Representation in Research

The participant populations enrolled in clinical trials should reflect the populations affected by the disease or condition for which the intervention is being tested. Representation in research is fundamental to good science. Everyone should be able to “see themselves” in clinical trials and research data and to understand whether approved vaccines, therapies, devices, and medications (including medication doses) are appropriate for them. Without proper representation of the people who will use the tested products, we cannot determine how safe or effective those products are for different individuals (e.g., people of varying ages, sexes, genders, body types, genetic backgrounds, co-existing health conditions, income levels, environmental exposures, and/or life stages).

Despite efforts, there is still a great deal to learn as we work toward greater access to clinical trials and improved health outcomes. The barriers that potential participants face in finding and accessing clinical trials differ, as do the approaches that might mitigate these challenges. For some people, reducing the burden of participation through the introduction of decentralized elements is helpful; for others, it involves translation, communication (e.g., plain language, visualization), reimbursement, community and caregiver involvement, among other approaches. And, while the MRCT Center released guidance and tools to address representation in research early in the COVID pandemic, we continue to learn more about the specific ways that people from different populations can best be supported to participate in clinical research.

Our work continues, and we remain committed to it. We are continually expanding our portfolio of tools and resources. Our aim is for everyone to have a “fair shot,” both in terms of the opportunity to participate in clinical trials and in terms of being able to trust the results of that research, conducted through rigorous and ethical research practices.

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

Objectives

Describe the obstacles potential participants are facing in accessing U.S. and multi-regional clinical trials, including scientific, ethical, and geographical challenges; and generate and share lessons learned about potential approaches for effective communication, recruitment, and retention of participants from a variety of backgrounds.
Support engagements and sustainable partnerships with community champions, organizations, and referring providers, and workforce development of clinical research personnel. Develop and disseminate actionable and scalable solutions (“tools”) to support representation in research, greater access to clinical trials, and improved health outcomes.

Key Milestones

November 2025: LGBTQIA+ Inclusion by Design Toolkit
March 2025: Launch of two additional tools in Global Representation: Embedding Ethical Considerations Relating to Global Representation and Working with Partner Countries to Strengthen Research Capacity Building Relating to Global Representation.
October 2024: Accessibility 101 Training Series
September 2024: Launch of two tools in Global Representation: Global Representation Roadmap and Model DAP.
May 2024: Toward a National Action Plan for Achieving Diversity in Clinical Trials released.
May 2023: Released the Accessibility by Design (AbD) Toolkit at a webinar.
June 2022: Held webinar to launch the Equity by Design Metrics Framework and User Guide.
June 2022: Launched IRB and HRPP Toolkit.
March-April 2022: Conducted a virtual six-part training on “Equity by Design in Clinical Research: Cancer Trials” for over 450 clinical research practitioners (live course, for CME credit; now available as an online course, not for CME credit).
April 2021 – July 2021: Leaning In webinar series “Driving Inclusion in Clinical Research” emphasizes how to plan for inclusion, implement recommendations, and sustain progress.
August 2020: MRCT Center releases Achieving Diversity, Inclusion, and Equity in Clinical Research Guidance Document.

Project Leadership & Staff

Willyanne DeCormier Plosky, Program Director, MRCT Center
Hayat Ahmed, Program Manager, MRCT Center
Barbara Bierer, Faculty Director, MRCT Center

Project Resources

Public Comments

September 18, 2025

E21 Inclusion of Pregnant and Lactating Women in Clinical Trials ›

Publication

August 6, 2025

Disparate data retention standards in biomedical research ›

Case Study
Tools

May 30, 2025

LGBTQIA+ Inclusion – Inclusive Imagery ›

Tools

May 30, 2025

LGBTQIA+ Inclusion – Inclusive Language Checklist ›

Tools

May 30, 2025

Sexual Orientation and Gender Identity (SOGI) Data Collection Checklist ›

Tools

May 30, 2025

Sexual Orientation and Gender Identity (SOGI) Data Privacy Checklist ›

Tools

May 30, 2025

Site Feasibility Decision Tree from the LGBTQIA+ Perspective ›

Tools

May 30, 2025

Exit Survey Inclusive of the LGBTQIA+ Perspective ›

Tools

May 30, 2025

LGBTQIA+ Inclusion by Design in Clinical Research Toolkit ›

Podcast

May 30, 2025

Trials Beyond Borders: Clinical Trials in Latin America—Aligning Global Research with Local Realities ›

