November 6, 2015

FDA and OHRP Issue Joint Draft Guidance on Minutes of IRB Meetings

The Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) have issued draft guidance titled, “Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs”.This draft guidance was prepared jointly by FDA and OHRP and is intended for institutions and IRBs responsible for oversight of human subject research under FDA and HHS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 This joint draft guidance is now available on FDA’s website at http://www.fda.gov/RegulatoryInformation/Guidances/ucm470046.htm, and OHRP’s website at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

This joint draft guidance is intended to assist institutions and IRBs responsible for preparing and maintaining minutes of IRB meetings. The draft guidance describes requirements for minutes and provides recommendations for meeting the regulatory requirements for minutes.

Comments are due by January 4, 2016.