A study that helps with the microbiological diagnosis of a clinical condition had been peer reviewed and accepted for publication when it was discovered that the study had no formal ethics committee approval and that the patients had given verbal rather than written consent. The journal contacted the authors, who responded by saying that the chairman of the ethics committee in their area did know of the study, and that asking people to give written consent might have reduced the numbers in the study and caused unnecessary distress. A letter was sent to the chairman of the ethics committee for his opinion, but the journal was not happy with the response received. The instinct would be not to publish the paper. What does COPE think?
_ The authors had short-circuited ethics committee approval; there were reduced numbers in the study; and any unnecessary distress to patients does give cause for concern. But written patient consent must be obtained. _ More information is required before this can be discussed further. _ This is a case that gives COPE an opportunity to act on its guidelines, and make it clear that authors should observe proper procedures.
The journal declined to publish the paper.