Conflict of interest issues in informed consent for research on human subjects: a South Asian perspective

Health research for progress in the control and conquest of disease afflicting man is unquestionable. Concerns arise when motives other than the advancement of scientific knowledge and benefit for individuals and society are the driving force behind clinical trials. These conflicts of interests become even more pronounced when dealing with populations rendered vulnerable by virtue of poverty and ignorance. South Asia with its teeming millions represents one such region. This essay examines the reasons that make this population vulnerable to exploitation. Informed consent in the process of research is an area where such conflicts are prone to arise. In order to ensure that conflicting interests of researchers and funding agencies are kept in check, the processes of informed consent and ethical review of research need to be strengthened. Suggestions are put forward to modify the consent process to match the needs of South Asia and to strengthen the ethical review process for safeguarding the rights of the study subjects. But perhaps the most important safeguard against exploitation is the virtuous researcher himself with noble intentions. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.     

Problems for biomedical research at the academia-industrial interface

Throughout much of the world, universities have driven towards industrial partnerships. This collaboration, which, in the biochemical field at least, has to continue if potential benefits for patients are to be realised, has brought with it a number of problems. These include the neglect of long-term research in favour of short-term projects, the curtailing of free dissemination of research information within university departments and the biasing of results of clinical trials by the financial interests of the investigators. It is very important that governments, universities, and industry itself address these problems. Universities should monitor the amount of basic, curiosity-driven research that is being carried on, compared with that which is more short-term goal orientated. PhD students and post-doctoral fellows should be exposed to the principles of bioethics early on in their careers. Further work is necessary on the terms of research contracts to protect, on the one hand, the rights of individual scientists and, on the other, industry from rogue scientists. Where problems arise, procedures should be in place for independent reviews to be conducted by bodies such as the Medical Research Council in the UK or the National Institutes of Health in the USA. The conflict-of-interest rules recently introduced for publication in medical journals should be extended to all branches of science.     

The Limitations of “Vulnerability” as a Protection for Human Research Participants

Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in the context of research, particularly international research, that the concept has lost force. In addition, classifying groups as vulnerable not only stereotypes them, but also may not reliably protect many individuals from harm. Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges.     

精神疾病诊断:科学的判断?伦理的判断?

自精神病学纳入医学的范畴之后,精神疾病的诊断因为其所声称的科学手段而被认为是科学的判断.20世纪中叶开始的反精神病学运动全面否定其科学性,认为精神疾病的诊断是单纯的伦理价值判断.两种观点都显得过于极端.精神疾病的特殊性决定了精神疾病的诊断是科学判断基础上的伦理判断.其中科学的判断不是决定性的,而是基础性的.决定性的是伦理的判断,只是这种伦理判断必须建立在科学判断的基础之上而已.     

Debriefing and accountability in deceptive research

Debriefing is a standard ethical requirement for human research involving the use of deception. Little systematic attention, however, has been devoted to explaining the ethical significance of debriefing and the specific ethical functions that it serves. In this article, we develop an account of debriefing as a tool of moral accountability for the prima facie wrong of deception. Specifically, we contend that debriefing should include a responsibility to promote transparency by explaining the deception and its rationale, to provide an apology to subjects for infringing the principle of respect for persons, and to offer subjects an opportunity to withdraw their data. We also present recommendations concerning the discussion of deception in scientific articles reporting the results of research using deception.     

The Rise of Citizen Science in Health and Biomedical Research

Citizen science models of public participation in scientific research represent a growing area of opportunity for health and biomedical research, as well as new impetus for more collaborative forms of engagement in large-scale research. However, this also surfaces a variety of ethical issues that both fall outside of and build upon the standard human subjects concerns in bioethics. This article provides background on citizen science, examples of current projects in the field, and discussion of established and emerging ethical issues for citizen science in health and biomedical research.     

Conflicts of interests and access to information resulting from biomedical research: an international legal perspective

Recently adopted international texts have given a new focus on conflicts of interests and access to information resulting from biomedical research. They confirmed ethical review committees as a central point to guarantee individual rights and the effective application of ethical principles. Therefore specific attention should be paid in giving such committees all the facilities necessary to keep them independent and qualified. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.     

