Report on Research Compliance 22, no. 5 (May, 2025)
When it comes to changes roiling the federally supported research landscape, April offered no letup from the first three months of the year; if anything, the pace and magnitude increased. In one instance, an agency—the HHS Office for Human Research Protections (OHRP)—has been thrown into a “crisis” and is down to nine employees. It would be fully staffed with 40 but has been underfunded for years. In 2022, it had 20 employees and was hobbling along then.[1]
As RRC was going to press, OHRP Director Molly Klote—who is appealing her April 1 reduction-in-force notice—unofficially announced the retirement of four OHRP staff, including longtime deputy director Julie Kaneshiro, who joined OHRP in 2002, and Lisa Buchanan, OHRP’s director of the Division of Compliance Oversight since 2019 and an OHRP employee since 2008.
The decline to nine employees as of April 20 was the result of retirements, loss of a probationary employee, Klote’s termination, more routine job changes and the federalwide job freeze. Natalie Klein, director of OHRP’s Division of Policy and Assurances, is now “the director of everything,” in the words of an agency employee who also referred to the staffing level as a crisis and requested anonymity.
Meanwhile, in whatever form it continues to exist, both OHRP and the Office of Research Integrity are scheduled to move to a new umbrella office, the Assistant Secretary for Enforcement, joining the Office for Civil Rights and two others, according to a leaked White House fiscal year 2026 budget document that also outlined HHS’ reorganization plan.
But more shocking was the bottom line for NIH: a 40% reduction, with funding dropping from $47 billion to $27 billion dispersed between eight institutes or centers, compared to the current 27. Overall, HHS’ budget would decline by a third. The plan also calls for the imposition of a 15% cap on facilities and administrative (F&A) costs for awards—a move NIH has already tried and is appealing after losing a lower court ruling.
Regardless of one’s view of the changes, “you have to recognize that the pace is extraordinary,” Heather Pierce, senior director for science policy and regulatory counsel for the Association of American Medical Colleges (AAMC), told RRC. “The pace of change, of news, of uncertainty…it’s exhausting for the research community.”
Since early February, Pierce has given dozens of talks and interviews on the F&A rates, grant terminations and the impact of changes at NIH. “I have had to stop using slides because they’re outdated—as I am walking into the room” to present them, she said. “So now it’s become like my shtick. Every time I talk, I start with: ‘I have breaking news!’”
She half-jokingly noted the need for more adjectives for unprecedented. “If you have more, will you send them? Because I am out,” said Pierce.
Hundreds of Incidents; Three Investigators
OHRP has oversight of some 2,300 institutional review boards (IRBs) that conduct billions of dollars of research funded by HHS. OHRP ensures they have a current federalwide assurance with the agency and investigates incidents of noncompliance with human subject regulations, also known as the Common Rule. It provides guidance and educational resources, including holding workshops. The drop in staff, however, means there is no one left in the Division of Education and Development.
OHRP’s most recent data showing cases for which it has jurisdiction indicates it received 53 complaints from Oct. 1 to March 31 and accepted 489 incident reports, which cover unanticipated problems involving risks to subjects or others, serious or continuing noncompliance with HHS regulations and suspensions or terminations of IRB approval. It has just three investigators now to review the reports and conduct inquiries.
RRC was first to report Klote’s pending termination and the dissolution of the Secretary’s Advisory Committee on Human Research Protections (SACHRP), which both occurred in early April as part of the wave of early retirements, terminations and funding cuts occurring across the federal government at the behest of the Department of Government Efficiency.[2] RRC also reported that SACHRP’s March meeting had been cancelled and not rescheduled. OHRP recently issued five determination letters; it was a priority of Klote’s to clean out the agency’s investigations backlog.[3]
OHRP Director: ‘Stay Strong!’
A month ago, Yvonne Lau retired as OHRP’s director of education, a position she held for nearly 11 years.
Kaneshiro also was acting OHRP director for the two years it took HHS to hire Klote in October, following the December 2022 retirement of Jerry Menikoff. After Klote was placed on administrative leave, Kaneshiro stepped into the acting role again. She retired under a voluntary early retirement option, effective April 19.
Over a two-day period on LinkedIn, Klote announced a total of four OHRP retirements.[4] She thanked Kaneshiro for her “unwavering commitment to the protection of human subjects in research,” which she said “has had a profound impact on our community and the field at large. Her guidance and insights have not only shaped policies but have also inspired those around her to uphold the highest ethical standards.” Klein’s “expertise and experience will serve HHS and the Common Rule agencies well,” Klote wrote.
She also expressed her gratitude for Kaneshiro’s “support, mentorship, and the positive influence you have had on so many. You leave behind a legacy that will continue to guide our efforts in ensuring the safety and well-being of research participants.”
Hours later, Klote, who is new to OHRP but has been with the federal government in other leadership roles for 35 years, shared news of Buchanan’s departure. She “has been a guiding force, tirelessly advocating for ethical research practices and ensuring compliance with the highest standards. Her dedication to this mission has not only strengthened our organization but has also inspired countless colleagues along the way,” Klote said of Buchanan. “The updates that she led to the incident reporting systems and complaint processes will have lasting positive effects.” Neither Kaneshiro nor Buchanan responded to RRC’s messages seeking comment on their departures.
Klote ended her post about Kaneshiro noting that, “as to my fate, I remain on administrative leave. There is no movement yet on my reinstatement. Stay strong!”
Deja Vu at DoE
That is apt advice as not only are new challenges and battles popping up, but the old ones also aren’t over. In a somewhat surreal repeat of NIH’s attempt in February to impose a 15% F&A cap, on Friday evening, April 11, the Department of Energy (DoE) announced that it will “no longer use the negotiated indirect cost rate for grants awarded to” institutions of higher education (IHEs), applying a 15% cap instead.[5]
This was exactly the same time frame for which NIH announced its cap, and, in identical fashion, Institutions and associations filed suit against DoE’s plan as soon as they could (the following Monday).
DoE’s policy change came just three days after AAMC, the Association of American Universities, Council on Governmental Relations and seven other organizations said they had “come together to spur the development of a more efficient and transparent model for funding indirect costs on federal research grants.”
DoE said the cap would be effective that day. Moreover, DoE said it was “undertaking action to terminate all grant awards to IHEs that do not conform with this updated policy.”
By April 16, U.S. District Judge Allison Burroughs had issued a temporary nationwide restraining order stopping the plan from going forward.
1 Theresa Defino, “In Wake of OHRP Director’s Complicated Legacy, Calls for Transparency, Resources, Enforcement,” Report on Research Compliance 20, no. 2 (February 2023), https://bit.ly/3W5uWm3.
2 Theresa Defino, “HHS Terminations Include New OHRP Director; SACHRP Folded,” RRC E-Alerts, April 3, 2025.
3 Theresa Defino, “OHRP Finds No Proof of Noncompliance by VCU Rainmaker PI, Issues Other Letters,” Report on Research Compliance 22, no. 5 (May 2025).
4 Dr. Molly Klote, LinkedIn profile, accessed April 21, 2025, https://bit.ly/42BACpB.
5 U.S. Department of Energy, “Department of Energy Overhauls Policy for College and University Research, Saving $405 Million Annually for American Taxpayers,” news release, April 11, 2025, https://bit.ly/3EDmcgD.
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