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.
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.
This webinar explored key challenges, opportunities, and best practices for successful partnerships between academia and the pharmaceutical industry to design and deliver platform trials for children and adolescents with cancer.
The Joint Task Force for Clinical Trial Competency (JTF), anchored at the MRCT Center, develops and disseminates standards and practices for the global clinical research workforce. By fostering a cohesive and collaborative approach, the JTF ensures that professionals have the competencies to conduct clinical trials ethically and effectively.
Our international team of investigators, educators, and clinical research professionals has developed and/or utilizes a framework that defines the knowledge, skills, and attitudes necessary for conducting safe, ethical, and high-quality clinical research.
The MRCT Center Annual Symposium returns to Boston for a full day of discussions on ethical, actionable, and practical solutions to today’s global clinical research challenges. Free and open to all, in person or online.
Keynote: Karim Mikhail, Director, Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration
We are pleased to welcome Karim Mikhail as this year’s keynote speaker. Director Mikhail will give an update on Operation TrialBlazer, the HHS roadmap for maintaining U.S. leadership in early clinical research and development, and the initiatives planned under it. He brings more than two decades of leadership across industry and FDA.
Panel 1 | Response to Keynote: Ideation to Implementation and Scale
Leaders from industry and academic medicine respond to the keynote and discuss how Operation TrialBlazer’s planned initiatives can move from roadmap to practice.
Panelists: Ginny Beakes-Read, Johnson & Johnson; Karen Hartman, Mayo Clinic; Jennifer Sheller, Merck
Moderators: Barbara Bierer, MRCT Center; Mark Barnes, Ropes & Gray and MRCT Center
Panel 2 | Returning Summary Results to Participants: Lessons from the EU and UK Experience: Optimizing for US Application
NIH has released a draft policy on sharing summary-level study results with participants, with comments due October 26. Participant, researcher, and regulator voices from the EU and UK join NIH to discuss what they learned returning aggregate results, what they would do differently, and what they recommend for those just getting started.
Panelists: Adam Berger, U.S. National Institutes of Health; Johanna Blom, University of Modena, Italy; Clive Collett, Health Research Authority, UK; Veronica Popa, EURORDIS
Moderator: Sylvia Baedorf Kassis, MRCT Center
Panel 3 | Post-Trial Obligations: An Integrated Decision Model for Clinical Trial Placement
This panel explores the circumstances that challenge trial placement, when durable access is achievable in a host country or community, and when reciprocal benefits are acceptable if it is not. Panelists will also discuss the MRCT Center’s draft Integrated Decision Model for Clinical Trial Placement, developed by its Post-Trial Responsibilities Task Force to guide sponsors.
Panelists: Ginny Acha, Merck; Joseph Ali, Johns Hopkins University; Karla Childers, Johnson & Johnson
Moderator: Sarah White, MRCT Center
MRCT Center Updates
Select initiatives from across our portfolio:
AI and the Administration of Research
Childhood Cancer Academic–Industry Collaborative Platform Trials (C3PT)
Proportionate Oversight in Decentralized Clinical Trials
TRACE
Thursday, October 22 | Data Sharing
The second day focuses on data sharing and is co-organized with Vivli. Attend one day or both, in person or virtually. Please click here to view the draft agenda.
Thursday, October 22. A day on data sharing, co-organized with Vivli. Charlie Blanchard, Associate Vice President, Head of Global Privacy and Data Protection at Amgen, will give the keynote address: “Sharing is Caring. So Why is Trusted Sharing Getting Harder? A Privacy Officer’s View from the Intersection of Science, Privacy, and Sovereignty.” Panels will focus on U.S. developments affecting international data sharing, the European Health Data Space, and electronic health records in U.S.
Location: Ropes & Gray, Boston, MA, and hybrid.
I am attending in person. What do I need to know?
The Annual Symposium will take place at the offices of Ropes & Gray, 800 Boylston St., Boston, MA, 02199
You will need a photo ID to enter. All attendees must pre-register to participate.
The Ropes & Gray offices are located inside the tower at the Prudential Center. Click here to view a map of the Prudential Center.
There is no charge to attend the MRCT Center Annual Meeting.
