Notice2026-19706
Draft NIH Policy on Sharing Summary Level Study Results With Clinical Research Participants
Primary source
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Published
September 25, 2026
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
NIH seeks public input on its proposed NIH Policy on Sharing Summary Level Study Results with Clinical Research Participants, including ways to promote and enable the research community to share summary level study results with clinical research participants.
Full Text
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<title>Federal Register, Volume 91 Issue 185 (Friday, September 25, 2026)</title>
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[Federal Register Volume 91, Number 185 (Friday, September 25, 2026)]
[Notices]
[Pages 60972-60975]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-19706]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Draft NIH Policy on Sharing Summary Level Study Results With
Clinical Research Participants
AGENCY: National Institutes of Health, HHS.
ACTION: Request for information.
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SUMMARY: NIH seeks public input on its proposed NIH Policy on Sharing
Summary Level Study Results with Clinical Research Participants,
including ways to promote and enable the research community to share
summary level study results with clinical research participants.
DATES: To ensure consideration, comments must be submitted on or before
October 26, 2026.
ADDRESSES: Comments must be submitted electronically to: <a href="https://osp.od.nih.gov/comment-form-draft-sharing-summary-results-policy/">https://osp.od.nih.gov/comment-form-draft-sharing-summary-results-policy/</a>.
Comments are voluntary and may be submitted anonymously. You may also
voluntarily include your name and contact information with your
response. Other than your name and contact information, please do not
include in the response any personally identifiable information or any
information that you do not wish to make public. Proprietary,
classified, confidential, or sensitive information should not be
included in your response. After the NIH Office of Science Policy (OSP)
has finished reviewing the responses, the responses may be posted to
the OSP website without redaction.
[[Page 60973]]
FOR FURTHER INFORMATION CONTACT: Adam Berger, Ph.D., Director, Clinical
and Healthcare Research Policy Division, Office of Science Policy,
(301) 496-9838 or <a href="/cdn-cgi/l/email-protection#96c5f5fff3f8f5f3c6f9fafff5efd6f9f2b8f8fffeb8f1f9e0"><span class="__cf_email__" data-cfemail="88dbebe1ede6ebedd8e7e4e1ebf1c8e7eca6e6e1e0a6efe7fe">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Background
Partnership with the public is essential to driving meaningful
scientific advances capable of improving the health of all. Returning
value to individuals who participate in clinical research enhances
partnerships and enables NIH to foster innovative health discoveries,
strengthen scientific resources to prevent disease, expand medical
knowledge, and uphold the highest standards of integrity and
accountability in scientific research. As outlined by the Novel and
Exceptional Technology and Research Advisory Committee (see: <a href="https://osp.od.nih.gov/wp-content/uploads/2025/12/NExTRACs-ENGAGE-Report_FINAL.pdf">https://osp.od.nih.gov/wp-content/uploads/2025/12/NExTRACs-ENGAGE-Report_FINAL.pdf</a>), returning research results is one important strategy
for returning value to research participants.
Sharing research results with clinical research participants, their
communities, others who could benefit from the results, and the broader
scientific audience can improve clinical research engagement,
accelerate the pace of scientific progress and improve scientific
outcomes to ensure that NIH-supported research translates discoveries
into improved health for Americans. Sharing results can, importantly,
help to build trust and communication between researchers and
participants, improve participant recruitment and retention rates,
enhance clinical research study design and feasibility, and ensure
health discoveries are meaningful, accessible, and understandable for
patients, clinicians, and participants who may benefit from the
research (see: <a href="https://doi.org/10.1136/bmjopen-2025-107270">https://doi.org/10.1136/bmjopen-2025-107270</a>). (see:
<a href="https://doi.org/10.1016/j.conctc.2023.101136">https://doi.org/10.1016/j.conctc.2023.101136</a>) (see: <a href="https://doi.org/10.1017/cts.2024.568">https://doi.org/10.1017/cts.2024.568</a>). Furthermore, incentivizing participation in
clinical research to strengthen retention bolsters rigor in clinical
research. Establishing NIH policy to make sharing summary level study
results standard practice directly supports the goals of HHS's
Operation TrialBlazer (see: <a href="https://www.hhs.gov/sites/default/files/operation-trialblazer.pdf">https://www.hhs.gov/sites/default/files/operation-trialblazer.pdf</a>), which seeks to strengthen America's
leadership in clinical research.
