Informed Consent

The HPRA wishes to highlight requirements within national law which define persons that can take consent; (European Communities (Clinical Trials on Medicinal Products For Human Use) Regulations, 2004 (S.I No. 190/2004, as amended).

Conditions and principles for the protection of clinical trial subjects are defined in Schedule 1 of the national regulations. The regulations require that a subject has had an interview with an investigator or another member of the investigating team, prior to informed consent to take part in the trial is sought. An investigator is defined in the legislation as an authorised health care professional, which is said to mean in the regulations, a registered medical practitioner or registered dentist.

Therefore, it is the view of the HPRA that in order for an informed consent process to be deemed compliant with the regulations, evidence must be available that the subject was interviewed by an investigator and that written consent should be obtained by the investigator. It is acknowledged that other study personal, such as research nurses, may be involved, in addition.