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.
Join the JTF Biannual Global Meeting on June 2, from 9:00 – 11:00 AM ET, to explore the latest advancements in clinical research workforce development and competency-based training. This session will feature global perspectives on implementing the JTF Framework, including:
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
How Arizona State University’s Clinical Research Management program integrates the JTF Framework into both its curriculum and accreditation approach
Comprehensive leveling of the Clinical Research Professional Career Ladder at Johns Hopkins University
All registrants will receive slides and a meeting summary after the meeting.
Abstract: The lines between research and care continue to blur. Pragmatic research studies comparing accepted therapies are increasingly embedded seamlessly into clinical practice. More and more, participation in research deemed promising is offered to patients before standard therapies are exhausted, sometimes as a first-line option. While the concept of “therapeutic misconception”—in very broad strokes, the tendency for individuals to misapply attributes of clinical care to research—has been a mainstay of research ethics for over 40 years, these developments provide an occasion, and perhaps even an urgent need, to revisit it and related topics. How exactly should we understand the therapeutic misconception and what it involves, particularly in cases where the line between research and care really is vague and hard to determine? Even more basically, how should we understand the relationship between research and care in the first place? Are concerns over therapeutic misconception still important, or do they perhaps reflect naïve understandings of research and care and the relation between them–particularly in cases where current options are limited?
This meeting is open to sponsors of the Bioethics Collaborative. For more information about the Bioethics Collaborative and how to become a sponsor, click here.
The Research, Development, and Regulatory Roundtable (R3) is a forum to discuss pre-competitive issues in drug and device development, regulatory oversight of clinical trials, and human subjects research. Meetings convene policymakers, legal counsel, academicians, industry representatives, and global regulators. The R3 is a cooperative endeavor coordinated by the MRCT Center and Ropes & Gray LLP.
This hybrid meeting is open to sponsors of the Research, Development, and Regulatory Roundtable.
Topic 1:
Trump Administration Changes to Notice and Comment Rulemaking at the U.S. Department of Health and Human Services
The notice-and-comment rulemaking process is a cornerstone of U.S. administrative law under the Administrative Procedure Act (APA). The APA, however, exempts from notice-and-comment rulemaking certain regulations that pertain to “agency management or personnel or to public property, loans, grants, benefits, or contracts.” The APA also contains a “good cause” exception that permits rulemaking to occur absent notice and comment in certain situations. In 1970, the U.S. Department of Health and Human Services adopted a policy through memorandum referred to as the “Richardson Waiver” that required HHS as a matter of policy to follow voluntarily the notice-and-comment requirements of the APA even in cases in which the subject matter of the rule could fall within an APA exception. HHS Secretary Robert F. Kennedy rescinded the Richardson Waiver in March 2025.
This session will explore the history of the Richardson Waiver and what its rescission means for future rulemaking by HHS, including a discussion of which types of rules may fall within one of the APA exceptions.
Topic 2:
Certificates of Confidentiality: Background and Practical Implications
Certificates of Confidentiality are a tool created by Congress that prevent the disclosure of research records and biospecimens containing identifiable, sensitive information except when certain conditions set forth in statute are satisfied. Notably, CoCs prevent the disclosure of such research records and biospecimens in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding. CoCs are issued automatically for all National Institutes of Health-supported research and must be issued by the U.S. Department of Health and Human Services (HHS) for other federal government-funded research. CoCs can also be applied for by persons conducting privately-funded research and in such cases can be issued by HHS on a discretionary basis.
In this session we will explore the history of CoCs, the contours of the protections offered by CoCs, and certain unanswered questions that remain regarding the extent to which law enforcement and courts will respect the protections offered by CoCs.
Join us on June 24 from 12 – 1 PM ET to 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.
Key Topics:
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
The terms and definitions going through Public Review
Please join us on Tuesday, June 24, from 3:00-4:00 pm ET for a webinar to launch 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 introduces 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.
Please join us on Thursday, June 26, from 1:00-2:00 pm ET, for a webinar in which we will discuss patient-centered approaches in the specific context of Gene Therapy (GT) Long-Term Follow-Up (LTFU) studies.
GTs have the potential for long-lasting and transformative health benefits, but there are also possible long-term health risks. Therefore, the FDA recommends long-term safety monitoring of recipients of certain types of GTs to minimize and better understand any health risks. Although important, these LTFU studies can last years and may pose significant burdens on patients, so it is critical to consider patient needs and preferences in the design and conduct of LTFU for GTs.
Three panelists will offer different perspectives on how we can put patients at the center of LTFU for GTs:
George Eastwood serves as Executive Director for the Emily Whitehead Foundation (EWF). The EWF funds groundbreaking research for pediatric cancer patients while simultaneously advocating for increased access to innovative therapies and supporting patients on their treatment journey. Mr. Eastwood will provide an overview of the Foundation’s work on addressing concerns about patient loss to follow-up in GT LTFU studies.
Dr. Jessica Scott is CEO of Legacy Health Strategies. As a patient engagement leader, she works to drive the culture change of increasing patient perspectives in the health care industry, which in turn will propel mutually beneficial outcomes for organizations and the patients they serve. She will share perspectives on how patient-centric approaches can be applied to GT LTFU.
Tesha Samuels has journeyed from a Sickle Cell patient to a beacon of hope, advocacy, and activism. Her story is a testament to the power of patient voices in shaping better, more compassionate healthcare systems. Her nonprofit, Journey to ExSCellence, is dedicated to empowering individuals affected by Sickle Cell Disease. Ms. Samuels will share perspectives on GT LTFU as both a patient herself and an advocate for others.
This meeting is open to sponsors of the Bioethics Collaborative. For more information about the Bioethics Collaborative and how to become a sponsor, click here.
The Research, Development, and Regulatory Roundtable (R3) is a forum to discuss pre-competitive issues in drug and device development, regulatory oversight of clinical trials, and human subjects research. Meetings convene policymakers, legal counsel, academicians, industry representatives, and global regulators. The R3 is a cooperative endeavor coordinated by the MRCT Center and Ropes & Gray LLP.
This hybrid meeting is open to sponsors of the Research, Development, and Regulatory Roundtable.
The Research, Development, and Regulatory Roundtable (R3) is a forum to discuss pre-competitive issues in drug and device development, regulatory oversight of clinical trials, and human subjects research. Meetings convene policymakers, legal counsel, academicians, industry representatives, and global regulators. The R3 is a cooperative endeavor coordinated by the MRCT Center and Ropes & Gray LLP.
This hybrid meeting is open to sponsors of the Research, Development, and Regulatory Roundtable.
This meeting is open to sponsors of the Bioethics Collaborative. For more information about the Bioethics Collaborative and how to become a sponsor, click here.
