University College London, Institute of Child Health, London, England.
Bull World Health Organ. 2009 Oct;87(10):772-9. doi: 10.2471/blt.08.051060.
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.
公共卫生干预措施通常在群体层面而非个体层面实施，而整群随机对照试验（cluster randomized controlled trials，RCT）是评估其效果的一种手段。我们通过来自孟加拉国、印度、马拉维和尼泊尔的六项此类试验的实例，讨论了在实施过程中出现的伦理问题及应对经验。我们将整群 RCT 置于公共卫生研究的更广泛背景下，重点讨论了如何协调个人自主权与共同利益之间的关系，以及在一般低收入环境下进行公共卫生研究的伦理问题。在简要介绍整群 RCT 之后，我们讨论了所面临的一些特殊挑战。其中包括群体同意的性质和责任，以及群体内个人对干预措施和数据收集的同意的必要性。我们还讨论了同意的时机与公共卫生策略的实施之间的关系，以及在复杂领域确保伦理审查和批准的问题。最后，我们考虑了关于对照组获益和应提供的标准护理的争论，以及试验后测试干预措施的采用问题。
