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  1. Clinical Trials and Human Subject Protection

FDA Policy for the Protection of Human Subjects

21 CFR Parts 50 and 56
Informed Consent; Standards for Institutional Review Boards for Clinical Investigations
[Docket No. 87N-0032]
56 FR 28025

June 18, 1991

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug Administration (FDA) is amending its regulations on institutional review boards (IRB's) and on informed consent to conform them to the "Federal Policy for the Protection of Human Research Subjects" (Federal Policy) published elsewhere in this issue of the Federal Register. Existing FDA regulations governing the protection of human subjects share a common core with the Federal Policy and implement the fundamental principles embodied in that policy.

EFFECTIVE DATE: August 19, 1991.

TEXT: https://archives.federalregister.gov/issue_slice/1991/6/18/28023-28032.pdf 

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