BERC-Luso is a project for building Ethics and Regulatory Capacity, to be developed in four sub-Saharan African countries: Angola, Guinea-Bissau, Mozambique and Cape Verde, and to be implemented in 2018–2021. National Ethics Committees (NECs) and National Regulatory Authorities (NRAs) have been engaged (6 institutions) with the partnership of 4 Portuguese institutions (experts in ethical review and regulatory supervision).
Considering that: 1) clinical trials are fundamental to improve healthcare and develop biomedical research; but 2) can only take place within regulatory systems and under ethical review protocols; and 3) some African countries still lack an adequate legislative framework and the expertise to assure good ethical review and regulatory supervision, it is urgent to change the current situation.
The BERC-Luso project will unfold at four different levels, each aiming at a specific goal in converging dynamics.
Legislative level: Presentation of a comparative study ofthe Portuguese Speaking African Partner Countries’ legislation on NECs and NRAs with recommendations for revision in compliance with the international requirements. The goal is to promote adequate internationally recognised legislation.
Educational level: Implementation of an intensive and comprehensive Education Programme, both theoretical and practical, reflexive and normative, ethical and legal, addressing the needs of the countries involved, within their cultural contexts, and in their own mother tongue. The goal is to promote capacity building.
Training level: Organisation of intensive internships, demanding participants to accurately apply everything they have learned to their everyday practice. The goal is to have knowledgeable and skilled experts.
Networking level: Build powerful digital tools to connect partner institutions, staff and participants during the project and beyond, creating a digital repository of documents, and different tools for ethical and regulatory evaluation.
These actions converge to provide internationally recognised legislation and expertise for the development of biomedical research for the benefit of the population.
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