Tiny HHS office tasked with protecting research participants’ safety is running on fumes

Manage alerts for this article Email this article Share this article By Megan MolteniJune 5, 2026 Megan Molteni[email protected]Megan covers the intersection of science and society. How is biomedical research funded? Who benefits? And how do new technologies reflect and shape our values? You can reach Megan on Signal at mmolteni.13. In 2021, the federal office charged with ensuring that the vast research enterprise bankrolled by the Department of Health and Human Services keeps study participants safe, received a report of a death by suicide involving a person enrolled in a study testing a treatment for depression and reduced mobility. Once the Office of Human Research Protections started looking into the death at the New York State Psychiatric Institute, it found problems that spread far beyond that one study, including failures in how the institute’s ethics board reviews proposed research. “We saw, holy smokes, this whole institution has issues,” said Lisa Buchanan, then director of the OHRP’s compliance division. The investigation became all-consuming. “It was probably 60-70% of our time,” she said.Advertisement The Food and Drug Administration got involved, as did the National Institutes of Health, which had provided grant funding to support the study. OHRP put a hold on all HHS-funded clinical research being conducted at NYSPI, and shortly after, the NIH suspended all grants for human subject research at the institute. Such severe actions are rare in the world of biomedical research. In the months that followed, NYSPI developed a comprehensive corrective action plan that included restructuring its human research protections program under new leadership, implementing additional mandatory training for scientists, and establishing new methods for reporting potential problems. As it began implementing these safeguards, OHRP dropped the ban on human research in October 2024. Two months later, NYSPI signed an agreement with HHS, promising that it would continue to follow through on its plan. HHS in turn agreed to monitor its progress — through reviews of monthly reports and by sending staff from HHS, NIH, and OHRP to conduct at least one on-site visit in the first year of the agreement, according to a copy obtained by STAT. But that required site visit has not taken place, according to three individuals familiar with the matter who spoke on the condition of anonymity because they were not authorized to talk about it. One reason for this lapse in monitoring, they said, is ongoing staffing shortages at OHRP in the wake of the Trump administration’s chaotic downsizing of the federal government that began early last year. Advertisement Since February 2025, OHRP has lost more than half of its employees, either through reductions in force, resignations, or early retirements. Among the departures were several of the agency’s top leaders, including Buchanan, OHRP director Molly Klote, and longtime deputy director Julie Kaneshiro, who had been with the agency since 2002. OHRP’s advisory committee was also disbanded last spring. In response to STAT’s questions, an HHS spokesperson said OHRP is continuing to receive and review monthly reports on the implementation of NYSPI’s corrective actions and pointed to an April 17, 2025, letter from OHRP indicating it intends to conduct a site visit to assess the institute’s progress in restructuring its human research protection program. HHS did not respond to further questions about when this might take place. OHRP has long been beset by anemic budgets and staffing challenges that complicated its mission to ensure compliance with federal ethics and safety regulations across multiple administrations. But under President Trump, the watchdog agency has experienced an unprecedented exodus of ethics expertise, raising concerns about its ability to effectively protect volunteers from the risks involved with participating in research, according to interviews with eight former OHRP employees, three former agency advisers, and members of the wider research ethics community. “The loss of numerous senior staff at OHRP creates a serious vacuum for the institutional memory of that office,” said Ivor Pritchard, a longtime research ethics expert who served as a senior adviser at OHRP from 2004 to 2024. The departure of the office’s top leaders was first noted in a newsletter published by the Health Care Compliance Association. But STAT’s own investigation reveals new details about the extent to which the federal watchdog has been weakened under Trump. Created in 2000 on the foundation of an earlier agency, OHRP has oversight of more than 13,000 institutions in the U.S. and internationally that conduct HHS-supported human research. It is responsible for designing policies to enhance protections for research participants, monitoring universities and other institutions for compliance and investigating those accused of violating federal rules, and educating scientists, ethics-review committees, and the public. At the time of its formation, experts recommended OHRP would need at least 42 employees to fulfill its responsibilities. Currently, OHRP has just 10, and has been without directors for each of its three divisions — policy, compliance, and education — for nearly a year.Advertisement As a result of staffing losses, OHRP has ceased offering free educational activities for universities and medical centers that conduct human studies, forcing them to pay for costlier research ethics