NIH has a longstanding commitment to making the results and data
generated from the research supported by the agency available to the
public and has been taking additional steps to further these efforts to
strengthen the science, enhance transparency, create value for
communities, and foster trust in research. For example, researchers
must proactively plan for how they intend to make their scientific data
available under the NIH Policy for Data Management and Sharing (see:
<a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html">https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html</a>),
clinical trials must report their results in <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> under
the NIH Policy on the Dissemination of NIH-Funded Clinical Trial
Information (see: <a href="https://grants.nih.gov/policy-and-compliance/policy-topics/clinical-trials/reporting/nih-policy">https://grants.nih.gov/policy-and-compliance/policy-topics/clinical-trials/reporting/nih-policy</a>), and published results are
made accessible to the public under the NIH Public Access Policy (see
<a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-047.html">https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-047.html</a>).
Yet, these efforts have largely focused on sharing data with the
scientific community, and not directly to participants.
Some clinical research studies are actively sharing research
results with participants. However, the inconsistency in practice
across the entirety of the research enterprise leaves a significant gap
(see: <a href="https://doi.org/10.1080/17512433.2019.1615441">https://doi.org/10.1080/17512433.2019.1615441</a>) (see: <a href="https://pubmed.ncbi.nlm.nih.gov/31827902">https://pubmed.ncbi.nlm.nih.gov/31827902</a>). To address this gap and strengthen
engagement and transparency with participants, NIH intends to set clear
requirements for sharing summary level study results in plain language
with participants, unless justifiably not appropriate. Reflecting best
practices, the goal of this new policy is to ensure that clinical
research participants are responsibly informed about the outcomes and
overall results, in ways that are understandable and meaningful to
them. Responsible sharing of summary level study results with
participants demonstrates that participants are partners in the
research process-ensuring findings are shared back with them in an
honest, accessible, and thoughtful way that respects the trust and
investment to which they contributed.
Summary level study results, also commonly known as aggregate
research results, are concise overviews of a clinical research study
after all data are compiled and analyzed, with information on the
objective, conduct, methodology as appropriate, cumulative outcomes or
key findings, relevance, limitations, and potential implications of the
clinical research study. Summary level study results are distinct from
individual research results that are participant-specific, such as
individual lab results. Research participants may want to receive
summary level study results for many reasons, including to understand
possible implications of the studies they participate in, and where
applicable, to inform their health behaviors. Sharing summary level
study results with participants has been identified as a best practice
by both research participants and the research community, and offering
to share summary level study results with participants enhances
transparency, demonstrates respect for participants' contributions, and
fosters trust and engagement in clinical research.
To inform the development of a Draft Policy on Sharing Summary
Level Study Results with Clinical Research Participants, NIH engaged
stakeholders in Spring 2026 by seeking input through a public listening
session and an on-demand portal for written input. In particular,
commenters provided perspectives on topics posed by NIH related to what
to include in summary level study results, as well as how and when to
share summary level study results with participants. NIH recognizes
that many researchers have already employed successful return tactics,
and NIH seeks to leverage best practice to implement a minimally low
burden approach. NIH also recognizes that expectations for robust
sharing of summary level study results with participants may in some
cases require additional support for participants for whom summary
level study results may provide more questions than answers. Thus, to
achieve the goals of a new policy, NIH intends to provide additional
supplemental materials for the community, which will also be informed
by input received from this request for information.
Draft NIH Policy on Sharing Summary Level Study Results With Clinical
Research Participants
I. Purpose
Through the NIH Policy on Sharing Summary Level Study Results
with Clinical Research Participants (also referred to as the Sharing
Summary Results Policy), NIH is furthering its commitment to
engaging research participants as partners. This Policy would
establish the requirement for researchers and institutions to
responsibly share summary level study results with clinical research
participants in plain language, unless justifiably not appropriate,
for all NIH-supported clinical research.
