Minutes of Meeting - Irish Council for Bioethics on ethical requirements for clinical trials

Minutes of Meeting held by Irish Council for Bioethics on ethical requirements for clinical trials on 23rd March in the Royal Irish Academy

Attendees: Ethics committee chairmen and secretaries, Health Research Board and ICORG. Prepared by : Siobhan Gaynor 24th March 2004

Speaker: Mr Tom McGuinn Chief Pharmacist Dept of Health & Children

* Outlined EU directive text and draft Irish regulations
* Directive has already been amended to allow IMB to review insurance indemnity issues and not ethics committees ( ie single review rather than duplication)
* In question & answer session Mr McGuinn said that Irish regulations would not be issued until mid-April
* In answer to questions he admitted that there would be a hiatus in approvals by ethics committees as they would have to be recognised by supervisory body which could take some time
* He acknowledged that supervisory body has not been established or terms of reference established
* He cannot say what resources will be available to supervisory body. Local ethics committees will have to be resourced by their appointing authority
* He has been advised that ongoing trials will come under the terms of Irish CT Act and will continue to do so until new system is established.
* In his opinion ethics committees will be covered under terms of clinical indemnity scheme.
* A number of ethics committees expressed their disquiet about the situation and said they would be advising their committees to stop all clinical trial work pending further clarification from the Dept of Health & Children.

Speaker: Stephanie Harcourt Northern Ireland Dept of Health

* Process to implement upcoming EU Directive on clinical trials in relation to Ethics Committees in Northern Ireland has been ongoing for 3 years and is nearing completing
* A collaborative consultative process was initially undertaken to establish requirements
* In line with other UK colleagues they decided to adopt the COREC model and set up a Northern Ireland Office for Regional Ethics Committee (ORECNI)
* Unlike other UK regions they decided to incorporate social research as well as trial research in this process.
* Office (ORECNI) has been established since July 2003 . Manager Dr Siobhan McGrath has been appointed since July 2003. http://www.orecni.org.uk.
* Old ethics committees were disbanded and process of establishing new ethics committees was commenced in 2002. This was a public recruitment process and 3 regional ethics committees for Northern Ireland have now been established and will commence operation on the 1st of May this year