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.
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.
Comments provided to: TEHDAS2, coordinated by the Finnish Innovation Fund SITRA
Description: The MRCT Center responded to 2 rounds of TEHDAS2 requests for public consultations addressing key operational components of the European Health Data Space (EHDS) in November 2025 and June 2026. Topics included: data minimisation, anonymisation and synthetic data; implementation of opt-out mechanisms for secondary use of health data; notification of significant findings; citizen information and transparency; handling research outcomes; international and third-country access to health data; and linkage of health datasets. Across these submissions, the MRCT Center emphasized the importance of balancing transparency, patient trust, scientific utility, privacy protection, and regulatory feasibility while ensuring that EHDS implementation remains workable within the realities of multinational clinical research. The MRCT Center’s comments reflected its longstanding focus on the ethical conduct of global clinical trials and highlighted the need for harmonized standards, clearly defined responsibilities, meaningful public communication, and alignment with existing European and international regulatory frameworks. Collectively, the responses sought to strengthen the practical implementation of EHDS while supporting responsible secondary use of health data for research and innovation.
MRCT Center TEHDAS2 Public Consultation Summaries
TEHDAS2 Draft Guideline for Health Data Access Bodies on international and third country access and transfer of electronic health data
The MRCT Center submitted comments emphasizing the importance of developing a clear, operational, and harmonized framework for international and third-country access to electronic health data under the European Health Data Space (EHDS). The MRCT Center noted that the draft guideline appropriately recognizes key challenges associated with international data access, including reciprocity requirements, governance responsibilities, cross-border data transfers, and the continuing applicability of GDPR. However, significant uncertainty remains regarding how reciprocity assessments will be conducted, how EHDS requirements interact with existing GDPR transfer mechanisms, and how Health Data Access Bodies (HDABs) will operationalize international access pathways in practice. The response highlighted concerns that inconsistent national implementation could create barriers to multinational research collaborations and limit the EHDS’s effectiveness. The MRCT Center recommended greater clarification regarding governance responsibilities, liability allocation, reciprocity assessments, and the relationship between EHDS requirements and GDPR Chapter V transfer mechanisms. Particular attention was devoted to the needs of multinational clinical research, including public-private research collaborations that routinely operate across jurisdictions. The Center also called for practical examples, decision-support tools, and standardized templates to support consistent implementation across Member States.
TEHDAS2 Draft Guideline on Linkage of Health Datasets
The MRCT Center submitted comments supporting the development of comprehensive guidance for the linkage of health datasets within the EHDS ecosystem. The MRCT Center noted that the draft guideline provides valuable technical guidance on privacy-preserving linkage methods and appropriately recognizes the importance of data quality, validation, and governance. However, the response identified several areas requiring further development, including the absence of common expectations regarding acceptable linkage quality, unresolved questions surrounding accountability for linkage decisions, and the lack of guidance for cross-border linkage activities. The Center highlighted concerns that inconsistent approaches to linkage quality assessment and governance could undermine comparability, reproducibility, and confidence in linked datasets across Member States. The MRCT Center recommended developing standardized frameworks for assessing and reporting linkage quality, conducting fitness-for-purpose evaluations, and increasing transparency regarding linkage methodologies and validation practices. The Center also called for stronger guidance on auditability, provenance, interoperability, metadata standards, and communicating linkage-related uncertainty to data users. The response emphasized the importance of balancing privacy protection with scientific utility while ensuring that linked health data can support robust research, regulatory decision-making, and public health objectives across the EHDS.
TEHDAS2 Draft Guideline for Health Data Access Bodies on Citizen Information Point (CIP)
The MRCT Center submitted comments supporting the development of Citizen Information Points (CIPs) as an important mechanism to promote transparency and public trust within the EHDS framework. The MRCT Center emphasized that CIPs should be viewed as a core tool for public accountability and not as a regulatory compliance requirement. The response highlighted the need for greater attention to meaningful transparency, plain language communications, accessibility, user experience, and comprehension by the individual. The MRCT Center noted that the act of publishing information is insufficient unless that information is understandable, accessible, timely, and relevant to the individuals whose data are being used.
The MRCT Center also identified several areas requiring further development, including the relationship between the EHDS transparency obligations, GDPR requirements, and existing clinical trial transparency systems such as the Clinical Trials Information System (CTIS). Recommendations included the development of standardized templates, lifecycle-based transparency models, clearer definitions, stronger accessibility requirements, plain language communication standards, mechanisms for citizen engagement and feedback, and harmonized approaches for communicating public benefit. The Center emphasized the importance of ensuring that CIP implementation supports trust, accountability, and meaningful public understanding across the 27 Member States.
TEHDAS2 Draft Guideline for Data Users on Handling Research Outcomes
The MRCT Center submitted comments emphasizing the importance of developing a cogent and practical framework for handling, reporting, and disseminating research outcomes generated through the secondary use of health data under EHDS. The MRCT Center noted that the draft guidance appropriately addresses key transparency objectives but will require additional clarification on several foundational concepts: the distinction between outcomes, results, and outputs; the definition of clinically significant findings; and the allocation of responsibilities amongst secondary data users, HDABs, and health data holders. The response also emphasized the need for greater consistency between this guideline and the companion Citizen Information Point (CIP) guidance.
