“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
In “Assessing Federal Policies to Reduce Economic Barriers to Clinical Trial Enrollment,” published in the Journal of Law, Medicine & Ethics, Barbara Bierer and colleagues analyze how federal means-tested benefit rules—across Medicaid, Supplemental Security Income, SNAP, and TANF—treat even modest clinical trial stipends as countable income, deterring low-income, elderly, disabled, rural, and other underserved populations from participation. They show that these hidden economic disincentives undermine efforts to achieve representative trial cohorts and exacerbate disparities. To address this barrier, the authors urge Congress to expand the Ensuring Access to Clinical Trials Act of 2015 and enact new legislation excluding all clinical trial payments from gross-income calculations for means-tested programs—an essential reform for ethical, inclusive research.
Albert-Rozenberg D, Peloquin D, Liss J, Hanson E, Bierer BE. Assessing Federal Policies to Reduce Economic Barriers to Clinical Trial Enrollment. Journal of Law, Medicine & Ethics. Published online 2025:1-10. doi:10.1017/jme.2025.61
The authors press for follow‑up models that reduce patient and caregiver burden, improve retention, and leverage decentralized methods and real‑world evidence. Achieving this vision will require sustained collaboration across disciplines and meaningful engagement with patient communities.
Chapman et al., Patient-centered long-term follow-up for gene therapies aligns with ethics and science, Molecular Therapy (2025), https://doi.org/10.1016/j.ymthe.2025.04.040
Barbara Bierer and Willyanne DeCormier Plosky co-authored an article, led by David Gerber (UT Southwestern), in the Journal of Clinical Oncology titled, “Financial Toxicity in Cancer Clinical Trials: An Issue in Need of Clarity and Solutions.” This work was spearheaded by the Equitable Access to Clinical Trials (EACT) Project, hosted by Lungevity, of which the MRCT Center is one participating organization. The article illustrates some of the non-medical costs that cancer trial participants often pay out-of-pocket, such as an average of $600 US for travel, which are an additional stressor during a difficult time for participants and their families. The authors then detail financial support approaches to address these costs, and special considerations for sponsors, contract research organizations, and sites. Finally, the article highlights recently introduced federal legislation that could significantly ameliorate some of the barriers for sponsors trying to implement financial support approaches and for participants trying to access them.
Published in:The Journal of Empirical Research on Human Research Ethics
Barbara Bierer and Willyanne DeCormier Plosky co-authored an article, led by Emily Nguyen (University of Virginia) and David Resnik (NIEHS/NIH), in the Journal of Empirical Research on Human Research Ethics titled, “An Analysis of Institutional Review Board Policies for Enrollment of Adults with Impaired or Uncertain Decision-Making Capacity.” Some people (at some times) may have uncertain or impaired decision-making capacity, due to medication side-effects, cognitive or developmental disabilities, psychiatric disorders, dementia, physical or emotional trauma, or stress. Unless it is determined that they lack capacity and require a legally authorized representative, people with uncertain or impaired decision-making have the right to decide for themselves, with assistance such as supported decision-making (if desired), whether they would like to participate in clinical trials. However, they must first be offered an equal opportunity to participate. We explore in this paper how this equal opportunity, legally supported by Section 504 of the Rehabilitation Act, may be affected by Institutional Review Board (IRB) policies that are oriented towards exclusion rather than inclusion.
In a commentary published in Trials, “Advocating for collaboration among key partners to promote diversity in clinical studies amid policy challenges in the United States of America”, Barbara Bierer and colleagues underscore the urgent need for sustained, cross-sector collaboration to protect and advance diversity in U.S. clinical research. Given the importance of representativeness of the participant population, the authors highlight practical, unified strategies—emerging from the 2023 Stanford Think Tank—to ensure inclusive participation across the clinical research enterprise.
Disabled people are often excluded from health research despite being the largest underserved group in many countries, having worked to enshrine legal mandates for fair treatment and equal opportunity, and driving innovations that benefit everyone. The article describes the research cycle, points at which disabled people currently face barriers, and actions that can be taken by the research community to better involve disabled people during those points in the research cycle. This call to action is made by authors from different countries around the world as part of the Disability Inclusion in Research Collaboration (DIRECT) to emphasize the critical importance of collaboration, learning, and support across countries on this issue.
Abstract: Carolyn Chapman and co-authors’ Target Article, “Consideration and Disclosure of Group Risks in Genomics and Other Data-Centric Research: Does the Common Rule Need Revision?” was published in The American Journal of Bioethics: Volume 25 Issue 2, in January 2025. The print publication of this article, which was initially published online in November 2023, was accompanied by 15 Open Peer Commentaries and one Editorial. In March, AJOB published an open-access reply to the commentaries titled “Wanted, but Elusive: Clear Solutions for Addressing Potential Group Harm in Data-Centric Research.” In the reply, Dr. Chapman and colleagues noted that their main goal with the Target Article was to generate discussion about what, if anything, should be done to ethically manage the potential for group harm in data-centric research; they thanked the commentators for their engagement with the issue. “Wanted, but Elusive” reviews key points in the articles, highlights common themes, and weighs recommendations and next steps.
