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

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.

Women's groups' perceptions of maternal health issues in rural Malawi.

BACKGROUND: Improvements in preventive and care-seeking behaviours to reduce maternal mortality in rural Africa depend on the knowledge and attitudes of women and communities. Surveys have indicated a poor awareness of maternal health problems by individual women. We report the perceptions of women's groups to such issues in the rural Mchinji district of Malawi. METHODS: Participatory women's groups in the Mchinji district identified maternal health problems (172 groups, 3171 women) and prioritised problems they considered most important (171 groups, 2833 women). In-depth qualitative data was obtained through six focus-group discussions with the women's groups, three with women's group facilitators, and four interviews with facilitator supervisors. FINDINGS: The maternal health problems most commonly identified by more than half the groups were anaemia (87%), malaria (80%), retained placenta (77%), obstructed labour (76%), malpresentation (71%), antepartum and postpartum haemorrhage (70% each), and pre-eclampsia (56%). The five problems prioritised as most important were anaemia (sum of rank score 304), malpresentation (295), retained placenta (277), obstructed labour (276). and postpartum haemorrhage (275). HIV/AIDS and sepsis were identified or prioritised much less because complexity and contextual factors hindered their consideration. INTERPRETATION: Rural Malawian women meeting in participatory groups showed a developed awareness of maternal health problems and the concern and motivation to address them. Community mobilisation strategies, such as women's groups, might be effective at reducing maternal mortality because they can draw on the collective capacity in communities to solve problems and make women's voices heard by decision-makers.

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

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.