Putting the well-being of African study participants first: Gabon establishes national ethics committee

French

As the number of health research conducted in sub-Saharan Africa increases, so does the need for improved review of the ethical and scientific rigour of these trials. As we work on increasing the quality of research, we should also work on ensuring the safety of research participants. The recently established National Bioethics Committee of Gabon, which was established with the help of a grant from the European and Developing Countries Clinical Trials Partnership (EDCTP), is an example of the progress made to safeguard the well-being of African study participants.

The newly formed National Bioethics Committee for research of Gabon currently comprises 19 members that represent the three main Gabonese research institutes (USS Libreville, URM Lambarene and CIRMF Franceville), as well as relevant Gabonese hospitals and ministries. This initiative was started with the help of an EDCTP grant, training support from the Vienna School of Clinical Research, the Government of the Republic of Gabon and a committed team of Gabonese nationals. Consequently, with complementary support of other partners including WHO, UNESCO, AMANET and the Institut Pasteur of Dakar the Committee was officially established.

The committee is now operational and anticipates starting reviewing protocols for clinical trials soon. Negotiations are currently underway to include the committee in UNESCO’s Global Ethics Observatory Database. Inclusion in this database means that not only the Committee has proven able to assess research, but that is also able to advise on ethical problems, formulate recommendations and foster debate, education and public awareness.

Why every country must have a National Ethics Committee
All clinical trials involving human participants must be reviewed and approved by a competent and independent research ethics committee. The research ethics committee must ensure that all studies are conducted in accordance with international ethics codes and guidelines. The ultimate goal of ethical review is that the dignity, rights, safety and wellbeing of research participants are protected.

In many African countries, ethics review capacity needs to be strengthened. Inadequate training, limited infrastructural facilities and lack of funding remain a big challenge. As the number of clinical trials conducted in Africa is growing, so is the requirement to empower the countries of Africa to conduct their own safety reviews of those trials. Currently, a number of organisations such as EDCTP, WHO, UNESCO, AMANET, COHRED and others are working hand-in-hand to help those countries to create and strengthen their institutional and National Bioethics Committees.

EDCTP strengthening of ethics committees in Africa
EDCTP is involved in the assessment of the ethics and regulatory environment of the countries where EDCTP-funded trials will be conducted and provides support in these areas. The ultimate aim is to reinforce the African ethics and regulatory environment in the long term. EDCTP has funded research ethics committees in Zimbabwe, Ghana, Malawi, Nigeria, Uganda and Gabon and is working hand-in-hand with COHRED to map ethics and regulatory capacity in Africa and with the World Health Organization (WHO) to strengthen the National Regulatory framework.

About EDCTP
EDCTP aims through research integration to accelerate the development of new or improved drugs, vaccines, diagnostics and microbicides against HIV/AIDS, malaria and tuberculosis, with a focus on phase II and III clinical trials in sub-Saharan Africa.

EDCTP supports integrated multicentre projects which combine clinical trials, capacity building and networking. The aim of integrating these three activities is to ensure that the developed capacity is utilised to successfully conduct the clinical trials in a sustainable way.

EDCTP is currently part of the European Commission’s Sixth Framework Programme (FP6) for research and technological development, the European Union’s main instrument for funding research in Europe.

The basis of EDCTP is partnership. It unites 14 participating European Union (EU) member states plus Norway and Switzerland with sub-Saharan African countries. The partnership helps EU Member States to integrate and coordinate their own national research and development programmes and form partnerships with their African counterparts.

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Note to the editor:
For more information please contact :

Ilona van den Brink
EDCTP Communications Officer
media[at]edctp.org
+31 70 349 44 22

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