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.
Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, Legal Experts, and Investigators!
330+ subscribers and counting!
Authored By: Tasha Mohseni
Happy New Year and welcome to the first CREST blog post in 2026!
It feels good to get back on the saddle and write to you all. I hope you all enjoyed the holidays with your family and loved ones.
I wish that 2026 brings you all success, good health, and whatever you were working towards last year that will be worthwhile.
For today’s article, I’d like to highlight top research administration and compliance conferences. These are events you don’t want to miss to develop professionally!
IMPORTANT: Events within this article were included only if they were a “conference” or “annual meeting” (i.e., no other event types such as workshops or webinars).
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As a general reminder, these are my own interpretations. Any legal information discussed within this post should be discussed with your institution.
MAGI is a WCG event that connects clinical research professionals who are committed to ensuring the quality, compliance, and efficiency.
Per the website, WCG is a partner to research sponsors, CROs, sites and participants in navigating the clinical research journey. WCG showcases their solutions in exhibit booths at various conferences. Further, they offer informative webinars (especially if you’re new to clinical research. You can view the following links below for educational materials:
Budgets: learning the nuances of ensuring your site is optimized for conducting clinical trials
Contracts: exploring field-tested, easily implemented negotiation tools and techniques that can help maintain control, improve turnaround times, and reduce last-minute scrambles
Billing compliance: strengthening research billing compliance development and program oversight
Quality and regulatory: ensuring adherence to the regulations on research participant protections
Clinical operations: mastering approaches to maintaining trial quality and effective tactics for protecting participant safety and data integrity
You can review the 2025 agenda to view workshops within these educational tracks
The PRIM&R Conference educates those involved in research and research oversight to support and achieve the advancement of ethical, responsible, and high-quality research.
PRIM&R is a nonprofit,โฏfounded in 1974 that works to ensure the highest ethical standards in research by:
Providing education,
Membership, and
Other professional resources to the research and research oversight community, including those who work with:
Human research protections programs (HRPPs),
Institutional review boards (IRBs),
Animal care and use programs,โฏand
Institutional animal care and use committeesโฏ(IACUCs).
Those who attend these conferences can use the session materials in preparation for the following certifications:
This also includes the PRIM&R Social Behavioral Educational Research Conference (SBER25). Attendees have the choice to either:
Attend PRIM&R 2025 only
Attend SBER 2025 only
Attend PRIM&R 2025 and SBER25
Educational tracks range from program administration, regulation-specific topics, quality control, post approval monitoring, emerging challenges, and many more!
NWABR offers three annual conferences and is currently accepting 2026 submissions.
NWABR is dedicated to promoting the public’s trust in ethically conducted biomedical research. You can read more about this organization here: About Us.
IRB, IBC & IACUC Conference Series
This conference is PERFECT if you wear multiple compliance hats or in a small HRPP.
You can review the 2025 program to see the various topics within these compliance areas.
Clinical Research Professional Conference Series
This conference is for clinical research professionals who ensure the ongoing integrity of research within their institutions.
You can review the 2025 program to see this year’s focus: quality initiatives and artificial intelligence (AI)
CyberBIO Conference Series
This conference includes experts across government, industry, and academia to discuss issues at the intersection of biomedical sciences and cybersecurity.
You can review the 2025 program once it is available (as of 9/23/25).
Clinical Research Project/Program Management Conference
This conference is designed to introduce, affirm, or elevate your understanding of project management in the field of clinical research.
The program will broaden the participantsโ knowledge of the regulatory framework, project management, planning and accounting, and achieving successful clinical trials. For more details, you can review:
This conference provides insights, practical tools, and real-life examples to navigate quality planning, control, assurance, and improvement in clinical research.
The event delivers vital information on developing and implementing effective quality management systems in line with FDA Regulations and ICH guidance. For more details, you can review:
FDA Clinical Trial Requirements, Regulations, Compliance and GCP Conference
This conference is designed to aid in the understanding of the FDA’s mission, responsibilities and authority and to facilitate interaction with FDA representatives.
The conference will focus on:
FDA Clinical Research Requirements,
Enhancing Success through Communication, and
Financial Incentives, and Assuring Confidence in Clinical Research
This conference will improve professional skills and understanding of the responsibilities of conducting clinical research in the pediatric population.
This program is designed to elevate attendees’ understanding and application across the:
SRAI provides research administrators globally with the knowledge, resources, and community they need to excel, collaborate, and drive impactful research.
Directly from the website, this organization is the only research management society in the world whose membership spans the entire spectrum of research institutions, including:
For-profit entities involved in research and development
Public and private colleges and universities
Research hospitals and institutes
Charitable and research-focused nonprofits
Federal, state, and local government bodies engaged in research
Annual Meeting
Folks who attend the SRAI 2026 conference will gain fresh perspectives on timely topics from the world’s leading research administration experts.
Sponsored Programs Planning, Development and Deliveries
Technology Solutions in Research Administration
Financial Management Conference
The Financial Management Conference is a virtual professional development event focused on financial and post-award management in research administration.
Sponsored Programs Planning, Development and Deliveries