Publication

May 23, 2025

Assessing Federal Policies to Reduce Economic Barriers to Clinical Trial Enrollment ›

Podcast

May 13, 2025

Podcast Episode 4: Clinical Trials in Latin America ›

Publication

May 12, 2025

Financial Toxicity in Cancer Clinical Trials: An Issue in Need of Clarity and Solutions ›

Publication

May 8, 2025

An Analysis of Institutional Review Board Policies for Enrollment of Adults with Impaired or Uncertain Decision-Making Capacity ›

Publication

April 25, 2025

Advocating for collaboration among key partners to promote diversity in clinical studies amid policy challenges in the United States of America ›

Publication

March 26, 2025

Comment: A global call to action for disability inclusion in health research ›

Guidance

March 24, 2025

Embedding Ethical Considerations Relating to Global Representation ›

Guidance

March 24, 2025

Working with Partner Countries to Strengthen Research Capacity Relating to Global Representation ›

Public Comments

March 11, 2025

Draft Guidance: Study of Sex Differences in the Clinical Evaluations of Medical Products; Guidance for Industry ›

Webinar

February 25, 2025

Workforce Development: Opportunities to Engage and Retain Talent in Clinical Research ›

Publication

February 12, 2025

The roadmap to integrate diversity, equity, and inclusion in hematology clinical trials: an American Society of Hematology initiative ›

Podcast

November 25, 2024

Podcast Episode 2: Trials Beyond Borders ›

Tools

November 18, 2024

Participant Questionnaire from the LGBTQIA+ Perspective ›

Publication

November 6, 2024

Towards A National Action Plan To Improve Representation In Clinical Trials ›

Webinar

October 23, 2024

Health Literacy Month Webinar Series ›

Webinar

October 22, 2024

Designing PowerPoint Presentations to Support Health Literacy and Accessibility ›

Training

October 20, 2024

Accessibility 101 Training Series ›

Public Comments

October 8, 2024

Public Comments submitted: “Remarks for Rep. Robin Kelly’s Roundtable to Diversify Clinical Trials” ›

Public Comments

September 25, 2024

Public Comments submitted: “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies FDA-2021-D-0789” ›

Tools

September 4, 2024

Global Representation Roadmap ›

Tools

September 4, 2024

Model Diversity Action Plan (DAP) ›

Podcast

August 28, 2024

Podcast Episode 1: Trials Beyond Borders ›

Publication

August 1, 2024

The Role of Institutional Review Boards in Improving the Inclusion of Sex and Gender as Variables in Clinical Research ›

Public Comments

July 22, 2024

Public Comments submitted: “NIH-OSP Draft NIH Intramural Research Program Policy: Promoting Equity Through Access Planning” ›

Public Comments

July 15, 2024

Public Comments submitted: “Federal Evidence Agenda on Disability Equity” ›

Webinar

July 9, 2024

Accessibility 101: How to Write Alt-Text and Map Participant Journeys ›

Public Comments

June 25, 2024

Comments Submitted: Cancer Clinical Trial Eligibility Criteria: Performance Status ›

Public Comments

June 24, 2024

Public Comments submitted: “Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications” ›

Public Comments

June 24, 2024

Public Comments submitted: “Cancer Clinical Trial Eligibility Criteria: Laboratory Values” ›

Webinar

June 11, 2024

Data Collection and Privacy: Tools and Resources for LGBTQIA+ Inclusion by Design ›

Publication

May 31, 2024

A Federally Qualified Health Center-led Ethics & Equity Framework & Workflow Checklist: An Invited Commentary in Response to a Relational Public Health Framing of FQHCs During COVID-19 ›

Publication

May 8, 2024

First, do no harm: a global perspective on diversity and inclusion in clinical trials ›

Framework

May 6, 2024

Toward a National Action Plan for Achieving Diversity in Clinical Trials ›

Public Comments

April 29, 2024

Comments Submitted: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products (FDA-2016-D-3561) ›

