Rethinking the Belmont Report?

This article reflects on the relevance and applicability of the Belmont Report nearly four decades after its original publication. In an exploration of criticisms that have been raised in response to the report and of significant changes that have occurred within the context of biomedical research, five primary themes arise. These themes include the increasingly vague boundary between research and practice, unique harms to communities that are not addressed by the principle of respect for persons, and how growing complexity and commodification in research have shed light on the importance of transparency. The repercussions of Belmont's emphasis on the protection of vulnerable populations is also explored, as is the relationship between the report's ethical principles and their applications. It is concluded that while the Belmont Report was an impressive response to the ethical issues of its day, the field of research ethics involving human subjects may have outgrown it.

The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research.

On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, thereby creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles. In carrying out the above, the Commission was directed to consider: (a) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (b) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (c) appropriate guidelines for the selection of human subjects for participation in such research and (d) the nature and definition of informed consent in various research settings. The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations. It is the outgrowth of an intensive four-day period of discussions that were held in February 1976 at the Smithsonian Institution's Belmont Conference Center supplemented by the monthly deliberations of the Commission that were held over a period of nearly four years. It is a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects. By publishing the Report in the Federal Register, and providing reprints upon request, the Secretary intends that it may be made readily available to scientists, members of Institutional Review Boards, and Federal employees. The two-volume Appendix, containing the lengthy reports of experts and specialists who assisted the Commission in fulfilling this part of its charge, is available as DHEW Publication No. (OS) 78-0013 and No. (OS) 78-0014, for sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402. Unlike most other reports of the Commission, the Belmont Report does not make specific recommendations for administrative action by the Secretary of Health, Education, and Welfare. Rather, the Commission recommended that the Belmont Report be adopted in its entirety, as a statement of the Department's policy. The Department requests public comment on this recommendation.

Ethical issues relevant to the assessment of suicide risk in nonclinical research settings.

BACKGROUND: Our laboratory recently confronted this issue while conducting research with undergraduate students at the University of Waterloo (UW). Although our main objective was to examine cognitive and genetic features of individuals with schizotypal personality disorder (SPD), the study protocol also entailed the completion of various self-report measures to identify participants deemed at increased risk for suicide. AIMS AND METHODS: This paper seeks to review and discuss the relevant ethical guidelines and legislation that bear upon a psychologist's obligation to further assess and intervene when research participants reveal that they are at increased risk for suicide. RESULTS AND CONCLUSIONS: In the current paper we argue that psychologists are ethically impelled to assess and appropriately intervene in cases of suicide risk, even when such risk is revealed within a research context. We also discuss how any such obligation may potentially be modulated by the research participant's expectations of the role of a psychologist, within such a context. Although the focus of the current paper is on the ethical obligations of psychologists, specifically those practicing within Canada, the relevance of this paper extends to all regulated health professionals conducting research in nonclinical settings.

Deception in psychology: moral costs and benefits of unsought self-knowledge.

Is it ethically permissible to use deception in psychological experiments? We argue that, provided some requirements are satisfied, it is possible to use deceptive methods without producing significant harm to research participants and without any significant violation of their autonomy. We also argue that methodological deception is at least at the moment the only effective means by which one can acquire morally significant information about certain behavioral tendencies. Individuals in general, and research participants in particular, gain self-knowledge which can help them improve their autonomous decision-making. The community gains collective self-knowledge that, once shared, can play a role in shaping education, informing policies and in general creating a more efficient and just society.

Procedural misconceptions and informed consent: insights from empirical research on the clinical trials industry.

This paper provides a simultaneously reflexive and analytical framework to think about obstacles to truly informed consent in social science and biomedical research. To do so, it argues that informed consent often goes awry due to procedural misconceptions built into the research context. The concept of procedural misconception is introduced to describe how individuals respond to what is familiar in research settings and overlook what is different. In the context of biomedical research, procedural misconceptions can be seen to function as root causes of therapeutic misconceptions.

Dissemination to research subjects: operationalizing investigator accountability.

Recent articles have argued from principles of bioethics for the right of research subjects to receive the results of the studies in which they have participated. We argue that accountability is a powerful tool of meso-level analysis appropriate to reasoning about answerability in research ethics, and that it captures the responsibility of researchers to disseminate study results to research subjects. We offer the following features of the research situation as relevant to the manner of dissemination to study subject, in addition to factors already proposed in the literature (risk and impact on health outcome): (a) features of the research subject in relation to identity, personal investment, disease, and community; (b) characteristics of the research study and field of inquiry in relation to certainty and significance; and (c) relationships among the research subjects and the healthcare workers involved in their care and in the research.

Module five: implementation of ethics review.

The objective of this module is to inform you on issues of concern for Research Ethics Committee members and investigators during the review process. The many guidelines on research ethics, including those from the South African Department of Health and the World Health Organisation, will be referred to extensively to educate you on the requirements of Research Ethics Committees. The evolution of the review process in South Africa will be detailed.

Objective assessment of covert antisocial behavior: predictive validity and ethical considerations.

Although less observable than the overt actions of fighting and assault, covert antisocial behaviors such as stealing and property destruction comprise an important subclass of externalizing behavior patterns, displaying considerable predictive power toward delinquency in adolescence. I discuss a laboratory paradigm for objective observation of such behaviors in children that has shown impressive concurrent and predictive validity among samples of boys with and without attention deficit hyperactivity disorder. Addressed herein are crucial questions regarding the ethics of tempting children to steal objects and small amounts of money and to deface property as well as the types of informed consent and debriefing procedures utilized in research with this paradigm. Weighing ethical considerations alongside the ability to predict delinquent behavior presents provocative issues for those interested in understanding the development of antisocial behavior.

DARPA on your mind.

Applied science may once again play a decisive role in changing the face of armed conflict, and the rest of human affairs, by shifting the battlefield to our very brains. The national-security establishment--and particularly the Pentagon's Defense Advanced Research Projects Agency (DARPA)--supports research at the intersection of neuroscience and national security that could ultimately enable authorities to do things like enhance (or muddle, or erase) memory, monitor crowds for individuals whose brain patterns correlate with aggressive behaviors, or control weapons from afar merely with thoughts. What are the dangers of such information falling into "the wrong hands," and are there any "right hands" for this kind of knowledge? Is any extension of human abilities justified by the need for government to protect its society?

Ethics in violence against women research: the sensitive, the dangerous, and the overlooked.

Traditional disciplinary guidelines are inadequate to address some of the ethical dilemmas that emerge when conducting research on violence against women and girls. This article is organized according to the ethical principles of respect for persons, privacy and confidentiality, justice, beneficence, and nonmaleficence. In the article, I describe dilemmas involved in cross-cultural research, research on children, informed consent, voluntariness, coercion, deception, safety, mandated reporting, and dissemination. In the article, I include examples from qualitative and quantitative studies in many nations. I also offer suggestions for researchers and institutional review boards.