Ethical challenges in cluster randomised controlled trials: Experiences from public health interventions in Africa and Asia.
Cluster randomized controlled trials are those in which groups (e.g. schools, villages, or districts) rather than individuals are randomly assigned to receive an intervention. They present a number of ethical challenges such as the need to reconcile individual autonomy with the common good, the problem of gaining consent on behalf of groups as well as individuals, the debates about benefits to control groups and standard of care, and the question of what happens when a trial ends. This briefing paper explores these challenges in more detail and describes some approaches that have been used to overcome them. [See also the record for the article on which this document is based: Osrin, D.; Azad, K.; Fernandez, A.; Manandhar, D.; Mwansambo, C.; Tripathy, P.; Costello, A.: Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Asia and Africa. Bull WHO (2009), 87 (10) 772-779. DOI:10.2471/BLT.08.051060].
Towards 4+5 Briefing Paper 6, April 2010; 2 pp.