NIH Proposes New Requirement to Share Study Results with Research Participants

On August 27, 2026, the National Institutes of Health (NIH) issued a Request for Information seeking public comment on a draft policy that would require researchers and institutions conducting NIH-supported clinical research to share summary-level study results with research participants in plain language. Comments are due October 26, 2026. NIH Notice NOT-OD-26-113

Importantly, this is a proposed policy, not a current requirement. NIH is specifically requesting feedback on implementation, administrative burden, and cost.

Key Dates

What would the draft policy require?

The proposed policy would apply broadly to all NIH-supported clinical research, including clinical trials, regardless of NIH funding level or funding mechanism. NIH describes “summary level study results” as a concise overview that may include the study’s objectives, conduct, methodology, aggregate findings, relevance, limitations, and potential implications. Similar to informed consent document requirements, investigators would be required to provide the communication in plain language.

• Provide participants with plain-language summary results. For clinical trials, results generally would be provided no later than one year after the primary completion date or the applicable ClinicalTrials.gov reporting deadline, whichever is later.
• Address participant access prospectively. Researchers would be expected to integrate plans for sharing results into study design and planning and would be encouraged to consult participants, IRBs, and institutional officials.
• Seek NIH approval for exceptions. If sharing results is justifiably inappropriate, an exception generally would need to be requested before enrollment of the first participant.
• Communicate delays or changed circumstances. Certain studies for which results are not complete within the applicable time period would require status updates to participants.
• Document compliance to NIH. Extramural recipients would confirm through the Research Performance Progress Report closeout process that results – or an appropriate status update – were provided to participants.

Potential impact on academic medical centers

Although returning aggregate study results may advance transparency and participant engagement, implementation of a uniform NIH requirement could create a meaningful additional operational burden, particularly for institutions with large and decentralized research portfolios.

Depending on the final policy and NIH guidance, institutions may need processes for drafting and reviewing plain-language summaries; determining whether IRB review is required; maintaining participant contact information and preferences over extended periods; translating or otherwise adapting communications for different populations; documenting delivery; managing exceptions; and incorporating compliance into study closeout processes. Investigators may also need to budget for these activities at the proposal stage.

The magnitude of the burden is likely to vary by the breadth and scope of institution and investigator portfolios. NIH itself acknowledges that implementation will require dedicated resources and incur costs and is specifically requesting information concerning reasonable and necessary implementation costs, infrastructure, tools, and lower-burden approaches.

Opportunity to comment

Academic medical centers may wish to consider submitting comments addressing practical implementation issues, including appropriate timelines, institutional versus investigator responsibilities, IRB considerations, participant tracking, translation and accessibility, treatment of long-term or longitudinal studies, exceptions, and whether NIH funding will adequately cover the associated costs.

Please contact us if you would like assistance evaluating the draft policy’s implications for your research enterprise or preparing comments for submission to NIH.