Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, Legal Experts, and Investigators!
โWe want to thank the leaders and members of the House and the Senate appropriations committees for the resolve and hard work so clearly demonstrated by the strong NIH provisions in this package. We are particularly grateful to Senate Labor-HHS Subcommittee Chair Shelley Moore Capito (R-WV), Ranking Member Tammy Baldwin (D-WI), House Subcommittee Chair Robert Aderholt (R-AL), and Ranking Member Rosa DeLauro (D-CT).
Even in these challenging times, the bill increases the overall NIH budget and includes new protections to help the agency fulfill its lifesaving mission. While cuts to several key research and public health agencies signal that this work is far from over, the legislation is a vast improvement over the devastating cuts included in the presidentโs FY26 budget proposal. We urge Congress to swiftly pass this legislation prior to the Jan. 30 funding deadline.โ
How did I end up reporting inaccurate information?
Remember the infamous government shutdown? Well, when Congress doesn’t approve the agency appropriation bills or a continuing resolution, the government shuts down. During a shutdown, federal agencies must discontinue all nonessential discretionary functions until new funding legislation is passed and signed into law. Only essential services and mandatory spending programs continue to function. The act that ended the government shutdown is known as a continuing resolution. A continuing resolution temporarily funds the government in the absence of full appropriations bills, often by continuing funding levels from the prior year.
So, now what?
The house and senate appropriation committees released HHS FY26 bill text (along with other agencies). Upon review of the bill text:
There was no mention of OHRP, OASH, or ASE
There wasn’t clear language regarding re-organization or consolidation of agencies within HHS
Though there will be investment into medical research, I can’t help but wonder about the compliance aspect. Rather, I’m concerned about the welfare of research participants as we enter the new year. Perhaps more details will be released (assuming Congress passes these appropriation bills). We will just have to wait and see, but you can guarantee I’ll write about it as soon as I hear anything.
Thank you for bearing with me as we navigate this complex regulatory landscape!
I always welcome folks to share information with me if what I’ve reported is incorrect or misunderstood. It is my promise and commitment to you to accurate report scientific and regulatory information.
Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, Legal Experts, and Investigators!
It can be easy to miss the bigger picture. This inspired me for today’s topic.
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Let’s dive right in!
I’m going to cover the re-organization of the Department of Health and Human Services (HHS) and how how this impacts the Office of Human Research Protections (OHRP). Specifically, I’d like to highlight:
The current HHS structure with OHRP under the Office of the Assistant Secretary for Health (OASH)
Introduce the Assistant Secretary of Enforcement (ASE)
Close with how I envision OHRP under the new ASE
As a general reminder, any legal information discussed within this post should be discussed with your institution.
Table of Contents:
What is OASH?
The Office of the Assistant Secretary of Health (OASH) develops policy recommendations for public health across HHS and its agencies. OASH is tasked with improving the health and well-being of Americans by leading on policy, practices, and programs. OASH seeks to restore scientific integrity and transparency to rebuild public trust and advance the public good. Below is the current organizational structure:
OHRP is one of these divisions that supports OASH.
OHRP fulfills responsibilities set forth in the Public Health Service (PHS) Act including:
Providing leadership for human research subjects protections within HHS and for the U.S. Government in cooperation with other Federal Agencies
Developing and monitoring as well as exercising compliance oversight relative to HHS regulations for the protection of human subjects in research conducted or supported by any component of HHS
Promoting and coordinating appropriate HHS regulations, policies, and procedures both within HHS and in coordination with other Departments and Agencies in the Federal Government
Establishing criteria for approval of assurances of compliance for the protection of human subjects with both domestic and foreign institutions engaged in HHS-conducted or supported research involving human subjects
Conducting programs of clarification and guidance for both the Federal and non-Federal sectors with respect to the involvement of humans in research; and directing the development and implementation of educational and instructional programs and generating educational resource materials
Evaluating the effectiveness of HHS policies and programs for the protection of human subjects
Serving as the liaison to Presidential, Departmental, Congressional, interagency, non-governmental, and international commissions and boards to examine ethical issues in medicine and research and exercises leadership in identifying and addressing such ethical issues
Promoting the development of approaches to enhance and improve methods, particularly quality improvement at the institutional level, to avoid unwarranted risks to humans participating as subjects in research covered by applicable statutes
Within this initiative, the Assistant Secretary for Enforcement (ASE) is introduced: “HHS will create a new Assistant Secretary for Enforcement to oversee the Departmental Appeals Board (DAB), Office of Medicare Hearings and Appeals (OMHA), and Office for Civil Rights (OCR) to combat waste, fraud, and abuse in federal health programs.”
