Ethics in cluster randomised trials: a grey zone

Abstract

" The authors highlight the fact that there is a lack of guidance for investigators, regulators, as well as research ethics committees, on how to examine the ethical challenges which might arise in CRTs. This has led to a lack of standardisation of approaches and differences of opinion about how CRTs should be conducted and regulated. Part of the problem arises because conventional research ethics examination of randomised clinical trials focuses on the individual as the unit of randomisation; linked to this is the requirement for autonomous decision-making of the participant and welfare interests focused on minimising risks. The authors surmise that currently there is, broadly, a convergence of the principles applicable in research ethics: respect for persons (leads to requirements around informed consent and confidentiality), beneficence (risk-benefit analysis), justice and respect for communities. CRTs, according to the authors, are challenging because: (a) they involve groups and not individuals -- and the moral status of groups is unclear -- and there is no common understanding on the same; and (b) unlike usual randomised control trials where the individual is the focal unit, the units of randomisation, experimentation and observation might differ in a CRT. Given this dissonance, the authors present six areas in which"(pg 253)