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.
Description: The authors provide an overview of past and ongoing efforts in community engagement in genomics studies and consider successes and opportunities for further improvement. They set out a vision for a more equitable and collaborative genomics where wider communities, including social, ethnic, and other communities that share a particular trait, are included in the research as peers and collaborators.
Description: A recent Frontiers in Pediatrics article, co-authored by Barbara Bierer and Elisa Koppelman of the MRCT Center, emphasizes the importance of directly involving children and adolescents in pediatric research design and execution, highlighting the benefits of incorporating their perspectives alongside those of parents and guardians. The authors provide theoretical, ethical, and practical recommendations for systematically engaging young participants to enhance the relevance and effectiveness of clinical studies.
Description: In the Health Affairs article “Towards A National Action Plan To Improve Representation In Clinical Trials,” co-authored by the MRCT Center’s Barbara Bierer, the authors address the critical need for increased diversity in clinical research to enhance health outcomes for underrepresented populations. They propose a comprehensive national strategy that includes policy reforms, community engagement, and the integration of diverse perspectives in trial design and implementation.
