Integrating JTF Competencies: Curriculum Design and Accreditation at Arizona State University
Comprehensive leveling of the Clinical Research Professional Career Ladder at Johns Hopkins University
Results from a Delphi study on data management competencies
Expanding the Core Competency Framework to include patient, participant, and public engagement and partnership: Updates from the Patient Participant Project workgroup
The MRCT Center collaborates with the World Health Organization (WHO), the African Vaccine Regulatory Forum (AVAREF), and other local organizations to build capacity for National Ethics Committees (NECs) across Africa and worldwide. Our work aims to strengthen the ability to apply ethical principles to the review of research, harmonize the clinical trial application review process, and build a robust, competent, and efficient system for the ethics review of clinical research in African countries. In support of that effort, we are co-creating common tools, templates, and other resources for use by ethics committees across Africa and beyond. We aim to develop and deliver curricula to strengthen and improve the clinical research process.
The online, on-demand training course on Ethics and Review of Interventional Clinical Research course is now freely available on the WHO Academy platform. Development for the second course in the series, Ethics and Review of Interventional Clinical Research II, is ongoing and anticipated to be available in the fall of 2025.
In 2025, the MRCT Center joined the Africa Clinical Trial Regulatory and Ethics System Optimization project as a Core Project Team Member. In this role, the MRCT Center will lead system assessments using the WHO Global Benchmarking Tool for Ethics Committees, provide training and capacity building for NECs/Institutional Review Boards (IRBs), define and implement an IRB reliance approach, and develop a national accreditation program under the NEC. Additionally, the MRCT Center will work collaboratively with the group to create a model fee structure for NECs to enable them to charge differentiated and meaningful fees, develop a financial sustainability plan, and support the development of robust ethics systems that integrate effectively with national regulatory authorities. This work is being carried out in collaboration with AVAREF and is supported by funding from the Gates Foundation.
OBJECTIVES
Help ensure that regional, national, and local ethics committees (ECs) are guided by established international and national ethics guidelines.
Help conduct assessments and provide targeted improvements to NECs using the WHO’s benchmarking tool for ECs.
Contribute to the development of individual development plans (IDPs) following WHO-based assessments, to understand needs and opportunities of NECs and the systems of ethical review.
Utilizing IDPs to identify common needs and challenges, develop sharable resources and support.
KeY MILESTONES
February 2025: Kick-off meeting with core team for the Africa Clinical Trial Regulatory and Ethics System Optimization project
October 2024: Released online course “Ethics and Review of Interventional Clinical Research”
February 2024: Meetings in Rwanda and Zimbabwe to strengthen and sustain the clinical trial ecosystem in Africa
January 2024: Meetings in Ethiopia for assessment of clinical trial system
May 2023: Presented MRCT Center’s capacity building effort at AVAREF meeting in Cameroon
December 2022: Clinical Trial Optimization visit in Kenya and Nigeria
March/April 2022:Training for Ethics Review of Clinical Research: A Virtual Training Course for Africa- Part 2
September 2021: Training for Ethics Review of Clinical Research: A Virtual Training Course for Africa – Part 1
project Leadership & sTAFF
Barbara E. Bierer, MD, Faculty Director, MRCT Center
Sarah White, MPH, Executive Director, MRCT Center
Willyanne DeCormier Plosky, DrPH, Program Director, MRCT Center
Hayat Ahmed, MSc, Program Manager, MRCT Center
Lauren Otterman, MBHL, Project Manager, MRCT Center
The Convergence Project is pleased to invite you to an upcoming virtual event hosted by the MRCT Center, focused on workforce development strategies to support a more dynamic and competitive clinical research workforce.
This meeting will bring together community leaders, policymakers, and researchers to discuss how to create and support pathways into the clinical trial workforce (e.g., part-time degree programs, community colleges, fellowships). Key topics will include workforce development, targeted recruitment, and actionable steps to drive systemic improvements. You’ll have the opportunity to engage with panelists leading programs in Georgia, North Carolina, West Virginia, and other states across the country.
We hope you can join us for this important conversation. We look forward to your participation!
Developed by: MRCT Center, in collaboration with ICH, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
The MRCT Center is pleased to announce the availability of an introductory video for the ICH E8(R1) Guideline – General Considerations for Clinical Studies. Posted on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) website, the MRCT Center developed this introductory video to provide an overview of the general principles in clinical research and quality by design.
The MRCT Center is currently developing a series of in-depth training modules to complement the video.
Developed by: MRCT Center, in collaboration with the World Health Organization
Description: This course was developed in partnership with the World Health Organization and aims to meet the growing demand for a training on the scientific and ethical aspects of interventional clinical trials. This course is tailored to research ethics committee members, chairs, administrative staff, and others who review clinical trial protocols. It will also benefit regulators, investigators, study staff, care providers, and others involved in clinical trials. This course is available free of charge worldwide.
Developed by: Joint Task Force for Clinical Trial Competency (JTF), Roche Portugal, and Agency for Clinical Research and Biomedical Innovation (AICIB).
