The podcast dedicated to the role of the legal and ethical framework behind FACILITATE is finally online! Wenkai Li, legal researcher at Vrije Universiteit Brussel, and Ciara Staunton, legal and ethical researcher at UNIMORE University, go deep into the legal challenges of returning individual clinical data to participants, a topic that’s at the core of this patient-centric project.
In short, the two researchers explain the idea behind: simpler, clearer, and more consistent access to the individual data of clinical trial participants. A process that is not easy, due to different systems and rules, attitudes and preferences of study participants that make returning individual data very challenging.
To clarify what is meant by legal and ethical framework in FACILITATE, Ciara uses the analogy of the colouring book, where law represents the outline that gives the boundaries, the structure, the lines that cannot be crossed. Ethical principles are the colours that bring the picture to life, representing what is right in different cultural, economic, or political contexts.
Ciara and Wenkai emphasize how FACILITATE goal is to build a system that respects both the legal rights and the lived experiences of participants. The goal is a process that’s legally sound, ethically thoughtful, and centred on the people.
