09/09/2025
Photo by Markus Winkler on Unsplash
On April 4th, 2025, the U.S. Food and Drug Administration (FDA) updated their Institutional Review Board (IRB) Guidance Manual, part of the Bioresearch Monitoring (BIMO) Compliance Program. There are eleven (11) BIMO compliance programs. BIMO manuals are written for field and remote reviewers/investigators and contain detailed guidance on what the BIMO inspections are to cover for each program. These manuals are distinct from FDA guidance for industry documents which are written to help relevant stakeholders comply with the FDA’s regulations and reflect the FDA’s thoughts on a specific topic. The operational perspective the manuals provide is a valuable resource when it comes to preparing for an inspection. It shows not only what the FDA may focus on during the inspection but it also provides helpful information on hosting an inspection, what documentation to have ready ahead of time, and how to potentially respond to questions the inspectors may have based on their categories of review. Passing a BIMO inspection is vital at any stage in clinical studies in order to continue with FDA regulated research. One of the compliance programs is for the IRBs. IRBs in particular must be able to demonstrate their compliance to all applicable rules and regulations that support the rights, safety, and welfare of the participants within the studies they review. Staying up to date with these sorts of regulatory updates will help better prepare for inspections and give IRBs a chance to update any relevant protocols or policies that may not be compliant with these new changes.
Here are a few of the notable revisions to the manual:
Electronic Systems, Records and Signatures: While the previous version of the IRB manual mentions it, the current revision puts a heavy emphasis on ensuring all electronic systems (eSystems), records, and signatures are 21 CFR Part 11 compliant. This means they need to be validated and able to store records and any subsequent edits in a way that leaves an audit trail that inspectors can easily identify and follow.
Veterans Affairs (VA) & Veterans Health Administration (VHA): For IRBs reviewing studies and facilities that are involved with VA/VHA, there is now a defined process regarding pre-inspections and when the Veterans Affairs Office of Research Oversight (VA-ORO) is expected to be involved. IRBs in this position should ensure they are familiar with the VA-ORO’s communications protocols.
Adoption of Remote Regulatory Assessments (RRAs): It was noted in a recent FDA guidance for industry “Conducting Remote Regulatory Assessments – Questions and Answers” that RRAs may be used in BIMO inspection (for more information see our previous entry on the guidance). RRAs in the context of BIMO IRB inspections were not fully formalized until this revision. This means that IRBs should be prepared for not only in person inspections but also remote ones which reinforces the need for eSystems to be properly established and maintained (please see our previous blog for an example of a warning letter to an IRB as a result of an RRA).
Heightened expectations for IRB governance: The updated manual includes more explicit details surrounding an IRB’s internal documentation and conduct. This includes recording of meeting minutes, IRB quorum, and avoidance of any conflicts of interest between IRB members and the studies being reviewed (For more information on IRB governance, see the FDA’s “IRB Written Procedures” guidance for institutions and IRBs as well as our previous blog entry on the topic).
The full manual is available on the FDA’s website. The updates to the IRB BIMO manual reflect the FDA’s focus on increased transparency and regulatory compliance as well as digital security of both the studies being reviewed and the IRB’s conduct/decision making. Failure to comply with these regulations may result in an FDA Form 483 and subsequent warning letter that if not properly addressed may lead to further enforcement actions from the FDA (please see our previous blog for an example of an IRB warning letter).
If you or your company are uncertain about what these changes entail or if you are BIMO inspection ready, take a look through our training and consulting services. Our Inspection Preparedness for Data Integrity & Governance: Part 11 online course explains what it means to be Part 11 compliant, requirements for recordkeeping that during BIMO inspections, as well as proper oversight practices of eSystems. We also offer training on how to prepare for, conduct, and follow-up on any BIMO inspection and how to properly address any findings that may result from these inspections. As always, make sure to subscribe to our free newsletter and blog to stay up to date on clinical trial related news such as this.
-The Clinical Pathways Team
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