Accessibility by Design (AbD) Toolkit

Toolkit

Date: May 4th, 2023

Description: The Accessibility by Design (AbD) in Clinical Research Toolkit is a comprehensive resource intended to be used by sponsors, institutions, investigators, ethics committees/IRBs, participants, and patient advocacy groups to support greater inclusion of people with disabilities in clinical research. It was developed by the MRCT Center in collaboration with people with disabilities, family caregivers, allies, disability rights advocates, and stakeholders working in clinical research, and aligns with the MRCT Center’s Achieving Diversity, Inclusion, and Equity in Clinical Research Guidance Document and the Equity by Design in Clinical Research Metrics Framework.

Toolkit

Related Resources:
Accessibility by Design (AbD) Toolkit

Webinar Slides

Excluding People with Disabilities from Clinical Research: Eligibility Criteria Lack Clarity and Justification (Publication)

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

Integrating Supported Decision-Making into the Clinical Research Process (Publication)

MRCT Center Leaning In Webinar Series: Driving Inclusion in Clinical Research – June 9, 2021: Improving Inclusion of Persons with Disabilities in Clinical Research (WEBINAR)

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

Equity by Design in Clinical Research: The EbD Metrics Framework (FRAMEWORK)

Amplifying Participant Voices: Crafting Respectful, Inclusive, and Understandable Patient Materials

Webinar

Presented on: October 23, 2023

Learn how these panelists incorporate participant perspectives to craft patient-facing materials that are accessible, culturally competent, and easy to understand. Collecting feedback enhances engagement, empowers patients, improves communication, and addresses information gaps, paving the way for enriched participant experiences and improved health outcomes.

Additional Resources

MRCT Center Health Literacy Website
Health Literacy Resources for IRBs
Health Literacy Best Practices
Accessibility by Design Toolkit
MRCT Plain-Language Clinical Research Glossary
Including Young People in Clinical Research Toolkit
Webinar Panelist Bio Book

Returning Individual Research Results and Data: Digging Deeper into Genetic Results and Secondary Findings

Webinar

Presented on: September 21, 2023

Presented at: Virtual

The MRCT Center released a series of case studies describing research stakeholder experiences of returning individual results to participants at a recent webinar in May.  Given the interest and number of questions we received, we offered three virtual “Digging Deeper” sessions to foster additional discussion and learning about topics that can be challenging to navigate. 

This webinar was the third of the three webinars in the Digging Deeper series. Megan Frone of the National Cancer Institute discussed a case about returning genetic/genomic results and secondary findings.

Returning Individual Research Results & Data: Digging Deeper into Genetic Testing Secondary Findings webinar recording

Related Resources

ACMG/AMP Recommendations for Return of Secondary Findings
NASEM Returning Individual Research Results to Participants

Case Study: Responsibly Returning Secondary Findings
May 2, 2023 webinar: Returning Individual Research Results and Data to Participants
July 27, 2023 webinar: Digging Deeper into Pfizer’s Patient Data Return Solution
August 17, 2023: Digging Deeper into IRB/HRPP Responsibilities
Return of Individual Results website

Defining “recklessness” in research misconduct proceedings

Publication

Published on: September 5, 2023

Published in: Accountability in Research

Mark Barnes, co-faculty director of the MRCT Center and Partner at Ropes & Gray, colleagues Minal Caron and Sarah Dohan at Ropes & Gray, and Barbara Bierer addressed the definition of “recklessness” in research misconduct proceedings, reviewing its history and application, and proposing a framework and factors to consider in recklessness determinations.

Returning Individual Research Results and Data: Digging Deeper Webinar Series

Webinar Series

Presented on: July 27, August 17 and September 21, 2023

The MRCT Center released a series of case studies describing research stakeholder experiences of returning individual results to participants at a recent webinar.  Given the interest and number of questions we received, we offered three virtual “Digging Deeper” sessions to foster additional discussion and learning about topics that can be challenging to navigate.  

Returning of Individual Research Results and Data: Digging Deeper into IRB/HRPP Responsibilities

Webinar

Presented on: August 17, 2023

Presented at: Virtual

Related Resources

Case Study: IRB/HRPP Responsibilities
May 2, 2023 webinar: Returning Individual Research Results and Data to Participants
July 27, 2023 webinar: Digging Deeper into Pfizer’s Patient Data Return Solution
Return of Individual Results website