DAFIDUMER (DFG)

The success and quality of medical research in the health care sector depends decisively on the possibility to use personal data for research purposes, in particular, personal health data, genome data and biomaterials collected in clinical contexts.
So far, all efforts to find a legally secure, ethically acceptable and effective method that meets all legal requirements, especially data protection requirements, as well as the challenges of networked and translational research have not yet brought the breakthrough success demanded by clinical research and practice. One concept which holds promise as a balancing solution between practicability and the rights of data subjects is the concept of data fiduciary.
The DFG-funded project “DAta FIDUciaries in MEdical Research” (DAFIDUMER), structured into a legal and ethical part, aims to lay the ethical and legal foundations for the data fiduciary concept in medical research and to jointly submit concrete proposals for its implementation.

The ethical subproject will examine to which extent existing ethical conceptualization of fiduciary relationships can be transferred to the context of data fiduciaries.
Main research questions will be:

• What are necessary features of a fiduciary relationship?
• Is it possible to apply these features to data processes? How must data fiduciary concepts be designed to meet the requirements of a fiduciary relationship? Which current data fiduciary concepts do not fulfil the requirements of fiduciary relationships (“misnomer”)? What additions are necessary to meet the requirements?
• Into what kind of trust architecture should the data fiduciary concept be integrated? How can data fiduciary concepts be embedded in a governance framework for secondary use of health data?
• What are the rights and duties of different stakeholders?