The products and outcomes of EDCTP have the African populations and research communities in mind as the major beneficiaries. In addition, most activities take place in African countries, and rely on the local study sites, institutions, expertise and human resources. Large clinical trials following international quality and ethical standards require extensive and costly infrastructural and organisational set-ups in developing countries. Thus, coordination and strengthening of the ethics and regulatory environment within Africa is an essential part of EDCTP’s activities.

To underpin the importance of ethics and regulatory frameworks to the African research setting, all EDCTP-funded projects must comply with internationally accepted standards, and EDCTP is actively involved in strengthening African national ethics and regulatory frameworks.

Compliance of EDCTP-funded projects with internationally accepted standards for ethical review
Regulatory authorities require that all new investigational medicinal products intended for use in humans must be shown to be safe, effective and of the highest quality. EDCTP therefore requires that all studies that are funded by EDCTP be performed in accordance with the standards and codes of conduct accepted by the International Conference on Harmonisation (ICH) guidelines and in compliance with the local ethical requirements of the countries where these studies are to be conducted.

According to these guidelines, all clinical trials have to be submitted to and approved by competent and independent Ethics Committees that comply with the World Health Organization Operational Guidelines for Ethics Committees. Additionally, the EDCTP Scientific Review Committee reviews for Integrated Projects take account of ethical review of projects recommended to be funded by EDCTP.