RD Research Services, LLC | Compliance Expertise for IRBs & Institutions

Research Compliance Chronicle: May 2025 Edition

Written by

Tasha Mohseni

in

,

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! 250+ subscribers and counting!

Advertisements

I hope everyone has been doing well! It’s time for another monthly recap of research and compliance news. For those who have not read this type of blog post before:

Research Compliance Chronicle:

  • At the beginning of each month, I will summarize key regulatory news related to research compliance from the previous month.
  • Consider this your one-stop shop for “ICYMI regulatory update”!

As a general reminder, these are my own interpretations. Any legal information discussed within this post should be discussed with your institution. Please note that only links will be provided from the Federal Register for the numerous rules published by the FDA.

Time to rewind May 2025:

Federal agencies

Committee of Finance: Press Releases

Wyden, Markey, King Introduce Resolution to Demand Public Input on Radical Upheaval at Federal Health Agencies

  • A resolution was called on the Trump administration to reverse course on a decision to stop seeking public input on many major changes to programs and policies overseen by the Department of Health and Human Services (HHS).
  • A key quote should be noted from this press release: โ€œPublic comment periods are a key component of our First Amendment rights and demonstrate a commitment to an engaged public to wise, representative government.โ€
  • Related (though not in this press release), HHS has created a form on Regulations.gov to submit ideas to rescind regulations that are not making the US health system better: Deregulation Suggestions Form

Wyden Slams RFK on Purging Public Records Teams at HHS After Publicly Promising โ€œRadical Transparencyโ€

  • A letter was written to Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. for firing HHS employees responsible for managing and responding to public records requests, despite publicly promising โ€œradical transparency.โ€
  • HHS sub-agencies are often responsible for managing public access to government records under the Freedom of Information Act (FOIA).
    • The sub-agencies which are impacted (and listed below), are responsible for handling exceptionally sensitive information, including health records, legal documents, and proprietary company information:
      • National Institutes of Health (NIH),
      • The Centers for Disease Control and Prevention (CDC),
      • The Administration for Children and Families (ACF), and
      • The Food and Drug Administration (FDA).
  • A copy of the full letter from the press release can be found here: HHS FOIA Closures Letter

DOD: Memos

Implementation of a 15% Indirect Cost Cap on Assistance Awards to Institutions of Higher Education

  • The DOD will pursue a lower cap on indirect cost rates for all new financial assistance awards to institutions of higher education.
    • This change is effective immediately.
  • It was also noted that the terms of existing awards to institutions of higher education will be revisited for additional savings.

DOE: Press Releases

Energy Department Slashes 47 Burdensome and Costly Regulations, Delivering First Milestone in Americaโ€™s Biggest Deregulatory Effort

  • The DOE announced the Energy Departmentโ€™s largest deregulatory effort in history, proposing the elimination or reduction of 47 regulations.
  • None of the 47 regulations relate to research with animals or humans.

ED: Press Releases

U.S. Department of Education Opens Foreign Funding Investigation into University of Pennsylvania After Discovering Inaccurate and Untimely Foreign Financial Disclosures

  • If you work within export controls and/or conflicts of interest, this press release is for you!
  • The University of Pennsylvania was found to have inaccurate and incomplete foreign disclosures.
  • Under Section 117 of the Higher Education Act (HEA) of 1965 (20 U.S.C. ยง1011f), U.S. colleges and universities receiving federal financial aid must disclose gifts, contracts, or restricted agreements from foreign sources valued at $250,000 or more annually.
    • Per the press release, Section 117 is intended to protect national security and academic integrity by monitoring foreign influence in higher education.

FDA: Guidance Documents

Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

  • This draft guidance provides recommendations for screening donors for evidence of, and risk factors for, infection with Mycobacterium tuberculosis (Mtb), the organism that causes tuberculosis.
  • Comments must be submitted for review by Monday, July 7, 2025.

Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

  • This draft guidance updates information regarding sepsis included in the guidance entitled โ€œEligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), Guidance for Industry,โ€ dated August 2007 (August 2007 HCT/P DE Guidance).
    • Once finalized, this guidance will update recommendations for making a donor eligibility determination when screening a donor for clinical evidence of sepsis and clinical signs to consider.
  • Comments must be submitted for review by Monday, July 7, 2025.

Electronic Submission Template for Medical Device Q-Submissions

  • This draft guidance is intended to represent one of several steps in meeting FDAโ€™s commitment to the development of electronic submission templates.
  • This will serve as a guided submission preparation tool for industry to improve submission consistency and enhance efficiency in the review process.
  • When finalized, this guidance will provide standards for:
    • The submission by electronic format,
    • A timetable for when the FDA intends to require Pre-Subs to be provided in electronic format, and
    • Criteria for waivers of and exemptions from the requirements.
  • Comments must be submitted for review by Monday, July 28, 2025.

Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program

  • The purpose of this guidance document is to provide an overview of the mechanisms available to submitters through which they can request interactions with the FDA related to medical device submissions.
  • Comments may be submitted at any time related to this final guidance document.

