title: Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia.
abstract: Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income settings in general. After a brief introduction to cluster RCTs, we discuss particular challenges we have faced. These include the nature of - and responsibility for - group consent, and the need for consent by individuals within groups to intervention and data collection. We discuss the timing of consent in relation to the implementation of public health strategies, and the problem of securing ethical review and approval in a complex domain. Finally, we consider the debate about benefits to control groups and the standard of care that they should receive, and the issue of post-trial adoption of the intervention under test.
authors.affiliation: University College London, Institute of Child Health, London, England. dosrin@ich.ucl.ac.uk
authors.forename: David
authors.initials: D
authors.lastname: Osrin
authors.forename: Kishwar
authors.initials: K
authors.lastname: Azad
authors.forename: Armida
authors.initials: A
authors.lastname: Fernandez
authors.forename: Dharma S
authors.initials: DS
authors.lastname: Manandhar
authors.forename: Charles W
authors.initials: CW
authors.lastname: Mwansambo
authors.forename: Prasanta
authors.initials: P
authors.lastname: Tripathy
authors.forename: Anthony M
authors.initials: AM
authors.lastname: Costello
mesh_terms: D000349:Africa; D001208:Asia; D016000:Cluster Analysis; D003695:Delivery of Health Care / Q000191:economics / Q000458:organization & administration; D004992:Ethics, Medical; D006302:Health Services Research / Q000941:ethics*; D006801:Humans; D007258:Informed Consent; D017146:Models, Organizational; D011634:Public Health; D015980:Public Health Practice / Q000941:ethics