training alternatives — or do without. The agency has stopped hosting community forums around the country to train scientists about research protections. Gone too are annual workshops to explore emerging questions in research ethics. “OHRP sits at the center of the research enterprise and oversight system,” said Ivy Tillman, executive director of Public Responsibility in Medicine and Research, a professional association that advocates for research ethics and provides certification to institutional review boards, which vet the safety and ethics of human studies. “This is a specialized field. You have to build up years of experience. At OHRP, that institutional knowledge is gone.” Tillman believes that the thousands of human research protections professionals spread out across the nation’s universities and medical centers will continue to uphold federal regulations and policies to the best of their abilities. But she feels they’ve lost a steadfast partner. One of her biggest concerns is that institutions are now having to make tough decisions on their own without the guiding hand of the experts at OHRP. “What message is the federal government sending about the importance of ethics and oversight?” Tillman said. “Especially at the local level, and that’s the level where the participants are impacted.” HHS did not answer questions about its plans to address staffing shortages and leadership vacancies at OHRP. In an emailed statement, HHS senior press secretary Emily Hilliard said that the protection of research participants is still a top priority for the department. “The Office for Human Research Protections (OHRP) remains fully engaged and capable to support the policy, education, and safety responsibilities related to protections for human subjects in research,” she wrote. Maintaining public trust, supporting scientific innovation, and ensuring meaningful informed consent in research are responsibilities currently being carried out “across multiple levels of HHS as NIH maintains dedicated staff focused on human research protections,” Hilliard added.Advertisement ‘A mission that’s easy to take for granted’ Most people would trace the history of research protections in America back to a 1972 New York Times story exposing a decades-long U.S. Public Health Service study in Tuskegee, Ala., that withheld treatment for syphilis from hundreds of Black men afflicted with the disease. But in fact, our modern system of institutional review boards, or IRBs, has its origins even earlier. In the 1950s, as the National Institutes of Health launched ambitious studies at its new research hospital, the Clinical Center, it began forming clinical review committees staffed by other scientists, and requiring its researchers to seek advice from them if their proposed study subjected humans to “unusual habits” or involved healthy volunteers. This model allowed the NIH to preserve researcher autonomy while instituting some safeguards against doing science that might produce a scandal. In the 1960s, the FDA adopted this requirement for clinical trials that could be used in seeking approval for new drugs. So when public outrage over the Tuskegee experiment prompted the passage of the National Research Act, led by Sen. Edward Kennedy of Massachusetts, there was already an entrenched model that Congress adopted almost wholesale. The 1974 law mandated ethical review for all federally funded studies through a decentralized system of IRBs housed within the nation’s growing number of research institutions. “You can see this as a form of embedded governance by self-regulation,” said Doni Bloomfield of Fordham Law School, who studies how the law encourages and limits technological progress. Some people, including Kennedy, “wanted a much stronger system than the NIH had, with more centralized oversight over clinical trials, but ultimately the NIH succeeded in keeping this fairly decentralized system in place,” Bloomfield said. Congress established a new agency to oversee that system, called the Office of Protection for Research Risks, or OPRR, located within the NIH. For much of its first decade, OPRR was dedicated primarily to educating the nation’s researchers about how to ethically study people. It rarely deployed the most powerful deterrent at its disposal — the ability to bar an entire institution from conducting or receiving federal funding for human subject research. Advertisement That began to change in the late 1990s, when a science and health policy researcher named Gary Ellis took over as director. Ellis was more assertive about flexing the little agency’s full compliance arsenal. During his tenure, OPRR shut down a number of the nation’s premier research institutions after finding systemic problems with the way they handled human subject protections, including Duke University and Rush-Presbyterian-St. Luke’s Medical Center in Chicago. The bad press ensuing from these actions was not exactly welcomed by leadership at the National Institutes of Health, who had an interest in seeing the research they funded move forward, Pritchard said. Recognition of this conflict of interest led to OPRR being dissolved in 2000 and reconstituted as OHRP, within the Office of the Assistant Secretary for Health at HHS. The reorganization, which effectively ousted Ellis, was supposed to give OHRP higher status and more powerful oversight. But in practice, it left funding of OHRP up to the discretion of the assistant secretary, a politically appointed position with frequent turnover. Any funding increase for OHRP would mean cuts to other