II. Scope
The Sharing Summary Results Policy applies to all clinical
research, including clinical trials, supported in whole or in part
by NIH, regardless of NIH funding level or funding mechanism,
including the NIH Intramural Research Program. This Policy is
applicable to all competing award applications, competitive
revisions,
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proposals for new clinical research contracts or orders, and other
funding agreements (e.g., Other Transactions, Cooperative
Agreements), received on or after [six months of the publication of
a final policy]. This Policy is applicable to all intramural
clinical research projects, conducted on or after [six months of the
publication of a final policy], including on-going or new studies.
III. Compliance and Enforcement
All recipients of NIH support for clinical research will be
required to comply with this Policy, which will be included in the
applicable terms and conditions of the award or agreement and in
applicable NIH intramural policies and procedures. Failure to comply
may provide a basis for enforcement actions, including but not
limited to, additional special terms and conditions or termination,
consistent with applicable grant regulations; applicable NIH
policies and procedures, including NIH intramural policies and
procedures; the Federal Acquisition Regulations; and/or other
authorities, as appropriate. Enforcement actions may affect future
funding decisions for the recipient institution, as authorized in
the NIH Grants Policy Statement. In cases where NIH proposes to
suspend, limit, or terminate financial assistance because of
noncompliance with this Policy, applicable HHS and Public Health
Service procedures shall govern.
IV. General Definitions
Clinical Research (see: <a href="https://grants.nih.gov/grants/glossary.htm#ClinicalResearch">https://grants.nih.gov/grants/glossary.htm#ClinicalResearch</a>).
Research with human subjects that is:
1. Patient-oriented research. Research conducted with human
subjects (or on material of human origin such as tissues, specimens,
and cognitive phenomena) for which an investigator (or colleague)
directly interacts with human subjects. It includes: (a) mechanisms
of human disease, (b) therapeutic interventions, (c) clinical
trials, or (d) development of new technologies; or
2. Epidemiological and behavioral studies; or
3. Outcomes research and health services research.
Studies falling under 45 CFR part 46.101(b)(4) (the ``Common
Rule'' prior to July 19, 2018) and 45 CFR part 46.104(d)(4) (the
``Revised Common Rule'' effective July 19, 2018, Exemption 4) are
not considered clinical research by this definition.
Clinical Trial (see: <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html">https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html</a>).
Per the NIH Definition of Clinical Trial (see: <a href="https://grants.nih.gov/grants/guide/notice-files/NOT/OD/15/015.html">https://grants.nih.gov/grants/guide/notice-files/NOT/OD/15/015.html</a>), a
research study in which one or more human subjects are prospectively
assigned to one or more interventions (which may include placebo or
other control) to evaluate the effects of those interventions on
health-related biomedical or behavioral outcomes.
Plain Language
Communication, including written, verbal, visual, and other
methods, that is clear, concise, well-organized, and follows best
practices for communicating with public audiences appropriate to the
research topic or field, culture, and context. Communication should
convey content relevant to the study results without using
unnecessary words, jargon, acronyms, or expressions.
Primary Completion Date (see: https://clinicaltrials.gov/study-
basics/glossary#p:~:text=a%20clinical%20trial./
,Primary%20completion%20date,/The%20date%20on).
The date that the final participant was examined or received an
intervention for the purposes of final collection of data for the
primary outcome, whether the clinical study concluded according to
the pre-specified protocol or was terminated. In the case of
clinical studies with more than one primary outcome measure with
different completion dates, this term refers to the date on which
data collection is completed for all of the primary outcomes.
Summary Level Study Results
A concise overview of a clinical research study after all data
are compiled and analyzed, with information on the objective,
conduct, methodology as appropriate, cumulative/aggregate outcomes
or key findings, relevance, limitations, and potential implications
of the study.
