Biobank Belgian Red Cross-Flanders
Objectives
The Biobank Belgian Red Cross-Flanders aims to obtain human body material (MLM) that is available from the activities of the Blood Service by Belgian Red Cross-Flanders to make available for scientific research (WO), without application to humans.
The WO for which the Biobank Belgian Red Cross-Flanders The general purpose of MLM is to gain greater insight into medical conditions and their treatment.
Within the above general objective, this MLM of the Biobank can Belgian Red Cross-Flanders be obtained for the following specific research applications :
- Use as a matrix for in vitro research and for qualification of biomolecules
- Isolation of cells for use in cell assays, cell culture, cell therapy research, studying signal transduction
- Extraction of RNA and DNA for the purpose of investigating well-defined target molecules
- Processing in growth media for microbiological applications and for cells and tissues
- Use in test methods for drugs and medical devices (hemolysis, toxicity, potency, degradation, …)
- Use as study or reference material in epidemiological research
- Research into blood transfusion, blood banking and blood disorders.
- Perfusion and preservation of organs
- Transplantation medicine
- Immunogenetics
- Tissue engineering
- Cell and tissue repair; Cell and tissue senescence
- Stem cell research and cytopoiesis
In terms of origin, nature and application of MLM, we distinguish:
- MLM originating from donors that at the Blood Service, blood or blood products, but which are not suitable for transfusion or have expired. The donor gives explicit signed consent for WO (primary use).
- On the one hand, this concerns MLM that is made anonymous before inclusion in the Biobank by the blood institution.
- On the other hand, it concerns MLM whose traceability is retained upon inclusion in the Biobank by means of a unique code (donation number). These are pseudonymised samples. This traceable MLM will be anonymised upon issue, to the extent legally permitted, by the manager of the Biobank if the donor has agreed to this and if traceability is not necessary for the intended WO.
- MLM originating from organ or stem cell donors or from patients that becomes available for WO after use for deferred diagnostics or validation. Usually this concerns WO in secondary use, exceptionally it concerns samples taken with informed consent for use for WO (primary use).
It mainly concerns blood and derivatives (cells, plasma, serum and/or DNA).
This MLM is provided by the Histocompatibility and Immunogenetics Laboratory (HILA) and by the Blood Bank laboratories for immunohematology of the Blood Service . For this MLM, traceability is maintained upon inclusion in the Biobank by means of a unique code. This traceable MLM will be anonymized upon issue, to the extent legally permitted, by the administrator of the Biobank if the donor has agreed to this and if traceability is not necessary for the intended WO.
Activities
Monitoring objectives
The Biobank Belgian Red Cross-Flanders ensures that only blood products or samples are made available for WO that are in accordance with the established objectives. With that aim, each application for the provision of MLM is assessed by the biobank. The specific application procedure can be found here .
Informed consent
In addition, the biobank ensures, as stipulated by law, that the donor has given his informed consent to use the supplied materials for WO. For MLM originating from donors at the Blood Service was immediately upon donation the explicit consent for the use of products not suitable for transfusion, of residual fractions and of residual samples for WO registered on the medical questionnaire. The presence of this consent on the medical questionnaire is systematically checked during the administrative processing of the donations and is registered in the blood bank IT system. MLM for which the consent is missing is excluded from the offer for the biobank.
The patient samples and organ donor samples that are available as residual material from the HILA or the blood bank labs of the Blood Service can only be used for WO if the patient or donor has not objected.
Anonymization and coding
In accordance with what is stated in the text of the informed consent in the medical questionnaire, MLM is obtained from donors at the Blood Service usually made anonymous. This is done by removing or making permanently illegible the unique donation number.
Information of a general nature that does not compromise anonymization can be provided with the MLM: gender, age and blood group + RhD of the donor, collection date, type of product.
If necessary for the research, MLM from the Blood Service and patient samples/organ donor samples from HILA and blood bank labs are also delivered coded. In this case, the label contains a unique identification code, but never directly identifying data such as a name or address.
Registration
All transactions of the biobank, in particular which products were delivered by the biobank, when and to whom, and whether those products were anonymised or coded, are recorded in a register for the FAMHP.
Legal and ethical framework
On 9 January 2018, the Royal Decree (KB) on biobanks was published. Together with the law of 19 December 2008, this KB determines the legal framework within which blood products for WO must be made available. Since 1 May 2019, only registered biobanks can provide MLM for WO. To this end, Belgian Red Cross-Flanders the operation of a biobank registered with the Federal Agency for Medicines and Health Products (FAMHP). The Biobank Belgian Red Cross-Flanders was registered under registration number BB190034 (assigned on 03/04/2019).
Ethical advice
In support of submitting the biobank to the FAGG, Belgian Red Cross-Flanders obtained a favorable opinion from the UZ/KU Leuven Research Ethics Committee regarding the objectives and activities of the biobank, as described below.
Written agreement
The provision of MLM for WO by the biobank must, by law, be the subject of a written agreement between the operator of the biobank and the receiving person or institution (Article 22, §2, paragraph 3 of the Act of 19 December 2008 on the acquisition and use of human body material for the purpose of medical application to humans or scientific research).
This agreement may take the form of a framework agreement (art. 10, §2 Royal Decree of 9 January 2018 on biobanks). Such a framework agreement describes in general terms the subject of the intended scientific research and lays down the conditions, responsibilities and liabilities with regard to the provision of MLM. Applications for various scientific research can be submitted under this overarching framework agreement.
Click here for more information about ordering MLM for scientific research.
Last modified on 21/10/24.
