The study conforms to the principles established by national and international regulations, including the Declaration of Helsinki and the Code of Ethics. All personal data is handled following Regulation (EU) 2016/679 of the European Parliament and of the Council, of April 27, regarding the protection of natural persons with regard to the processing of personal data and the free circulation of these data (General Data Protection Regulation, GDPR) and the corresponding national laws of the participating countries.
Prior to analysis, all data will be subject to appropriate safeguards to respect patients' data protection rights, including full de-identification and re-identification risk analysis in accordance with GDPR articles 6e, 9.2j and 89.
The proposed data collection procedures are relevant and limited to the purposes of the project. The data collected will be stored on secure servers and will be pseudonymised using encrypted identifiers to ensure privacy. Registration data at the individual country level will only be accessed by researchers from that country with the appropriate permissions.
The entire research protocol will be subject to ethical review in each country.
All forecast models will be publicly available, including interpretable measures of forecast accuracy and the individual importance of predictors.
The entire research protocol will be subject to ethical review in each country.
All forecast models will be publicly available, including interpretable measures of forecast accuracy and the individual importance of predictors.
The risk of intrusive interventions caused by false positive predictions will be avoided because the final decision regarding treatment and individual rights restrictions will always rest with the end user, clinician and or patient, and never with the CDSS. However, the intensity of the proposed interventions will always depend on the level of certainty of the prediction and will be proportional to the risk detected.
All participants in the implementation research will give their explicit informed consent to participate, including the fact that the suicide risk assessment is based on machine learning techniques applied to their medical data, in accordance with articles 6.1a and 9.2a of the GDPR.
Implementation research will provide indications of clinical efficacy as well as potential benefits versus harms of the personalized CDSS when it is subsequently applied on a large scale.
Small-scale clinical trials of the CDSS will always be conducted in settings where high-quality, effective treatment is available.
The PERMANENS project is supported by Instituto de Salud Carlos III (ISCIII) and by the European Union NextGenerationEU, Mecanismo para la Recuperación y la Resiliencia (AC22/00006; AC22/00045), the Swedish Innovation Agency (no. 2022-00549), the Research Council of Norway (project no. 342386) and the Health Research Board Ireland (ERAPERMED2022) under the frame of ERA PerMed.
