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

Tips for Success

  • Build strong, positive relationships with pharmaceutical companies and other potential Sponsors early in the therapy development process to ensure your patient community is represented in the DSMB.
  • Work with your Scientific/Medical Advisory Board as well as researchers focused on your disease to learn more about the IRB process at their respective institutes.
  • Encourage your Scientific/Medical Advisory Boards and researchers to serve on their own institutional IRBs.
  • Introduce Sponsors to your Scientific/Medical Advisory Board as well as other known specialists for your disease and select members of your patient community to potentially increase the expertise on the DSMB.
  • Communicate the protections that IRB and DSMB provide participants of clinical trials to your disease community.

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)