Ethical and Legal Guidance for Mental Health Practitioners Who Wish to Conduct Research in a Private Practice Setting

Mental health practitioners, even when they have research training, rarely contribute to the scientific literature. One reason for this may be that they need help addressing the ethical and legal issues they encounter as they contemplate undertaking research in a clinical practice setting. To address that need, we offer several types of guidance for conducting research in a private practice setting in a way that meets high ethical and legal standards. We describe the situations in which ethical review of a research proposal by a federally registered institutional review board (IRB) is legally required, and identify alternate mechanisms that practitioners can use to obtain an ethical review when a formal IRB review is not required by law. We discuss legal and ethical requirements of conducting single-case studies in a practice setting. We provide a rationale, and free and inexpensive options, for obtaining a formal certificate of training in human subjects research. And we offer guidance for obtaining informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization from research participants. We conclude with a brief discussion of other legal and professional issues to consider when conducting research in private practice.     

Ethical decision-making in research: Identifying all competing interests

Ethical dilemmas are the result of conflicts between potential benefits or harms for two or more competing interests. Therefore, ethical decision-making implies a responsibility to identify those interests, harms, and benefits. For this purpose, researchers have responsibilities to the research, the subjects of research, other researchers, the institution, society, the environment, and self.     

美国人类受试者使用的历史

所有关于研究伦理的国际法典及实际中的关于人体受试者研究领域的各国立法及规则都表明了保护主义的姿态,他们的主旨是保护个人不受伤害和剥削。这种保护主义姿态有其重要的历史原因,起草这些文件具有这样的目的;保证像被纳粹医生-研究者犯下的罪行,试验药物Thalidomide引发的灾难及Tuskegee梅毒研究对伦理道德的亵渎永远不会重演,近些年来社会对临床研究的理解已发生了戏剧性转变,如经AIDS积极分子努力的结果,人们已以宽容和有益的心态广泛接受临床试验。虽然这种姿态的转变已产生了在指导进行临床研究方面的政策及实践某些重要的改善,但人们必须认识到,这种新的接受正像先前的过度保护主义一样的错误,其应该维护一个平衡的比例。我们的政策应反映出鼓励符合伦理学的研究的要求,同时要保持必要的防范以保护受试者的权益。     

The continuing need for disinterested research

For scientific knowledge to be trustworthy, it needs to be dissociated from material interests. Disinterested research also performs other important non-instrumental roles. In particular, academic science has traditionally provided society with reliable, imaginative public knowledge and independent, self-critical expertise. But this type of science is not compatible with the practice of instrumental research, which is typically proprietary, prosaic, pragmatic and partisan. With ever-increasing dependence on commercial or state funding, all modes of knowledge production are merging into a new, ‘post-academic’ research culture which is dominated by utilitarian goals. Growing concern about conflicts of interest is thus a symptom of deep-seated malaise in science and medicine. An expanded version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.     

Ethical challenges in the COVID-19 research context: a toolkit for supporting analysis and resolution

ABSTRACTCOVID-19 is compromising all aspects of society, with devastating impacts on health, political, social, economic and educational spheres. A premium is being placed on scientific research as the source of possible solutions, with a situational imperative to carry out investigations at an accelerated rate. There is a major challenge not to neglect ethical standards, in a context where doing so may mean the difference between life and death. In this paper we offer a rubric for considering the ethical challenges in COVID-19 related research, in the form of an ethics toolkit for global research developed at the University of Edinburgh in collaboration with more than 200 global researchers from around the world. This toolkit provides a framework to support confrontation of ethical conflicts through the integrated and iterative analysis of Place, People, Principles and Precedents, throughout the research journey. Two case analyses are offered to exemplify the utility of the toolkit as a flexible and dynamic tool to promote ethical research in the context of COVID-19.     

Informed consent as a prescription calling for debate between analysts and researchers(1)

This article is a review of the international scientific literature on informed consent and its use in some of the constituent organizations of the International Psychoanalytical Association (IPA). Because psychoanalysis comprises a theory based on practice, the dearth of clinical material for study, training and research purposes is a serious problem for analysts. Supervisions, presentations at scientific societies and congresses, publications and teaching material involve patients to an extent that goes beyond the work done in their sessions. Should consent be requested in these cases? This contribution addresses controversial and long‐standing issues such as informed consent and confidentiality, audio recording of treatments, knowledge production, the ambivalence of participating subjects over time and the perspective of analysts and patients respectively. The authors consider the various alternative approaches available for the handling of these ethical dilemmas without losing sight of the patient’s dignity and personal rights, while also taking account of the position of the analyst.     

