asked the Minister for Health his present views on the Clinical Trials Act, 1987 which came into effect on 1 December 1988; and if, in view of the fact that it would appear to leave members of ethical committees who approve clinical trials liable if anything goes wrong, he is considering amending the legislation to ensure that this Act does not halt clinical research in hospitals.
Ceisteanna—Questions. Oral Answers. - Clinical Trials.
14.
The Control of Clinical Trials Act, 1987 provides a balanced framework to facilitate clinical research and to protect those who participate in clinical trials. I am aware of legal opinion on the lines of that mentioned by the Deputy in her question and I have taken steps to try to reassure the members of ethics committees that on the basis of the legal advice available to me the Act is structured in a manner that effectively defines the duty of care of the ethics committee and its members, a duty of care that would be limited to foreseeable potential risks and that it would be extremely unlikely that liability would fall on an ethics committee or its individual members unless negligence on their part were established.
In this context, sections 8, 9 and 10 of the Act are particularly relevant in relation to defining the duty of care of an ethics committee towards participants in a clinical trial. Under section 8, an ethics committee would consider the justification for a trial and assess the potential risks to be incurred by participants in relation to the objectives of the trial. Under section 9, a participant in a clinical trial would consent to participate having been informed and advised beforehand of full details about the trial, including any potential risks, discomfort or possible side-effects involved and inherent in this is an acceptance by the participant that there is a degree of risk involved in the trial. Under section 10, an ethics committee have to satisfy themselves that sufficient security is set aside to compensate a participant who may suffer injury or loss as a result of a clinical trial.
Specifically in relation to security for compensation for participants who suffer injury of loss as a result of a trial, I am advised that consideration of the limit of duty of care which an ethics committee owe to a participant has to be made in the context of the Act as a whole and with particular reference to sections 8 and 9. If an ethics committee are satisfied reasonably that adequate security is available having regard to the nature and risk of a particular trial based on a reasonable estimate of possible loss or damage, they would have properly carried out their duty and the question of their being negligent would not arise. In this regard, it would not be reasonable to expect an ethics committee to provide for anything beyond what could be deemed to be the possible foreseeable risks associated with a particular trial.
The situation referred to in the question is limited to a small number of hospitals and I am hopeful that it can be resolved so that clinical research will continue in those hospitals. I will of course keep the Act under review in the light of its operation towards achieving its twin objectives of facilitating research and protecting participants. If, after a reasonable period of its implementation, the Act is shown not to be achieving both of these objectives I will propose an amendment to it to ensure that it does so.
I should like to thank the Minister for his thorough reply. Obviously, this is a grey area. Members of ethics committees have received their own legal advice which is contrary to that made available to the Minister. Is the Minister prepared to make that legal opinion available to members of ethics committees?
Those who were concerned about this aspect of the legislation have had a number of meetings with officials of my Department at which they discussed the matter. I would be glad to have our legal advisers meet with the legal advisers of the hospitals concerned so that they will be made aware of how our legal opinion was arrived at.
Will the Minister be prepared to lodge copies of the guidelines in the Dáil Library for the information of Members?
Yes.