Organization and Tasks
The Ethics Committee is a collegial body, multidisciplinary in composition, which operates fully autonomously. It evaluates proposals for clinical trials to be carried out at the Santa Lucia Foundation and approves their implementation, according to scientific, ethical and economic criteria. The Committee is informed by the guidance given by international health agencies, general medical ethics, the Helsinki Declaration as well as the guidelines of Good Clinical Practice. It promotes the training and preparation of the staff involved in clinical research, while focusing on the individual.
The Secretary of the Ethics Committee is responsible for the literature of the research, its data preservation as well as the dissemination of the Committee's proceedings. The Secretary maintains and updates the registry of all clinical trials and keeps direct relationships with the Office of the Ministry of Health in areas related to its research.
Evaluation of Proposed Research Projects
All Research programs to be implemented at the Santa Lucia Foundation must fall within the areas of neuroscience and neuromotor rehabilitation, consistent with the scientific mission of the Foundation, as an Institute of Health Care and Scientific Research (IRCCS).
The Ethics Committee of the Santa Lucia Foundation also evaluates research protocols and clinical drug trials of others, inclusive of non-profit, public and private organizations, including pharmaceutical companies. Also, within the Ethics Committee's competence are requests for observational studies in compliance with the guidelines provided by the Italian Agency for pharmaceutical evaluation (AIFA).
Members of the Ethics Committee
President: Dr. Mons. Lorenzo Leuzzi
Vice-President: Dr. Carmela Razzano
Members: Prof. Carlo Caltagirone (Scientific Director FSL), Dr. Maria Giulia Colombini, Giuseppina Fanari, Dr. Giuseppe Guaglianone, Dr. Giuseppe Lavra, Dr. Maria Rosaria Milana, Ing. Marco Iosa, Prof. Emiliano Giardina, Dr. Stefano Paolucci, Prof. Claudio Franchini, Dr. Carmelina Razzano, Dr. Antonino Salvia, Prof. Vincenzo Maria Saraceni, Prof. Marco Trabucchi, Dr. Marco Molinari, Dr. Marco Tramontano
Office of the Secretary: Dr. Stefano Paolucci (Manager), Ms. Elisa Battisti
Submission of Application Documents for Evaluation by the Ethics Committee:
- Regulation of clinical research protocols
- Request for clinical projects
- Request for drug trials
- Request for pharmaceutical observational studies
- Request for research from the non profit sector
- Informed patient consent issues – Participation in experimental studies
- Informed patient consent issues – Participation in tesla magnetic resonance studies