Vol. 486 No. 5
68 Mrs. Owen asked the Minister for Health and Children the procedures required before medical testing can be carried out on humans; and if he will give a commitment to have such procedures examined and revised in view of the extreme trauma caused by a proposed testing regime of 100 residents in St Ita's Hospital, Portrane, County Dublin. [2957/98]
The proposed study in St. Ita's Hospital referred to by the Deputy was one which involved using vitamin D and calcium supplements, which are available on supermarket shelves, to improve the treatment of people with a mental handicap at the hospital. Clients in St. Ita's include some in the more severe category of mental handicap and many have complicating conditions such as epilepsy or brittle bones. There is an increased risk of people with brittle bones suffering fractures during epileptic fits. This proposal was to improve the treatment of the brittle bone condition for this group of clients in order to reduce the risk of fracture.
The statutory procedures which govern studies, such as the above proposed study, are set out in the Control of Clinical Trials Acts. 1987 and 1990. The Acts set out the procedures to be followed in seeking approval for such trials and the granting of permission by proposed participants, including those circumstances where a person may be incapable of comprehending the nature, significance or scope of consent for this purpose. In addition to client or family consent, three other requirements would have to be fulfilled before the proposed study could have commenced: approval from the hospital's ethics committee; approval from the hospital's management committee; and clients whose families had given consent would, in addition, have to be screened for medical suitability for the study.
I would like to state that these procedures were being followed in the case of the proposed study in St. Ita's Hospital and that the motivation for undertaking the study was to further the best interests of the clients. However, in view of the anxiety which has been expressed by families because of the misunderstanding about the nature of the study, the medical practitioner concerned has withdrawn her request for consent from families and has informed the hospital authorities that she will not be requesting the hospital management committee or the hospital ethics committee to consider her proposals for such a study.