Public Comments

April 29, 2024

Public Comments submitted: “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products” ›

Webinar

March 7, 2024

REACH: Advancing DEI in Human Participant Research ›

Public Comments

February 15, 2024

Comment on the NPRM regarding regulations to title II of the Americans with Disabilities Act: Accessibility of Medical Diagnostic Equipment of State and Local Government Entities ›

Public Comments

November 11, 2023

Comment on the NPRM Request of the Office for Civil Rights (OCR) re: Discrimination on the Basis of Disability in Health and Human Services Programs or Activities ›

Public Comments

November 10, 2023

Comment on the American Community Survey SOGI Test ›

Public Comments

September 30, 2023

Comments and Suggestions on Updating the NIH Mission Statement ›

Publication

August 30, 2023

Acknowledging Complexity and Reimagining IRBs: A Reply to Discussions of the Protection–Inclusion Dilemma ›

Publication

August 11, 2023

Review of diversity, equity, and inclusion by ethics committees: A Delphi consensus statement ›

Publication

August 9, 2023

Enhancing diversity of clinical trial populations in multiple sclerosis ›

Publication

May 25, 2023

Guest Blog: New Tools to Support Inclusion of People with Disabilities in Clinical Research ›

Flyer
Publication

May 15, 2023

DEI in Clinical Research: Tools & Resources for Incorporating DEI in IRB/HRPP Processes (AAHRPP poster) ›

Webinar

May 4, 2023

Accessibility by Design (AbD) Toolkit Release ›

Tools

May 4, 2023

Accessibility by Design (AbD) Toolkit ›

Publication

March 29, 2023

Data visualization explorer: A tool for participant representation ›

Annual Report

December 15, 2022

2022 MRCT Center Annual Report ›

Proceedings

December 14, 2022

MRCT Center 2022 Annual Meeting Proceedings ›

MRCT Sponsor Resource
Presentation

December 14, 2022

MRCT Center 2022 Annual Meeting Slides ›

Publication

December 7, 2022

Protecting the Vulnerable and Including the Under-Represented ›

Publication

October 21, 2022

Supported decision-making can advance clinical research participation for people with disabilities ›

Publication

October 3, 2022

Excluding People With Disabilities From Clinical Research: Eligibility Criteria Lack Clarity And Justification ›

Public Comments

October 2, 2022

Nondiscrimination in Health Programs and Activities Proposed Rule Section 1557 of the Affordable Care Act ›

Tools

October 1, 2022

Diversity, Inclusion, and Equity in Clinical Research: Institutional Review Board Oversight Points to Consider for IRB Reviewers to assess DEI factors at Initial and Continuing Review ›

Publication

September 28, 2022

Externalist, Process-Based Approach to Supported Decision-Making ›

Webinar

September 22, 2022

FDA Office of Minority Health and Health Equity Webinar Introducing MRCT Center’s “Achieving Diversity, Inclusion, and Equity in Clinical Research” Guidance Document and Supplemental Toolkit ›

Presentation

July 14, 2022

Equitable Practices for Children’s Vision Research ›

Publication

July 1, 2022

Implementing expanded COVID-19 testing in Massachusetts community health centers ›

Video
Webinar

June 30, 2022

Launch Of Equity By Design (EBD) In Clinical Research: The EBD Metrics Framework ›

Webinar

June 23, 2022

Supporting IRB Efforts To Advance Diversity And Inclusion In Clinical Research Tools And Resources ›

Webinar

June 14, 2022

Launch of Online Health Literacy Training For IRB Members and Staff ›

Presentation

June 14, 2022

Equity by Design: Utility of a Metrics Framework and Metrics To Evaluate Progress on Diversity, Equity, and Inclusion in Clinical Research ›

Presentation

June 14, 2022

Diversity and Inclusion in Clinical Trials: Concrete Strategies for Enhancing Health Equity ›

Framework

June 1, 2022

Equity by Design in Clinical Research: The EbD Metrics Framework ›

Tools

June 1, 2022

Diversity, Inclusion, and Equity in Clinical Research: IRB Resources ›

Tools

June 1, 2022

Diversity, Inclusion, and Equity in Clinical Research: Resources for IRBS/HRPPS to Provide to Investigators/research Teams ›

