Consent In Medical Research Research Articles

Incentivization and the moral problem of involuntary consent in medical research

Incentivization and the moral problem of involuntary consent in medical research

The value of communities and their consent: A communitarian justification of community consent in medical research.

Community engagement is increasingly defended as an ethical requirement for biomedical research. Some forms of community engagement involve asking the consent of community leaders prior to seeking informed consent from community members. Although community consent does not replace individual consent, it could problematically restrict the autonomy of community members by precluding them from research when community leaders withhold their permission. Community consent is therefore at odds with one of the central principles of bioethics: respecting autonomy. This raises the question as to how community consent can be justified or even required. This paper aims to provide an answer to this question by arguing, based on the work of Taylor and Kymlicka, that community practices are important for the identity and autonomy of community members. When these practices are incompatible with a solitary focus on individual informed consent, they need to be protected by making these decision-making practices (including asking permission to community authorities) part of the consent process. Since these decision-making practices are important for the autonomy of community members, community consent with the goal of protecting these practices is not necessarily in conflict with autonomy.

Examining consent for interventional research in potential deceased organ donors: a narrative review.

In the last decade, research in transplant medicine has focused on developing interventions in the management of the deceased organ donor to improve the quality and quantity of transplantable organs. Despite the promise of interventional donor research, there remain debates about the ethics of this research, specifically regarding gaining research consent. Here, we examine the concerns and ambiguities around consent for interventional donor research, which incorporate questions about who should consent for interventional donor research and what people are being asked to consent for. We highlight the US and UK policy responses to these concerns and argue that, whereas guidance in this area has done much to clarify these ambiguities, there is little consideration of the nature, practicalities and context around consent in this area, particularly regarding organ donors and their families. We review wider studies of consent in critical care research and social science studies of consent in medical research, to gain a broader view of consent in this area as a relational and contextual process. We contend a lack of consideration has been given to: what it might mean to consent to interventional donor research; how families, patients and health professionals might experience providing and seeking this consent; who is best placed to have these discussions; and the socio-institutional contexts affecting these processes. Further, empirical research is required to establish an ethical and sensitive model for consent in interventional donor research, ensuring the principles enshrined in research ethics are met and public trust in organ donation is maintained.

Previous Involvement in Research and Knowledge Regarding Basic Research Methods Among Doctors Working at Primary Care in Central Region, Saudi Arabia.

Introduction:The cumulative outcomes of health research in the modern times had a huge effect on human health and longevity. The primary care physicians are the first point of contact between the health system and the society. Therefore their responsibility is higher to provide the latest information to their patients, in the context of rapidly changing field of medical science. Doctors are expected to have a basic knowledge of research methodology in order to develop a critical thinking and this is the rationale to include the research activity is an integral part of post-graduate medical training.Aim:We aimed to assess the previous involvement in research activities and knowledge in basic research methods among primary care physicians in central region, Saudi Arabia.Methods:It was a cross sectional descriptive study conducted on a conveniently selected sample of doctors (N=80) working under general directorate of health affairs in Riyadh region, Ministry of Health. The data was collected through a pre-designed, self-administered survey instrument containing closed ended questions.Results:The mean age of the physicians was observed to be 44.7 ± 9.6 years. About 32% doctors had previous experience of writing a research proposal while only 20% had any publication in a scientific journal. About 45% had attended workshop on research methodology within last five years. Only one item related to ‘consent in medical research’ was answered correctly by 60% respondents. The correct responses in other knowledge items scored less than 50% (ranging from 18.8% to 37.5%). The proportion of doctors having any publication was observed to significantly higher among younger age (p<0.05). Significantly higher proportion was observed for “having experience of proposal writing” and “paper presentation in a scientific conference” among family medicine and other specialties as compared to general practice (p<0.05).Conclusion:We found low previous engagement with research among doctors with low level of knowledge regarding basic research methods. This was particularly evident among general practitioners as compared specialist doctors. Regular conduction of research workshop with encouragement to undertake small research activities at the primary care should be promoted.

