The ethical and legal regulation of HIV-vaccine research in Africa: lessons from Cameroon, Malawi, Nigeria, Rwanda and Zambia.

Ethical and legal frameworks are important for ensuring that the goals of scientific research are realised while at the same time the rights and welfare of human participants are adequately protected. A balance in attaining these two goals can be achieved if such frameworks provide for legally binding structures and processes to oversee, regulate, and monitor research on human participants according to accepted norms and standards. From 2007 to 2009, an ethical/legal audit, sponsored by the WHO/UNAIDS Ethics, Law and Human Rights Working Group of the African AIDS Vaccine Programme (AAVP ELH), was conducted in regard to five African countries (Cameroon, Malawi, Nigeria, Rwanda and Zambia) to determine whether these countries have adequate laws, ethical guidelines and policies in place to regulate HIV-vaccine research. This article discusses the findings of the audit with a view to highlighting key lessons that can be learnt from these countries. The article provides the context of the audit by highlighting its rationale, aims and methods. We discuss the general findings of the audit and the complex issues arising from HIV-vaccine research, specifically. Lastly, we propose specific ways in which the ethical/legal frameworks guiding research with human participants in these countries can be improved.