Programme de bourses "Echanges Universitaires"

Project TRREE for Africa

Training and resources in research ethics evaluation for Africa

Definition: TRREE-for Africa is a web-based training and capacity building initiative on the ethics of research involving humans conducted in African countries. It will provide e-learning, i.e. distance learning on research ethics evaluation available on the web (http://trree.org/site/en_trree_home.phtml) and on CD-Rom and e-resources, i.e. a participatory web-site making available international, regional and national regulatory and policy resources. All the material developed by TRREE for Africa will be available free of charges.

Aims: TRREE for Africa aims to develop a training program and capacity building resources in research ethics for all those involved in clinical trials in Africa (e.g. researchers, ethics committees, institutions, research participants, regulators). It may also be of interest to health authorities, funding agencies and universities, as well as to political authorities, patients and the media. Partners from 6 African countries will, amongst other things, lead the needs assessment for the current project to ensure that the capacity building and training material address issues that are key for African countries.
In African countries as everywhere else in the world, training and adequate resources are key to build research ethics capacity. Based on African contributions and perspectives, this project hopes to increase protection of the welfare and interests of African citizens who participate in trials. By promoting the highest ethical standards during the conduct of research as well as supporting a robust ethics review process, this project will improve the quality of clinical trials conducted in Africa and eventually the treatment of diseases like HIV-AIDS, malaria and tuberculosis, an important concern for all.

Design: The base of the project is to develop a basic program which takes into account the main international requirements to interpret them in the light of the African requirements and sensibilities.
TRREE for Africa takes account of already existing programs in order to avoid repeating the same subjects.
This is a bilingual project (in a first step) as TRREE partners are from French and English speaking countries. Thereafter, it will be possible to add other languages.
This program is inspired by a project financed by the Government of Québec in Canada (http://ethique.msss.gouv.qc.ca/site/fr_formation_ethique.phtml) which framework can easily be used for other countries. The training program is divided in 4 levels:
Level 1 will provide general training (Module 1) in research ethics as well as international and European regulation for all involved in research with humans;
Level 2 will provide specific training for key responsibilities of research participant protection systems. E.g. Module 2.1 covers the research ethics evaluation function and Module 2.2 covers research partnerships in clinical trials;
Level 3 will provide specific training to fulfil national requirements of the African partners.
Level 4 will provide more in-depth analysis of key and pressing ethical issues relevant to research involving humans in Africa.

Objectives: TRREE for Africa has three general objectives:
First, to increase knowledge as well as practical skills of those involved in the management and conduct of ethics evaluation and research partnerships.
Second, to create a participatory process that will nourish lasting partnerships with and amongst African partners.
Third, to create a resource that will facilitate the dissemination of knowledge in European and African countries. Overall, this will strengthen the research ethics evaluation capacities in African countries.
Moreover, Completion of the course will prepare individuals to be more eligible for intensive face to face research ethics training already offered or being developed in Africa, especially by the participants in the TRREE for Africa project. For instance, face to face programmes might make successful completion of the course a prerequisite to face to face attendance. It is also hoped that the learning will be bi-directional, with so called developed countries learning from African perspectives

Timeline: This project is lasting 24 months, from 1st of November 2006 to 1st November 2008.

Follow up: TRREE for Africa has an open texture. This mean it is not limited to a deadline point. The framework developed can be used for other countries than African ones. This is also an ongoing process: each participant can bring his own experiences to increase the value of the project.

Budget: Total budget: 269’220 €. This is for the first part. Once this initial phase is completed, additional funding will be sought to complete the level 2 modules for other actors, to add countries (African, European, etc.) to the level 3 national modules, and to complete thematic level 4 modules. African partners will be increased to broaden the base of contributions.

Team:
Coordinator: Dominique Sprumont (Université de Neuchâtel)

Working Group: Marie Hirtle (Groupe FEE- Canada), manager
Wen Kilama (African Malaria Network Trust-Tanzania)
Peter Ndumbe (Centre for the Study and Control of Communicable Diseases-Cameroon)
Ogobara Doumbo (Malaria Research and Training Centre-Mali)
Marcel Tanner (Swiss Tropical Institute)
Dirk Lazareth (German Reference Centre for Ethics and Life Sciences)

Advisory Board: Douglas Wassenaar (South African Research Ethics Training Initiative)
Charles Becker (Centre national de recherche Scientifique- Sénégal)
Clement Adebamowo (West African Bioethics - Nigeria)
Marie-Charlotte Bouësseau (WHO)
John R. Williams (WMA)