Informed consent for clinical trials
The HPRA wishes to highlight requirements within national law which define persons who can obtain informed consent, which differ for trials authorised under the Clinical Trials Directive (CTD) or Clinical Trials Regulation (CTR).
Clinical trials authorised under the Clinical Trials Directive (CTD)
Conditions and principles for the protection of clinical trial subjects are defined in Schedule 1 of S.I 190 of 2004, as amended. 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, the HPRA consider 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.
Clinical trials authorised under the Clinical Trials Regulation (CTR)
Rules regarding the protection of trial subjects and informed consent are defined in Chapter V of the CTR. Under Article 29(2)(c), the CTR requires that a subject has had a prior interview with a member of the investigation team who is appropriately qualified according to the law of the Member State concerned. In Ireland, the national requirements for who may conduct the interview and obtain informed consent are defined under Part 4 of S.I 99 of 2022. These regulations require that the interview prescribed by Article 29(2)(c) of the CTR is conducted by the investigator or by a registered medical practitioner, a registered dentist, or a registered nurse, whose training, experience and qualifications have been assessed by the investigator and determined to be appropriate to qualify him, or her, to conduct the interview.
Any persons whom the investigator has determine as suitable to obtain informed consent should be clearly delegated this task by the investigator. If delegated, the investigator would still be required to have oversight of the informed consent process, as with any other delegated tasks. Such oversight should be appropriately documented so that it can be demonstrated on inspection. It is also important to note that the investigator will still be responsible for determining if a subject is eligible to enrol in a trial, regardless of whether the task of obtaining informed consent has been delegated.
Please consult the HPRA Guide to the CTR for further information on informed consent.