ArticleTrials2019
Ethical issues in the design and conduct of stepped-wedge cluster randomized trials in low-resource settings.
Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
13 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Evidence-based interventions to reduce mortality among preterm and low-birthweight neonates in low-income and middle-income countries: a systematic review and meta-analysis.BMJ global health · 2021Pooled it
- Arts-Based Interventions for Professionals in Caring Roles During and After Crisis: A Systematic Review of the Literature.Frontiers in psychology · 2020Pooled it
- Mono-Professional Simulation-Based Obstetric Training in a Low-Resource Setting: Stepped-Wedge Cluster Randomized Trial.JMIR medical education · 2025Trial
- Trial
- Considerations Before Selecting a Stepped-Wedge Cluster Randomized Trial Design for a Practice Improvement Study.Annals of family medicineTrial
- AI-Assisted Chest X-Ray Interpretation in Resource-Limited Settings: LuAna Stepped-Wedge Trial Protocol.JMIR research protocols · 2026Article
- Applications and implementation considerations for stepped-wedge designs in sub-Saharan Africa: a systematic review.Frontiers in epidemiology · 2026Review
- Ethical considerations in implementation research: a scoping review of key principles, unintended consequences, and emerging ethical guidance.Implementation science communications · 2025Review
- Article
- Stakeholders' experiences of ethical challenges in cluster randomized trials in a limited resource setting: a qualitative analysis.Research ethics · 2024Article
- Empowering local research ethics review of antibacterial mass administration research.Infectious diseases of poverty · 2022Review
- Consent, decisional capacity and guardianship in mental health research.Wellcome open research · 2022Article
- Article
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Authors and funding
6 authors.
Funding
Abstract
backgroundStepped-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.
methodsWe 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.
resultsIn 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. DISCUSSION: 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.
conclusionThe 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.
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