UCL logo

UCL Discovery

UCL home » Library Services » Electronic resources » UCL Discovery

Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia

Osrin, D; Azad, K; Fernandez, A; Manandhar, DS; Mwansambo, CW; Tripathy, P; Costello, AM; (2009) Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia. B WORLD HEALTH ORGAN , 87 (10) 772 - 779. 10.2471/BLT.08.051060. Gold open access

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.

Type: Article
Title: Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia
Open access status: An open access publication
DOI: 10.2471/BLT.08.051060
Publisher version: http://www.ncbi.nlm.nih.gov/pmc/ articles/PMC27553...
Keywords: DEVELOPING-COUNTRIES, CLINICAL-RESEARCH, DESIGN, PERSPECTIVE
UCL classification: UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Pop Health Sciences > Institute for Global Health
URI: http://discovery.ucl.ac.uk/id/eprint/152938
Downloads since deposit
0Downloads
Download activity - last month
Download activity - last 12 months
Downloads by country - last 12 months

Archive Staff Only

View Item View Item