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Press Release
Coalition Submits Comments on Three Federal Proposals Affecting Research Oversight, Participant Protections, and Clinical Trial Access
September 24, 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 joint comments to three federal agencies late last month, addressing a range of significant proposals that would affect investigational new drug review, clinical trial participant compensation, and federal research funding oversight.
On August 24, the coalition submitted comments to the U.S. Food and Drug Administration on its Expedited Investigational New Drug Pilot Program. The coalition supported efforts to improve and accelerate investigational new drug review, while emphasizing that expedited processes must maintain rigorous scientific review, independent ethical oversight, strong conflict-of-interest protections, and safeguards for research participants.
The coalition also submitted comments to the U.S. Department of Health and Human Services, Office of Inspector General, regarding the federal Anti-Kickback Statute and its application to clinical trial participant remuneration. The coalition supported a new safe harbor for appropriate financial support provided to research participants, noting that reimbursement and reasonable compensation can reduce barriers to clinical trial participation, provided appropriate safeguards remain in place to protect against fraud, abuse, and undue influence.
In a third comment, also submitted August 24, the three-group coalition addressed the National Science Foundation's proposal on Information Guidance on Financial Assistance. The coalition called upon NSF “to halt or significantly revise implementation of its proposed guidance” and to preserve scientific peer review as the basis for merit determinations to avoid changes that could weaken protections for research participants, increase institutional burden, and disrupt the scientific research pipeline.
"By working together, our coalition has been able to address these proposals with the substantive, well-informed review they deserve. Together, AAHRPP, NACHRP and PRIM&R are amplifying the voice of research participants, institutions, and oversight professionals throughout the United States," the coalition said in a joint statement.
To read the coalition's comments to the FDA, click here
To read the coalition's comments to HHS-OIG, click here
To read the coalition's comments to NSF, click here
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 joint comments to three federal agencies late last month, addressing a range of significant proposals that would affect investigational new drug review, clinical trial participant compensation, and federal research funding oversight.
On August 24, the coalition submitted comments to the U.S. Food and Drug Administration on its Expedited Investigational New Drug Pilot Program. The coalition supported efforts to improve and accelerate investigational new drug review, while emphasizing that expedited processes must maintain rigorous scientific review, independent ethical oversight, strong conflict-of-interest protections, and safeguards for research participants.
The coalition also submitted comments to the U.S. Department of Health and Human Services, Office of Inspector General, regarding the federal Anti-Kickback Statute and its application to clinical trial participant remuneration. The coalition supported a new safe harbor for appropriate financial support provided to research participants, noting that reimbursement and reasonable compensation can reduce barriers to clinical trial participation, provided appropriate safeguards remain in place to protect against fraud, abuse, and undue influence.
In a third comment, also submitted August 24, the three-group coalition addressed the National Science Foundation's proposal on Information Guidance on Financial Assistance. The coalition called upon NSF “to halt or significantly revise implementation of its proposed guidance” and to preserve scientific peer review as the basis for merit determinations to avoid changes that could weaken protections for research participants, increase institutional burden, and disrupt the scientific research pipeline.
"By working together, our coalition has been able to address these proposals with the substantive, well-informed review they deserve. Together, AAHRPP, NACHRP and PRIM&R are amplifying the voice of research participants, institutions, and oversight professionals throughout the United States," the coalition said in a joint statement.
To read the coalition's comments to the FDA, click here
To read the coalition's comments to HHS-OIG, click here
To read the coalition's comments to NSF, click here
About PRIM&R
Since 1974, Public Responsibility in Medicine and Research (PRIM&R) has advanced the highest ethical standards in the conduct of research. Through education, membership services, professional certification, public policy initiatives, and community building, PRIM&R supports the professionals responsible for ensuring that research is conducted ethically.
As research evolves, PRIM&R is leading the way in helping the research oversight community navigate the ethical and governance challenges posed by artificial intelligence and other emerging technologies. Through expanded resources, programming, and convenings, PRIM&R equips its community with the knowledge and connections needed to respond thoughtfully to a rapidly changing landscape. By collaborating with experts across the research enterprise, PRIM&R continues to shape the national conversation on AI governance while advancing its longstanding mission to support ethical research oversight.
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
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
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