BRTI Institutional Review Board

Ethics Research Unit

The Ethics Research Unit Zimbabwe has a long history of conducting health research studies most of which are in collaboration with institutions in the sub-region, Europe and North America. The increasing collaboration in health research between industrialized and developing countries continues to cause concern regarding the potential for exploitation of human subjects in developing countries, especially in view of the ongoing need for clinical trials for anti-retroviral therapies and the treatment of opportunistic infections in resource limited settings.

Few studies have been conducted on the ethical conduct of clinical trials and therefore there is limited information and evidence that can be used to formulate plans and policies. Of particular concern is the lack of research initiated and conducted by researchers in the developing countries themselves. With the growth in international collaborative research, it is imperative that researchers from both developing and industrialized countries continually advance their understanding of their own perspectives on ethical review as well as the perspectives of their partners. This can be achieved by developing communication strategies that promote dialogue between researchers and ethics boards with a view to ensuring that both parties are responsive to the needs of each other.

It is against this background that an Ethics Research Unit (ERU) was set up at the BRTI in 2008 with financial support from the European and Developing Countries Clinical Trials Partnership (EDCTP). The Unit currently comprises seven members as follows: two scientists, a medical expert with years of experience in ethics; one Research Officer, one Documentation Officer, a Finance Consultant and an Information Technology Officer. The focus of the Unit is research and communication of ethical issues surrounding research involving human subjects in Africa.

Specifically, the objectives of the Unit are as follows:

• To respond to the research needs in the ethical conduct and review of human subjects research in Southern Africa and provide evidence that can be used for policy development and planning

• To strengthen the administrative capacity of current and future ethical review committees to provide efficient, effective and timely review of research proposals

• To assist researchers in ensuring that their studies accord with ethical research principles through the dissemination of guidelines on ethical issues in heath research to researchers

• To improve the awareness of researchers of good research practice through the production and dissemination of an ethics handbook and regular electronic newsletter that highlights key issues in the conduct of ethical research

In fulfilling its obligations, the Unit consults with the Research Council of Zimbabwe (RCZ), the body responsible for overseeing all research in Zimbabwe, the Medical Research Council of Zimbabwe (MRCZ), which hosts the National

Ethics Committee and the Medicines Control Authority of Zimbabwe (MCAZ) responsible for all clinical trials research involving drugs, medicines and devises. It also collaborates with the College of Health Sciences (CHS) of the University of Zimbabwe.