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On November 8, 1978, the Public Health Service Act (Pub. L. 95-622) was amended, thereby creating the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. One of the charges of the Commission was to biennially report to the President, the Congress, and appropriate Federal agencies on the protection of human subjects of biomedical and behavioral research. In carrying out the above, the Commission was directed to include a review of the adequacy and uniformity (1) of the rules, policies, guidelines, and regulations of all Federal agencies regarding the protection of human subjects of biomedical or behavioral research which such agencies conduct or support, and (2) of the implementation of such rules, policies, guidelines, and regulations by such agencies, and may include such recommendations for legislation and administrative action as the Commission deems appropriate.
Individualism, in both its political and attitudinal senses, reinforces societal and institutional racism in the United States. Because of individualism's dominant focus on self-interest and self-reliance, any application of "participatory democracy" in community-based biomedical and behavioral research is fraught with dilemmas similar to those that Gunnar Myrdal observed between American racism and democracy. The research establishment is overwhelmed by well-meaning non-minorities who recognize racism and its consequences in health, but only greater representation of people-of-color in the health establishment can ameliorate the inherent contradictions of "participatory democracy" which is so fundamental to the process of community-based participatory research.
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Moral postures concerning research involving human subjects are diverse in part because of the diversity of issues at stake in, for example, disputes over conflicts of rights and duties, concerning values, and with regard to duties to persons with interests in goods and values. I have presented three ethical principles around which to gather these questions: I) respect for human subjects as free agents; II) concern to foster the best interests of human subjects; and III) concern to maximize the benefits accruable to society. I have indicated that these three abstract considerations arise around four procedural foci for research involving humans: A) the requirement of free and informed consent of competent human subjects; B) the requirement of proxy consent from incompetent human subjects; C) the avoidance of coercion in the consent context; and D) an interest in having research involving humans redound to the general good of society. These are at best guidelines, or outlines, of the central ethical issues at stake. They must in each case of research be applied with care and followed with prudence. One can never have a means of simply deducing answers. Basic ethical principles represent, rather, our best attempt to map out the terrain of rights and values.
This notice requests public comment on the Report of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research entitled "compensating Research Subjects," which was issued in June 1982.
Many critics of U.S. regulation to protect human subjects of biomedical and behavioral research deem the system inherently unworkable and variously inadequate or unnecessary. Many deem its rationale, the Belmont Report, outdated and philosophically deficient. Some would scrap or revamp the system. These criticisms and prescriptions are challenging factually, legally, and ethically. Similar minimalist, audited self-regulation operates smoothly elsewhere in life science. Events suggest Belmont's continuing validity in its administrative-law role as interpretive touchstone for human subjects protection regulations. U.S. human subjects protection and related regulations are constitutionally grounded and consistent with U.S. obligations under human rights law. Criticisms that the system is inconvenient do not respond to ethical and legal duties--to acknowledge the innate dignity of human subjects of research, to recognize and squarely face ethical issues in human subjects research, to heed applicable domestic and international law, to say no to projects when no is warranted, to foster researcher involvement in the system, to focus on substance rather than form, and to resist automaticity. If the system is to function protectively and reasonably efficiently, then the legitimacy of the pertinent law and Belmont's legal role should be recognized as the primary resource for interpreting the human subjects regulations; the system and proposed changes should be viewed critically for efficacy rather than convenience; and policy and practice should emphasize (a) predictability, stability, and clarity of the regulatory system, and (b) resources and will to comply and enforce.
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As nursing homes become increasingly important sites for biomedical and behavioral research, researchers must address the ethical problems of increased vulnerability and the high prevalence of mental and physical disorders in the nursing home population. Obtaining valid informed consent is but one of the many difficult issues that confronts the investigator in the nursing home. Efforts should be made to involve nursing home residents, as well as family and staff members, in the review of research. The benefits and burdens of research protocols should be equitably distributed, and potential conflicts of interest for staff members and physicians should be minimized or their potential adverse impact ameliorated. Appropriate attention to these ethical concerns may facilitate nursing home research while still safeguarding vulnerable residents. We offer proposed guidelines for the ethical conduct of research in nursing homes in an effort to stimulate discussion among investigators, nursing home staff and residents, residents' families, and ethicists.
This notice summarizes the reports of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, provides information on how these reports may be obtained, and requests public comment on the reports. The following summaries are intended to highlight conclusions and recommendations and do not provide in themselves complete information. It is strongly suggested that interested persons obtain complete copies of reports in order to fully understand the context in which various conclusions and recommendations were made.
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