/ Regulatorik

New documents for the research consent

From now on, new, nationally harmonised information and consent documents for obtaining patient consent regarding the further use of data and samples for research purposes will apply.

The further use of routinely collected patient data and samples for research purposes requires the consent of patients. This applies, for example, to retrospective data evaluations from our hospital information systems or the research-related use of samples from the pathology biobank. Obtaining such consent is known as "research consensus", which is synonymous with the "general consensus" at the University Hospital of Basel. Usually, patients treated as inpatients or outpatients receive the information and consent documents from the admission staff or other employees when they enter the USB.

From mid-January 2020, the current documents will be replaced by the nationally harmonized General Consent version. The USB thus contributes to a nationally harmonised patient enquiry. The documents were approved by the five university hospitals and endorsed and approved by the swissethics Board of Directors.

The documents now consist of information and the consent form. They will be available in four languages (German, English, French, Italian). Translations in other languages will follow. The consent form now contains two signature lines. One for the patient and one for the legal representative, if necessary. The internal process on the USB remains unchanged. Patients who have made a decision so far do not need to be asked again.