Publication

June 1, 2022

Strategies to Optimize Inclusion of Women in Multi-National Clinical Trials ›

Tools

June 1, 2022

Diversity, Inclusion, and Equity in Clinical Research: Diversity & Inclusion Overlay: NIH-FDA Phase 2 and 3 IND/IDE Clinical Trial Protocol Template ›

Tools

June 1, 2022

Diversity, Inclusion, and Equity in Clinical Research: Diversity & Inclusion Overlay: TransCelerate’s Common Protocol Template ›

Tools

June 1, 2022

Diversity, Inclusion, and Equity in Clinical Research: Incorporating DEI into Clinical Research Protocol Templates ›

Tools

June 1, 2022

Diversity, Inclusion, and Equity in Clinical Research: An IRB Resource for Investigators and Research Teams– Practical Points to Consider: Payment to Research Participants ›

Tools

June 1, 2022

Diversity, Inclusion, and Equity in Clinical Research: An IRB Resource for Participants: Costs and Payments ›

Tools

June 1, 2022

Diversity, Inclusion, and Equity in Clinical Research: Procedural & Logistical Checklist ›

Tools

June 1, 2022

Diversity, Inclusion, and Equity in Clinical Research: IRB Health Literacy Training ›

Tools

June 1, 2022

Diversity, Inclusion, and Equity in Clinical Research: Approaches to Support IRB members ›

Tools

June 1, 2022

Diversity, Inclusion, and Equity in Clinical Research: HRPP and IRB Statement of Commitment to Inclusion ›

Tools

June 1, 2022

Diversity, Inclusion, and Equity in Clinical Research: IRB Statement of Commitment to Inclusion ›

Tools

June 1, 2022

Diversity, Inclusion, and Equity in Clinical Research: IRB Membership Self-Assessment Template (Self-Evaluation Survey) ›

Public Comments

May 31, 2022

Diversity Plans to Improve Enrollment of Participants From Underrepresented Populations ›

Training

May 1, 2022

Equity by Design in Clinical Research: A Six-Part Course ›

Publication

April 28, 2022

IRBs and the Protection-Inclusion Dilemma: Finding a Balance ›

Publication

April 8, 2022

Dr. Barbara Bierer is Featured in the Exploring Drug Discovery and Development Article “Scientists and Communicators Team Up To Increase Clinical Trial Participation” ›

Publication

March 7, 2022

Advancing the Inclusion of Underrepresented Women in Clinical Research ›

Publication

March 4, 2022

Applying Civil Rights Law to Clinical Research Title VI’s Equal Access Mandate ›

Publication

January 1, 2022

Promoting Equity By Design In Cancer Trials ›

Annual Report

December 7, 2021

2021 MRCT Center Impact Report ›

Publication

October 28, 2021

Integrating Supported Decision-Making into the Clinical Research Process ›

Publication

September 14, 2021

Evaluating the frequency of English language requirements in clinical trial eligibility criteria: A systematic analysis using ClinicalTrials.gov ›

Publication

July 21, 2021

Fair payment and just benefits to enhance diversity in clinical research ›

Webinar

July 14, 2021

MRCT Center Driving Inclusion in Clinical Research webinar: Simplifying the Complexity of Translation in Clinical Research ›

Webinar

June 9, 2021

MRCT Center Driving Inclusion in Clinical Research webinar: Improving Inclusion of Persons with Disabilities in Clinical Research ›

Webinar

May 12, 2021

MRCT Center Driving Inclusion in Clinical Research webinar: Inducement or Fair Compensation? Impact on Diverse Participation ›

Webinar

April 14, 2021

MRCT Center Driving Inclusion in Clinical Research webinar: How to Begin ›

Presentation

February 28, 2021

Rare Inspiration. Changing Lives: Sarah White is part of an Alexion panel honoring Rare Disease Day ›

Webinar

February 10, 2021

MRCT Center Leaning In webinar: Role of Data in Diversity: Genetics and Real World Data ›

