Diversity, Inclusion, and Equity in Clinical Research: Diversity & Inclusion Overlay: NIH-FDA Phase 2 and 3 IND/IDE Clinical Trial Protocol Template

Tools

Developed on: June 2022

Developed by: MRCT Center Diversity Workgroup

Related Resources

Procedural & Logistical Checklist

An IRB Resource for Participants: Costs and Payments

An IRB Resource for Investigators and Research Teams– Practical Points to Consider: Payment to Research Participants

An IRB Resource for Investigators and Research Teams: Including the Community Voice in Clinical Research

Incorporating DEI into Clinical Research Protocol Templates

Diversity & Inclusion Overlay: TransCelerate’s Common Protocol Template

Integrating Considerations for Diversity, Equity, and Inclusion (DEI) into a Recruitment Strategy Document 

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

IRB Resources

MRCT Post-Trial Responsibilities Toolkit Version 1.1

Released on: December 6, 2017

Developed by: MRCT Center Post-Trial Responsibilities Workgroup

Including Young People in Research

Tools

Published on: March 21, 2023

Description: The “Including Young People in Research” toolkit offers tools, checklists, and considerations to support the intentional inclusion of the youth perspective in pediatric clinical trials and product development. These materials can assist investigators, Institutional Review Boards (IRBs)/Ethics Committees (ECs), sponsors, and others working with children and adolescents to engage youth respectfully and thoughtfully, helping to ensure that their perspectives are valued, gathered, appropriately weighted, and integrated. We expect that individuals will adapt these tools to their local context and specific study needs. We invite you to watch our short companion video for additional details on how to use and adapt these tools.

Tools, checklists, and considerations to assist investigators, Institutional Review Boards (IRBs), Ethics Committees (ECs), sponsors, and those working with children and adolescents to thoughtfully engage youth and ensure their perspectives are valued, weighted, and integrated.

Including Young People in Clinical Research – PDF

Including Young People in Clinical Research – A “How-to” Guide

Related Resources

Promoting Global Clinical Research in Children: Informing the Future (webinar)

Promoting Global Clinical Research in Children: Informing the Future (presentation slides)

Guiding Principles for Protecting Children in and through Pediatric Clinical Research

Advancing International Pediatric Clinical Research webinar series

Pediatric Research Information Materials

Prioritizing Young People’s Voices in Clinical Research – Part 1 (video)

Prioritizing Young People’s Voices in Clinical Research – Part 2 (video)

Prioritizing Young People’s Voices in Clinical Research – Part 3 (video)

Time to Listen: Hearing from Young People in Clinical Research – Part 1  (video)

Time to Listen: Hearing from Young People in Clinical Research – Part 2  (video)

Data Contributor Agreement Word Document

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Data Use Agreement Word Document

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