From Dynamic Consent to Dynamic Governance: An Architecture for the Traceability of HSR

Bio-medical research that involves human subjects is strictly regulated. Free and informed consent of participants is in general a legal requirement for research institutions. To obtain, to maintain, and to manage informed consent of participants is a delicate task for an organization. In addition to the relationship with the patient, it is subject to dependencies, e.g., on evolving legal frameworks and on new research technologies. The usage of online platforms to inform the participant and maintain the relationship is called dynamic consent. It brings advantages, but it fails to cope with issues related to dynamic regulation and organisation of research. Where physical or logical centralization of data is not an option (for reasons discussed), the traceability of consent through multiple institutions and over borders requires other methods and techniques. Based on a model of e-governance for complex requirements, the paper studies how traceability, seen as the control function of a service owned by the State, provided by the research institution, and used by the participant, can be deployed locally by institutions on their dynamic consent management system, and collaboratively in a peer-to-peer, distributed, individually autonomous way. A minimal set of conditions is translated into an architecture for the dynamic governance of informed consent and of its traceability.