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Press Release
PRIM&R and AAHRPP Submit Recommendations to NIH on Controlled-Access Data Policy and Proposed Revisions to Genomic Data Sharing Policy
FOR IMMEDIATE RELEASE
March 26, 2026
BOSTON— Public Responsibility in Medicine and Research (PRIM&R) and the Association for the Accreditation of Human Research Protection Programs (AAHRPP) submitted a coordinated response to the National Institutes of Health (NIH) focused on proposed revisions to NIH’s Controlled-Access Data Policy and Genomic Data Sharing Policy. As stated in the request for information, NIH requested public input on its “proposal to establish harmonized and transparent policy requirements for protecting human participant research data. Specifically, NIH proposes (1) establishing policy requirements for which data should be controlled access under NIH data-sharing policies, and (2) revising the NIH Genomic Data Sharing Policy to simplify and harmonize requirements.”
The joint recommendation, submitted March 17, draws on the deep expertise of PRIM&R and AAHRPP in research ethics and human subject protections.
The PRIM&R and AAHRPP joint submission noted Jan. 24 reporting from The New York Times, titled, “Genetic Data From Over 20,000 U.S. Children Misused for ‘Race Science,’’’ which raised concerns about how researchers accessed and used data from the Adolescent Brain Cognitive Development Study (ABCD Study). The ABCD Study “is the largest long-term study of brain development and child health in the United States,” according to the study’s website, which noted the NIH-funded study invited nearly 12,000 children ages 9 to 10 to participate.
“The New York Times article … suggests NIH may need further investments in resources to perform effective data oversight functions required to maintain the public’s trust, such as ensuring data are only released to eligible researchers and used for their approved purposes,” the joint PRIM&R-AAHRPP comment to the NIH stated. “Inadequate oversight can adversely affect the entire research enterprise and lead to decreased participation in studies and negatively affect participants’ willingness to donate biospecimens to research or allow their data to be deposited in NIH repositories. Without sustained public trust and active participation in research, the trajectory of important scientific discovery may be significantly compromised.”
The organizations’ formal comments to the NIH also shared recommendations on a range of issues, including federal oversight and accountability, transparency and research participant engagement, and training and stewardship.
By aligning their recommendations, PRIM&R and AAHRPP aim to ensure that federal efforts to streamline research do not compromise the safety or rights of participants. “We hope our comments are useful to the NIH. PRIM&R and AAHRPP stand ready to provide any further assistance or input that might be of use,” PRIM&R Executive Director Ivy Tillman said.
“AAHRPP appreciates NIH seeking comments on the appropriate focus and parameters of data-sharing oversight. With a constantly evolving research landscape, NIH's role in advancing sensible, ethically sound policy in this area has never been more important. As always, AAHRPP is grateful for the opportunity to partner with PRIM&R to share our ideas on these topics," said AAHRPP President and CEO Elyse Summers, JD.
To read the full text of the official comments submitted to NIH, click here.
About AAHRPP
AAHRPP, founded in 2001, is a nonprofit organization that accredits human research protection programs. Currently, more than 600 entities from diverse research settings—including hospitals, independent review boards, clinical research organizations, universities, and Veterans Affairs facilities—are accredited. Find out more at www.aahrpp.org.
March 26, 2026
BOSTON— Public Responsibility in Medicine and Research (PRIM&R) and the Association for the Accreditation of Human Research Protection Programs (AAHRPP) submitted a coordinated response to the National Institutes of Health (NIH) focused on proposed revisions to NIH’s Controlled-Access Data Policy and Genomic Data Sharing Policy. As stated in the request for information, NIH requested public input on its “proposal to establish harmonized and transparent policy requirements for protecting human participant research data. Specifically, NIH proposes (1) establishing policy requirements for which data should be controlled access under NIH data-sharing policies, and (2) revising the NIH Genomic Data Sharing Policy to simplify and harmonize requirements.”
The joint recommendation, submitted March 17, draws on the deep expertise of PRIM&R and AAHRPP in research ethics and human subject protections.
The PRIM&R and AAHRPP joint submission noted Jan. 24 reporting from The New York Times, titled, “Genetic Data From Over 20,000 U.S. Children Misused for ‘Race Science,’’’ which raised concerns about how researchers accessed and used data from the Adolescent Brain Cognitive Development Study (ABCD Study). The ABCD Study “is the largest long-term study of brain development and child health in the United States,” according to the study’s website, which noted the NIH-funded study invited nearly 12,000 children ages 9 to 10 to participate.
“The New York Times article … suggests NIH may need further investments in resources to perform effective data oversight functions required to maintain the public’s trust, such as ensuring data are only released to eligible researchers and used for their approved purposes,” the joint PRIM&R-AAHRPP comment to the NIH stated. “Inadequate oversight can adversely affect the entire research enterprise and lead to decreased participation in studies and negatively affect participants’ willingness to donate biospecimens to research or allow their data to be deposited in NIH repositories. Without sustained public trust and active participation in research, the trajectory of important scientific discovery may be significantly compromised.”
The organizations’ formal comments to the NIH also shared recommendations on a range of issues, including federal oversight and accountability, transparency and research participant engagement, and training and stewardship.
By aligning their recommendations, PRIM&R and AAHRPP aim to ensure that federal efforts to streamline research do not compromise the safety or rights of participants. “We hope our comments are useful to the NIH. PRIM&R and AAHRPP stand ready to provide any further assistance or input that might be of use,” PRIM&R Executive Director Ivy Tillman said.
“AAHRPP appreciates NIH seeking comments on the appropriate focus and parameters of data-sharing oversight. With a constantly evolving research landscape, NIH's role in advancing sensible, ethically sound policy in this area has never been more important. As always, AAHRPP is grateful for the opportunity to partner with PRIM&R to share our ideas on these topics," said AAHRPP President and CEO Elyse Summers, JD.
To read the full text of the official comments submitted to NIH, click here.
About AAHRPP
AAHRPP, founded in 2001, is a nonprofit organization that accredits human research protection programs. Currently, more than 600 entities from diverse research settings—including hospitals, independent review boards, clinical research organizations, universities, and Veterans Affairs facilities—are accredited. Find out more at www.aahrpp.org.
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
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