Retrospective ethical approval?

Case number:
98-31

Case text (Anonymised)

A paper reported a questionnaire study of patients’ views on their preferences between minimal access and open access surgery. The questionnaires had been given to patients attending two types of clinic. The paper made no mention of ethical approval and the author was asked to clarify. He responded that he had not obtained ethical approval but that he had spoken to the chairman of the hospital ethics committee who would consider giving this retrospectively. A subsequent email from the chairman of the ethics committee to the journal expressed doubt about the value of retrospective approval, pointing out that when a study was reviewed prospectively it was possible to suggest changes to the protocol, which obviously could not be done when it was viewed retrospectively. The chairman added that “it is certainly not a foregone conclusion that we would have passed this study.” The internal editorial committee considered this case in particular, and the general issue of retrospective ethical approval, when the authors have simply forgotten or not thought of obtaining it. They were unanimous in deciding that retrospective ethical approval was not acceptable and that this paper must be rejected,  explaining the reason.

Advice: 

The editor was advised to inform the head of the author’s institution that the study had gone ahead without ethics committee approval.

Follow up: 

The paper was rejected, and the editor informed the head of the institution concerned.

Year: