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

Project description

A new path for research ethics in Portuguese-speaking Africa

In Portuguese-speaking Africa, research ethics infrastructure is often fragmented, impeding effective clinical trials (CTs) and scientific integrity. The EU-funded CT-Luso project will address this by overhauling ethics and legal frameworks across five countries. Specifically, it will update the diagnosis of research ethics systems, draft strategic recommendations, and create a policy roadmap for legislative and procedural reforms. CT-Luso aims to enhance existing laws, promote codes of scientific integrity, and fortify the skills of research ethics committees, national regulatory authorities, and researchers through advanced training. By fostering international collaboration, interdisciplinary education, and tailored hands-on experience, CT-Luso seeks to build a new framework that requires strong political commitment for both legislative and procedural transformation.

Objective

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.

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Programme(s)

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Topic(s)

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Funding Scheme

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HORIZON-JU-CSA - HORIZON JU Coordination and Support Actions

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Call for proposal

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(opens in new window) HORIZON-JU-GH-EDCTP3-2023-01

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Coordinator

ORDEM DOS FARMACEUTICOS
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 923 867,50
Address
RUA DA SOCIEDADE FARMACEUTICA 18
1169 LISBOA
Portugal

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Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 923 867,50

Participants (11)

Partners (10)

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