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CORDIS

Strengthening Ethics and Responsible conduct of Clinical Trials in East and Sub-Saharan Africa

Projektbeschreibung

Förderung der Ethik bei klinischen Studien in Ost- und Subsahara-Afrika

Die afrikanischen Länder südlich der Sahara benötigen bessere Regulierungsfähigkeiten für die Bewertung und Nutzung von Daten aus klinischen Studien. Daher besteht ein dringender Bedarf an kontinuierlichem Kapazitätsaufbau und Informationsaustausch zwischen den Ethikkommissionen der Forschung, den nationalen Aufsichtsbehörden sowie dem öffentlichen und privaten Sektor. Das EU-finanzierte Projekt SERCEA zielt darauf ab, die ethischen Normen bei klinischen Studien in ganz Ost- und Subsahara-Afrika zu fördern. Dazu gehört die Schaffung eines umfassenden Rahmenwerks, die Bereitstellung zugänglicher Daten, die Entwicklung einer E-Learning-Plattform und die Einrichtung von Forschungsethikkommissionen in Krankenhäusern. Das Konsortium arbeitet mit Institutionen und Partnern zusammen, um einen soliden regulatorischen Rahmen für klinische Studien zu schaffen.

Ziel

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.

Programm/Programme

Koordinator

UNIVERSITEIT MAASTRICHT
Netto-EU-Beitrag
€ 205 000,00
Adresse
MINDERBROEDERSBERG 4
6200 MD Maastricht
Niederlande

Auf der Karte ansehen

Region
Zuid-Nederland Limburg (NL) Zuid-Limburg
Aktivitätstyp
Higher or Secondary Education Establishments
Links
Gesamtkosten
€ 205 000,00

Beteiligte (4)