Babies needlessly subjected to a painful procedure for research

A paper was received, which detailed a research project conducted on newborn babies, which involved taking an invasive (and painful) sample from them. The paper was worthy of publication from the point of view of scientific value, but two issues worried the editors. First, it was unclear whether the sick babies’ samples were going to be used as part of their clinical management or whether these samples were taken simply for the trial. The referee thought that certain reported parameters indicated the latter. Second, and more worryingly, the control group of healthy babies had a similar sample taken. The control group comprised all the babies meeting the inclusion criteria. The editors were concerned that this would not have been possible without some coercion of the parents. The editors wrote to the authors, asking for elucidation and learned that the samples were, indeed, taken by staff when they were collecting another routine sample. The authors added: “We took the chance and asked parents for consent in taking a little more blood . . . our ethics committee would never sanction [the invasive procedure] in normal infants just for research. ” The editors then asked for clarification of the precise nature of the ethics committee approval and parent consent forms, pointing out that the routine sample collection would not involve the invasive procedure performed except in limited circumstances. The authors responded by withdrawing the paper and declining to send the relevant documents. They complained that the editors had mistrusted them. Should this be taken further? The editors think it should, on the grounds that the babies were unnecessarily subjected to a painful procedure.