ICYMI: HHS FY26 Budget Re-Org: Assistant Secretary for Enforcement (ASE)

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.

Eager to skip ahead to today’s topic?

Jump to the Table of Contents.

• LinkedIn
• Mail
• Bluesky
• Facebook

Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, Legal Experts, and Investigators!

330+ subscribers and counting!

Why does January always feel so long?

It can be easy to miss the bigger picture. This inspired me for today’s topic.

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.

(Back to the Contents)

What is OHRP?

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

OHRP is comprised of multiple subparts, including the formerly terminated Secretary’s Advisory Committee on Human Research Protections (SACHRP).

• I strongly encourage you to read about the newly formed organization as a result of SACHRP termination: National Advisory Committee on Human Research Protections (NACHRP): Interview with Julie Kaneshiro

(Back to the Contents)

What is ASE?

To quickly bring you up to speed:

• In March 2025, HHS announced a new initiative, Make America Healthy Again, in response to Executive Order (EO) 14210 “Implementing the President’s “Department of Government Efficiency” Workforce Optimization Initiative”
  • The EO was issued in February 2025
  • 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.”
• Then, in September 2025, the House Appropriations Committee approved the HHS FY26 budget (including the creation of ASE and re-organization within HHS)

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

(Back to the Contents)

A Grim Future for OHRP Under ASE

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:

1. What is considered a “limited number” of for-cause compliance assessments?
2. How is OHRP supposed to prioritize which HRPPs and IRBs receive such assessments?
3. What happens if there’s more complaints and/or incidents than originally projected?
4. 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.

(Back to the Contents)

---

I hope you found this article insightful!