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.
On May 22, in recognition of Clinical Trials Week, MRCT Center Executive Director Sarah White convened the ICH E6(R3) Expert Working Group’s regulator and industry topic leads, Cheryl Grandinetti, U.S. FDA; David Nickerson, EMD Serono and PhRMA ; and Rebecca Stanbrook, RESaltas GmbH and EFPIA , for “Good Clinical Practice in Practice: Implementing ICH E6(R3).” The panel walked through the guideline’s foundational concepts (Quality by Design, Quality Management, Critical to Quality Factors, and risk proportionality), grounded those concepts in a working case example using Risk-Based Quality Management principles, and discussed the practical challenges teams are encountering as they translate ICH E6(R3) into protocols, processes, and day-to-day oversight. The recording and slides are available here.
The webinar is part of the MRCT Center’s broader work as the training partner for the revised ICH E6(R3) Good Clinical Practice guideline. In collaboration with the ICH E6(R3) Expert Working Group, the MRCT Center has been developing a five-module course to help sponsors, investigators, and trial teams put the modernized guideline into practice. Module 1 (Introduction and Foundational Concepts) launched in October 2025, and Module 4 (Informed Consent) followed in January 2026. Module 3 (Data Governance) and Module 5 (Essential Records) are scheduled for release this summer, with Module 2 (Responsibilities and Oversight) to follow. The full course is available through the MRCT Center training library and the ICH Training Library.
This webinar, the fourth in the MRCT Center’s AI Digital Twins and Synthetic Data series, focused on data provenance and quality, model validation, and the emerging infrastructure needed to support the clinical and regulatory adoption of these technologies. Panelists explored how to evaluate whether the models used are credible, whether the data underlying them are reliable and traceable, and whether the outputs can be verified and validated for use in regulatory and clinical decision-making. They also discussed what it means for a model to be “fit for purpose,” how definitional differences among these technologies shape regulatory review, and how clinicians, sponsors, reviewers, and regulators may use, interpret, and deploy these tools.
Panelists: Daniele Bertolini, Principal Machine Learning Scientist, Unlearn.AI | Tina Morrison, VP, Scientific Strategy, EQTY Lab | Chao-Yi Wu, Assistant Professor of Neurology, Massachusetts General Hospital
Moderator: Barbara Bierer, Faculty Director, MRCT Center
The MRCT Center, CANTRAIN, and EUPATI hosted a webinar to unveil the results of the JTF-Patient Partner Project. This collaborative effort integrated patient and caregiver expertise directly into the JTF Framework, bringing together patient partners, academic researchers, study staff, industry representatives, and others to reimagine what patient partnership within clinical research teams should entail.
The proposed update includes a supplement focused on operationalizing patient partnership in clinical research. The results are both actionable and aspirational – a blueprint for building more skilled, inclusive, and equitable research teams that generate more responsive and impactful outcomes.
Description: Barbara Bierer and Trevor Baker of the MRCT Center, with Donna Snyder of WCG and Peter Rentzepis, formerly of Harvard Medical School, published “Use of AI as a Research Recruitment Tool: Ethical Elements, Considerations, and Recommendations” in the American Journal of Bioethics. Recruitment is often the most time-consuming and costly stage of a clinical trial, making it a frequent target for AI implementation, yet formal regulatory guidance and best practices for AI-driven recruitment remain limited. The authors examine AI use across five domains of the recruitment process and advance a framework of ethical considerations and recommendations to inform investigators, sponsors, CROs, regulators, and IRBs as they develop, test, and evaluate these tools.
Rentzepis, P., Snyder, D. L., Baker, T., & Bierer, B. E. (2026). Use of AI as a Research Recruitment Tool: Ethical Elements, Considerations, and Recommendations. The American Journal of Bioethics, 1–21. https://doi.org/10.1080/15265161.2026.2649234
Description: Mark Barnes, Faculty Co-Director of the MRCT Center and partner at Ropes & Gray, co-authored “More Transparency Needed on Misconduct” in Science with Michael Lauer, former Deputy Director of Extramural Research at the National Institutes of Health and member of the MRCT Center External Advisory Board. The editorial argues that scientists found to have committed research or professional misconduct too often resign quietly and move to new institutions that are unaware of their history, perpetuating a cycle that erodes public trust in science. The authors propose a confidential national scientist databank, modeled on the National Practitioner Data Bank established for the medical profession in 1990, that would require research institutions to report findings of misconduct and query the databank before hiring, enabling transparency without functioning as an automatic bar to employment.
The MRCT Center has released the first three tools in the Pregnancy Privacy Protections for Participants (P4) Toolkit. These resources inform research teams, IRBs, and participants about data privacy risks if a participant becomes pregnant during a study.
Following the Dobbs decision, the changing landscape of reproductive rights in the U.S. has introduced new challenges for clinical trials, both for studies of pregnancy-related conditions and for any trial involving participants who could become pregnant. Because pregnancy testing and outcomes may be tracked during screening and throughout a trial, it is important to carefully consider how, and how well, clinical trial data can be protected, and how to communicate pregnancy privacy risks to potential and enrolled participants. These issues were explored in a MRCT Center Bioethics Collaborative forum, “Impact of Dobbs on Reproductive Health: Unintended Consequences for and on Research” and in the recent NEJM Evidence paper “Disclosure of Pregnancy-Related Privacy Risks in Clinical Research Post-Dobbs.“
The first two are directed toward clinical research teams and IRBs. The third is for research staff to adapt and share with participants; it is written in plain language and highlights terms defined in the MRCT Center’s Clinical Research Glossary. Each tool is a prototype; the introductory page instructs teams to revise content according to their specific study and local legislative and site context.
Published in: Journal of Law, Medicine, and Ethics
Description: Mark Barnes, Faculty Co-Director of the MRCT Center and partner at Ropes & Gray, with co-authors, published International Ethical Principles for Banking and Secondary Research Use of Human Biospecimens and Associated Data: The Seattle Principles in the Journal of Law, Medicine & Ethics. International biospecimen sharing is essential to advancing science and developing therapies that benefit all populations — yet the field lacks a harmonized ethical and regulatory framework across jurisdictions. Drawing on extensive stakeholder engagement through forums including ISBER, PRIM&R, and the UN General Assembly Science Summit, the authors propose eleven foundational principles covering transparency, consent, privacy, community welfare, governance, and responsible stewardship of biospecimen resources, with the goal of establishing common ethical ground for the global research community.
Published in: Journal of Law, Medicine, and Ethics
Description: Benjamin Silverman of Mass General Brigham, Barbara Bierer, and MRCT Center colleague Willyanne DeCormier Plosky, with co-authors, published Supported Decision-Making for Clinical Research Participants with Mental Illness in the Journal of Law, Medicine, and Ethics. Because mental illness can be dynamic and variable in nature, decision-making capacity presents nuanced challenges for research participation. The authors examine supported decision-making — a strategy that enables individuals to select trusted others to help them understand and communicate decisions — with particular attention to the implications for people with intermittent or episodic mental illness.
Published in: Therapeutic Innovation & Regulatory Science
Description: In “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, Barbara Bierer and co-authors analyze findings from a survey of 1,436 parents across 34 European countries on their experiences with and preferences for cross-border clinical trial participation. Among families who reported being excluded from a trial abroad, 34.7% cited language barriers or country of residence as the reason. The authors conclude that language accommodation is feasible and should be incorporated into trial design, and that language should be used as an eligibility criterion only when scientifically justified.