FDA: Press Releases

FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities

  • Per the FDA, this change builds upon the Office of Inspection and Investigations Foreign Unannounced Inspection Pilot program in India and China.
    • The change aims to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies.  
  • The FDA will evaluate the agencyโ€™s policies and practices for improvements to the foreign inspection program.
  • Unannounced inspections will also help expose bad actors before they can put American lives at risk.

FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout Timeline

  • The FDA announced an aggressive timeline to scale use of artificial intelligence (AI) internally across all FDA centers by June 30, 2025.
    • This also includes the completion of a new generative AI pilot for scientific reviewers.
  • The generative AI tools allow the FDA to spend less time on repetitive tasks that slow down the review process.

FDA Takes Action to Address Data Integrity Concerns with Two Chinese Third-Party Testing Firms

  • The FDA issued General Correspondence Letters to two third-party testing companies in China after discovering data that was falsified or invalid.
    • They couldn’t ensure the reliability and validity of biocompatibility testing and animal safety and performance testing studies conducted at their respective testing facilities.
  • The General Correspondence Letters are the latest step taken to address concerns around testing data and the integrity of data coming from foreign countries.

FDA: Federal Register

Rule: Medical Devices

Clinical Chemistry and Clinical Toxicology Devices; Classification of the Breast Milk Macronutrients Test System
Clinical Chemistry and Clinical Toxicology Devices; Classification of the Voriconazole Test System
Clinical Chemistry and Clinical Toxicology Devices; Classification of the Plazomicin Test System
Gastroenterology-Urology Devices; Classification of the Temporarily-Placed Urethral Opening System for Symptoms of Benign Prostatic Hyperplasia
Hematology and Pathology Devices; Classification of the Coagulation System for the Measurement of Whole Blood Viscoelastic Properties in Perioperative Patients
Immunology and Microbiology Devices; Classification of the Cytomegalovirus Nucleic Acid Detection Device for Congenital Cytomegalovirus Infection
Immunology and Microbiology Devices; Classification of the Device to Detect and Identify Microbial Nucleic Acids by Fluorescence In Situ Hybridization in Clinical Specimens
Immunology and Microbiology Devices; Classification of the Device to Detect and Measure Non-Microbial Analytes to Aid in the Detection and Identification of Localized Human Infections
Immunology and Microbiology Devices; Classification of the Device to Detect Nucleic Acids from Non-Viral Microorganism(s) Causing Sexually Transmitted Infections and Associated Resistance Marker(s)
Immunology and Microbiology Devices; Classification of the DNA-Based Test to Measure Minimal Residual Disease in Hematological Malignancies
Immunology and Microbiology Devices; Classification of the Microbial Nucleic Acid Storage and Stabilization Device
Immunology and Microbiology Devices; Classification of the Inherited Nucleotide Repeat Disorder Deoxyribonucleic Acid Test
Immunology and Microbiology Devices; Classification of the Zika Virus Serological Reagents

Rule: New Animal Drugs

Approval of New Animal Drug Applications, Withdrawal of Approval of New Animal Drug Application, Change of Sponsor; Technical Amendments

GAO: Reports and Testimonies

GAO-25-107335: Human Organ-On-A-Chip: Technologies Offer Benefits Over Animal Testing but Challenges Limit Wider Adoption

  • Human organ-on-a-chip (OOC) is an emerging technology that incorporates human adult cells in a small laboratory device.
  • OOCs are designed to mimic how organs work, such as the brain, heart, or lungs. 
  • Currently, OOCs cannot replace animal testing but may be used alongside animals.

HHS: Federal Register

Notification of HHS Documents Identified for Rescission

  • The following documents listed below have been rescinded:
    • Extension of Designation of Scarce Materials or Threatened Materials Subject to COVID-19 Hoarding Prevention Measures; Extension of Effective Date With Modifications, 86 FR 35810 (July 7, 2021).
    • Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction; Repeal of Current Regulations and Issuance of New Regulations: Delay of Effective Date and Resultant Amendments to the Final Rule, 66 FR 15347 (Mar. 19, 2001).
    • Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder, 86 FR 22439 (Apr. 28, 2021).
    • Notification of Interpretation and Enforcement of Section 1557 of the Affordable Care Act and Title IX of the Education Amendments of 1972, 86 FR 27984 (May 25, 2021).

Request for Information (RFI): Ensuring Lawful Regulation and Unleashing Innovation To Make American Healthy Again

  • HHS is planning the largest deregulatory effort in the history of this department per Trump’s deregulation initiatives.
  • HHS seeks input from all interested parties on how to dramatically deregulate across all areas that they touch.
  • HHS also welcomes other submissions explaining how regulations, guidance, paperwork requirements, and other regulatory obligations can be repealed.

