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July 16, 1982

Ethics and Regulation of Clinical Research

JAMA. 1982;248(3):371. doi:10.1001/jama.1982.03330030069036

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Research with human subjects is an essential part of modern medicine. Since the 1960s, when knowledge of research abuses surfaced and federal regulation of human subject research began, it has been a focus of ethical and regulatory controversy. Today, a regulatory system of prior review by mixed-peer bodies, called "institutional review boards" (IRBs), is firmly in place in every hospital, medical school, and research facility in the country.

Robert Levine's Ethics and Regulation of Clinical Research is an excellent summary of the key ethical and regulatory issues that arise in running the IRB system. The author draws on his wide experience in human subject research as chair of the Human Use Committee of the Yale University School of Medicine, as consultant and member of various national commissions, as editor of Clinical Research and IRB: A Review of Human Subject Research, and as a prolific writer and speaker on the subject.