support staff of 12 and further assisted by a number of consultants from medicine, philosophy, law, and the social and natural sciences. The public was allowed access to the commission's deliberations, as well as to draft papers; the commission also held several public hearings and made site visits. During its four years, the National Commission issued ten reports: five dealt with special groups of subjects (fetuses, prisoners, children, patients undergoing psychosurgery, and the institutionalized mentally infirm); two dealt with research review (reports on IRBs and on disclosure of information under the Freedom of Information Act); one provided ethical guidelines for delivery of health services by DHEW; and one reported the results of the "special study" (the implications of research advances, the topic inherited from the Mondale bill).

The best-known of the National Commission's reports was the Belmont Report (1978a), which abstracted the general principles for protection of research subjects that lay behind its other reports on particular aspects of biomedical and behavioral research. It set forth three comprehensive principles to "serve as a basic justification for the many practical ethical prescriptions and evaluation of human actions": (1) respect for persons, (2) beneficence, and (3) justice. Respect for persons requires that individuals be treated as autonomous agents, while persons with diminished autonomy are entitled to protection. Beneficence calls not only for protecting individuals from harm, but also for making efforts to secure their well-being.1 Justice relates to fairness in distribution of the benefits and burdens of research. The commission's provision of these explicit principles for the analysis of ethical issues in language that was clear and accessible to a lay audience enabled the general public to engage in informed and effective discussion of such issues, and opened up a whole new field for public discourse.

The recommendations in the commission's report on fetal research were made in May 1975 and were quickly translated into proposed federal regulations. In that instance, DHEW's need for regulations was at least as important in provoking a rapid response as was the commission's statutory "action-forcing power" (i.e., the secretary had to either accept the commission's recommendations or make public the reasons for rejection). Not all of the commission's recommendations were as influential, however, and while its core points provided the basis for what are now government-wide regulations on human subjects research, several of the reports had little influence. For example, DHEW did not respond to the commission's report on the institutionalized mentally infirm (1978c). But in light of the novel nature of this enterprise, the work of the commission was impressive:

1  

While the Belmont Report did not employ the term "non-maleficence" (to do no harm), the language it employed makes it clear that it encompasses this notion in the discussion of beneficence.



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