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
October is Health Literacy Month! Please join us on Thursday, October 30, from 12 – 1 PM ET for a webinar to explore teach-back (TB) within the clinical research context.
We begin with teach-back—its essential elements, how to use it, and why it is important to safe, high-quality, equitable health care and research. We then explore approaches for incorporating teach-back into different types of clinical research conversations.
The session will center on the importance of strong verbal communication skills and the ways teach-back can be used by study teams to foster clear, impactful, and empowering dialogue with patients, participants, and caregivers.
We will explore how study teams can simplify complex verbal information through plain language, assess and confirm understanding via teach-back throughout the recruiting and informed consent process, and support participant understanding throughout their clinical research experience. Registrants will receive tips and resources to support incorporating this best practice into their everyday clinical research processes.
Objectives:
Explain what teach-back is, its importance, and why to use it;
Describe approaches that support incorporating teach-back into clinical research conversations across the clinical trial life cycle;
Identify and access resources that explain how to use teach-back.
Please join us on Tuesday, September 30, 2025, from 11:00 am–12:30 pm ET for a webinar on the applications of AI digital twins and synthetic data to clinical trials. Digital twins refer to simulated models of individual patients designed to predict disease trajectories and/or treatment responses, offering the potential to enhance statistical power, optimize trial design, and limit the number of participants assigned to a control arm. Synthetic data are artificially generated datasets that mirror the statistical properties of verified clinical data. Both technologies are or are being developed for use in the design, conduct, and analysis of clinical trials, and with the intention of use for regulatory submissions. This webinar will serve as an introduction to these emerging technologies and a starting point for examining their implications, opportunities, and challenges in clinical research.
Key Topics:
Introduction to digital twins and synthetic data, including their core functions and how they differ from traditional statistical modeling approaches.
Exploration of ethical, statistical, and regulatory considerations for adopting digital twins and synthetic data in the design and conduct of clinical trials.
A panel discussion featuring expert perspectives on the evolving role of AI digital twins and synthetic data in clinical research.
Reproductive Health Considerations in Clinical Research
The Supreme Court’s June 2022 decision in Dobbs v. Jackson Women’s Health Organization introduced new challenges for the conduct of clinical trials involving people of reproductive potential, for the study of pregnancy-related conditions, and for participants in clinical research and research staff. The changing landscape of reproductive rights in the U.S. requires further consideration by clinical research stakeholders. Among other concerns, reproductive health intersects with clinical research with respect to the privacy of clinical trial participants.
The MRCT Center has started initial work to better understand whether and how reproductive privacy risks are addressed in study protocols, and particularly in informed consent documents. We are also exploring, through interviews with IRB chairs and research leaders across the country, existing approaches to reproductive health privacy protections and participant communication in single and multi-site trials.
Through this process, we are also working to identify recommendations for improved practices, which we plan to develop into a practical toolkit. The toolkit will include guidance documents on key privacy considerations, recommendations for notifying participants of privacy risks and communicating the importance of pregnancy reporting, best practices for addressing incidental pregnancies in research, and guidelines on medical record documentation. It will also explore the protections afforded by and the limits of Certificates of Confidentiality upon which the research community has relied.
OBJECTIVES
Evaluate current practices regarding reproductive privacy risks in clinical research informed consent forms and develop standardized guidance for addressing these concerns.
Develop resources to help research institutions mitigate participant privacy risks in the pregnancy testing and reporting processes, and to support research teams in communicating the risks to staff and participants.
Create standardized guidance for multi-site trial investigators to effectively manage the complexities of conducting research across jurisdictions.
KeY MILESTONES
January 2025: IRB protocol, “Pregnancy-Related Privacy Risks in Clinical Trials: Understanding Current Risks and Approaches,” approved
Dr. Carla Saenz, Regional Advisor for Bioethics at the Pan American Health Organization (PAHO), speaks with Willyanne DeCormier Plosky, MRCT Center Program Director, to unpack the clinical trial landscape in Latin America.
They discuss:
How demographics, healthcare infrastructure, and insurance models shape who can—and does—participate
Ethical and regulatory strategies to broaden inclusion
The influence of CIOMS and other international guidance on local trial ethics
Designing global studies that honor regional contexts without sacrificing scientific rigor
This episode highlights the critical need for equitable access and culturally responsive research in today’s global trial environment.
For more about the MRCT Center’s work on Global Representation in Clinical Trials, click here.
Please join us on Friday, September 12 from 11 AM – 12 PM ET for a webinar to discuss the MRCT Center’s ongoing work related to the challenges of post-trial continued access to investigational products. Post-trial continued access is a shared responsibility and should be determined before the trial begins. Even with the best planning, complex situations can arise that require research sponsors to balance various tradeoffs and impacts on stakeholders. The MRCT Center’s Post-Trial Continued Access Task Force has developed resources to guide equitable and fair decision-making related to the continued provision of the investigational medicine, or continued maintenance of the investigational significant risk device after the trial.
This webinar will introduce a series of resources, including principles, frameworks, and recommendations. Case studies will also be presented to illustrate unique complexities that sponsors and investigators must consider.
The Joint Task Force for Clinical Trial Competency (JTF), anchored at the MRCT Center, develops and disseminates standards and practices for the global clinical research workforce. By fostering a cohesive and collaborative approach, the JTF ensures that professionals have the competencies to conduct clinical trials ethically and effectively.
Our international team of investigators, educators, and clinical research professionals has developed and/or utilizes a framework that defines the knowledge, skills, and attitudes necessary for conducting safe, ethical, and high-quality clinical research.
This guidance document is intended to be used as a tool to supplement the review, discussion, and deliberation of Research Ethics Committees reviewing clinical trial protocols.
This tool was developed by Barbara E. Bierer, MD (The MRCT Center of Brigham & Women’s Hospital and Harvard), Jeffrey D’Souza, PhD (University of Toronto), Caroline M. Kithinji, PhD (Kenya Medical Research Institute), and Winfred B. Nazziwa, MS (Uganda National Council for Science & Technology), in collaboration with the African Vaccines Regulatory Forum (AVAREF).
“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
