CAPACITY BUILDING
Our Work

Research Ethics Committee Systems Optimization

Research Ethics Committee Systems Optimization

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

Project Resources