A study was submitted in which the authors describe a new surgical technique, which includes radiofrequency coagulation, to treat complete prolapse of the rectum. They say in their paper that: “in the treatment of complete rectal prolapse, no operation stands out in comparison to the others.” The authors do not seem to have received either ethics committee approval or consent from the patients. How should the editors proceed?
_ The committee assumed that the editor had already queried whether or not the authors had ethical approval and consent. _ What constitutes research in a surgical case series is a very grey area. _ How “informed”would the patient consent be? _ If the editor has any remaining doubts then he should report the authors to the head of their institution.
The case was sent to the journal’s ethics committee as well as COPE, who disputed the authors’ suggestion that their country “did not have any ethical committee whose permission is needed to carry out any new procedure.” The authors’ country had recently enacted research guidelines. The key issue would be whether surgical innovations would fall within the guidelines’ remit. The editor wrote to the authors including the new guidelines adopted in their country and invited a reply. It was unclear who the editor should approach as a higher authority, because the authors appeared to be working at their own organisation. The journal’s ethics committee suggested that if there is no local ethics committee, then the editor should consider writing to the relevant licensing body. The author wrote back to the editor, contesting that his use of the established technique in the context described was experimental and providing references for the technique. The editor referred the file to another senior editor who felt that this case was on the borderline between clinical innovation and research. Any problems with the work were unintentional and below the threshold of work requiring censure. The journal’s ethics committee debated the case again and decided that no further action was required. It had been a useful interchange and it would be useful to debate with the readership where clinical innovation ends and research begins.