Guidance
Apr 17, 2012

Federal Regulations - ARCHIVED

04/23/2021: This page has been archived. IRBMED Guidance pages throughout Research A-Z link to relevant federal websites Regulations enforced by the Food and Drug Administration (FDA) 21 CFR 50 -- Protection of Human Subjects 21 CFR 56 --...
Guidance
Jun 17, 2011

AHRQ: Mandatory Use of Data Safety and Monitoring Plans

The Agency for Healthcare Research and Quality ( AHRQ ) has issued notice requiring Data Safety and Monitoring Plans (DSMPs) for certain AHRQ-conducted or -supported projects. As of May 6, 2011, the inclusion of DSMPs will be considered pa of...
Guidance
Jul 24, 2007

Guidelines For Using Magnitude Of Harm In Categorizing Risk Level

The probability* and magnitude of harm or discomfort anticipated in the research and not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or...

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