Chapter 6. Ethical guidelines for HIV research: a contextual implementation process

Abstract

Objective – To take stock of evidence on the implementation of ethics guidelines for HIV research.
Design – Review of literature and discussion by an international group of experts.
Setting – Multiple countries where HIV research has been conducted.
Subjects – Not applicable.
Main outcome measure(s) – How ethics guidelines for HIV research are implemented in diverse settings and to what extent this influences human subject protection and the conduct of research.
Results – Evidence on implementation of guidelines is scarce but 3 major points can be observed across settings. First, the requirements of ethical review have pushed research beyond the domain of technical expertise and require attention to social and political factors that few researchers are prepared to deal with. Secondly, local conditions directly influence the implementation of informed consent, the definition and application of standards of care for participants, and the process of community consultation and representation. Thirdly ethics guidelines represent greater burdens for researchers but at the same time can contribute to higher standards within and outside of research projects.
Conclusions – More systematic evidence is needed on implementation, on the correspondence between local and global understandings of ethics, and on the innovative approaches developed in various settings.