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Randomised evaluation of government health programmes does present a challenge to standard research ethics frameworks
  1. Samuel I Watson1,
  2. Mary Dixon-Woods2,
  3. Richard J Lilford1,3
  1. 1 Warwick Medical School, University of Warwick Medical School, Coventry, UK
  2. 2 THIS Institute, University of Cambridge, Cambridge, UK
  3. 3 Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom
  1. Correspondence to Dr Samuel I Watson, Warwick Medical School, University of Warwick Warwick Medical School, Coventry CV4 7AL, UK; s.watson.1{at}


In a recent issue of Journal of Medical Ethics (JME), we discussed the ethical review of evaluations of interventions that would occur whether or not the evaluation was taking place. We concluded that standard research ethics frameworks including the Ottawa Statement, which requires justification for all aspects of an intervention and its roll-out, were a poor guide in this area. We proposed that a consideration of researcher responsibility, based on the consequences of the research taking place, would be a more appropriate way delineate the scope of research ethics review. Weijer and Taljaard present a counterargument to our proposal, which we address in this reply. They claim that a focus on researcher responsibility will weaken the protection of research participants and link it to ‘unethical research’ and a ‘government experimenting on its own people’. However, the moral responsibility of researchers is defined in terms of the consequences of the research on human welfare and harm, not in opposition to it. Weijer and Taljaard argue that researchers must justify what they are studying whether or not they have any control over it and that governments must justify their programmes, including by demonstrating equipoise, to a research ethics committee if they implement them in a randomised way. We strongly disagree that this is a defensible way to define the scope of research ethics review and argue that this provides no further protections to research participants beyond what we propose, but places a potential barrier to learning from government programmes.

  • research ethics
  • policy guidelines/Inst review boards/review cttes
  • clinical trials

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  • Contributors SIW comprised the first draft of this reply. SIW, MD-W and RJL revised the reply and agreed on a final version.

  • Funding This study was funded by Wellcome Trust National Institute for Health Research.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; internally peer reviewed.

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