Ethics in Human Subjects Research

Ana S. Iltis

During the latter part of the 20th century, significant attention was paid to abuses of human subjects and to the development of a system for overseeing human research and a framework for the ethical conduct of such research. The Code of Federal Regulations (C.F.R.) governs much of the research conducted in the United States or by U.S. investigators abroad. Nevertheless, compliance with the regulations governing human research does not guarantee the ethical conduct of research. The regulations require ethical insight to be interpreted and applied appropriately, and regulations may not capture ethical issues that emerge in light of social changes or scientific and technological developments. The Office of Human Research Protections (OHRP), part of the U.S. Department of Health and Human Services, periodically offers additional guidance; professional organizations and institutions may produce codes of ethics or guidelines that address the ethical conduct of research on humans; and several international codes ...

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