Ensuring the safety and well-being of patients
INOC – the Candiolo National Cancer Institute ensures that every clinical trial proposed by the Institute’s physicians and researchers is reviewed by a competent Ethics Committee (CET) , selected based on the type of study and in accordance with national and European regulations.
Before a clinical trial can begin it must pass rigorous evaluation by independent bodies. The goal is to protect the safety, rights and welfare of the people involved.
Identification of the relevant ethics committee
Depending on the nature of the study, the relevant Ethics Committee is:
- For clinical trials with drugs: CET identified by the sponsor as the “Single Ethics Committee” at the national level (Decree 30.01.2023);
- For studies with medical devices and prospective pharmacological observational studies: reference CET for the Study Coordinating Center;
- for other types of studies (nonpharmacological, observational nonpharmacological, cell/tissue studies, nutritional studies, requests for therapeutic or compassionate use): AOU City of Health and Science of Turin Territorial Interagency Ethics Committee;
- for interventional drug studies: drug trials follow the European Regulation 536/2014, which ensures high standards of safety and transparency. The process is managed through the Clinical Trials Information System (CTIS), the European portal that enables the submission and evaluation of clinical trials.
The evaluation takes place in two phases:
— AIFA (the Italian Medicines Agency) verifies the scientific quality of the study and the drug involved;
— the Regional Ethics Committee (CET) evaluates the ethical aspects, participant protection, and safety.
The Role of the Ethics Committee
The CET is an independent body that ensures only studies that respect the participants are conducted.
Before each study begins, it verifies that:
- the study is ethical and scientifically sound;
- The information provided to patients is clear and complete;
- the procedures provided are safe;
- the rights and dignity of participants are always protected.
Without the approval of the Ethics Committee, no study can begin.