Report on Research Compliance 22, no. 8 (August, 2025)
In the end, the final termination letter arrived in the mail on July 18.
For nearly three months—about half of the length of time she was director of the HHS Office for Human Research Protections (OHRP)—Molly Klote, M.D., had been haunting her email for news. Initially placed on administrative leave on April 1 with 60 days’ pay, last month Klote was officially severed from the federal government she’d served for more than three decades, part of a federalwide reduction-in-force (RIF) that hit HHS particularly hard.
Although HHS announced plans to fire 10,000 workers, some individual decisions appear to make little sense. It’s hard to find a better example than Klote’s. HHS did not respond to repeated requests to explain Klote’s termination.
Klote’s convinced it happened because of an error a human resources (HR) person made filling out the federal personnel form, known as the SF-50, when Klote joined OHRP in October from the Departrment of Veterans Affairs (VA). Perplexingly, Klote’s position was listed as being in the Immediate Office of the Assistant Secretary for Health (OASH). Her understanding is that everyone in the immediate office was RIF’d.
But she wasn’t part of that office; she was the director of a program office, filling the top job in a critical agency that had been vacant for nearly two years, following the retirement of Jerry Menikoff in December 2022. Klote wrote to OASH and specific HR folks assigned to OHRP, explaining the mistake and others in her RIF notice. The notice also said she’d earned a “3” on her last performance evaluation. In her previous position with the VA Office of Research and Development, Klote, who retired from the Army as a colonel in 2018, had actually earned a “5”—the top rating.
Klote’s exclusive comments to RRC in extensive and candid interviews mark the first time she has publicly detailed her work at OHRP and the circumstances surrounding her termination. While still on the payroll, Klote was not permitted to speak to the press.
“I don't believe I was targeted specifically. I also don’t think that OHRP was targeted. I think decisions were made and email notices sent based on inaccurate files that no one had time to fact-check,” Klote told RRC, adding that she “pointed out the error a number of times in a number of ways,” to no avail.
After the final letter came, Klote had “mixed feelings,” she told RRC that day. “I heard that some people received separation emails earlier this week and I was confused why I didn’t, so receiving something in writing, especially after having no official communication since April 1, helps with closure.”
The letter provided “relief,” as it ended the “strange limbo” she and others have been in for months—months marked by miscommunication, reversals, silence and confusion for Klote and other federal workers.
For Klote, the saga began March 28, a Friday. That afternoon, she was told she would be RIF’d, then waited all weekend for the RIF email to arrive. When no email came, she reported for work on Monday; she was told that the Friday notification was a mistake and that she would not be RIF’d. Yet, the next morning, the RIF email came. It was the same day other federal staff showed up for work in person only to learn they had been terminated and were prohibited from entering their offices.
Klote began the process of forming a consulting firm she planned to launch after her final day as a fed. The April 1 RIF notice said that it was June 2. Hearing silence or conflicting information about her status, Klote turned to Reddit and learned that a court had paused RIFs, but it was unclear if the court order applied to her and other senior executives. No word came until June 4, two days after Klote thought her service had ended; it was from the HHS ethics office, reminding the blind-copied group of their ethical responsibilities while they remained on administrative leave. The July 18 notification letter, however, listed July 14 as her last day of federal employment. Many of the most recent RIFs happened after the U.S. Supreme Court on July 8 reversed a lower court order barring mass terminations and agency reorganizations.
“This is not exactly how I wanted to end my 36 years in the government,” she said. “It’s just so incredibly disappointing. I’m just disappointed on how it all worked out, how we’ve all been treated; for some people it’s been cruel.”
RRC was first to report news of Klote’s termination and dissolution of the Secretary’s Advisory Committee on Human Research Protections (SACHRP), with STAT later carrying the story. SACHRP members who had unexpired terms recently regrouped as the National Committee on Human Research Protections, which is not affiliated with the federal government.
Supporters Rallied, Contacted Congress
RRC subsequently reported that OHRP had dropped from 14 to nine employees; in recent years, the chronically underfunded agency had 20 but is supposed to have at least 42, Klote said, citing a manpower staffing assessment when OHRP was created 25 years ago. Many were aghast at Klote’s termination, the loss of SACHRP and the dwindling number of OHRP staff. The research compliance community began to rally opposition to these changes.