V. Requirements
The Sharing Summary Results Policy requires NIH-supported
researchers conducting clinical research studies to:
<bullet> Share summary level study results in plain language
with research participants.
[cir] For clinical trials: no later than one year after the
primary completion date, or by the date results must be reported in
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>in accordance with NIH GPS 4.1.3.1 (see: <a href="https://grants.nih.gov/grants/policy/nihgps/html5/section_4/4.1.3_clinical_trials_registration_and_reporting_in_clinicaltrials.gov_requirement.htm">https://grants.nih.gov/grants/policy/nihgps/html5/section_4/4.1.3_clinical_trials_registration_and_reporting_in_clinicaltrials.gov_requirement.htm</a>) or NIH Policy Manual Chapter 3007, whichever is
later, to align with existing reporting requirements that are
specific to clinical trials.
[cir] For extramural clinical research that is not a clinical
trial: no later than the end of the period of performance, as
defined in NIH GPS 1.2 (see: https://grants.nih.gov/grants/policy/
nihgps/HTML5/section_1/
1.2_definition_of_terms.htm#:~:text=The%20time%20interval%20between,a
s%20Budget%20period), if the analyses needed to finalize summary
level study results are complete. If the analyses are not completed
by this time, researchers must provide a status update to NIH and to
research participants to inform them when, where, and how they will
receive summary level study results.
[cir] For all NIH intramural clinical research studies including
clinical trials, researchers must provide annual status updates to
participants to inform them when, where, and how they will receive
summary level study results, beginning no later than six months
after the policy effective date.
[cir] If sharing summary level study results with research
participants is justifiably not appropriate and summary level study
results will not be shared, exceptions may be requested, subject to
NIH Institute, Center, or Office (ICO) approval. Generally, a
justification should be submitted before the enrollment of the first
participant. If no exception is requested or if the exception is not
approved by the NIH ICO, sharing summary level study results is
required.
[cir] Researchers are encouraged to consult with research
participants, IRBs, and relevant institutional officials to
determine effective strategies for integrating sharing summary level
study results with research participants in plain language into
clinical research study designs and planning phases to ensure timely
sharing with research participants.
<bullet> Ensure that research participants are offered, whether
or not they receive summary level study results.
<bullet> If the clinical research study experiences unforeseen
circumstances, and it is no longer possible to share summary level
study results, this information must be shared with participants.
This communication must provide details on why sharing is no longer
possible. Any change is subject to NIH approval. Changes are also
subject to IRB approval, as necessary.
<bullet> Confirm with NIH that summary level study results were
shared, or a status update was provided to research participants.
For NIH-funded extramural research institutions, this should occur
in the Research Performance Progress Report (RPPR) during close out.
Proposed Supplemental Guidance
The NIH recognizes that meaningful engagement with research
participants is already taking place, including studies that are
successfully sharing summary level study results with participants and
communities. However, as a taxpayer funded institution reliant on
public trust and participation, it is critical that the research
community work in tandem to share best practices and leverage
expertise. Additional resources may be required to ensure participant
preferences are prioritized when sharing summary level study results.
To that end, NIH is considering the value of issuing supplemental
guidance to assist in supporting aspects of this policy, addressing
participant preferences and experiences, best practices for
researchers, and implementation needs. NIH is seeking feedback on these
topics and the corresponding issues listed below. Please note these are
proposed rather than final guidance topics and this list is not
exhaustive. If you feel additional supplemental guidance is needed
beyond what is being proposed, be sure to identify the proposed topic
in your response. Your input will help inform and shape potential
supplemental guidance aimed at assisting researchers to effectively
share summary level study results with clinical research participants.
[[Page 60975]]
I. Participant Preferences and Experiences
NIH is seeking input to better understand what information clinical
research participants would like to receive as shared summary level
study results. The agency believes incorporation of participant
preferences is essential for sharing summary level study results in a
meaningful way. Participant preferences may be shaped by their personal
experiences or by what they believe would be important to know in the
future. Your feedback will help ensure researchers develop and share
summary level study results that are relevant, valuable, and meaningful
to participants; and are transparent in communicating expectations with
participants.
