11. December 2025

A step into the digital future: First e-consent for clinical studies at the University Hospital Basel

The international research group led by Prof. Elisabeth A. Kappos is the first study team to implement electronic informed consent (e-consent) at University Hospital Basel.

Following the revision of the Swiss Human Research Ordinance (HRO), which entered into force on 1 November 2024, it has become possible in Switzerland to obtain patients’ consent for clinical trials and research projects electronically (swissethics.ch). This form of e-consent is now being used for the first time in a research project at University Hospital Basel. The Ethics Committee for Northwest and Central Switzerland has approved the corresponding application. Since the start of the project in November 2025, initial patient feedback indicates that e-consent is perceived as a convenient and beneficial option.

Quality of life as key outcome in plastic surgery: breast surgery register

E-consent is being introduced within the breast surgery register of the Clinic for Plastic, Reconstructive, Aesthetic and Hand Surgery. The focus is on systematic outcome research, taking into account not only surgical and clinical parameters, but also patients' quality of life. Under the leadership of DKF research group leader Prof. Elisabeth A Kappos, Prof. Martin Haug and Dr. Séverin Wendelspiess, the previously retrospective registry is being expanded to prospectively include all breast operations performed at the clinic. Basic medical data, indications for surgery, progression, complications and the aforementioned patient-reported quality of life (PROMs) will be recorded. The planned prospective follow-up over at least ten years enables the comparison of different surgical methods and provides valuable insights into the long-term quality of life of patients beyond routine follow-up care. In addition, the planned parallel implementation of AI-assisted and robotic procedures and, in particular, innovative approaches such as nerve-sparing mastectomy and restoration of sensitivity thanks to nerve reconstruction can be scientifically evaluated. The latter are directly linked to the quality of life of affected patients.

Digital consent via REDCap

Consent can be given either in paper form or electronically via the data protection-compliant and validated REDCap system, which was implemented in collaboration with the Data Management Team at the Department of Clinical Research. Both new patients and those already included in the registry can participate in the research project. The latter do not have to come to the hospital again in person to sign the declaration of consent, but can also use the e-consent option. For this purpose, the identity is first verified by telephone before the e-consent procedure is initiated. Once the study information has been provided, there is a 24-hour reflection period before consent can be given digitally.

"Patients now have the advantage of being able to give their consent flexibly and from any location. Previously, the often laborious 'paper route' led to a lot of data loss, and the e-variant is also more environmentally friendly and cost-saving. The feedback from patients has been extremely positive, and they are grateful for this innovative option," says Elisabeth Kappos. "I am extremely grateful to Séverin Wendelspiess for his commitment in bringing this innovation efficiently to our patients!"

For research groups who would also like to use e-consent in the future, Prof. Elisabeth A Kappos and her team will be happy to provide further information.

Dr. Séverin Wendelspiess, Resident Physician, Department of Plastic, Reconstructive, Aesthetic and Hand Surgery at the University Hospital Basel, is in charge of the e-consent project.