Descripción del proyecto
Mejorar las normas éticas de los ensayos clínicos en África oriental y subsahariana
Los países del África subsahariana necesitan una mayor capacidad reguladora para la evaluación y el uso de los datos de los ensayos clínicos. En consecuencia, existe una necesidad acuciante de desarrollo continuo de capacidades y de intercambio de información entre los comités de ética de la investigación, los organismos reguladores nacionales y los sectores público y privado. En el proyecto SERCEA, financiado con fondos europeos, pretende mejorar las normas éticas de los ensayos clínicos en África oriental y subsahariana. Esto supondrá el establecimiento de un marco integral, el suministro de datos accesibles, el desarrollo de una plataforma de educación virtual y la creación de comités de ética de la investigación en los hospitales. El consorcio colaborará con instituciones y socios a fin de establecer un marco reglamentario coherente para los ensayos clínicos.
Objetivo
The increased number of Clinical Trials taking place in Africa as well as the complexity of Clinical Trials designs require that the countries have the regulatory capacity to review, monitor and utilize data generated from the research. Research Ethics Committees/Institutional Review Boards, Institutional Animal Care and Use Committees and National Regulatory Agencies (NRAs) are required to be abreast with the evolving landscape thus require continuous capacity building as well as have platforms to share Clinical Trials information with both the public and private sector. The 11th Annual National Research Ethics Conference held in 2021 in Uganda highlighted challenges in the low and middle income countries for research ethics and open science specifically, the lack of infrastructure for open data sharing and fair data management. Specifically, i) lack of the national and regional guidelines and codes of conduct for scientific integrity ii) limited training and education in responsible conduct of research and pharmacovigilance. This proposal focuses on strengthening ethics and responsible conduct of Clinical Trials in East and Sub-Saharan Africa project through the establishment of a research ethics and integrity framework, open data access framework for Clinical Trials, E-learning platform for the Good Research Regulatory Research Practice Course and establishing Research Ethics Committees in National Regional Hospitals. The consortium will leverage on the legal establishment of the institutions, collaborative efforts with the partner institutions, East African Health Research Commission (EAHRC), African Vaccine Regulatory Forum (AVAREF). Having a robust regulatory system, encompassing research integrity and open science will ensure that Clinical Trials is conducted to the highest ethical standards and in compliance with existing polices and laws, hence protection of safety, rights and welfare of the individual participants, community, researcher and sponsors.
Ámbito científico
Palabras clave
Programa(s)
- HORIZON.2.1 - Health Main Programme
Convocatoria de propuestas
Consulte otros proyectos de esta convocatoriaRégimen de financiación
HORIZON-JU-CSA - HORIZON JU Coordination and Support ActionsCoordinador
6200 MD Maastricht
Países Bajos