Limerick East): The conducting of clinical trials is governed by the provisions of the Control of Clinical Trials Acts, 1987-1990. Under this legislation a clinical trial may only be conducted provided that formal approval has first been granted by the Irish Medicines Board.
The practitioner involved in providing the treatment referred to can initiate clinical trials in respect of the treatment provided the required approval is first obtained from the Irish Medicines Board. The initiative for seeking such approval, however, is entirely a matter for the practitioner himself. I understand that to date no application has been made to the board for such an approval in relation to the particular treatment referred to.