Biobank Belgian Red Cross-Flanders
As a blood establishment, the Blood Service of Belgian Red Cross-Flanders has a mission to deliver sufficient and safe blood products for transfusion. This is why we exist and why we collect blood, plasma and platelets daily.
Products 'not for transfusion'
In processing these donations, there are sometimes products that are not suitable for transfusion to patients, for example because of deviating laboratory results or other quality defects. In addition, there are "residual fractions": parts of blood donations that are not used for transfusion, or only to a certain extent. Finally, there are residual blood samples, which remain after performing the mandatory tests.
These unsuitable products, residual fractions and samples can still be put to useful use. The Blood Service therefore makes them available for scientific research, both internally and by third parties. University researchers, pharmaceutical firms and biotech companies often need these products to conduct their scientific research.
Biobank Belgian Red Cross-Flanders: contribution to scientific research in Flanders
In order to continue to do so in the future, Belgian Red Cross-Flanders has had a biobank since April 13, 2019. The Biobank makes human body material available (subject to donor consent ) for scientific research. Through the Biobank, Belgian Red Cross-Flanders, and you as a donor, contribute to scientific research in Flanders. The objectives and activities of our Biobank have been concretized and received a favorable opinion from a recognized ethical committee. The Biobank Belgian Red Cross-Flanders was registered with the Federal Agency for Medicines and Health Products (FAMHP) under registration number BB190034 (granted on 03/04/2019).
Biobank: objectives
The objectives of the Biobank of Belgian Red Cross-Flanders, approved by the Research Ethics Committee UZ/KU Leuven, are:
1. General purpose: to obtain more insight into medical conditions and their treatment
2. Specific research applications:
- Use of blood products (plasma, ...) as a matrix for in vitro research and for qualification of biomolecules
- Isolation of cells for use in cell assays, cell culture*, cell therapy*, studying signal transduction
- Extraction of RNA and DNA with a view to research into well-defined target molecules
- Processing into growth media for microbiological applications and for cells* and tissues*
- Use in testing methods for drugs and medical devices (hemolysis, toxicity, potency, degradation, ...)
- Use as study or reference material in epidemiological research
- Research i.in connection with blood transfusion and blood banking
- Transplant medicine
- Immunogenetics
*only for in vitro application; the use for cultivation of material intended for administration to humans is excluded
Only scientific research that meets the general objective and one (or more) of the specific applications is eligible for making products from the Biobank available Belgian Red Cross-Flanders. Each application is assessed on this basis by the manager of the biobank.
Biobank: only with your consent as a donor
The Biobank Belgian Red Cross-Flanders makes human bodily material available only with the donor's consent. The medical questionnaire you fill out as a blood, plasma and platelet donor with every donation contains a statement. With this you give your consent or not to the use of your donation material for scientific research. Only with the donor's consent can donations that do not qualify for transfusion, residual fractions of that donation or residual samples be distributed by the biobank. This is strictly controlled by a thorough review of each medical questionnaire and an electronic control system during the processing of products and samples. If the donor does not give consent, the unsuitable products, residual fractions and samples are destroyed. In turn, patient and organ donor samples from the Histocompatibility and Immunogenicity Laboratory at Blood Service may not be used if the patient or donor objects.
Biobank: anonymization of products
As a rule, the products delivered by the biobank are anonymized. This means that it is made totally impossible to know or trace their origin. This also makes it impossible to link results arising from the scientific research back to the donor. Only in exceptional circumstances are biobank products delivered coded. The products or samples then carry a unique code through which your personal data can be linked to the materials and test results. No direct identity information of the donor is ever communicated.
Patient and organ donor samples originating from the Histo-compatibility and Immunogenetics Laboratory of the Blood Service are always delivered in coded form. In this case, the identification of the patient concerned and other relevant data are transmitted to the researcher in a coded manner. Conversely, findings of the scientific research relevant to the patient can be fed back.
Biobank: legal framework
On January 9, 2018, the Royal Decree on biobanks was published. Together with the law of December 19, 2008 (Law on the acquisition and use of human bodily material with a view to the medical application to humans or scientific research), this royal decree defines the legal framework within which the provision of blood products for scientific research must take place as of May 1, 2019. In accordance with this legislation, the Biobank Belgian Red Cross-Flanders was notified to the Federal Agency for Medicines and Health Products (FAMHP). The notification number assigned by the FAGG is BB190034.
Biobank: contact details
Not through the biobank: products for validation and educational purposes
The Biobank Belgian Red Cross-Flanders only makes products available for scientific research (cfr. the legal framework on biobanks and the acquisition and use of human bodily material for the purpose of scientific research).
In addition, Blood Service makes blood products and samples available to medical la-boratoria or research centres for the validation of test systems etc. or to educational institutions for didactic activities. Broadly speaking, we use the same methods and principles for this as for the biobank. We strictly monitor donor consent, assess the purpose of use and anonymize the products for external users.