in-depth interviews (IDIs conducted immediately after their 4, 24 and 52 week follow-up visits. Results 99 women completed interviews at 4-weeks, 83 at 24-weeks, and 74 at 52 weeks (a total of 256 interviews. In all interviews there was evidence of good comprehension and retention of key trial messages including that the gel is not currently know to be effective against HIV; that this is the key reason for conducting the trial; and that women should stop using gel in the event of pregnancy. Conclusions

  15. "I didn't sign up for this!": Informed consent in social network research

    OpenAIRE

    Hutton, Luke; Henderson, Tristan

    2015-01-01

    This work was funded by the Engineering and Physical Sciences Research Council (EPSRC) through a Doctoral Training Grant. The issue of whether, and how, to obtain informed consent for research studies that use social network data has recently come to the fore in some controversial cases. Determining how to acquire valid consent that meets the expectations of participants, while minimising the burden placed on them, remains an open problem. We apply Nissenbaum’s model of contextual integrit...

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

    Science.gov (United States)

    2013-01-01

    Graham Nixon, Jennifer Teal, Mike Davis, Robert Smith, Linda Fischetti, David Parker, Zachary Gillen, and John Mattison, “The Department of...April 8, 2011. 74 Patient Privacy, Consent, and Identity Management Dimitropoulos, Linda L., Shaun J. Grannis, Alison K. Banger, and David H...Goldstein, Melissa M., and Alison L. Rein, Consumer Consent Options for Electronic Health Information Exchange: Policy Considerations and Analysis, March 23

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

    Science.gov (United States)

    Dranseika, Vilius; Piasecki, Jan; Waligora, Marcin

    2017-02-01

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

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

    Directory of Open Access Journals (Sweden)

    Siriwardhana Chesmal

    2008-02-01

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

  19. Procedures of recruiting, obtaining informed consent, and compensating research participants in Qatar: findings from a qualitative investigation.

    Science.gov (United States)

    Killawi, Amal; Khidir, Amal; Elnashar, Maha; Abdelrahim, Huda; Hammoud, Maya; Elliott, Heather; Thurston, Michelle; Asad, Humna; Al-Khal, Abdul Latif; Fetters, Michael D

    2014-02-04

    Very few researchers have reported on procedures of recruiting, obtaining informed consent, and compensating participants in health research in the Arabian Gulf Region. Empirical research can inform the debate about whether to adjust these procedures for culturally diverse settings. Our objective was to delineate procedures related to recruiting, obtaining informed consent, and compensating health research participants in the extremely high-density multicultural setting of Qatar. During a multistage mixed methods project, field observations and qualitative interviews were conducted in a general medicine clinic of a major medical center in Qatar. Participants were chosen based on gender, age, literacy, and preferred language, i.e., Arabic, English, Hindi and Urdu. Qualitative analysis identified themes about recruitment, informed consent, compensation, and other research procedures. A total of 153 individuals were approached and 84 enrolled; the latter showed a diverse age range (18 to 75 years); varied language representation: Arabic (n = 24), English (n = 20), Hindi (n = 20), and Urdu (n = 20); and balanced gender distribution: women (n = 43) and men (n = 41). Primary reasons for 30 declinations included concern about interview length and recording. The study achieved a 74% participation rate. Qualitative analytics revealed key themes about hesitation to participate, decisions about participation with family members as well as discussions with them as "incidental research participants", the informed consent process, privacy and gender rules of the interview environment, reactions to member checking and compensation, and motivation for participating. Vulnerability emerged as a recurring issue throughout the process among a minority of participants. This study from Qatar is the first to provide empirical data on recruitment, informed consent, compensation and other research procedures in a general adult population in the Middle East and Arabian Gulf. This

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

    Science.gov (United States)

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

    2015-01-01

    Background The development of Electronic Health Records (EHRs) forms an integral part of the information strategy for the National Health Service (NHS) in the UK, with the aim of facilitating health information exchange for patient care and secondary use, including research and healthcare planning. Implementing EHR systems requires an understanding of patient expectations for consent mechanisms and consideration of public awareness towards information sharing as might be made possible through integrated EHRs across primary and secondary health providers. Objectives To explore levels of public awareness about EHRs and to examine attitudes towards different consent models with respect to sharing identifiable and de-identified records for healthcare provision, research and planning. Methods A cross-sectional questionnaire survey was administered to adult patients and members of the public in primary and secondary care clinics in West London, UK in 2011. In total, 5331 individuals participated in the survey, and 3157 were included in the final analysis. Results The majority (91%) of respondents expected to be explicitly asked for consent for their identifiable records to be accessed for health provision, research or planning. Half the respondents (49%) did not expect to be asked for consent before their de-identified records were accessed. Compared with White British respondents, those from all other ethnic groups were more likely to anticipate their permission would be obtained before their de-identified records were used. Of the study population, 59% reported already being aware of EHRs before the survey. Older respondents and individuals with complex patterns of interaction with healthcare services were more likely to report prior awareness of EHRs. Individuals self-identifying as belonging to ethnic groups other than White British, and those with lower educational qualifications were less likely to report being aware of EHRs than White British respondents and

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

    Science.gov (United States)

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

    2015-04-01

    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. 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. 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. 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 respondents with degree-level education

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

    Science.gov (United States)

    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

    2013-01-01

    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

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

    Science.gov (United States)

    Söderfeldt, Ylva; Groß, Dominik

    2014-04-01

    Morgellons is a medically contested diagnosis with foremost dermatological symptoms. Patients experience fibers emerging from the skin, together with a range of other somatic, psychiatric, and neurological complaints. Within the medical community, it is generally held to be a variation of delusional parasitosis/delusional infestation, which is usually treated with antipsychotics. Little attention has been paid in the literature to the ethical aspects of treating patients with Morgellons disease. The communicative strategies suggested in the literature display significant ethical issues, primarily the use of therapeutic privilege, i.e. withholding information from the patient. Since this limits patient autonomy, that approach is ethically problematic. Instead, the physician has an ethical obligation to respect the patient's autonomy, provide full information, and seek consent before initiating a psychiatric referral.

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

    Science.gov (United States)

    Carlisle, John R

    2002-05-01

    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.

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

    Science.gov (United States)

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

    2014-12-16

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

  6. Developing ethical strategies to assist oncologists in seeking informed consent to cancer clinical trials.

    Science.gov (United States)

    Brown, R F; Butow, P N; Butt, D G; Moore, A R; Tattersall, M H N

    2004-01-01

    Randomised clinical trials have come to be regarded as the gold standard in treatment evaluation. However, many doctors see the discussion of a clinical trial as an intrusion into the doctor-patient relationship and find these discussions difficult to initiate. Detailed informed consent is now a requirement of patient participation in trials; however, it is known that patients commonly fail to understand and recall the information conveyed. These difficulties for doctors and patients raise questions about the ethical integrity of the informed consent process. In this study, we have developed a set of communication strategies underpinned by ethical, linguistic and psychological theory, designed to assist doctors in this difficult task. Initially, audiotape transcripts of 26 consultations in which 10 medical oncologists invited patients to participate in clinical trials were analysed by expert ethicists, linguists, oncologists and psychologists, using rigorous qualitative methodology. A subset of seven of these was subjected to detailed linguistic analysis. A strategies document was developed to address themes which emerged from these analyses. This document was presented to relevant expert stakeholders. Their feedback was incorporated into the final document. Four themes emerged from the analysis; (a) shared decision-making, (b) the sequence of moves in the consultation, (c) the type and clarity of the information provided and (d) disclosure of controversial information and coercion. Detailed strategies were developed to assist doctors to communicate in these areas. We have developed a set of ethical strategies which may assist health professionals in this difficult area. A training package based on these strategies is currently being evaluated in a multi-centre randomised controlled trial.

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

    Science.gov (United States)

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

    2017-11-28

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

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

    Science.gov (United States)

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

    1998-10-01

    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.

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

    Directory of Open Access Journals (Sweden)

    Carlo Petrini

    2011-12-01

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

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

    Directory of Open Access Journals (Sweden)

    Gitanjali B

    2003-01-01

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

  11. Dare we rethink informed consent? | de Roubaix | South African ...

    African Journals Online (AJOL)

    ... provision of information intended to remove the information (i.e. power) differential between doctor and patient. ICP is fundamentally flawed, since it is impossible to comprehensively and explicitly inform. A fundamental problem is our reliance on the containerconduit metaphor of informing. As a linguistic act, this metaphor ...

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

    Science.gov (United States)

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

    2016-10-01

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

  13. An evaluation of the informed consent process for elective surgery at a university hospital.

    Science.gov (United States)

    Aisuodionoe-Shadrach, O I; Ogunlade, O S; Amoran, O E

    2006-01-01

    To evaluate on a limited scale the process and quality of the consenting process in our local environment following the increasingly important issue of informed consent and its validity to most physicians and hospital administrators in the face of an emerging litigious Nigeria society. A 22 item questionnaire was administered on 60 consecutive patients admitted for elective surgery into the general and specialty surgical wards of the University College Hospital over a one month period. No question in our study achieved the ideal standard of 100%. At the time of admission, 57 of the 60 patients knew their clinical diagnosis from the primary surgical team with 90% (n=54) of the subjects expressing varying degrees of satisfaction with the information they had on their condition. Only about 32% of the patients got additional information on the diagnosis and planned surgery from sources other than the admitting surgical team. In this group of participants there was no significant difference in the sufficiency of information obtained between the two sources (p > 0.05) Ninety percent of the subjects however preferred they had all the information about their operation much earlier than the pre-operation day. Patients satisfaction with overall information obtained during the consenting process was only 'very sufficient' in 35% of the cases. Notwithstanding the information derived by patients from their primary surgeons in addition to alternate sources, satisfaction with overall information obtained was marginal at 35%. There is a need to look into methods of improving the process, quality and validity of informed consent.

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

    Science.gov (United States)

    Mariscal-Crespo, M I; Coronado-Vázquez, M V; Ramirez-Durán, M V

    To analyse the readability of informed consent forms (ICF) used in Public Hospitals throughout Spain, with the aim of checking their function of providing comprehensive information to people who are making any health decision no matter where they are in Spain. A descriptive study was performed on a total of 11,339 ICF received from all over Spanish territory, of which 1617 ICF were collected from 4 web pages of Health Portal and the rest (9722) were received through email and/or telephone contact from March 2012 to February 2013. The readability level was studied using the Inflesz tool. A total of 372 ICF were selected and analysed using simple random sampling. The Inflesz scale and the Flesch-Szigriszt index were used to analyse the readability. The readability results showed that 62.4% of the ICF were rated as a "little difficult", the 23.4% as "normal", and the 13.4% were rated as "very difficult". The highest readability means using the Flesch index were scored in Andalusia with a mean of 56.99 (95% CI; 55.42-58.57) and Valencia with a mean of 51.93 (95% CI; 48.4-55.52). The lowest readability means were in Galicia with a mean of 40.77 (95% CI; 9.83-71.71) and Melilla, mean=41.82 (95% CI; 35.5-48.14). The readability level of Spanish informed consent forms must be improved because their scores using readability tools could not be classified in normal scales. Furthermore, there was very wide variability among Spanish ICF, which showed a lack of equity in information access among Spanish citizens. Copyright © 2017 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

  15. An Audit of the Knowledge and Attitudes of Doctors towards Surgical Informed Consent (SIC

    Directory of Open Access Journals (Sweden)

    Bushra Ashraf

    2014-11-01

    Full Text Available Background The Surgical Informed Consent (SIC is a comprehensive process that establishes an informationbased agreement between the patient and his doctor to undertake a clearly outlined medical or surgical intervention. It is neither a casual formality nor a casually signed piece of paper. The present study was designed to audit the current knowledge and attitudes of doctors towards SIC at a tertiary care teaching hospital in Pakistan. Methods This cross-sectional qualitative investigation was conducted under the auspices of the Department of Medical Education (DME, Pakistan Institute of Medical Sciences (PIMS, Shaheed Zulfiqar Ali Bhutto Medical University (SZABMU, Islamabad over three months period. A 19-item questionnaire was employed for data collection. The participants were selected at random from the list of the surgeons maintained in the hospital and approached face-to-face with the help of a team of junior doctors detailed for questionnaire distribution among them. The target was to cover over 50% of these doctors by convenience sampling. Results Out of 231 respondents, there were 32 seniors while 199 junior doctors, constituting a ratio of 1:6.22. The respondents variably responded to the questions regarding various attributes of the process of SIC. Overall, the junior doctors performed poorer compared to the seniors. Conclusion The knowledge and attitudes of our doctors particularly the junior ones, towards the SIC are less than ideal. This results in their failure to avail this golden opportunity of doctor-patient communication to guide their patients through a solidly informative and legally valid SIC. They are often unaware of the essential preconditions of the SIC; provide incomplete information to their patients; and quite often do not ensure direct involvement of their patients in the process. Additionally they lack an understanding of using interactive computer-based programs as well as the concept of nocebo effect of informed

  16. Allegations of Failure to Obtain Informed Consent in Spinal Surgery Medical Malpractice Claims.

    Science.gov (United States)

    Grauberger, Jennifer; Kerezoudis, Panagiotis; Choudhry, Asad J; Alvi, Mohammed Ali; Nassr, Ahmad; Currier, Bradford; Bydon, Mohamad

    2017-06-21

    Predictive factors associated with increased risk of medical malpractice litigation have been identified, including severity of injury, physician sex, and error in diagnosis. However, there is a paucity of literature investigating informed consent in spinal surgery malpractice. To investigate the failure to obtain informed consent as an allegation in medical malpractice claims for patients undergoing a spinal procedure. In this retrospective cohort study, a national medicolegal database was searched for malpractice claim cases related to spinal surgery for all years available (ie, January 1, 1980, through December 31, 2015). Failure to obtain informed consent and associated medical malpractice case verdict. A total of 233 patients (117 [50.4%] male and 116 [49.8%] female; 80 with no informed consent allegation and 153 who cited lack of informed consent) who underwent spinal surgery and filed a malpractice claim were studied (mean [SD] age, 47.1 [13.1] years in the total group, 45.8 [12.9] years in the control group, and 47.9 [13.3] years in the informed consent group). Median interval between year of surgery and year of verdict was 5.4 years (interquartile range, 4-7 years). The most common informed consent allegations were failure to explain risks and adverse effects of surgery (52 [30.4%]) and failure to explain alternative treatment options (17 [9.9%]). In bivariate analysis, patients in the control group were more likely to require additional surgery (45 [56.3%] vs 53 [34.6%], P = .002) and have more permanent injuries compared with the informed consent group (46 [57.5%] vs 63 [42.0%], P = .03). On multivariable regression analysis, permanent injuries were more often associated with indemnity payment after a plaintiff verdict (odds ratio [OR], 3.12; 95% CI, 1.46-6.65; P = .003) or a settlement (OR, 6.26; 95% CI, 1.06-36.70; P = .04). Informed consent allegations were significantly associated with less severe (temporary or emotional) injury (OR

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

    Directory of Open Access Journals (Sweden)

    Melissa Upjohn

    2016-10-01

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

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

    Science.gov (United States)

    Seniuk, Patrick

    2018-02-13

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

  19. Informed consent for research involving people with dementia: a grey area.

    Science.gov (United States)

    Cubit, Katrina

    2010-01-01

    Research involving people with dementia has been flagged as a key priority by Alzheimer's International. Dementia has been an Australian National Health Priority since 2005, yet there are no clear guidelines for seeking and obtaining informed consent from people with dementia to participate in observational research. Informed consent is an ethical requirement for the conduct of research involving humans. Although many people with dementia are able to express a desire to be involved in research, the insidious progression of the disease reduces a person's ability to understand and appreciate the consequences of involvement. This paper explores the author's journey of seeking and obtaining informed consent for a mixed methods study which involved the observation of older people with dementia.

