Representation in Research
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Global populations/People living outside the US

The MRCT Center’s August 2020 guidance on optimizing representation in clinical research, while comprehensive, largely reflects US-centric perspectives and regulatory frameworks. Through stakeholder consultations with sponsors, regulators, ethics committees, investigators, and participants, this project aims to deepen understanding of representation in multi-regional research and expand the Center’s tools to incorporate varied global viewpoints. Key challenges include varying definitions of demographic categories across countries, ethical concerns about incentivizing vulnerable populations, and differing regulatory approaches to promoting inclusion. The project has produced several resources: guidance on embedding ethical considerations in global representation, strategies for building research capacity with partner countries, a Global Representation Roadmap offering a seven-stage process for implementing DEI strategies across international portfolios, and a Model Diversity Action Plan that meets FDA requirements while emphasizing broader international perspectives and strategies for overcoming barriers to inclusive recruitment beyond the United States. Continued work is needed to understand how representation priorities differ across regions and how these varying perspectives shape multi-country research design and implementation.

Please note: The tools listed above are living documents and will be improved with use. We welcome feedback, suggestions, useful references, resources, and concerns.

Acknowledgments

Many thanks to everyone who has so thoughtfully collaborated on these projects. Members who have chosen to be publicly acknowledged are listed in the links below, with the titles and organizational affiliations that they had at the time of the product launch. Please note that each member served in their individual capacity, and the views and findings expressed in project materials are those of the authors and do not imply endorsement or reflect the views or policies of the U.S. Food and Drug Administration or the affiliated organization or entity of any member who contributed to this work.

Leadership team

  • Dr. Barbara Bierer, Faculty Director, MRCT Center
  • Hayat Ahmed, Program Manager, MRCT Center
  • Dr. Willyanne DeCormier Plosky (she/her/hers), Program Director, MRCT Center
  • Katharine White, Consultant

Reviewers (DAP Model and Roadmap)

  • Lloryn Hubbard, (she/her) Formerly Director, Patient Diversity, PPD Clinical Research Services
  • Ms. Racquel W. Bruton, Associate Director, Clinical Operations Program Lead, Biogen
  • Tinaya Gray, Global Head of Diversity in Clinical Trials & Executive Director Site Engagement, ICON plc

Reviewers (capacity strengthening and ethical considerations)

Subject matter experts involved in other capacities

DEI people DEI people DEI people DEI people DEI people DEI people DEI people DEI people DEI people
Global populations/People living outside the US Resources for IRB/HRPP members Resources for IRB/HRPP members Limited English Proficiency (LEP) populations Disabled populations/People with disabilities Disabled populations/People with disabilities Disabled populations/People with disabilities LGBTQIA+ populations LGBTQIA+ populations Financially challenged and underinsured populations Financially challenged and underinsured populations Financially challenged and underinsured populations Underrepresented Populations in General Underrepresented Populations in General Underrepresented Populations in General Disabled populations/People with disabilities Disabled populations/People with disabilities Disabled populations/People with disabilities with disabilities
Underrepresented Populations in General Disabled populations/People with disabilities Global populations/People living outside the US Financially challenged and underinsured populations LGBTQIA+ populations Limited English Proficiency (LEP) populations Resources for IRB/HRPP members
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