Abstract
Background
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.
Methods
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.
Results
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.
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.
Conclusion
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.
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Details
1 Indian Law Society, Centre for Mental Health Law and Policy, Pune, India (GRID:grid.32056.32) (ISNI:0000 0001 2190 9326)
2 Epidemiological Research Center in Sexual and Reproductive Health, Guatemala City, Guatemala (GRID:grid.32056.32)
3 Western University, Rotman Institute of Philosophy, London, Canada (GRID:grid.39381.30) (ISNI:0000 0004 1936 8884)
4 University of Birmingham, Institute of Applied Health Research, Birmingham, UK (GRID:grid.6572.6) (ISNI:0000 0004 1936 7486)
5 University Medical Center Utrecht, Utrecht University, Julius Center, Utrecht, The Netherlands (GRID:grid.6572.6)