Tools
Released on: September 22, 2026
Focus Area: Clinical Trials & Research
Just in Time: Responding to the NIH Draft Policy for Sharing Summary Study Results with Participants
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
Implementing ICH E6(R3): Practical Risk-Proportionate Strategies for IRBs, Investigators, and Study Teams
(co-presented with PRIM&R)
Webinar
September 23, 2026 @ 1:00 pm – 2:00 pm
The MRCT Center is co-presenting a PRIM&R webinar on putting ICH E6(R3) into practice, and CIP credits are available. E6(R3) was adopted in January 2025 (Principles and Annex 1) and June 2026 (Annex 2). Quality by design, fit-for-purpose, risk proportionality, and essentiality of a record are now everyday vocabulary. What does that mean for IRBs, Investigators, and research teams? How do IRBs approach protocol review with a risk-proportionate lens? How do Investigators exercise appropriate oversight of research and determine which essential records should be maintained on file? David Nickerson, Head of Clinical Quality Management at EMD Serono and PhRMA Topic Lead for ICH E6(R3); Rebecca Stanbrook, Consultant at RESaltas GmbH, EFPIA Topic Lead for ICH E6(R3); and Benjamin C. Silverman, MD, Senior IRB Chair in Human Research Affairs at Mass General Brigham, will lead the panel, moderated by Sarah White, MRCT Center Executive Director.
Expertise of European Clinical Trial Units in Conducting and Managing Cross-Border Pediatric Clinical Trials for Rare Diseases
Publication
Publication: Therapeutic Innovation and Regulatory Science
Date Published: June 18, 2026
Description: “Expertise of European Clinical Trial Units in Conducting and Managing Cross-Border Pediatric Clinical Trials for Rare Diseases,” published in Therapeutic Innovation & Regulatory Science and led by Begonya Nafria of the Institut de Recerca Sant Joan de Déu with co-author Barbara Bierer, surveyed 43 clinical trial units across 17 European countries on their experience managing international participants in pediatric trials for rare diseases. Those units had received patients from 81 different countries, and the good practice they reported most often was providing written and verbal translation of informed consent documents, patient-reported outcome measures, and quality of life scales when these were not available in a family’s native language. The authors also documented 20 cases of discrimination, most stemming from language requirements written into eligibility criteria, and conclude that routine translation, professional interpretation, and dedicated support structures are needed for equitable access regardless of a child’s native language or nationality.
Disclosing the Possibility of Early Trial Termination to Prospective Clinical Trial Participants
Publication
Publication: Therapeutic Innovation and Regulatory Science
Date Published: June 10, 2026
Description: Participants are rarely informed of the possibility that a trial may stop early. Here, Nora Hutchinson, Luke Gelinas, and Barbara Bierer argue that disclosure during the informed consent process would support participant decision-making, temper concerns if termination does occur, and promote transparency and trust in the research enterprise.
Public Comments submitted to FDA: RFI on proposed “Expedited Investigational New Drug Pilot Program”
Public Comment
Comments provided on: August 24, 2026
Comments provided to: FDA
Description: The MRCT Center submitted a public comment to FDA on the request for information on the proposed “Expedited Investigational New Drug Pilot Program.” The MRCT Center comments support FDA’s goal of accelerating first-in-human studies but caution that the proposed pilot could unintentionally add complexity, cost, and potential conflicts of interest unless QRI roles, standards, accountability, and interactions with FDA are clearly defined and standardized. The submission recommends a more flexible and inclusive QRI model, stronger safeguards for independence and confidentiality, a centralized review platform, transparent performance metrics, and evaluation based on end-to-end development timelines and participant safety rather than speed alone.
Public Comments submitted: Medicare and State Health Care Programs – RFI Federal Anti-Kickback Statute and Beneficiary Inducements
Public Comment
Comments provided on: August 24, 2026
Comments provided to: Office of Inspector General (OIG) and Department of Health and Human Services (HHS)
Description: August 24: The MRCT Center submitted a public comment to the Office of Inspector General (OIG) and the Department of Health and Human Services (HHS) in response to their request for information on examining whether existing fraud-and-abuse regulations appropriately balance the commitment to program integrity with advancing biomedical research and ensuring access to clinical trials. The MRCT Center fully endorsed the adoption of an AKS safe harbor that permits clinical trial sponsors and other funders to provide funds to compensate and cover costs incurred by clinical trial participants without raising AKS or Beneficiary Inducement CMP concerns.
Returning Summary Results to Participants: Lessons from the Research Community
October 27, 2026 @ 11:00 am – 12:00 pm
This webinar will focus on returning aggregate study results to participants as a patient-focused best practice that centers health literacy. After an introduction to the newly released NIH policy, contextualized within the global history of returning results, the panel will feature academic researchers discussing the essential elements of sharing their findings with participants, including why and how they do it, and what they have learned along the way. Attendees will come away with lessons they can incorporate as they consider their own return of results processes.
Deliverables
Projects
Just in Time: Responding to the NIH Draft Policy for Sharing Summary Study Results with Participants
September 3, 2026 @ 1:00 pm – 2:00 pm
On Thursday, September 3, 1-2 PM ET the MRCT Center hosted a webinar featuring MRCT Center Faculty Director Barbara Bierer and the NIH Office of Science Policy’s Adam Berger to discuss last week’s release of the NIH Draft Policy for Sharing Summary Level Study Results with Clinical Research Participants for public comment. This policy, once finalized, will ensure that participants in NIH-funded clinical research receive the results of thestudies in which they participate. The policy extends beyond clinical trials to all clinical research involving human participants.
After a brief introduction, the draft policy was presented and discussed, followed by a discussion of active issues and considerations for institutional implementation. We also focused on supplemental guidance that would be helpful for the NIH to develop, followed by time for open questions.
Deliverables
Projects
Public Comments submitted on Regulation for Federal Financial Assistance
Public Comment
Comments provided on: July 13, 2026
Comments provided to: Office of Management and Budget (OMB)
Description: The MRCT Center submitted a public comment on the Office of Management and Budget’s proposed rule revising the Uniform Guidance for federal financial assistance (2 C.F.R. Part 200), Docket No. OMB-2026-0034. The comment addresses the two provisions that would most affect international clinical research. It agrees that competent U.S. entities should have priority when research can be done well here, but cautions that the proposed “domestic-first framework” would bar the subawards, procurements, and other international elements on which many trials depend for enrollment, biomaterials, equipment, and specialized expertise. It further argues that the proposed prohibition on collaborations with “covered foreign countries” and “covered foreign entities” is undefined and unworkable in practice. Both provisions rest on amorphous terms such as “national interest,” duplicate existing scientific review, and would chill legitimate international collaboration to the detriment of U.S. science and clinical medicine. The MRCT Center urges OMB to give considerably more consideration to the meaning, interpretation, and implementation of any rule of this kind.