project

Summary Information

LusoAfro-BioEthics: Strengthening Bioethics Committees in Lusophone African Region Project Reference: CSA2016ERC-1423

In the last decade, in Lusophone African countries, like in other countries from Africa, health research has increased and in response Research Ethics Committees (REC) have been established namely in Universities, Research Centers and Ministries of Health. But RECs in these countries still face a serious lack of staff trained in research ethics, and the “language divide” is an important barrier faced by them, as the main ethics educational resources are only available in English. Being aware of this issues, and recognizing that although the strengthening of RECsis primarily a national issue, much can be gained by taking advantage of networking by establishing a north south consortium, in order to strength the ethical framework of African Lusophone Countries (ALC) to conduct clinical and health research.

Objectives

The main objective is to strength capacity for health research ethics review in Lusophone African Countries.

More specifically the objectives are:

  1. To improve institutional and personnel capacities of the three African Lusophone Countries Research Ethics Committees;
  2. To enhance the efficiency of clinical/health research applications reviews;
  3. To promote collaborative/ networking activities in research ethics in Lusophone Countries; and
  4. To share good practices on Standard Operation Procedures, Protocol Review and international regulatory ethical and legal norms and standards and to promote the establishment of University of Cape Verde Institutional Review Board.

Impact

All actions developed in this project aim to improve Research Ethics Committees (RECs) institutional and personnel capacities and to enhance the efficiency of clinical trials/health research applications reviews of these countries will strengthen the functionality, recognition and performance of National Ethics Committees (NECs) in sub-Saharan African countries.

In order to strengthen RECs functionality and performance will be developed face to face workshops and online Educational Resources for Research Ethics in Portuguese language in several topics identified through the analysis of the questionnaires, self-assessment tools and brainstorming. This project will also elaborate and deliver several Guidelines and other Documents in Portuguese, namely focused on Informed Consent, Protocol Review, SOPs, assessing operational characteristics of RECs and other relevant topics identified at the beginning of the project.

By developing capacities for ethical review of clinical trials and health research in Angola and Mozambique and by the creation of the Institutional Review Board (IRB) of the University of Cape-Verde, this project will enhance the ability of such countries to conduct and host clinical trials, one of the main expected impacts of EDCTP2. The development of networking activities between NECs and IRBs from African Lusophone countries (namely Angola, Mozambique and Cape-Verde) and its linkage to Portugal RECs, will be achieved through the establishment of an online collaborative platform and several seminars to share good practices. These network initiatives will encourage a greater coordination and alignment of national research efforts in the three countries.

The effectiveness of the project will be monitored on a regular basis using several indicators that will give a clear picture of whether the project is moving in the right direction and measure progress towards planned goals.

The following target groups will benefit from the Project:
– RECs chairs
– RECs members from Angola and the 8 Mozambique RECs and future REC members from Cape-Verde
– Health researchers (both clinical, biomedical and public health investigators)
– Medical students
– Civil society in general