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Ethical issues

The CSRC Programme adheres to the ethical principles of the Declaration of Helsinki for medical research involving human subjects, the Charter of Fundamental Rights of the European Union (2000/C 364/01), and the European Convention on Human Rights. The project has been approved by the Medical Research Ethics Committee of Parc de Salut Mar (CEIC-PSMar) (Protocol 2017/7431/I), the Clinical Research Ethics Committee of the Institut d'Investigació e Innovació Parc Taulí (CEIC-I3PT) (Protocol 1.1-2017), and by the ethics committees of other participating centres.

The epidemiological study involves processing data from health registries (PADRIS). The Catalan Agency for Health Quality and Evaluation (AQuAS) is responsible for managing, anonymising and de-identifying these data. The processing of these data adheres to the principle of data minimisation: the only data that have been processed are those strictly relevant to the aims of the project and that can reasonably be presumed to potentially be predictive of suicidal behaviour.

The clinical study involves collecting data from clinical samples. All study participants have signed two informed consent forms related to the use and preservation of sociodemographic, clinical and neuropsychological information, as well as the biological samples obtained. 

Registry linking adheres to the Order SAS/3470/2009 and the European Union Data Protection Directive (Directive 95/46/CE). All data processed in the Risk Code Project have been completely anonymised and de-identified.