gms | German Medical Science

Background/research question: According to the Swiss Law on Research in Humans, the reuse of routinely collected genetic and non-genetic data and samples from patients for research purposes requires the consent of patients. So far, a paper-based “general consent” process with a handwritten signature is established at all five Swiss University Hospitals.

Presenting paper consent forms to patients require resources in terms of printing, assigning, explaining, collecting and transferring into the clinic system. Analysis of consent data from 2018 at the University Hospital Basel showed that 37.7 % of patients in the outpatient and inpatient sector (47’291 out of 128’886) returned a decision. Of those patients, 86.1 % (40’719 out of 47’291) agreed to share their data and samples. Therefore, putting more effort into the distribution of the general consent by facilitating the access to the consent form should enlarge the general consent patient pool and support the success of research initiatives in personalized health.

The goal of this project is to extend the general consent process with a flexible, patient centric and admission-independent electronic consent pathway. All five Swiss University Hospitals agreed to participate in a usability testing of an electronic consent pathway at their institution.

Methods: Based on a nationwide template for a general consent form, a user interface prototype for the collection of the general consent was developed by the Department of Clinical Research Basel. The prototype is currently evaluated in the form of a usability testing in different settings at the five Swiss university hospitals. Two options of giving consent are explored using 1) patients’ mobile phones without any involvement of hospital personnel and 2) a hospital device (tablet) with explicit confirmation of patient identity by hospital personnel. Usability issues will be documented by respective recruiters in each hospital with feedback of patients collected by a survey directly after usability testing.

Results: The usability testing is ongoing, but results will be available at the end of 2019.

Conclusion: This project has the potential to significantly advance the development of digital solutions to tailor one of the central prerequisites allowing data exchange, sharing and interoperability for research purposes.

Competing interests: The authors declare no conflict of interest. This project is funded by the Swiss Personalized Health Network (SPHN).