Participants in the Spotlight: NIH to Extend Plain Language Results Requirement to Funded Studies

The US National Institutes of Health (NIH) released a draft policy Aug. 27, requiring researchers to share plain language study results directly with clinical research participants. Comment period closes Oct. 26.

What's new: NIH opens comment period on proposed participant results-sharing requirement

NIH released a draft policy that would require researchers to share plain language summaries of study results directly with clinical research participants. This is a proposal, open for public comment until Oct. 26, not a final requirement.

The policy applies to all NIH-supported clinical research, not just clinical trials, but also studies that may not currently be in your disclosure tracking:

• Clinical trials
• Epidemiological and behavioral studies
• Outcomes research and health services research
• Patient-oriented research conducted with human subjects

Studies supported in whole or in part by NIH are in scope, regardless of funding level or mechanism. Even partial NIH funding is sufficient.

For clinical trials, results must be shared no later than one year after the primary completion date, or by the ClinicalTrials.gov reporting deadline, whichever is later. For extramural non-trial studies, the trigger is the end of the period of performance if analyses are complete; if not, researchers must notify both participants and NIH with a status update on timing. Exceptions require NIH Institute, Center, or Office approval and are generally expected before the first participant enrolls.

Why it matters: The NIH policy aligns more closely with good clinical practice (GCP) and goes further than the Final Rule

Returning results to participants in plain language is increasingly recognized as an ethical obligation. Participants contribute their time, health, and trust to research; sharing what that research found is a meaningful part of honoring that contribution. GCP guidance, ICH E6(R3),¹ adopted by FDA as final guidance in September 2025, reflects that shift globally, identifying communicating results to participants as a GCP consideration and requiring informed consent materials to inform participants that results will be made available to them.

The 2016 Final Rule, which expanded clinical trial registration and results reporting requirements under the Food and Drug Administration Amendments Act of 2007 FDAAA,² explicitly declined to require plain language summaries, citing the risk that such summaries could not be consistently produced without being misleading or promotional. While the US has not yet set a compliance date for E6(R3), this draft policy moves NIH-funded research closer to fulfilling that expectation, converting a GCP consideration into a condition of funding and reaching study types outside the scope of the Final Rule.

For sponsors, this introduces a new category of disclosure obligation for US studies. No US regulation currently requires plain language summaries for participants. Under this draft policy, they would need to be planned and resourced as part of the study lifecycle, with timelines tied to the primary completion date, not closeout.

What's next: Have a plan

Start by reading the draft policy with your regulatory and clinical operations colleagues. If your organization has relevant experience or concerns, consider submitting comments independently or through the Pharmaceutical Research and Manufacturers of America (PhRMA) or other industry organizations that may be coordinating responses. Comments are more likely to shape implementation guidance than the core requirement.

Before the policy is finalized:

• Review your NIH-funded portfolio, including non-trial studies, against the clinical research definition
• For mixed-funding studies, confirm with your grants management office whether partial NIH support brings them into scope
• Begin assessing whether plain slanguage summary processes exist for in-scope studies or need to be built

Submit comments by Oct. 26 at https://osp.od.nih.gov/comment-form-draft-sharing-summary-results-policy/. The draft policy notice is NOT-OD-26-113 — please verify the direct URL before publishing.

The bottom line

For the first time in US clinical research, participants in NIH-funded studies would have a right to hear what the science found. Plan for 2027 and start preparing now.

References:

¹Good Clinical Practice (GCP) guidance, ICH E6(R3), issued in 2025 by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Sets the ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human participants. Available at: https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf

²Food and Drug Administration Amendments Act of 2007 (FDAAA), Title VIII, expanded clinical trial registration and results reporting requirements for applicable clinical trials of FDA-regulated drugs, biological products, and devices. The 2016 Final Rule implemented these expanded requirements through 42 CFR Part 11. Available at: govinfo.gov/content/pkg/PLAW-110publ85/html/PLAW-110publ85.htm