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Evaluation View Video

2025 PRIM&R Annual Conference

Foundations of Research Ethics and Oversight

IRB Operations and Management

Regulatory Frameworks and Compliance

D04 - Inclusive Informed Consent: Engaging People with Disabilities in Research Participation

Saturday, November 8, 2025
10:30 AM - 11:45 AM ET
Location: Ballroom I
Human Subject Research - HSR Learning Lab Series Call for Session Proposal - CSP Live Streamed Session Live Session Recorded CIP Accredited
CLICK HERE to view captioning for this session! 

People with disabilities (PWDs) remain significantly underrepresented in clinical research, often due to systemic barriers in the informed consent process and a lack of reasonable accommodations. This session will explore the regulatory requirements and flexibilities within the Common Rule that can support inclusive, accessible informed consent practices for individuals with physical or cognitive disabilities. It will also highlight key findings and recommendations from the National Council on Disability’s August 2024 report, which outlines actionable steps for healthcare practitioners, study teams, institutions, and federal agencies to reduce bias, improve accessibility, and ensure the meaningful participation of PWDs in clinical trials. Attendees will gain practical strategies for enhancing inclusion through improved consent processes and institutional practices.

Learning Objectives:

  • Describe key components and regulatory flexibilities in the Common Rule that facilitate effective informed consent, and analyze insights from the National Council on Disabilitys 2024 report on the exclusion of people with disabilities from clinical trials
  • Identify best practices and practical strategies for providing reasonable accommodations in the informed consent process for participants with physical disabilities, and summarize key recommendations from the National Council on Disability to promote inclusive trial participation
  • Discuss strategies for assessing and supporting cognitive capacity to consent, including the use of supported decision-making, and examine how researchers, IRBs, and funders can implement NCD recommendations to enhance inclusion of people with disabilities in clinical trials