Public Responsibility in Medicine and Research (PRIM&R) and The Consortium to Advance Effective Research Ethics Oversight, known as AEREO, wrote joint public statements, along with others, calling for “strong support for OHRP, its mission, and its expert staff” in light of “recently reported changes in OHRP leadership and the Office’s ongoing capacity to oversee federally funded research.”
PRIM&R President Ivy Tillman and members of her staff have continued to advocate on behalf of OHRP, meeting with congressional staff on Capitol Hill, including from the Health, Education, Labor and Pensions Committee, connecting them “with people who could share more about the ramifications of leadership changes at OHRP.” Yet, these efforts failed to stop the termination process. Asked if Congressional staff had committed to take action, the association said in a statement to RRC that they “have been receptive to the information and insights we shared.”
A high-ranking administrator at a major research university who requested anonymity called the loss of Klote “unfortunate,” citing the long vacancy before her appointment and the dashed hopes that Klote represented to the research community “for renewed direction and stronger leadership at a time when the research oversight system is facing real challenges.”
AEREO co-chair Holly Fernandez Lynch, associate professor of medical ethics and law at the University of Pennsylvania and a former SACHRP member, told RRC the reasons for Klote’s termination are unfathomable. She, Tillman and other co-authors published a related article in the Journal of the American Medical Association.
“The lack of an OHRP director speaks volumes about what this administration values—and what it doesn’t. On what grounds could they possibly have objected to Molly Klote, a literal veteran and a longtime veteran of ethical human subjects research oversight? On what grounds could they justify further decimating the staff?” Fernandez Lynch asked.
Fernandez Lynch said administration officials also have “shown they don’t care about advancing science and medical research. These actions show this administration doesn’t care about participant protection. Institutions and all research ethics professionals will have to continue to fill the gap. But we have regulations and government oversight of research for a reason. I hope the U.S. doesn’t get a terrible reminder of the history that led us to our current system.”
That’s a fear—among others—that Klote also shares.
No Response to Early ‘Olive Branch’ to Kennedy
In fact, with no knowledge of her own impending termination or how several members of her staff would feel forced to retire, in March Klote went to HHS headquarters in Washington, D.C., and hand-delivered a “welcome to HHS” letter to support staff of newly installed HHS Secretary Robert F. Kennedy Jr. She even affixed one of the custom “OHRP” lapel pins she’d earlier had made at her own expense to help boost staff morale and commemorate the agency’s 25th anniversary. Klote never received an acknowledgement of the letter or pin.
“I was trying to put out an olive branch, to get the OHRP name in front of him, so that if we were to come up for any kind of cuts, maybe they would think twice about it,” she told RRC. The letter, Klote said, reminded Kennedy “of his family’s connection to the mission of OHRP. It was Senator Ted Kennedy who got Nixon to sign the National Research Act, which is what launched the National Commission, which wrote the Belmont Report, which then, ultimately, forged the creation of OHRP.”
She added a personal P.S.: Klote’s mom and Kennedy’s “went to daily mass at St. Luke Catholic Church in McLean, Virginia, for almost 10 years together,” she wrote.
At that time, she didn’t make a pitch for more resources—“I was going to save that for an in-person meeting” at OHRP’s offices in Rockville, Md., she said. But making the pitch was something she knew she needed to do, had always known; she’d become acutely aware of OHRP’s shortcomings through her many interactions with OHRP over the years. She was with the VA for six years, where she was most recently one of the deputy directors of the Office of Research and Development. From 2015 to 2018, Klote was director of the Army Human Research Protections Office.
Menikoff’s retirement provided an opportunity for her to come and make OHRP better. In her view, OHRP staff lacked “boots-on-the-ground, practical experience of trying to implement the Common Rule or the guidance documents and the policies that they put out. They had lost touch, or never had touch, with that practical implementation side of it,” Klote said.
In contrast, “I had two experiences running research programs and a lot of experience trying to make the regulations work for the researchers and for the protection of human subjects,” she added. “So, coming in the door, I had a totally different perspective on how things should run.”
‘Making Some Real Headway’
She also faced OHRP’s dire financial and staffing situation, which would only worsen. OHRP’s budget “has been $6 million since 2013—with not even an inflationary increase,” said Klote, yet OHRP’s oversight responsibilities grew to encompass 13,000 institutions and 6,000 institutional review boards, while the portfolio of NIH (not including other HHS agencies) grew to $47 billion. Klote worked to strengthen the justification to increase OHRP’s fiscal year (FY) 2026 budget request to Congress.
