Table 1 Regulatory framework for ethics approval for biomedical research in five African countries

Burkina Faso

Institutional review (only three in the country) and national review (National Ethics Committee, constituted in 2002, Ministry of Health)

Sequential manner (institutional and then national) (submitted in French)

Under auspices of the Ministry of Health

Ghana

Each health research institute has its own institutional review and institutions that fall under the Ghana Health Service also require additional review by the Ghana Health Service Ethical Review Board in Accra

Scientific approval from the institution precedes submission for ethics review

Ghana Health Service

Data protection Act (2012)

For international projects, an appendix with the Ghana specific protocol must be submitted

Sequential submission for review

Kenya

Institutional review and nationally accredited ethics review boards

Institutional Scientific Steering Committee approval prior to submission for Institutional Ethics review. National review is done at the research institutions with accredited ethics review committees

Science and Technology Act (2001)

(Previously Kenya Medical Research Institute (KEMRI) Ethics Review Committee approval required for biomedical research)

National Council for Science and Technology (NCST) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (2004)

Ministry of Health (MOH) - Human Biological Materials

South Africa

Universities and the medical research council have their own institutional ethics committees

Only need approval from institutional ethics committee (hospital-based research requires additional approval from the hospital and research in rural communities requires provincial approval)

National Health Act No. 61 (2003)

National Research Ethics Council (http://www.nhrec.org.za)

Export permit required from the Department of Health for biological sample transfer

Medical Research Council: Guidelines on Ethics in Medical Research: General Principles (2002)

Tanzania

National Health Research Ethics Committee (NHREC) (2002)

Application directly to the NHREC

Ministry of Health (MOH)

National Institute for Medical Research (NIMR), National Health Research Ethics Committee (NHREC)

NIMR responsible for coordination of Health Research in Tanzania and coordination of Formation of Institutional Health Research Committees to Formally Approve for Local Health Research

National Institute for Medical Research, Act of Parliament No. 23, of 1979

Tanzania Commission for Science and Technology, Act No. 7 of 1986 (COSTECH)

COSTECH Guidelines on Research Permits and Clearance (2006)

DNA Act (Act No. 8/09) (2009) Provides guidelines and oversight for laboratories that work with DNA