Report on Research Compliance 22, no. 6 (June, 2025)
When Jerry Menikoff retired at the end of 2022 after leading the HHS Office for Human Research Protections (OHRP) for 14 years, he left behind an agency limping along with 20 employees, less than half of what it needed. For nearly two years afterward, Julie Kaneshiro, deputy director and a steady hand at the agency for more than two decades, stepped in as OHRP’s number one and two, until Molly Klote, M.D., a 35-year federal veteran, was hired away from her job as chief research officer for the Veterans Health Administration.
In Kaneshiro’s words, Klote’s appointment triggered a “very hopeful time.” It didn’t last.
As RRC was first to report, Klote—on the job just six months—was among the 10,000 HHS employees to receive termination notices in early April. Kaneshiro, who joined OHRP before there was an OHRP (more about that later), again became acting director. But now she, too, is gone, having made the “very hard decision” to retire early, Kaneshiro told RRC in an exclusive interview. Under the Trump administration, with retirements, regular job changes amid a hiring freeze, terminations and the loss of interns, OHRP has slid to nine employees.[1]
“It was a dilemma for me, frankly, because I very much wanted to stay and continue to work in the office and be part of the stabilization and the rebuilding,” she said. “But given the uncertainty about additional changes coming or that were possible and the impact those could have on my financial well-being, I ultimately made a very hard decision to protect my own financial well-being.”
In addition to discussing her regret and disappointment at having to retire, Kaneshiro looked back over her career, addressed the promise lost with Klote’s termination and expressed hope that HHS will embrace and support OHRP’s vital role. The separation is still so fresh that Kaneshiro referred to her association with OHRP in the present tense throughout the interview, correcting herself several times.
Lisa Buchanan, director of OHRP’s Division of Compliance Oversight, retired at the same time as Kaneshiro. She did not respond to RRC’s request for comments. Klote, placed on administrative leave with termination effective 60 days later, declined to comment, but said on LinkedIn she is appealing the reduction-in-force (RIF) notice.
Kaneshiro, who has a master’s degree in public policy and philosophy, found her way to OHRP when it was then called the Office for Protection From Research Risks and was part of NIH. An NIH management intern at the time, Kaneshiro became enamored with the work and had hoped to continue with the office.
Deputy Role Was All-Encompassing
NIH hired her as a senior policy analyst in 1991, a position she held for 10 years before joining OHRP in 2002 as its policy team leader. At that time, OHRP had 40 employees. In addition to investigating possible violations of the Common Rule among 13,000 institutions, OHRP manages federalwide assurances, required before accepting HHS funding for human subjects research, and sponsors a variety of educational programs.
Menikoff promoted her to deputy director in 2014. In this position, she “oversaw every aspect of the office; it was really a partnership with the director. All the divisions reported to me, and, given the short staff, I really did work in each of those divisions to varying extents, depending on the need. I would go on site visits and be directly involved in some investigations that the compliance division was conducting.”
It was about this time that OHRP’s funding “peaked,” she said, and then began to “dwindle.” Congress has funded OHRP at just over $6 million annually in recent years, enough to support barely 20 employees, according to budget documents. But OHRP never pushed for more than slight increases, which sometimes Congress granted.
To cope, the agency simply stopped filling positions when they became vacant, a situation that Kaneshiro revealed during a conference at the end of 2022. At the time, she reported that OHRP was supposed to have 32 employees but was holding open 12 slots.[2]
Asked if she blames Menikoff for the funding woes, Kaneshiro said there were “various causes” behind the losses, but acknowledged that, “as an academic,” Menikoff was less skilled at navigating the federal bureaucracy. She also noted that OHRP historically has been part of the general HHS budget and, as such, doesn’t have a high profile. “We don’t have our own separate line-item funding, so it’s easy for us to get buried.”
Termination Brought ‘Shock and Sadness’
Kaneshiro, who was “acquainted” with Klote before she joined OHRP, said Klote “saw right away what our biggest need was—and that was staffing. And the way that you increase your staffing is through getting an increase in your budget. She’s also a very creative person and was looking at various options for trying to get additional funding.” Klote’s background gave her the expertise to “do fundraising within the federal government. She knew how to create those kinds of partnerships, even externally,” Kaneshiro said.
OHRP staff felt “shock and sadness” when Klote received her termination notice. “We failed to recognize that she was even vulnerable to being RIF-d. Because she had had such a long federal tenure, it was surprising she was let go through a RIF process,” Kaneshiro told RRC.
Kaneshiro said it is “unclear” whether the termination was the result of Klote perhaps being considered a probationary employee because she had been at OHRP only six months.
Days before Klote received her termination email, HHS had notified OHRP that it planned to dissolve the Secretary’s Advisory Committee on Human Research Protections (SACHRP). Created in 2003 (replacing an earlier panel), SACHRP technically reports to HHS Secretary Robert F. Kennedy Jr. but in reality, it is an arm of OHRP, which staffs it, vets the 11 members and controls the agendas for its thrice-yearly meetings.
