The National Coordination Center of Territorial Ethics Committees for clinical trials on medicines and medical devices (“National Coordination Center”) has drawn up guidelines for the collection of informed consent (“Guidelines”) for participation in clinical trials, pursuant to Legislative Decree No. 211 of June 24, 2003 and Regulation (EU) 536/2014.
On July 31, 2020, the Guidelines were published on the website of the Italian Medicines Agency (Agenzia Italiana del Farmaco – “AIFA”). They provide instructions for creating clear and adequate information that can ensure effective communication between doctors and patients and their families in order to obtain valid and informed consent. The Guidelines describe the relevant rules and principles on consent and participation in clinical trials, as well as the process that should be followed to obtain informed consent.
In particular, the process for obtaining informed consent must meet certain requirements, described in detail by the Guidelines. It is worth noting that, according to the Guidelines, in order to facilitate the participation of all patients potentially interested to clinical trials, in certain situations, to be assessed on a case-by-case basis, remote electronic tools may be used for the patient information process as well as to collect consent.
Moreover, the annexes to the Guidelines contain examples of forms that may be used to (i) obtain consent from adult participants, (ii) obtain consent from parents or legal guardians, (iii) obtain consent from mature children (i.e., children between twelve and seventeen years of age), and (iv) relay information addressed to children.
Please note that the examples above include descriptions of the envisaged processing of patients’ personal data, but they also refer to additional information that must be reported in the form concerning consent to the processing of personal data. However, that form is not included in the Guidelines, even though the explicit reference to the need to attach a dedicated personal data consent form to the relevant consent form (in addition to other forms addressing possible consent for specific items, such us genetic data/samples, that may be needed depending on the nature of the trial) is a key instruction for operators.
The Guidelines and the consent forms attached therein represent the best practice for collecting informed consent in clinical trials on medicines. Therefore, the National Coordination Center strongly recommends following the Guidelines.
The Guidelines and consent forms are available on the following page of the AIFA website.