A continental breakfast, lunch, and cocktails/appetizers are offered. Please let us know if you have dietary restrictions.
Meeting slides and related resources will be shared with all registrants after the meeting.
Please share the registration information with others in your network.
You are also invited to attend a day focused on Data Sharing, co-organized with Vivli, on Thursday, October 22.
Location: Ropes & Gray, Boston, and virtual.
This event is also free for all registrants.
Click here for a list of hotels near the Prudential Center.
I am attending virtually. What do I need to know?
There are two separate Zoom coordinates, one for Wednesday’s program and one for Thursday’s program. Those coordinates will be shared one week in advance via email.
Can I attend some events in-person and others virtually?
Yes! While in-person attendance is preferred, virtual participation – either entirely or in part – is welcome. Please indicate which events you will attend in-person or remotely on the registration form. Note: cocktails on Wednesday, October 21 are only open to in-person attendees for Wednesday’s meetings.
Do I need to register separately for the Vivli/Mrct center meeting on Thursday, October 23?
No, you can register for all events from the same registration form.
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).
Sarah White, Executive Director, MRCT Center Dr. Willyanne DeCormier Plosky, Program Director, MRCT Center
The MRCT Center serves as technical lead for the TRACE (Trial Regulatory and Clinical Ethics Optimization) project, a partnership working to strengthen clinical trial ethics capacity across Sub-Saharan Africa. Work with Nigeria, Rwanda, Zimbabwe, and Tanzania expanded in 2026 to include Kenya. The Center supports each country’s distinct needs in capacity building and financial sustainability, with particular attention to parallel submission, registration, accreditation pathways, in-country reliance, and sustainable financing models.
In early June, the TRACE core team convened in Harare, Zimbabwe, hosted by the Medicines Control Authority of Zimbabwe (MCAZ), with opening remarks from MCAZ leadership and the Gates Foundation and a keynote from Dr. Aspect Jacob Vengani (AJV) Maunganidze, Zimbabwe’s Permanent Secretary for the Ministry of Health and Child Care. Over four days, all five countries reported progress against project milestones and worked through the practical challenges of strengthening national ethics oversight: shortening protocol review timelines, advancing accreditation and in-country reliance models, and building toward financial sustainability. Each country left Harare with concrete commitments and timelines for the months ahead, with continued technical support from the MRCT Center. The meeting reaffirmed the Center’s role as technical lead and coordinating partner across the five-country partnership.
Each TRACE country used the meeting to report progress against project milestones and to surface the practical challenges of strengthening national ethics oversight systems and coordinating with regulatory systems. Day 1 focused on ethics committee readiness and country progress towards achieving protocol review and approval within 60 days of submission, including parallel submission and identifying where delays were occurring between ethics and regulatory review. Day 2 focused on developing and revising necessary SOPs and guidelines to achieve readiness, and on discussing exemplar models of ethics committee accreditation and in-country reliance, with MRCT providing updates and facilitating a working session in which each country agreed on its direction forward. Day 3 addressed digital systems, with live demonstrations from Zimbabwe and Tanzania, followed by a financial sustainability workstream led by the MRCT Center’s Willyanne DeCormier Plosky, who guided countries through financial questions and an advocacy template to support government and other funding. Dr. DeCormier Plosky also demonstrated a prototype digital dashboard developed by the MRCT Center that can be customized by country teams for tracking, visualizing, and forecasting expenses and revenue. Day 4 focused on country metrics, including ethics review timelines, project budgets, and potential paths forward, culminating in each country presenting its top commitments and timelines for the months ahead.
The meeting closed with country teams carrying forward concrete commitments, from completing IRB training, digital platform rollouts, and revised codes of ethics, to finalizing fee structures and joint applications, inclusive of all five countries, for additional sources of grant funding. In addition, the MRCT Center, it will continue its support, including guidance in developing SOPs and tools for EC review and ongoing technical assistance for developing sustainable accreditation and reliance models. As the TRACE partnership moves toward its 2026 and 2027 milestones, the meeting in Harare reaffirmed the MRCT Center’s role as technical lead and coordinating partner across a partnership spanning five countries and a shared commitment to stronger, more sustainable research ethics systems.
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.
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.