In the six months Klote was director, “we were making some real headway,” she said,” really moving in a good direction. There were so many things we were working on.”
In an earlier interview with RRC, Julie Kaneshiro, who recently retired as OHRP’s longtime deputy and was acting director before Klote was hired and after she was put on leave, described her tenure as ushering in a period of hope, which, unfortunately, didn’t last.[1]
Klote immediately launched a number of initiatives within OHRP—for example, insisting that staff issue closeout letters on investigations that had been languishing, in one case for a decade. She also started projects with VA, including adapting for HHS programs she knew worked, such as an online determination tool. VA also agreed to fund a new staff member to conduct research on how well parts of the Common Rule are, and aren’t, working. She collaborated across HHS agencies to get a handle on their implementation of the Common Rule. (For details on these and other projects.)[2]
Klote spent her final six weeks or so trying to reverse the termination of three probationary employees, knowing she could not replace them due to a federal hiring freeze, and assisting the State Department wind down clinical trials that the U.S. Agency for International Development had run, as it was being shuttered.
And then came the email on April 1.
“Of all the people that could have been let go from OHRP, I was the one probably in the best situation to be let go. I have my military retirement pay. I like having an income, but more importantly, I liked doing the work,” Klote said. “I didn’t have to work at the VA. I didn’t have to work at OHRP. I took those jobs because I wanted to make a difference.”
‘Higher Vigilance Is Needed’
When she thought her final day was June 2, Klote penned a farewell that she posted on LinkedIn, in which she “warned that noncompliance rates may potentially increase if institutions are not vigilant. Not all noncompliance results in danger to participants, but it does put investigators and the science they are trying to prove at risk. It also puts the institutions they represent at risk,” Klote told RRC.
Klote acknowledged that “the worst thing that could happen is that a patient is harmed. But harm itself is not the only result. If the science is corrupted through protocol noncompliance, people’s time and specimens can also be wasted and that undermines trust in the system.” She added that “higher vigilance is needed, especially when oversight organizations are no longer adequate to achieve the levels of auditing and support that would give confidence to the system.”
Klote fears that without a strong—and functioning—OHRP, the other Common Rule agencies are “going to fall away” from the regulation and “they’re all going to make up their own rules. The Common Rule group is just a coalition of the willing. There’s no requirement to sign on to the Common Rule,” she pointed out.
Another result will be the “civilian community” doing the same thing, leaving the national research field without a “baseline.” The exception might be regulations issued and enforced by the Food and Drug Administration (FDA), Klote said, but FDA itself is also undergoing restructuring and downsizing.
Promise of Future Resources ‘Unlikely’
She also expressed to RRC her concerns about HHS’ reorganization announced this spring, which would dissolve OASH and put OHRP under a new Assistant Secretary for Enforcement, which may also encompass the Office for Civil Rights and the Office of Research Integrity. That reorganization may be in flux, as the White House has still not submitted a detailed FY 2026 budget request.
“The risk of putting it under enforcement—that’s not OHRP’s main job. Our main job is policy and protections,” Klote said. “We do enforcement, we do audits…but that’s not what we want the community to see as our primary role. We are more about educating to prevent the bad things from happening.”
Klote has established her consulting firm, Klote Medical Research Advisors LLC, which promises to deliver “experience you need, guidance you can trust.”
Would she come back to OHRP if someone said, “Oops! We made a mistake?”
“It’s hard to answer,” Klote said. “The OHRP I left was already in bad shape due to years of budget neglect and leadership neglect. Without some guarantees for the authority to hire and additional funding to be able to do the mission, which are both unlikely to be promised, what is the role of OHRP? Is OHRP where I think I can do the most good now?”
She had “hoped to lead the solution to correct” OHRP’s weakened state, which is now in “worse condition by the early retirements and voluntary separations. My fear is that it will take a significant problem happening in a research study to bring attention back to this topic.”
1 Theresa Defino, “’I Really Wanted to Stay’: Amid Success, Regrets, OHRP’s Kaneshiro Hopes Agency Will Be Rebuilt,” Report on Research Compliance 22, no. 6 (June 2025), https://bit.ly/4f0CLRC.
2 Theresa Defino, “Klote’s Termination Disrupts Major Efforts Launched to ‘Fix’ OHRP, the Common Rule,” Report on Research Compliance 22, no. 8 (August 2025).
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