OHRP and FDA Announce the Availability of a Draft Guidance Document on IRB Meeting Minutes

November 5, 2015

The Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA) have issued draft guidance titled, “Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs.” This draft guidance was prepared jointly by OHRP and FDA and is intended for institutions and IRBs responsible for oversight of human subject research under HHS and FDA regulations. This joint draft guidance is now available on OHRP’s website at: http://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/index.html and FDA's website at: http://www.fda.gov/RegulatoryInformation/Guidances/ucm470046.htm. Comments are due by January 4, 2016.

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