In June, the HHS Office for Human Research Protections (OHRP) let the research community know it planned to revise federalwide assurance (FWA) forms to remove the box that allows voluntary application of the Common Rule to non-federally funded or supported research.
But OHRP has not followed up that announcement—not terribly surprising given the loss of OHRP staff, including the director, since the Trump administration imposed layoffs and a hiring freeze last spring. At the same time, HHS dissolved the Secretary’s Advisory Committee for Human Research Protections (SACHRP). Still, that flexibility to “uncheck the box” already exists.
OHRP has not issued guidance on regulatory flexibilities. Without this, not as many institutions have taken this step as otherwise might. The new National Committee for Human Research Protections (NACHRP) aims to change that.
Webcast Drew Hundreds
By the middle of this year, individuals serving on NACHRP—mostly former SACHRP members who still had time on their terms—hope to issue their first set of recommendations, which will delve into an institutional review board (IRB) administrative oversight model for minimal risk research that doesn’t fall under the Common Rule.
The topic appears to have significant interest already, perhaps also a reflection of the loss of SACHRP: several hundred people plugged into NACHRP’s live webcast Dec. 8 to learn about the topic, which Ben Mooso, an IRB specialist at University of California, Berkeley, who spoke during the webcast, described as “really near and dear to my heart.”
The purpose of the forthcoming recommendations is to “improve the work that we do in an ethical fashion without necessarily strictly following the Common Rule” for appropriate studies, said Mooso. Others also discussed NACHRP’s overall purpose and possible future topics (see story, p. 3).[i]
Desire to Prevent Burnout
The Common Rule defines minimal risk research as “no more risky than what we encounter in our daily lives or…a basic medical exam,” Mooso said. NACHRP’s recommendations will apply to what Mooso termed “unregulated research.”
These are studies that are not supported by federal agencies, overseen by OHRP nor required to comply with Food and Drug Administration regulations. However, state laws and regulations still apply—as do policies and procedures imposed by institutions where the work is conducted.
Not applying the Common Rule to these types of minimal risk studies would be useful because “we’re in a period now where IRBs are facing an increased workload and mission creep…we’re being asked to do more with the same resources or even, sometimes, less resources. And often, these IRB offices get turned into an institutional one-stop-shop for all research compliance, not necessarily just human subjects protections. And this causes a potential for burnout amongst our colleagues,” Mooso said.
The Common Rule already provides for “commensurate protections with expedited and exempt review,” Mooso said. “The generic pathway for IRB review is the full committee path. Anything that doesn’t fit into expedited or exempt goes full board.”
Eric Mah, whose SACHRP term would not have expired for more than two more years, also spoke during the webcast, which was hosted by Public Responsibility in Medicine and Research. He acknowledged the topic was “advanced” and said he hoped it would spark discussion among IRB members and human research protection program “senior leaders.”
“Burnout is a real concern in our profession, in our offices throughout the country,” Mah agreed. “This is an endemic concern. And so, we have to recognize that we have to, and can, control the work that we do.”
Focus on Level of Risk
NACHRP is “bringing this topic to you to show one way by which you can do the work differently, that is less burdensome, that may have less procedural requirements,” and that will “save us time in doing the work,” Mah said.
The recommendations will include “background on the purpose and why unchecking the box [is] important and a regulatory flexibility,” as well as a “generic” standard operating procedure on how to do a review, Mah said, along with “practical applications that your organization can adopt or edit, to suit your own program, the culture, the practices.”
The speakers did not present proposed recommendations during the webcast, but intend to do so during future meetings to solicit input before NACHRP finalizes them. As part of his presentation, Mah explained that the first step in a review process is to determine the “level of risk” a study poses to participants.
“When I do a review, I ask myself some basic questions, but fundamentally, ‘What is happening in this study?’ I think that’s where we all have to start,” Mah said. “Some people start with the consent form. Some people start with the protocol. Some people start with the application submission. But one of the first approaches to this is to focus on assessing the level of risk and that enables us to know, ‘Where does this need to be routed?’”—whether full IRB review or through an IRB administrative office approval process.
NACHRP members still believe that “all greater-than-minimal-risk-research, even unfunded greater-than-minimal-risk-research, which is probably a small proportion of the research out there…should go to full board [under] the Common Rule framework,” Mah said.
He noted that an administrative IRB approval for unregulated research “should not vary significantly from the deliberative process, from the critical thinking, you apply to approve another study.”
‘A Return to How Things Were’
A reviewer needs to ensure that “someone who’s considering research understand[s] what that means as best as we can share with them, and then ensure, of course, that they agree to do it,” Mah said, adding that whether an informed consent document is needed will vary.
After reviewing the various considerations that fall under the Belmont Report—respect for persons, beneficence and justice—privacy concerns also need to be addressed, including whether a HIPAA waiver or limited data set agreement is required, Mah added.
Once reviewers have appropriately determined the research is minimal risk and “are applying Belmont appropriately, then [a study] is approvable,” Mah said. “No longer do you have to be concerned about checking all the right expedited categories or checking the right exemption category and getting that perfect. I feel like that takes away from the application and the grounding of Belmont, which is really what’s more important here.”
Mah called this process “a return to how things used to be, in some ways, before the checkbox, kind of audit culture [began] to take a bigger stage.”
He added a “reminder,” saying that, “sometimes, maybe many times, it’s okay to approve a study as originally submitted, even if not perfect. What perfect is can be debated…but I do also think that sometimes as reviewers we think we have to find something or it doesn’t demonstrate we’re doing our job.”
Participants who “agree to the risk and maybe potential loss of privacy” should be allowed to join a study and IRBs should “not be overly paternalistic,” Mah said.
Although OHRP has not indicated whether it plans to move forward with the FWA changes, NACHRP member and former OHRP Deputy Director Julie Kaneshiro said she expects that it will. This makes NACHRP’s first project “so timely now,” she said during the webcast.
Klote Offers Praise—and Caution
Former OHRP Director Molly Klote told RRC that NACHRP’s tackling of regulatory flexibilities demonstrates “leadership [that] is precisely what the research oversight community needs.” NACHRP “is doing the work the federal government cannot do” for studies over which it has no authority, she said via email.
Dividing research leaders into two types—“firefighters (burning out, drowning in compliance theater for minimal-risk studies) and the visionaries (wanting to modernize but trapped by outdated rules)”—Klote said that the check-the-box “culture forces everyone into the firefighter role, wasting precious HRPP [human research protection program] resources on imaginary fires, formatting errors in no-risk consent forms and endless debates over exemption categories, when those resources should be protecting participants in actual high-risk research through post-approval compliance monitoring.”
An administrative approval pathway “could be the lifeline firefighters desperately need and visionaries have been waiting for,” Klote said. “However, make no mistake: Administrative approval must still be an honest review, grounded in the Belmont principles. It cannot become a rubber stamp. Even minimal risk research can destroy community trust if handled disrespectfully or paternalistically.”
The three Belmont principles “are non-negotiable, even if the regulatory bureaucracy is streamlined,” Klote said, offering what she called “a critical warning to institutional officials: Do not try to implement administrative review approvals until you have the policy written, vetted, signed and fully trained into your HRPP. If you move forward without a robust internal standard in place, you are walking an ethical tightrope without a net.”
[i] Theresa Defino, “NACHRP Goal: ‘Provide Opportunities for Community Participation,’” Report on Research Compliance 23, no. 1 (January 2026): 3.
Report on Research Compliance 23, no. 1 (January, 2026)
https://www.hcca-info.org/publications/newsletters/report-research-compliance
