BOX B-1

National Research Act Section 202(a)(2)

The Commission shall identify the requirements for informed consent to participation in biomedical and behavioral research by … prisoners … The Commission shall investigate and study biomedical and behavioral research conducted or supported under programs administered by the Secretary [DHEW] and involving prisoners…to determine the nature of the consent obtained from such persons or their legal representatives before such persons were involved in such research; the adequacy of the information given them respecting the nature and purpose of the research, procedures to be used, risks and discomforts, anticipated benefits from their research, and other matters necessary for informed consent; and the competence and the freedom of the persons to make a choice for or against involvement in such research. On the basis of such investigation and study the Commission shall make such recommendations to the Secretary as it determines appropriate to assure that biomedical and behavioral research conducted or supported under programs administered by him meets the requirements respecting informed consent identified by the Commission.

In carrying out this charge, the commission used elements of a principle-based ethical framework that would be more fully fleshed out in the Belmont Report (NCPHSBBR, 1976a), a response to its charge to identify the relevant ethical principles that relate to and support research with human subjects. This 20-page document discussed the line to be drawn between practice of biomedical and behavioral therapy and research in those areas. It identified three philosophical principles or general prescriptive judgments that were particularly relevant to research with human subjects: respect for persons, beneficence, and justice.

The first principle—respect for persons—“incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection” (NCPHSBBR, 1979a). The second principle—beneficence—demands that persons be “treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being” (NCPHSBBR, 1979a). The concerns of the final principle—justice—are found in the answer to the question that the report poses: “Who ought to receive the benefits of research and bear its burdens?” (NCPHSBBR, 1979a). It is clear that the concerns raised by the report remain central to the analysis of this document.



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