The National Coordination Centre of the Territorial Ethics Committees for Clinical Trials on Medicinal Products for Human Use and Medical Devices has been preparing and distributing the following documents for a few months now. They are the result of a shared elaboration among the members of the Centre, which is made up of various competences in the institutional, bioethical, clinical-scientific and patient representation fields:

Guidelines for the collection of Informed Consent for participation in clinical trials;
Information Sheet and Informed Consent form for patient participation in a clinical trial;
Information Sheet and Informed Consent form for parent(s) or legal guardian(s) for the purpose of including a minor in a clinical trial;
Informed Consent for inclusion of a minor in a clinical trial;
Informed Consent Form for the inclusion of a minor in a clinical trial – Minor aged between 6 and 11 years.

The documents are available in the Coordination Centre section at the following link.

In order to improve the process of sharing information and making decisions and to guarantee greater protection for patients, the survey is published with the aim of understanding whether the documents are fully applicable or require further study and whether training and information on specific aspects are necessary.

It is possible to participate in the survey up to and including Monday 12 February.
ACESS HERE 

For questions or support needs, please send your request to: centrodicoordinamento@aifa.gov.it