President's Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
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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.
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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The theology of John Calvin has deeply affected the American mentality through two streams of thought, Puritanism and Jansenism. These traditions formulate moral problems in terms of absolute, clear principles and avoid casuistic analysis of moral problems. This approach is designated American moralism. This article suggests that the bioethics movement in the United States was stimulated by the moralistic mentality but that the work of the bioethics has departed from this viewpoint.
As the fifth national bioethics commission has concluded its work and a sixth is currently underway, it is time to step back and consider appropriate measures of success. This paper argues that standard measures of commissions' influence fail to fully assess their role as public forums. From the perspective of democratic theory, a critical dimension of this role is public engagement: the ability of a commission to address the concerns of the general public, to learn how average citizens resolve moral issues in healthcare, and to monitor public opinion on the topics addressed in the commission. Such a public forum role is supported by the critical literature within bioethics, which has deemed some commissions successful, supported more generally by the history of bioethics as a reform discourse that has brought socially important values into the medical domain, and supported more generally still by the example of the great social issues commissions of the 1960s.
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In the future there is likely to be a large array of DNA-based tests to diagnose single-gene disorders and to identify predispositions to genetically influenced disorders. This article focuses on ethical, legal, and psychological implications of testing healthy children and adolescents for such disorders. Testing may offer medical or psychological benefits but may harm parent-child bonds or the child's self-concept. Clinicians may encounter situations where they must weigh the child's or adolescent's wishes against wishes of parents. We examine the legal history and current status of minors as health care consumers; psychosocial research on their maturity to make choices; impact of testing on intrafamilial relationships; views of national commissions on appropriate ages of assent and full informed consent; ethical and legal requirements for competence in children and adolescents; and disclosure of genetic information. We propose guidelines for predictive genetic testing and counseling of children and discuss risks and benefits of testing.