Released: January 9, 2025
Developed by: Joint Task Force for Clinical Trial Competency (JTF), Maroof International Hospital, National University of Medical Sciences (NUMS), Munaza Jamil of McMaster University
Date: June 24, 2025
Abstract
As part of the MRCT Center’s AI and Ethical Research project, the Framework for Review of Clinical Research Involving AI was co-developed by the MRCT Center and WCG, in collaboration with a diverse, multi-stakeholder task force.
This resource offers institutional review boards (IRBs) and other oversight entities a structured, practical approach to evaluating protocols that involve artificial intelligence in research with human participants. The framework addresses emerging ethical and regulatory challenges specific to AI—such as algorithmic bias, adaptive learning, data identifiability, and the need for human oversight—while aligning with foundational ethical principles and applicable U.S. regulations. Through tools including a decision tree for regulatory applicability, developmental stage-specific review guidance, and targeted ethical considerations, the framework supports consistent, thorough review processes that protect participants and promote the responsible use of AI in clinical research.
Date: April 25, 2025
The Post-Trial, Continued Access Responsibilities to Investigational Significant-Risk Device Framework: Scenarios that Require Further Consideration outlines five key milestones, specific scenarios, and considerations to support organizations in making equitable and transparent decisions regarding continued access to investigational significant-risk devices. A companion framework addressing investigational medicines is also available. Both frameworks are intended to be used alongside the Principles of Post-Trial Responsibilities – Continued Access, a set of 12 foundational principles that define the shared obligations of stakeholders in ensuring appropriate post-trial, continued access.
To learn more about the Post-Trial Responsibilities – Continued Access, click here.
Date: November 13, 2024
The Post-trial, Continued Access Responsibilities to Investigational Medicines Framework: Scenarios that Require Further Consideration comprise 5 milestones, specific scenarios, and considerations that organizations can utilize to make equitable and fair decisions related to continued access to an investigational medicine. A framework for investigational significant risk devices is also available. The frameworks are designed to be used in coordination with the Principles of Post-Trial Responsibilities, a set of 12 grounding principles that identify the shared responsibilities of post-trial, continued access.
Released in: August 2024
Developed by: Joint Task Force for Clinical Trial Competency (JTF), Roche Portugal, and Agency for Clinical Research and Biomedical Innovation (AICIB).
Presented on: May 6, 2024
Racial and ethnic minorities comprise a significant portion of the U.S. population, yet their representation in clinical trials remains disproportionately low. Addressing this disparity is crucial for equitable healthcare outcomes. Despite recent legislative efforts to improve diversity in clinical trials, and many individual organizational efforts, a national plan to include diverse patients does not exist.
The Clinical Trials Transformation Initiative (CTTI), Milken Institute’s FasterCures, and the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center), and the National Academies Forum on Drug Discovery, Development, and Translation coordinated a series of three convenings (June, September, and November 2023) to inform the publication of a National Action Plan to increase diversity in clinical trials. This national action, which includes eight domains and action steps intended to drive system-wide collective action, is now available here.
Please note, the 4th [hybrid] meeting in this series, entitled “Toward a Framework to Improve Diversity and Inclusion in Clinical Trials,” will be hosted by NASEM in Washington DC on May 20. You can find out more information and register here. This workshop will build on the National Action Plan. We will be focusing on commitment to strategies for equitable participation and innovative trial design to support community investment, engagement, and workforce development.
Released in: April 2024
Developed by: Joint Task Force for Clinical Trial Competency (JTF), National Center for Health Research (NCHR) Ministry of Health and Prevention United Arab Emirates, Phoenix Clinical Research, Lebanese American University, and Sanofi.
Released in: October 2023
Developed by: Joint Task Force for Clinical Trial Competency (JTF), Comprehensive and Integrative Medicine Institute (CIMI), Medical Statistics and Informatics, Daegu Catholic University Medical Center (MSI, DCUMC)
Developed on: July 2023
Developed by: Joint Task Force for Clinical Trial Competency, MRCT Center, Xunyuan, School of Public Health: Capital Medical University, Beijing Tiatan Hospital: Capital Medical University.