Myth or Magic? Towards a Revised Theory of Informed Consent in Medical Research.

Although the principle of informed consent is well established and its importance widely acknowledged, it has met with criticism for decades. Doubts have been raised for a number of different reasons. In particular, empirical data show that people regularly fail to reproduce the information provided to them. Many critics agree, therefore, that the received concept of informed consent is no more than a myth. Strategies to overcome this problem often rest on a flawed concept of informed consent. In this paper, it is suggested that informed consent is a communicative act between two persons. The challenge is to elucidate the norms and constraints for successfully performing such a communicative act. The view developed here has major consequences with regard to the standards for information disclosure as well as for the general scope of informed consent.

Authentication of Patients and Participants in Health Information Exchange and Consent for Medical Research: A Key Step for Privacy Protection, Respect for Autonomy, and Trustworthiness.

Genome and other data are already being used in areas including cancer and rare diseases. Data-sharing and secondary uses are likely to become much broader and far more extensive; thus, obtaining proper consent for these new uses of data is an important issue. Obtaining consent through online methods may be an option to overcome the problems associated with one-off, paper-based informed consent. When the process of obtaining consent takes place remotely, authentication must be assured. Patients may also choose to store some of their own information online, such as genetic information, and allow healthcare professionals to access this data. In this health information transfer and exchange process, it is vital that anyone accessing this information be correctly authenticated to protect patients' privacy. In this article, we first clarified that authentication has two roles: i.e., not only to prevent impersonation but also to prove intent, which is a vital step to ensure that medical research and health information exchange are conducted ethically. We then set out methods of authentication. As a result, we were able to make suggestions about the requirements for authentication and a possible method of authentication for these purposes. We considered problems of biometrics and recommended two-factor authentication without biometrics as a workable solution. However, three-factor authentication including biometrics seems likely to be used once biometrics become more common.

Opt-out as an acceptable method of obtaining consent in medical research: a short report.

BackgroundA prospective cohort study was set up to investigate a possible association between antibiotic prescribing and antibiotic resistance of E. coli urinary tract infection in the community. Participation of patients with urinary tract infection was obtained through an opt-out methodology. This short paper reports on the acceptability of the opt-out recruitment approach.MethodsParticipating practices (22) were requested to send a urine sample from all patients presenting with symptoms of urinary tract infection. Upon receipt of the sample in the laboratory, a letter explaining the study, an opt-out form and a freepost envelope were sent to all adult patients. A website with additional information and including an 'opt-out' button was set up for the study.ResultsA total of 1362 urine samples were submitted by the 22 participating practices representing 1178 adult patients of whom 193 actively responded to the letter: 142 opted out by letter, 15 through the website, 2 by phone and 12 sent the letter back without indication, making a total of 171 patients or 14.5% opt-out; the remaining 22 patients (1.9%) explicitly opted in. The total group consisted of 80% women and the mean age was 50.9 years (sd 20.8). No significant differences were found between patients who participated and those who opted out in terms of age, gender or whether the urine sample was positive or not.ConclusionsOverall the opt-out method was well received and participation in the study reached 85.5%. The low number of complaints (2) indicates that this is a generally acceptable method of patient recruitment. The 14.5% opt-out shows that it effectively empowers patients to decline participation. The similarity between patients opting out and the rest of the patients is reassuring for extrapolation of the results of the study.

Correspondence

The article by Keegan and Levenson on patient confidentiality (vol 71(7), 2010, p. M105) is well written, but does not deal with two matters in the General Medical Council (2009) guidance. The first is that the guidance (paragraphs 36 and 42) advises that public interest can justify disclosure of patient information without consent for medical research. The common law duty of confidentiality underlies the presumption that all information given by a patient to his/her doctor will be treated in confidence and that disclosing it without consent or other legal basis will be a breach of that duty. This is fundamental to maintaining the trust of patients in the custodians of their records, so that they may consult freely.

