Gynaecologist guilty of misconduct for procedure on five women without consent
A consultant gynaecologist has been found guilty of professional misconduct for carrying out unauthorised research on five female patients without their consent during a routine surgical procedure at St Luke's Hospital in Kilkenny seven years ago.
A fitness-to-practise inquiry of the Medical Council found that three allegations of professional misconduct against Professor Ray O'Sullivan were proven beyond reasonable doubt.
They related to the consultant's insertion of an abdominal rectal pressure catheter to measure intravaginal pressure while carrying out a hysteroscopy on five different women on September 4-5, 2018 at St Luke's Hospital.
A separate allegation related to Professor O'Sullivan's failure to obtain advance approval, to produce a research protocol or to comply with professional guidelines about the use of the catheter.
The inquiry held this week heard that Professor O'Sullivan had made admissions in relation to all the allegations and had accepted since February 2020 that his actions represented 'an error of judgement' on his behalf.
A letter from his solicitors accepted at the time that with the benefit of hindsight, the consultant should have sought ethical approval for what he was doing in accordance with the Declaration of Helsinki – a set of ethical principles adopted internationally for medical research involving humans.
The chairperson of the inquiry, Jill Long, said the fitness-to-practise committee also noted that medical records contained no reference to any consent having been obtained from any of the five female patients in advance of the procedure.
Ms Long said the committee's conclusions were also based on a systems analysis review of what happened by the Ireland East Hospital Group, of which St Luke's Hospital in Kilkenny is a part.
She also observed that the issue arose while Professor O'Sullivan alone had taken the decision to conduct a feasibility study of using the catheter to measure intravaginal pressure while performing a diagnostic hysteroscopy.
Ms Long said the purpose of the research on the five patients was to see if a future proposed study was even possible.
She explained that the research was to determine if there was a better alternative that could be developed to the traditional method of carrying out such an examination as the use of a speculum caused 'so much more discomfort'.
The three-member committee concluded that the proven allegations represent professional misconduct in so far as they represented a serious falling short of the standards of conduct expected of medical practitioners.
Ms Long said it did not consider that the actions represented professional misconduct on the basis that doctors of experience, competence and good repute would consider them 'disgraceful or dishonourable' or amounted to poor professional performance.
She said the committee were satisfied with the finding of professional misconduct notwithstanding the fact that Professor O'Sullivan's motivation was 'benign' as he had failed to carry out the 'fundamental step' of obtaining consent from the patients for an additional and separate procedure.
The use of the abdominal rectal pressure catheter by Professor O'Sullivan had already been the subject of extensive legal proceedings over the past few years.
In May 2023, the Supreme Court ruled by a 4-1 majority that the HSE had acted fairly and reasonably when it suspended the consultant and recommended that he should be dismissed from his former job at St Luke's Hospital.
The previous year, Professor O'Sullivan settled a long-running legal battle with the HSE over his suspension on foot of a complaint made in 2019 about his use of unauthorised and unapproved actions and procedures on the five female patients.
However, the HSE sought to have one discrete issue relating to the fairness of its decision to suspend Professor O'Sullivan and to recommend his dismissal determined by the Supreme Court after the Court of Appeal had ruled in March 2022 that the consultant was entitled to an order quashing the HSE's decision.
Professor O'Sullivan currently works at the First IVF fertility clinic in Clane, Co Kildare.
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