programs in the assistant secretary’s purview, like teenage pregnancy prevention and environmental public health. “It’s a mission that’s easy to take for granted,” Kaneshiro, OHRP’s former deputy director, told STAT. “It’s not an exciting initiative that any administration would want to come and fund; it’s more of a baseline necessity.” From its peak of about $7.5 million in 2003, OHRP’s budget sank slowly southward, before flattening out in 2013 at around $6 million a year, where it has since hovered without even adjustments for inflation. At the same time, the NIH’s extramural research budget grew from about $23 billion to $38 billion. “The budget of OHRP was slashed under multiple administrations in both parties, really in response to the old complaint that researchers don’t want other people telling them what to do,” said Stephen Rosenfeld, former chair of OHRP’s advisory committee. Advertisement Rosenfeld, a hematologist who worked in research and hospital administration at the NIH and its Clinical Center for two decades, acknowledges the importance of academic freedom, but the consequence of those decisions weakened the agency’s oversight powers. Enforcement actions — investigations, site visits, institutional audits — are expensive; it all takes a lot of time and person-power. OHRP relies on IRBs from the thousands of universities, medical centers, and other research institutions it oversees to self-report instances where federal rules aren’t being followed. And up until 2022, all of those reports — hundreds each year, sent by mail, fax, and email — were read, assessed for seriousness, and manually entered into a database by OHRP staff. With so much time spent processing the reports, the division had little left to actually investigate what was inside them. So as its budget shrank, OHRP shifted its focus toward education and policy. “If OHRP’s budget was a fixed percentage of the NIH budget and OHRP wasn’t underneath all these other things and had its own standing, I think things would be very different,” Rosenfeld said. A new leader set out to restore OHRP’s influence Molly Klote didn’t have the power to change OHRP’s authority or the source of its budget. But when she took over as head of the agency in October 2024, she came in with a mission to revive its influence. “Everyone respected it because of what it was, but it was an office that didn’t really produce a lot,” said Klote, who left a long career with the U.S. Army Medical Corps and then the Department of Veterans Affairs to take the top job at OHRP. The agency had introduced a handful of policies in recent years meant to decrease paperwork for institutions and increase the visibility of risks to participants during study enrollment, but no one knew if they actually reduced administrative burden or improved protections. “I saw there was an opportunity to actually put OHRP back in a position where it could lead and drive the conversation on evidence-based policymaking,” she said.Advertisement Klote’s hiring was a signal that HHS wanted change, too. In 2017, the Office of the Inspector General had issued a report finding that OHRP needed to be more transparent about its compliance activities and recommending that it be given more independence and resources to do its job. Toward the end of President Biden’s term, the Office of the Assistant Secretary of Health earmarked a $2 million bump for OHRP in its budget proposal for fiscal year 2026. It also hired outside experts to conduct a new analysis of what levels of staffing OHRP would need to be effective. And the office brought in Klote, who in addition to her vast experience in human research protection, also knew a lot about getting stuff done in government. Without any immediate funds available for hiring, Klote went to leaders at flusher federal agencies, pitching that they sponsor positions in OHRP dedicated to studying whether existing policies made research participants safer. By January, she said she had extracted verbal commitments from top officials at the VA and the NIH for a combined $2 million over the next five years to create an embedded team focused on evidence-based work. OHRP staff told STAT that after many years of limping along, some of them had started to feel cautiously optimistic that the fate of their agency might finally turn around. Then, the second Trump presidency began. “It literally just squashed us like a bug,” Buchanan said. In February 2025, his administration eliminated thousands of probationary positions across public health and science agencies, targeting employees who had been hired in the previous one to two years. At OHRP, three people were affected by that first wave of mass firings. Klote fought back, and she was ultimately able to get one — a longtime Navy lawyer — reinstated. On April 1, as thousands more public servants were fired as part of a massive HHS reorganization, Klote heard from someone in human resources. The good news, he told her, was that only one person at OHRP was being laid off. The bad news is it was her. Advertisement Klote would later learn it was an error. It was the result of a clerical misclassification, a single-digit screwup that put her in the wrong office, one that had just been eliminated entirely. She was told it would be fixed. But after weeks and then months went by with no update, leaving Klote in legal limbo and still drawing a paycheck she thought could be better used by her colleagues, she decided it was time to move on. During that time, OHRP’s other most senior leaders — Kaneshiro, Buchanan, and