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May 23, 1980

Protecting and informing human research subjects

JAMA. 1980;243(20):1985-1993. doi:10.1001/jama.1980.03300460005002

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Most physicians in private practice will never encounter an Institutional Review Board (IRB) and probably have only a vague notion of what such an entity does.

Yet IRBs—which review human research proposals at medical schools and large hospitals to ensure that subjects' rights are protected—can be instrumental in expanding or limiting the office practitioner's future therapeutic arsenal, asserts Sanford Chodosh, MD.

"The therapies of today are based on the research of five to ten years ago," points out Chodosh, a clinical investigator at Boston University School of Medicine and chairman of the IRB at Boston City Hospital. Following revelations several years ago that a few investigators had disregarded subjects' rights, "a real threat to development of new therapies emerged in the form of [government] regulation that inhibits some clinical research," he adds.

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In this climate, "the IRB has the responsibility for promoting