In this issue of JME, Watson et al call for research evaluation of government health programmes and identify ethical guidance, including the Ottawa Statement on the ethical design and conduct of cluster randomised trials, as a hindrance. While cluster randomised trials of health programmes as a whole should be evaluated by research ethics committees (RECs), Watson et al argue that the health programme per se is not within the researcher’s control or responsibility and, thus, is out of scope for ethics review. We argue that this view is wrong. The scope of research ethics review is not defined by researcher control or responsibility, but rather by the protection of research participants. And the randomised evaluation of health programmes impacts the liberty and welfare interests of participants insofar as they may be exposed to a harmful programme or denied access to a beneficial one. Further, Watson et al’s claim that ‘study programmes … would occur whether or not there were any … research activities’ is incorrect in the case of cluster randomised designs. In a cluster randomised trial, the government does not implement a programme as usual. Rather, researchers collaborate with the government to randomise clusters to intervention or control conditions in order to rigorously evaluate the programme. As a result, equipoise issues are triggered that must be addressed by the REC.
- research ethics
- clinical trials
- policy guidelines/inst. review boards/review cttes
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Contributors CW wrote the first draft of the manuscript. MT provided critical review and revisions of the manuscript. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.
Funding This work is supported by a Canadian Institutes of Health Research project grant (PJT-153045).
Competing interests CW receives consulting income from Eli Lilly and Company Canada. MT has no competing interests to declare.
Patient consent for publication Not required.
Ethics approval Ethics approval was not required for this conceptual work.
Provenance and peer review Not commissioned; internally peer reviewed.
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