Centre for Mental Health Law and Policy, Indian Law Society, Pune, India.
Epidemiological Research Center in Sexual and Reproductive Health, Guatemala City, Guatemala.
Trials. 2019 Dec 19;20(Suppl 2):703. doi: 10.1186/s13063-019-3842-1.
Stepped-wedge cluster randomized trials (SW-CRTs) are increasingly popular in health-related research in both high- and low-resource settings. There may be specific ethical issues that researchers face when designing and conducting SW-CRTs in low-resource settings. Knowledge of these issues can help to improve the ethical conduct of SW-CRTs in a global health context.
We performed an ethical analysis of two studies using SW-CRT designs in low-resource settings: the Que Vivan Las Madres study conducted from 2014 to 2017 in Guatemala and the Atmiyata study conducted from 2017 to 2018 in rural parts of India. For both case studies, we identified and evaluated the classification of the study as research or nonresearch and the ethical issues regarding the justification of the design, including the delayed rollout of an intervention that had a promising effect.
In our case studies, some minor ethical issues surfaced about the registration and stakeholder pressure on the order of randomization, but both included good justification for the design and delayed rollout. Our analysis did, however, demonstrate that careful consideration of the role of randomization and registration of the trials is important.
SW-CRTs can provide an opportunity for rigorous evaluation of interventions destined to be rolled out on the basis of limited evidence. Furthermore, in SW-CRTs, the underlying objective is often to provide a robust evaluation of the effectiveness for generalized dissemination, and this makes the SW-CRT no less a research study than any other form of cluster randomized trial.
The design and conduct of stepped-wedge cluster randomized trials raises at least two ethical issues that need special consideration in both high- and low-resource settings: the justification for using the design, specifically the delayed rollout of the intervention to the control group, and the classification of the study as research or nonresearch. In our case studies, these issues did not seem to raise special ethical scrutiny in low-resource settings. Further ethical evaluation will hopefully result in specific ethical guidelines for the use of SW-CRTs in both high- and low-resource settings to contribute to responsible functioning of these trials and adequate protection of participants.
在高资源和低资源环境中，阶梯式楔形集群随机对照试验（SW-CRTs）越来越受到健康相关研究的欢迎。在低资源环境中设计和进行 SW-CRT 时，研究人员可能会面临特定的伦理问题。了解这些问题有助于在全球健康背景下提高 SW-CRT 的伦理规范。
我们对两项在低资源环境中使用 SW-CRT 设计的研究进行了伦理分析：2014 年至 2017 年在危地马拉进行的 Que Vivan Las Madres 研究和 2017 年至 2018 年在印度农村地区进行的 Atmiyata 研究。对于这两个案例研究，我们确定并评估了研究的分类，即研究或非研究，以及设计的合理性的伦理问题，包括延迟推出具有良好效果的干预措施。
在我们的案例研究中，关于注册和利益相关者对随机顺序的压力，出现了一些较小的伦理问题，但都对设计和延迟推出进行了很好的论证。然而，我们的分析确实表明，仔细考虑随机化和试验注册的作用很重要。
SW-CRT 为在有限证据的基础上推出干预措施提供了严格评估的机会。此外，在 SW-CRT 中，基本目标通常是为广泛传播提供有效的稳健评估，这使得 SW-CRT 与任何其他形式的集群随机试验一样，都是一项研究。
阶梯式楔形集群随机对照试验的设计和实施至少提出了两个需要在高资源和低资源环境中特别考虑的伦理问题：设计的合理性，特别是将干预措施延迟到对照组，以及研究的分类，即研究或非研究。在我们的案例研究中，这些问题在低资源环境中似乎没有引起特别的伦理审查。进一步的伦理评估有望为高资源和低资源环境中 SW-CRT 的使用制定具体的伦理准则，以促进这些试验的负责任运作，并充分保护参与者。
