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

Descripción del proyecto

Un nuevo camino para la ética en la investigación en el África lusófona

En el África lusófona, la infraestructura de ética en la investigación suele estar fragmentada, lo que dificulta la realización de ensayos clínicos satisfactorios y la integridad científica. En el proyecto CT-Luso, financiado con fondos europeos, se abordará esta cuestión mediante la revisión de los marcos ético y jurídico en cinco países. En concreto, se actualizará el diagnóstico de los sistemas de ética en la investigación, se elaborarán recomendaciones estratégicas y se creará una hoja de ruta política para acometer reformas legislativas y normativas. El equipo de CT-Luso se propone mejorar la legislación vigente, promover códigos de integridad científica y fortalecer las competencias de los comités de ética en la investigación, las autoridades normativas nacionales y los investigadores mediante una formación avanzada. Gracias al fomento de la colaboración internacional, la educación interdisciplinar y la experiencia práctica a medida, en CT-Luso se pretende elaborar un nuevo marco que requiere un fuerte compromiso político para la transformación tanto legislativa como procedimental.

Objetivo

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.

Programa(s)

Coordinador

ORDEM DOS FARMACEUTICOS
Aportación neta de la UEn
€ 923 867,50
Dirección
RUA DA SOCIEDADE FARMACEUTICA 18
1169 LISBOA
Portugal

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Región
Continente Área Metropolitana de Lisboa Área Metropolitana de Lisboa
Tipo de actividad
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Enlaces
Coste total
€ 923 867,50

Participantes (11)

Socios (10)