NIH Seeks Comments on Proposed Policy for Distributing Clinical Research Results to Participants

On August 27, 2026, the National Institutes of Health (“NIH”) issued a Request for Information seeking public comment on its proposed NIH Policy on Sharing Summary Level Study Results with Clinical Research Participants (“Draft NIH Policy”). The proposal would make sharing plain-language summaries of study results with research participants standard practice for NIH-supported clinical research, unless sharing is justifiably inappropriate. NIH reiterated on October 22, 2026, that the comment period closed October 26, 2026.

NIH’s proposal reflects a shift in emphasis toward communicating study results directly to research participants. NIH already has policies addressing scientific data management and sharing, public access to publications and reporting results from NIH-funded clinical trials. Those policies, however, have largely focused on sharing information with the scientific community rather than directly with research participants. The proposed policy would address this gap by establishing a clear expectation that participants be afforded an opportunity to receive the overall findings of the research to which they contributed.

What Would Change?

If finalized as proposed, the policy would establish requirements that institutions should evaluate against their current practices.

• Broader participant-facing results sharing. The proposal would apply to clinical research supported in whole or in part by NIH, including NIH intramural research, subject to the policy’s scope and exclusions. Existing ClinicalTrials.gov reporting and publication practices should not be assumed, standing alone, to satisfy the proposed obligation to share results directly with participants.
• Defined timing and status updates. For clinical trials, summaries generally would be shared no later than one year after the primary completion date or the applicable ClinicalTrials.gov results-reporting deadline, whichever is later. For extramural clinical research that is not a clinical trial, summaries generally would be shared by the end of the period of performance if the analyses are complete. If those analyses are incomplete, researchers would provide a status update to NIH and participants explaining when, where and how results will be shared. NIH intramural clinical research would be subject to annual participant status updates beginning no later than six months after the policy’s effective date.
• A process for exceptions. Institutions seeking not to share results would generally need to request approval from NIH with justification ordinarily submitted before the first participant enrolls. If unforeseen circumstances subsequently make sharing impossible, the proposal would require communication to participants explaining why, with changes subject to NIH approval and IRB approval as necessary. The key question, however, is what circumstances would justify an exception – not merely how to request one. The Draft NIH Policy does not define when sharing would be “justifiably not appropriate” or identify circumstances warranting an exception. Institutions should consider seeking clarification from NIH on when sharing summary-level results would be considered “inappropriate” and what justification would support approval.
• Institutional accountability and enforcement. NIH-funded extramural institutions would confirm at closeout through the Research Performance Progress Report that results were shared or that an appropriate status update was provided. The policy would be incorporated into applicable award terms and conditions and NIH intramural policies and procedures. Noncompliance could result in enforcement action, potentially including special terms and conditions or termination.

What Is Clarification Rather Than Entirely New?

The proposal builds on existing research practices in several respects, while adding a more explicit participant-facing expectation.

• Aggregate results are distinct from individual results. The proposed policy concerns a concise overview of the study’s objectives, conduct, methodology as appropriate, aggregate findings, relevance, limitations and potential implications. It expressly distinguishes these summaries from participant-specific information, such as individual laboratory results. NIH is developing its policy framework in phases: the current proposal addresses summary-level results, while a subsequent phase is intended to address the responsible return of individual research results.
• Plain-language communication is the focus. The proposal calls for communication that is clear, concise and appropriate to the research topic, audience, culture and context, without unnecessary jargon or acronyms. Making a publication publicly available or reporting trial results to a government database is not necessarily equivalent to communicating an understandable summary directly to participants.
• Existing reporting timelines remain relevant. For clinical trials, the proposal expressly accounts for applicable ClinicalTrials.gov reporting deadlines when establishing the participant-sharing timeline. This aligns the proposed approach with existing reporting obligations while adding a distinct participant-communication expectation.
• Implementation timing would be prospective. The Draft NIH Policy contemplates applicability to specified competing award applications, competitive revisions, new clinical research contracts or orders and other funding agreements received on or after six months following publication of a final policy. It separately addresses NIH intramural clinical research conducted on or after that implementation point, including ongoing and new studies. Institutions should review the final language before determining precisely which projects are covered and when.

NIH also acknowledges that many researchers already share results with participants and sought input on best practices, participant preferences, implementation needs and approaches that minimize administrative burden. Potential supplemental guidance remains under consideration and should not be confused with binding requirements in the Draft NIH Policy.

Considerations for Research Institutions

NIH-funded research institutions should evaluate:

• Existing practices: Identify which research programs already provide participant-facing summaries and where gaps may exist.
• Roles and responsibilities: Determine who would prepare, review, approve and distribute summaries, including how responsibilities would be allocated among investigators, sponsors, research administration and institutional stakeholders.
• Study planning and budgets: Assess whether protocols, budgets, participant communications and study closeout workflows should account for preparing and sharing plain-language results.
• IRB and participant engagement: Consider how participant preferences, communication methods and appropriate IRB review should be incorporated into study planning.
• Exceptions and documentation: Develop a potential process for requesting exceptions, documenting communications, managing delays and completing NIH reporting.
• Implementation costs: Evaluate staffing, translation, accessibility, dissemination infrastructure and other costs that may be necessary to communicate results effectively across different study designs and populations.

These issues align with NIH’s express request for feedback on participant preferences, effective practices, administrative burden and the resources required to implement the proposal.

Where to Find the Draft NIH Policy

The Draft NIH Policy can be difficult to locate because it is embedded in NIH’s Request for Information rather than presented as a standalone policy document. The most direct route is to search for Notice NOT-OD-26-113 on the NIH Grants & Funding website. The notice contains both the proposed policy and NIH’s specific questions for public comment.

• Read the full notice and embedded draft policy (NOT-OD-26-113).
• Review NIH’s Return of Research Results policy-development page.

Comments were due October 26, 2026. The proposal remains a draft and should not be treated as a final, binding NIH requirement.

If you have questions or would like more information about this topic, please contact:

• Rebecca Merrill at remerrill@hallrender.com or (984) 244-5383;
• Summer Martin at smartin@hallrender.com or (984) 244-5382;
• John Tyson at jtyson@hallrender.com or (317) 429-3664; or
• Your primary Hall Render contact.