Resources

• Case Study
• Tools

LGBTQIA+ Inclusion – Inclusive Imagery

• Tools

LGBTQIA+ Inclusion – Inclusive Language Checklist

• Tools

Site Feasibility Decision Tree from the LGBTQIA+ Perspective

• Tools

Exit Survey Inclusive of the LGBTQIA+ Perspective

• Tools

Sexual Orientation and Gender Identity (SOGI) Data Collection Checklist

• Tools

LGBTQIA+ Inclusion by Design in Clinical Research Toolkit

• Tools

Sexual Orientation and Gender Identity (SOGI) Data Privacy Checklist

• Podcast

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

• Publication

Assessing Federal Policies to Reduce Economic Barriers to Clinical Trial Enrollment

• Publication

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

• Publication

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

• Publication

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

• Publication

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

• Guidance

Embedding Ethical Considerations Relating to Global Representation

• Guidance

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

• Public Comments

Draft Guidance: Study of Sex Differences in the Clinical Evaluations of Medical Products; Guidance for Industry

• Webinar

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

• Podcast

Podcast Episode 2: Trials Beyond Borders

• Tools

Participant Questionnaire from the LGBTQIA+ Perspective

• Publication

Towards A National Action Plan To Improve Representation In Clinical Trials

• Webinar

Health Literacy Month Webinar Series

• Webinar

Designing PowerPoint Presentations to Support Health Literacy and Accessibility

• Training

Accessibility 101 Training Series

• Public Comments

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

• Public Comments

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

• Tools

Global Representation Roadmap

• Tools

Model Diversity Action Plan (DAP)

• Podcast

Podcast Episode 1: Trials Beyond Borders

• Publication

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

• Public Comments

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

• Public Comments

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

• Webinar

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

• Public Comments

Comments Submitted: Cancer Clinical Trial Eligibility Criteria: Performance Status

• Public Comments

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

• Public Comments

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

• Webinar

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

• Publication

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

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

• Framework

Toward a National Action Plan for Achieving Diversity in Clinical Trials

• Public Comments

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

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

• Webinar

REACH: Advancing DEI in Human Participant Research

• Public Comments

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

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

Comment on the American Community Survey SOGI Test

• Public Comments

Comments and Suggestions on Updating the NIH Mission Statement

• Publication

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

• Publication

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

• Publication

Enhancing diversity of clinical trial populations in multiple sclerosis

• Publication

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

• Flyer
• Publication

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

• Webinar

Accessibility by Design (AbD) Toolkit Release

• Tools

Accessibility by Design (AbD) Toolkit

• Publication

Data visualization explorer: A tool for participant representation

• Annual Report

2022 MRCT Center Annual Report

• Proceedings

MRCT Center 2022 Annual Meeting Proceedings

• MRCT Sponsor Resource
• Presentation

MRCT Center 2022 Annual Meeting Slides

• Publication

Protecting the Vulnerable and Including the Under-Represented

• Publication

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

• Publication

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

• Public Comments

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

• Tools

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

Externalist, Process-Based Approach to Supported Decision-Making

• Webinar

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

Equitable Practices for Children’s Vision Research

• Publication

Implementing expanded COVID-19 testing in Massachusetts community health centers

• Video
• Webinar

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

• Webinar

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

• Presentation

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

• Webinar

Launch of Online Health Literacy Training For IRB Members and Staff

• Presentation

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

• Tools

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

• Tools

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

• Tools

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

• Tools

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

• Tools

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

• Tools

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

• Tools

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

• Publication

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

• Tools

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

• Framework

Equity by Design in Clinical Research: The EbD Metrics Framework

• Tools

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

• Tools

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

• Tools

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

• Tools

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

• Tools

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

• Public Comments

Diversity Plans to Improve Enrollment of Participants From Underrepresented Populations

• Training

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

• Publication

IRBs and the Protection-Inclusion Dilemma: Finding a Balance

• Publication

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

• Publication

Advancing the Inclusion of Underrepresented Women in Clinical Research

• Publication

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

• Publication

Promoting Equity By Design In Cancer Trials

• Annual Report

2021 MRCT Center Impact Report

• Publication

Integrating Supported Decision-Making into the Clinical Research Process

• Publication

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

• Publication

Fair payment and just benefits to enhance diversity in clinical research

• Webinar

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

• Webinar

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

• Webinar

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

• Webinar

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

• Presentation

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

• Webinar

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

• Webinar

MRCT Center Leaning In webinar: Stakeholder Roles and Responsibilities

• Webinar

MRCT Center Leaning In webinar: Data Standards and Analysis

• Annual Report

2020 MRCT Center Impact Report

• Webinar

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

• Proceedings

MRCT Center 2020 Annual Meeting Proceedings

• Presentation

MRCT Center 2020 Annual Meeting Slides Part 1

• Presentation

MRCT Center 2020 Annual Meeting Slides Part 2

• Webinar

Heterogeneity of Treatment Effects in Clinical Trials: Methods and Innovations

• Publication

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

• Webinar

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

• Webinar

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

• Presentation

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

• Webinar

MRCT Center Leaning In webinar: Workforce Development

• Presentation

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

• Webinar

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

• Webinar

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

• Webinar

MRCT Center Leaning In Webinar Series

• Publication

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

• Presentation

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

• Presentation

Achieving Diversity, Inclusion, and Equity In Clinical Research

• Publication

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

• Podcast

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

• Podcast

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

• Podcast

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

• Principles

Achieving Diversity, Inclusion, and Equity in Clinical Research

• Tools

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

• Framework

Defining Diversity

• Tools

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

• Case Study

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

• Tools

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

• Case Study

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

• Tools

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

• Case Study

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

• Case Study

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

• Case Study

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

• Guidance
• Tools

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

• Case Study

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

• Case Study

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

• Case Study

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

• Framework

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

• Case Study

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

• Tools

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

• Framework

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

• Tools

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

• Case Study

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

• Tools

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

• Case Study

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