Date of Award

10-2010

Document Type

Dissertation

First Advisor

Jocelyn Downie

Abstract

An intense debate has occurred regarding research involving humans in developing countries in recent years. Research in this area has focused mainly on examining the ways in which the economic inequalities in healthcare between developing countries and developed countries have affected the types of research conducted in developing countries by external sponsors. Research has also focused on how these inequalities, and the difficulties in applying the international ethical guidelines, give rise to ethical concerns and controversies. Recent literature has therefore examined several ethical concerns in health research in developing countries. What is missing in the literature on research oversight in developing countries, however, is a broader analysis from a governance and legal perspective which critically examines the structure and adequacy of any existing governance systems and the potential effect of these systems on the protection of human participants in these countries. The major argument that this thesis makes and attempts to explore, therefore, is that there is need to take a more comprehensive and systemic view of the regulation of research involving humans in developing countries. This is particularly necessary given steps taken recently by several developing countries to establish governance mechanisms for health research involving humans. To undertake this analysis, the thesis adopts a hybrid framework of governance, drawing from the understandings and strengths of "traditional" and "new" governance. This framework acknowledges the important role of government but also takes into account other components which may not always be dependent on government and law. Further, in line with this framework, the thesis argues for the need to recognise, in scholarship and operation, the interrelationships between the different components of research governance - ethical, institutional, and legal. For more specific analysis, the thesis focuses on Nigeria, a populous, influential, developing country in Africa, which has taken steps in recent years to regulate health research involving humans. It examines the historical and political context of these governance efforts, and analyses the adequacy of current governance arrangements. Based on the analyses, it makes several recommendations to improve the emerging governance arrangements for health research involving humans in Nigeria.

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