Biobank research and the right to privacy

What is privacy? What does privacy mean in relation to biobanking, in what way do the participants have an interest in privacy, (why) is there a right to privacy, and how should the privacy issue be regulated when it comes to biobank research? A relational view of privacy is argued for in this article, which takes as its basis a general discussion of several concepts of privacy and attempts at grounding privacy rights. In promoting and protecting the rights that participants in biobank research might have to privacy, it is argued that their interests should be related to the specific context of the provision and reception of health care that participation in biobank research is connected with. Rather than just granting participants an exclusive right to or ownership of their health information, which must be waived in order to make biobank research possible, the privacy aspect of health information should be viewed in light of the moral rights and duties that accompany any involvement in a research based system of health services.     

A WAY FORWARD FOR SOCIOLOGICAL RESEARCH ON SCIENCE AND RELIGION: A REVIEW AND A RIFF

John Evans’s new book Morals Not Knowledge pushes scholars to rethink contemporary debates about religion and science by moving past the rhetoric of societal elites to examine the perspectives of everyday Americans, identifying the moral conflicts at the heart of debates. We review Evans’s key contributions while also extending and challenging his arguments, urging consideration of how renewed moral debates might be informed by a broader set of U.S. “publics.” Drawing on empirical research, we highlight four sets of voices that are missing from Evans’s analysis. Specifically, we highlight the voices of racial and ethnic minorities, religious communities (as opposed to individuals), members of minority religious traditions, and everyday religious scientists. Through doing so we offer avenues for future research on these diverse publics that will help facilitate a broader set of better and more informed debates about moral conflict between religious and scientific communities.     

Are social networking profiles reliable indicators of sensational interests?

Sensational interests are sometimes reported on the personal profiles of social networking web sites such as Facebook. Can these reports be validated against established psychometric tools used by forensic psychologists? Given that web sites and personal profiles can be used as evidence of a person’s ‘character’ in legal contexts, evaluating their reliability and validity is important. This study evaluated the reliability of extracting data from the interests and activities sections of Facebook profiles, linking them to general personality and Sensational Interests Questionnaire (SIQ) scores. Data from 694 user profiles (N = 352 males) were linked to the Big Five personality traits, age, and educational attainment. Three independent raters coded the number of sensational topics reported by a user in each section. In Poisson regression analyses, higher SIQ Violent Occultism scores predicted a larger count of sensational interests, and sensational activities in males only. Higher SIQ Militarism scores predicted a larger number of sensational interests in males, but a smaller number in females. Although the number of sensational interests reported by social networking users on their personal profiles is potentially informative, further research should investigate gender differences, and why females with greater Militarism scores are less likely to report what these specific interests are.     

Evidence-Based Ethical Problem Solving: An Idea Whose Time Has Come

This is an account of the evolution of ideas and the confluence of support and vision that has eventuated in the founding of the Journal of Empirical Research on Human Research Ethics (JERHRE). Many factors have contributed to the creation of this rather atypical academic journal, including a scientific and administrative culture that finally saw the need for it, modern electronic technology, individuals across the world who were committed to somehow finding common ground between researchers and those charged with ethical oversight of research, a network of helpful colleagues, and a university whose administration gave moral support to the endeavor in a time of fiscal austerity. Perhaps equally important were the decisions to make JERHRE a nonprofit undertaking, to emphasize the implications of empirical research for specific best practices, to serve the educational needs of those concerned with human research, and to seek to stimulate the interest of students in gaining an evidence-based understanding of the research contexts in which they decide to work. This article explores the ‘chemistry’ that has made it possible to develop a somewhat unorthodox journal and set of related activities.     

Nonrelativist Ethical Standards for Goal Setting in Psychotherapy

A number of authors have commented on the topic of mandated reporting in cases of suspected child maltreatment and the application of this requirement to researchers. Most of these commentaries focus on the interpretation of current legal standards and offer opinions for or against the imposition of mandated reporting laws on research activities. Authors on both sides of the issue offer ethical arguments, although a direct comparison and analysis of these opposing arguments is rare. This article critically examines the ethical arguments made by authors on both sides of the debate. The conclusion is reached that researchers should be mandated reporters of child maltreatment because the current arguments do not justify their exclusion from current ethical and legal standards. The author makes recommendations for the ethically responsible conduct of research in regard to this topic and legal implications are discussed.