Reflecting thwarted desires to continue their terms, while answering calls from trial administrators and oversight leaders, seven former members of the highest-ranking federal advisory panel on human research protections—terminated by the Trump administration in late March—have launched their own national committee.
The website for the National Advisory Committee on Human Research Protections (NACHRP) went live in mid-June, but as of RRC’s deadline, members hadn’t formally announced their effort.[1] The committee takes its name from the HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP). RRC was first to report that SACHRP was dissolved at the same time HHS terminated Molly Klote, director for just six months of the Office for Human Research Protections (OHRP), to which SACHRP reported.[2]
“My personal hope for NACHRP is that our community engages with us by raising issues of concern and partners with us on developing guidance to ensure any guidance has value,” Eric Mah, associate dean at the University of California San Diego (UCSD) and a NACHRP founder, told RRC. Mah, who stressed that he was speaking as a private citizen and not on behalf of UCSD, had served less than half his term when SACHRP was folded. Mah’s four-year term began July 5, 2023.
SACHRP had been operating since 2003; its 11-member panel met three times a year for two-day meetings. Members labored sometimes for years to produce detailed recommendations that often included implementation strategies. The first sign that something was amiss was that its March meeting was cancelled and not rescheduled.
NACHRP Will Host Removed Documents
An entry on the government website for committees impaneled under the Federal Advisory Committee Act notes that SACHRP was terminated in compliance with Executive Order 4217, “Commencing the Reduction of the Federal Bureaucracy.”
One resource NACHRP plans to offer may be of immediate assistance to the trial community. Under orders from HHS, OHRP removed certain SACHRP recommendations that contained the word “justice” and addressed LGBTQ, diversity, equity and inclusion.[3] NACHRP plans to post SACHRP’s recommendations along with ones it issues on its own.
Mah said NACHRP “hope[s] to have a full set of past guidance posted on our website, if needed. Removing previously issued guidance across agencies on the scale that has been widely reported is a level of censorship most Americans are unaccustomed to. It is deeply concerning.”
Klote told RRC this will also “make it easier for people to actually access the information and will decrease burden on OHRP to fulfill” requests for missing documents. She noted that, although OHRP is providing them upon request, “that means someone has to know the documents ever existed.”
More Freedom Than SACHRP
All of the new committee members listed on NACHRP’s website were recent appointees to SACHRP, with the exception of Julie Kaneshiro, the longtime OHRP deputy director who retired at the end of April.[4] As of May, OHRP had fallen from a staff of 20 to just nine—it should have 40—following the loss of Klote, four retirements, removal of probationary employees and regular job changes occurring during a hiring freeze.[5]
Kaneshiro told RRC she is eager to work with NACHRP. “I’m honored and happy to be a member to try to contribute to the thinking about ethical and regulatory issues in human research,” she said.
Klote also offered her support to NACHRP members, saying she is “looking forward to seeing what they do.” Klote noted that NACHRP “will not be subject to the same constraints of SACHRP” and should still have the ear of federal research oversight officials at OHRP and the Food and Drug Administration (FDA).
“Just because they are not an official federal advisory committee doesn’t mean that OHRP and FDA can’t consider their recommendations,” she said. “I think a group of dedicated human research professionals who can contribute ideas to the national conversation on the ethical conduct of research is valuable no matter who runs it.” Two months ago, Klote commented on a LinkedIn post that “perhaps some nonprofit group will create a national research protections advisory committee that can still take on these issues and provide information to OHRP and the community.”
NACHRP intends to mirror SACHRP’s role as a “trustworthy and pragmatic advisory committee,” Mah said. It currently lacks funding, and all members serve voluntarily.
Push Came From SACHRP, Peers
“Like my other colleagues on SACHRP, I was deeply disappointed to hear the committee would no longer be meeting,” Mah said. “When news spread about SACHRP ending and OHRP losing personnel, I joined colleagues and issued a joint statement of support for OHRP and co-authored a commentary in JAMA. About the same time period, I received messages from colleagues that there would be a void without SACHRP to provide guidance and heard questions about whether anything could be done about it.”
This spurred a “conversation with other SACHRP members who still had time remaining on their four-year appointments, to see if they wanted to volunteer on a new grass-roots advisory committee, which would be unaffiliated with the federal government,” Mah explained. “We had already been screened, vetted and appointed to serve on SACHRP, and so we would be the founding members with the possibility of expanding members if there was need.”