P66 Opt out as an acceptable method of obtaining consent in medical research

IntroductionA prospective cohort study was set up to investigate a possible association between antibiotic prescribing and antibiotic resistance of Escherichia coli urinary tract infection in the community. A direct link...

Analysis of the status of informed consent in medical research involving human subjects in public hospitals in Shanghai

ObjectivesThe objectives of the study are to understand the current practice of informed consent in medical research in public hospitals in Shanghai, and to share our views with other countries,...

Consent in medical research and its retraction

Consent in medical research and its retraction

Chapter 7: Informed consent and xenotransplantation clinical trials

This essay explores the meaning and implications of informed consent in xenotransplantation clinical trials from both ethically justifiable and international perspectives. In international and national codes and guidelines involving human subject research and in the laws of many nations, the informed consent of research subjects is obligatory. Its moral foundations include and also extend beyond respect for individual persons as autonomous agents in Western nations. Axioms regarding the value of human life and duties to protect innocent and vulnerable persons from harm, duress, and deceit underlie Western individualism and are broadly shared in many non-Western cultures. Accents on family and/or community consent in China and other nations are compatible with individual consent as long as family and community consent supplement, rather than replace, individual consent. Reflecting its moral foundations, informed consent in medical research is rightly characterized as "voluntary" or "freely given" informed consent because it encompasses researchers' disclosure and subjects' comprehension of all the relevant information about the protocol that reasonable persons would want to know in order to freely and affirmatively enroll in the research. The interplay between these conceptual foundations of informed consent and the realities of xenotransplantation research defines what the nature and functions of consent should be in xenotransplantation clinical trials. Because these trials involve a complex body of medical information, numerous procedures, numerous risks (associated with failure rates, immunosuppression, xenogeneic infections, and so on) and the subject's obligation to abide by extensive national and international precautionary guidelines, informed consent should be enacted as an organized, sequential, thoughtfully paced, jargon-free process of communication. The features and functions of consent forms or consent documents should accord with this process. Rather than being virtually equated with informed consent, consent documents should be utilized as templates of relevant, essential, and understandable information that contribute to comprehension and voluntary enrollment. In xenotransplantation clinical research, the consenting process must cover a large number of topics, including treatment choices, participation information, study procedures, information about risks associated with immunosuppression, xenogeneic infections, discomforts, and other matters. In addition, due to infectious risks, subjects are obliged to 10 post-protocol responsibilities. Two of the three unique moral issues regarding informed consent in xenotransplantation trials involve what to do to minimize post-protocol infectious risks and what to do about international and national guidelines that affirm the subject's right to withdraw from participation in medical research at any time. The third moral issue centers on issues involving the enrollment of children and mentally incapacitated adults. The other chapters in this consensus statement demonstrate that, morally and logically, favorable harm-benefit determinations precede considerations of informed consent. When these harm-benefit assessments are favorable enough to warrant the onset of clinical trials, informed consent emerges as a pivotal moral precondition for these trials.

Informed Consent for Medical Research: An Ethical Imperative

Informed Consent for Medical Research: An Ethical Imperative

Not worth the paper it's written on? Informed consent and biobank research in a Norwegian context

In January 2003 the Norwegian Parliament passed the Biobanks Act, regulating biobank research in Norway. There have been strong differences of opinion both in the process of making the law as well as in its first years of implementation. The main controversy relates to what kind of informed consent should be required for biobank research. Central to the controversy over current interpretations of the Biobanks Act is the informed consent given by the donors to the biobank of the Nord-Trøndelag Health Study (HUNT), and whether the consent given ‘was worth the paper it was written on’. This article traces the history behind the informed consent procedure of the blood samples in the largest research biobank in Norway, the HUNT biobank. Second, findings from a focus group study with biobank participants are presented. Third, a philosophical analysis is made of the concept of informed consent in light of the findings from the focus-group study as well as the history behind the HUNT biobank. Findings from the focus-group study show that the consenters base their participation on trust in the researchers and the regulation of research in Norwegian society, rather than on specific information on the research in question. The history behind the HUNT biobank fosters trust. The story provides a strong case for not limiting the debate to legalistic and formalistic ethics but also including a research ethics that says that process and trust matter. Otherwise no informed consent in medical research is worth the paper it is written on.

