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Ethical Considerations in Human Experimentation

During the past several years, there has been increasing interest in and concern for the ethical and moral considerations that pertain to the conduct of biomedical research in human beings. At the present time, before approving a research project, virtually all private or governmental agencies in the United States that support clinical research require written assurances from prospective investigators or institutions, that the rights and welfare of participating human subjects will be protected during all phases of the study. Research institutions have thus established committees to review proposed research in human subjects at their institutions, or utilize ad hoc committees for this purpose. Review committees must be competent to review a proposed study scientifically and to determine the acceptability of the study in terms of local law, standards of professional conduct and community practice. These committees should include a variety of professional and scientific personnel from the institution, as well as representatives from the community, such as lawyers, clergymen, or members of consumer-interest groups who may add other dimensions to the opinion of the scientific or professional members. BASIC PRINCIPLES OF ETHICS IN RESEARCH INVOLVING HUMAN SUBJECTS.-Any research that involves human subjects must be based upon scientific principles that provide a sound rationale for the research. The justification for the research should be based upon findings obtained from laboratory or animal experiments, findings from other clinical studies, or scientifically established facts. Research involving human subjects should be conducted by or be under the supervision of clinical investigators who are scientifically qualified and experienced. All study personnel should be skilled and exercise great care in carrying out the study's procedures. The principal clinical investiga-