Focus Area: Clinical Trials & Research

Protecting the Vulnerable and Including the Under-Represented

Publication

Published on: December 7, 2022

Published in: Journal of Empirical Research on Human Research Ethics

Published recently in the Journal of Empirical Research on Human Research Ethics, Luke Gelinas, David Strauss, Hayat Ahmed, Barbara Bierer, and others co-authored an article entitled, “Protecting the Vulnerable and Including the Under-Represented: IRB Practices and Attitudes.”  A pilot national survey of IRB Chairs was conducted to assess attitudes and practices with regard to protecting the vulnerable and including under-represented groups in research.

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Advancing International Pediatric Clinical Research: Facilitating Pediatric Medicines Development

Webinar

Presented on: November 29 & 30, 2022

Presented at: Advancing International Pediatric Clinical Research webinar series: Facilitating Pediatric Medicines Development: Models of Global Cooperation

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Part One

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Part Two

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Related Resources

See related webinars, maintained on our website: 

Informing the Future from COVID-19 Lessons Learned 

Time To Listen: Hearing From Young People in Clinical Research

Assent and consent in the field: culture, context, and respect

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

Toolkit & Users Guide

Developed on: August 2020

Developed by: MRCT Center Diversity Workgroup

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Study Design Logic Model (PDF)
Study Design Logic Model (Editable PDF)
Study Design Key Performance Indicators (PDF)
Screen Failure Tracking Log (PDF)
Screen Failure Tracking Log (Word Doc)
Eligibility and Enrollment Log (PDF)
Eligibility and Enrollment Log (Word Doc)
Site Selection Logic Model (PDF)
Site Selection Logic Model (Editable PDF)
Site Selection Key Performance Indicators (PDF)
Feasibility Decision Tree (PDF)
Feasibility Questionnaire Modification Checklist (PDF)
Recruitment Strategy Document Template (PDF)
Recruitment Strategy Document Template (Word Doc)
Recruitment Strategy Logic Model (PDF)
Recruitment Strategy Logic Model (Editable PDF)
Recruitment Strategy Key Performance Indicators (PDF)
Recruitment Contingency Action Plan (PDF)
Participant Time Commitment Model (PDF)
Recruitment, Conduct, and Retention Logic Model (PDF)
Recruitment, Conduct, and Retention Logic Model (Editable PDF)
Recruitment, Conduct, and Retention Key Performance Indicators (PDF)

Related Resources

See related Resources, maintained on our project specific website:
Diversity, Inclusion, and Equity in Clinical Research

Introduction 

Participant and Community Engagement 

Participant Awareness, Knowledge, and Access

Workforce and Diversity: Training and Development 

Data Variables and Collection 

Stakeholder Commitments and the Future 

Institutions as an ethical locus of research prioritization

Publication

Released on: April 6, 2017

Published in: Journal of Medical Ethics

Ensuring that clinical trials, once launched, successfully complete and generate useful knowledge is an important and indeed ethically imperative goal, given the risks and burdens borne by research participants. Since there are insufficient willing research participants to power all the trials that are currently undertaken,1 addressing underenrolment will require prioritisation decisions that reduce the number of trials competing for participants. While there are multiple levels at which research priority-setting can and does take place, competition between trials often plays out in real time at the institutional or site level, where complex decisions must be made about how to manage overlapping trials in ways that balance different considerations, including the risk of non-completion. We sought to explore what research institutions in particular might ethically do to mitigate the risk that competition between trials will contribute to recruitment shortfalls.

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

Presentation

Released on: June 14, 2022

Published in: BIO International Convention, San Diego CA

Dr. Willyanne DeCormier Plosky, Program Manager at the MRCT Center, presented on this panel, which explored emerging principles and concrete strategies for addressing demographic disparities and achieving representativeness in clinical trials. The panel was organized and moderated by Lindsay Cobbs (BeiGene USA Inc.), and also included Melika Davis (BeiGene USA Inc.), Jacqueline Corrigan-Curay (FDA); Meg Alexander (Ovid Therapeutics Inc.), and Tesheia Johnson (Yale University) as speakers. See the recording here.

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

Presentation

Released on: June 14, 2022

Published in: BIO International Convention, San Diego CA

Dr. Willyanne DeCormier Plosky, Program Manager at the MRCT Center, presented on this panel, which was organized by the MRCT Center to discuss the origins, development, structure, and lessons learned from pilot testing of the Equity by Design (EbD) in Clinical Research Metrics Framework. The panel was moderated by Camelia Thompson (BIO), and also included Neha Londono (Seagen Inc.); and Inez Ruiz-White (Otsuka Pharmaceuticals) as speakers. See the recording here.

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