Description du projet
Améliorer l’éthique des essais cliniques en Afrique de l’Est et subsaharienne
Les pays d’Afrique subsaharienne doivent impérativement renforcer leurs capacités réglementaires concernant l’évaluation et l’utilisation des données issues des essais cliniques. Il existe par conséquent un réel besoin de développement des capacités et d’échange d’informations continus entre les comités d’éthique de la recherche, les organismes de réglementation nationaux et les secteurs publics et privés. Le projet SERCEA, financé par l’UE, entend renforcer les normes éthiques des essais cliniques en Afrique de l’Est et subsaharienne. Cela implique la mise en place d’un cadre global, la fourniture de données accessibles, le développement d’une plateforme d’apprentissage en ligne et la création de comités d’éthique de la recherche au sein des hôpitaux. Le consortium collabore étroitement avec des institutions et des partenaires afin d’établir un cadre réglementaire solide pour les essais cliniques.
Objectif
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.
Champ scientifique
Mots‑clés
Programme(s)
- HORIZON.2.1 - Health Main Programme
Régime de financement
HORIZON-JU-CSA - HORIZON JU Coordination and Support ActionsCoordinateur
6200 MD Maastricht
Pays-Bas