Presented on: March 27, 2023
Description: This case study describes how an IRB navigated returning results of a new COVID-19 assay from a non-CLIA-certified lab during a public health emergency.
Related Resources:
Link to IRR Roadmap by Role.
Date: April 5, 2023
A discussion about the MRCT Center’s collaboration with CDISC to promote the MRCT Center’s Clinical Research Glossary, a freely available plain language glossary of commonly used clinical research terms developed with and for patients and their caregivers, as a global research standard.
Learn about the MRCT Center’s robust process of developing the plain language glossary, the CDISC public review process, and how this collaboration will empower patients and participants with the necessary tools and information to make informed research decisions.
Related Resources:
Presentation Slides
Audience Q&A
Speaker Bios
Link to Public Review Website
Helpful Video Tutorial about how to submit a Public Comment
Link to a Public Review Outreach Template
Date: May 4th, 2023
Description: Learn about the Accessibility by Design (AbD) in Clinical Research Toolkit, developed by the MRCT Center in collaboration with people with disabilities, caregivers, allies, disability rights advocates, and stakeholders working in clinical research.
We present the background, structure, and key themes of the AbD Toolkit. Invited speakers then discuss their experiences as participants, caregivers, and leaders in clinical research and how the AbD Toolkit may be utilized to facilitate change.
Related Resources:
Accessibility by Design (AbD) Toolkit
Integrating Supported Decision-Making into the Clinical Research Process (Publication)
MRCT Center Diversity, Inclusion, and Equity in Clinical Research Guidance Document and Toolkit
Equity by Design in Clinical Research: The EbD Metrics Framework (FRAMEWORK)
Released on: November 2019
Developed by: MRCT Center Post-Trial Responsibilities Workgroup
Released on: August 6, 2020
Developed by: MRCT Center Post-Trial Responsibilities Workgroup
Released on: October 2019
Developed by: MRCT Center Post-Trial Responsibilities Workgroup
Presented on: May 2023
Presented at: 2023 Annual AAHRPP Conference
The MRCT Center has developed a set of practical diversity, equity, and inclusion (DEI) tools for IRBs and HRPPs, designed to improve the involvement of underrepresented populations in clinical research. In 2021, a task force of 28 IRB and HRPP professionals, convened by the MRCT Center, created 15 DEI tools. The tools underwent rigorous review and revision during nine months of monthly meetings and additional correspondence.
Three highlighted tools in the poster include:
Hayat Ahmed, MS, Program Manager at the MRCT, showcased this poster at the Annual AAHRPP conference in May 2023. Conference participants awarded Ms. Ahmed the distinguished poster prize.
Comments provided on: January 17, 2019
Comments provided to: U.S. Department of Health and Human Services (HHS), Washington, DC,
May 4, 2023
The Accessibility by Design (AbD) in Clinical Research Toolkit is now available here. The AbD toolkit was developed with people with disabilities, caregivers, allies, disability rights advocates, and stakeholders in clinical research.
On May 4th, the MRCT Center held a webinar in which Dr. Willyanne DeCormier Plosky presented the background, structure, and key themes of the AbD Toolkit. Invited speaker Cecile González-Cerimele shared lessons learned as a family caregiver during clinical trials, a leader in the planning and conducting of clinical research, and a member of the EnAble employee resource group at Eli Lilly. Duke Morrow could not attend but shared, via moderator Dr. Barbara Bierer, his lived experience as a person with a disability, trial participant, and [community] IRB member. “Any researcher must put aside any knowledge they have learned academically and accept the lived experience of the participants.”
The MRCT Center welcomes your feedback on the AbD Toolkit. Please send suggestions, additional tools and resources, and concerns to mrct@bwh.harvard.edu. We look forward to continuing to work together with people with disabilities, their allies, study teams, sites, and sponsors to further the inclusion of people with disabilities in clinical research.
