Comments provided on: February 24, 2025
Comments provided to: U.S. Food and Drug Administration; FDA-2024-D-2402
Description: The MRCT Center’s public comments on the FDA’s draft guidance, Considerations for Including Tissue Biopsies in Clinical Trials, recommend enhanced clarification on biopsy justification, prioritization of less invasive methods, consent specificity for future research, and strengthened IRB considerations to improve ethical rigor and participant protections.
Published on: March 11, 2025
Published in: The American Journal of Bioethics
Abstract: Carolyn Chapman and co-authors’ Target Article, “Consideration and Disclosure of Group Risks in Genomics and Other Data-Centric Research: Does the Common Rule Need Revision?” was published in The American Journal of Bioethics: Volume 25 Issue 2, in January 2025. The print publication of this article, which was initially published online in November 2023, was accompanied by 15 Open Peer Commentaries and one Editorial. In March, AJOB published an open-access reply to the commentaries titled “Wanted, but Elusive: Clear Solutions for Addressing Potential Group Harm in Data-Centric Research.” In the reply, Dr. Chapman and colleagues noted that their main goal with the Target Article was to generate discussion about what, if anything, should be done to ethically manage the potential for group harm in data-centric research; they thanked the commentators for their engagement with the issue. “Wanted, but Elusive” reviews key points in the articles, highlights common themes, and weighs recommendations and next steps.
Submitted on: February 4, 2025
Submitted to: Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration
The MRCT Center submitted public comments in response to FDA’s draft guidance on the accelerated approval program, suggesting areas needing further clarification such as the identification and validation of surrogate endpoints, the rigor and timeliness of confirmatory trials, expansion of public disclosures for regulatory actions, increased transparency regarding decision-making and withdrawal, and global considerations in the absence of international harmonization of these regulations.
Presented on: December 5, 2024
Presented at: Virtual
This webinar was co-hosted by the MRCT Center and NYU’s Pediatric Gene Therapy and Medical Ethics (PGTME) Working Group as a part of their 5th Annual Lunchtime Learning Series. The panel on Long-Term Follow-Up (LTFU) was moderated by Dr. Carolyn Chapman and captured the ethical, regulatory, and operational challenges of LTFU studies through diverse viewpoints and perspectives.
Comments provided on: January 15, 2025
Comments provided to: Chief Counsel, National Telecommunications and Information Administration
Description: The NTIA’s proposed rule on the “Ethical Guidelines for Research Using Pervasive Data” aims to increase U.S. privacy protections with a heightened focus on responsible use. In response, the MRCT Center has submitted a public comment that recommends enhancing safeguards through expanded legislative protections, increased transparency, continuous ethical oversight, and periodic review of data practices to address data advancements and mitigate risks to individuals and communities.
Proceedings from: Joint Task Force for Clinical Trial Competency Biannual Global Meeting on December 10, 2024
Held at: Virtual Meeting
Key Topics:
Comments provided on: December 13, 2024
Comments provided to: U.S. Food and Drug Administration
Description: The FDA draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice,” (FDA-2024-D-2052) highlights the need for maintaining scientific rigor and data reliability when using real world data (RWD) amidst diverse healthcare settings. The MRCT Center comments addressed data quality when using clinical (and variable) data, ethical and practical challenges of randomization in clinical settings, vulnerabilities in data privacy and security, and participant safety while promoting innovative approaches and pilot programs to refine implementation strategies for this purpose.
Comments provided on: November 29, 2024
Comments provided to: U.S. Department of Justice
Description: The DOJ Notice of Proposed Rulemaking (NPRM), “Provisions Pertaining to Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons,” (DOJ-NSD-2024-0004) aims to safeguard sensitive U.S. personal- and government-related data from countries of concern or covered persons, emphasizing national security and data protection. MRCT Center comments highlighted the need to balance these security measures with global health priorities, recommending explicit public health and research exemptions, alignment with international standards, refined definitions, and transparent compliance to support access to health-related data and the advancement of science, medicine, and individual and public health.
Episode 2 of the Trials Beyond Borders podcast is now available on all streaming platforms. In this episode, Racquel Bruton, Associate Director and Clinical Trials Diversity Portfolio Lead at Biogen, and Willyanne DeCormier Plosky, Program Director at the MRCT Center, discuss how sponsor companies are enhancing representation in clinical trials, particularly outside the US. Racquel highlights Biogen’s longstanding commitment to reaching underrepresented populations and explores how the MRCT Center’s roadmap can help organizations develop effective diversity action plans. Tune in to learn practical insights on operationalizing diversity strategies.
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.
LGBTQIA+ Inclusion by Design in Clinical Research Toolkit
LGBTQIA+: Inclusive Imagery Case Study
LGBTQIA+: Inclusive Language Checklist
SOGI Data Collection Checklist
SOGI: Data Privacy Checklist
Site Feasibility Decision Tree from the LGBTQIA+ Perspective
Participant Questionnaire from the LGBTQIA+ Perspective
Exit Survey Inclusive of the LGBTQIA+ Perspective
