The Model Diversity Action Plan (DAP) was developed in response to the FDA’s latest directive aimed at improving diversity within clinical trial participation. Built upon the MRCT Center’s Recruitment Strategy Document, this framework supports compliance with FDA standards. The Model DAP also outlines clear objectives that extend beyond the FDA’s initial guidelines, emphasizing a broader international viewpoint. Sponsors are encouraged to delineate specific regions and countries targeted for trial inclusion, detailing proactive strategies designed to overcome obstacles related to diverse, inclusive, and equitable recruitment practices, particularly outside the United States. While these additional details may not always be mandatory for FDA submissions, they are pivotal in fostering a comprehensive approach to trial design and execution. Moreover, the Model DAP expands on the FDA’s suggested five sections within their draft guidance, ensuring alignment with regulatory expectations while advancing global standards in clinical research diversity and inclusion. This dynamic document will evolve as the FDA guidance is finalized.
The Global Representation Roadmap provides a structured approach for stakeholders to define and implement DEI strategies across their global clinical research portfolios. It guides organizations through a seven-stage process tailored to account for varying dimensions of DEI across different countries and contexts. Key focuses include clarifying organizational DEI objectives, defining epidemiology by therapeutic area in target countries, and considering ethical implications in site selection. The Global Representation roadmap prompts stakeholders to address country-specific regulatory requirements related to diversity and outlines minimum actions in their absence. It advocates for proactive DEI targets and capacity-building initiatives, while emphasizing ongoing community engagement and accountability through periodic ethics checkpoints. Additionally, it encourages the use of program-specific Diversity Action Plans to enhance recruitment effectiveness and ensure continuous improvement and transparency in Global Representation efforts.
To celebrate Health Literacy Month, the MRCT Center presented three engaging and informative webinars to provide practical tools for incorporating health literacy and accessibility best practices into communicating participant-facing clinical research information.
The Research Ethics Action Collaborative for HRPPs (REACH) is an initiative spearheaded by the MRCT Center, AAHRPP, PRIM&R, and Mass General Brigham to curate, align, and disseminate tools to advance access to and inclusion in research—for all potential participants–tailored for Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), and the broader community.
Description: Join the REACH collaborative for a dynamic webinar focused on improving PowerPoint presentations through clear, accessible, and inclusive considerations. This session will begin by continuing the discussion from the first two October 2024 MRCT Center webinars on developing impactful and empowering participant-facing materials (such as Informed Consent forms) and utilizing plain language. We will show, through examples from the Accessibility by Design in Clinical Research Toolkit, how these health literacy principles congruently apply from a disability perspective. Because so much communication is now virtual, we’ll then move to exploring how to make PowerPoint content not only readable and approachable, but also formatted for accessibility and inclusiveness of people with disabilities. Whether you’re a researcher, HRPP, or involved in other areas of clinical research, this webinar will provide valuable insights into creating presentations that are both accessible and engaging.
Key Topics:
Learn about the core concepts of health literacy and why they matter in clinical research. Understand how these principles can improve the clarity of your presentations.
Explore hands-on approaches for integrating readability and health literacy principles into your PowerPoint slides.
Participate in a moderated discussion and Q&A session to delve deeper into the application of plain language and readability in presentations. Share your experiences and get answers to your questions.
To celebrate Health Literacy Month this October, the MRCT Center invites you to participate in three engaging and informative webinars. These sessions will provide practical tools and foster robust discussions, benefiting anyone interested in incorporating health literacy and accessibility best practices into communicating participant-facing clinical research information.
Description: Join the MRCT Center for this webinar that will feature experts from the Dana Farber Cancer Institute who will share their experience in developing a patient advocacy-driven return of results process for making Plain Language Summaries available to participants in breast cancer-related studies.
The moderator, Sylvia Baedorf Kassis, will join the panelists, Paula Steeves, Lead Patient Advocate, Breast Oncology, Dana-Farber Cancer Institute, and Timothy Erick, Science Writer, Dana-Farber Cancer Institute.
Please join us as we discuss:
The core elements of creating and disseminating Plain Language Summaries.
What results to return, who to involve in the creation process, and how to approach dissemination.
How to start returning results with your study participants. Share your experiences and get answers to your questions in a moderated discussion and Q&A session.
To celebrate Health Literacy Month this October, the MRCT Center invites you to participate in three engaging and informative webinars. These sessions will provide practical tools and foster robust discussions, benefiting anyone interested in incorporating health literacy and accessibility best practices into communicating participant-facing clinical research information.
Description: This informative webinar will leverage experience from the Office of Human Research Protections, the All of Us Research Program, and the MRCT Center to highlight resources and approaches for communicating informed consent information in innovative, participant-centered ways that support empowered decision-making.
The moderator, Sylvia Baedorf Kassis, will join the panelists, Marianna Azar of the Office for Human Research Protections and Katherine Blizinsky from the All of Us Research Program.
Implementing a participant-centric approach, utilizing the Clinical Research Glossary, and integrating innovative elements into the consent process.
Participate in a moderated discussion and Q&A session to delve deeper into ways to enhance the informed consent process. Share your experiences and get answers to your questions.
We look forward to sharing this important work with you.
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:It is generally agreed that sponsors and other entities undertaking research in limited-resource settings incur certain duties of reciprocity. These obligations ensure that host communities are treated fairly and not exploited, given the burdens and risks of research undertaken by community members. However, the expectations, content, and limitations of these obligations are not defined. The next Bioethics Collaborative will be devoted to understanding and assessing different approaches to satisfying the ethical contorts of reciprocity for research undertaken in these settings.
Published in:Essentials of Translational Pediatric Drug Development (Academic Press)
Description: Mariana Kruger, Moji Adeyeye, and Barbara Bierer co-authored a book chapter entitled “Pediatric drug development issues during public health emergencies” in the book Essentials of Translational Pediatric Drug Development. In their chapter, the authors outline the regulatory and ethical issues that arise during public health emergencies, focusing on pediatric drug development.
Comments provided to: National Institutes of Health (NIH) Office of Science Policy (OSP)
Description: The MRCT Center recommended that NIH OSP (1) clarify and expand on the methods to promote equitable access, (2) consider greater flexibility in the application of this policy to investigational products, and (3) require direct engagement with community stakeholders and patient advocacy groups when NIH assesses the impact of the policy.
