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

Project description

Improving ethics in clinical trials in east and sub-Saharan Africa

Sub-Saharan African countries require enhanced regulatory capabilities for the evaluation and use of data derived from clinical trials. As a result, there is a pressing need for continuous capacity development and information exchange among research ethics committees, national regulatory agencies, and the public and private sectors. The EU-funded SERCEA project aims to enhance ethical standards in clinical trials across east and sub-Saharan Africa. This involves the establishment of a comprehensive framework, the provision of accessible data, the development of an e-learning platform and the establishment of research ethics committees within hospitals. The consortium is dedicated to collaborating with institutions and partners to establish a robust regulatory framework for clinical trials.

Objective

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.

Programme(s)

Coordinator

UNIVERSITEIT MAASTRICHT
Net EU contribution
€ 205 000,00
Address
MINDERBROEDERSBERG 4
6200 MD Maastricht
Netherlands

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Region
Zuid-Nederland Limburg (NL) Zuid-Limburg
Activity type
Higher or Secondary Education Establishments
Links
Total cost
€ 205 000,00

Participants (4)