Like Mah, Alison Bateman-House, assistant professor in the Division of Medical Ethics at NYU Grossman School of Medicine, was appointed to SACHRP in 2023. She told RRC NACHRP will “fill the void” left by SACHRP, and noted that its recommendations, such as those on the “best interests standard,” help ensure consistency “across sites or between studies.”
When human subjects research is halted, institutional review board (IRB) approval lapses or is “suspended for some other reason, those in oversight roles may nevertheless believe that continuing some or all of the research interventions would be in the best interest of the participating subject(s),” Bateman-House said, noting regulations and guidance don’t define subjects’ best interests.
“The abrupt shuttering of SACHRP does not mean that this sort of question will never again arise, only that the body to which it would have been directed is no longer there. So, something is needed to fill the void,” she said.
Mission to Advance Protections
According to its website, NACHRP’s mission is “dedicated to the advancement and protection of the rights, welfare, and dignity of human research participants. We aim to provide clear, practical, and ethically grounded guidance to the research community, including investigators, [IRBs], Human Research Protection Programs (HRPPs), regulators, and the public.”
NACHRP “is non-partisan and seeks to uphold the ethical principles established in established ethical frameworks (e.g., Belmont Report, Declaration of Helsinki), to promote consistent interpretation of federal regulations and guidance, and to address emerging ethical challenges arising from advances in science, medicine, and technology,” with activities to include “collaborative dialogue, expert analysis and consensus building.”
To date, the new shadow SACHRP has not named a chair nor the topics it intends to address. Leadership positions and logistics are still being worked out, Mah said. He also noted that NACHRP’s website “is still a work in progress” and requested that the community “be patient with us as we grow and mature as a grass-roots effort. I also hope they join our listserv.” (To do so, visit https://mailchi.mp/393dc1e643c7/nachrp).
‘So Much Ground to Cover’
In addition to Klote, Michelle Watkinson, IRB training and communications manager for Rutgers University’s HRPP, has been publicly advocating for greater resources for OHRP and lamenting the dissolution of SACHRP; she recently shared her efforts with RRC.[6] After learning of NACHRP from RRC, Watkinson said she “couldn’t be more proud of the NACHRP founders for uniting their expertise and demonstrating resilience in their shared mission to advance ethical, inclusive, and transparent protections for human research participants.”
She added that following the loss of SACHRP, “many of us (HRPP/IRB professionals along with researchers) want access to guidance that moves the regulations forward.”
Watkinson also has a few ideas for what NACHRP should tackle.
“There’s so much ground to cover,” she told RRC. “I’d welcome guidance on the use of [artificial intelligence] in research, including as a tool for analysis and data storage; the inclusion of people with disabilities—both as research participants and as researchers; [and] ethical engagement with marginalized communities, including LGBTQ+ individuals and undocumented populations, who are increasingly under attack and deserve equitable protection and respect in research spaces.”
She also offered praise for NACHRP’s plan to post SACHRP’s work.
“Expertise guided by courage is essential, especially in a time when public health and civil rights are under threat from divisive, authoritarian rhetoric and policy,” Watkinson said. “Releasing SACHRP’s previously suppressed recommendations—developed by a bipartisan, evidence-driven body—can help restore transparency and trust. NACHRP builds on that legacy, carrying forward a torch of knowledge, equity and integrity to illuminate this critical moment in research ethics.”
1 National Advisory Committee on Human Research Protections, accessed June 24, 2025, https://nachrp.org/.
2 Theresa Defino, “HHS Terminations Include OHRP Director; SACHRP Folded,” RRC E-Alerts, April 3, 2025, https://bit.ly/44tUlcQ.
3 Theresa Defino, “OHRP Under Trump: No SACHRP Meeting, Justice, LGBTQ Recommendations Gone,” Report on Research Compliance 22, no. 4 (April 2025), https://bit.ly/3GbwHIX.
4 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/3ZK2XJQ.
5 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/44s5Npp.
6 Theresa Defino, “Rising Above Fear, Rutgers HRPP Trainer Rallies for OHRP Crippled by Staff Losses,” Report on Research Compliance 22, no. 6 (June 2025), https://bit.ly/45vgYif.
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