Using patient data and samples collected during routine clinical treatments for research purposes requires the consent of the patients. This applies, for example, to retrospective data evaluations from hospital information systems or to samples from biobanks such as those in pathology.
Patient consent for research purposes is called "research consent", in some hospitals also "general consent".
What does the research consent cover?
The research consent at the University Hospital Basel (USB) covers the further use of coded, non-genetic and genetic patient data as well as biological material (samples) (Art. 29, 32 Human Research Ordinance, HRO). In addition, information is provided on possible anonymisation of genetic patient data and samples (Art. 30 HRO).
For how long is the consent given valid?
A given consent is valid indefinitely and independently of the time at which the data were collected or samples taken.
Can a given consent be withdrawn?
Yes, withdrawals can be reported by telephone or in writing to the respective clinic or by email to email@example.com, stating the patient name and date of birth. After withdrawal, the data and samples will no longer be used for new projects.
Is someone allowed to sign on behalf of the patient?
The legal representative (e.g. daughter, son or spouse) may sign the consent form on behalf of the patient if the patient is incapable of judgement. In the case of children under the age of 14, the parents or legal representative may sign. From the age of 14, adolescents must sign themselves (if they are able to judge). The representation is listed in detail in accordance with the Swiss Civil Code ZGB Art. 378 (1).
Are data and/or samples passed on to pharmaceutical industry or to foreign institutes?
In principle, this is possible. However, data or samples will be transmitted exclusively in coded form. The data protection provisions of the receiving country must meet at least the same requirements as those in Switzerland.
Where at the USB is the research consent obtained?
Under the project management of the Department of Clinical Research (DKF) and due to intensive cooperation of all USB departments, the research consent processes have been introduced practically throughout the entire hospital since 2016. More than 90,000 decisions are currently recorded. Of all patients who have made a decision, 85% agree to further use of data and samples for research purposes. We are still interested in continuously optimizing the process with the help of the departments. Please feel free to contact us with your ideas and comments.
How does the USB research consent process work?
Patients receiving inpatient or outpatient treatment usually receive the information and consent documents from the admission staff or other staff when they enter the hospital. As of January 2020, the documents correspond to the nationally harmonized General Consent version. The documents are currently available in four languages (German, English, French and Italian). Further translations will follow. The documents consist of one and a half pages of information and a consent form. Please note that the consent form may not be copied. If you have any questions regarding the creation of the form, please contact the local administrative staff or Julia Maurer, PhD.
For ethical and organisational reasons, patients who enter the hospital via the emergency department are asked for their research consent either as part of the patient satisfaction survey or during the second contact (follow-up examinations).
How and where are patient decisions made available?
Signed consent forms are recorded in the e-archive via an automated scanning procedure. The decisions are then directly visible in the most important hospital information systems (ISMed and PathoWin).
A list of patient decisions can be prepared for researchers for feasibility studies on research projects. For the creation of a database with specific patient data by the ICT department from the hospital information systems, patient decisions on research consent are also taken into account. Please use the DKF contact form for such requests.
Status of information November 2019.