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.
Description: In “Genetic Therapies for Rare Diseases: Developing Ethical Regulatory Policies,” a commentary published in the Hastings Bioethics Forum, Carolyn Riley Chapman, former lead of the MRCT Center’s Cell and Gene Therapies project, and co-author Nirvan Bhatia argue that the U.S. should adopt a differentiated approval system for gene-based therapies for rare diseases, conferring different tiers of regulatory approval based on different levels of evidence. The authors contend that this approach would improve patient access to innovative therapies while increasing transparency about evidentiary standards and providing stronger incentives for timely post-marketing studies. The MRCT Center’s Toolkit for Supporting the Design and Conduct of Long-Term Follow-Up Studies for Gene Therapies, released in January, offers practical guidance on related challenges in gene therapy research.
What does it take to deploy digital twins and synthetic data in clinical evidence generation — and what do regulators expect when you do?
In this third webinar in the MRCT Center’s Digital Twins and Synthetic Data series, a multidisciplinary panel examines the real-world application of these technologies across the clinical trial lifecycle. The discussion covers evidence quality and validation, regulatory benchmarks, model transparency, and the evolving landscape of FDA and EMA expectations. Panelists draw on experience spanning machine learning, FDA policy development, and drug development leadership to offer practical, grounded perspectives on what adoption looks like today — and where the field is headed.
Topics include:
Defining digital twins and synthetic data: key distinctions and appropriate uses
Reducing control arms and enhancing statistical power in randomized and single-arm trials
Applications across rare disease, oncology, and common conditions
Machine learning vs. traditional statistical approaches: complementary, not competing
Regulatory acceptance: FDA draft guidance, EMA qualification of PROCOVA, and engagement strategies
Model evaluation benchmarks and performance validation across development phases
Cultural and organizational barriers to adoption — and how to address them
Panelists: Daniele Bertolini, Principal Machine Learning Scientist, Unlearn.AI | Tala Fakhouri, VP Consulting AI & Digital Policy and Real World Evidence, Parexel | Karen Smith, Board Director, Context Therapeutics, Skye Bioscience, and Sangamo Therapeutics
Moderator: Barbara Bierer, Faculty Director, MRCT Center
Published in:Journal of Clinical and Translational Science
Abstract: Barbara Bierer and MRCT Center colleagues Walker Morrell, Ava Glazier, and Deborah Zarin, together with Luke Gelinas of Advarra and Tony Tse of the National Institutes of Health, published Characterization of Key Information Sections in Informed Consent Forms Posted on ClinicalTrials.gov in the Journal of Clinical and Translational Science. The 2018 revised Common Rule requires informed consent forms to open with a “concise and focused” key information (KI) section, but provides no guidance on content or format. Analyzing federally funded treatment trial ICFs posted on ClinicalTrials.gov, the authors found that three-quarters included an identifiable KI section averaging one page—yet readability showed little improvement over full ICFs, and a meaningful minority omitted core content such as the main reasons to join or not join a study. The authors call for consensus-based guidelines to help researchers and IRBs develop KI sections that are both compliant and genuinely useful to participants.
Gelinas L, Morrell W, Tse T, Glazier A, Zarin DA, Bierer BE. Characterization of key information sections in informed consent forms posted on ClinicalTrials.gov. Journal of Clinical and Translational Science. 2023;7(1):e185. doi:10.1017/cts.2023.605
