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Compliance In Focus
Posted by Emily Haglund on Thu, Jan 7, 2016

Minutes of Institutional Review Board (IRB) Meetings: Draft Guidance for Institutions and IRBs

The draft guidance “Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and New_Draft_Guidance_Released_by_FDA-1IRBs” was released jointly by the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) in November 2015. This draft guidance document is intended to assist institutions and IRBs responsible for preparing and maintaining minutes of IRB meetings, describe requirements for minutes, and provide recommendations for meeting the regulatory requirements for minutes.

This draft guidance document was developed based on the regulatory citations given to IRBs from both the FDA and OHRP. Examples of non-compliances observed include:

  • Minutes are missing.
  • Minutes lack sufficient detail to show the vote on actions taken by the IRB, including the number of members voting for, against, and abstaining.
  • Minutes are incomplete and only describe voting actions as “passed unanimously.”
  • Minutes do not clearly indicate, or contain discrepancies about, what the IRB approved.
  • The IRB maintains multiple sets of minutes with different information for the same meeting.
  • Minutes fail to include a summary of the discussion of controverted issues.

To address these non-compliances, the draft guidance document provides details on how to document attendance at the meeting (specifically for members, alternates, consultants, and guests), defining and documenting a quorum, describing how to document actions (approve, require modifications, disapprove, suspension, termination), and other IRB review responsibilities.

This draft guidance document is another important step in further influencing the infrastructure of IRBs in the United States. Other guidance documents, specifically for IRBs and Informed Consent, have steadily been released to further support the IRB process.

IRBs are a critical aspect of the clinical research process and this guidance document is another example and strategic step the FDA and OHRP has taken to further ensure the rights, safety, and welfare of human clinical research subjects are protected. Comments for this draft guidance are due by early 2016!

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Topics: Draft Guidance, IRBs, FDA, Office for Human Research Protections, Meetings

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