Clinical trials conducted in Ireland generally involve the testing of new drugs on persons who actually suffer from the condition for which the drug is being developed. Clinical trials are regulated by the Clinical Trials Acts 1987 and 1990 and by the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 (SI No 190 of 2004) which implement Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.
Information in regard to the numbers of participants taking part in clinical trials is being assembled and I will arrange to have it forwarded to the Deputy when it becomes available. Participants in clinical trials are generally recruited by the clinician treating them for a pre-existing condition.
There is no requirement on those conducting clinical trials to forward information on the nationality of those taking part in clinical trials to any official agency. In regard to any compensation that might have been paid, this would be a private matter between those involved in any settlement and no information is available to my Department on this issue.