  20. Cultural aspects related to informed consent in health research: A systematic review.

    Science.gov (United States)

    Halkoaho, Arja; Pietilä, Anna-Maija; Ebbesen, Mette; Karki, Suyen; Kangasniemi, Mari

    2016-09-01

    In order to protect the autonomy of human subjects, we need to take their culture into account when we are obtaining informed consent. This study describes the cultural aspects related to informed consent in health research and is based on electronic searches that were conducted using the Scopus, PubMed, CINAHL, and Cochrane databases published between 2000 and 2013. A total of 25 articles were selected. Our findings indicate that cultural perspectives relating to the informed consent process are essential during the whole research process and particularly crucial in the planning phase of a study. Our study indicates that appropriate communication between different stakeholders plays a vital role in cultural understanding. The researchers' awareness of cultural differences and their ability to work in a culturally sensitive way are key factors in improving study participation and retention in a multicultural context. Taking cultural aspects into account during the whole research process improves the quality of research. © The Author(s) 2015.

  1. Informed Consent in the Medical Care of Transgender and Gender-Nonconforming Patients.

    Science.gov (United States)

    Cavanaugh, Timothy; Hopwood, Ruben; Lambert, Cei

    2016-11-01

    Informed consent as a model of care has evolved as an alternative to the standard model of care recommended by the World Professional Association for Transgender Health's Standards of Care, version 7, which emphasizes the importance of mental health professionals' role in diagnosing gender dysphoria and in assessing the appropriateness and readiness for gender-affirming medical treatments. By contrast, the informed consent model for gender-affirming treatment seeks to acknowledge and better support the patient's right to, and capability for, personal autonomy in choosing care options without the required involvement of a mental health professional. Clinicians' use of the informed consent model would enable them both to attain a richer understanding of transgender and gender-nonconforming patients and to deliver better patient care in general. © 2016 American Medical Association. All Rights Reserved.

  2. 10 CFR Appendix A to Part 850 - Chronic Beryllium Disease Prevention Program Informed Consent Form

    Science.gov (United States)

    2010-01-01

    ... 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 Informed...

  3. An audit of aspects of informed consent and pain relief in general ...

    African Journals Online (AJOL)

    There is the need to adequately inform patients about their disease, treatment options, surgery and post-operative complications. Adequate pain relief after surgery leads to less morbidity. Two important aspects of surgical practice are being addressed in this paper, the need for informed consent and post operative pain ...

  4. The Deaconess Informed Consent Comprehension Test: an assessment tool for clinical research subjects.

    Science.gov (United States)

    Miller, C K; O'Donnell, D C; Searight, H R; Barbarash, R A

    1996-01-01

    We developed an instrument to assess comprehension of informed consent information among 275 adults entering one of four ambulatory trials. At the conclusion of trial enrollment, subjects rated their understanding of the information presented and completed the Deaconess Informed Consent Comprehension Test (DICCT). Subjects completed the vocabulary subtest of the revised Weschler Adult Intelligence Scale (WAIS-R) and the reading subtest of the revised Wide Range Achievement Test (WRAT-R). The DICCT for 50 subjects was scored by 2 blinded investigators. Interrater agreement was 0.84 (df = 49, p < 0.001). To investigate the DICCT's potential validity, its scores were correlated with WAIS-R vocabulary scores (r = 0.44, df = 199, p < 0.01) and WRAT-R reading scores (r = 0.39, df = 268, p < 0.01). Understanding of consent information was rated as thorough by 70% of subjects. The mean +/- SD DICCT score was 20.4 +/- 3.9. The DICCT is a reliable instrument to assess comprehension of informed consent information. There is preliminary evidence for the scale's validity. The subjects believed that they had greater understanding of study information than was shown by the DICCT.

  5. A consumer perspective on informed consent and third-party issues.

    Science.gov (United States)

    Terry, S F; Terry, P F

    2001-01-01

    Our two children were diagnosed with a rare genetic disorder, which led us to establish a research foundation. This led to in-depth consideration of issues surrounding informed consent from a consumer perspective. Third-party issues arose as central to the formulation of ethical policy in the establishment of a blood and tissue bank and an epidemiologic study. We suggest that a number of myths--privacy is possible, samples can be stripped of identifiers, humans are subjects, voluntary informed consent is attainable, genetics is about the individual only, genetic information is different than other medical information, research is altruistic, the public will learn truths about genetic research via media, and research is culturally competent--make it difficult to resolve the issues intrinsic to informed consent. A number of important elements could make policy decisions less complicated. These include conducting culturally competent research; conveying noncoercive hope, not hype; contacting the voluntary informant only; asking the informant to extend contact to other family members; requiring a comprehensive informed consent process for all contacted; and engaging in state-of-the-art data protections. There is a need for a "Genomic Hippocratic Oath," creating an ethical basis for research similar to the one vowed by health care professionals. Establishing ethical policies as a result of the collaboration of policy makers, researchers, and consumers will allow research to progress ethically at a rapid rate. If regulations are oppressive, they will thwart research; if they are too lenient, participants will not receive protections needed to participate safely.

  6. PATIENT'S RIGHT TO INFORMED CONSENT IN REPUBLIC SRPSKA: LEGAL AND ETHICAL ASPECTS (WITH SPECIAL REFERENCE TO PHYSICAL REHABILITATION).

    Science.gov (United States)

    Milinkovic, Igor; Majstorovic, Biljana

    2014-12-01

    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).

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

    Directory of Open Access Journals (Sweden)

    Yann Joly

    Full Text Available Biobanks are important resources which enable large-scale genomic research with human samples and data, raising significant ethical concerns about how participants' information is managed and shared. Three previous studies of the Canadian public's opinion about these topics have been conducted. Building on those results, an online survey representing the first study of public perceptions about biobanking spanning all Canadian provinces was conducted. Specifically, this study examined qualitative views about biobank objectives, governance structure, control and ownership of samples and data, benefit sharing, consent practices and data sharing norms, as well as additional questions and ethical concerns expressed by the public.Over half the respondents preferred to give a one-time general consent for the future sharing of their samples among researchers. Most expressed willingness for their data to be shared with the international scientific community rather than used by one or more Canadian institutions. Whereas more respondents indicated a preference for one-time general consent than any other model of consent, they constituted less than half of the total responses, revealing a lack of consensus among survey respondents regarding this question. Respondents identified biobank objectives, governance structure and accountability as the most important information to provide participants. Respondents' concerns about biobanking generally centred around the control and ownership of biological samples and data, especially with respect to potential misuse by insurers, the government and other third parties. Although almost half the respondents suggested that these should be managed by the researchers' institutions, results indicate that the public is interested in being well-informed about these projects and suggest the importance of increased involvement from participants. In conclusion, the study discusses the viability of several proposed models for

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

    Science.gov (United States)

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

    2015-01-01

    Biobanks are important resources which enable large-scale genomic research with human samples and data, raising significant ethical concerns about how participants' information is managed and shared. Three previous studies of the Canadian public's opinion about these topics have been conducted. Building on those results, an online survey representing the first study of public perceptions about biobanking spanning all Canadian provinces was conducted. Specifically, this study examined qualitative views about biobank objectives, governance structure, control and ownership of samples and data, benefit sharing, consent practices and data sharing norms, as well as additional questions and ethical concerns expressed by the public. Over half the respondents preferred to give a one-time general consent for the future sharing of their samples among researchers. Most expressed willingness for their data to be shared with the international scientific community rather than used by one or more Canadian institutions. Whereas more respondents indicated a preference for one-time general consent than any other model of consent, they constituted less than half of the total responses, revealing a lack of consensus among survey respondents regarding this question. Respondents identified biobank objectives, governance structure and accountability as the most important information to provide participants. Respondents' concerns about biobanking generally centred around the control and ownership of biological samples and data, especially with respect to potential misuse by insurers, the government and other third parties. Although almost half the respondents suggested that these should be managed by the researchers' institutions, results indicate that the public is interested in being well-informed about these projects and suggest the importance of increased involvement from participants. In conclusion, the study discusses the viability of several proposed models for informed consent

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

    Science.gov (United States)

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

    2015-01-01

    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

  10. Participation in dementia research: rates and correlates of capacity to give informed consent.

    Science.gov (United States)

    Warner, J; McCarney, R; Griffin, M; Hill, K; Fisher, P

    2008-03-01

    Many people participating in dementia research may lack capacity to give informed consent and the relationship between cognitive function and capacity remains unclear. Recent changes in the law reinforce the need for robust and reproducible methods of assessing capacity when recruiting people for research. To identify numbers of capacitous participants in a pragmatic randomised trial of dementia treatment; to assess characteristics associated with capacity; to describe a legally acceptable consent process for research. As part of a pragmatic randomised controlled trial of Ginkgo biloba for mild-moderate dementia, we used a consenting algorithm that met the requirements of existing case law and the exigencies of the new Mental Capacity Act. We decided who had capacity to give informed consent for participation in the trial using this algorithm and sought predictors of capacity. Most participants (76%) with mild-moderate dementia in this trial were unable to give informed consent according to the legal criteria. When adjusted for confounding, the Mini Mental State examination did not predict the presence of capacity. Cognitive testing alone is insufficient to assess the presence of capacity. Researchers and clinicians need to be aware of the challenging processes regarding capacity assessment. We outline a procedure which we believe meets the ethical and legal requirements.

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

    Science.gov (United States)

    Mchale, Jean V

    2017-10-01

    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.

  12. 10 CFR 727.5 - What acknowledgment and consent is required for access to information on DOE computers?

    Science.gov (United States)

    2010-01-01

    ... 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...

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

    Science.gov (United States)

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

    2014-01-01

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

  14. Interventions to improve research participants' understanding in informed consent for research: a systematic review.

    Science.gov (United States)

    Flory, James; Emanuel, Ezekiel

    2004-10-06

    Available data suggest that prospective research participants may frequently not understand information disclosed to them in the informed consent process. Little is known about how understanding can be improved. To review research on interventions to improve research participants' understanding of information disclosed in the informed consent process. A search of MEDLINE was performed using the terms informed consent and clinical research and informed consent and (comprehension or understanding) from 1966 to March 2004 , which included randomized controlled trials, longitudinal trials, and controlled trials with nonrandom allocation that compared the understanding of research participants who had undergone only a standard informed consent process to that of participants who had received an intervention to improve their understanding. A comprehensive bibliography of empirical research on informed consent published in January 1999 was also reviewed, as were personal files and all issues of the journals IRB and Controlled Clinical Trials. Study design, quality criteria, population characteristics, interventions, and outcomes for each trial were extracted. The statistical significance of the interventions' effects on understanding were noted, as were mean scores for understanding for each group of each trial. For those trials that measured the secondary outcomes of satisfaction and willingness to enroll, results were also summarized. Thirty studies described 42 trials that met inclusion criteria. Of 12 trials of multimedia interventions, 3 showed significant improvement in understanding. Of 15 trials of enhanced consent forms, 6 showed significant improvement in understanding (all Pcasting doubt on their practical relevance. Of 5 trials of extended discussion, 3 showed significant improvement in understanding (all P<.001) and 2 showed trends toward improvement (P=.054 and P=.08). Of 5 trials of test/feedback, all showed significant improvement in understanding (all P

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

    Science.gov (United States)

    2014-01-01

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

  16. Ethical issues of informed consent in malaria research proposals submitted to a research ethics committee in Thailand: a retrospective document review.

    Science.gov (United States)

    Adams, Pornpimon; Prakobtham, Sukanya; Limpattaracharoen, Chanthima; Suebtrakul, Sumeth; Vutikes, Pitchapa; Khusmith, Srisin; Wilairatana, Polrat; Adams, Paul; Kaewkungwal, Jaranit

    2017-08-14

    The informed-consent process should be one of meaningful information exchange between researchers and study participants. One of the responsibilities of research ethics committees is to oversee appropriate informed consent. The committee must consider various matters before deciding whether the process is appropriate, including the adequacy and completeness of the written information provided to study participants, and the process of obtaining informed consent. This study aimed to identify, quantitatively and qualitatively, consent-related issues in different types of malaria proposals submitted to the Faculty of Tropical Medicine, Ethics Committee. This study reviewed proposal documentation submitted to two panels of the Ethics Committee of the Faculty of Tropical Medicine, Mahidol University, from 2011 to 2015. The documentation included proposals, notifications to researchers of review outcomes and ethical issues of concern to committee members. Each element of the informed-consent process was identified and analyzed by study classification, design, and specimen use, including whether the study involved a vulnerable population. Summative content analysis was used to analyze patterns of common issues raised in reviews. Of the 112 proposals reviewed, 63 required an informed consent process. All researchers proposed communicating with their study participants; however, about two-thirds needed to improve their explanations of study procedures (study activities and specimen/data-collection process) to participants. About 40% of the proposals attracted comments on informed-consent process elements--risk and discomfort, vulnerable status, and compensation. Studies that planned to collect or use new/linked specimens raised more issues around informed consent than studies using linked data/records. Studies that involved vulnerable populations raised more issues than those that did not. The committee usually asked researchers to clarify, elaborate, revise, or paraphrase

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

    Science.gov (United States)

    Ramos, S Raquel

    2017-11-01

    Health information exchange is the electronic accessibility and transferability of patient medical records across various healthcare settings and providers. In some states, patients have to formally give consent to allow their medical records to be electronically shared. The purpose of this study was to apply a novel user-centered, multistep, multiframework approach to design and test an electronic consent user interface, so patients with HIV can make more informed decisions about electronically sharing their health information. This study consisted of two steps. Step 1 was a cross-sectional, descriptive, qualitative study that used user-centric design interviews to create the user interface. This informed Step 2. Step 2 consisted of a one group posttest to examine perceptions of usefulness, ease of use, preference, and comprehension of a health information exchange electronic consent user interface. More than half of the study population had college experience, but challenges remained with overall comprehension regarding consent. The user interface was not independently successful, suggesting that in addition to an electronic consent user interface, human interaction may also be necessary to address the complexities associated with consenting to electronically share health information. Comprehension is key factor in the ability to make informed decisions.

