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Press Release
Coalition Comments on OMB Rule That Would Make Significant Changes to Federal Grant Regulations
FOR IMMEDIATE RELEASE
July 29, 2026
BOSTON — A three-organization coalition – The Association for the Accreditation of Human Research Protection Programs (AAHRPP), National Advisory Committee on Human Research Protections (NACHRP), and Public Responsibility in Medicine and Research (PRIM&R) – submitted a joint statement to the Office of Management and Budget, which is considering significant changes to federal grant regulations that will significantly impact how federally funded research is reviewed, funded, and managed.
In its July 13 comments, the coalition wrote: “The new rule would significantly alter current practices, which would create unintended negative consequences for research participants and reduce public trust in science. For these reasons we ask that the final rule not adopt proposed changes that would: (1) subordinate scientific and peer review to the discretion of a senior appointee or designee; or (2) alter the process for suspending and terminating projects in a way that permits the abrupt termination of awards without a transition period sufficient to protect enrolled participants.”
“As drafted, several provisions of the proposed rule do not account for the legal and ethical obligations owed to research participants under the Common Rule (45 CFR part 46), FDA regulations (21 CFR parts 50 and 56), and the Belmont Report,” AAHRPP, NACHRP, and PRIM&R wrote.
In the conclusion of their comments, the coalition letter stated, “Scientific discovery, including a robust clinical trials pipeline, has been a powerful economic engine for the U.S. for decades. In addition to weakening protections for research participants, the proposed OMB rule would increase burden on research organizations and divert efforts away from activities that fuel scientific discovery. Collectively, these changes would undermine the U.S. position as a global leader in research.”
PRIM&R also submitted supplemental comments to amplify the concerns of the more than 3,200 active members throughout the research enterprise.
“In summary, the PRIM&R community raised the following concerns regarding the proposed rule. Peer review, respondents said, should remain the primary basis for funding decisions. Respondents also consistently expressed concern that allowing appointees to override or supersede scientific peer review would undermine confidence in the fairness, integrity, and credibility of the federal research enterprise. Scientific merit should remain the principal criterion for funding decisions. Research oversight professionals depend on rigorous peer review as an important foundation for evaluating the ethical acceptability of research,” PRIM&R Executive Director Ivy R. Tillman wrote.
To read the coalition comments, click here
To reach the PRIM&R’s supplemental comments, click here
July 29, 2026
BOSTON — A three-organization coalition – The Association for the Accreditation of Human Research Protection Programs (AAHRPP), National Advisory Committee on Human Research Protections (NACHRP), and Public Responsibility in Medicine and Research (PRIM&R) – submitted a joint statement to the Office of Management and Budget, which is considering significant changes to federal grant regulations that will significantly impact how federally funded research is reviewed, funded, and managed.
In its July 13 comments, the coalition wrote: “The new rule would significantly alter current practices, which would create unintended negative consequences for research participants and reduce public trust in science. For these reasons we ask that the final rule not adopt proposed changes that would: (1) subordinate scientific and peer review to the discretion of a senior appointee or designee; or (2) alter the process for suspending and terminating projects in a way that permits the abrupt termination of awards without a transition period sufficient to protect enrolled participants.”
“As drafted, several provisions of the proposed rule do not account for the legal and ethical obligations owed to research participants under the Common Rule (45 CFR part 46), FDA regulations (21 CFR parts 50 and 56), and the Belmont Report,” AAHRPP, NACHRP, and PRIM&R wrote.
In the conclusion of their comments, the coalition letter stated, “Scientific discovery, including a robust clinical trials pipeline, has been a powerful economic engine for the U.S. for decades. In addition to weakening protections for research participants, the proposed OMB rule would increase burden on research organizations and divert efforts away from activities that fuel scientific discovery. Collectively, these changes would undermine the U.S. position as a global leader in research.”
PRIM&R also submitted supplemental comments to amplify the concerns of the more than 3,200 active members throughout the research enterprise.
“In summary, the PRIM&R community raised the following concerns regarding the proposed rule. Peer review, respondents said, should remain the primary basis for funding decisions. Respondents also consistently expressed concern that allowing appointees to override or supersede scientific peer review would undermine confidence in the fairness, integrity, and credibility of the federal research enterprise. Scientific merit should remain the principal criterion for funding decisions. Research oversight professionals depend on rigorous peer review as an important foundation for evaluating the ethical acceptability of research,” PRIM&R Executive Director Ivy R. Tillman wrote.
To read the coalition comments, click here
To reach the PRIM&R’s supplemental comments, click here
About PRIM&R
Since 1974, PRIM&R has advanced the highest ethical standards in the conduct of research. We accomplish this mission through education, membership services, professional certification, public policy initiatives, and community building. PRIM&R is a 501(c)3 nonprofit. Find out more at www.primr.org
About NACHRP
The National Advisory Committee on Human Research Protections (NACHRP) is dedicated to the advancement and protection of the rights, welfare, and dignity of human research participants. NACHRP aims to provide clear, practical, and ethically grounded guidance to the research community, including investigators, Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), regulators, and the public. Find out more at nachrp.org
About AAHRPP
The Association for the Accreditation of Human Research Protection Programs (AAHRPP) is an independent, non-profit accrediting body, and uses a voluntary, peer-driven, educational model to ensure that HRPPs meet rigorous standards for quality and protection. To earn accreditation, organizations must provide tangible evidence—through policies, procedures, and practices—of their commitment to scientifically and ethically sound research and to continuous improvement. Find out more at www.aahrpp.org
Media Contact:
Daniel McLean
Public Engagement Manager
Public Responsibility in Medicine and Research (PRIM&R)
Direct: 617-303-1877
dmclean@primr.org
www.primr.org