Final Guidance Released on IRB Written Procedures

06/03/2025

Photo by Nick Fewings on Unsplash

In February 2025, the US Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) Office for Human Research Protection (OHRP) released the final guidance “Institutional Review Board (IRB) Written Procedures.” IRB’s (or Institutional Ethics Committee’s (IEC)) primary objective is to protect the rights, safety and welfare of clinical trial participants by reviewing essential trial documentation such as protocols, amendments, and informed consent forms as well as other participant facing materials including participant advertisements, questionnaires, and diaries. They also review the interim reports from trials on an annual basis (at minimum) that include incidences of adverse events or protocol deviations to determine if the trial should continue as planned or be suspended or terminated early.

In order for these review periods to be conducted effectively, it is important that IRB members follow clear written procedures that comply with HHS regulations (45 CFR part 46) and FDA regulations (21 CFR part 50 and part 56). Since IRBs are required by abide by these regulations, the term must is used throughout the guidance which is unique to the many other guidance that only use should as they are only providing recommendations or suggestions. There are four function and operations that IRBs must follow written procedures for per the HHS and FDA regulations:

  1. Conducting initial and continuing review of research.

  2. Determining which projects require review more often than annually.

  3. Ensuring prompt reporting to the IRB of proposed changes in research activity and that any changes are approved by the IRB before implementation.

  4. Ensuring prompt reporting of any:

    • Unanticipated problems involving risks to human subject or others.

  • Instance of serious or continuing noncompliance of HHS or FDA regulations

  • Suspension or termination of IRB approval.

The key element of this guidance is the Written Procedures Checklist which is intended to assist IRBs in preparing and maintaining detailed written procedures. The checklist contains recommendations for IRB “activities” however, there are footnotes for all applicable underlying regulations. The checklist is divided into four subsections which correspond to the four operations and procedures mentioned above:

I. IRB Initial and Continuing Review of Research; Reporting IRB Findings and Actions:

  1. Conducting review at a meeting of the convened IRB.

  2. Conducting review via expedited review procedures.

  3. Determining that the criteria for IRB approval of research are met.

II. Frequency of IRB Review; Verification Regarding Material Changes:

  1. Determining the approval period/continuing review interval of the proposed research.

  2. Determining whether the proposed research requires verification from sources other than the investigator that no material changes have occurred since the last IRB review.

III. Reporting of Proposed Changes to the IRB; Prior IRB Review and Approval of Changes:

  1. Reporting changes in research to the IRB, including:

  • Informing investigators that they may not initiate changes to research without prior IRB review and approval except when necessary to eliminate apparent immediate hazards to subjects.

  • Ensuring that changes in research are being reported to the IRB before they are initiated.

  • Process for notifying the IRB of any changes made to eliminate apparent immediate hazards to subjects that did not have prior IRB approval.

IV. Reporting of Unanticipated Problems, Serious or Continuing Noncompliance, and Any Suspension or Termination of IRB Approval:

  1. Identifying who is responsible for promptly reporting of:

  • Unanticipated problems involving risks to human subjects or others.

  • Serious or continuing noncompliance. 

  • Suspension or termination of IRB approval.

2. Reviewing information about unanticipated problems involving risks to human subjects or others.

The full guidance is available on the FDA website and is open for online or written comments at any time here. IRB written procedures is a vital topic to fully understand, it is often errors in these procedures or lack of compliance with them that are cited in FDA warning letters to IRBs (for examples of these warning letters please see our previous posts from 04/23/2024 and 03/10/2025). Next week we will cover frequently asked question from the public to the FDA concerning IRBs and the protection of human participants in research. For those who have not already, please visit our website and sign up for our free blog and newsletter on FDA and other clinical trial related news and content, while you’re there, have a look at our course catalog to see if any of our services are the right fit for you or your company.   

-The Clinical Pathways Team

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