U.S. Department of Health and Human ServicesHHS National Institutes of HealthNIH National Center for Advancing Translational SciencesNCATS
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Serve On Boards To Review And Monitor Clinical Trials

Overview

Members of your patient group can help review and monitor clinical trials by serving on Institutional Review Boards (IRBs) and Data Safety and Monitoring Boards (DSMBs). IRBs approve, monitor, and review biomedical and behavioral research involving humans to assure that appropriate steps are taken to protect the rights and welfare of human participants. DSMBs are independent groups of experts who monitor patient safety and treatment efficacy during clinical trials.

Resources

Institutional Review Board
Guidance for Institutional Review Boards: Frequently Asked Questions – IRB Registration U. S. Food and Drug Administration (FDA) (link)
Guidance Document: Institutional Review Boards Frequently Asked Questions U. S. Food and Drug Administration (FDA) (link)
Recommendation on IRB Membership and Definition of Non-scientist Human Health and Services (HHS) Office of Human Research (link)
Data Safety and Monitoring Board
Guidance Document: Establishment and Operation of Clinical Trial Data Monitoring Committees U. S. Food and Drug Administration (FDA) (link)
Fact Sheet: Data Safety Monitoring Boards Global Advocacy for HIV Prevention (link)