  18. Do Dogs Provide Information Helpfully?

    Directory of Open Access Journals (Sweden)

    Patrizia Piotti

    Full Text Available Dogs are particularly skilful during communicative interactions with humans. Dogs' abilities to use human communicative cues in cooperative contexts outcompete those of other species, and might be the result of selection pressures during domestication. Dogs also produce signals to direct the attention of humans towards outside entities, a behaviour often referred to as showing behaviour. This showing behaviour in dogs is thought to be something dogs use intentionally and referentially. However, there is currently no evidence that dogs communicate helpfully, i.e. to inform an ignorant human about a target that is of interest to the human but not to the dog. Communicating with a helpful motive is particularly interesting because it might suggest that dogs understand the human's goals and need for information. In study 1, we assessed whether dogs would abandon an object that they find interesting in favour of an object useful for their human partner, a random novel distractor, or an empty container. Results showed that it was mainly self-interest that was driving the dogs' behaviour. The dogs mainly directed their behaviour towards the object they had an interest in, but dogs were more persistent when showing the object relevant to the human, suggesting that to some extent they took the humans interest into account. Another possibility is that dogs' behaviour was driven by an egocentric motivation to interact with novel targets and that the dogs' neophila might have masked their helpful tendencies. Therefore, in study 2 the dogs had initial access to both objects, and were expected to indicate only one (relevant or distractor. The human partner interacted with the dog using vocal communication in half of the trials, and remaining silent in the other half. Dogs from both experimental groups, i.e. indicating the relevant object or indicating the distractor, established joint attention with the human. However, the human's vocal communication and the

  19. Do Dogs Provide Information Helpfully?

    Science.gov (United States)

    Piotti, Patrizia; Kaminski, Juliane

    2016-01-01

    Dogs are particularly skilful during communicative interactions with humans. Dogs' abilities to use human communicative cues in cooperative contexts outcompete those of other species, and might be the result of selection pressures during domestication. Dogs also produce signals to direct the attention of humans towards outside entities, a behaviour often referred to as showing behaviour. This showing behaviour in dogs is thought to be something dogs use intentionally and referentially. However, there is currently no evidence that dogs communicate helpfully, i.e. to inform an ignorant human about a target that is of interest to the human but not to the dog. Communicating with a helpful motive is particularly interesting because it might suggest that dogs understand the human's goals and need for information. In study 1, we assessed whether dogs would abandon an object that they find interesting in favour of an object useful for their human partner, a random novel distractor, or an empty container. Results showed that it was mainly self-interest that was driving the dogs' behaviour. The dogs mainly directed their behaviour towards the object they had an interest in, but dogs were more persistent when showing the object relevant to the human, suggesting that to some extent they took the humans interest into account. Another possibility is that dogs' behaviour was driven by an egocentric motivation to interact with novel targets and that the dogs' neophila might have masked their helpful tendencies. Therefore, in study 2 the dogs had initial access to both objects, and were expected to indicate only one (relevant or distractor). The human partner interacted with the dog using vocal communication in half of the trials, and remaining silent in the other half. Dogs from both experimental groups, i.e. indicating the relevant object or indicating the distractor, established joint attention with the human. However, the human's vocal communication and the presence of the

  20. Medico legal aspects on neuromonitoring in thyroid surgery: informed consent on malpractice claims.

    Science.gov (United States)

    Demontis, R; Pittau, M R; Maturo, A; Petruzzo, P; Calò, G

    2017-01-01

    The purpose of this paper is to provide a forensic profile framework of neuromonitoring in thyroid surgery, regarding the information given to the patient and its classification as part of professional liability in the event of recurrent injury. Evaluation and reflections on the required behaviour of the surgeon on providing details on the operation before the informed consent is given and to outline the possible legal implications regarding professional liability as a result of recurrent injury. In particular, if it is an obligation to inform the patient about using this method and if it is possible for the surgeon to freely choose whether to employ this method, which is still burdened by a certain percentage of error and for that reason it cannot be defined a "standard of care". To recognize neuromonitoring the role of standard of care in surgery of the thyroid means attribute a role of method able to avoid the surgeon to cause iatrogenic damage to the laryngeal nerve. For the foregoing reasons that is not true, determining false positives and false negatives, and this can be a double edged sword for the surgeon. Although the progress in the field of thyroid surgery made in the last decade, currently there is no scientific reassuring evidence to completely avoid the possibility of producing an iatrogenic lesion of the laryngeal nerve. Information given to the patient prior to surgery should respect the requirements of completeness, freedom and honesty in order to allow the patient to self-determination.

  1. Could the decision of trial participation precede the informed consent process? Evidence from Burkina Faso.

    Directory of Open Access Journals (Sweden)

    Lea Paré Toe

    Full Text Available Over the last years, the number of clinical trials carried out in low-income countries with poor medical infrastructure and limited access to health care has increased. In these settings, the decision of participating in a clinical study may be influenced by factors related to participants' vulnerability that limit the efficacy of the informed consent.A mixed methods social science study, based on the triangulation of qualitative and quantitative data, was carried out in a socio-economically disadvantaged and semi-urban area of Bobo Dioulasso, Burkina Faso. The study aimed at assessing the relevance of the informed consent procedure on the decision-making process of the parents and/or guardians of potential participants in a pediatric malaria trial.For most parents (70.4%, the decision of participating had already been taken before undergoing the informed consent process and was based on the information conveyed through the community. Access to free and good quality health care often inspired this decision. In addition, the parents' willingness to have their child included in the trial made them develop active strategies to achieve this purpose.In a context of socio-economic vulnerability and poor access to free health care, the process of informed consent does not always accomplish its goal of informing people and enabling them to make a free and informed decision. This information role is somehow anticipated by the community and trial participation becomes a strategic action to secure otherwise unavailable health resources leading community members to decide on participation even prior to the informed consent process.

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

    Science.gov (United States)

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

    2017-02-01

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

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

    Directory of Open Access Journals (Sweden)

    Facio Flavia M

    2012-10-01

    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.

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

    Science.gov (United States)

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

    2012-10-10

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

  5. Data research on child abuse and neglect without informed consent? Balancing interests under Dutch law.

    Science.gov (United States)

    Hoytema van Konijnenburg, Eva M M; Teeuw, Arianne H; Ploem, M Corrette

    2015-12-01

    According to the Declaration of Helsinki, participation of human subjects in medical research is only acceptable if subjects have given their consent. But in child abuse and neglect, many studies use a design in which subjects do not actively participate. Data in these studies are gathered from sources such as medical records or Child Protective Services. As long as such data are used anonymously, this does not interfere with individual privacy rights. However, some research is only possible when carried out with personally identifiable data, which could potentially be misused. In this paper, we discuss in which situations and under which conditions personal data of children may be used for a study without obtaining consent. In doing so, we make use of two recent studies, performed in our hospital, in which we encountered this issue. Both studies involved collecting personal data. After careful consideration, we decided not to ask informed consent; instead, we arranged for specific safeguards to protect the subject's and their parents' privacy as well as possible. Altogether, we conclude that our approach fits within the Dutch legal framework and seems a reasonable solution in situations in which individual privacy rights are at odds with the public interest of child abuse and neglect research. We argue that, although, in principle, data research is only acceptable after informed consent is obtained, the law should allow that, under specific circumstances and safeguards, this requirement is put aside to make research in the field of child abuse and neglect possible. • In principle, data research is only acceptable after informed consent is obtained.• In practice, this is not always feasible. • Under specific circumstances and safeguards, the informed consent requirement can be put aside.

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

    Directory of Open Access Journals (Sweden)

    Eccles Martin P

    2008-12-01

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

  7. ['Informed consent' in public health activities: based on the universal declaration on bioethics and human rights, UNESCO].

    Science.gov (United States)

    Meng, Kwang-Ho

    2008-09-01

    The objective of this paper is to discuss the importance of obtaining informed consent for conducting epidemiological studies and public health activities, based on the Report of the UNESCO's Working Group on Informed Consent. The Report of the UNESCO's Working Group on Informed Consent was reviewed and discussed in connection with the ethical considerations of public health activities and epidemiological research. It was at the Nuremberg Trial for the German war criminals of the Second World War that the principle of 'consent' was first stated as a consequence of the medical abuses carried out during the War. As a result of the Trial, the Nuremberg Code came out in 1947. Since then, various international declarations or ethical principles on 'informed consent' have been developed and published. These ethical principles on 'informed consent' have mostly to do with the clinical research that involves human subjects, and not with epidemiological studies and public health activities. However, UNESCO recently issued a comprehensive Report on Informed Consent based on the Universal Declaration on Bioethics and Human Rights adopted in 2005, and this included detailed guidelines on informed consent in epidemiological studies and public health activities. Universal Declaration on Bioethics and Human Rights emphasizes the principle of autonomy to protect the human rights of the human subjects involved in any public health activities and epidemiological research. As a practical guideline, obtaining informed consent is strongly recommended.

  8. Variation of community consultation and public disclosure for a pediatric multi-centered "Exception from Informed Consent" trial.

    Science.gov (United States)

    Holsti, Maija; Zemek, Roger; Baren, Jill; Stanley, Rachel M; Mahajan, Prashant; Vance, Cheryl; Brown, Kathleen M; Gonzalez, Victor; King, Denise; Jacobsen, Kammy; Shreve, Kate; van de Bruinhorst, Katrina; Jones, Anne Marie; Chamberlain, James M

    2015-02-01

    disclosure activities were more efficient and cost-effective if they were part of an in-hospital resource for patients and families. There is substantial variation in Institutional Review Boards' interpretations of the federal regulations for community consultation and public disclosure. One of the goals of community consultation and public disclosure efforts for emergency research is to provide community members an opportunity to opt out of Exception from Informed Consent research; however, rarely do patients or their legally authorized representatives report having learned about a study prior to enrollment. © The Author(s) 2014.

  9. Informed consent in clinical trials using stem cells: Suggestions and ...

    African Journals Online (AJOL)

    The workshops used role-playing simulations, to demonstrate how to effectively obtain fuller IC, to members of several Japanese research groups preparing for clinical stem cell trials. Workshop results were correlated with the results of a 2013 workshop on what information patients want when considering participation in ...

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

    Science.gov (United States)

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

    2017-06-24

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

  11. 10 CFR 745.116 - General requirements for informed consent.

    Science.gov (United States)

    2010-01-01

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

  12. 21 CFR 50.25 - Elements of informed consent.

    Science.gov (United States)

    2010-04-01

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

  13. 7 CFR 1c.116 - General requirements for informed consent.

    Science.gov (United States)

    2010-01-01

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

  14. Obligation of the radiologist to obtain informed consent

    Energy Technology Data Exchange (ETDEWEB)

    Narr, H.

    1983-06-01

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

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

    DEFF Research Database (Denmark)

    Lebech, Anne Mette

    1997-01-01

    The practice of informed consent in biomedicine is so widely spread that it must be considered the most important principle within bioethics, and the most universally appealed to within recent legislation. There seems to be a consensus as to its value in research on autonomous persons, but also a...

  16. You told me, Right? - Free and Informed Consent in European Patent Law

    DEFF Research Database (Denmark)

    Schovsbo, Jens Hemmingsen; Hellstadius, Åsa

    2017-01-01

    This paper concerns the rule in EU patent law that for patent applications pertaining to human biological material the person from whose body the material is taken must have had the opportunity of expressing free and informed consent (FIC) in accordance with national law. We argue that the patent...

  17. Confidentiality, Informed Consent, and Ethical Considerations in Reviewing the Client's Psychotherapy Records

    Science.gov (United States)

    Blunt, David R.

    2006-01-01

    Ethical dilemmas that break the confidentiality of the client eventually test the psychologist's boundaries such that not taking action may place the patient in a position where they suffer, hurt themselves, or others. The effectiveness in obtaining a valid informed consent might depend upon the therapists training, experience, and sound judgment…

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

    NARCIS (Netherlands)

    Miller, Lantz E.

    2017-01-01

    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

  19. Shared decision making through informed consent in chiropractic management of low back pain.

    Science.gov (United States)

    Dagenais, Simon; Brady, O'Dane; Haldeman, Scott

    2012-01-01

    The purpose of this study was to propose questions that may be helpful to educate patients considering treatment approaches to manage low back pain (LBP) and to determine if the information currently presented in informed consent (IC) documents at chiropractic colleges is sufficient to help a patient considering chiropractic management of LBP make a fully informed decision. Questions to inform decision making for a patient contemplating any intervention for LBP were developed by the authors based on their clinical and research experience. Answers to the questions were suggested based on findings from recent clinical practice guidelines and systematic reviews. Institutions that are members of the Association of Chiropractic Colleges (ACC) were surveyed and asked to provide a copy of the IC documents currently used in their outpatient educational clinics. The IC documents were analyzed to determine if they stated (or implied) information that may be helpful in addressing each of the proposed questions. The list of 20 questions included 4 questions on each of the following 5 topics: condition, proposed treatment, potential benefits, potential harms, and possible alternatives. A total of 21 ACC institutions were contacted, of which 20 responded. The number of questions that could potentially be answered with information provided in the IC documents ranged from 2 to 13, with a mean of 6.5, including a mean of 3.6 stated answers and 2.9 implied answers. Some information to help patients consider chiropractic management of LBP is currently included in the IC documents used in clinics of ACC institutions. However, many of the questions that could help achieve shared decision making are not included. Modifying IC documents may help patients understand the nature, benefits, harms, costs, and alternatives to LBP care. Copyright © 2012 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

  20. Increased Relevance and Influence of Free Prior Informed Consent ...

    African Journals Online (AJOL)

    This paper examines unique opportunities provided by international discourses and practices of the Green Economy approach and valuation of ecosystem services (as promoted under the international climate change regime) on the sustainable management of indigenous forests and lands in Peru. It examines the ...

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

    Science.gov (United States)

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

    2015-02-01

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

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

    Science.gov (United States)

    Robeson, Richard; King, Nancy M P

    2014-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Brant McGee

    2010-06-01

    Full Text Available The 2000 Report of the World Commission on Dams (WCD found that dams can threaten the resources that provide the basis for indigenous and other peoples’ culture, religion, subsistence, social and family structure – and their very existence, through forced relocation – and lead to ecosystem impacts harmful to agriculture, animals and fish. The WCD recommended the effective participation of potentially impacted local people in decisions regarding dam construction. The international right to free, prior, and informed consent (FPIC accorded to indigenous peoples promises not only the opportunity to participate in decisions affecting their lands and livelihoods but to stop unwanted development by refusing consent as well. The newly developed concept of community referenda, held in areas potentially impacted by development projects, provides an accurate measure of the position of local voters on the proposed project through a democratic process that discourages violence, promotes fair and informed debate, and provides an avenue for communities to express their consent or refusal of a specific project. The legal basis, practical and political implications, and Latin American examples of community referenda are explored as a means of implementing the critical goal of the principle of FPIC, the expression of community will and its conclusive impact on development decision-making.

