A paper was submitted, describing surgery on the sexual organs of four women. The paper was poorly written and hard to follow, but it seems that this surgery was undertaken primarily because of the unsatisfactory sexual experiences of the women’s partners. There was no mention of ethics committee approval or of the women having given consent, not only for the surgery but also for taking part in an experiment. The paper came from overseas. The editor wrote to the author asking him to advise whether he obtained ethics committee approval and whether the women had consented on both counts. Is this the right approach? Should this case be pursued if no answers are forthcoming?
_ It is hard to define where clinical innovation ends and research begins. It is well known that surgeons can make changes to procedures without ethics approval, but this case raises the issue of the ethics of the surgery being undertaken. _ Informed consent was necessary, but as there was no evidence as to what this surgical procedure would do, and as it is difficult to understand any rationale for the surgery, it would be impossible to fully inform any patients undergoing these operations. _ Refer the case to the professional regulatory body in the author’s country to see if this procedure is within their realm of professional conduct.
The editor wrote to the regulatory body, but received no response.