Webinar

January 27, 2021

MRCT Center Leaning In webinar: Stakeholder Roles and Responsibilities ›

Webinar

January 13, 2021

MRCT Center Leaning In webinar: Data Standards and Analysis ›

Annual Report

December 20, 2020

2020 MRCT Center Impact Report ›

Webinar

December 9, 2020

MRCT Center Leaning In webinar: Study Conduct (Recruitment, Retention) ›

Proceedings

December 3, 2020

MRCT Center 2020 Annual Meeting Proceedings ›

Presentation

December 3, 2020

MRCT Center 2020 Annual Meeting Slides Part 1 ›

Presentation

December 3, 2020

MRCT Center 2020 Annual Meeting Slides Part 2 ›

Webinar

November 30, 2020

Heterogeneity of Treatment Effects in Clinical Trials: Methods and Innovations ›

Publication

November 19, 2020

Committing to diversity, equity and inclusion: A call to action for clinical trials ›

Webinar

November 18, 2020

MRCT Center Leaning In webinar: Study Design, Eligibility, Site Selection & Feasibility ›

Webinar

November 10, 2020

PRIM&R WEBINAR: “THE IRB’S ROLE IN ACHIEVING DIVERSITY IN RESEARCH” ›

Presentation

November 5, 2020

Achieving Diversity, Inclusion, Equity In Clinical Research: McKinsey Regulatory Affairs Leaders’ Roundtable ›

Webinar

October 28, 2020

MRCT Center Leaning In webinar: Workforce Development ›

Presentation

October 20, 2020

The Roles and Responsibilities of the IRB in Addressing Diversity in Clinical Research ›

Webinar

October 19, 2020

Ropes & Gray webinar: “Achieving Diversity, Inclusion, & Equity in Clinical Research” ›

Webinar

October 14, 2020

MRCT Center Leaning In webinar: Community Awareness, Access, Knowledge ›

Webinar

October 14, 2020

MRCT Center Leaning In Webinar Series ›

Publication

September 29, 2020

Emerging work on Diversity & Clinical Trials: A Spotlight on the MRCT ›

Presentation

September 23, 2020

The Way Forward: From ‘diagnosis’ to ‘treatment’ of COVID-19 ›

Presentation

September 22, 2020

Achieving Diversity, Inclusion, and Equity In Clinical Research ›

Publication

September 8, 2020

Biopharmas Must Address The Reality Of Racial Disparities In Health Outcomes Exposed By Covid-19 ›

Podcast

August 25, 2020

Dr. Bierer discusses Diversity in Clinical Research on the Clinical Trials Guru podcast ›

Podcast

August 20, 2020

Dr. Bierer is a guest on the Clinical Research Podcast with ECRG Media ›

Podcast

August 14, 2020

Dr. Barbara Bierer is a guest on the Sree Sreenivasan Daily, Global Show podcast ›

Principles

August 6, 2020

Achieving Diversity, Inclusion, and Equity in Clinical Research ›

Tools

August 2, 2020

Diversity, Inclusion, and Equity in Clinical Research: Guidance Toolkit & User Guide: Stakeholder Commitments and the Future ›

Framework

August 1, 2020

Action for Change: Diversity, Inclusion, and Equity in Clinical Research. ›

Framework

August 1, 2020

Diversity, Inclusion, and Equity In Clinical Research: Diversity Principles And Suppositions ›

Framework

August 1, 2020

Defining Diversity ›

Tools

August 1, 2020

Diversity, Inclusion, and Equity in Clinical Research: Guidance Toolkit & User Guide: Participant Awareness, Knowledge, and Access ›

Tools

August 1, 2020

Diversity, Inclusion, and Equity in Clinical Research: Guidance Toolkit & User Guide: Data Variables and Collection ›

Tools

August 1, 2020

Diversity, Inclusion, and Equity in Clinical Research: Guidance Toolkit & User Guide: Workforce and Diversity: Training and Development ›

Tools

August 1, 2020

Diversity, Inclusion, and Equity in Clinical Research: Guidance Toolkit & User Guide: Participant and Community Engagement ›

Tools

August 1, 2020

Diversity, Inclusion, and Equity in Clinical Research: Guidance Toolkit & User Guide: Introduction ›

