HHS and FDA Release Joint Final Guidance: IRB Written Procedures

On 17 May 2018, the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) released joint final guidance entitled “Institutional Review Board Written Procedures: Guidance for Institutions and IRBs.” This guidance also includes a checklist for IRBs when developing and reviewing their written procedures. CITI Program modules are up-to-date with this guidance. To learn more about IRB written procedures, check out our IRB Administration course that includes a specific module about HRPP/IRB policies and procedures.