New Guidance for IRB Written Procedures Released: Impact to Sponsor and Investigators


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The Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) have been harmonizing their regulations and guidances to reduce regulatory burden and enhance human subject protections. Additionally, Title III, section 3023 of the 21st Century Cures Act requires the Secretary of HHS to harmonize HHS subject protections with FDA’s. In accordance with these missions, the OHRP and FDA have jointly released a guidance “Institutional Review Board Written Procedures: Guidance for Institutions and IRBs” (May 2018). The purpose of the guidance is to facilitate Institutional Review Boards (IRBs) in clearly writing their procedures. Following clearly written procedures advances the protection of human subjects.

Key takeaways from the guidance include:

  • To answer frequently asked questions about the scope of written procedures, the FDA and OHRP developed a “Written Procedures Checklist”

  • The guidance’s “Written Procedures Checklist” includes regulatory requirements and suggestions to incorporate into written procedures

  • Content of written procedures should include:

    • Initial and continuing review

    • Frequency of Review

    • Reporting proposed changes

    • Reporting unanticipated problems

    • Additional topics, including scope, membership, and functions

How does the guidance affect sponsors and investigators?

  • IRBs can decide to share their procedures with sponsors and investigators to increase awareness of the IRB’s requirements

  • Some of the written procedures are suggested to include:

    • Tracking study approvals

    • Communication to the investigator

    • Process for notifying the IRB of changes to protocol procedures

    • Review of the qualifications of the investigator, study staff, and site

    • Management of a noncompliant investigator

Providing a checklist of required and suggested content to be provided in IRB written procedures should facilitate IRBs in developing more detailed written procedures. Some of the suggested written procedures directly affect interactions with the investigator or sponsor, so clarification of these procedures would facilitate communications with the IRB. In turn, sponsors and investigators would have an increased understanding of the requirements of the IRB. Ultimately, following the IRB’s written procedures would facilitate the goal of the IRB: human subject protection.


-The Clinical Pathways Team

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