Carolyn Chapman, MRCT Center Member of the Faculty and Lead Investigator, will moderate and co-sponsor a webinar, “What’s up with Long-Term Follow-Up: ethical, regulatory, operational challenges,” with the Pediatric Gene Therapy and Medical Ethics (PGTME) Working Group at the Division of Medical Ethics, NYU Grossman School of Medicine. The webinar is part of PGTME’s fifth annual Lunchtime Lecture Series.
Key Topics:
Why and How Long-Term Follow-up (LTFU) studies are conducted for Gene therapies
Ethical, Regulatory, and Operational Challenges of LTFU studies
Maximizing the value and minimizing the burden of LTFU studies
Published on: November 18, 2024 and updated on May 30, 2025
The “Exit Survey Inclusive of the LGBTQIA+ Participant Perspective” is one tool in the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit and the third of three tools in the section of the Toolkit directed more toward participants. It is important for participants in clinical research activities to give feedback about their experiences. This feedback helps research teams and organizations better understand the participant’s experience of the research activity and learn where they can improve on efforts to empower research participants and the participants’ supporting families, friends, and communities. One way to gather feedback is through a survey, which may be given to participants periodically (e.g., once a month), and/or (as an exit survey) at the end of research activities. In this tool, we aim to show examples of the topics that participants may be asked about in a survey or interview or, if not asked, that the participant may wish to share with the research team in a patient portal, email, or other format.
Please note that the Exit Survey Inclusive of the LGBTQIA+ Participant Perspective has been comprehensively updated in the 2.0 version, particularly in questions 21c-f and in the footnotes for those questions and response options. We have also included a new appendix to this tool, which provides a summary of Key Resources and Recommendations for SOGI Data Collection. These resources and recommendations are drawn from documented best practice and are meant to support researchers designing surveys and research participants that are considering how they might give feedback on their participation experience.
Published on: November 18, 2024 and updated on May 30, 2025
The “Participant Questionnaire from the LGBTQIA+ Participant Perspective” is one tool in the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit, and the second of three tools in the section of the Toolkit directed more toward participants. There are numerous questions that participants may want to ask as they move from thinking about possible trials and sites to starting the process of enrolling and participating in a trial. Some of these questions may be covered by informational materials given to participants during the informed consent process and study visits, and some may not be. This list is to help participants prepare so that they can get the answers that they need and feel comfortable before continuing with the trial. The Participant Questionnaire tool is divided into sections that include questions to ask the research team, questions you may want to ask family, friends, and others you trust, and questions to ask yourself. It includes questions that anyone might want to ask and adds questions that LGBTQIA+ people (and/or their accompanying friends and family) might also want to ask.
Published on: November 18, 2024 and updated on May 30, 2025
The “Site Feasibility Decision Tree from the LGBTQIA+ Participant Perspective” is one tool in the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit, and the first of three tools in the section of the Toolkit directed more toward participants. This tool is meant to empower potential LGBTQIA+ participants to assess whether a site may be trustworthy and welcoming. This tool is structured in tiers, with checkpoints in between. The first tier is potential capacity, where we provide prompts, or “determination factors” based on what IS happening at a site (or in the area nearby) that LGBTQIA+ people can use in considering whether the site is potentially a good place to participate in a study. In the second tier we focus on “historical capacity,” or the things that the site HAS/HAD done to support the well-being of LGBTQIA+ people that may inspire confidence that the site is trustworthy.
Details: The Joint Task Force for Clinical Trial Competency (JTF), anchored at the MRCT Center, is dedicated to developing and disseminating standards and practices for the clinical research workforce. The JTF fosters a cohesive, global approach to ensuring that professionals have the necessary competencies to conduct clinical trials effectively and ethically.
The public is invited to attend virtual biannual meetings, which happen twice a year.
