FUNDACION CNIC CARLOS III
Melchor Fernández Almagro, 3
Postal Code: 28029, Madrid, Spain
Phone: (+34) 91 4531200
Fax: (+34) 91 4531245
Guarantees and confidentiality
The CNIC Santander PESA study has been thoroughly reviewed by two ethics committees, the Comité de Bioética de España (Spanish Bioethics Committee) and the Comité de Ética de la Investigación del Instituto Carlos III (Carlos III Institute of Health Ethics Committee), and by the Agencia Nacional de Evaluación y Prospectiva (ANEP; Spanish National Evaluation and Forecasting Agency).
Studies conducted with human subjects or medical samples are strictly regulated by Spanish law. The law demands protection of the confidentiality of all study participants. All stored data and information will therefore be anonymous, so that participants cannot be identified.
Each patient will be randomly assigned a number, and the association between name and number will be stored in an independent database that can be accessed only by the introduction of two passwords. Furthermore, the law states that no data can be passed to third parties without the express consent of the participant. This restriction includes the Medical Services department of the Banco Santander.
Under the law, anyone enrolled in the study can withdraw their consent at any time without the need to provide any explanation. Samples from anyone who does withdraw from the study will be destroyed.