From Dynamic Consent to Dynamic Governance: An Architecture for the Traceability of HSR
In Human Subject Research (HSR), dynamic consent generally refers to the online management of informed consent (IC) between a research institution and a participant.
The term evokes the changing conditions of consent (the result) by binding the two words. The underlying information technologies (the means) are implicit. The reasons for change are confined to the digital channel and its analog endpoints.
Closer to the etymon, dynamic governance refers to the en-force-ment of rules that determine how researchers and other stakeholders in research implement IC in a socio-technical environment.
Multiple sources of change exist for HSR that have consequences on IC and on its legality, scope, and duration. The regulator cannot enforce informed consent without a control function. The paper describes design constraints for distributed consent management systems and for the traceability of IC in the general context of HSR
Available at: 10.1109/ICEDEG65568.2025.11081531