Control of Clinical Trials Act, 1987

Security for compensation.

10.—(1) A person shall not—

(a) conduct a clinical trial, or

(b) administer any substance or preparation for the purpose of a clinical trial,

unless such person establishes to the satisfaction of the ethics committee that he can provide sufficient security to ensure that adequate funds are available to provide appropriate compensation for each participant who may suffer injury or loss as a result of the trial.

(2) It shall be a good defence for a person prosecuted for contravening subsection (1) to show that he reasonably believed that the provisions of that subsection had been complied with.