After several days of confusion over who at the Mater hospital in Dublin decided to defer trials of a cancer drug, it has finally been confirmed that a clinical trials advisory group, chaired by Mater chief executive Brian Conlan, was responsible.
The decision, taken last Thursday, was made on the basis that the wording of an information leaflet for patients involved in the trials ran counter to the hospital's Catholic ethos.
The leaflet stated that female participants in the trials of a drug considered capable of prolonging life in those with advanced lung cancer, would have to agree to use birth control since the drug could affect an unborn child.
While it advised methods of birth control that ran counter to the hospital's ethos it also said abstinence was acceptable.
Mark Rodgers, managing director of Roche Ireland, the company behind the trial drug Tarceva, said yesterday the row over what the company wanted suggested to him that the committee which deferred approving the trial "did not examine the full documentation supplied".
But the Mater hospital said last night that while the word abstinence was included, it still had concerns. It added that following the introduction last year of an EU directive governing clinical trials - which allowed such trials to go ahead in any hospital once they were approved by the Irish Medicines Board and by one hospital ethics committee in the State - the hospital's management committee decided to set up an advisory group to approve any applications for clinical trials.
This group has six members and Mr Conlan is the only hospital board member on the group. A hospital spokesman refused to name other members but said they represented management, medical and nursing disciplines.
In June Mr Conlan wrote to the hospital board saying his group was receiving clinical trial applications which contravened the hospital's ethos.
The Mater said the advisory group deferred its decision on the Tarceva trial because it knew another committee in the hospital, with three members, was drafting the wording of an extra information leaflet which would be given to trial participants and would reflect the hospital's ethos.
Fr Kevin Doran, Mater chairman John Morgan, and a nurse tutor, Sr Eugene Nolan, are on this group which will report on its leaflet to a full meeting of the hospital board on October 18th.
A hospital spokesman said that if the board adopted the wording at that stage, the advisory group could give the trial the go-ahead.
Fr Doran, also secretary to the Catholic bishops' bioethics commission, told The Irish Times the decision to defer the clinical trial had not been made by any committee of which he was a member. Neither was it made by the hospital's ethics committee.
Since news of the trial's deferral emerged on Monday, the hospital has given several answers to questions on who made the decision. First it said it was the ethics committee, then it said it was a subcommittee of the board, and then it said it was the entire hospital board. Late last night it said it was the decision of its clinical trials advisory group.
The trial which has been delayed at the Mater would have involved a small number of patients. The trial is already under way at hospitals in Cork, Galway and Tallaght and at Beaumont and St James's hospitals.