Yvonne Lau — took the early retirement offers pushed by the U.S. DOGE Service. So when Klote resigned last August, Natalie Klein, who had been serving as OHRP’s director of policy since 2021, stepped in as OHRP’s acting director. Kaneshiro chose to leave over concerns about the administration’s plans to reclassify broad swaths of the federal workforce into “policy career positions” — a change that would make those people vulnerable to being fired at will, losing retirement benefits without the right to appeal. “There was so much turmoil, so much lack of clarity about how this would play out, so I decided not to take that risk, ultimately,” Kaneshiro said. In February, the administration finalized a rule creating this new category of at-will employees called Schedule Policy/Career, and on Wednesday, the president issued an executive order spelling out which existing civil service positions would be transitioned. Nearly all of the estimated 8,000 federal workers impacted by the order hold high-level positions overseeing agency policy and spending, including Klein. Had Kaneshiro stayed, her position also would have been affected. Before Kaneshiro and others left, they devoted most of their days to wrapping up investigations into allegations of noncompliance with federal ethics rules. “We knew we’d very likely be losing a lot of staff with knowledge about those cases,” she said. Between January and May of last year, OHRP sent out 10 determination letters, closing investigations into nine research institutions. Many of the investigations had been open for years, some more than a decade, largely due to OHRP’s understaffing. Sometimes the reason they were still open is because the agency was supposed to put out new guidance in response to the investigation, and staff hadn’t gotten around to doing it. “We were always feeling like we weren’t doing as much as we ought to, particularly in the area of compliance,” Kaneshiro said.Advertisement OHRP staff met with attorneys and sat down and went through each case. “We decided we could just go ahead and close them out because there was nothing at this point that the institutions could do,” Klote said. “All the immediate actions had already been taken.” One of the letters, sent to the New York State Psychiatric Institute, acknowledged that OHRP was closing the investigation with the understanding that it would continue to monitor NYSPI through December 2026, as part of the administrative agreement it had signed with the federal government two years before. “We have a robust human subjects protection program and continue to work with our federal partners at the Office of Human Research Protections and the National Institutes of Health to reopen critical research studies, while simultaneously ensuring the safety of any volunteer who participates in them and the integrity of the data acquired,” NYSPI Executive Director Josha Gordon said in a statement. Gordon assumed the role in August 2024, after serving for eight years as the head of the National Institute of Mental Health. “Oversight of this process is ongoing, and we continue to report our progress in full compliance with the terms of our administrative agreement.” Meanwhile, OHRP continues to have just three investigators — two of whom have been on the job less than two years — to review new allegations of noncompliance and conduct further inquiries. The agency’s most recent data show that between Oct. 1, 2025, and March 31, 2026, it received 103 complaints and 352 incident reports. According to agency data, there are currently three active cases, which include investigations conducted in response to allegations as well as “not-for-cause” oversight evaluations. The latter might be initiated if a research institute is receiving large amounts of HHS funding to conduct studies with thousands or tens of thousands of participants but has reported very few instances of noncompliance. “If you hear nothing, that’s a sign there’s a problem, because no one’s perfect,” Buchanan said. Before she left, OHRP had started to think about how it could use artificial intelligence to flag those kinds of patterns, or to identify institutions repeatedly reporting different studies with the same types of ethical lapses. “We have a database, but we hadn’t gotten to the point where we could do a trend analysis,” Buchanan said. “It was still an area that needed to be developed, which requires funding.” Who’s watching the watchers? These days, most of OHRP’s resources appear to be devoted to processing the paperwork that make up the backbone of the U.S. human research protection system. In order to conduct human subjects research with federal funds, the Common Rule requires institutions to have two pieces of paper in hand. The first is what’s called a Federal Wide Assurance, or FWA, which has to be renewed every five years. It’s essentially a commitment on the part of an institution that all the science going on under its roof for that period of time will adhere to federal ethics regulations. Having a single FWA means less paperwork — institutions don’t have to make that commitment for every individual study conducted by their scientists. By putting the whole institution on the hook, it also gives OHRP a bigger cudgel because problems with a single study resulting in the revocation of an FWA will shut down an institution’s entire research profile. The other document is proof that an institution’s IRB meets federal standards and has registered with HHS. Just keeping these systems running for the 13,000 institutions currently