English Archives

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.

View Tools

View Video Resource

Including Young People in Clinical Research – PDF

2023-12-07 Peds Toolkit v4.1 (1)

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)

Advancing International Pediatric Clinical Research: Promoting Global Clinical Research in Children: Informing the Future

Webinar

Presented on: March 21, 2023

The fifth and final part of the FDA-supported virtual conference series on Advancing International Pediatric Clinical Research showcased select resources and materials from the larger body of work developed by the MRCT Center pediatric working group initiative, including highlights from the four prior webinars in this series.

View Video

Pediatric Video Series

The MRCT Center presented a five-part virtual conference series, Advancing International Pediatric Clinical Research, to advance the design, review, oversight, and conduct of global pediatric clinical trials. These videos, shared in the webinars, were produced in collaboration with the International Children’s Advisory Network (iCAN.)

Prioritizing Young People in Research

iCAN, in collaboration with the MRCT Center, produced a three-part video series that showcases young people from around the globe who have been involved in medical care and clinical research. The youth in the videos share some their thoughts on various aspects of what is important about including and listening to young people in clinical research.

Prioritizing Young People’s Voices in Clinical Research Part 1

Prioritizing Young People’s Voices in Clinical Research Part 2

Prioritizing Young People’s Voices in Clinical Research Part 3

Time to Listen

Dr. Gianna ‘Gigi’ McMillan, an academic bioethicist and member of the MRCT Center pediatrics project, recorded in-depth interviews with three young people from India, Spain, and the US to create this 2-part video series, Time to Listen. In part 1, young people share their experience in clinical research and best practice guidance on communicating and conveying information to children and adolescents. Part 2 shows young people’s responses after watching adults discuss the goal of elevating their perspective at an international webinar.