The PICASO Ethical Guidelines were based upon the project’s Ethical Principles. The guidelines were implemented in the project by means of the development of a check list, The PICASO Ethical Check List. The Check List is a tool for the project to check if the Ethical Principles were implemented and that applicable regulatory requirements were fulfilled.
The Check List was formatted as a series of questions aimed to ensure that the trials were conducted in an ethically sound manner with respect to the involvement of patients and their personal data. The Check List was used to assess compliance with the Ethical Guidelines as well as relevant data protection and privacy regulations. In fact, annual compliance and monitoring reports (internal reports) were completed which were largely based upon the results of completed Check Lists. Both trials have shown compliance with the Ethical Guidelines and the PICASO Ethical Board has also approved the annual compliance reports indicating that the PICASO project and in particular the two project trials have been conducted in an ethically sound manner.
The PICASO Ethical Guidelines and the Ethical Check List are available in D3.3 The PICASO Ethical Guidelines.