eConsent: Basis for future research projects

In order to be able to use patient data, which are generated daily in the clinical routine of hospitals, for research purposes, the written consent of the respective patients is required (general consent). In the future, it should be possible to collect and manage these consents digitally.

Currently, the general consent is documented exclusively on paper and manually transferred to the local hospital systems. These processes are labor-intensive and time-consuming. In addition, the processes offer little flexibility in everyday hospital life. A digital solution should help save time, avoid errors and increase the response rate.

Application in Usability Testing


A first prototype of the electronic application already exists. First user tests, so-called usability tests, with patients could be carried out in all participating hospitals. Two versions were tested. One for private mobile devices and another developed for hospital internal tablets. The aim of the usability testing was to find out how the users cope with the information and the process of this app.

eConsent

Mobile app for the collection of patient consent for use of health-related data for research purpose

Affiliated institutions
University Hospitals Basel, Bern, Geneve, Lausanne und Z├╝rich, University Children's Hospital Basel

In Collaboration with
swissethics, Swiss Clinical Trial Organisation (SCTO), Swiss Biobanking Platform (SBP), Swiss Research Network of Clinical Pediatric Hubs (SwissPedNet)

Funding
Swiss Personalized Health Network (SPHN) Infrastructure Development Projects 2017

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First results with over 100 test persons show that the usability is rated as very good. A broad majority of the persons support the further development of the e-General Consensus. It also became clear that patients are very concerned about data protection.

Further developments

Parallel to the technical development, legal clarifications are currently still underway, which focus primarily on the possible use of electronic signatures and ensuring complete data protection. Therefore, it is still open by when the electronic collection and administration of patient consent can actually be integrated into everyday hospital life. In the meantime, the experts at the DKF are continuing to work on a patient-friendly technical solution.


Contact

Denis Falcetta, PhD

Specialist Regulatory Affairs, DKF

Email

July 2020