Bernet, Niklaus S
Everink, Irma HJ
Schols, Jos MGA
Halfens, Ruud JG
Richter, Dirk
Hahn, Sabine
Article History
Received: 28 July 2021
Accepted: 14 February 2022
First Online: 18 February 2022
Declarations
:
: Full Research Ethics Committee approval was granted by the Ethics Committee of the Canton of Bern on 4 October 2011 (application no. 122/11) and the other twelve local ethics committees. From the second measurement in 2012 onwards, on the recommendation of the Ethics Committee of the Canton of Bern, which was approved by the remaining local ethics committees and the Swiss Association of Research Ethics Committees, the authorisation requirement was waived, as the measurement was reclassified as a quality measurement and thus did not fall under the Swiss Human Research Law and within the remit of research ethics committee. The key factors were the aim of the data collection (documentation and development of quality of care), the type of data collected (only data that is also collected as part of the regular nursing process) and the fact that no intervention is carried out. In the course of the reclassification of the measurement as a quality measurement, the ethics committees also agreed that written patient consent is no longer required and therefore written patient information followed by oral consent from the patients or their legal representatives is sufficient. Accordingly, all patients received an information letter before the measurement explaining the aim and purpose of the quality measurement. On the day of the measurement, oral informed consent was obtained directly from the patients. For patients who were not able to assimilate the information and give their oral informed consent themselves, the legal representative was asked to give oral informed consent on behalf of the patient. The participating hospitals were advised to document the oral informed consent of the patients. Participation in the measurement was voluntary. Patients’ wishes not to participate in the measurement were always respected. Non-participation had no negative consequences for the patients. The data was collected pseudonymously to prevent possible conclusions about the identity of the patients.
: Not applicable.
: The authors declare that they have no competing interests.