Dan Neville
Ceist:191 Mr. Neville asked the Minister for Health and Children if written consent was obtained from patients in psychiatric institutions prior to completing clinical trials. [30278/00]
Written Answers. - Clinical Trials.
Dan Neville
Ceist:245 Mr. Neville asked the Minister for Health and Children further to Parliamentary Question No. 265 of 5 December 2000, the names of the psychiatric institutions in which clinical trials were conducted in the past. [29600/00]
Dan Neville
Ceist:246 Mr. Neville asked the Minister for Health and Children the number of trials and the number of patients involved in the carrying out of clinical trials over the years in psychiatric institutions here. [29601/00]
Dan Neville
Ceist:247 Mr. Neville asked the Minister for Health and Children if he will have a public investigation undertaken into clinical trials which have been carried out over the years on patients in psychiatric institutions here. [29602/00]
I propose to take Questions Nos. 191, 245, 246 and 247 together.
The detailed information concerning numbers of participants and locations of trials is not available in the Department and I have, therefore, referred the Deputy's questions to the Irish Medicines Board and requested that it provide me with the information sought, upon receipt of which I undertake to respond to the Deputy.
As the Deputy is aware, the Control of Clinical Trials Act, 1987, introduced strict regulatory controls on the conducting of clinical trials in Ireland. Since the introduction of this Act, proposals for clinical trials must be assessed by the Irish Medicines Board and the IMB's approval must be obtained for all clinical trials including those conducted in psychiatric hospitals. All proposals to carry out trials are first assessed by internal staff of the IMB and then discussed at a clinical trials sub-committee meeting. The members of this committee are all physicians/surgeons in clinical practice and include a professor of psychiatry as a member. A decision to approve or reject a trial is then forwarded to the executive committee of the IMB and subsequently to the Human Medicines Advisory Committee. The IMB has also advised that all trials are conducted according to internationally accepted standards of good clini cal practice – GCP. The IMB has a GCP inspector on its staff to ensure that these standards are applied. The proposed trial must also have the approval of an ethics committee in the hospital or institution concerned prior to commencement.
Section 9 of the Control of Clinical Trials Act, 1987, sets out the requirement for informed consent by participants in clinical trials. Properly given, informed consent constitutes an important safeguard for the participant. For the purpose of ensuring that the consent is valid, the Act requires that the consent must be given in writing and signed by the person who is to be the participant in the trial; and the person consenting is capable of comprehending the nature, significance and scope of his consent, and the consent is obtained by or on behalf of the person conducting the trial.
To ensure informed consent, the Act – section 9(4) – requires that the person conducting the trial make sure that the volunteer is made aware of the following matters the objectives of the trial, the manner in which the substance or preparation is proposed to be administered; the risks and any discomfort involved in and the possible side effects of the trial; and whether the trial will involve the administration of placebos.
The consent must be given in writing and signed by the person who is to be the participant. There are special provisions applying under section 9(7) in the case of patients who, for practical and other reasons, are unable to give their written and signed consent. These provisions require: (a) where the patient is capable of comprehending the significance of his consent, he can give his consent to the doctor treating him for that illness in any other manner provided it is clearly given and in the presence of two witnesses who are present at the same time. In such cases the consent must be expressed in writing and be attested by the signatures of the two witnesses; (b) where the patient is incapable of comprehending the significance of the consent to be given, he can only participate in the trial if written and signed consent to such participation is obtained from a person, or persons, who in the opinion of the Ethics Committee is or are competent to give such consent on his behalf. Such a person or persons must be independent of the person arranging to conduct the trial and of the doctor or dentist conducting the trial.
It should be noted that in both these instances it is not permissible to conduct a clinical trial unless the substance or preparation under trial is to be administered for the purpose of saving the life of the patient, restoring his health, alleviating his condition or relieving his suffering.
In his 1999 report, the inspector of mental hospitals noted that all drug trials in psychiatric hospitals are the subject of approval by local ethics committees and are in conformity with existing legislation. The Mental Health Bill, which is currently before the Oireachtas, will prohibit the conduct of clinical trials on patients who are held involuntarily for psychiatric care and treatment.
Given that there is a solid legislative framework in place for the conduct of clinical trials generally and given that there is a rigorous process provided for specifically in relation to the matter of consent, I do not propose to undertake an investigation at this stage. However, if the Deputy has specific concerns about an individual case or individual areas, I will have enquiries made if he lets me have the details.
Question No. 192 withdrawn.