A report into the failure of a senior hospital consultant at St Luke’s Hospital, Kilkenny, to obtain consent before carrying out gynaecological “exploratory work” on women patients is under consideration by Ireland East Hospital Group.
Obstetrician and gynaecologist Prof Ray O'Sullivan says he did not feel he needed to obtain consent before carrying out tests on five women patients last year. The hospital maintains he should have obtained consent, has sought his suspension and has reported the matter to the Medical Council.
The tests were stopped last September after nursing staff raised concerns over whether the required consents had been obtained from a regional hospital ethical committee and from the patients themselves.
The tests, which were carried out by junior staff unaware there was an issue with consent, involved flushing the vaginas of the women with water, inserting a miniature scope for monitoring, and measuring the pressure within the vagina. The equipment involved, including tubes and pressure gauges, was brought in from outside the hospital.
Investigation of symptoms
The women involved had been referred to the hospital for investigation of their symptoms.
Speaking to The Irish Times, Prof O’Sullivan said the issue “had more to do with preliminary, exploratory work – as to whether you need consent for that before you engage in an actual clinical trial. It was more technical than anything else.”
Asked if he felt he needed consent, he replied: “I felt I didn’t need consent. I didn’t because we weren’t actually doing the research. We were just seeing if a particular procedure that we were planning on doing as part of the research could be done.”
Tests stopped
Once the issue became know, the hospital stopped the tests and informed the patients, who were told investigations into the matter would be completed within weeks.
The hospital commissioned a report from Prof Peter Doran, a scientist at UCD's school of medicine, which was critical of the failure to secure consent.
Ireland East Hospital Group then commissioned a second report. Prof O’Sullivan said he was sure that report would say “that’s fine, fire ahead with the research but just get the ethical approval going forward for the actual research”.
A spokeswoman for the hospital group said its chief executive Mary Day had "only received the report on Friday and hasn't had a chance to review it".
Asked whether an apology would be made to the women affected, she replied she had “nothing further to say”.
