Descrizione del progetto
Migliorare l’etica nelle sperimentazioni cliniche nell’Africa orientale e subsahariana
I paesi dell’Africa subsahariana necessitano di maggiori capacità normative per la valutazione e l’utilizzo dei dati derivati dalle sperimentazioni cliniche. Di conseguenza, è urgente la necessità di un continuo sviluppo delle capacità e dello scambio di informazioni tra i comitati etici della ricerca, le agenzie di regolamentazione nazionali e i settori pubblico e privato. Il progetto SERCEA, finanziato dall’UE, mira a migliorare gli standard etici nelle sperimentazioni cliniche nell’Africa orientale e subsahariana. Ciò comporta la creazione di un quadro completo, la fornitura di dati accessibili, lo sviluppo di una piattaforma di e-learning e l’istituzione di comitati etici della ricerca all’interno degli ospedali. Il consorzio è impegnato a collaborare con istituzioni e partner per stabilire un solido quadro normativo per le sperimentazioni cliniche.
Obiettivo
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.
Campo scientifico
Parole chiave
Programma(i)
- HORIZON.2.1 - Health Main Programme
Argomento(i)
Meccanismo di finanziamento
HORIZON-JU-CSA - HORIZON JU Coordination and Support ActionsCoordinatore
6200 MD Maastricht
Paesi Bassi