FDA shares FAQs on IRBs

06/17/2025

In February 2025 the US Food and Drug Administration (FDA) posted a series of frequently asked questions (FAQ) on their website from the public regarding Institutional Review Boards (IRB) and the protection of human subjects in research. These questions and the FDA’s answers were released at the same time as their “Institutional Review Board (IRB) Written Procedures” final guidance (which we covered last week) and may help facilitate understanding and clarify any grey areas in the new guidance. There is an extensive 66 FAQs which covers many who, what where, when, and whys of IRBs and are divided into 8 categories:

1.   IRB Organization: This section covers general questions such as:

  • What is an IRB?

  • Do IRBs have to formally called by that name?

  • Must an institution establish its own IRB?

It also contains more specific questions:

  • Does an IRB or institution have to compensate subjects if injury occurs as a result of participation in a research study?

  • Is the purpose of the IRB review of informed consent to protect the institution or the subject?

2.   IRB Membership: This is an area that needs to be paid close attention, incomplete or inadequate IRB rosters have been included in multiple FDA warning letters to IRBs in the past (see our previous posts 03/28/2023 & 04/23/2024 for examples of such warning letters).

  • The IRB regulations require an IRB to have a diverse membership. May one member satisfy more than one membership category?

  • Which IRB members should be considered to be scientists and non-scientists?

3.   IRB Procedures: This section in particular ties into the final guidance on IRB written procedure and is also an area where noncompliance with or inadequate written procedure may result in a warning letter (see 03/10/2025 as an example). Multiple questions in this section are in regards to sponsor/IRB interactions:

  • Are sponsors allowed access to IRB written procedures, minutes and membership rosters?

  • How can a sponsor know whether an IRB has been inspected by FDA, and the results of the inspection?

  • Does FDA prohibit direct communication between sponsors and IRBs?

4.   IRB Records:

  • Are annual IRB reviews required when all studies are reviewed by the IRB each quarter?

  • 21 CFR 56.115(a)(1) requires that the IRB maintain copies of "research proposals reviewed." Is the "research proposal" the same as the formal study protocol that the investigator receives from the sponsor of the research?

  • What IRB records are required for studies that are approved but never started?

5.   Informed Consent Process: Obtaining informed consent from prospective research participants is essential for all trials as it is a participant’s right. IRBs must be diligent when reviewing the informed consent process to ensure each participant received a full and proper explanation of the trial, the risks, benefits, and requirements throughout its lifecycle.

  • Is getting the subject to sign a consent document all that is required by the regulations?

  • If an IRB uses a standard "fill-in-the-blank" consent format, does the IRB need to review the filled out form for each study?

  • Who should be present when the informed consent interview is conducted?

  • Are there alternatives to obtaining informed consent from a subject?

6.   Informed Consent Document Content: The informed consent document itself should balance between containing all of the necessary information about the trial and being presented in a way that facilitates understanding.

  • May an IRB require that the sponsor of the study and/or the clinical investigator be identified on the study's consent document?

  • Who should be listed on the consent as the contact to answer questions?

  • Must informed consent documents be translated into the written language native to study subjects who do not understand English?

7.   Clinical Investigations:

  • Does a physician, in private practice, conducting research with an FDA regulated product, need to obtain IRB approval?

  • Does a clinical investigation involving a marketed product require IRB review and approval?

8.   General Questions: This final section addresses all the other areas not covered above including more niche areas of clinical research:

  • What are the IRB's general obligations towards intraocular lens (IOL) clinical investigations?

  • Do Radioactive Drug Research Committees (RDRCs) have authority to approve initial clinical studies in lieu of an IND?

  • How have the FDA policies on enrollment of special populations changed?

The full list of FAQs can be found on the FDA website and for those who wish to comment may do so here. To keep up to date on FDA activity such as this and other trial related news, please visit our website and sign up for our free blog and newsletter. While you are there have a look at our online store and course catalog to see if any our services are the right fit for you or your company.

-The Clinical Pathways Team

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