Dan Neville
Ceist:265 Mr. Neville asked the Minister for Health and Children if drug experiments were carried out at any-time on patients in mental institutions here. [28734/00]
Written Answers. - Clinical Trials.
Clinical trials have been carried out over the years on patients in psychiatric institutions in this country.
Up to 1987, a voluntary scheme of control over the conduct of clinical trials operated whereby these trials required the approval of the National Drugs Advisory Board and also the approval of an ethics committee in the hospital or institution in which the trials were carried out.
Since the introduction of the Control of Clinical Trials Acts, 1987 and 1990, the Irish Medicines Board is required to give approval for clinical trials including those conducted in psychiatric hospitals. The supporting data, protocols, patient information leaflets and consent forms associated with these trials would all have been assessed by the internal staff of the IMB and considered by the relevant advisory committees prior to approval. These trials would have been conducted under the supervision of consultants and would have had approval by the relevant local ethics committee prior to commencement.
Drug research is essential for the rejection of ineffective or toxic drugs and the confirmation by ongoing assessment of the effectiveness and safety of existing therapeutic drugs. There is a regulatory requirement in almost all countries, including Ireland, that such trials be conducted before an application for a marketing authorisation would be considered. In the pre-marketing phase this process of development is a lengthy one involving various stages of investigation ranging from chemical development to experimentation on animals and finally to testing on humans. The tests on humans are extensive and include those carried out on healthy volunteers, on patients suffering from the condition for which the substance or preparation is intended to treat and on patients suffering from certain complications which could affect the behaviour of the drug under trial in the body.
The question of the involvement of humans in clinical trials has received much attention over the years and has prompted several examinations, at both national and international level, of the controls applicable to such trials. At international level, in 1964 the World Medical Assembly adopted the Declaration of Helsinki which contains recommendations guiding physicians in biomedical research involving human subjects. This declaration has been revised on two occasions since, in 1975 and 1983, and compliance with it is a prerequisite for approval of clinical trials by most drug regulatory agencies.
In 1987, the Control of Clinical Trials Act, 1987, replaced the voluntary arrangement for the clearance of submissions for trials through the then National Drugs Advisory Board. The Act introduced strict regulatory controls on the conducting of clinical trials in Ireland, under which a person proposing to conduct a clinical trial must first seek and be granted the permission of the Irish Medicines Board before undertaking the trial. In addition to such permission, the approval of an appropriate ethics committee must also be obtained. The Act also provides a range of protections for persons participating as volunteers in clinical trials and includes the requirement for adequate informed consent as set out under section 9 of the Act.