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February 25, 1983

Human Subjects Research: A Handbook for Institutional Review Boards

Author Affiliations

Boston University Schools of Medicine and Public Health Boston

JAMA. 1983;249(8):1065. doi:10.1001/jama.1983.03330320063042

This article is only available in the PDF format. Download the PDF to view the article, as well as its associated figures and tables.


According to the editors, this book "is designed to fill the perceived need for an operational guide to IRB function... for the IRB member [and] the IRB staff person." There is a need for such a book, and this volume makes a reasonable, if flawed, attempt to meet it.

Institutional Review Boards (IRBs) have existed in most teaching hospitals for more than 15 years. Their primary purpose is the protection of human subjects, but they also protect the institution and the research enterprise itself. Institutional Review Boards review research proposals to ensure that risks are outweighed by benefits, subjects are protected, and informed consent is obtained.

Few dispute these goals, but IRBs have been criticized for getting involved in minutia and creating red tape. In response, both the Department of Health and Human Services and the Food and Drug Administration issued new regulations in 1981 that streamline review for most