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Section IV. Ethical Directives for Human Research


German Guidelines on Human Experimentation [1931]

Nuremberg Code [1947]

Principles for Those in Research and Experimentation, World Medical Association [1954]

Article Seven, International Covenant on Civil and Political Rights, General Assembly of the United Nations [1958]

Declaration of Helsinki, World Medical Association [1964, revised 1975, 1983, 1989, 1996, 2000]

The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research [1979]

DHHS Regulations for the Protection of Human Subjects (45 CFR 46) [June 18, 1991]

Summary Report of the International Summit Conference on Bioethics [1987]

Recommendation No. R (90) 3 of the Committee of Ministers to Member States Concerning Medical Research on Human Beings, Council of Europe [1990]

International Ethical Guidelines for Biomedical Research Involving Human Subjects, Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization [1993, revised 2000]

Directives pertaining to the ethics of research on human subjects generally fall into two categories: (1) national or international policies and/or laws and (2) policies of professional groups, e.g., medicine, nursing, epidemiology, and psychology. In addition, directives may pertain either to research in general or to specific types of research. For example, the U.S. Food and Drug Administration (FDA), the Recombinant DNA Advisory Committee of the National Institutes of Health, and the Medical Research Council of Canada all have guidelines governing gene therapy, investigational drugs, or reproductive technologies; and the Ethics Committee of the American Fertility Society has issued a comprehensive document, "Ethical Considerations of the New Reproductive Technologies.

Due to space limitations, research directives issued by professional associations and those pertaining to specific areas of research are not printed in this section; but a selection of such documents are listed in the bibliography to the Appendix. In addition, some of the professional codes included in other sections contain guidelines on research.

The documents in this section are organized chronologically except for the 1991 United States DHHS regulations, which follow The Belmont Report because of the two documents' interdependence.

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