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

    Science.gov (United States)

    Braude, Hillel; Kimmelman, Jonathan

    2012-03-01

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

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

    Science.gov (United States)

    Sinoff, Gary

    2012-09-01

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

  6. Gene therapy and informed consent decision making: nursing research directions.

    Science.gov (United States)

    Kaspar, Rita W; Wills, Celia E; Kaspar, Brian K

    2009-07-01

    Recent gene therapy clinical trials have demonstrated significant promise for treating a number of genetic neuromuscular disorders. Although nurses are experienced in educating patients and families about the benefits and risks of conventional therapeutics, there are significant challenges for guiding patients through the decision-making phase of gene therapy clinical trial participation. The first part of this review provides an overview and update on neuromuscular gene therapy, including viral delivery principles and historical progress. The second part discusses risk/benefit perception of gene therapy and factors affecting the decision making for patients interested in participating in a trial. Future challenges for gene therapy are targeted high-efficiency delivery, and additional research on developing patient-centered decision support interventions.

  7. iCONCUR: informed consent for clinical data and bio-sample use for research.

    Science.gov (United States)

    Kim, Hyeoneui; Bell, Elizabeth; Kim, Jihoon; Sitapati, Amy; Ramsdell, Joe; Farcas, Claudiu; Friedman, Dexter; Feupe, Stephanie Feudjio; Ohno-Machado, Lucila

    2017-03-01

    Implementation of patient preferences for use of electronic health records for research has been traditionally limited to identifiable data. Tiered e-consent for use of de-identified data has traditionally been deemed unnecessary or impractical for implementation in clinical settings. We developed a web-based tiered informed consent tool called informed consent for clinical data and bio-sample use for research (iCONCUR) that honors granular patient preferences for use of electronic health record data in research. We piloted this tool in 4 outpatient clinics of an academic medical center. Of patients offered access to iCONCUR, 394 agreed to participate in this study, among whom 126 patients accessed the website to modify their records according to data category and data recipient. The majority consented to share most of their data and specimens with researchers. Willingness to share was greater among participants from an Human Immunodeficiency Virus (HIV) clinic than those from internal medicine clinics. The number of items declined was higher for for-profit institution recipients. Overall, participants were most willing to share demographics and body measurements and least willing to share family history and financial data. Participants indicated that having granular choices for data sharing was appropriate, and that they liked being informed about who was using their data for what purposes, as well as about outcomes of the research. This study suggests that a tiered electronic informed consent system is a workable solution that respects patient preferences, increases satisfaction, and does not significantly affect participation in research.

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

    Science.gov (United States)

    Gonzalo, Gianella

    2013-04-01

    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.

  9. Ethical and practical challenges in implementing informed consent in HIV/AIDS clinical trials in developing or resource-limited countries.

    Science.gov (United States)

    Mystakidou, Kyriaki; Panagiotou, Irene; Katsaragakis, Stelios; Tsilika, Eleni; Parpa, Efi

    2009-09-01

    Ethical issues regarding HIV/AIDS human research in the developing world remain under continuous evaluation; a critical area of concern includes informed consent. This paper reviews several of the most important ethical and practical aspects of informed consent in HIV research in developing countries. Enhancement of overall understanding of such key issues might promote higher ethical standards of future research. The major objective was to address informed consent in human research in non-Western societies, and specifically in HIV clinical trials of affected adults. Secondary end-points included the consent complexities in HIV research involving vulnerable patient populations in resource-limited nations, such as children, adolescents and women. A systematic review of the published literature using MEDLINE and EMBASE from 1998 until December 2008 was performed, using the search terms 'HIV/AIDS', 'informed consent', 'clinical trials', 'developing world'. Ethical complexities such as participants' diminished autonomy, coercion or monetary inducement, language difficulties, illiteracy or lack of true understanding of the entire study, cultural barriers mainly due to communitarianism and social diversities were identified in the 44 studies reviewed. Informed consent of vulnerable patient populations must be tailored to their sex and developmental age, while counselling is fundamental. Children and adolescents' assent must be ensured. Local language is to be used, while trusted community leaders and local cultural representatives may convey information. Despite the heterogeneity of studies, similarities were identified. Providing adequate and comprehensive information and assessing the true understanding of the research represent fundamental prerequisites. Potential solutions to the critical areas of concern include peer counselling and meetings with local community leaders or local cultural representatives. International investigators of HIV human research should bear

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

    Directory of Open Access Journals (Sweden)

    Loré Cosimo

    2007-10-01

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

  11. Ethics and the law: is there common ground on informed consent for disparities in hospital outcomes?

    Science.gov (United States)

    Housri, Nadine; Coombs, Mary; Orandi, Babak J; Pawlik, Timothy M; Koniaris, Leonidas G

    2011-08-16

    The association between procedure volume at institutions and outcomes of cancer surgeries has been widely published in the medical literature; discussed in the lay press; and, during the past 15 years, incorporated into quality improvement endeavors. In certain cases, institutional volume has become a proxy for quality. Despite the vast amount of retrospective data on this topic, physicians generally have been unsure how to approach the information and interpret it for their patients. Even more challenging to some physicians has been deciding whether the data oblige them to either direct patients with cancer to high-volume centers for care or discuss the data with these patients as part of informed consent. An additional challenge is that physicians must understand laws related to these issues and that these laws are unclear. This article reviews the ethical arguments for including disparities in hospital outcomes as part of informed consent and examines whether legal precedent can shed light on this debate.

  12. Informed Consent

    Science.gov (United States)

    ... Publications Optimal Access Resources Members Contact Us Publications ACS Publications ACS Catalog About the ACS Catalog About the ... Newsroom Press Releases Media Resources The FIRST Trial ACS Publications ACS in the News Stay Up to Date ...

  13. More information, less understanding: a randomized study on consent issues in neonatal research.

    Science.gov (United States)

    Freer, Yvonne; McIntosh, Neil; Teunisse, Saskia; Anand, Kanwaljeet J S; Boyle, Elaine M

    2009-05-01

    Valid consent for research requires comprehensive and understandable information to be disclosed to participants. The way that information is shared varies, but regulatory bodies usually determine style. Some reports have suggested that although information may be all-inclusive, it does little to support understanding. To explore the impact of various information-sharing approaches on parents' understanding of a research study and the validity of their consent. This was a randomized, controlled trial. Parents of immature but well infants admitted to a large tertiary NICU in Edinburgh, Scotland, were randomly assigned within 72 hours of their infant's admission to receive 1 of 2 information leaflets, with or without a standardized verbal explanation, for a hypothetical intensive care research study. The leaflets differed in length and in the amount of detail in which the study process, risks, benefits, and patient rights were described. A questionnaire was used to elicit understanding about the purpose of the research, design of the study, procedures involved, and the consent process. Forty-one parents participated in the study. Those who received the longer leaflet without verbal explanation gained only limited understanding of the purpose of the research. The procedures involved in the study were understood better by those who received the shorter leaflet. Issues relating to consent and study design were readily understood in all groups. Irrespective of documentation style, verbal explanation significantly improved understanding. Differences in understanding had little effect on whether a parent would enroll his or her infant into the study. Verbal explanation significantly enhances understanding of the research process for participants regardless of the style of written documentation. However, shorter written information may lead to better understanding than lengthy, more complex documentation.

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

    Science.gov (United States)

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

    2017-02-01

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

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

    NARCIS (Netherlands)

    Vallely, A.; Lees, S.; Shagi, C.; Kasindi, S.; Soteli, S.; Kavit, N.; Vallely, L.; McCormack, S.; Pool, R.; Hayes, R.J.

    2010-01-01

    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

  16. Probabilistic information and decision making in the health context: The package leaflet as basis for informed consent

    OpenAIRE

    Osimani, Barbara; Rigotti, Eddo

    2012-01-01

    Medical decisions are paradigmatically uncertain. Awareness of this uncertainty at the policy level has produced a strict regulation of the information exchange related to medical issues, e.g. by means of the institute of the informed consent or through tight administrative norms regulating the pharmaceutical communication towards the public. As a special support of such sort of information, also the drug package leaflet has been object of thorough legal regulation, especially developed in ...

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

    Science.gov (United States)

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

    2017-01-01

    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.

  18. The use of multimedia as an adjunct to the informed consent process for ankle ligament reconstruction surgery.

    Science.gov (United States)

    Batuyong, Eldridge; Birks, Christopher; Beischer, Andrew D

    2012-06-01

    Obtaining "informed consent" is an integral aspect of surgery that can be fraught with difficulty. This study assessed the efficacy of a multimedia education tool in improving patients' understanding when used as an adjunct to the traditional verbal consent process regarding ankle lateral ligament reconstruction surgery. A total of 56 patients (28 males and 28 females) were recruited with a mean age of 36 years. A standardized verbal discussion regarding surgical treatment was provided to each patient. Understanding was then assessed using a knowledge questionnaire. Subsequently, each patient observed a multimedia educational program following which the knowledge questionnaire was repeated. Additional supplementary questions were then given regarding the ease of understanding and satisfaction with the 2 methods of education delivery. The patients answered 75% of the questions correctly before the multimedia module compared with 88% after it (P multimedia tool performed as well as the treating surgeon. Multimedia tools used in sequence after a verbal consent resulted in improved patient understanding of pertinent information regarding ankle lateral ligament reconstruction surgery. Therapeutic Level II.

  19. 5 CFR 890.910 - Provider information.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Provider information. 890.910 Section 890.910 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS..., and FEHB Benefit Payments § 890.910 Provider information. The hospital provider information used to...

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

    Directory of Open Access Journals (Sweden)

    Riden Heather E

    2012-11-01

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

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

    DEFF Research Database (Denmark)

    Ploug, Thomas; Holm, Søren

    2017-01-01

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

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

    Directory of Open Access Journals (Sweden)

    SHIRIN HABIBI KHORASANI

    2015-04-01

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

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

    Science.gov (United States)

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

    2013-01-01

    Background Optimum comprehension of informed consent by research participants is essential yet challenging. This study explored correlates of lower comprehension of informed consent among 1334 participants of a cohort study aimed at estimating HIV incidence in Pune, India. Methods As part of the informed consent process, a structured comprehension tool was administered to study participants. Participants scoring ≥90% were categorised into the ‘optimal comprehension group’, whilst those scoring 80–89% were categorised into the ‘lower comprehension group’. Data were analysed to identify sociodemographic and behavioural correlates of lower consent comprehension. Results The mean ± SD comprehension score was 94.4 ± 5.00%. Information pertaining to study-related risks was not comprehended by 61.7% of participants. HIV-negative men (adjusted OR [AOR] = 4.36, 95% CI 1.71–11.05) or HIV-negative women (AOR = 13.54, 95% CI 6.42–28.55), illiteracy (AOR= 1.65, 95% CI 1.19–2.30), those with a history of multiple partners (AOR = 1.73, 95% CI 1.12–2.66) and those never using condoms (AOR = 1.35, 95% CI 1.01–1.82) were more likely to have lower consent comprehension. Conclusions We recommend exploration of domains of lower consent comprehension using a validated consent comprehension tool. Improved education in these specific domains would optimise consent comprehension among research participants. PMID:24029848

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Science.gov (United States)

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

    2009-12-01

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

  6. [Descriptive Study on the Application of Informed Consent in Health Centers of Galicia Spain].

    Science.gov (United States)

    Rodríguez Piñero, José Emilio; Tabernero Duque, María Jesús; Rodríguez Calvo, María Sol

    2018-01-01

    The aims of this study were to know the opinion and general knowledge of patients about the informed consent (IC), and their participation in the decision-making (DM) process. A descriptive, transversal, observational, qualitative and quantitative study was designed with 120 patients randomly surveyed at the 8 University Hospital Complexes of Galicia, Spain. The mean age was 52.14 years, with 50% of men. 84.21% of the ICs provided by non-medical personnel were limited to delivering and reading it. 90% of patients after signing the IC, trust their doctor. Only 50% of the professionals tried to involve the patient in DM. 53.33% of the patients participated in DM. 45.83% patients signed for having understood and accepted the explanation, being completely satisfied 95 of the patients surveyed (79.17%). It is essential to change the attitude of non-medical health professionals involved in the DM process, because their involvement is not being promoted. Although less than half of the respondents have signed the IC for having understood, the degree of satisfaction and confidence in the doctor was not compromised.

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

    Science.gov (United States)

    Abay, Serebe; Addissie, Adamu; Davey, Gail; Farsides, Bobbie; Addissie, Thomas

    2016-01-01

    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 comply with the

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

    Directory of Open Access Journals (Sweden)

    Serebe Abay

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

  9. An audit of patients′ views on consent and information in the endoscopy unit

    Directory of Open Access Journals (Sweden)

    Affifa Farrukh

    2013-01-01

    Full Text Available Background and Objectives: There is paucity of literature about the views of patients on endoscopy practices. The present study was undertaken to determine the views of patients on consent and information in the endoscopy suite and to compare patients′ views about the environment of an endoscopy unit with the standard guidelines set out by British Society of Gastroenterology. Materials and Methods: A total of 103 patients were given an anonymous questionnaire about their views on endoscopy practice. The anonymous questionnaire comprising of seven items was developed. It addressed a range of issues regarding information, consent, and discussion of results. It was distributed by the endoscopy unit′s receptionist to consecutive patients attending for either a gastroscopy or lower intestinal procedure. Results: The majority of patients (63% did not want to receive information prior to the procedure. In addition, only a minority (29% wanted discussions about the test to be in private. Immediately before the procedure, 40% of patients wanted to discuss the test with doctors, 23% with nurses and less than 1% with another patient (Fisher exact test, P < .0009. Thirty-five percent of patients appeared not to want to discuss the test at all. A total of 87% of patients wished to sign consent forms immediately prior to the test rather than a day before hand. A total of 51% wanted to do this in the endoscopy room itself and only 45% wanted to sign a consent form in a separate room (c 2 = 1.05 n.s.. Conclusions: These views contrast strongly with the standards advocated by national societies and the accreditation boards for endoscopy units in the UK.

  10. Participatory improvement of a template for informed consent documents in biobank research - study results and methodological reflections.

