DEBATE: Should government #policy interventions evaluated in #stepped #wedge #trials be considered ‘research interventions’ and reviewed by the research ethics committee? An exchange in @ClinTrialsJ.
#researchethics #steppedwedge #REC

2/ NO, says @rjlilford and @siwatson. https://journals.sagepub.com/doi/full/10.1177/1740774520920543

3/ “Our main point is that researchers should not have to obtain ethics committee approval for the intervention when they have had no part in its design and implementation but only want to evaluate it prospectively…”

4/ #REC review premised on participants being “exposed to risk…for the benefit if others.” But a “trial may be done to find out whether the expected benefit is of sufficient magnitude to justify its costs…Not to invite participation in research would involve the greater risk.”

5/ Researchers “can only be accountable for actions that they control.” Thus, “randomisation done by policy makers for non-research purposes does not require ethics committee approval.”

6/ “Intervention development and implementation requires ethics approval if done by researchers but not if done entirely by policy makers.”

7/ YES, says @karlahemming @coryegoldstein @TomPMarshall M Taljaard @CIR_TOH @charlesweijer https://journals.sagepub.com/doi/full/10.1177/1740774520920578

8/ “In our article, we ask whether stepped wedge cluster randomized trials ought to be considered research and to require review by the research ethics committee. Our answer to both questions is unreservedly ‘yes’.”

9/ Even when the intervention is of known or likely benefit, participants are exposed to risk. “Access to the intervention will be delayed or denied in the control condition, and the ethical permissibility of this is pivotal to the trial.”

10/ “The ethics committee must ensure that ‘individuals in the control arm must not be deprived of effective care or programs to which they would have access, were there no trial’.”

11/ “Lilford and Watson’s proposal stands research ethics on its head. Research ethics is not about the policing of researcher responsibilities, it is about the protection of research participants.”

12/ “With rare exceptions, policy makers do not allocate interventions to citizens by chance; they roll it out to the whole population or to those most in need.”

13/ “The choice of a stepped wedge design ‘signals that researchers and government are working together to plan the roll-out of a programme so that it may be evaluated’.”

14/14 Whatever their role in the intervention, researchers are authors of the design. “‘And it is the design that triggers equipoise issues, including the justification of the study intervention and control conditions, that must be assessed by the research ethics committee’.”

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