Publication
Published on: October 28, 2021
Published in: American Journal of Bioethics
Integrating Supported Decision-Making into the Clinical Research Process
Focus Area: Clinical Trials & Research
IRR: Implementing a Robust, Scalable Participant Data Return Solution
Case Study
Released on: March 27, 2023
Description: This case study outlines how an industry sponsor designed an initiative to return clinical trial data to participants.
IRR: Supporting Participant Decision-Making in Genetic Testing Studies
Case Study
Released on: March 27, 2023
Description: This case study shares an example of how one institution created an educational tool to support decision-making for potential participants in a genetic testing study.
Related Resources:
IRR Roadmap by Role.
IRR: Returning Routine Lab Results to Participants During a Clinical Trial
Case Study
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.
IRR: Responsibly Returning Secondary Findings
Case Study
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.
Post-Trial Responsibilities: Continued Access to an Investigational Medicine
Principles
Released on: December 7, 2017
Developed by: MRCT Center Post-Trial Responsibilities Workgroup
Post-Trial Responsibilities to Research Participants
Presentation
Presented on: June 20, 2017
Presented at: DIA 2017 Global Annual Meeting in Chicago, IL
MRCT Center Post-Trial Responsibilities Definitions
Ethical Considerations for Clinical Investigations of Medical Products involving Children: Guidance for Industry, Sponsors, and IRBs
Public Comment
Comments provided on: December 20, 2022
Comments provided to: Food and Drug Administration re: Docket No. FDA-2022-D-0738
Promoting Global Clinical Research in Children
Presentation
Presented on: October 14, 2019
Presented at: 2019 Annual Meeting of the members and Coordinating Group of the European network of paediatric research at the EMA (Enpr-EMA) in Amsterdam