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.
Description: Mark Barnes, Barbara Bierer, and colleagues authored a synthesis of prior defamation cases in research misconduct and provided advice for institutions and other parties to minimize potential defamation liability of those proceedings.
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.
Description: A new iteration of the federal Right to Try (RTT) law is gaining momentum. Like the federal RTT law and grounded in similar principles, RTT 2.0 laws sit outside of FDA purview. This article discusses the federal RTT law in comparison to the U.S. Food and Drug Administration (FDA) expanded access pathway, compares RTT with RTT 2.0, and explores the challenges of each.
Description: Analyzing approximately 5000 US pediatric interventional studies registered on ClinicalTrials.gov from 2019 to 2022, 23.4% explicitly included English language requirements in the eligibility criteria and only a small minority provided any justification for the exclusion. Since approximately one-fifth of US households speak a language other than English, this requirement limits access to trials and the generalizability of the research results.
