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.
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.
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
Description: Barbara Bierer, Ava Glazier, and Willyanne DeCormier Plosky published “Disclosure of Pregnancy-Related Privacy Risks in Clinical Research Post-Dobbs” in NEJM Evidence. The review examines how routine clinical research practices — such as pregnancy testing, contraception requirements, and incidental pregnancy reporting — have created new privacy risks for participants, clinicians, and investigators following the 2022 Dobbs v. Jackson Women’s Health Organization decision and offers practical guidance for investigators and IRBs navigating this shifting legal landscape.
Carolyn Chapman, Mena Shaikh, Ava Glazier, Andrew Creamer, and Barbara Bierer published Ethical, Legal, and Social Issues (ELSI) in Human Somatic Gene Therapy Clinical Research: A Scoping Review in Human Gene Therapy. Dozens of gene therapies have been approved, and hundreds more are in development, prompting the need to better characterize the ethical, legal, and social implications (ELSI) of this emerging therapeutic class. The authors conducted a scoping review to map these issues across the literature, identifying themes related to risk–benefit assessment, engagement and communication, justice and access, ethical trial design, and the influence of financial and regulatory decision-making. The article also discusses potential approaches to address these ELSI as gene-therapy research expands.