The NIH is interested in receiving information on:
<bullet> What participants find valuable when receiving summary
level study results and what, in addition to the final result(s), they
find relevant to be shared.
<bullet> Participants' preferred method(s) for receiving summary
level study results and expectations for what information should be
communicated.
<bullet> Participant/family/community concerns about receiving
summary level study results, and how they could be addressed.
II. Best Practices for Researchers
NIH recognizes that many researchers are already leading the way in
sharing summary level study results with clinical research
participants. The agency aims to learn from these existing efforts to
identify best practices for the research community. Clinical research
encompasses a broad spectrum of research studies, with unique
considerations for different scenarios. By understanding how the
research community currently prepares and shares summary level
findings, NIH can develop potential guidance reflecting this expertise.
Your feedback on current methods and challenges will help establish
best practices and ensure the research community has the necessary
resources to share clear and impactful summary level study results with
clinical research participants.
The NIH is interested in receiving information on:
<bullet> Effective, low burden approaches for developing summary
level study results that are in plain language and culturally and
contextually appropriate.
<bullet> Key elements that are most important to include, helpful
formats, and strategies to promote understanding.
<bullet> Considerations for identifying which results should be
returned (e.g., primary vs. secondary results) including for specific
study populations, study designs, and longitudinal studies.
<bullet> Situations where sharing summary level study results is
not possible or desirable.
<bullet> Considerations for sharing summary level study results
with individuals other than the research participants, such as parents/
guardians/caregivers of participants.
III. Implementation Needs
NIH acknowledges that sharing summary level study results with
clinical research participants requires dedicated resources. The agency
is seeking your expertise to identify tools, methods, and resources
that are most effective for this process, from creation to
dissemination of the summary level study results. Importantly, NIH
recognizes that sharing summary level study results with participants,
while integral to the research process, will incur costs, and seeks to
fully understand the reasonable and necessary costs associated with
activities needed to enable sharing of summary level study results.
Your feedback will ensure that NIH can provide support and address the
implementation needs of the research community.
The NIH is interested in receiving information on:
<bullet> Types of activities required to share summary level study
results to participants and the anticipated costs associated with those
activities for different kinds of studies.
<bullet> Information on resources, infrastructure and other non-
monetary supports that would help prospectively plan for and implement
the requirement to share summary level study results in a way that is
understandable and meaningful to all clinical research participants in
a study.
<bullet> Any existing methods, tools, best practices, or guiding
principles that enable sharing summary level study results more
effectively.
Request for Input
The National Institutes of Health (NIH) is seeking public input on
a new policy proposal requiring summary level study results from NIH
supported clinical research to be shared with participants of those
studies. NIH is also seeking input on areas for which supplemental
guidance would enable successful implementation with minimal
administrative burden. Through this policy, NIH intends to strengthen
respectful, transparent partnerships with clinical research
participants and enable them to benefit through translation of
discoveries into improved health.
NIH seeks public input on its proposed NIH Policy on Sharing
Summary Level Study Results with Clinical Research Participants,
including ways to promote and enable the research community to share
summary level study results with clinical research participants. NIH
welcomes input from researchers, clinical research participants,
clinicians, professional organizations, and other interested members of
the public. Comments are also sought on specific considerations for how
NIH can promote and enable the research community to feasibly share
summary level study results with clinical research participants with
minimal administrative burden. This feedback may inform the
identification of topics and content for potential supplemental
guidance.
This notice is being published in accordance with a statement made
by the NIH Director found here (<a href="https://www.nih.gov/about/nih/nih/director/statements/roadmap/engaging/public/partners/clinical/research">https://www.nih.gov/about/nih/nih/director/statements/roadmap/engaging/public/partners/clinical/research</a>).
Dated: September 18, 2026.
Matthew Memoli,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2026-19706 Filed 9-24-26; 8:45 am]
BILLING CODE 4167-05-P
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