BRIEF HISTORY OF DEVELOPING BIOETHICAL GUIDELINES

The German “Guidelines on Human Experimentation” (1931) is thought to be the first guideline for therapeutic and scientific research on human subjects. It remained in force until 1945, but it had no discussion of genetic research. The Nuremberg Code (1947), which considered general guidelines for experiments on human subjects, also had no discussion regarding genetic research.

The World Medical Association issued the first historical predecessor of the Declaration of Helsinki in 1954. Since then, the Declaration has been issued and revised five times. Although the most important aspects of ethical issues concerning research on human subjects were discussed in the last version of the Declaration, special ethical considerations in the field of genetic research such as gene therapy, privacy of genetic information, sex selection, cloning, eugenics, and patent and licensing have not been included.

Respect for persons, beneficence, justice, informed consent, disclosure of information, and volunteerism are some topics that were debated in the Belmont Report, issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979. The U.S. Department of Health and Human Services issued Regulations for the Protection of Human Subjects in 1991. In addition to more detailed explanations regarding some critical bioethical terminology currently in use, this important document addressed the role of Institutional Review Boards (IRB) in addressing human subjects in biomedical research, requirements for and documentation of informed consent, and motherfetus rights during pregnancy.

The Summary Report of the International Summit Conference on Bioethics toward an International Ethic for Research involving Human Subjects of 1987 is a brief document that addresses international cooperation on both the elaboration of principles and on the implementation of ethics review processes involving human subjects. The Council for International Organizations of Medical Sciences, in collaboration with the World Health Organization, issued a series of guidelines for biomedical research involving human subjects in 1993. No particular bioethical consideration in the area of genetic research can be seen in this document. In short, discussions of current topics of ethical problems of genetic research should be included in new versions of international bioethical guidelines.1

1  

Reich, W.T., ed. Encyclopedia of Bioethics. Wiley Interscience, Georgetown: 1995.



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