Ensuring the Safety and Well-Being of Patients
The Candiolo Cancer Institute ensures that every clinical trial proposed by its physicians and researchers is reviewed by a competent Ethics Committee (CET), selected according to the nature of the study and in compliance with national and European regulations.
Before any clinical trial can begin, it must undergo a rigorous evaluation by independent bodies. The primary objective of this process is to safeguard the safety, rights, and well-being of all participants.
Identification of the Relevant Ethics Committee
Depending on the type of study, the reference Ethics Committee is:
- Clinical trials with medicinal products: CET designated by the sponsor as the national “Single Ethics Committee,” in accordance with Ministerial Decree 30.01.2023. Medical device studies and prospective pharmacological observational studies: CET designated as the reference Ethics Committee for the Study Coordinating Center.
- Other study types (non-pharmacological research, observational non-pharmacological studies, cell/tissue studies, nutritional studies, and requests for therapeutic or compassionate use): Territorial Interagency Ethics Committee of the AOU City of Health and Science of Turin Territorial Interagency Ethics Committee
- Interventional drug studies: conducted in accordance with EU Regulation 536/2014, which ensures high standards of safety, transparency, and oversight. The process is managed through the Clinical Trials Information System (CTIS), the European platform for submission and evaluation of clinical trials.
The evaluation process takes place in two steps: - AIFA – Italian Medicines Agency assesses the scientific validity of the study and the investigational medicinal product;
- Territorial Ethics Committee (CET) evaluates ethical aspects, participant protection, and safety considerations.
The Role of the Ethics Committee
The CET is an independent body responsible for ensuring that only ethically and scientifically appropriate studies are approved and initiated.
Before any study begins, the CET verifies that:
- the study is ethically and scientifically sound
- the information provided to participants is clear, complete, and understandable
- the procedures involved are safe and appropriate
- the rights, dignity, and welfare of participants are fully protected
Without the approval of the Ethics Committee, no clinical study can be initiated at the Candiolo Cancer Institute.