Language: English

Continued Access to Investigational Products: Guiding Equitable and Fair Decisions

Webinar

Date: September 12, 2025

This webinar explores the MRCT Center’s work addressing the challenges of post-trial, continued access to investigational products. Post-trial access is a shared responsibility that should be planned before a trial begins. Even with careful planning, complex situations may arise, requiring sponsors to balance competing priorities and the needs of diverse stakeholders.

The MRCT Center’s Post-Trial Continued Access Task Force has developed principles, frameworks, and recommendations to guide equitable and fair decision-making about the continued provision of investigational medicines or the maintenance of significant-risk investigational devices after a trial ends.

The session includes a case study examining a scenario in which a trial’s primary endpoint is not met, but a subpopulation benefits, illustrating the difficult decisions sponsors and investigators must navigate in determining whether—and how—to provide post-trial, continued access.

Speakers:

  • Karla G. Childers, BA, MSJ, MSBE – Vice President, Bioethics, Policy & Partnerships, Johnson & Johnson
  • Brandy Ellis – Lived Experience Advocate
  • Ben Rotz, RPh – Associate Vice President, Global Medical Policy, Strategy, and Operations, Eli Lilly & Company

Moderated by:
Sarah White, MPH, Executive Director, MRCT Center

2025-09-11b Webinar Slide DeckDownload
Framework: Post-trial, Continued Access Responsibilities to Investigational Significant-Risk Devices – Scenarios that require further consideration
Framework: Post-trial, Continued Access Responsibilities to Investigational Medicines
Principles of Post-Trial Responsibility: Continued Access to an Investigational Product
Post Trial Responsibilities: Continued Access

The roadmap to integrate diversity, equity, and inclusion in hematology clinical trials: an American Society of Hematology initiative

Publication

Published on: February 12, 2025

Published in: Blood Advances

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.

View article

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

Disparate data retention standards in biomedical research

Publication

Published on: August 6, 2025

Published in: Accountability in Research

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.

View article

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

Podcast Episode 4: Clinical Trials in Latin America

Podcast

Presented on: May 13, 2025

Trials Beyond Borders: Clinical Trials in Latin America—Aligning Global Research with Local Realities

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.

Research Ethics Review: Guidance for Clinical Trials

Tool

Published: July 16, 2025

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).

With Fillable Comment Boxes
For Print – without fillable comment boxes
2025_MRCT_AVAREF_Ethics-Review-Tool_07-10-2025_Comment-boxes_FillableDownload
Research Ethics Committee Systems Optimization


Defamation Claims Arising from Research Misconduct Cases: Best Practices for Institutions

Publication

Published on: April 21, 2025

Published in: Journal of Law, Medicine & Ethics

 “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.

View article

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

Managing Multi-Institutional Jurisdiction in Cases of Research Misconduct

Managing Multi-Institutional Jurisdiction in Cases of Research Misconduct

Publication

Published on: April 28, 2025

Published in: Journal of Law, Medicine & Ethics

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.

View article

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

Defamation Claims Arising from Research Misconduct Cases: Best Practices for Institutions

Benefits that Offset Research Risks and Burdens are Qualitatively Different

Publication

Published on: May 8, 2025

Published in: The American Journal of Bioethics

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. 

View article

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

Patient-Centered Long-Term Follow-Up for Gene Therapies

Webinar

Presented on: June 26, 2025


This on-demand webinar, presented on June 26, examines the FDA’s recommendations for long-term safety monitoring of gene therapy recipients—recognizing both the transformative benefits and potential health risks—and highlights the critical need to design follow-up studies around patient needs and preferences to minimize burdens. Building on prior discussions of platform trials and registries, this webinar emphasizes strategies to reduce burden and enhance participant-centered practices. Perspectives include insights from a foundation tackling patient loss to follow-up, expertise on embedding patient-centric culture change into study design, and a patient advocate’s lived experience emphasizing the power of patient voices in shaping compassionate, sustainable LTFU frameworks.

Watch on YouTube

Innovative Approaches for Gene Therapy Long-Term Follow-Up
Patient-centered long-term follow-up for gene therapies aligns with ethics and science
Cell and Gene Therapies

A Framework for AI Adoption and Oversight in Clinical Research

Webinar

Presented on: June 24, 2025

This webinar launched the MRCT Center and WCG’s Review Framework for Protocols Involving Artificial Intelligence (AI). This framework supports Institutional Review Boards (IRBs) in reviewing research where AI is part of the intervention. The framework was developed through a multi-disciplinary task force, and these actionable tools offer both (1) structured guidance grounded in U.S. regulations and (2) ethical considerations to assist IRBs in evaluating benefits and risks while ensuring oversight and transparency across the AI development lifecycle. This session introduced a practical decision-making resource intended to help IRBs determine when and how to apply appropriate and proportionate oversight to protocols involving AI.

Key Topics:

  • Introduction to the IRB review framework focusing on aligning review practices with existing regulations and ethical standards.
  • Structured questions IRBs can use to assess risk, benefits, and ethical considerations when AI is used as a research intervention.
  • An expert panel discussion on navigating ethical considerations and the question of “AI Exceptionalism” during IRB review.
A Framework for AI Adoption and Oversight in Clinical Research
2025_AI-Toolkit_06-24-2025Download