Case Study

August 1, 2020

Diversity, Inclusion, and Equity in Clinical Research Case Study: PCSK9 ›

Case Study

August 1, 2020

Diversity, Inclusion, and Equity in Clinical Research Case Study: Omapatrilat ›

Case Study

August 1, 2020

Diversity, Inclusion, and Equity in Clinical Research Case Study: Clopidogrel ›

Case Study

August 1, 2020

Diversity, Inclusion, and Equity in Clinical Research Case Study: Bucindolol ›

Case Study

August 1, 2020

Diversity, Inclusion, and Equity in Clinical Research Case Study: Multiple Sclerosis Research Mythbusting Series ›

Case Study

August 1, 2020

Diversity, Inclusion, and Equity in Clinical Research Case Study: Embedding Diversity & Inclusion Within a Pharmaceutical Company ›

Case Study

August 1, 2020

Diversity, Inclusion, and Equity in Clinical Research Case Study: Diverse Recruitment at Yale Center for Clinical Investigation ›

Case Study

August 1, 2020

Diversity, Inclusion, and Equity in Clinical Research Case Study: Diverse Patient Engagement at a Pharmaceutical Company ›

Case Study

August 1, 2020

Diversity, Inclusion, and Equity in Clinical Research Case Study: Data-driven Diversity Assessments at a Medical Device Company ›

Case Study

August 1, 2020

Diversity, Inclusion, and Equity in Clinical Research Case Study: All of Us Research Program ›

Case Study

August 1, 2020

Diversity, Inclusion, and Equity in Clinical Research Case Study: Achieving and Exceeding Clinical Trial Participant Diversity Targets ›

Tools

August 1, 2020

Diversity, Inclusion, and Equity in Clinical Research: Guidance Toolkit & User Guide: Study Design, Conduct and Implementation ›

Guidance
Tools

August 1, 2020

MRCT Center Diversity, Inclusion, and Equity in Clinical Research Guidance Document and Toolkit ›

Public Comments

June 29, 2020

Response To FDA’s Request For Comments On Strategic Priorities For The Office Of Minority Health And Health Equity (OMHHE) ›

Presentation

June 8, 2020

Diverse representation and inclusion in clinical research: Justification, opportunities, and solutions ›

Tools

June 1, 2020

Diversity, Inclusion, and Equity in Clinical Research: An IRB Resource for Investigators and Research Teams: Including the Community Voice in Clinical Research ›

Publication

January 2, 2020

Committing to the Inclusion of Diverse Populations in Clinical Research ›

Annual Report

December 4, 2019

2019 MRCT Center Impact Report ›

Principles

November 1, 2019

Diverse Representation and Inclusion in Clinical Research Principles ›

Presentation

October 29, 2019

Evolving science in clinical trials in special populations ›

Tools

October 29, 2019

Diversity, Inclusion, and Equity in Clinical Research: Integrating Considerations for Diversity, Equity, and Inclusion (DEI) into a Recruitment Strategy Document ›

Tools

October 29, 2019

Diversity, Inclusion, and Equity in Clinical Research: An IRB Resource for Investigators and Research Teams– Practical Points to Consider: Payment to Research Participants ›

Presentation

October 8, 2019

Efficiencies in Clinical Research: A USA perspective ›

Presentation

October 5, 2019

An investigator perspective Data sharing in trials: Should all trials share all their data? ›

Presentation

October 3, 2019

A USA perspective on diversity and inclusion ›

Tools

October 2, 2019

Diversity, Inclusion, and Equity in Clinical Research: A Resource for HRPPs: Planning a Strategy to Address Diversity, Equity, and Inclusion ›

Public Comments

July 30, 2019

Enhancing the Diversity of Clinical Trial Populations – Comments to FDA ›

Public Comments

January 17, 2019

Comments on US Department of Health & Human Services Healthy People 2030 Objectives ›

Other

December 5, 2018

Representation of Diverse Populations in Clinical Trials Info Sheet ›

Annual Report

December 5, 2018

2018 MRCT Center Impact Report ›

Presentation

November 15, 2018

Does Diversity Matter in the Conduct of a Clinical Trial? ›

Project-Specific Website

CLINICAL TRIALS & RESEARCH