Webinar
Date: September 3, 2026
On August 27, 2026, NIH released a draft policy that would require NIH-supported researchers to share summary level study results with clinical research participants in plain language. One week later, the MRCT Center convened this webinar to walk through what the draft policy says, what it would require, and how to comment before the October 26, 2026 deadline.
The draft policy applies to all NIH-supported clinical research, not only clinical trials, regardless of funding level or mechanism. Sharing is the default expectation: where it is justifiably inappropriate, an exception must be requested and approved.
In this session:
Barbara E. Bierer, MD, Faculty Director of the MRCT Center and Professor of Medicine at Harvard Medical School, sets the context: what “summary level study results” means, why returning them is grounded in justice, beneficence, and respect for persons, and how the draft policy fits alongside international standards and regulations, including ICH E6(R3), CIOMS, the Declaration of Helsinki, and EU Regulation 536/2014. She then maps the participant journey from planning and IRB review through preparing and delivering a plain language summary, and raises the open questions the policy leaves to implementation: platform and pragmatic trials, cluster randomized designs, studies that terminate early, registries and repositories, multi-site coordination, and FDA-regulated research.
Adam C. Berger, PhD, Director of the Division of Clinical and Healthcare Research Policy in the NIH Office of Science Policy, presents NIH’s thinking behind the draft. He covers the goal of building trust and transparency in clinical research, the evidence on participant expectations, and the specific requirements under consideration: timelines for clinical trials, extramural research, and intramural research; planning and communication expectations; participant choice; and compliance and reporting.
The session closes with discussion and audience questions.
Comment on the draft policy by October 26, 2026:
NIH comment form: https://osp.od.nih.gov/comment-form-draft-sharing-summary-results-policy/
Draft policy and RFI (NOT-OD-26-113): https://grants.nih.gov/grants/guide/notice-files/NOT-OD-26-113.html
NIH is seeking comment on the purpose, definitions, scope, requirements, and compliance sections of the draft policy, and on proposed supplemental guidance covering participant preferences and experiences, best practices for researchers, and implementation needs. Each section allows up to 8,000 characters.
Related:
Return of Results Efforts
The original MRCT Center Return of Aggregate Results initiative and recent efforts are described here: https://mrctcenter.org/project/aggregate-results/
Proposal to FDA with Transcelerate in 2017
NIH Draft Policy on Returning Summary-Level Results to Participants
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-26-113.html
NIH Roadmap for engaging the public as partners in clinical research
More information about Operation TrialBlazer can be found here:
https://www.hhs.gov/press-room/hhs-launches-clinical-trials-reform-initiative.html
Comments on the NIH draft policy will be accepted through October 26, 2026.
https://osp.od.nih.gov/comment-form-draft-sharing-summary-results-policy
MRCT Center Clinical Research Glossary
MRCT Center upcoming Health Literacy Month webinar registration:
https://mrctcenter.org/tribe-events/returning-results-to-participants-in-practice