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

  • Pamela Andanda
  • Paschal Awah
  • Paul Ndebele
  • Olanrewaju Onigbogi
  • Daniel Udatinya
  • Malala Mwondela


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.

Keywords: Africa, clinical trials, country profiles, ethics, guidelines, health research, HIV/AIDS, legislation, policy

African Journal of AIDS Research 2011, 10(4): 451–463

Author Biographies

Pamela Andanda
University of the Witwatersrand, Private Bag 3, Wits 2050, Johannesburg, South Africa
Paschal Awah
Ipas, PO Box 5027, Chapel Hill, North Carolina 27514, United States
Paul Ndebele
University of Botswana, Office of Research and Development, Private Bag UB00708, Gaborone, Botswana
Olanrewaju Onigbogi
University of Lagos, College of Medicine, Department of Community Health and Primary Care, PO Box 35950, Agodi, Ibadan, Nigeria
Daniel Udatinya
Rwanda Ministry of Health, PO Box 84, Kigali, Rwanda
Malala Mwondela
Zambia AIDSLaw Research and Advocacy Network (ZARAN), Plot No. 22, Katemo Road, Rhodes Park, PO Box 39088, Lusaka, Zambia

Journal Identifiers

eISSN: 1608-5906
print ISSN: 1727-9445