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.
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.
Learn about the MRCT Center’s Clinical Research Glossary, a collaboratively developed plain language resource designed to enhance understanding of clinical research terminology. Discover how you can participate in the annual Public Review—an essential step toward making these terms a CDISC global standard. Your involvement ensures the glossary remains accurate, inclusive, and effective for informed decision-making in clinical research. Now open through July 5.
Key Topics:
The terms and definitions going through Public Review
Why your voice matters in Public Review
How to easily participate and submit feedback
The role of Public Review in shaping global clinical research standards
Public Review is a Critical Part of the Clinical Research Glossary process.
Part of being a CDISC global plain language standard means all new terms and definitions, plus change requests we received throughout the year, go through a public review process.
Public Review of the Clinical Research Glossary happens every June.
After definitions are developed by the Clinical Research Glossary team, Public Review ensures the definitions get an extra review by people who were not involved in the project. This helps us be more confident that the definitions are clear and easy to understand.
Send us your feedback using the MRCT Center Public Review process.
The MRCT Center’s process uses a simple survey to collect feedback.
This process will not require reviewers to create an account, but we do ask for name, organization and email address. Collecting this information allows us to validate the entry and follow-up with each person to let them know how the comment was addressed.
You can send us feedback on already posted definitions all year round and suggest new words for us to consider whenever you want. Click here to contact us.
The CDISC Public Review process is also an option if you know how to use JIRA
This works great if you already have a CDISC login and are familiar with the process. Individuals will need to create accounts to provide comments via JIRA.
CDISC has kindly provided video instructions here.
This resource offers institutional review boards (IRBs) and other oversight entities a structured, practical approach to evaluating protocols that involve artificial intelligence in research with human participants. The framework addresses emerging ethical and regulatory challenges specific to AI—such as algorithmic bias, adaptive learning, data identifiability, and the need for human oversight—while aligning with foundational ethical principles and applicable U.S. regulations. Through tools including a decision tree for regulatory applicability, developmental stage-specific review guidance, and targeted ethical considerations, the framework supports consistent, thorough review processes that protect participants and promote the responsible use of AI in clinical research.
The MRCT Center Clinical Research Glossary is more than a reference—it’s a tool for clarity, connection, and accessibility across the clinical research ecosystem. Organizations from patient advocacy groups to health systems, academic journals, and recruitment platforms are integrating the glossary to meet the distinct needs of their audiences.
Whether embedded in health literacy trainings, linked within patient education portals, or aligned with technical terminology in scholarly publications, these five implementation stories demonstrate the glossary’s real-world utility in empowering patients, caregivers, professionals, and the public to engage with research using a shared, plain language vocabulary.
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
Integrating JTF Competencies: Curriculum Design and Accreditation at Arizona State University
Comprehensive leveling of the Clinical Research Professional Career Ladder at Johns Hopkins University
Results from a Delphi study on data management competencies
Expanding the Core Competency Framework to include patient, participant, and public engagement and partnership: Updates from the Patient Participant Project workgroup
This meeting was presented to the Bioethics Collaborative. The Bioethics Collaborative is a forum to propose, share, and discuss ethical challenges in multi-national clinical trials. Meetings convene individuals from academia, industry, patient/participant groups, ethics committees, government, and others.
Abstract:The September 2024 meeting of the MRCT Center’s Bioethics Collaborative, Impact of Dobbs on Reproductive Health: Unintended Consequences for/on Research, examined how shifting abortion laws in the wake of the Dobbs decision create new risks and ethical challenges for clinical research. Participants discussed the implications for informed consent, site selection, data privacy, and the use of Certificates of Confidentiality (CoCs), particularly in states with restrictive abortion laws. The group explored how legal uncertainty may deter participation, complicate IRB review, and jeopardize data protection for both participants and research staff. The session concluded with recommendations for guidance development, including consent language, institutional training, and privacy safeguards in a rapidly evolving legal landscape.
This meeting was presented to the Bioethics Collaborative. The Bioethics Collaborative is a forum to propose, share, and discuss ethical challenges in multi-national clinical trials. Meetings convene individuals from academia, industry, patient/participant groups, ethics committees, government, and others.
Abstract:The December 2024 session of the MRCT Center’s Bioethics Collaborative, Is It Time to Retire the Concept of Deidentification?, convened experts to explore the limitations of current deidentification standards in the face of advancing technologies and evolving data landscapes. Participants examined the ethical and regulatory frameworks underpinning HIPAA and the Common Rule, debated the feasibility and implications of redefining “identifiability,” and emphasized the growing risk of reidentification, particularly for minoritized groups. Discussions underscored the need for greater public engagement, transparency, and nuanced protections that balance data utility with privacy, while considering interim policy approaches amid calls for systemic reform.
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.