The dissolution of SACHRP is a “significant loss,” Kaneshiro said, adding that “the need for it still exists.” The committee served as a “conduit, on a regular basis, to the regulated community so that we would have more insight in terms of the ethical and regulatory issues that the regulated community was facing.” RRC will discuss the work of SACHRP in a future issue.
Pride at Partnerships
Looking back over her career, Kaneshiro said her “overarching” goal was to “build partnerships and collaborations.” This reflects back to her time working on the 2003 Privacy Rule, for which she was detailed from NIH to the Office for Civil Rights (OCR). “That’s something that involved a lot of collaboration across the federal government,” she recalled. While detailed to OCR, Kaneshiro ran “multiple working groups of different federal partners, different agencies.”
Drafting and implementing the 2018 revised Common Rule was also a significant success and one that “required a similar type of collaboration across all the other Common Rule departments and agencies, even though HHS had the lead. I’m really glad we were able to get that done,” she said.
Kaneshiro also counts as achievements actions taken against New York State Psychiatric Institute as a result of deficiencies in its human research protection program. RRC will detail the investigation and corrective actions taken in a subsequent issue.
Support OHRP, Increase Trust
RRC asked Kaneshiro to assess how OHRP is functioning with just nine employees.
“I’m very confident in the abilities of the people who remain, not just their ability, but their commitment. We really do have a terrific staff. I’ve always said this to our staff and others that OHRP was small, but really mighty. Our staff that remain will continue to do the baseline necessary to maintain the imperative mission-critical functions that are established by statute, but it’s going to be difficult to do more than that in the short run. You cannot have three divisions and [an] office director with nine people. There’s going to have to be a lot more just teamwork to carry out whatever priorities that the office identifies for itself.”
Moreover, “so much of what our role was to be sort of a leader, across the federal government, even outside the federal government with our non-federal partners, to try to improve human research protections across the country,” Kaneshiro said. “I’m hopeful that we’ll be able to, that the office will be able to hire people with the necessary expertise to carry out that work.”
“If we’re just really focusing on the highest priority issues of just trying to fulfill our statutory requirements, a lot of that kind of proactive outreach, which I think ultimately is our best protection for human subjects, is not going to be as robust, certainly, if we’re able to do it at all going forward,” she added. “We, on the outside, myself included now, really need to advocate” for OHRP to be rebuilt and “not be silent about this.” Some, like Michelle Watkinson, the institutional review board manager of training and communications for Rutgers University’s human research protection program, are already heeding this call.[3]
A leaked HHS document calls for OHRP to move to a new Office of the Assistant Secretary for Enforcement, joining the Office of Research Integrity and OCR. Kaneshiro said she hopes that, if this happens, it won’t diminish OHRP’s policy and educational activities, saying the agency’s job is “much more holistic” than enforcing the Common Rule.
HHS needs to recognize that many of its priorities are “dependent on research and research with people or research with people’s data” and that “we need to have trust in science in order for science to advance. In the absence of that, we are not going to have people who are willing to volunteer. The human research system is largely built on trust, but the system has to be trustworthy. And OHRP was a significant part, I believe, in ensuring that the system is trustworthy.”
Saying Goodbye to ‘Family’
Kaneshiro didn’t plan to step away from her own role, but she saw what was happening to OHRP and across the federal government. In addition to mass layoffs, President Donald Trump signed executive orders resurrecting what is known as Schedule F, which reclassifies workers to political positions so they can be more easily terminated, and outlawing unions representing federal workers.
Early retirement “was something that I had to decide quite quickly because of the time constraints I was under,” she said, adding it also meant saying goodbye to the longtime coworkers who had become like family. “The beauty of being a small, tight-knit group is that we really did have more than just a workplace relationship. I expect we are, in the short and long term, going to be there for each other.”
Since she left OHRP, Kaneshiro has been occupied with the graduation from college of one daughter and the return home of another following the end of the school year. She hasn’t started job hunting and isn’t sure when she will.
“The full impact of what this means for me in my career is not yet really settled. I don’t really have any kind of tangible plan at this point,” Kaneshiro said. “I do want to be present in the field in some capacity. This work, for me, it wasn’t just a job. I really love this work. I think it’s really important work. And because I was in the government for so many years—33 years—in some ways it also is liberating to not have the same constraints on me that I had for all of those years working in this field. [I’m still] figuring out how to effectively, appropriately use that freedom. I want to find something that is related to the field but suits me from where I am now.”
“And something—obviously—outside of the federal government.”
1 Theresa Defino, “And Then There Were Nine: Disappearing OHRP To Join Enforcement Agency; NIH Cuts Outlined,” Report on Research Compliance 22, no. 5 (May 2025), https://bit.ly/4dlWlqo.
2 Theresa Defino, “With Greater Than Half Its Positions Vacant, OHRP Employing More Technology, ‘Creative’ Spending,” Report on Research Compliance 20, no. 1 (January 2023), https://bit.ly/47JYIzz.
3 Theresa Defino, “Rising Above Fear, Rutgers HRPP Trainer Rallies for OHRP Crippled by Staff Losses,” Report on Research Compliance 22, no. 5 (June 2025).
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