Health Research Governance in Africa Law, Ethics, and Regulation Biomedical Law and Ethics Library Series

The globalisation of research has resulted in the increased location of research involving humans in developing countries. Countries in Africa, along with China and India, have seen research grow significantly. With emerging infectious diseases, such as Ebola and Zika, emphasising the risk of public health crises throughout the world, a further increase in health research, including clinical research in developing countries, which are often the sites of these diseases, becomes inevitable. This growth raises questions about domestic regulation and the governance of health research.

This book presents a comprehensive and systemic view of the regulation of research involving humans in African countries. It employs case studies from four countries in which research activities continue to rise, and which have taken steps to regulate health research activity: South Africa, Nigeria, Kenya, and Egypt. The book examines the historical and political contexts of these governance efforts. It describes the research context, some of the research taking place, and the current challenges. It also looks at the governance mechanisms, ranging from domestic ethical guidelines to legal frameworks, the strengthening of existing regulatory agencies to the role of professional regulatory bodies. The book analyses the adequacy of current governance arrangements within African countries, and puts forward recommendations to improve the emerging governance systems for health research in African and other developing countries. It book will be a valuable resource for academics, researchers, practitioners and policy-makers working in the areas of health research, biomedical ethics, health law and regulation in developing countries.

1: Introduction; 2: Governance as an Analytical Framework for Health Research Involving Humans; 3: Components of Health Research Governance Systems; 4: Health Research Needs in African Countries: A Prelude to the Case Studies; 5: Health Research Governance in South Africa; 6: Health Research Governance in Nigeria; 7: Health Research Governance in Kenya; 8: Health Research Governance in Egypt; 9: Health Research Governance in Africa: Here to Stay But How Best?

Cheluchi Onyemelukwe-Onuobia is Associate Professor at the Babcock School of Law and Security Studies, Babcock University, Nigeria and Managing Partner at Health Ethics and Law Consulting, Nigeria. She is also a member of Nigeria’s National Health Research Ethics Committee.