OHRP and FDA Institutional Review Board (IRB) Written Procedures UPDATE (2025)

Modified on March 5, 2026 to remove the “subscribe” option. This blog has been retired and replaced by the S.P.I.R.I.T. newsletter.

Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, and Investigators! 300+ blog subscribers and counting!

I’ve been thinking a lot about my wonderful connections on LinkedIn. I encourage you to connect with me if you haven’t already! I love meeting new people and exchanging ideas.

I’m very fortunate to have knowledgeable people who are willing to share their expertise in my network. Especially when it comes to FDA-related material. I’ve learned a lot just from following along with what folks report. As well as their opinions on guidance documents. This by no means makes me an expert (yet), but I know with time I will get there. The FDA Clinical Investigator Training Course I completed last year really provided great exposure. In my mind I knew there was a plethora of information. But to actually see it and learn about it was a whole different animal! Which brings me to my next point.

I have seen a handful of posts stating how OHRP and the FDA “silently” updated their IRB Written Procedures guidance.

Due to the change in administration, I have been following OHRP and the FDA more diligently. I was aware that this guidance document was updated in February 2025. My error was assuming that other folks knew about this change. They always say don’t assume anything because “it makes an ass out of ‘u’ and ‘me’.” Alright, let’s move past the puns and get down to business!

I can understand why my connections referred to this as a “silent update.” There wasn’t necessarily a press release or formal announcement from either agency. Which got me thinking…there’s a need to make this information more well known. It would have been beneficial to have written about this back in January.

However, you’ll soon see why I’m glad I didn’t think of reporting this until now.

I would like to review the current guidance and share key takeaways. Further, I’d like to reveal why reporting this information to you now is even better than when it first occurred.

As a general reminder, these are my own interpretations. Any legal information discussed within this post should be discussed with your institution.

Let’s get ready to review:

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2025 update on the FDA website

In February 2025, the FDA (in collaboration with OHRP) published the updated version of the IRB Written Procedures guidance. Before I dive into the key takeaways, I’d like to share the grand reveal. In other words, why I’m glad I didn’t think of posting about this until now.

Time to dig a little deeper

Just for giggles…

I decided to go to the OHRP website.

I anticipated that OHRP’s website would reflect the same guidance text as the FDA website. However, I was also hoping to see the 2018 version of this guidance document. I always love to compare prior versions with newer versions to see what changes were actually made. This would be useful when summarizing key takeaways.

Cue eyebrow raising…

When I finally located the guidance on OHRP’s website, I was greeted by an unexpected bulletin.

The bulletin reads (for those who may have visual difficulties from reading text from an image):

• This document has been changed in accordance with President Trump’s January 20, 2025, Executive Order, Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government.
• NOTE: This guidance was initially issued in May 2018 and replaced OHRP’s July 1, 2011 guidance titled, “Guidance on Written IRB Procedures.”
  • In June 2025 it was changed and reissued in accordance with President Trump’s January 20, 2025 Executive Order, “Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government.”
  • The June 2025 updates include revisions to item 34 of the table under “IRB Membership.”
  • References in this guidance to HHS regulations at 45 CFR part 46, subpart A, are to this subpart in effect at the time this guidance was originally published, and not to subpart A as amended by a final rule published January 19, 2017 (82 Fed. Reg. 7149) and not to an interim final rule published January 22, 2018 (83Fed.Reg. 2885).

I’d like to highlight the following quote from the OHRP bulletin:

“In June 2025 it was changed and reissued in accordance with President Trump’s January 20, 2025 Executive Order, ‘Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government.‘The June 2025 updates include revisions to item 34 of the table under ‘IRB Membership’.“

Item 34 describes diversity in IRB membership (e.g., representation of multiple professions, scientific and nonscientific members, nonaffiliated members). There is also reference to the two regulations related to IRB membership (45 CFR 46.107 and 21 CFR 56.107). I plan to discuss Item 34 (as well as any other potential changes) in the last section of this post. First, let’s touch base on the regulations and Trump’s EO.

Connecting the dots…

I immediately thought of two posts related to Trump’s EO.