Now that we have some background information, let’s talk about ASE.
Directly from the HHS FY26 budget justification, ASE will centralize executive oversight over several mission-critical offices:
Departmental Appeals Board (DAB)
Office for Civil Rights (OCR)
Office of Medicare Hearings and Appeals (OMHA)
Office for Human Research Protections (OHRP)
This consolidation is designed to streamline oversight, improve enforcement and adjudication coordination, provide education and guidance on relevant legal authorities, and strengthen HHS’s ability to fulfill its legal obligations to the public. ASE will:
Ensure individuals and institutions attain resolution of complaints, disputes, and appeals
Encourage compliance through regulations, guidance, education, and technical assistance
Enforce legal compliance and adjudication under federal statutes and regulations
As someone with an accounting and program management background, I can appreciate cutting costs. Having said that…
Cost reduction should NOT equal mission reduction.
OHRP’s mission will take an even bigger blow.
I was alarmed when I didn’t see OHRP mentioned in the HHS press release or fact sheet.
In the press release, it was indicated that ASE would be comprised of DAB, OMHA, and OCR. Further, it was noted in the fact sheet that “A new Administration for a Healthy America (AHA) will consolidate the OASH, HRSA, SAMHSA, ATSDR, and NIOSH, so as to more efficiently coordinate chronic care and disease prevention programs and harmonize health resources to low-income Americans.” This made me wonder…where is OHRP in the midst of this?
Reviewing OHRP’s approved budget is an even sadder story.
I did feel some relief once I saw OHRP was mentioned within the HHS FY26 budget justification. However, it slowly disappeared as I read through the budget requests for each unit. HHS signaled where OHRP falls on the totem pole. Directly copied from the budget justification:
“The Office for Human Research Protection also requests non-trust fund budget authority that will maintain minimal operations. This includes conducting a limited number of for-cause compliance assessments of human research protection programs or institutional review boards, processing approximately 800-1,000 incident reports, and approximately 400-600 complaints about research. Develop guidance, the fulfillment of the FWA and IRB registration missions, and the ability to develop educational tools and resources will be limited.”
OHRP already had limited staff and resources with great responsibility. How is OHRP supposed to act on their duties under the PHS Act when the budget request is so specific? I have so many questions about this budget request:
What is considered a “limited number” of for-cause compliance assessments?
How is OHRP supposed to prioritize which HRPPs and IRBs receive such assessments?
What happens if there’s more complaints and/or incidents than originally projected?
Why are resources (i.e., educational tools) and enforcement mechanisms (i.e., FWA) that uphold public trust in research on the back burner?
OHRP is going to need support and expertise from research compliance professionals such as ourselves for education and guidance development. NACHRP and PRIM&R could potential lead such efforts.
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 hope everyone is doing well and had a fantastic 4th of July! It’s the perfect time to get away to spend time with family. Whether it be a staycation and even get something yummy on the grill. Or you actually get out of town for some R&R. Being in Arizona, it’s a little difficult to escape the heat.
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.
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I have seen a handful of posts stating how OHRP and the FDA “silently” updatedtheir 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:
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):
The June 2025 updates include revisions to item 34 of the table under โIRB Membership.โ
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:
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.
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 โsexโ and not โgenderโ 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:
Image of 45 CFR 46.107 from OHRPโs website citing โsexโ versus โgenderโ
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:
Screenshot of OHRP website for 45 CFR 46.107 stating the page is no longer available.
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”):
Screenshot of OHRP eCFR stating “gender” in IRB membershipScreenshot of FDA eCFR stating “gender” in IRB membership
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!
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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, โGuidance on Written IRB Proceduresโ
FDA’s 1998 โAppendix H: A Self-Evaluation Checklist for IRBsโ (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.
