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New International Ethical Guidelines for Research Involving Human Subjects
- Yale University School of Medicine, New Haven, CT 06510. Acknowledgments: Several passages in this editorial are derived from a lecture presented at the Eleventh Annual Meeting of the International Clinical Epidemiology Network (INCLEN), Cairo, Egypt, 26 January 1993, and from a commentary to be published in the INCLEN Newsletter. The CIOMS/WHO International Ethical Guidelines for Biomedical Research Involving Human Subjects can be obtained from CIOMS, c/o World Health Organization, Avenue Appia, 1211 Geneva 27, Switzerland.
In March 1993, the Council of International Organizations of Medical Sciences (CIOMS), in collaboration with the World Health Organization (WHO), issued their International Ethical Guidelines for Biomedical Research Involving Human Subjects [1]. This document, an extensive revision of the CIOMS-WHO guidelines published in 1982 [2], provides guidance for the proper application of the principles of the Declaration of Helsinki [3, 4] and focuses particularly on research sponsored by or initiated in developed countries and carried out in developing countries.
The first international code of ethics for research involving human subjects, the Nuremberg Code, was developed from 1947 to 1949 by the Nuremberg Military Tribunals during their trial of the Nazi physician-researchers; the Code's immediate purpose was to provide a set of standards for judgment of outrages committed in the name of science by the Nazi physician-researchers [3].
In 1964, the World Medical Association issued the Declaration of Helsinki [3, 4], which adapted the principles of the Nuremberg Code to the existential realities of medical research [3]. For example, the Declaration replaced the Nuremberg Code's first principle (The voluntary consent of the human subject is absolutely essential) [4] with a recognition of the legitimacy of proxy consent for research involving children and persons with cognitive impairment. Unlike the Nuremberg Code, the Declaration of Helsinki reflects the fact that research protocols might, and often do, include components expected to provide direct therapeutic, diagnostic, or prophylactic benefit to individual subjects and that ethical justification of such beneficial modalities should differ from that of nonbeneficial procedures.
The 1982 CIOMS-WHO Guidelines added, among other things, a requirement for review and approval of all proposed research by an ethical review committee [2]. The Declaration of Helsinki, even in its third and most recent revision in 1989 [5], calls only …
