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The SEARCH home-based neonatal care (HBNC) trial generated a heated debate amongst health activists, researchers and demographers in India upon its publication in the Lancet in 1999. More than a decade after the Lancet article, a new debate has been sparked, this time on the ethics of the study. Against this backdrop, we identify three key questions which require in-depth discussion. First, was the choice of the study design (cluster nonrandomised control trial), appropriate given the circumstances relating both to the study site and the locale? Second, was it ethical not to offer any intervention to the control units given that a known treatment existed? Third, do contemporary research ethics guidelines satisfactorily address all the ethical issues related to the study design? This paper examines the first question. We draw three main conclusions from this critical appraisal of the HBNC trial. First, the study design of the trial is motivated by the paradigm of evidence-based programmes and policy formulation. Second, generally speaking, the HBNC study design passes the internal and external validity tests but raises important ethical questions. Third, these questions transcend the HBNC trial to apply to many other social and health interventions studies; as such, the HBNC trial should be studied as a paradigmatic case.

SEARCH’s HBNC trial: towards a broader debate on the ethics of social intervention research