Ethics and Regulatory Capacity Building Partnership for Clinical Trials in Portuguese-speaking African Countries

CT-Luso intends to (1) draw an updated diagnosis and screenshot of the research ethics infrastructure in the 5 Portuguese-speaking African Countries (PSAC), (2) identify the needed transformations, draft strategic recommendations to carry out this transformation and design a policy roadmap for its implementation, (3) reinforce existing legislation and promote the necessary regulations for a robust ethical-legal framework, supporting the revision of internal regulations for the operation of RECs and NRAs, and promote the development of codes of scientific integrity in research institutions, (4) strengthen the skills of RECs and NRAs, researchers (senior, junior and post-graduate students) by drafting guidelines for the practice of the different roles required by the evaluation of CTs.It is necessary to work with all 5 PSAC simultaneously on four different levels, all equally indispensable and complementary: legislative, institutional, professional, and procedural, which in turn requires political commitment.

CT-Luso proposes to reach the abovementioned objectives by (1) building an international team of legal experts and promoting dialogue for the co-creation of legislative and organizational recommendations (2) creating an interdisciplinary and cross-sectoral education (3) creating an advanced progressive training program for members of RECs, NRA, CTs Centres and researchers (4) hands-on experience developed in a finely tuned manner and according to country specificities, complementing the previous education and training programs (5) assess whether each PSAC has the necessary installed capacity to be included in the international CTs roadmap and in particular to create a Portuguese-speaking cluster by simulating the procedures under the development of an academic CT (6) in parallel, the legislative and regulatory transformations to be implemented will require the political power involvement, acting in a double approach, both bottom-up and top-down.