asked the Minister for Health his views on recent reports (details supplied) indicating that the new Control of Clinical Trials Act, 1987, which is due to come into force shortly will bring medical research effectively to a halt; and if he will make a statement on the discussions which have taken place between himself and hospital and college representatives on the Control of Clinical Trials Act.
Written Answers. - Clinical Trials.
201.
I propose to commence the Act with effect from 1 December 1988.
The Act is designed to provide a framework of controls within which medical research would continue while, at the same time, the rights of those participating in clinical trials would be safeguarded. One of the mechanisms provided for in the Act to protect the volunteer is the provision that the approved ethics committee for the trial must satisfy itself in relation to the adequacy of the financial arrangements made to compensate individuals in the event of injury or loss arising from such trials.
While some concern has been expressed by certain ethics committees in relation to their potential liability arising from this statutory function, I am confident that the matter at issue is not insurmountable and that it will be possible, arising from the discussions referred to by the Deputy in the question and bearing in mind the provisions of the Act as a whole, to reach a satisfactory conclusion for the ethics committees concerned.