BLUF: The National Institutes of Health (NIH), part of the Department of Health and Human Services (HHS), published a notice on September 25, 2026 seeking public input on a draft policy for sharing summary-level clinical study results directly with research participants, with comments due October 26, 2026.

The notice asks the research community — including NIH-funded investigators and institutions — for feedback on how to promote and enable the practice of returning summary-level results to the people who took part in the underlying studies. NIH has not yet finalized the policy; this is a draft open for public comment.

Why it matters: Organizations holding NIH grants or contracts that involve clinical research should review the draft policy now, since a finalized version could add new participant-communication obligations to how study results are reported and disseminated. Institutions running multi-site clinical trials have a direct stake in how NIH ultimately defines "summary level" results and who is responsible for sharing them.

By the numbers:

• Comment deadline: October 26, 2026
• Document type: Notice (draft policy, request for public input)
• Issuing components: HHS and NIH

The notice does not itself impose new requirements; it opens a comment period on the draft policy's approach before NIH decides how to proceed. Contractors and grantees involved in NIH-funded clinical trials can use the comment window to flag implementation concerns — such as data formatting, timing, or cost — before the policy is finalized.

Source: Federal Register