D2.1 Report on Ethical Framework for handling personal data, and sharing and access to data within TRUSTY

This deliverable aims to specify premises for the handling of personal data, such as informed consent, conditions for privacy protection through pseudo-anonymization, and effective means for consent withdrawal, in accordance with GDPR, the former Article 29 Working Party Guidelines, relevant national legislation, and relevant international standards. The overall goal of the current D2.1 is to define a Code of Conduct that has been agreed upon by all users of collected and linked data in the consortium in order to guide the transparent and responsible re-use and sharing of consented and non-consented data (registries, spontaneous reports, research data, etc.), as GDPR establishes the limits and premises for handling personal data in Europe. Because different rules apply to different types of data, the primary task here is to define the ethical and legal requirements for collecting and bringing data into the project. The document is divided into three sections: one on good research practices that all TRUSTY project partners agreed to follow, another on data management and privacy issues, and a third on participant recruitment criteria.