    Science.gov (United States)

    Bossert, Sabine; Kahrass, Hannes; Heinemeyer, Ulrike; Prokein, Jana; Strech, Daniel

    2017-12-20

    For valid informed consent, it is crucial that patients or research participants fully understand all that their consent entails. Testing and revising informed consent documents with the assistance of their addressees can improve their understandability. In this study we aimed at further developing a method for testing and improving informed consent documents with regard to readability and test-readers' understanding and reactions. We tested, revised, and retested template informed consent documents for biobank research by means of 11 focus group interviews with members from the documents' target population. For the analysis of focus group excerpts we used qualitative content analysis. Revisions were made based on focus group feedback in an iterative process. Focus group participants gave substantial feedback on the original and on the revised version of the tested documents. Revisions included adding and clarifying explanations, including an info-box summarizing the main points of the text and an illustrative graphic. Our results indicate positive effects on the tested and revised informed consent documents in regard to general readability and test-readers' understanding and reactions. Participatory methods for improving informed consent should be more often applied and further evaluated for both, medical interventions and clinical research. Particular conceptual and methodological challenges need to be addressed in the future.

  11. Comparison of group counseling with individual counseling in the comprehension of informed consent: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bose Anuradha

    2010-05-01

    Full Text Available Abstract Background Studies on different methods to supplement the traditional informed consent process have generated conflicting results. This study was designed to evaluate whether participants who received group counseling prior to administration of informed consent understood the key components of the study and the consent better than those who received individual counseling, based on the hypothesis that group counseling would foster discussion among potential participants and enhance their understanding of the informed consent. Methods Parents of children participating in a trial of nutritional supplementation were randomized to receive either group counseling or individual counseling prior to administration of the informed consent. To assess the participant's comprehension, a structured questionnaire was administered approximately 48-72 hours afterwards by interviewers who were blinded to the allocation group of the respondents. Results A total of 128 parents were recruited and follow up was established with 118 (90.2% for the study. All respondents were aware of their child's participation in a research study and the details of sample collection. However, their understanding of study purpose, randomization and withdrawal was poor. There was no difference in comprehension of key elements of the informed consent between the intervention and control arm. Conclusions The results suggest that the group counseling might not influence the overall comprehension of the informed consent process. Further research is required to devise better ways of improving participants' understanding of randomization in clinical trials. Trial Registration Clinical Trial Registry - India (CTRI: CTRI/2009/091/000612

  12. Local media influence on opting out from an exception from informed consent trial.

    Science.gov (United States)

    Nelson, Maria J; DeIorio, Nicole M; Schmidt, Terri; Griffiths, Denise; Daya, Mohamud; Haywood, Liana; Zive, Dana; Newgard, Craig D

    2010-01-01

    News media are used for community education and notification in exception from informed consent clinical trials, yet their effectiveness as an added safeguard in such research remains unknown. We assessed the number of callers requesting opt-out bracelets after each local media report and described the errors and content within each media report. We undertook a descriptive analysis of local media trial coverage (newspaper, television, radio, and Web log) and opt-out requests during a 41-month period at a single site participating in an exception from informed consent out-of-hospital trial. Two nontrial investigators independently assessed 41 content-based media variables (including background, trial information, graphics, errors, publication information, and assessment) with a standardized, semiqualitative data collection tool. Major errors were considered serious misrepresentation of the trial purpose or protocol, whereas minor errors included misinformation unlikely to mislead the lay reader about the trial. We plotted the temporal relationship between opt-out bracelet requests and media reports. Descriptive information about the news sources and the trial coverage are presented. We collected 39 trial-related media reports (33 newspaper, 1 television, 1 radio, and 4 blogs). There were 13 errors in 9 (23%) publications, 7 of which were major and 6 minor. Of 384 requests for 710 bracelets, 310 requests (80%) occurred within 4 days after trial media coverage. Graphic timeline representation of the data suggested a close association between media reports about the trial and requests for opt-out bracelets. According to results from a single site, local media coverage for an exception from informed consent clinical trial had a substantial portion of errors and appeared closely associated with opt-out requests. Copyright 2008. Published by Mosby, Inc.

  13. The changing nature of consent.

    Science.gov (United States)

    Trathen, Andrew

    2015-02-01

    Consent is a foundational principle of medical and dental ethics. The importance of the concept has changed over time and it is now viewed as more important than it has ever been, both within the profession and by wider society. This article looks at the nature of consent historically, the changes it has undergone, and some of the contemporary challenges in this area. The philosophical basis of consent is considered, looking at two lines of thought relating to autonomy and prevention of harm. The difficulty and appropriateness of providing 'fully-informed' consent is then considered along with some of the modern problems relating to consumerist culture, and the social changes that have caused them. By looking at consent from a social and philosophical standpoint, we can broaden our thinking to give context to the day-to-day practicalities of obtaining consent in practice. These practicalities are addressed in subsequent articles within this issue of the Primary Dental Journal.

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

    DEFF Research Database (Denmark)

    Ploug, Thomas; Holm, Søren

    2012-01-01

    Background Denmark has implemented a comprehensive, nationwide pharmaceutical information system, and this system has been evaluated by the Danish Council of Ethics. The system can be seen as an exemplar of a comprehensive health information system for clinical use. Analysis The paper analyses 1...... issues in relation to autonomy and control of information, issues that will also occur in relation to other similar comprehensive health information systems. Some of these issues are well understood and their impact can be judged using the heuristic which is provided. More research is, however needed...

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

    Science.gov (United States)

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

    2013-09-01

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

  16. Reassessing the approach to informed consent: the case of unrelated hematopoietic stem cell transplantation in adult thalassemia patients.

    Science.gov (United States)

    Pisu, Salvatore; Caocci, Giovanni; d'Aloja, Ernesto; Efficace, Fabio; Vacca, Adriana; Piras, Eugenia; Orofino, Maria Grazia; Addari, Carmen; Pintor, Michela; Demontis, Roberto; Demuru, Federica; Pittau, Maria Rita; Collins, Gary S; La Nasa, Giorgio

    2014-08-12

    The informed consent process is the legal embodiment of the fundamental right of the individual to make decisions affecting his or her health., and the patient's permission is a crucial form of respect of freedom and dignity, it becomes extremely important to enhance the patient's understanding and recall of the information given by the physician. This statement acquires additional weight when the medical treatment proposed can potentially be detrimental or even fatal. This is the case of thalassemia patients pertaining to class 3 of the Pesaro classification where Allogenic hematopoietic stem cell transplantation (HSCT) remains the only potentially curative treatment. Unfortunately, this kind of intervention is burdened by an elevated transplantation-related mortality risk (TRM: all deaths considered related to transplantation), equal to 30% according to published reports. In thalassemia, the role of the patient in the informed consent process leading up to HSCT has not been fully investigated. This study investigated the hypothesis that information provided by physicians in the medical scenario of HSCT is not fully understood by patients and that misunderstanding and communication biases may affect the clinical decision-making process. A questionnaire was either mailed or given personally to 25 patients. A second questionnaire was administered to the 12 physicians attending the patients enrolled in this study. Descriptive statistics were used to evaluate the communication factors. The results pointed out the difference between the risks communicated by physicians and the risks perceived by patients. Besides the study highlighted the mortality risk considered to be acceptable by patients and that considered to be acceptable by physicians. Several solutions have been suggested to reduce the gap between communicated and perceived data. A multi-disciplinary approach may possibly help to attenuate some aspects of communication bias. Several tools have also been

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

    Directory of Open Access Journals (Sweden)

    Satish Chandrasekhar Nair

    2015-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Abraar Karan

    2014-01-01

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

  19. From dams to development justice: Progress with 'free, prior and informed consent' since the World Commission on Dams

    National Research Council Canada - National Science Library

    Joji Cariño; Marcus Colchester

    2010-01-01

      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...

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

    Science.gov (United States)

    Klein, Eran; Ojemann, Jeffrey

    2016-08-01

    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.

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Directory of Open Access Journals (Sweden)

    Megan M Campbell

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

  3. Requesting a unique personal identifier or providing a souvenir incentive did not affect overall consent to health record linkage: evidence from an RCT nested within a cohort.

    Science.gov (United States)

    Ni, Michael Y; Li, Tom K; Hui, Rex W H; McDowell, Ian; Leung, Gabriel M

    2017-04-01

    It is unclear if unique personal identifiers should be requested from participants for health record linkage: this permits high-quality data linkage but at the potential cost of lower consent rates due to privacy concerns. Drawing from a sampling frame based on the FAMILY Cohort, using a 2 × 2 factorial design, we randomly assigned 1,200 participants to (1) request for Hong Kong Identity Card number (HKID) or no request and (2) receiving a souvenir incentive (valued at USD4) or no incentive. The primary outcome was consent to health record linkage. We also investigated associations between demographics, health status, and postal reminders with consent. Overall, we received signed consent forms from 33.3% (95% confidence interval [CI] 30.6-36.0%) of respondents. We did not find an overall effect of requesting HKID (-4.3%, 95% CI -9.8% to 1.2%) or offering souvenir incentives (2.4%, 95% CI -3.1% to 7.9%) on consent to linkage. In subgroup analyses, requesting HKID significantly reduced consent among adults aged 18-44 years (odds ratio [OR] 0.53, 95% CI 0.30-0.94, compared to no request). Souvenir incentives increased consent among women (OR 1.55, 95% CI 1.13-2.11, compared to no souvenirs). Requesting a unique personal identifier or providing a souvenir incentive did not affect overall consent to health record linkage. Copyright © 2017 Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

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

    2008-11-19

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

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

    Directory of Open Access Journals (Sweden)

    Abelson Julia

    2008-11-01

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

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

    Science.gov (United States)

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

    2012-05-01

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

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

    Science.gov (United States)

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

    2017-10-01

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

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

    Science.gov (United States)

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

    2015-01-01

    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.

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

    Science.gov (United States)

    Benito, Javier Jiménez; García, Sonia Ester Rodríguez

    2016-09-01

    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.

  10. Oil exploitation, development justice and the utility of free, prior and informed consent in northwest Kenya

    DEFF Research Database (Denmark)

    Owiso, Michael

    2017-01-01

    relations among actors. This chapter explores the relationship between conflict and oil extraction management in Northwest Kenya where conflicts pitting communities, oil companies and the government are imminent. Extant literature in this field focusing on Africa reveals the abundance of resources, external...... manipulation, internal weaknesses of the state in Africa, illiteracy among the local populations and extreme levels of poverty, among others, as significantly contributing to resource conflicts in the region. This contribution is anchored on the free, prior and informed consent framework as a remedy...

  11. Informed consent in Dutch dental practice: knowledge, attitudes and self-efficacy of dentists.

    Science.gov (United States)

    Schouten, B C; Eijkman, M A; Hoogstraten, J; den Dekker, J

    2001-02-01

    The introduction of the 'Medical Treatment Contract Act' in the Netherlands 5 years ago, established some major rights and duties of both patients and members of the medical profession. The aim of this study was to assess Dutch dentists' knowledge, attitudes and self-efficacy with regard to several topics of this act. A questionnaire was sent to 806 dental practitioners; 41.6% of them responded. Results show that dentists are well informed about some of the most important topics of this law, such as the requirement to obtain the patient's consent to major dental treatments. The results concerning their attitude and self-efficacy, however, are less positive. A majority of the respondents believe that the principle of informed consent will lead to a commercialization of the dentist-patient relation. Also, fear for legal procedures and difficulty with what patients must be informed about appears present. It is concluded that improvement of the implementation of the requirements of this legislation in dental practice requires both a change in attitude and an enhancement of the communicative skills of dentists.

  12. Concise informed consent to increase data and biospecimen access may accelerate innovative Alzheimer's disease treatments.

    Science.gov (United States)

    Hake, Ann M; Dacks, Penny A; Arnerić, Stephen P

    2017-11-01

    Informed consent forms that restrict the distribution of data and samples have been an impediment to advancing Alzheimer's disease (AD) understandings and treatments. The Coalition Against Major Disease public-private partnership developed concise addenda to responsibly broaden data access of informed consent forms. Coalition Against Major Disease members identified key elements for ensuring data and biospecimen access, and patient privacy protection according to applicable US law. Collaboration with the Alzheimer's Association established the understandability and relevance of the addenda with AD patients and Care Partners. Two key findings are (1) patients with dementia and Care Partners were shocked that their data and samples are not broadly shared and (2) with diverse feedback, two concise addenda were created to enable data and sample sharing both within and outside future sponsored studies (see Boxes). Increasing the access of valuable anonymized patient-level clinical trial data has the potential to inform the foundational and regulatory science required to deliver innovative treatments for AD.

  13. Checklist to improve informed consent process in pediatric surgery: A pilot study.

    Science.gov (United States)

    Firdouse, Mohammed; Wajchendler, Amy; Koyle, Martin; Fecteau, Annie

    2017-05-01

    The purpose of this study was to develop and validate a checklist to standardize surgical informed consent process. A checklist was created following a literature search. Consent processes were observed from general surgery (GS) and urology (US) in the pre- and post-intervention phases. Competent patients/guardians were asked to complete a satisfaction questionnaire. All trainees and staff surgeons were interviewed on the checklist's utility. 73 observations (GS=39, US=34) and 66 observations (GS=30, US=36) were made in the pre- and post-intervention phase, respectively. Our checklist increased the frequency with which surgeons explained alternative treatments (pre-intervention 23.3% vs. post-intervention 81.8%), the role of trainees (15.1% vs. 72.7%), and the potential outcomes of not pursuing surgery (60.3% vs. 87.9%). The patient/guardian average satisfaction score increased between phases within GS (mean[standard deviation] 3.55[0.58] vs. 3.85[0.24]); p=0.002), but not within US (3.53[0.61] vs. 3.52[0.54]); p=0.705) or the overall sample (3.54[0.59] vs. 3.67[0.46]); p=0.329). Interestingly, there was no significant improvement in patient/guardian average anxiety levels in GS (X2=0.069, p=0.793), US (X2=0, p=1) or the overall sample (X2=0.143, p=0.706) following the intervention. Our checklist aids in standardizing the informed consent process. However, it did not significantly change satisfaction or anxiety levels of patients and guardians. Prognosis study. Level III. Copyright © 2017 Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

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

    2016-06-01

    The US Food and Drug Administration and the Department of Health and Human Services outline regulations allowing an exception from informed consent (EFIC) for research conducted in an emergency setting. Acute care clinical trials using EFIC must include community consultation and public disclosure (CC/PD) activities. We describe our experience using social media to facilitate the CC/PD process in two trauma resuscitation clinical trials. We conducted local CC/PD activities for two multicenter trauma clinical trials, Pragmatic, Randomized Optimal Platelet and Plasma Ratios (PROPPR) and Prehospital Tranexamic Acid Use for Traumatic Brain Injury (ROC-TXA). As part of the CC/PD process, we developed research study advertisements using the social media Web site Facebook. The Facebook advertisements directed users to a regional study Web site that contained trial information. We targeted the advertisements to specific demographic users, in specific geographic areas. We analyzed the data using descriptive statistics. During the study periods, the PROPPR Facebook advertisement was displayed 5,001,520 times (12 displays per target population) with 374 individuals selecting the advertisement. The ROC-TXA Facebook advertisement was displayed 3,806,448 times (8 per target population) with 790 individuals selecting the advertisement. Respondents to both Facebook advertisements were mostly male (52.6%), with the highest proportion between the ages 15 years and 24 years (28.2%). Collectively, 26.9% of individuals that clicked on the Facebook advertisement spent more than 3 minutes on the study Web site (3-49 minutes). Commonly accessed Web pages were "contact us" (PROPPR, 5.5%; ROC-TXA, 7.7%), "study-specific FAQs" (PROPPR, 2.4%; ROC-TXA, 6.7%), and "opt out of research" (PROPPR, 2.5%; ROC-TXA, 3.8%). Of 51 total individuals viewing the opt out of research information (PROPPR, 19; ROC-TXA, 32), time spent on that specific page was modest (PROPPR, 62 seconds; ROC-TXA, 55 seconds

  15. Practicing provider-initiated HIV testing in high prevalence settings: consent concerns and missed preventive opportunities

    OpenAIRE

    Shayo Elizabeth H; Blystad Astrid; Njeru Mercy K; Nyamongo Isaac K; Fylkesnes Knut

    2011-01-01

    Abstract Background Counselling is considered a prerequisite for the proper handling of testing and for ensuring effective HIV preventive efforts. HIV testing services have recently been scaled up substantially with a particular focus on provider-initiated models. Increasing HIV test rates have been attributed to the rapid scale-up of the provider-initiated testing model, but there is limited documentation of experiences with this new service model. The aim of this study was to determine the ...

