October 14, 2020

Clinical trials: National Coordination Center of Ethics Committees issues Guidelines for the collection of informed consent

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.

< Back to blog
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and healthcare industry.
...
Read more
Our highly-ranked team of professionals will provide news, insights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

This blog will be a place for focusing on digital health, telemedicine and artificial intelligence, as well as more traditional topics: from the protection of intellectual properties to performance of clinical trials, from the market access to advertising and competition issues, from internal and criminal investigations to M&A and venture capital transactions.

Close
September 21, 2022
Payback for medical devices: Decree quantifying the exceeding of the expenditure ceiling for medical devices at national and regional level for the years 2015, 2016, 2017 and 2018 published ...
September 1, 2022
The 2021 annual law for market and competition addressing, as to the healthcare sector, reimbursement of drugs, intermediate distribution, patent linkage and institutional accreditation of p...
July 19, 2022
Guidelines for the implementation of the Electronic Health Record (EHR) to ensure dissemination, uniformity and accessibility of the EHR at national level now published in the Official Gazet...
June 6, 2022
The National Coordination Centre for Ethics Committees published new draft agreements for conducting clinical trials on drugs and medical devices
April 27, 2022
EU Medical Device Coordination Group (MDCG) approves “Guidance” on the borderline between medical devices and medicinal products in order to support the uniform application of Regulation...
Search by...
Search
Follow us on
Follow us on