A paper reported a randomised controlled trial relating to a common investigational procedure. There are two different postural positions into which a patient may be put while the procedure is carried out, and individual operators may have a preference for one or the other, but both are in routine use. The purpose of the randomised controlled trial was to find out whether the procedure is technically more successful in one or other of the patient positions, and whether there was any patient preference. It is a clinically relevant question, and the study produced an apparently useful and meaningful result. The paper reported that the patients consented verbally to random assignment, but as the clinical reviewer pointed out, there was no mention of ethical approval. The authors were asked about this. They replied that they had not applied for ethics committee approval, having discussed this carefully among themselves, on the basis that the only variable in the study was the position adopted by the patient, and that both positions were part of standard and established practice. The editors felt some sympathy with this argument, but suggested the authors ask the ethics committee whether they thought that approval had been required, and if so, whether they would consider giving it retrospectively. The ethics committee chairman replied that the project certainly should have been submitted for ethics committee approval and that it was not possible to offer retrospective review or approval. He also added that had the committee considered it, they would probably not have been satisfied with simple verbal consent and would have required this in writing, with the patients being given 24 hours to consider whether they wanted to take part. Should the editors now reject the paper, or should they consider accepting it with an explanatory commentary about the ethical issue?
_ This had been an experiment, because the subjects had been randomly assigned. Ethics approval should therefore have been obtained. _ It was, however, an important study and should be published, but with an editorial commentary, highlighting that verbal consent alone is insufficient and that ethics committee approval should have been obtained, and perhaps including the opinion from an ethics committee chair. _ The danger was that patient groups might be outraged. _ The patients should be informed that the paper is to be published.
The ethics committee of the journal felt that what the authors had done was reasonable. But the paper was eventually rejected on scientific grounds. Had acceptance been recommended, the journal’s editorial advisory committee would have followed COPE’s advice to publish the paper with an editorial commentary.