  16. Evaluating the quality of informed consent and contemporary clinical practices by medical doctors in South Africa: An empirical study

    Science.gov (United States)

    2013-01-01

    Background Informed consent is a legal and ethical doctrine derived from the principle of respect for autonomy. Generally two rights derived from autonomy are accorded legal protection. The constitutional right to bodily integrity followed by the right to bodily well-being, protected by professional negligence rules. Therefore healthcare professionals treating patients' without valid consent may be guilty of infringing patients' rights. Many challenges are experienced by doctors obtaining informed consent in complex multicultural societies like South Africa. These include different cultural ethos, multilingualism, poverty, education, unfamiliarity with libertarian rights based autonomy, and power asymmetry between doctors and patients. All of which could impact on the ability of doctors to obtain legally valid informed consent. Methods The objective of this study was to evaluate whether the quality of informed consent obtained by doctors practicing in South Africa is consistent with international ethical standards and local regulations. Responses from 946 participants including doctors, nurses and patients was analyzed, using a semi-structured self-administered questionnaire and person triangulation in selected public hospitals in Durban, KwaZulu-Natal, South Africa. Results The median age of 168 doctors participating was 30 years with 51% females, 28% interns, 16% medical officers, 26% registrars, 30% consultant/specialists. A broad range of clinical specialties were represented. Challenges to informed consent practice include language difficulties, lack of interpreters, workload, and time constraints. Doctors spent 5-10 minutes on consent, disclosed most information required to patients, however knowledge of essential local laws was inadequate. Informed consent aggregate scores (ICAS) showed that interns/registrars scored lower than consultants/specialists. ICAS scores were statistically significant by specialty (p = 0.005), with radiologists and anaesthetists

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

    Science.gov (United States)

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

    2017-08-01

    Language barriers disrupt communication and impede informed consent for patients with limited English proficiency (LEP) undergoing healthcare procedures. Effective interventions for this disparity remain unclear. Assess the impact of a bedside interpreter phone system intervention on informed consent for patients with LEP and compare outcomes to those of English speakers. Prospective, pre-post intervention implementation study using propensity analysis. Hospitalized patients undergoing invasive procedures on the cardiovascular, general surgery or orthopedic surgery floors. Installation of dual-handset interpreter phones at every bedside enabling 24-h immediate access to professional interpreters. Primary predictor: pre- vs. post-implementation group; secondary predictor: post-implementation patients with LEP vs. English speakers. Primary outcomes: three central informed consent elements, patient-reported understanding of the (1) reasons for and (2) risks of the procedure and (3) having had all questions answered. We considered consent adequately informed when all three elements were met. We enrolled 152 Chinese- and Spanish-speaking patients with LEP (84 pre- and 68 post-implementation) and 86 English speakers. Post-implementation (vs. pre-implementation) patients with LEP were more likely to meet criteria for adequately informed consent (54% vs. 29%, p = 0.001) and, after propensity score adjustment, had significantly higher odds of adequately informed consent (AOR 2.56; 95% CI, 1.15-5.72) as well as of each consent element individually. However, compared to post-implementation English speakers, post-implementation patients with LEP had significantly lower adjusted odds of adequately informed consent (AOR, 0.38; 95% CI, 0.16-0.91). A bedside interpreter phone system intervention to increase rapid access to professional interpreters was associated with improvements in patient-reported informed consent and should be considered by hospitals seeking to improve

  18. Evaluating the quality of informed consent and contemporary clinical practices by medical doctors in South Africa: an empirical study.

    Science.gov (United States)

    Chima, Sylvester C

    2013-01-01

    Informed consent is a legal and ethical doctrine derived from the principle of respect for autonomy. Generally two rights derived from autonomy are accorded legal protection. The constitutional right to bodily integrity followed by the right to bodily well-being, protected by professional negligence rules. Therefore healthcare professionals treating patients' without valid consent may be guilty of infringing patients' rights. Many challenges are experienced by doctors obtaining informed consent in complex multicultural societies like South Africa. These include different cultural ethos, multilingualism, poverty, education, unfamiliarity with libertarian rights based autonomy, and power asymmetry between doctors and patients. All of which could impact on the ability of doctors to obtain legally valid informed consent. The objective of this study was to evaluate whether the quality of informed consent obtained by doctors practicing in South Africa is consistent with international ethical standards and local regulations. Responses from 946 participants including doctors, nurses and patients was analyzed, using a semi-structured self-administered questionnaire and person triangulation in selected public hospitals in Durban, KwaZulu-Natal, South Africa. The median age of 168 doctors participating was 30 years with 51% females, 28% interns, 16% medical officers, 26% registrars, 30% consultant/specialists. A broad range of clinical specialties were represented. Challenges to informed consent practice include language difficulties, lack of interpreters, workload, and time constraints. Doctors spent 5-10 minutes on consent, disclosed most information required to patients, however knowledge of essential local laws was inadequate. Informed consent aggregate scores (ICAS) showed that interns/registrars scored lower than consultants/specialists. ICAS scores were statistically significant by specialty (p = 0.005), with radiologists and anaesthetists scoring lowest, while

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

    Directory of Open Access Journals (Sweden)

    N. Demosthenous

    2011-01-01

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

  20. A survey on surgeons' perceived quality of the informed consent process in a Swiss paediatric surgery unit.

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    Guinand, Julie; Gapany, Christophe; Simon, Jeanne-Pascale; Wasserfallen, Jean-Blaise; Joseph, Jean-Marc

    2015-01-01

    To evaluate the levels of satisfaction and opinions on the usefulness of the informed consent form currently in use in our Paediatric Surgery Department. Qualitative study carried out via interviews of senior paediatric surgeons, based on a questionnaire built up from reference criteria in the literature and public health law. Physicians with between 2 and 35 years experience of paediatric surgery, with a participation rate of 92 %, agreed on the definition of an informed consent form, were satisfied with the form in use and did not wish to modify its structure. The study revealed that signing the form was viewed as mandatory, but meant different things to different participants, who diverged over whom that signature protected. Finally, all respondents were in agreement over what information was necessary for parents of children requiring surgery. Paediatric surgeons seemed to be satisfied with the informed consent form in use. Most of them did not identify that the first aim of the informed consent form is to give the patient adequate information to allow him to base his consent, which is a legal obligation, the protection of physicians by the formalisation and proof of the informed consent being secondary. Few surgeons brought up the fact that the foremost stakeholder in paediatric surgery are the children themselves and that their opinions are not always sought. In the future, moving from informed consent process to shared decision-making, a more active bidirectional exchange may be strongly considered. Involving children in such vital decisions should become the norm while keeping in mind their level of maturity.

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

    Science.gov (United States)

    Furuno, Yuichi; Sasajima, Hiroyasu

    2015-07-01

    Informed consent has now become common in medical practice. However, a gap still exists between doctors and patients in the understanding of clinical conditions. We designed medical comics about "subarachnoid hemorrhage" and "intracerebral hemorrhage" to help doctors obtain informed consent intuitively, quickly, and comprehensively.Between September 2010 and September 2012, we carried out a questionnaire survey about medical comics with the families of patients who had suffered an intracerebral or subarachnoid hemorrhage. The questionnaire consisted of 6 questions inquiring about their mental condition, reading time, usefulness of the comics in understanding brain function and anatomy, pathogenesis, doctor's explanation, and applicability of these comics.The results showed that 93.8% responders would prefer or strongly prefer the use of comics in other medical situations. When considering the level of understanding of brain function and anatomy, pathology of disease, and doctor's explanation, 81.3%, 75.0%, and 68.8% of responders, respectively, rated these comics as very useful or useful.We think that the visual and narrative illustrations in medical comics would be more helpful for patients than a lengthy explanation by a doctor. Most of the responders hoped that medical comics would be applied to other medical cases. Thus, medical comics could work as a new communication tool between doctors and patients.

  2. Standard operating procedure for audio visual recording of informed consent: an initiative to facilitate regulatory compliance.

    Science.gov (United States)

    Parikh, P M; Prabhash, K; Govind, K B; Digumarti, R; Pandit, S; Banerjee, I; Biyani, R; Deshmukh, A; Doval, D; Bhattacharyya, G S; Gupta, S

    2014-01-01

    The office of the Drugs Controller General (India) vide order dated 19 th November 2013 has made audio visual (AV) recording of the informed consent mandatory for the conduct of all clinical trials in India. We therefore developed a standard operating procedure (SOP) to ensure that this is performed in compliance with the regulatory requirements, internationally accepted ethical standards and that the recording is stored as well as archived in an appropriate manner. The SOP was developed keeping in mind all relevant orders, regulations, laws and guidelines and have been made available online. Since, we are faced with unique legal and regulatory requirements that are unprecedented globally, this SOP will allow the AV recording of the informed consent to be performed, archived and retrieved to demonstrate ethical, legal and regulatory compliance. We also compared this to the draft guidelines for AV recording dated 9 th January 2014 developed by Central Drugs Standard Control Organization. Our future efforts will include regular testing, feedback and update of the SOP.

  3. Linguistic Strategies for Improving Informed Consent in Clinical Trials Among Low Health Literacy Patients.

    Science.gov (United States)

    Krieger, Janice L; Neil, Jordan M; Strekalova, Yulia A; Sarge, Melanie A

    2017-03-01

    Improving informed consent to participate in randomized clinical trials (RCTs) is a key challenge in cancer communication. The current study examines strategies for enhancing randomization comprehension among patients with diverse levels of health literacy and identifies cognitive and affective predictors of intentions to participate in cancer RCTs. Using a post-test-only experimental design, cancer patients (n = 500) were randomly assigned to receive one of three message conditions for explaining randomization (ie, plain language condition, gambling metaphor, benign metaphor) or a control message. All statistical tests were two-sided. Health literacy was a statistically significant moderator of randomization comprehension (P = .03). Among participants with the lowest levels of health literacy, the benign metaphor resulted in greater comprehension of randomization as compared with plain language (P = .04) and control (P = .004) messages. Among participants with the highest levels of health literacy, the gambling metaphor resulted in greater randomization comprehension as compared with the benign metaphor (P = .04). A serial mediation model showed a statistically significant negative indirect effect of comprehension on behavioral intention through personal relevance of RCTs and anxiety associated with participation in RCTs (P literacy, with a benign metaphor being particularly effective for patients at the lower end of the health literacy spectrum. The theoretical model demonstrates the cognitive and affective predictors of behavioral intention to participate in cancer RCTs and offers guidance on how future research should employ communication strategies to improve the informed consent processes. © The Author 2016. Published by Oxford University Press.

  4. The use of multimedia as an adjunct to the informed consent process for Morton's neuroma resection surgery.

    Science.gov (United States)

    Wang, Calvin; Ammon, Peter; Beischer, Andrew D

    2014-10-01

    The purpose of this study was to assess if a computer-based multimedia education module (MEM) improved patients' comprehension when used as an adjunct to the standard verbal consent process for Morton's neuroma resection surgery. Nineteen patients (15 females and 4 males) considered candidates for Morton's neuroma resection surgery were prospectively recruited. A standardized verbal discussion was had with each patient regarding risks and benefits of surgery, alternative treatments, and the usual postoperative course. Patient understanding was then assessed with a questionnaire. Each patient subsequently viewed the MEM and the questionnaire was repeated. Patients also rated ease of understanding and satisfaction with both methods of patient education. Patients answered a significantly greater proportion of correct answers after viewing the MEM module (85%), compared to verbal discussion alone (61%) (P = .002). Patients rated both the ease of understanding of the module and amount of information provided by the module as a mean of 9.3 cm on a 10 cm Visual Analog Scale (VAS). The majority of patients (76%) rated the multimedia tool as having answered their questions about surgery as well or better than the treating surgeon. An interactive multimedia educational tool was a useful adjunct to the informed consent process for patients considering Morton's neuroma resection surgery. Level II, prospective cohort study. © The Author(s) 2014.

  5. "I understood…but some parts were confusing and hard to grasp": Patients' perception of informed consent forms and clinical trials in Eldoret, Kenya.

    Science.gov (United States)

    Naanyu, Violet; Some, Fatma F; Siika, Abraham M

    2014-01-01

    A signed informed consent (IC) form proves voluntary participation in a study. Yet the development of accessible and understandable IC forms comes with its own set of challenges, particularly when conducting international research. This study explores understanding by participants in an Eldoret-based clinical trial of IC and its implications as well as whether they will volunteer for future trials. In mid-2010, in-depth interviews with trial participants were recorded in audio format. Content analysis provides a description of trial participants' experiences and thoughts. All participants were informed about the trial and its voluntariness and they consented. However, some were too ill to scrutinize trial details. Thus, they relied on their health care provider's advice, or on their guardians. In general, participants understood their role and were happy to volunteer or invite others to participate in future trials. They also emphasised the importance of an open on-going dialogue in order for participants to be able to ask questions. Clinical trial participants in Eldoret seem to understand their role, but rely on providers and guardians when consenting. They are very willing to participate in future trials. Evaluation of research participants' opinions may improve trial protocols, increase comprehension and guard against manipulation of study participants. In addition, this research focus should guide development of consent forms and process that facilitates a truly IC.

