Language: English

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.

YouTube: Clinical Research Competencies to Support Effective Patient Partner Engagement
2026-09-03 Bierer Berger RORDownload

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

Plain Language Summary Guidance Document Submitted to the FDA – open for comments

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

https://www.nih.gov/about-nih/nih-director/statements/roadmap-engaging-public-partners-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

www.mrctcenter.org/glossary

MRCT Center upcoming Health Literacy Month webinar registration:

https://mrctcenter.org/tribe-events/returning-results-to-participants-in-practice

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. 

MRCT Center Comments FDA-2026-N-4699Download

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.

MRCT Center HHSIG-2602-NDownload

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.

Public Comments submitted to TEHDAS2 regarding Health Data Access Bodies for public consultation

Public Comment

Comments provided on: June 28, 2026

Comments provided to: TEHDAS2, coordinated by the Finnish Innovation Fund SITRA

Description: The MRCT Center submitted responses to several TEHDAS2 draft guidelines to Health Data Access Bodies offered for public consultation, including one on international and third country access and transfer of electronic health data; on linkage of health data sets; on informing citizens about the use of health data; and on handling research outcomes. We continue our efforts to engage the stakeholders and guide policy development towards a harmonized data-sharing system for secondary use purposes related to the European Health Data Space (EHDS). 

Public Comments submitted in support of the European Data Protection Board Guidelines 1/2026

Public Comment

Comments provided on: June 25, 2026

Comments provided to: European Data Protection Board

Description: The MRCT Center submitted a public comment in support of the European Data Protection Board’s Guidelines 1/2026 on the processing of personal data for scientific research purposes. The comment welcomes the Guidelines as a meaningful step toward clearer interpretation of the GDPR’s research provisions, endorsing the presumption of compatibility for secondary research, broad consent, and a research-specific approach to controller and processor roles. It also asks the EDPB to clarify how the Guidelines interact with the European Health Data Space, to allow GDPR data-processing consent to be included in the clinical trial consent form, to provide clearer examples of when erasure may compromise a trial, and to provide a workable pathway for sharing pseudonymized data.

Language as an Eligibility Criterion in Pediatric Study Protocols Conducted in Europe (2007–2024) Reported in the ClinicalTrials.gov Database

Publication

Publication: Pharaceutical Medicine

Date Published: June 22, 2026

Description: “Language as an Eligibility Criterion in Pediatric Study Protocols Conducted in Europe (2007–2024) Reported in the ClinicalTrials.gov Database,” published in Pharmaceutical Medicine and led by Begonya Nafria with co-author Barbara Bierer, examined pediatric clinical trial protocols conducted in the EU and found that language-based eligibility requirements, only a minority of which offered any scientific justification, limited cross-border access to trials for pediatric patients.

Parents’ Perspectives on Access to Pediatric Rare Disease Cross-Border Clinical Trials in Europe: Experiences of Language Inclusion and Preferences

Publication

Publication: Therapeutic Innovation and Regulatory Science

Date Published: March 18, 2026

Description: “Parents’ Perspectives on Access to Pediatric Rare Disease Cross-Border Clinical Trials in Europe: Experiences of Language Inclusion and Preferences,” 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 parents of children living with a disease about access to cross-border trials in Europe. Of 1,436 responses, 10% of families had participated in a clinical trial, and 30.1% of those had traveled abroad to do so. Among parents whose children were excluded from cross-border trials, roughly one-third cited language or country barriers as the reason.