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.