supported by HHS requires at least three full-time employees, according to former agency staffers. “Dr. Klein is doing exactly what I would have done in her situation, which is she is keeping the electronic systems running,” Klote said. Historically, OHRP’s policy division pushed forward a number of significant changes, including strengthening informed consent requirements in a 2018 revision to the Federal Policy for the Protection of Human Subjects, known as the “Common Rule.” And it exerted outsize influence across the federal government in how different agencies interpret the Common Rule. “If you talk to people out in the field of research at universities and other institutions, very often you will see an inclination to follow OHRP’s guidance, not just for HHS-funded research but for all federally sponsored research because the other agencies are likely to agree with the HHS position,” Pritchard said. But even before Trump’s cuts, activity in OHRP’s policy division had all but stopped, following the 2024 ruling by the Supreme Court that ended the doctrine of Chevron deference. The historic overturning of precedent effectively stripped HHS and its sub-agencies of the power to independently interpret statutes, including human subject protections regulations. “There was a lot of fear and anxiety among the HHS attorneys,” Klote said. “We were really struggling about how we could continue moving our mission in policy and guidance forward.” OHRP’s division of education, which was small to begin with, lost all of its subject matter experts to RIFs or early retirements. Previously, it held annual workshops on new topics in research ethics such as psychedelics and AI, which typically drew more than 1,000 participants, according to former employees. In 2025, the office was hoping to tackle neuroethics — questions of sentience in brain organoids and considerations for recipients of brain-computer interfaces. That event never happened. Instructional videos and interactive programs the OHRP staff developed still live on its website, but no new educational products have appeared in over a year. And newsletters that were once published monthly dwindled to just three in 2025. A celebration of OHRP’s 25th anniversary, which staff had planned to kick off conversations about how to update the Common Rule to meet current challenges, was also canceled. “The idea was not just to apply the regulations, it was really to facilitate and generate a culture of doing ethical research across the board,” said Lau, who led OHRP’s education division from 2014 until April of last year. “It was not meant to operate like a police station, it’s meant to operate to encourage and ensure that research institutions and their scientists really embrace that attitude. It’s a lot harder to do that now.” Holly Fernandez-Lynch, a lawyer and bioethicist at the University of Pennsylvania and a former member of OHRP’s advisory committee, described OHRP as a “decimated” agency. “After the enforcement heyday of the ’90s, the agency switched to training people,” she said. “Now, they’re not able to enforce or train.” That doesn’t mean the U.S. research enterprise is going to devolve overnight into producing another Tuskegee, Fernandez-Lynch said. The research ethics standards that exist today are very different from the safeguards of half a century ago. What concerns her is that it’s going to be much harder going forward to measure the slow erosion of ethics in research because no one is there to make sure those standards are being satisfied. “It’s a question of who’s watching the watchers,” she said. “If you don’t have that, it doesn’t mean that nothing bad is happening.” Compounding that risk is a simultaneous contraction of human research protection professionals at institutions across the U.S. Faced with the ongoing threat of the administration imposing a 15% cap on the indirect cost rate paid to support their overhead costs, many universities and medical centers paused hiring or downsized the offices that provide on-the-ground oversight to studies involving human participants, according to PRIM&R, whose members represent more than 1,000 research institutions in the U.S. and abroad. “We talk about the pipeline of scientists in the United States and what the federal changes have done to that, but we are also talking about the pipeline of research ethics and oversight professionals,” Tillman said. “We are very concerned about what the next generation is going to inherit.” STAT’s coverage of bioethics is supported by a grant from the Greenwall Foundation and the Boston Foundation. Our financial supporters are not involved in any decisions about our journalism. Clinical trials, ethics, HHS, NIH, research Submit a correction requestReprints Megan Molteni Science Writer Megan covers the intersection of science and society. How is biomedical research funded? Who benefits? And how do new technologies reflect and shape our values? You can reach Megan on Signal at mmolteni.13. Recommended Politics June 4, 2026 STAT Plus: Drug companies, patient groups urge FDA to pause commissioner’s voucher program D.C. Diagnosis June 4, 2026 STAT Plus: RFK Jr.’s second year: Vacancies, not vaccines Advertisement Politics June 3, 2026 STAT Plus: Trump administration to strip job protections of top NIH officials, grants staff Business June 3, 2026 STAT Plus: HaloMD faces lawsuit alleging No Surprises Act middleman used ‘sham letter,’ misleading data Health June 3, 2026 STAT Plus: NIH cuts weakened network primed to respond to outbreaks like Ebola Subscriber Picks