Protection of human subjects; standards for institutional review boards for clinical investigations--Food and Drug Administration. Final rule.

The Food and Drug Administration (FDA or agency) is establishing standards governing the composition, operation, and responsibility of institutional review boards (IRBs) that review clinical investigations, involving human subjects, conducted pursuant to requirements for prior submission to FDA or conducted in support of applications for permission to conduct further research or to market regulated products. These regulations and the protection of human research subjects regulations adopted by the Department of Health and Human Services (HHS or Department) published in the January 26, 1981 issue of the Federal Register, establish a common framework for the operation of IRBs that review research funded by HHS and research conducted under FDA regulatory requirements. Compliance with these regulations is intended to provide protection of the rights and welfare of human subjects involved in clinical investigations.