ABSTRACT
Health research involving humans is one area of human endeavour in which the areas of governance and regulation have particular relevance. This chapter presents an analysis of health research involving humans using a governance analytical framework. It considers the role of law in the governance of research involving humans in developing countries. Concerns about overregulation, inefficiency of regulating institutions, legalism, inflexibility and costs of regulation, and arguments in favour of deregulation have gained ground in recent years. Much has thus been made of the concept of "new" governance, which allows greater participation of private actors in social regulation. Health research involving humans, given its nature and the issues connected therewith, has been the subject of much ethical analysis. There is certainly a preoccupation in the literature with research ethics and institutional and research practice. Effectiveness is arguably the most fundamental and basic measure for assessing the success of public action.
