Released on: March 27, 2023
Description: This case study demonstrates how an industry sponsor operationalized returning routine laboratory results to participants during an ongoing, multi-site clinical trial.
Related Resources:
IRR Roadmap by Role.
Released on: March 27, 2023
Description: This case details the experience of a research team returning secondary findings to participants in a genetic testing study.
Related Resources:
IRR Roadmap by Role.
Comments provided on: December 20, 2022
Comments provided to: Food and Drug Administration re: Docket No. FDA-2022-D-0738
Achieving Diversity, Inclusion, and Equity in Clinical Research A link to the guidance document: https://mrctcenter.org/diversity-in-clinical-research/
The Joint Task Force for Clinical Trial Competency (JTF) is an international team of investigators, educators and clinical research professionals that has developed a framework that defines the knowledge, skills and attitudes necessary for conducting safe, ethical and high-quality clinical research.
Published on: December, 2018
Published in: Journal of Clinical and Translational Science
Presented on: March 21, 2023
Presented at: MRCT Center Webinar series, Advancing International Pediatric Clinical Research: Time to Listen—Hearing from young people in clinical research
Description: Dr. Gianna “Gigi” McMillan, an academic bioethicist and MRCT Center pediatrics project member, recorded in-depth interviews with three young people from India, Spain, and the US to create this 2-part video series, Time to Listen.
Part 2: Young people respond after watching adults discuss the goal of elevating their perspective at an international webinar.
Themes:
Date: March 21, 2023
A “how-to” video to support the Including Young People in Clinical Research toolkit. These tools, checklists, and considerations are offered to assist investigators, Institutional Review Boards (IRBs), Ethics Committees (ECs), sponsors, and those working with children and adolescents to engage youth respectfully and thoughtfully.
