SPHN - Development and Usability Testing of an Electronic General Consent Prototype.

Background: 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. Unfortunately, the so far established paper-based processes are intrinsically linked to the hospital admission process, labour intensive and not yielding the targeted return rates. Therefore, the overall goal of the presented SPHN project is to increase patient reach by providing hospitals with a patient-centric, user-friendly and admission-independent electronic general consent pathway. As part of the project, feasibility of different digital pathways was evaluated in a usability testing.

Methods: Based on a nationwide harmonised template, a mobile centric progressive web application was developed by the Department of Clinical Research Basel. Usability of the application and according user journeys were evaluated at all partner hospitals. Two options of giving consent were explored using 1) patients' smartphones without any involvement of hospital personnel and 2) a hospital device (tablet) with explicit confirmation of patient identity by hospital personnel. Participant signatures were captured as a picture of a handwritten signature on paper taken with the camera of the smartphone or tablet. Usability issues and feedback of participants were documented directly after usability testing.

Results: In total, 122 users agreed to participate in the usability testing using a tablet or smartphone. The general consent request workflow on the smartphone or tablet was regarded as user friendly and easy to navigate by 96% of all participants. However, capturing a picture of a handwritten signature resulted in usability issues in multiple cases, i.e. due to missing pen or paper.

Conclusion: Usability testing of our prototype application showed a broad acceptance of participants regarding the use of mobile electronic devices to give general consent. Therefore, we believe that easy-to-use digital general consent processes provide effective means to increase the patient pool for health-related research. Further discussions with legislative bodies are required to find patient centric, feasible and legally acceptable solutions in the specific case of electronic general consent for the near future.