Description: The TRACE Author Group, led by Kara L. Neil and Jeanine Condo and including Barbara Bierer, Willyanne DeCormier Plosky, and Sarah White of the MRCT Center, published “Strengthening clinical trial ethics and regulatory oversight in Africa: lessons from the TRACE initiative” in Nature Medicine. The authors report early results from the TRACE Project in Kenya, Nigeria, Rwanda, Tanzania, and Zimbabwe, where coordinating ethics and regulatory review into a single, parallel process drove the fastest gains in trial readiness. In Zimbabwe, a joint electronic platform linking the medicines regulator and the national ethics review function reduced approval times by at least 20%. The authors recommend that parallel review become standard practice across African clinical trial systems.
Neil, K.L., Condo, J. & on behalf of The TRACE Author Group. Strengthening clinical trial ethics and regulatory oversight in Africa: lessons from the TRACE initiative. Nat Med (2026). https://doi.org/10.1038/s41591-026-04645-7
Description: “Reproductive Privacy Risk Disclosure in US Clinical Trial Informed Consent Forms After the Dobbs Decision,” published in JAMA Network Open and led by Ava Glazier, formerly of the MRCT Center, with co-authors Willyanne DeCormier Plosky and Barbara Bierer of the MRCT Center, examined whether informed consent forms tell participants about possible privacy risks that pregnancy monitoring can carry after the Dobbs decision. Of 195 US interventional trials that began after the 2022 decision and posted a consent form on ClinicalTrials.gov, more than half (59%) required pregnancy testing, yet none addressed reproductive privacy risks. The authors call for guidance on when and how to explain these risks, site-specific consent language for multisite trials, and a coordinated, nationwide effort to give all participants clear, consistent disclosure.
Glazier A, DeCormier Plosky W, Bierer BE. Reproductive Privacy Risk Disclosure in US Clinical Trial Informed Consent Forms After the Dobbs Decision. JAMA Netw Open. 2026;9(10):e2637862. doi:10.1001/jamanetworkopen.2026.37862
Published in: Clinical Pharmacology & Therapeutics
Description: “Exclusion of Participants for Substance Use in Clinical Trials,” published in Clinical Pharmacology & Therapeutics and led by Willyanne DeCormier Plosky of the MRCT Center with co-authors Benjamin C. Silverman of Mass General Brigham, David H. Strauss of Columbia University, and Barbara Bierer, analyzed ClinicalTrials.gov protocols to learn whether people who use substances are excluded from clinical trials, and why. The authors found that 43% of interventional protocols (110 of 254) excluded people who use substances, and that protocols defined substance use inconsistently, varying by level, timing, and type of substance. Most of those studies (63%) gave no rationale or none specific to substance use. The authors argue that inclusion should be as broad as the study question allows and exclusion only as narrow as participant safety and scientific validity require and call for guidance that standardizes how substance use is defined and assessed in eligibility criteria. When people who use substances and their healthcare providers determine it is appropriate to participate in clinical trials, the generalizability of safety and efficacy data for the medical products tested in the study may be improved.
Description: In their commentary published in the American Journal of Bioethics (AJOB) titled “Inclusion Beyond, And Not Limited To, Consent Discussions,” Willyanne DeCormier Plosky and Barbara Bierer advocate for expanding attention to inclusion beyond the informed consent process, such as in the pre-study processes of developing eligibility criteria and study outcome measures, on-study processes such as planning for communication platforms and associated services (e.g., help desks, concomitant software or tools), and post-study processes such as return of results in accessible formats. They also contend that universal design supporting more user-friendly clinical trial components (e.g., ICFs, patient portals) may be more effectively achieved when the preferences and needs for study communication and participation processes are adapted from minoritized populations to apply to studies involving majority populations rather than using the default “reasonable person” to adapt clinical trial components to anyone other than that default “reasonable person.”
DeCormier Plosky, W., & Bierer, B. E. (2026). Inclusion Beyond, And Not Limited To, Consent Discussions. The American Journal of Bioethics, 26(10), 42–44. https://doi.org/10.1080/15265161.2026.2717109
Publication:Therapeutic Innovation and Regulatory Science
Date Published: June 18, 2026
Description: “Expertise of European Clinical Trial Units in Conducting and Managing Cross-Border Pediatric Clinical Trials for Rare Diseases,” 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 43 clinical trial units across 17 European countries on their experience managing international participants in pediatric trials for rare diseases. Those units had received patients from 81 different countries, and the good practice they reported most often was providing written and verbal translation of informed consent documents, patient-reported outcome measures, and quality of life scales when these were not available in a family’s native language. The authors also documented 20 cases of discrimination, most stemming from language requirements written into eligibility criteria, and conclude that routine translation, professional interpretation, and dedicated support structures are needed for equitable access regardless of a child’s native language or nationality.
Publication:Therapeutic Innovation and Regulatory Science
Date Published: June 10, 2026
Description: Participants are rarely informed of the possibility that a trial may stop early. Here, Nora Hutchinson, Luke Gelinas, and Barbara Bierer argue that disclosure during the informed consent process would support participant decision-making, temper concerns if termination does occur, and promote transparency and trust in the research enterprise.
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.
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.
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