The MRCT Center highlighted areas that should be strengthened, including alignment with existing clinical research frameworks such as the EU Clinical Trials Regulation, Good Clinical Practice, and ICH E6(R3). Additional recommendations focused on establishing mechanisms to manage commercially sensitive information, clarifying reporting obligations for product and service development, addressing AI and machine learning outputs, strengthening governance around significant findings, and developing practical tools such as reporting templates and responsibility matrices. The Center underscored the need to balance transparency, research integrity, public trust, and legitimate commercial interests while ensuring that EHDA requirements can be implemented consistently across the multinational clinical research environments.
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.
Comments provided to: NIH National Library of Medicine
Description: The MRCT Center submitted a public comment in response to the NIH National Library of Medicine’s request for information, “Future Directions for the NLM Information Resource Grants (G08) Program.” The comment affirms strong support for NLM’s mission and the trustworthy resources it offers through PubMed, ClinicalTrials.gov, GenBank, and MedlinePlus, and proposes several ways to expand the G08 program with a focus on clinical trials and research. It recommends deploying libraries and librarians as trusted access points that help the public find and interpret research information; extending these resources to rural and historically underserved areas as entry points for digital trial methods and study recruitment; improving the utility of ClinicalTrials.gov through electronic health record integration for point-of-care trial matching, more complete eligibility criteria, plain-language trial summaries, and machine-readable protocol templates; and providing educational resources on the responsible and practical use of AI technologies. The comment urges NLM to foster an AI-ready research information ecosystem grounded in data interoperability standards, computable metadata, benchmark datasets, FAIR research outputs, and systems that protect personal health information.
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.
This recording is from the JTF Biannual Global Meeting held June 22, 2026. The meeting focused on two recent proposed revisions to the JTF Framework: the JTF-Patient Partner Project (P3) and an update to Domain 6. Speakers presented the proposed updates, discussed them with users of the JTF Framework, and gathered input on further changes needed as the Framework moves toward Version 4.0.
How do leading organizations turn plain language from an aspiration into everyday practice? In this June 2026 MRCT Center webinar, three users of the Clinical Research Glossary share how they put it to work, from global pharma to grassroots patient advocacy.
The Clinical Research Glossary is a free, publicly available resource that translates complex clinical research terms into clear, plain-language definitions. It empowers patients, participants, and the public to make informed decisions about their care and research participation. Developed by the MRCT Center with a diverse, multi-interest-holder workgroup, its definitions have been part of the CDISC global data standards since 2023.
This session highlights real-world adoption and impact, followed by a panel discussion and audience Q&A.
Speakers
Anna Subrizi, Senior Director, Patient Empowerment, Bristol Myers Squibb. How the Glossary is embedded in BMS’s Universal Patient Language (UPL) program and used across teams for plain language summaries, informed consent forms, and patient materials.
Sudipta Chakraborty, PhD, Head, Health Literacy & Plain Language Center of Excellence, Biogen. How the Glossary became the exclusive reference for Biogen’s Plain Language Glossary 2.0 and anchors a cross-functional content reuse initiative.
R. Bernard Coley, Co-Chair, Special Interest Group – Black Diaspora; Care Partner and Research Advocate; recipient of the 2026 World Parkinson Coalition Robin A. Elliott Community Service Award. How the Glossary supports community education, including the Black Parkinson’s Disease Summit.
Moderator: Sylvia Baedorf Kassis, Program Director, MRCT Center
What’s covered
The MRCT Center and its ongoing commitment to health literacy
The Clinical Research Glossary and the collaboration with CDISC
The 2026 public review (June 12 to July 13): 27 definitions up for review, 24 new and 3 updated
Enterprise use cases from Bristol Myers Squibb and Biogen
Community and advocacy use cases in Parkinson’s disease education
Public Review is a Critical Part of the Clinical Research Glossary process.
Part of being a CDISC global plain language standard means all new terms and definitions, plus change requests we received throughout the year, go through a public review process.
Public Review of the Clinical Research Glossary happens every June. Public Review is now open: June 12 – July 13, 2026
After definitions are developed by the Clinical Research Glossary team, Public Review ensures the definitions get an extra review by people who were not involved in the project. This helps us be more confident that the definitions are clear and easy to understand.
Help us spread the word about Public Review! Click here for the Media Kit.
Send us your feedback using the MRCT Center Public Review process.
The MRCT Center’s process uses a simple survey to collect feedback.
This process will not require reviewers to create an account, but we do ask for name, organization and email address. Collecting this information allows us to validate the entry and follow-up with each person to let them know how the comment was addressed.
You can send us feedback on already posted definitions all year round and suggest new words for us to consider whenever you want. Click here to contact us.
The CDISC Public Review process is also an option if you know how to use JIRA
This works great if you already have a CDISC login and are familiar with the process. Individuals will need to create accounts to provide comments via JIRA.
CDISC has kindly provided video instructions here.
Description: Barbara Bierer and Trevor Baker of the MRCT Center, with co-authors Rishabh Goel and Sammy Mustafa of Bond Health and Harvard Medical School’s Department of Biomedical Informatics, published “Large Language Models in Informed Consent — Opportunities, Evidence, and Challenges” in NEJM AI. Informed consent forms remain lengthy, cognitively demanding, and written at a level beyond most participants’ reading level, contributing to gaps in perceived understanding and recall of key study elements. This narrative review maps the emerging landscape of LLM applications for informed consent across seven domains: glossary generation, plain language rewriting, visual aid generation, accessibility and document formatting, translation, teach-back and comprehension assessment, and chatbot-assisted consent. For each domain, the authors synthesize the available evidence, surface principal failure modes such as hallucination, omission, and demographic bias, and outline mitigation strategies and considerations for integration with research ethics committee review.
