A Consent Tool for Secondary Use of Biomedical Data.

To pursue scientific goals with patient data usually requires informed consent from the data subjects. Such a consent constitutes a contract between the research institute and the patient. Several issues must be included in the consent to be valid, for example, how the data is processed and stored as well as specifics of the research questions for which the data is going to be used. Here, we describe the development and the implementation of a user-friendly IT solution that supports the process-oriented obtainment of consents. Current solutions often focus only on the benefits for the researcher. Our solution intends to add value to all participants and to reduce paperwork to a minimum. The consent Tool was evaluated by a usability test using the UEQ Method (User Experience Questionnaire) and received positive feedback - both efficiency and originality were rated above the average UEQ-Benchmark. Nevertheless, the lack of compatibility with the technical infrastructure of the hospital was a significant shortcoming. Hence, although there is a general interest in digitized solutions in the healthcare sector, there are still many hurdles to implement them and roll them out.