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

    Science.gov (United States)

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

    2015-01-01

    Since the 2010 NASA authorization to make the Life Sciences Data Archive (LSDA) and Lifetime Surveillance of Astronaut Health (LSAH) data archives more accessible by the research and operational communities, demand for data has greatly increased. Correspondingly, both the number and scope of requests have increased, from 142 requests fulfilled in 2011 to 224 in 2014, and with some datasets comprising up to 1 million data points. To meet the demand, the LSAH and LSDA Repositories project was launched, which allows active and retired astronauts to authorize full, partial, or no access to their data for research without individual, study-specific informed consent. A one-on-one personal informed consent briefing is required to fully communicate the implications of the several tiers of consent. Due to the need for personal contact to conduct Repositories consent meetings, the rate of consenting has not kept up with demand for individualized, possibly attributable data. As a result, other methods had to be implemented to allow the release of large datasets, such as release of only de-identified data. However the compilation of large, de-identified data sets places a significant resource burden on LSAH and LSDA and may result in diminished scientific usefulness of the dataset. As a result, LSAH and LSDA worked with the JSC Institutional Review Board Chair, Astronaut Office physicians, and NASA Office of General Counsel personnel to develop a "Remote Consenting" process for retrospective data mining studies. This is particularly useful since the majority of the astronaut cohort is retired from the agency and living outside the Houston area. Originally planned as a method to send informed consent briefing slides and consent forms only by mail, Remote Consenting has evolved into a means to accept crewmember decisions on individual studies via their method of choice: email or paper copy by mail. To date, 100 emails have been sent to request participation in eight HRP

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

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    Marsh Vicki

    2007-11-01

    Full Text Available Abstract Background Formal checks of participant understanding are now widely recommended to improve informed consent processes. However, the views of the participants these assessments are designed to protect are rarely considered. In this paper the findings of a qualitative study aimed at documenting community reactions to a semi-structured questionnaire ('quiz' are reported. The quiz was administered to 189 mothers after consenting for their children to participate in a malaria vaccine trial on the Kenyan Coast. Methods Once the malaria vaccine trial was underway, focus group discussions were held with some of these mothers (nine groups; 103 mothers, and with community-based field staff attached to the malaria vaccine trial (two groups of five workers. Individual interviews with other trial staff were also held. Results The quiz prompted community members to voice concerns about blood sampling and vaccine side-effects, thereby encouraging additional discussions and interactions between the research team and potential study participants. However, it also caused significant upset and concern. Some of the quiz questions, or the way in which they were asked, appeared to fuel misconceptions and fears, with potentially negative consequences for both the study and community members. Conclusion Formal approaches to checking study understanding should be employed with sensitivity and caution. They are influenced by and impact upon complex social relationships between and among researchers and community members. Adequate consideration of these contexts in assessments of understanding, and in responding to the issues raised, requires strong social science capacity.

  8. Participant understanding and recall of informed consent for induced pluripotent stem cell biobanking.

    Science.gov (United States)

    McCaughey, Tristan; Chen, Christine Y; De Smit, Elisabeth; Rees, Gwyneth; Fenwick, Eva; Kearns, Lisa S; Mackey, David A; MacGregor, Casimir; Munsie, Megan; Cook, Anthony L; Pébay, Alice; Hewitt, Alex W

    2016-09-01

    The ability to generate human induced pluripotent stem cells (iPSCs) has opened new avenues for human disease modelling and therapy. The aim of our study was to determine research participants' understanding of the information given when donating skin biopsies for the generation of patient-specific iPSCs. A customised 35-item questionnaire based on previous iPSC consent guidelines was sent to participants who had previously donated samples for iPSC research. The questionnaire asked pertinent demographic details, participants' motivation to take part in iPSC research and their attitudes towards related ethical issues. 234 participants were contacted with 141 (60.3 %) complete responses received. The median duration between recruitment and follow-up questioning was 313 days (range 10-573 days). The majority of participants (n = 129, 91.5 %) believed they understood what a stem cell was; however, only 22 (16.1 %) correctly answered questions related to basic stem cell properties. We found no statistically significant difference in responses from participants with different levels of education, or those with a health sciences background. The poor understanding amongst participants of iPSC research is unlikely to be unique to our study and may impact future research if not improved. As such, there is a need to develop an easily understood yet comprehensive consent process to ensure ongoing ethical progress of iPSC biobanking.

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

    Science.gov (United States)

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

    2014-01-10

    The current doctrine of informed consent for clinical care has been developed in cultures characterized by low-context communication and monitoring-style coping. There are scarce empirical data on patients' norm perception of information disclosure in other cultures. We surveyed 470 adults who were planning to undergo or had recently undergone a written informed consent-requiring procedure in a tertiary healthcare hospital in Saudi Arabia. Perceptions of norm and current practice were explored using a 5-point Likert scale (1 = strongly agree with disclosure) and 30 information items in 7 domains: practitioners' details, benefits, risks, complications' management, available alternatives, procedure's description, and post-procedure's issues. Respondents' mean (SD) age was 38.4 (12.5); 50.2% were males, 57.2% had ≥ college education, and 37.9% had undergone a procedure. According to norm perception, strongly agree/agree responses ranged from 98.0% (major benefits) to 50.5% (assistant/trainee's name). Overall, items related to benefits and post-procedure's issues were ranked better (more agreeable) than items related to risks and available alternatives. Ranking scores were better in post-procedure respondents for 4 (13.3%) items (p perception, strongly agree/agree responses ranged from 93.3% (disclosure of procedure's name) to 13.9% (lead practitioner's training place), ranking scores were worse for all items compared to norm perception (p < 0.001), and post-procedure status, younger age, and lower educational level were associated with better ranking scores for 15 (50.0%), 12 (40.0%), and 4 (13.3%) items, respectively (p < 0.001 to 0.009). 1) even in an overall high-context communication culture, extensive and more information than is currently disclosed is perceived as norm, 2) the focus of the desired information is closer to benefits and post-procedure's issues than risks and available alternatives, 3) male, post-procedure, and older patients are in favor of more

  10. "I understood…but some parts were confusing and hard to grasp": Patients′ perception of informed consent forms and clinical trials in Eldoret, Kenya

    Directory of Open Access Journals (Sweden)

    Violet Naanyu

    2014-01-01

    Full Text Available Background: A signed informed consent (IC form proves voluntary participation in a study. Yet the development of accessible and understandable IC forms comes with its own set of challenges, particularly when conducting international research. Purpose: This study explores understanding by participants in an Eldoret-based clinical trial of IC and its implications as well as whether they will volunteer for future trials. Materials and Methods: In mid-2010, in-depth interviews with trial participants were recorded in audio format. Content analysis provides a description of trial participants′ experiences and thoughts. Results: All participants were informed about the trial and its voluntariness and they consented. However, some were too ill to scrutinize trial details. Thus, they relied on their health care provider′s advice, or on their guardians. In general, participants understood their role and were happy to volunteer or invite others to participate in future trials. They also emphasised the importance of an open on-going dialogue in order for participants to be able to ask questions. Conclusion: Clinical trial participants in Eldoret seem to understand their role, but rely on providers and guardians when consenting. They are very willing to participate in future trials. Evaluation of research participants′ opinions may improve trial protocols, increase comprehension and guard against manipulation of study participants. In addition, this research focus should guide development of consent forms and process that facilitates a truly IC.

  11. INTEGRATED INFORMATION SYSTEM ARCHITECTURE PROVIDING BEHAVIORAL FEATURE

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    Vladimir N. Shvedenko

    2016-11-01

    Full Text Available The paper deals with creation of integrated information system architecture capable of supporting management decisions using behavioral features. The paper considers the architecture of information decision support system for production system management. The behavioral feature is given to an information system, and it ensures extraction, processing of information, management decision-making with both automated and automatic modes of decision-making subsystem being permitted. Practical implementation of information system with behavior is based on service-oriented architecture: there is a set of independent services in the information system that provides data of its subsystems or data processing by separate application under the chosen variant of the problematic situation settlement. For creation of integrated information system with behavior we propose architecture including the following subsystems: data bus, subsystem for interaction with the integrated applications based on metadata, business process management subsystem, subsystem for the current state analysis of the enterprise and management decision-making, behavior training subsystem. For each problematic situation a separate logical layer service is created in Unified Service Bus handling problematic situations. This architecture reduces system information complexity due to the fact that with a constant amount of system elements the number of links decreases, since each layer provides communication center of responsibility for the resource with the services of corresponding applications. If a similar problematic situation occurs, its resolution is automatically removed from problem situation metamodel repository and business process metamodel of its settlement. In the business process performance commands are generated to the corresponding centers of responsibility to settle a problematic situation.

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

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    Mitchell, E.M

    2003-11-01

    Just over half the population in Britain today are women, and each is likely to spend over one-third of her life in the post menopausal state. The number of post-war 'Baby Boomers' is having a profound effect on interest in the menopause and increasing awareness of Hormone Replacement Therapy (HRT). Patients are no longer prepared to passively accept the advice of their doctor, and should make an informed decision over its use, after having been given up-to-date information. Some of the claimed benefits of taking HRT are not fully proven and the risks and disadvantages must be considered, notably the increased risk of breast cancer and the effect on the sensitivity and specificity of the mammographic image. The long-term benefits are still uncertain. Available information needs to be comprehensible, credible, and up to date. Whether to initiate the taking of HRT is one of the most important decisions a woman entering mid-life will make, so she needs to be given information she can understand in order to make an informed decision. HRT and informed consent are topics relevant to mammography, which was the rationale in writing this paper as part of a Post Graduate Certificate in Mammographic Studies.

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

    Science.gov (United States)

    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

    2007-01-01

    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. Copyright 2007 S. Karger AG, Basel.

  14. Multiagency Initiative to Provide Greenhouse Gas Information

    Science.gov (United States)

    Boland, Stacey W.; Duren, Riley M.

    2009-11-01

    Global Greenhouse Gas Information System Workshop; Albuquerque, New Mexico, 20-22 May 2009; The second Greenhouse Gas Information System (GHGIS) workshop brought together 74 representatives from 28 organizations including U.S. government agencies, national laboratories, and members of the academic community to address issues related to the understanding, operational monitoring, and tracking of greenhouse gas emissions and carbon offsets. The workshop was held at Sandia National Laboratories and organized by an interagency collaboration among NASA centers, Department of Energy laboratories, and the U.S. National Oceanic and Atmospheric Administration. It was motivated by the perceived need for an integrated interagency, community-wide initiative to provide information about greenhouse gas sources and sinks at policy-relevant temporal and spatial scales. Such an initiative could significantly enhance the ability of national and regional governments, industry, and private citizens to implement and evaluate effective climate change mitigation policies.

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

    Science.gov (United States)

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

    2010-01-01

    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.

  16. Informed consent in medical decision-making in commercial gestational surrogacy: a mixed methods study in New Delhi, India.

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    Tanderup, Malene; Reddy, Sunita; Patel, Tulsi; Nielsen, Birgitte Bruun

    2015-05-01

    To investigate ethical issues in informed consent for decisions regarding embryo transfer and fetal reduction in commercial gestational surrogacy. Mixed methods study employing observations, an interview-guide and semi-structured interviews. Fertility clinics and agencies in Delhi, India, between December 2011 and December 2012. Doctors providing conceptive technologies to commissioning couples and carrying out surrogacy procedures; surrogate mothers; agents functioning as links for surrogacy. Interviews using semi-structured interview guides 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. Informed consent, number of embryos transferred, fetal reduction, conflict of interest among the involved parties. None of the 14 surrogate mothers were able to explain the risks involved in embryo transfer and fetal reduction. The majority of the doctors took unilateral decisions about embryo transfer and fetal reduction. The commissioning parents were usually only indirectly involved. In the qualitative analysis, difficulties in explaining procedures, autonomy, self-payment of fertility treatment and conflicts of interest were the main themes. Clinical procedural decisions were primarily made by the doctors. Surrogate mothers were not adequately informed. There is a need for regulation on decision-making procedures to safeguard the interests of surrogate mothers. © 2015 Nordic Federation of Societies of Obstetrics and Gynecology.

  17. IMPLEMENTASI PERSETUJUAN TINDAKAN KEDOKTERAN (INFORMED CONSENT DALAM PERJANJIAN TERAPEUTIK OLEH TENAGA KESEHATAN TERHADAP PASIEN RUMAH SAKIT DI PROVINSI BALI

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    Ida Ayu Sri Kusuma Wardhani

    2014-03-01

    Full Text Available Health is the most important part of human life that can affect productivity and optimal human activity. When a person's health is compromised, then that person will seek treatment in health care facilities in the hospital one of them in order to get action. Measures of medicine containing the high risk should get written consent from patient/family called Informed Consent. The legal relationship between health professionals with patients occurs because of the agreement that causes the therapeutic relationship inspaningverbintenis law (treaty effort. Similarly in the Bali Provincial Hospital in any medical act especially those containing a high risk, which is done by some health professionals are also using the Informed Consent. But if there is negligence actions that cause harm, who will be responsible for the risks in the suffering patient / family? and how the efforts of patient / family to resolve medical disputes against the risk of Informed Consent? The method used in this research is an empirical law derived from primary data and secondary data. The nature of the study is descriptive, with qualitative data analysis. Overall the results of these analyzes are presented in the description which describes the complete problem under study, along with a critical discussion. Based on the Theory of Legal System of L. M. Friedman, legal systems theory described by Soerjono Soekanto be legal efficacy theory, the theory of Hans Kelsen responsibility, and legislation as well as the results of research in the field, it is known that the liability of health professionals based on Informed Consent Agreement Therapeutic Hospital in Bali province is on the doctor who signed the operator of the informed consent form. However, if the patient / family prosecute acts of negligence committed by health professionals, the hospital will be responsible jointly and severally against such negligence. From the result of  research in the hospital in the province of

  18. Evaluation of the quality of informed consent in a vaccine field trial in a developing country setting

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    London Leslie

    2008-09-01

    Full Text Available Abstract Background Informed consent is an ethical and legal requirement for research involving human participants. However, few studies have evaluated the process, particularly in Africa. Participants in a case control study designed to identify correlates of immune protection against tuberculosis (TB in South Africa. This study was in turn nested in a large TB vaccine efficacy trial. The aim of the study was to evaluate the quality of consent in the case control study, and to identify factors that may influence the quality of consent. Cross-sectional study conducted over a 4 month period. Methods Consent was obtained from parents of trial participants. These parents were asked to complete a questionnaire that contained questions about the key elements of informed consent (voluntary participation, confidentiality, the main risks and benefits, etc.. The recall (success in selecting the correct answers and understanding (correctness of interpretation of statements presented were measured. Results The majority of the 192 subjects interviewed obtained scores greater than 75% for both the recall and understanding sections. The median score for recall was 66%; interquartile range (IQR = 55%–77% and for understanding 75% (IQR = 50%–87%. Most (79% were aware of the risks and 64% knew that they participated voluntarily. Participants who had completed Grade 7 at school and higher were more likely (OR = 4.94; 95% CI = 1.57 – 15.55 to obtain scores greater than 75% for recall than those who did not. Participants who were consented by professional nurses who had worked for more than two years in research were also more likely (OR = 2.62; 95% CI = 1.35–5.07 to obtain such scores for recall than those who were not. Conclusion Notwithstanding the constraints in a developing country, in a population with low levels of literacy and education, the quality of informed consent found in this study could be considered as building blocks for establishing

