Ensuring the safety and well-being of patients
IRCCS Istituto di Candiolo ensures that each clinical trial proposed by the Institute’s physicians and researchers is evaluated by a competent Ethics Committee (TEC) , chosen according to the type of study and national and European standards.
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 stages:
– AIFA – Italian Drug Agency verifies the scientific quality of the study and the drug involved;
– Territorial Ethics Committee (TEC) evaluates ethical aspects, participant protection and safety.
The Role of the Ethics Committee
The TEC is an independent body that allows only studies that respect the people involved to be initiated.
Before the start of each study verify 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.