• Trump’s Gender Ideology EO: Impact on HSR
• Federal Guidance Repository: Offset to Trump’s EOs
  • Please note that the Federal Guidance Repository is no longer being updated. I am moving to a new platform. This is a slow moving project, but stay tuned for later this year (early next year)!

The first post provides a great description of Trump’s Gender Ideology EO for those who are unaware. The second post ties in nicely to helping us connect the dots.

Upon reflection, I realized that this was in reference to Trump’s definitions of “sex” versus “gender identity” within the EO.

The EO states that when administering or enforcing sex-based distinctions, every agency and all Federal employees acting in an official capacity on behalf of their agency shall use the term “sex” and not “gender” in all applicable Federal policies and documents.

In my mind, this would include guidance documents and regulatory text.

To move our discussion forward, let’s review key information from the second post. When this was first published in February 2025, OHRP had the Common Rule regulation text available on their website. Under 45 CFR 46.107 you would have seen the following:

This would be aligned with Trump’s EO and the OHRP bulletin.

Interestingly enough, when you click on the aforementioned link the page no longer exists:

OHRP has removed their version of the regulatory text. It has replaced it with direct links to the Electronic Code of Federal Regulations (eCFR).

This got me thinking…

What does the eCFR say for OHRP’s regulation (45 CFR 46.107) and the FDA regulation (21 CFR 56.107) for IRB membership?

In both screenshots below, you will notice that “gender” is still referenced (as opposed to “sex”):

Per the EO, agencies have 120 days to make changes to regulations, guidance, forms, and communications and share an update. This would put us at May 20, 2025. The screenshots for the FDA and OHRP eCFR were obtained July 3, 2025. I wonder when the eCFR will be changed to be compliant with the EO. Only time will tell!

What has changed between the 2018 and 2025 version?

It took some digging, but I was able to find the original 2018 version via the Federal Register. Then, I navigated to Regulations.gov and looked up the specific FDA docket. I created a Google Spreadsheet to review updates in activities from 2018 – 2025. Upon review, I was surprised to see only ONE item has changed. Can you guess which one?

That’s right…only Item 34 (where reference to gender in 2018 was removed in the 2025 version).

The FDA and OHRP have either updated or released new guidance since 2018. To put this in perspective, I reviewed the FDA guidance documents database. The IRB written procedures guidance falls under the Good Clinical Practice (GCP) topic. Therefore, I filtered on GCP to see how many related guidance documents have been released since the original 2018 guidance. Not counting the 2025 guidance, the FDA has released 11 guidance documents of interest to IRBs.

You’re telling me there are no other recommended actions for IRBs to consider having written procedures for? Seven years have gone by since the last update.

As the author of this post, I’m unsure how to feel about this. As for my readers, I’m curious of how you feel about this. I strongly encourage you to leave a comment below.

Where do we go from here?

For my closing thoughts (as well as something to think about):

• According to the 2018 Federal Register, the guidance at that time superseded the following documents:
  • OHRP’s July 1, 2011, “Guidance on Written IRB Procedures”
  • FDA’s 1998 “Appendix H: A Self-Evaluation Checklist for IRBs” (formerly part of FDA’s Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors)
• Therefore, it took seven years for OHRP to update and 20 years for the FDA to update (well…a collaborative update, but an update nonetheless)
• Further, the 2025 guidance doesn’t have any notation that this guidance supersedes the 2018 document
  • How are IRBs supposed to interpret this?
  • Was the 2025 guidance simply updated in haste just to comply with Trump’s EO?

With staff limitations both at the FDA and OHRP, who knows when another formal update will be made.

Though this sounds grim, I have hope.

My hope lies within the newly developed organization, National Advisory Committee on Human Research Protections (NACHRP). NACHRP is composed of former appointees of SACHRP and OHRP who are now volunteering to support our community. They do not have any federal affiliations. The following article provides a nice background for those who are unfamiliar with NACHRP: Their Terms Ended by Trump, SACHRP Members Form New Committee, Vow to Continue ‘Mission’

I can’t wait to see what guidance documents they’ll issue for the IRB community!

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I hope you found this post useful!