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Jun2022

Diversity, equity, and inclusion have become a focal point since the COVID-19 pandemic exposed the disproportionate —and systemically ingrained— health disparities certain populations suffer from in the United States. Attention has finally shifted to realize that study populations in clinical research should generally mirror the characteristics of the population affected by the condition being studied or for whom the product or intervention is intended.

The appropriate inclusion of diverse populations in clinical research is necessary if we are to reduce disparities and understand how biological variability, genetics, social determinants of health, and other factors contribute to disease prevalence, course, treatment, and prevention in affected subgroups. The inclusion of understudied and underserved populations informs clinical decision-making and health policy and can help address mistrust of research and healthcare. Unfortunately, it is well known that clinical trials fail to reflect the diversity of affected populations, as recent data on clinical trials for the treatment of COVID-19 infection have shown. Equitable representation in clinical research is long overdue.

In addition to biological understanding and health equity, representativeness and inclusion are important to fairness in the distribution of the opportunities and potential benefits of participation in research. Institutions that conduct clinical research —and their HRPPs— bear some responsibility to attend to the distribution of opportunities and potential benefits, as do the IRBs that review, approve, and monitor clinical research. Appropriate inclusion, access to the potential benefits of research, "equitable selection" of participants, and advancing trials that render participation that is attentive to the needs of all participants and all of society are necessary for the IRB to consider.

IRBs have the difficult responsibility of both protecting participants from harm and ensuring the inclusion of underrepresented participants in research. But how to balance these apparently conflicting responsibilities is challenging. Quotas and overly prescriptive approaches required by the IRB will be problematic, and thus thoughtful case-based consideration is required. Some first steps that will further the development of best practices in the field include drawing attention to diversity and inclusion as a goal; setting reasonable expectations as a condition of study approval, at continuing review, and at study close out; and committing to the necessary discussion, deliberation, and collaboration among institutions, IRBs, and investigators.

In response to this challenge, the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center) convened both a Task Force of IRB and HRPP representatives and a Delphi Panel of experts, to discuss if, and how, the IRB should exercise its position to review research studies for elements of diversity and inclusion and then to consider what resources would be helpful or necessary. These efforts resulted in the development of specific consensus recommendations outlining the responsibilities that HRPPs and IRBs have with respect to diversity, equity, and inclusion in clinical research and suggestions for their review and oversight of research protocols.

In addition, a suite of strategies, tools, and resources were developed for IRBs, HRPPs, and investigators to adapt or use to help initiate this work. On June 23, 2022, the MRCT Center will host a free public webinar to launch these resources and to share lessons learned from the assembled experts in this field. This work cannot be done alone; it requires the community to learn and grow together.

The Multi-Regional Clinical Trials Center at Brigham and Women's Hospital and Harvard (MRCT Center) is a research and policy center created to address the conduct, oversight, ethics and regulatory environment of clinical trials, with a focus on multi-site, transnational clinical trials. The MRCT Center works by engaging and convening a diverse set of stakeholders from industry, academia, CROs, government and institutional regulatory bodies, patient and patient advocacy groups and others to identify challenges and deliver ethical, actionable, and practical solutions for the global clinical trial enterprise, with a focus on emerging economies. Over the past decade, the MRCT Center's efforts have contributed to the implementation of best practices, increased transparency and safety for participants. The majority of the MRCT Center resources are freely available on their website.

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