Tool
Published: July 16, 2025
This guidance document is intended to be used as a tool to supplement the review, discussion, and deliberation of Research Ethics Committees reviewing clinical trial protocols.
This tool was developed by Barbara E. Bierer, MD (The MRCT Center of Brigham & Women’s Hospital and Harvard), Jeffrey D’Souza, PhD (University of Toronto), Caroline M. Kithinji, PhD (Kenya Medical Research Institute), and Winfred B. Nazziwa, MS (Uganda National Council for Science & Technology), in collaboration with the African Vaccines Regulatory Forum (AVAREF).