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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.
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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.
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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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