  19. Improving Validity of Informed Consent for Biomedical Research in Zambia Using a Laboratory Exposure Intervention

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    Zulu, Joseph Mumba; Lisulo, Mpala Mwanza; Besa, Ellen; Kaonga, Patrick; Chisenga, Caroline C.; Chomba, Mumba; Simuyandi, Michelo; Banda, Rosemary; Kelly, Paul

    2014-01-01

    Background Complex biomedical research can lead to disquiet in communities with limited exposure to scientific discussions, leading to rumours or to high drop-out rates. We set out to test an intervention designed to address apprehensions commonly encountered in a community where literacy is uncommon, and where complex biomedical research has been conducted for over a decade. We aimed to determine if it could improve the validity of consent. Methods Data were collected using focus group discussions, key informant interviews and observations. We designed an intervention that exposed participants to a detailed demonstration of laboratory processes. Each group was interviewed twice in a day, before and after exposure to the intervention in order to assess changes in their views. Results Factors that motivated people to participate in invasive biomedical research included a desire to stay healthy because of the screening during the recruitment process, regular advice from doctors, free medical services, and trust in the researchers. Inhibiting factors were limited knowledge about samples taken from their bodies during endoscopic procedures, the impact of endoscopy on the function of internal organs, and concerns about the use of biomedical samples. The belief that blood can be used for Satanic practices also created insecurities about drawing of blood samples. Further inhibiting factors included a fear of being labelled as HIV positive if known to consult heath workers repeatedly, and gender inequality. Concerns about the use and storage of blood and tissue samples were overcome by a laboratory exposure intervention. Conclusion Selecting a group of members from target community and engaging them in a laboratory exposure intervention could be a useful tool for enhancing specific aspects of consent for biomedical research. Further work is needed to determine the extent to which improved understanding permeates beyond the immediate group participating in the intervention

  20. Improving validity of informed consent for biomedical research in Zambia using a laboratory exposure intervention.

    Directory of Open Access Journals (Sweden)

    Joseph Mumba Zulu

    Full Text Available Complex biomedical research can lead to disquiet in communities with limited exposure to scientific discussions, leading to rumours or to high drop-out rates. We set out to test an intervention designed to address apprehensions commonly encountered in a community where literacy is uncommon, and where complex biomedical research has been conducted for over a decade. We aimed to determine if it could improve the validity of consent.Data were collected using focus group discussions, key informant interviews and observations. We designed an intervention that exposed participants to a detailed demonstration of laboratory processes. Each group was interviewed twice in a day, before and after exposure to the intervention in order to assess changes in their views.Factors that motivated people to participate in invasive biomedical research included a desire to stay healthy because of the screening during the recruitment process, regular advice from doctors, free medical services, and trust in the researchers. Inhibiting factors were limited knowledge about samples taken from their bodies during endoscopic procedures, the impact of endoscopy on the function of internal organs, and concerns about the use of biomedical samples. The belief that blood can be used for Satanic practices also created insecurities about drawing of blood samples. Further inhibiting factors included a fear of being labelled as HIV positive if known to consult heath workers repeatedly, and gender inequality. Concerns about the use and storage of blood and tissue samples were overcome by a laboratory exposure intervention.Selecting a group of members from target community and engaging them in a laboratory exposure intervention could be a useful tool for enhancing specific aspects of consent for biomedical research. Further work is needed to determine the extent to which improved understanding permeates beyond the immediate group participating in the intervention.

  1. Providing sexual information to ostomy patients.

    Science.gov (United States)

    Gloeckner, M R; Starling, J R

    1982-09-01

    Forty patients with a permanent colostomy, ileostomy, or ileal conduit were interviewed. Besides changes in sexual performance postoperatively, the authors specifically attempted to determine answers to other sexual variables such as attractiveness, appliance problems, and partner reactions. The extent of information provided to patients on sexuality prior to the permanent ostomy was also examined. There was a significant but predictable incidence of male impotence and female dyspareunia after surgery. Despite innumerable sexual variables, other than performance, which these patients faced postoperatively, 42 per cent received no information regarding sexuality at the time of ostomy surgery. most patients (97.5 per cent) stated that sexuality, including variables other than performance, should be discussed primarily by the surgeon prior to permanent ostomy surgery. The enterostomal therapist has an important role in the total patient adjustment in the long-term postoperative period.

  2. Do drug advertisements provide therapeutic information?

    Science.gov (United States)

    Stimson, G V

    1977-01-01

    In this study of advertisements appearing in medical periodicals and by direct mail advertising to general practitioners, Dr. Stimson, a sociologist, concludes that from what is intended to provide therapeutic information hardly any therapeutic information is provided. He reminds the reader of the safeguards which surround all drug advertising by law and by the code of practice of the Association of the British Pharmaceutical Industry but these safeguards do not appear to control real or potential sins of omission. Frequently in these advertisements the literature relating to the drug is quoted but Dr. Stimson found that it was difficult to trace all the papers quoted in different types of medical library. (Some references quoted were to unpublished papers but surely the blame should be shared in this situation?) Dr. Stimson also gives a vivid and fascinating glimpse of what he calls the 'images and stereotypes' of the patients who, it is claimed, would benefit from the drug being advertised. Certainly most general practitioners must be aware that when they prescribe that image is displaced by an individual but the portrait gallery is indeed depressing. However, to balance these advertisements drug companies issue data sheets which must be more informative than advertisements and conform to regulations in their format. Unfortunately data sheets are only issued every 15 months whereas the 'average general practitioner is potentially exposed to 1,300 advertisements every month'. In other words, the data sheet and not the advertisement should be the guideline but it arrives too infrequently to offset the lack of therapeutic information contained in advertisements. PMID:870694

  3. An integrated conceptual framework for evaluating and improving 'understanding' in informed consent.

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    Bossert, Sabine; Strech, Daniel

    2017-10-17

    The development of understandable informed consent (IC) documents has proven to be one of the most important challenges in research with humans as well as in healthcare settings. Therefore, evaluating and improving understanding has been of increasing interest for empirical research on IC. However, several conceptual and practical challenges for the development of understandable IC documents remain unresolved. In this paper, we will outline and systematize some of these challenges. On the basis of our own experiences in empirical user testing of IC documents as well as the relevant literature on understanding in IC, we propose an integrated conceptual model for the development of understandable IC documents. The proposed conceptual model integrates different methods for the participatory improvement of written information, including IC, as well as quantitative methods for measuring understanding in IC. In most IC processes, understandable written information is an important prerequisite for valid IC. To improve the quality of IC documents, a conceptual model for participatory procedures of testing, revising, and retesting can be applied. However, the model presented in this paper needs further theoretical and empirical elaboration and clarification of several conceptual and practical challenges.

  4. Challenging the knowledge base and skillset for providing surgical consent by orthopedic and plastic surgeons in the Netherlands: an identified area of improvement in patient safety

    NARCIS (Netherlands)

    Leclercq, Wouter K. G.; Sloot, Sarah; Keulers, Bram J.; Houterman, Saskia; Legemaate, Johan; Veerman, Margot; Thomas, Leslie; Scheltinga, Marc R.

    2016-01-01

    Background: Successfully completing a surgical informed consent process is an important element of the preoperative consult. A previous study of Dutch general surgeons demonstrated that the implementation of SIC did not meet acceptable standards. However, the quality of the SIC process in the

  5. Application of Ethics for Providing Telemedicine Services and Information Technology.

    Science.gov (United States)

    Langarizadeh, Mostafa; Moghbeli, Fatemeh; Aliabadi, Ali

    2017-10-01

    technology, access to information has become simpler than the past. This has prompted hackers to seize the opportunity. This research shows that the ethical issues in telemedicine can be investigated from several aspects like technology, doctor-patient relationship, data confidentiality and security, informed consent, patient's and family's satisfaction with telemedicine services. Following ethical issues in telemedicine is a primary aspect of high quality services. In other words, if therapists abide by ethical rules, they can provide better services for patients. Attention to ethical issues in telemedicine guarantees a safer use of the services.

  6. "Because I want to be informed, to be part of the decision-making": Patients' insights on informed consent practices by healthcare professionals in South Africa.

    Science.gov (United States)

    Chima, S C

    2015-12-01

    Informed consent (IC) is a legally enforceable right in South Africa based on constitutionally protected rights to bodily integrity and well-being. In terms of the law, patients cannot be involved in medical treatment or research without IC. Healthcare providers must inform patients about diagnosis, risks, benefits, treatment options, and right of refusal in a language patients understand based their literacy level. This study reports an empirical study on patients' perceptions of IC as practiced by doctors and nurses in South Africa. A cross-sectional study, using a bilingual semi-structured questionnaire was conducted among patients attending randomly selected public hospitals in eThekwini Metropolitan Municipality (Durban), KwaZulu-Natal province. Competent patients or legal surrogates were eligible for inclusion. IC was obtained from all participants. Four hundred and four participants completed questionnaires of which 68% were female. The median age of participants was 35 years (range 11-91 years). Most respondents spoke IsiZulu (55%), were single (56%), unemployed (66%), and with secondary school education (69%). Patients were generally informed about the diagnosis (81%), risks (57%), and benefits of treatment (61%). Few were informed about treatment options (41%), recommended treatment (28%), and right of refusal (25%). IC was obtained verbally in 73% of cases. Patients favored disclosure of all material risks (78%) and few consulted surrogates before decision-making (76%). There was an association between participant's age and knowledge of the age of consent (P = 0.005). Most patients were satisfied with information disclosed (91%) and did not feel coerced. Some were afraid to ask questions for fear of losing free treatment (8%). This study reveals that South African patients are aware of the right to IC, but many were vulnerable due to indigence. Barriers to IC include poverty, language, and low educational level. South African patients prefer disclosure

  7. [Nationwide Survey on Informed Consent and Ethical Review at Hospitals Conducting Post-marketing Studies Sponsored by Pharmaceutical Companies].

    Science.gov (United States)

    Urushihara, Hisashi; Murakami, Yuka; Matsui, Kenji; Tashiro, Shimon

    2018-01-01

     Under the Japanese drug regulatory system, post-marketing studies (PMS) must be in compliance with Good Post-marketing Study Practice (GPSP). The GPSP Ordinance lacks standards for the ethical conduct of PMSs; although only post-marketing clinical trials are subject to Good Clinical Practice. We conducted a web-based questionnaire survey on the ethical conduct of PMSs in collaboration with the Japanese Society of Hospital Pharmacists and pharmacists belonging to the Society. 1819 hospitals around Japan answered the questionnaire, of which 503 hospitals had conducted company-sponsored PMSs in 2015. 40.2% of the hospitals had obtained informed consent from participating patients in at least one PMS conducted in 2015, the majority of which was in written form. The first and second most frequent reasons for seeking informed consent in PMSs were to meet protocol requirements, followed by the requirement to meet institutional standard operational procedures and the request of the ethical review board of the hospital. Ethical review of PMSs was conducted in 251 hospitals. Despite a lack of standards for informed consent and ethical review in PMSs, a considerable number of study sites employed informed consent and ethical review for PMSs. While company policies and protocols are likely to be major determinants of the ethical conduct of PMSs, the governmental regulatory agency should also play a significant role in implementing a standardized ethical code for the conduct of PMSs.

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

    Science.gov (United States)

    King, Cheryl A.; Kramer, Anne C.

    2008-01-01

    Intervention research with youths at elevated risk for suicidal behavior and suicide--a vulnerable and high risk population--presents investigators with numerous ethical challenges. This report specifically addresses those challenges involving the informed consent and assent process with parents/guardians and youths. The challenges are delineated…

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

    Science.gov (United States)

    Papadimos, Thomas J; Papadimos, Alexa T

    2004-01-01

    Rising tuition costs have forced university students to become creative in finding ways to fund their education. Some female university students have decided that ova donation may be an acceptable alternative in which to pay for their tuition. This alternative presents itself because of the insufficient number of ova available for assisted reproduction and emerging stem cell technologies. Young female university students are encouraged by Internet sources and respectable electronic and print media to donate their ova in the cause of assisted reproduction for monetary compensation. While university students generally exhibit autonomy, the constraining influence of their financial predicament compromises the elements of informed consent (voluntariness, competence, capacity, understanding, and disclosure) as to their making an autonomous decision in regard to egg donation. Thus, any moral possibility of giving informed consent is negated. Informed consent can only occur through autonomy. A female university student in need of financial resources to pay for her education cannot make an autonomous choice to trade her genes for tuition. Donated ova are not only needed for assisted reproduction, but for stem cell technologies. While the long-term health of women who donate their ova is of concern (a potential risk of cancer after long term use of ovulation induction), of equal concern is the possibility of a growth in the trade of ova targeting third world and Eastern European women where the precedence for autonomy and informed consent is not well established. PMID:15248892

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

    Directory of Open Access Journals (Sweden)

    Papadimos Alexa T

    2004-07-01

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

  11. A case of inappropriate apolipoprotein e testing in Alzheimer's disease due to lack of an informed consent discussion.

    Science.gov (United States)

    Furman, Christian D; Earnshaw, Lori A; Doukas, David J; Farrer, Lindsay A; Friedland, Robert P

    2014-11-01

    Apolipoprotein E (APOE) genetic testing is used to assist in the diagnosis of Alzheimer's Disease (AD). Whenever genetic testing is performed, an informed consent process should occur. In this case, a patient with memory loss presented to the neurologist. The neurologist ordered a lumbar puncture (LP). The LP was performed by a neuroradiologist who also ordered APOE genetic testing. The patient received no genetic counseling, nor was an informed consent document offered. After the testing was completed, the neurologist faced an ethical dilemma. His solution was to offer the genetic testing to the patient in order to have an informed consent process. It was clear that the patient and her adult children did not want the genetic testing and that they would have been burdened with the results. The neurologist opted not to disclose the results. Genetic counseling and a signed informed consent document are required prior to any genetic testing. In this case, neither occurred and it led to an ethical dilemma that was ultimately resolved by the neurologist. As the population ages and AD becomes more prevalent, there is a need to expand the workforce of genetic counselors and educate physicians who commonly treat AD about genetic testing. © The Author(s) 2014.

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

    Science.gov (United States)

    Lad, Pramod M; Dahl, Rebecca

    2014-01-01

    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.

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

    Science.gov (United States)

    2011-01-01

    the websites. Finally, brokers' roles in follow up care, their prices, and the speed of surgery were the most commonly included business dimensions on the reviewed websites. Conclusion Canadian medical tourism brokers currently lack a common standard of care and accreditation, and are widely lacking in providing adequate risk communication for potential medical tourists. This ha