Ensuring equitable access to clinical trials is a shared responsibility. In practice, a broad scope exists to operationalize these commitments and improve the inclusion of people with disabilities. Standardized measures to track the participation of people with disabilities in clinical trials have not been agreed to by clinical research stakeholders nor included in study data collection templates. However, the language used in eligibility criteria often excludes people with disabilities without justification. This is striking given that there are 1 billion people globally, including 240 million children, with a disability. People with disabilities comprise the largest minority group in the U.S., where 1 in 4 (and 1 in 3 Black and Hispanic) adults report a disability. Most of us will experience a disability and care for a loved one with a disability during our lifetime.
As part of this shared responsibility, the Multi-Regional Clinical Trials Center has convened a working group on the inclusion of people with disabilities in clinical research. This working group, inclusive of people with disabilities and disability rights advocates, seeks to bring forward (in multiple fora) key issues impacting clinical research participation that have been identified by people in the disability community. The MRCT Center has also developed, in collaboration with people with disabilities, caregivers, disability rights advocates, and stakeholders working in clinical research, the Accessibility by Design (AbD) in Clinical Research Toolkit. The AbD Toolkit complements existing resources for audiences in clinical care and international health by collating broadly applicable guidance and incorporating specificity appropriate to the clinical research community. It provides key points and tools in five themes: Planning for AbD (General Considerations), Implementing AbD (Communication Accessibility), Implementing AbD (Physical Accessibility), Innovating AbD (Newer Strategies for Inclusion), and Upholding AbD (Accountability and Advocacy). Together we can make accessible research design and thoughtful consideration of accommodations a routine part of research planning and conduct.
Related Assets
- Accessibility 101 Training Series
- Webinar: Accessibility 101: How to Write Alt-Text and Map Participant Journeys
- MRCT Center Comment on Cancer Clinical Trial Eligibility Criteria: Performance Status
- MRCT Center Comment on Declaration of Helsinki Public Comment Period Two (see sections on vulnerable populations and on informed consent)
- MRCT Center 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
- MRCT Center 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
- MRCT Center Comments and Suggestions on Updating the NIH Mission Statement
- Enhancing diversity of clinical trial populations in multiple sclerosis
- Guest Blog: New Tools to Support Inclusion of People with Disabilities in Clinical Research
- Accessibility by Design (AbD) in Clinical Research Toolkit
- Accessibility by Design (AbD) Toolkit Release Webinar
- Integrating Supported Decision-Making into the Clinical Research Process
- Supported decision-making can advance clinical research participation for people with disabilities
- Excluding People with Disabilities from Clinical Research: Eligibility Criteria Lack Clarity and Justification
- Externalist, Process-Based Approach to Supported Decision-Making
- MRCT Center Comment on Nondiscrimination in Health Programs and Activities Proposed Rule Section 1557 of the Affordable Care Act
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
- Dr. Willyanne DeCormier Plosky (she/her/hers), Program Director, MRCT Center
Workgroup members
- Leslie P. Francis, Alfred C. Emery Professor of Law, Professor of Philosophy, and Adjunct Professor in Family and Preventive Medicine, Internal Medicine, and Political Science, University of Utah
- Ari Ne’eman, Assistant Professor of Health Policy and Management, Harvard School of Public Health; Co-Founder of the Autistic SelfAdvocacy Network
- Benjamin C. Silverman, Senior IRB Chair, Mass General Brigham; Instructor in Psychology, Harvard Medical School
- Michael Ashley Stein, Visiting Professor of Law, Harvard Law School; Co-founder and Executive Director of the Harvard Law School Project on Disability
- David H. Strauss, Associate Professor of Psychiatry, Columbia University Medical Center
Reviewers (Abd Toolkit)
- Mary Butterworth, Chief Executive Officer, Developmental Disability WA
- Ann Connor, Director of Research Operations in Neurology, Beth Israel Deaconess Medical Center; President, New England Chapter International Association of Clinical Research Nurses
- Jenny Downs, Principal Research Fellow, Head of the Development and Disability Research Program and Head of the Child Disability Team, Telethon Kids Institute, Perth, Australia; Adjunct Associate Professor, Centre for Child Health Research, The University of Western Australia
- Matthew Dwyer, Directeur RSE (Corporate Social Responsibility), Co-Chair EnAble Employee Resource Group, Eli Lilly and Company
- Leslie P. Francis, Alfred C. Emery Professor of Law, Professor of Philosophy, and Adjunct Professor in Family and Preventive Medicine, Internal Medicine, and Political Science, University of Utah. *Author of AbD toolkit Tool D.II: “Legal, regulatory, and guidance elements of which to be aware for supported decision-making”
- Nora Groce, Professor, Cheshire Chair of Disability and Inclusive Development, and Director of the International Disability Research Centre, University College London
- Cecile González-Cerimele, Senior Director, Diversity & Inclusion in Clinical Trials, Eli Lilly and Company
- Alicia Gorman, PhD Candidate, School of Allied Health, Curtin University (Western Australia); Principal Speech Pathologist, Younique Therapy
- Rebecca Langbein, Universal and Inclusive Design Consultant, Disability Solutions
- Katherine McDonald, Associate Dean of Research and Professor of Public Health, Falk College, Syracuse University; Chair, Institutional Review Board (IRB), Syracuse University
- Duke Morrow, Community Member, Institutional Review Board, University of Michigan
- Ari Ne’eman, PhD Candidate in Health Policy, Harvard University; Co-Founder of the Autistic SelfAdvocacy Network
- Maya Sabatello, Associate Professor of Medical Sciences, and Co-Director, Precision Medicine: Ethics, Politics and Culture Project, Center for Precision Medicine and Genomics, Department of Medicine and Division of Ethics, Department of Medical Humanities and Ethics, Columbia University
- Ariel Schwartz, Assistant Research Professor and Director of the UNH-4U Program, University of New Hampshire Institute on Disability
- Victoria Shepherd, Senior Research Fellow (Nurse), Centre for Trials Research, Cardiff University
- Benjamin C. Silverman, Senior IRB Chair, Mass General Brigham; Instructor in Psychology, Harvard Medical School
- Rachel Skoss, Senior Research Fellow, University of Notre Dame Australia; Past Chair of the Ministerial Advisory Council on Disability (WA)
- Michael Ashley Stein, Visiting Professor of Law, Harvard Law School; Co-founder and Executive Director of the Harvard Law School Project on Disability
- David H. Strauss, Associate Professor of Psychiatry, Columbia University Medical Center
- Courtney Wooden, Associate, EERP (MIH) Rotational Program (Design Hub Patient & Site Experience, Diversity, and Inclusion in Clinical Trials), Eli Lilly and Company