HHS: Press Releases

Secretary Kennedy to World Health Assembly: The United States Is Holding the World Health Organization (WHO) Accountable

  • Secretary Robert F. Kennedy, Jr. articulated the Trump Administrationโ€™s decision that it fully intends to withdraw from the World Health Organization (WHO).
  • He also shared his vision for the future of global health.
  • You can also check out my piece on impacts on human research due to WHO withdrawal here: Trumpโ€™s WHO Withdrawal EO | Impact on HSR

NIH: Notices

NOT-OD-25-104: Updated NIH Policy on Foreign Subawards

  • NIH must ensure it can transparently and reliably report on each dollar spent.
  • As a result, NIH is establishing a new award structure.
    • This will prohibit foreign subawards from being nested under the parent grant.
  • This new award structure will include:
    • A prime with independent awards that are linked to the prime that will allow NIH to track the projectโ€™s funds individually,
    • While scientific progress will be reported collectively by the primary institution, under the Research Performance Progress Report.
  • NIH anticipates implementing the new award structure by no later than September 30, 2025, prior to Fiscal Year 2026.

NOT-OD-25-110: Updated NIH Processes for No-Cost Extensions

  • This notice alerts the extramural community that NIH has temporarily disabled the No-Cost Extension functionality in eRA Commons.
  • At this time, all requests for NCEs must be submitted as a prior approval request in eRA Commons, for NIH review and approval.
  • Requests for activities that do not align with the NIH mission and agency priorities will not be approved.

NOT-OD-25-112: Implementation Update: Improving the Safety and Security of Biological Research

  • The purpose of this notice is to inform the biomedical research community of the following immediate actions NIH is taking in response to the May 5, 2025, Executive Order on Improving the Safety and Security of Biological Research. 
    • Policies, actions, and definitions defined in this Executive Order supersede NIHโ€™s implementation of the White House Office of Science and Technology Policy (OSTP) May 2024 U.S. Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (DURC/PEPP Policy).
    • NIH will not accept competitive applications for grants and cooperative agreements submitted for due dates after today and/or R&D contract proposals submitted to solicitations issued after today for dangerous gain-of-function research, as defined in Section 8 of the Executive Order.
    • NIH intends to suspend ongoing funding in accordance with guidance developed under Section 3(b) of the Executive Order.
      • All NIH awardees should review ongoing research activities to proactively identify potential dangerous gain-of-function research and identify safe actions to halt such research and to effectively comply with guidance once established. 

NOT-CA-25-037: Request for Information (RFI): Benchmarks for Artificial Intelligence in Cancer Research and Care

  • The purpose of this Request for Information (RFI) is to solicit broad community input on priority artificial intelligence (AI) benchmarks and associated benchmark datasets to advance the development, evaluation, and validation of AI applications in cancer research  and care.
  • A benchmark typically includes a dataset, a problem specification, and a defined score.

NOT-OD-25-118: Request for Information on Responsibly Developing and Sharing Generative Artificial Intelligence Tools Using NIH Controlled Access Data

  • NIH is requesting input on effective strategies for mitigating controlled-access human genomic data leakage when developing and sharing generative AI tools and applications.
  • To uphold the principles espoused in the NIH Genomic Data Sharing Policy, NIH has temporarily paused the sharing of generative AI models and their parameters based on NIH human genomic controlled-access data, as well as the retention of these tools beyond the projectโ€™s closeout (see NOT-OD-25-081).

NSF: Policy Updates

Implementation of Standard 15% Indirect Cost Rate

  • Effective May 5, 2025, NSF will apply a standard indirect cost rate not to exceed 15% to all grants and cooperative agreements awarded to IHEs for which indirect costs are allowable.
Advertisements

Presidential actions

Improving the safety and security of biological research

Increasing efficiency at the Office of the Federal Register

Restoring Gold Standard Science

Advertisements

Proposed bills

H.R.3246 – To amend the Animal Welfare Act to allow for the adoption or non-laboratory placement of certain animals used in Federal research, and for other purposes.

H.R.3295 – To amend the Public Health Service Act to improve the accuracy and transparency of animal use data collected by the National Institutes of Health from entities that conduct biomedical and behavioral research with funds provided under such Act.

H.R.3498 – To award posthumously a Congressional Gold Medal to Henrietta Lacks, in recognition of her immortal cells which have made invaluable contributions to global health, scientific research, our quality of life, and patients’ rights.

H.R.3521 – To modernize clinical trials and remove barriers for participation in clinical trials, and for other purposes.

  • Congressman Raul Ruiz, M.D. and Congressman Larry Bucshon, M.D. announced the introduction of bipartisan legislation to improve participation in clinical trials by underrepresented populations.
    • This Act builds on the successes of clinical trials legislation passed into law last Congress by addressing economic barriers that can prevent participation in clinical trials.
  • More details can be reviewed via the press release: Ruiz introduces Clinical Trial Modernization Act
  • The bill can be reviewed here: H.R.3521

H.R.3631 – To criminalize fraudulent statements made with respect to clinical vaccine trials.

I hope you found this post insightful and worth sharing with your colleagues!

Advertisements

Comments

Leave a Reply

More posts

Discover more from RD Research Services, LLC | Compliance Expertise for IRBs & Institutions

Subscribe now to keep reading and get access to the full archive.

Continue reading