NIH opens comment on policy requiring trial results shared with participants

The National Institutes of Health has opened public comment on a draft policy that would require every clinical study it supports to return plain-language summary results to the people who took part in it. The request for information, published as FR Doc. 2026–19706 in the Federal Register of September 25, 2026, gives the public until October 26, 2026 to respond. The draft, titled Draft NIH Policy on Sharing Summary Level Study Results With Clinical Research Participants, was signed on September 18, 2026 by Matthew Memoli, Principal Deputy Director of the NIH.

The proposal, also called the Sharing Summary Results Policy, would establish a requirement for researchers and institutions to share summary level study results — concise overviews of a study after all data are compiled and analyzed, covering objective, conduct, methodology, cumulative outcomes or key findings, relevance, limitations and potential implications — in plain language, “unless justifiably not appropriate.” The NIH frames the change as a correction of an imbalance: existing rules already push results toward the scientific community, including the NIH Policy for Data Management and Sharing (NOT-OD-21-013), mandatory reporting in ClinicalTrials.gov under the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information, and the NIH Public Access Policy (NOT-OD-25-047), but “these efforts have largely focused on sharing data with the scientific community, and not directly to participants.”

The agency says the inconsistency of current practice “leaves a significant gap,” and that sharing results with participants has been identified as a best practice by both participants and researchers. It also links the policy to HHS’s Operation TrialBlazer, which seeks to strengthen U.S. leadership in clinical research, and to the Novel and Exceptional Technology and Research Advisory Committee. To prepare the draft, NIH held a public listening session and an on-demand written-input portal in Spring 2026.

Scope: all NIH-funded clinical research

The policy would apply to all clinical research, including clinical trials, supported in whole or in part by NIH, regardless of funding level or funding mechanism, including the NIH Intramural Research Program. It would cover competing award applications, competitive revisions, proposals for new clinical research contracts or orders, and other funding agreements such as Other Transactions and Cooperative Agreements received on or after six months from publication of a final policy, as well as intramural projects conducted on or after that date, including ongoing studies.

Deadlines and exceptions

• Clinical trials: summary results no later than one year after the primary completion date, or by the date results must be reported in ClinicalTrials.gov under NIH GPS 4.1.3.1 or NIH Policy Manual Chapter 3007, whichever is later.
• Extramural clinical research that is not a clinical trial: no later than the end of the period of performance, as defined in NIH GPS 1.2, if the analyses needed to finalize the results are complete.
• Intramural studies, including trials: annual status updates to participants.
• If analyses are not finished in time, researchers must give NIH and participants a status update on when, where and how results will arrive.
• Exceptions require a justification submitted to the NIH Institute, Center or Office, generally before the first participant is enrolled.

What NIH wants to hear

The request for information asks for feedback in three areas: participant preferences and experiences; best practices for researchers; and implementation needs. Specific questions include:

• What participants find valuable in summary results, and their preferred methods for receiving them.
• Effective, low-burden approaches to plain-language results that are culturally and contextually appropriate.
• Which results should be returned, such as primary versus secondary results, and for which populations, study designs and longitudinal studies.
• Situations where sharing is not possible or desirable, and sharing with parents, guardians or caregivers.
• The activities and costs required, and the resources, infrastructure and non-monetary supports needed.

NIH acknowledges that sharing results “requires dedicated resources” and “will incur costs,” and says it wants to understand reasonable and necessary costs. Comments are voluntary, may be submitted anonymously, and should exclude personally identifiable, proprietary, classified or confidential information; responses may be posted to the Office of Science Policy website without redaction. The contact is Adam Berger, Ph.D., Director of the Clinical and Healthcare Research Policy Division, Office of Science Policy, at (301) 496–9838.

Compliance and enforcement

All recipients of NIH support for clinical research would have to comply, with the policy written into award terms and conditions and intramural policies. Failure to comply could trigger enforcement actions, including additional special terms and conditions or termination, and could affect future funding decisions for the recipient institution, as authorized in the NIH Grants Policy Statement.

For patients and communities, the draft would turn a courtesy into an obligation across the federally funded research enterprise, requiring that the people who volunteer for studies be told what their participation produced. For researchers and institutions, it means new planning, cost and reporting duties, with the comment period now the main chance to shape how those duties are defined.

Source: Federal Register, Vol. 91, No. 185, September 25, 2026, Notices, p. 60973 (official reference: FR Doc. 2026–19706).