Mr Larry Warren had sat on the committee for almost a year but had to step down shortly after the committee was re-constituted to bring it into line with the EU Directive on Clinical Trials.
The Directive, which became Irish law in May 2004, insists that one-third of all ethics committee members be lay people.
It is believed that Mr Warren
had been put forward as a lay person but this was not accepted by the Department as he
is heavily involved with a patient advocacy group which has an office on the Beaumont campus.Lay members of ethics committees are not permitted to be involved in research or have links with the Hospital. According to minutes of the June meeting of the Beaumont Hospital board, Beaumont Chief Executive Mr Liam Duffy sought clarification as to why Mr Warren was at the May 27 meeting of the ethics committee, and in what capacity.
In a letter dated July 8, the convenor of the committee said that Mr Warren
had attended the May meeting "in the capacity of guest member".He
had since stepped down from the committee as the Department of Health
had not accepted him as a lay member, the Hospital board was told in July.
The board noted that in future, any issues in relation to membership of the committee should be referred to the Hospital board rather than directly to the Department of Health
It is understood that there is no provision for guest members of the public to attend ethics committees under the EU Clinical Trials Directive.However, the Department told IMN
it had no objection to Mr Warren
attending the meeting in question as he
was invited so he
could be informed in person that he
did not meet the criteria set out.
Under the Directive, ethics committees can be granted permission by the Department of Health
to give an opinion on trials in any hospital in the State.Beaumont was recognised by the Department for this purpose in March.
A Beaumont spokesperson said Mr Warren
was not acceptable as a lay member as he
had a conflict of interest.Lay members are not permitted to be involved with advocacy groups or have other interests in medical research, said the spokesperson.Mr Warren, who is Chief Executive of the Alpha 1 Foundation which has an office in the RCSI building at Beaumont, told IMN that the Department of Health did not regard him as a lay person in the sense suggested by the EU Directive. He
said lay people are not usually expected to have knowledge of disease areas or involvement in research.
Asked how long he
had been active on the committee, Mr Warren
said it was no more than a year.After the committees were reconstituted in the wake of the new legislation, it became clear that he
could not remain on the committee. The Department of Health
said lay members of ethics committees cannot participate in the promotion or conduct of clinical research."As Mr Warren is the Chief Executive of the Alpha 1 Foundation, which supports research projects, he does not meet the above criterion and therefore cannot be appointed as a lay member," it said.
The Foundation headed by Mr Warren
aims to highlight anti-trypsin deficiency, an inherited condition affecting more than 1,000 Irish people.