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.
Published in:International Journal of Technology Assessment in Health Care
Abstract: In this scoping review detailing the challenges of assessing new technologies for use in children, authors Nora Hutchinson, Lauren Otterman, Elisa Koppelman, Barbara E. Bierer, and colleagues highlight the substantial difficulties in incorporating children within the population-wide health technology assessment (HTA) system, as well as the uncertainty accompanying pediatric HTAs due to data constraints, lack of guidance and/or variation in guidance, between HTA bodies.
Hutchinson N, Otterman L, Bain PA, Koppelman E, Bierer BE. A Scoping Review of Challenges in Pediatric Health Technology Assessments with a Focus on Pharmaceutical Interventions. International Journal of Technology Assessment in Health Care. Published online 2025:1-34. doi:10.1017/S0266462325103188
October 22: In the article “Characteristics of long-term follow-up studies for gene therapies registered on ClinicalTrials.gov,” published in Gene Therapy, co-authors Carolyn Chapman, Emina Berbic, Ava Glazier, and Barbara Bierer report a descriptive study of key characteristics of LTFU gene therapy study protocols registered in ClinicalTrials.gov. The analysis enabled a better understanding of how registered LTFU studies are currently designed and stimulated ideas for improvement. Most notably, the results suggest a lack of harmonization in how safety outcomes are monitored and reported across LTFU studies. Standardization and/or harmonization of data and outcome reporting may increase the scientific value of these studies.
Chapman, C.R., Glazier, A., Berbić, E. et al. Characteristics of long-term follow-up studies for gene therapies registered on ClinicalTrials.gov. Gene Ther (2025). https://doi.org/10.1038/s41434-025-00571-4
In a Blood Advances article titled “The roadmap to integrate diversity, equity, and inclusion in hematology clinical trials: an American Society of Hematology initiative,” Barbara E. Bierer and co-authors outline a comprehensive strategy to address barriers to diversity, equity, and inclusion (DEI) in clinical research for classical hematologic diseases. These trials face unique challenges, including small sample sizes, methodological limitations, and underrepresentation of diverse populations. Through surveys and five international focus groups with patients, advocates, academia, regulators, industry, and research organizations, the team identified eight priority areas: (1) harmonizing demographic terminology, (2) engaging lived experience experts, (3) mitigating implicit bias, (4) strengthening the role of ethics committees and institutional review boards in upholding justice, (5) broadening eligibility criteria, (6) leveraging decentralized trial designs, (7) improving access to trial information, and (8) increasing engagement of community physicians. Implementing solutions in these areas will foster accessible, inclusive trials and generate representative data to improve research quality, regulatory decision-making, and patient care.
Alice Kuaban, Alysha K. Croker, Jeffrey Keefer, Leonard A. Valentino, Barbara E. Bierer, Stephen Boateng, Donna DiMichele, Patrick Fogarty, C. Michael Gibson, Anna M. Hood, Lloryn Hubbard, Antonella Isgrò, Karin Knobe, Leslie Lake, Iman Martin, Michel Reid, Jonathan C. Roberts, Wendy Tomlinson, Lanre Tunji-Ajayi, Harriette G.C. Van Spall, Caroline Voltz-Girolt, Allison P. Wheeler, Alan E. Mast, Stephanie Seremetis; The roadmap to integrate diversity, equity, and inclusion in hematology clinical trials: an American Society of Hematology initiative. Blood Adv 2025; 9 (4): 687–695. doi: https://doi.org/10.1182/bloodadvances.2024013945
In an Accountability in Research article titled “Disparate data retention standards in biomedical research”, Barbara Bierer and Carolyn Lye, Minal Caron, Lauren Walsh, and Mark Barnes discuss disparate data retention standards for biomedical research. The article summarizes the divergent data retention standards set forth by federal agencies, grant programs, and research institutions, as well as other applicable requirements under law, contract, and policy. The authors also discuss the importance of data retention in the context of research professionalism, data sharing efforts, intellectual property issues, and research integrity challenges, and provide recommendations for both institutions and applicable federal agencies to streamline and clarify data retention standards.
Lye, C. T., Caron, M. M., Walsh, L., Bierer, B. E., & Barnes, M. (2025). Disparate data retention standards in biomedical research. Accountability in Research, 1–28. https://doi.org/10.1080/08989621.2025.2543884
“Defamation Claims Arising from Research Misconduct Cases: Best Practices for Institutions,” published in the Journal of Law, Medicine & Ethics, co-authored by Barbara Bierer and Mark Barnes, as well as Nathaniel Jaffe, Minal Caron, and Lauren Walsh, analyzes nine instances in which defamation suits were employed to obstruct misconduct investigations. It summarizes the legal bases of such claims and key defenses (e.g., Strategic Lawsuit Against Public Participation, truth, opinion), then distills institutional best practices—from calibrated public disclosures to stringent confidentiality protocols—to protect both scientific integrity and institutional resilience.
Jaffe N, Caron M, Walsh L, Bierer B, Barnes M. Defamation Claims Arising from Research Misconduct Cases: Best Practices for Institutions. Journal of Law, Medicine & Ethics. 2025;53(1):47-54. doi:10.1017/jme.2025.37
In the article “Managing Multi-Institutional Jurisdiction in Cases of Research Misconduct,” published in the Journal of Law, Medicine & Ethics, co-authors Mark Barnes and Barbara Bierer examine the persistent challenges of jurisdictional ambiguity when research misconduct spans multiple institutions. Together with Leslie Thornton and Devin Cohen, they outline key gaps in current regulatory guidance and propose a framework for collaborative resolution that safeguards fairness and research integrity. The article calls for clearer delineation of institutional responsibilities and improved mechanisms for inter-institutional coordination in misconduct investigations.
Thornton L, Cohen D, Barnes M, Bierer BE. Managing Multi-Institutional Jurisdiction in Cases of Research Misconduct. Journal of Law, Medicine & Ethics. 2025;53(1):41-46. doi:10.1017/jme.2025.36
In the article “Benefits that Offset Research Risks and Burdens are Qualitatively Different,” published in The American Journal of Bioethics, Barbara Bierer joins co-authors Luke Gelinas and Benjamin C. Silverman to examine how indirect benefits offered to research participants (e.g., payments, access to medicines) differ fundamentally from direct benefits that justify risk. The authors argue that these categories of benefit must be conceptually and ethically distinguished in research design and review. Their commentary challenges current interpretations of benefit-risk assessment and calls for greater nuance in ethical review frameworks.
Gelinas, L., Silverman, B. C., & Bierer, B. E. (2025). Benefits that Offset Research Risks and Burdens are Qualitatively Different. The American Journal of Bioethics, 25(5), 78–80. https://doi.org/10.1080/15265161.2025.2488293
