Highlights
Implementing e-Consent: A Step into the Digital Future
They drive digital innovation to improve patients’ quality of life: Prof. Elisabeth A. Kappos and
Dr. Séverin Wendelspiess
Innovative solution based on new legal basis
In 2025, the Department of Clinical Research (DKF) supported the first implementation of electronic informed consent (e-consent) at University Hospital Basel (USB) within the DKF research group of Prof. Elisabeth A. Kappos. The legal basis for e-consent was established by the revision of the ordinances of the Swiss Human Research Act (HRA), which came into force on 1 November 2024. This amendment introduced explicit provisions for electronically documented consent, setting regulatory standards for validity, data protection, and auditability. The DKF Data Management team enabled the operationalisation of these legal requirements through the GCP-compliant software REDCap®, which fulfils all compliance criteria related to data security and traceability.
Prof. Kappos’s research project applying the e-consent is nested within USB’s plastic breast surgery registry, enrolling adult patients who have undergone any form of breast surgery with the involvement of the department of plastic, reconstructive, aesthetic and hand surgery since 2014. Designed to span at least two decades with a ten-year recruitment-period, it will collect long-term patient reported outcome measures, encompassing not only surgical and clinical parameters, but also their quality of life and will specifically evaluate surgical innovations such as re-innervated breast reconstruction, nerve-sparing mastectomy and robotics.
“Patients now have the advantage of being able to give their consent regardless of location. Previously, the often tedious ‘paper trail’ led to a lot of data loss. Feedback from patients has been overwhelmingly positive; they are grateful for this option.”
Prof. Elisabeth A. Kappos​
​
Associate Professor Department of Plastic, Reconstructive, Aesthetic and Hand Surgery, University Hospital Basel
The Impact of Breast Surgery on Patients’ Quality of Life
_
Project Lead
Prof. Elisabeth A. Kappos, Associate Professor Department of Plastic, Reconstructive, Aesthetic and Hand Surgery, University Hospital Basel
Prof. Martin Haug,
Deputy Head of Department of Plastic, Reconstructive, Aesthetic and Hand Surgery, University Hospital Basel
Dr. Séverin Wendelspiess, Resident Physician, Department of Plastic, Reconstructive, Aesthetic and Hand Surgery, University Hospital Basel
_
Study design
Single centre clinical prospective and retrospective observational study.
_
Key data
Project duration 20 years, with a recruitment period of 10 years.
Adults who have undergone any kind of breast surgery with involvement of the department of Plastic, Reconstructive, Aesthetic and Hand Surgery at the University Hospital Basel since 2014, can be enrolled.
_
e-consent in clinical research
In Switzerland, electronic informed consent may incorporate digital tools to deliver study information, such as videos, podcasts, interactive websites or apps for tablets and smartphones. Study participants can give their consent either by signing a paper form by hand or by providing an electronic signature alongside that of the investigator or other authorised person conducting the consent process.
_
Legal basis
KlinV Art. 7c, KlinV-Mep Art. 3b, and HFV Art. 8c
swissethics – Guidance on electronic informed consent (e-Consent)