asked the Minister for Health whether there is an obligation to inform patients using drugs which are still in their trial phase of this fact; and if he is satisfied that general practitioners receive sufficient information about such drugs to advise their patients on them.
Written Answers. - Drugs in Trial Phase.
37.
The Control of Clinical Trials Act, 1987, which came into force in December 1988 places a statutory obligation on doctors to inform patients using drugs which are still in their trial phase.
This particular statutory requirement forms an essential prerequisite to the concept of informed consent on the part of those participating in clinical trials which is a basic and central element of the procedures set out in the Act for protecting the participant. In summary, the provisions of the Act in this respect require that the participant must be given sufficient information in a comprehensible form in order to enable him to make an informed judgment on whether to participate or not and his consent must be given in writing.
Under the statutory scheme now in place, a trial may not proceed without the prior approval of the Minister and the ethics committee approval of the trial. One of the general conditions which will be attaching to all ministerial permissions is that the permission holder must ensure that each doctor, including general practitioners, involved in a clinical trial receives sufficient information about the drugs in question to ensure that they can advise their patients on them in accordance with the provisions of the Act.