Abstract
BackgroundCluster randomized trials are common in health research in low- and middle-income countries raising issues that challenge interpretation of standard ethical guidelines. While the Ottawa Statement on the ethical design and conduct of cluster randomized trials provides guidance for researchers and research ethics committees, it does not explicitly focus on low- and middle-income settings.Main bodyIn this paper, we use the lens of the Ottawa Statement to analyze two cluster randomized trials conducted in low- and middle-income settings in order to identify gaps or ethical issues requiring further analysis and guidance. The PolyIran trial was a parallel-arm, cluster trial examining the effectiveness of a polypill for prevention of cardiovascular disease in Golestan province, Iran. The PASTAL trial was an adaptive, multistage, parallel-arm, cluster trial evaluating the effect of incentives for human immunodeficiency virus self-testing and follow-up on male partners of pregnant women in Malawi. Through an in-depth case analysis of these two studies we highlight several issues in need of further exploration. First, standards for verbal consent and waivers of consent require methods for operationalization if they are to be employed consistently. Second, the appropriate choice of a control arm remains contentious. Particularly in the case of implementation interventions, locally available care is required as the comparator to address questions of comparative effectiveness. However, locally available care might be lower than standards set out in national guidelines. Third, while the need for access to effective interventions post-trial is widely recognized, it is often not possible to guarantee this upfront. Clarity on what is required of researchers and sponsors is needed. Fourth, there is a pressing need for ethics education and capacity building regarding cluster randomized trials in these settings.ConclusionWe identify four issues in cluster randomized trials conducted in low- and middle-income countries for which further ethical analysis and guidance is required.
Highlights
We identify four issues in cluster randomized trials conducted in low- and middle-income countries for which further ethical analysis and guidance is required
Cluster randomized trials (CRTs) are an increasingly important method used in health research, including research conducted in low- and middle-income countries (LMICs)
Our ethical analysis of two case studies reveals gaps in the Ottawa Statement and shows that further work is required on ethical issues of CRTs in the LMIC setting
Summary
Our ethical analysis of the PolyIran and PASTAL trials reveals gaps in the Ottawa Statement and shows that further work is required on ethical issues of CRTs in the LMIC setting. Standards for verbal consent and waivers of consent require methods for operationalization if they are to be employed consistently. The appropriate choice of a control arm remains contentious, and the acceptability of locally available care as the comparator in implementation CRTs, especially when such care falls below national standards, should be assessed. There is a pressing need for ethics education and capacity building on CRTs. Fourth, there is a pressing need for ethics education and capacity building on CRTs These identified gaps and ethical issues will inform a forthcoming revision process for the Ottawa Statement
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