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 Moreover, the Model DAP expands on the FDA’s suggested five sections within their draft guidance, ensuring alignment with regulatory expectations while advancing global standards in clinical research diversity and inclusion.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.
Comments provided to: National Institutes of Health
Description: The MRCT Center submitted public comments on the NIH Request for Information regarding Strategies for Maximizing Public Engagement in NIH Supported Clinical Research (NOT-OD-24-133). The MRCT Center recommended that NIH encourage researchers and their institutions to establish continuous and bilateral relationships with the communities where they intend to conduct research prior to, during, and after the research. Researchers should cultivate bi-directional partnerships with the communities, budget for those activities, and provide training. Several of our collaborators with meaningful lived experiences, including study participants, patient advocates, and clinical researchers, contributed to the response.
Comments provided to: National Institutes of Health
Description: We recommended that NIH require plain language summaries for all manuscripts submitted to PubMed Central. We supported NIH’s proposal to eliminate the embargo period for publications while requesting further consideration of the practical implementations of the proposed change, sensitive to the potential increase in costs to manuscript submission and other unintended consequences.
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.
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.
Comments provided to: Office of Science and Technology Policy
The MRCT Center submitted public comments on the White House Office of Science and Technology Policy (OSTP) Request for Information entitled, “Federal Evidence Agenda on Disability Equity,” published at 89 Fed. Reg. 46924 (May 30, 2024). The collection of reliable disability data remains a challenge to researchers, and we applaud the OSTP’s commitment to measurements of health equity that is inclusive of people with disabilities. We share OSTP’s vision for bringing disability data to the foreground and your enthusiasm for understanding where and how best to include questions on disability. In our comments, we focused on information that would be helpful for the understanding of healthcare, health disparities, and clinical research and refrained from commenting on specific survey methodology used in federal and international data collection that is beyond our area of expertise. The MRCT Center pointed the OSTP to standard practices standard practices to safeguard privacy and security, as outlined by federal policy (HIPAA, OHRP, FDA, DOD, NIH, and others) that include a management plan for secure storage and transfer of data throughout the life cycle of the project; communicating clearly with participants when, why, and how disability data will be collected and used; always providing an option for participants to opt-out of answering any or all disability data questions; and only making disability data available [to research teams] through a controlled access environment. We advocate for plain language, logical reading order, the ability to easily go back and correct answers, and the provision of reasonable accommodations during the informed consent process and in any survey/measurement instrument (whether in print, on a computer, or mobile device). Finally, we note that for any form of disability data collection, people with disabilities must first be asked to participate, and that barriers such as inappropriately restrictive screening criteria should be eliminated.
The MRCT Center and the Research Ethics Action Collaborative for HRPPs (REACH) presented the first webinar in the Accessibility 101 series on July 9, 2024
People with disabilities are the largest minority population in the United States, yet they are often excluded from clinical trials, both as participants and as researchers. Federal regulations, such as the recently updated Section 504 of the Rehabilitation Act, prohibit discrimination based on disability. Many accommodations are easy and low or no cost. It is incumbent upon all of us to build accessibility into our everyday thinking, meetings, presentations, and planning.
This webinar featured two interactive exercises in which participants learned:
Basic information about disability statistics and disability rights, and, as shown through the Accessibility by Design in Clinical Research Toolkit, different types of support that you can readily implement.
How to find the Check Accessibility and Alt Text features in PowerPoint and write appropriate Alt Text.
How to map out the participant’s (and family caregiver’s or supporter’s) journey from different disability perspectives, from getting to/into the site location, navigating within the site to the different areas they must access, and interacting with different forms of medical equipment and technology.
More about REACH: 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. Click here to learn more.
Description: Sylvia Baedorf Kassis and Barbara E. Bierer were co-authors on a paper published in “Cancer” entitled “Acupuncture for hot flashes in hormone receptor‐positive breast cancer: A pooled analysis of individual patient data from parallel randomized trials.” The MRCT Center helped advise the study teams in the coordination and conduct of multi-national, collaborative research.