Book Review: Informed Consent in Medical Research

Book Review: Informed Consent in Medical Research

Informed Consent in Medical Research by L. Doyal and J.S. Tobias

Informed Consent in Medical Research by L. Doyal and J.S. Tobias

Book Review: Informed consent in medical research

Book Review: Informed consent in medical research

Informed consent in medical research

That people should only be enrolled in medical research if they have given free and informed consent is now an unquestioned principle of research ethics. It is however a recent innovation. Prior to the prominence given to consent to participation in research in the condemnation of German doctors arraigned at Nuremberg in 1945, informed consent had appeared in American litigation, but only as an issue in clinical malpractice suits. Informed consent as an ethical requirement in medical research had arisen in some earlier European contexts. Despite the Nuremberg judgement, informed consent by participants in research was not widely recognised as ethically mandatory until the early 1970s. This delay seems to have been due in part to scepticism about the practicability of truly informed consent, but medical paternalism and the circumstances surrounding military research during the Cold War period may have contributed.

The centennial of the Yellow Fever Commission and the use of informed consent in medical research.

The year 2000 marked the centennial of the discovery of the mode of transmission of yellow fever. Informed consent was systematically used for the first time in research. This process was the result of a complex social phenomenon involving the American Public Health Association, the US and Spanish Governments, American and Cuban scientists, the media, and civilian and military volunteers. The public health and medical communities face the AIDS pandemic at the beginning of the 21st Century, as they faced the yellow fever epidemic at the beginning of the 20th Century. Current medical research dilemmas have fueled the debate about the ethical conduct of research in human subjects. The AIDS pandemic is imposing enormous new ethical challenges on the conduct of medical research, especially in the developing world. Reflecting on the yellow fever experiments of 1900, lessons can be learned and applied to the current ethical challenges faced by the international public health research community. The English version of this paper is available too at: http://www.insp.mx/salud/index.html.

Informed Consent for Medical Research by the Elderly

Much has been written about the possible lack of capacity of the elderly, especially certain vulnerable populations of older individuals, to give informed consent for medical research. Several small studies have shown a deficit for comprehension of consent material, by the elderly, especially those with less education, but this appears small in comparison to an overall deficit in the general population. A number of investigations have suggested that deficits in executive control functions (ECFs) may be related to lack of capacity to make clinical judgments, but these have yet to be applied to research. Many methods have been piloted to measure capacity and to improve comprehension, some of which may help, although none has been proved conclusively to do either. As the elderly experience significant morbidity and mortality from a vast array of illnesses, the use of the elderly as subjects of medical research is especially important. To prevent older individuals from being coerced into participating or potentially being harmed by scientific investigation, they must give informed consentto their involvement. However, there are many studies to suggest that they are not well informed. A discussion ensued in the 1970s and 1980s about whether or not the elderly deserved special protection as a class of individuals, based on their possible increased risk during medical experimentation, but it was ultimately decided that, because the majority of elderly are perceived to be cognitively intact, they need not receive additional safeguards (High & Doole, 1995, Behavioral Science and Law, 13, 319-335). The U.S. Department of Health and Human Services in 2000 ( Federal Registrar Rules and Regulations, 46, 8366-8392) reviewed existing protections for subjects of human research and deemed they were inadequate, issuing new guidelines. This article reviews evidence that differences exist between the ability of young and old in their capacity to give consent. Alterations in methods of obtaining consent may help individuals to give a more informed consent, and even enable subjects who lack the capacity to consent, such as cognitively impaired individuals, to participate in research. However an ideal means of screening or altering the consent process has yet to be devised. Many of these methods are briefly considered.