Undermining Federal Oversight of Research Ethics

In recent months there has been considerable attention given to the risks to science under the Trump Administration, such as the billions of dollars in cancelled research grants and the extraordinary termination of thousands of employees at the Department of Health and Human Services (HHS).[1] Following less-noticed cuts, federal oversight of research ethics is also under serious threat.

The Office for Human Research Protections (OHRP) within the HHS provides leadership, education, guidance and, rarely, enforcement activity to protect participants in research that the department conducts or funds.[2] Since 2003 the HHS Secretary’s Advisory Committee on Human Research Protections has provided advice to OHRP on complex and difficult topics in clinical research.

Importantly, OHRP is responsible for oversight of institutional review boards (IRBs), the committees that review research for the protection of the safety, welfare and rights of trial participants. In addition to freestanding commercial IRBs, which have taken on a larger role in recent years, these boards are at academic medical centers, health care systems and federal agencies.

In the spring of 2025, the Trump administration disbanded the Secretary’s Advisory Committee on Human Research Protections, and the OHRP was reduced to about 10 staff members.[3],[4] Full staffing levels for OHRP would be about 40 employees. The director of OHRP, who had only begun work in October 2024, was laid off.[5] In May 2025 there was no longer a staff directory on the OHRP website.[6]

The OHRP has had insufficient resources to begin with, which is why it has historically been able to conduct few inspections of IRBs and little in the way of formal guidance and enforcement activities.[7] IRBs at institutions that receive federal grants face a loss of support from cancelled federal research grants as well as decreases in the overhead rates that HHS pays for grants. Moreover, unless some of the cuts are reversed, IRBs will receive even less federal guidance and oversight than the insufficient amounts they have been receiving.[8]

In 1999, 18-year-old Jesse Gelsinger traveled from Arizona to Philadelphia for a gene-transfer trial for his rare genetic disorder at the University of Pennsylvania. Gelsinger’s death in a trial in which the participants were not adequately protected against the risks of the treatment triggered a national conversation about protecting research subjects. This discussion led to many of the reforms, including the creation of OHRP, that the Trump administration is now undermining.[9],[10]

Participants in clinical research studies are the unpaid volunteers who make medical progress possible. At a minimum, they deserve and should expect adequate protections. Private groups, such as those offering accreditation, certification and evaluation, will do what they can to support IRBs and mitigate the effects of the unprecedented assault on medical research in the United States. None of these groups, however, can substitute for the essential roles of the federal government and the OHRP.
 

References

[1] US Senate HELP Committee Minority Report. Trump’s war on science. May 13, 2025. https://www.sanders.senate.gov/wp-content/uploads/HELP-Committee-Minority-Report-Trumps-War-on-Science.pdf. Accessed May 22, 2025.

[2] U.S. Department of Health and Human Services. Office for Human Research Protections. About OHRP. https://www.hhs.gov/ohrp/about-ohrp/index.html. Accessed May 22, 2025.

[3] Molteni M, Silverman E. Federal advisory panel on ethical, legal issues in human health research disbanded. Stat News. April 3, 2025. https://www.statnews.com/2025/04/03/hhs-advisory-committee-human-research-protections/ . Accessed May 21, 2025.

[4] Defino T. HHS terminations include OHRP director, SACHRP folded. Report on Research Compliance. April 3, 2025. https://lists.healthresearch.org/resadm-l/msg/28452155/. Accessed May 21, 2025

[5] Ibid.

[6] Page not found. https://www.hhs.gov/ohrp/about-ohrp/staff/index.html. Accessed May 21, 2025

[7] Lynch HF, Tillman I, Summers EI, Mah E. Preserving research ethics oversight amid decimation of the research enterprise. JAMA. April 28, 2025. https://jamanetwork.com/journals/jama/fullarticle/2833415. Accessed May 22, 2025.

[8] Goozner M. HHS axes human subject protectors. May 1, 2025. https://gooznews.substack.com/p/hhs-axes-human-subject-protectors. Accessed May 22, 2025.

[9] Ibid.

[10] Shalala D. Protecting research subjects  what must be done. N Engl J Med. 2000;343(11):808-810. https://www.nejm.org/doi/abs/10.1056/NEJM200009143431112. Accessed May 22, 2025.