Key topics discussed at this meeting:
Duke University’s Workforce Engagement and Resilience Program
Community of Practice & JTF Competency Framework:
The Research Professionals Network Workshops
Developing Team Sciences Competencies for Clinical Research Professionals
Accreditation of Academic Programs in Clinical Research
Promotion of the JTF Core Competency Framework in Asia and Africa
Deploying the JTF Framework across the world: Translations and Applications
Details: The Joint Task Force for Clinical Trial Competency (JTF), anchored at the MRCT Center, is dedicated to developing and disseminating standards and practices for the clinical research workforce. The JTF fosters a cohesive, global approach to ensuring that professionals have the necessary competencies to conduct clinical trials effectively and ethically.
The public is invited to attend virtual biannual meetings, which happen twice a year.
Key topics discussed at this meeting:
Integrating JTF Framework into Takeda’s R&D’s Knowledge Development Academy (KDA)
Update on Translations
JTF Competency Survey in Low and Middle Income Countries: Initial Analysis of Results
Clinical Research Core Competencies: An Adaptation of the JTF Framework to Switzerland
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.
Topics: (1) The HALT Fentanyl Act and its effect on research involving controlled substances; (2) Executive Order on Increasing Medical Marijuana and Cannabidiol Research; (3) Declaration of Taipei
HALT Fentanyl Act and Research. On July 16, 2025, President Trump signed the Halt All Lethal Trafficking of Fentanyl (“HALT Fentanyl”) Act into law. The law permanently reclassifies “fentanyl-related substances” into Schedule I of the Controlled Substances Act (“CSA”), and much of the political commentary and media attention related to the legislation have focused on this specific provision and its potential impact on the nation’s fentanyl crisis. However, the HALT Fentanyl Act also contains numerous significant reforms related to research activities with controlled substances, including provisions streamlining the process for conducting research with any Schedule I controlled substance. We will discuss takeaways from the HALT Fentanyl Act that drug developers, academic medical centers, research institutions, and others involved in nonclinical or clinical research with controlled substances should consider for their ongoing and future research activities.
Executive Order on Increasing Medical Marijuana and Cannabidiol Research. On December 18, 2025, President Donald Trump signed an executive order that may breathe new life into efforts to move marijuana to a less restrictive schedule under the Controlled Substances Act (“CSA”). Executive Order 14370, entitled “Increasing Medical Marijuana and Cannabidiol Research” (the “EO”), recognizes that marijuana’s historical position in schedule I—the most restrictive of the CSA’s schedules—has hampered research, and it urges the Attorney General to complete the ongoing rulemaking process to move marijuana to schedule III. The EO also directs further action by the administration to facilitate medical research and improve access to certain hemp products. We will discuss the specifics of the Executive Order and what it may mean for researchers conducting research on marijuana and cannabidiol products. The discussion will be led by Ropes & Gray partners Josh Oyster and David Peloquin, who co-authored a short alert on the topic earlier this year.
The Declaration of Taipeiis an ethical guideline by the World Medical Association (WMA) and was adopted in 2016, for the collection, storage, and use of health data, biological materials, and health databases and biobanks. A meeting is taking place in December 2025 in Taipei, Taiwan, to discuss revisions to the Declaration of Taipei. Barbara Bierer is attending this meeting and will lead a discussion of key changes to the Declaration that were discussed at the meeting.
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:
In September 2023, the MRCT Center’s R3 forum devoted a session entirely to issues that arise when conducting research involving the PRC. Since that time, there have been several developments that affect research with a nexus to the PRC. These include updates to the PRC’s requirements for processing sensitive personal data in the context of clinical trials, scrutiny of arrangements involving the PRC from an export control perspective, the implementation of the DOJ’s Bulk Data Rule, and reliance by different components of the U.S. Department of Health and Human Services on Executive Order 14117 (which served as the basis for the DOJ Bulk Data Rule) to make policy announcements regarding research involving the PRC.
This session of the MRCT R3 will explore these latest developments and discuss additional changes that may be on the horizon. Speakers will include Ropes & Gray partners Katherine Wang, who routinely counsels life sciences clients on PRC laws and regulations, Brendan Hanifin, who advises companies on customs/export controls and CFIUS, and David Peloquin, who advises clients on a wide range of clinical research and data protection matters.
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.
