What data and biological samples are collected at NUM?
Data and biological samples form the basis of medical research. During your examination at NUM partner sites and as part of NUM studies, various types of data and biological samples may be collected. The data and biological samples collected depend on the specific treatment objective or on the research questions to be answered as part of a study. Data may include personal details, such as your date of birth, gender or age, as well as information about your health, such as blood test results, diagnoses or X-ray images. Biological samples are samples taken from the human body that can be used for medical investigations, such as blood, tissue, urine, saliva or stool samples.
What does ‘secondary use’ mean?
As part of your examination or participation in a study, data or biological samples are collected from you for a specific purpose, such as making a diagnosis or, in the case of study participation, to answer a particular research question. These collected data and biosamples may also be of great significance for further future research questions. If you are being treated at a German University Hospital or another site that cooperates with the NUM, you can also give your consent for your data (health data) and biological samples to be used for future medical research projects beyond the originally defined purpose. In this case, this is referred to as the ‘secondary use’ or ‘further use’ of these data and biosamples.
Broad Consent: The basis for data collection for secondary use
In order to obtain your consent to the secondary use of your data and biological samples, the NUM generally uses what is known as ‘broad consent’. ‘Broad’ in this context means that consent is not limited to a single specific research project, but permits use for various research projects that have not yet been determined at the time of your consent.
Such broad consent is important because it is not yet known which medical questions researchers will be investigating in the future. However, before your data or biological samples may be used for a new research project, the project is carefully assessed. This ensures that the use is scientifically sound, ethically justifiable and compliant with data protection regulations.
The protection of your data is a top priority for NUM. For this reason, your health data and biosamples are, as a rule, only made available for research purposes in pseudonymised or anonymised form. This means that researchers cannot draw any direct conclusions about your identity. Nor will any information be included in publications or research reports that could identify you personally. Furthermore, you can usually specify that certain forms of secondary use are excluded. For example, you can exclude the further use of your biological samples or stipulate that your data must not be transferred to countries outside the European Union with a lower standard of data protection.
Under the broad consent framework, in most cases you can also decide whether further data – such as data from your health insurance provider – may be used for research.
Your consent is voluntary. You may withdraw it at any time without giving a reason. Doing so will not result in any disadvantages for your medical treatment or participation in a study. You may also exercise your general rights regarding the processing of your personal data at any time. These so-called data subject rights are enshrined in the European General Data Protection Regulation (GDPR) (an overview can be found here).
The exact conditions and risks associated with the use of your data will be explained to you by the relevant (study) staff at your centre and will also be provided to you in writing. If you have any questions, you can contact your treating centre or the NUM study management team at any time.
Although state-of-the-art pseudonymisation or anonymisation techniques are used to pseudonymise or anonymise your data, complete anonymity of your data – particularly your genetic data – cannot be guaranteed. The relevant (study) staff will explain any potential risks to you, and you will have the opportunity to ask questions.
Further information on the research projects within the NUM can be found here.
Information from the German Biobank Network (GBN)
What happens to biological samples and health data in a biobank? The explanatory videos produced by the German Biobank Network (GBN) explain how it all works – for adults, as well as for children and their carers. Further information is available at biobanken-verstehen.de.