Sharing study results with participants would become a requirement for NIH-supported research under a draft policy NIH released on August 27, 2026. Every participant in an NIH-supported clinical study, trial or not, would be offered a plain-language summary of what the study found, and for a trial it would be due within a year of primary completion or by the ClinicalTrials.gov results date, whichever is later. The summary is written by the investigator's team. Getting it to a participant three years after their last visit is the site's problem, and it depends on records the site starts keeping at consent. Comments close on October 26, 2026.
In short
- August 27, 2026: NIH released draft policy NOT-OD-26-113 on sharing summary level results with participants; comments close October 26, 2026 (NIH, 2026).
- One year: the draft deadline for a trial, counted from primary completion or the ClinicalTrials.gov results date, whichever is later (NIH, 2026).
- 42%: the share of trial participants who said they received results after the study, against 58% who received none (CISCRP via Clinical Leader, 2026).
- 94%: of participants who got an overall summary found it somewhat or very helpful (CISCRP via Clinical Leader, 2026).
What the draft policy would require
NIH's notice sets out the requirement in a few lines. Researchers would "share summary level study results in plain language with research participants." The scope is wide: "all clinical research, including clinical trials, supported in whole or in part by NIH," regardless of funding level or mechanism, and including NIH's own intramural program.
The deadlines differ by study type:
| Study type | When results are due |
|---|---|
| Clinical trial | One year after primary completion, or the ClinicalTrials.gov results date, whichever is later |
| Extramural research, not a trial | End of the period of performance, if analyses are complete; otherwise a status update |
| NIH intramural research | Annual status updates to participants, starting within six months of the effective date |
Three further lines matter to a site. Researchers must "ensure that research participants are offered, whether or not they receive summary level study results," which reads as a choice each participant makes. If sharing becomes impossible, participants must be told why. And the institution confirms with NIH that results or a status update went out, in the Research Performance Progress Report at close-out. An exception is possible, but it generally has to be requested before the first participant is enrolled.
Butler Snow reports the proposed effective date as generally six months after the final policy is published, for new applications and funding actions.
Why the gap is real
The policy exists because most participants never hear what happened. CISCRP's 2025 survey, reported by Clinical Leader in May 2026, found 42% of participants received study results after completion and 58% received none, and that fewer than half had consistently reported receiving results across the decade from 2015. Participants do want them: 88% said regular study updates would be somewhat or very important to their experience.
For a site, that is a retention argument as much as a compliance one. The same report says participants who received results were more likely to recommend research participation to others. The next study's referrals start with the last study's letters. Our guide to patient retention in clinical trials covers the contact that keeps participants in a study; this is the contact after it ends.
Five things a site can do before the policy is final
- List which of your studies are NIH-supported. Include NIH subawards and NIH-funded networks, not only grants in the PI's name. The draft covers research supported "in whole or in part by NIH."
- Ask every participant how they want results, at consent. Post, email, text or a portal, and whether a caregiver should receive them. New wording in consent materials goes to the IRB first. NIH's request for information asks for exactly this: participants' "preferred method(s) for receiving summary level study results."
- Record the answer where a coordinator can find it in three years. Not in a paper binder that leaves with the study. The preference, the contact details and the date they were last confirmed.
- Refresh contact details at the last visit. People move. A trial whose results arrive a year after primary completion may be reaching participants whose last visit was long before that.
- Put the results date on the study calendar now. The draft ties it to primary completion or the ClinicalTrials.gov results date, whichever is later. Our ClinicalTrials.gov results reporting guide explains how that second date is set.
The mistake most sites will make at step 3
They will treat the participant's preference as part of the consent form and file it with the signed copy. The consent form is the right place to ask. It is the wrong place to look it up. When the summary is ready, someone needs a list of every participant, their current address or number, the method they chose and whether they opted out, pulled in an afternoon. A site that has to open 200 binders to build that list will send late or not at all. The same applies to participants who withdrew: each participant is to be offered that choice, and a withdrawal note should record whether they still want the results.
Commenting before October 26
NIH is asking three sets of questions: what participants value and how they want results, best practice for researchers, and implementation needs, including "the anticipated costs associated with those activities for different kinds of studies." A site that has run a results mailing knows the real work: tracing addresses, translation, printing, returned mail and the calls that follow. That is the evidence NIH says it wants, and sites are the ones who have it. Comments go through NIH's Office of Science Policy comment form and may be anonymous.
Where this fits in site operations
A results letter is the last contact in a study, and it relies on the same records as every visit reminder before it: the right number, the right channel and a note of who asked not to be contacted. Participant messaging that follows those preferences and flags who did not answer is part of the clinical research operations work we build. We do not write results summaries or decide what a study reports; the investigator and sponsor do.
The policy is a draft. The addresses you will need are being collected now.
