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

Julia Maurer1, Ramon Saccilotto1, Jörg Willers1

  • 1Department of Clinical Research, University and University Hospital Basel, Basel.

Studies in Health Technology and Informatics
|June 24, 2020
PubMed
Summary

Digital general consent processes using mobile devices are well-accepted by patients, increasing reach for health research. Further legislative discussions are needed for patient-centric electronic consent solutions.

Keywords:
SPHNelectronic general consentpersonalized health

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Area of Science:

  • Health Informatics
  • Clinical Research
  • Patient Consent

Background:

  • Swiss law requires patient consent for reusing genetic and non-genetic data for research.
  • Current paper-based consent processes are labor-intensive and have low return rates.
  • The SPHN project aims to improve patient reach through a user-friendly, admission-independent electronic consent pathway.

Purpose of the Study:

  • To evaluate the feasibility and usability of digital general consent pathways.
  • To develop a patient-centric, user-friendly electronic general consent process.
  • To assess patient acceptance of mobile electronic devices for providing consent.

Main Methods:

  • Developed a mobile-centric progressive web application based on a harmonized template.
  • Conducted usability testing with 122 participants at partner hospitals.
  • Explored two consent options: patient's smartphone or hospital-provided tablet.

Main Results:

  • 96% of participants found the general consent workflow user-friendly and easy to navigate.
  • Broad acceptance of mobile electronic devices for general consent.
  • Usability issues were identified with capturing handwritten signatures due to missing materials.

Conclusions:

  • Digital general consent processes are broadly accepted and can increase the patient pool for health research.
  • Mobile electronic devices are a feasible option for obtaining general consent.
  • Further legislative discussions are necessary for patient-centric and legally acceptable electronic consent solutions.