During the process of the digitalization of healthcare, data plays a central role in the provision of health-related services. The project "Virtual Consent Assistant for Informed and Data-Sovereign Patient Consent", or ViCon for short, funded by the German Federal Ministry of Education and Research (BMBF), is researching new human-technology dialogs. In this context, a virtual consent assistant is to support citizens in providing informed consent to the processing of patient-related data. In the context of ViCon, the interdisciplinary consortium initially faces the following three guiding questions:
- What level of freedom of choice and what type of consent do citizens actually want regarding disclosure of certain types of personal data in different research contexts?
- What is the basis for citizens' trust in a virtual consent assistant and which aspects, for example, have either a positive or negative effect on citizens' trust? What design elements must the ViCon assistant have in order to gain the trust of citizens and users?
The assistant is to serve as a mediator and a point of trust between data-processing entities on the one hand and citizens on the other. New human-technology dialogs are to be developed, that enable citizens to independently inform themselves in generally understandable language about the intended use of the respective data release. As well as to understand the opportunities and risks involved.
A consortium consisting of the company Kairos, the FernUniversität in Hagen, the Center for Ethics, Law, Economics and Social Sciences in Medical Research (ceres) of the University of Cologne and the Fraunhofer IMW under the leadership of the Fraunhofer ISST is committed to the succesful implementation of this goal. The joint project is funded by the BMBF with approx. 1.8 million euros.
The consortium covers a wide range of research fields, which are expressed in the following sub-goals:
- The first sub-goal is to quantify how comprehensible existing consents are. This is in order to derive how large the existing information or knowledge deficit (competence) is in the use of consents for data release.
- The second sub-goal deals with the development of consent options that contribute to ensuring self-determination, privacy and trust. While taking into account ethical and legal principles ("ethics in and by design") as well as an ethical framework concept for the use of ViCon.
- The third sub-goal is to research the measure of citizens' trust in the release of data. Based on this, measures will be investigated that promote an increase in digital trust and thus the release of research-relevant data.
- The fourth sub-goal involves the elaboration, development and evaluation of a media-didactic concept. This is for addressing the information deficit and trust by identifying needs for the preparation and reformulation of content while backing this up with learning concepts for promoting digital sovereignty. For this purpose, an adaptive learning environment with recommender systems as decision support and signals with prompting character, so-called prompts (hint stimulus) for individual feedback as well as a concept for self-reflection will be designed and implemented. It is through this media-didactic framework that citizens will be able to consciously and specifically focus on their own knowledge, information, action and learning needs with regard to informed consent in their everyday lives, trigger personalized learning processes and self-reflexively assess the consequences of their actions. The focus is on the participatory involvement of the target group from the very beginning.
- The fifth sub-goal ultimately consists of merging the other sub-goals into "ViCon" as a human-technology dialogue system. Whereby, informed consent is implemented with the aim of sovereign control of data flows for clinical research and care.
Federal Ministry of Education and Research (BMBF)