Information declaration of consent
Our ability to diagnose and treat diseases has progressed significantly in recent decades. These progresses are the result of long-standing medical research in which doctors, scientists and patients of several generations have actively participated.
An important part of this research relies on patients’ health-related data from medical history, such as results of laboratory analyses, therapy information or genetic predispositions. Any biological material collected during the hospital stay and which is no longer needed for the treatment, is also extremely valuable for research. These leftover samples can be for example blood, urine or tissue samples.
This leaflet explains how patients can contribute to medical progress and provides information in terms of data protection and associated rights. Thank you for your interest and attention.
Frequently asked questions about the General Consent
What is the General Consent?
The general consent is an information letter with a declaration of consent. Persons treated in the hospital may, with the signature of the general consent, consent to the reuse of their data and samples for research projects.
How can you make your contribution to research?
If you sign the following consent form (link to: General Consent) with «Yes», you will make your health-related data and any remaining samples available for research. The consent applies to all data that has already been collected in the hospital or will be collected in the future. This applies in the same sense for biological samples.
Is there a benefit for you if you sign?
You have no direct benefit yourself. However, the reuse of your data or samples may in the future lead to important findings for the prevention or treatment of diseases. In individual cases (e.g. new findings, relevant new therapies) this information is made available for you and you may be contacted.
Are there financial advantages or disadvantages?
There are no additional costs for you. It is by law impossible to generate money with your data and samples. Therefore, there is no financial benefit for you or for the hospital.
Will you be informed if your data or biological material is further used for research?
With your consent you allow the transfer/use of your data or samples without you being specifically informed about which research projects are being carried out.
What would be a concrete example of how your data might be used?
During a hospital stay, certain medications were used to treat a disease in a patient and the patient was discharged in good health. There is another therapy drug on the market that is used by other hospitals. Now we would like to compare both medications. We might for instance want to know, whether one therapy works better or is better tolerated compared to the other.
How are your health-related data and samples protected?
Your data will be processed and protected in the hospital according to the legal regulations. Only authorized hospital personnel, such as doctors, will have access to the unencrypted data from your medical history and access to your unencrypted samples. Biological samples are kept in biobanks. If your data and samples are used for research projects, they will be encrypted or anonymised.
What is a biobank?
A biobank is a structured collection of different samples under certain biobanking regulations.
What is the difference between "encrypted" and "anonymous"?
"Encrypted" means that all personal information, such as your name or date of birth, is replaced by a code (e.g. SCS-001). The key showing which code belongs to which person is kept safe by a person not involved in the research project. People who do not have access to the key cannot identify you. If data and samples are "anonymised", there is no key which leads back to your person.
Who is allowed to use your health-related data and samples?
Your data and samples will be made available to authorized researchers at our hospital for research projects or may be used in research projects in collaboration with other public or private institutions (other hospitals, universities or pharmaceutical companies). The projects can be carried out in Switzerland or abroad and may include genetic analyses. For research projects abroad at least the same data protection requirements apply as in Switzerland. Research projects are generally subject to a review by the responsible ethics committee.
Why can your data be forwarded to home and abroad?
One reason for the disclosure would be e.g. the national or international cooperation of researchers. This is often necessary to obtain the necessary number of cases that make a statistical analysis meaningful.
What are genetic data?
Data resulting from the analysis of biological material (e.g. blood, urine, tissue) of a subject, for instance by a chromosome, deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) analysis.
Who decides which research projects may be carried out?
The responsible ethics committee (for Basel: Ethics Commission Northwest and Central Switzerland, www.eknz.ch) checks whether the legal requirements are met and whether the research projects comply with scientific and ethical standards.
Does the revocation of your consent have to be in writing?
Yes. Just like the consent itself, the revocation must also be in writing. Please contact St. Clara Forschung AG (firstname.lastname@example.org).
Are you informed about research results?
Data and sample research projects usually do not yield information that is directly relevant to the health of an individual. If, however, a significant result is found and a medical measure is available, it is possible that you are contacted by the hospital.