Netherlands

Radboud Biobank

The Radboud Biobank offers disease-based biobanks a centralized facility to optimize the use and distribution of biomaterial for scientific research. All collections are professionally and sustainably maintained using high-quality and secure standardized protocols for ICT, legal-ethical aspects, sample collection, processing and storage, communication and distribution. The Radboud Biobank includes biomaterial (e.g. DNA, serum, plasma, tissue, urine and faeces – depending on the specific patient group), images, associated clinical data (patient, disease-specific and phenotypic data) and derived information (genotypic data, microarray gene expressions). Patient advocates and other relevant stakeholders are actively involved in the governance of the Radboud Biobank. The Radboud Biobank envisions that the scientific data mobilized by this infrastructure will lead to improved health in patients and reinforce biomedical research.

Key facts

Name of the connected EIT Health partner:
Number of individuals:
Biobank confirmed willingness to provide samples/data for EIT Health studies: Biomaterial and clinical data from the Radboud Biobank are available to researchers worldwide. Each research application is reviewed by the Institutional Review Board (IRB). Access is open for investigators from the department that initiated the diseased-based biobank and for investigators who seek cooperation with them. Cooperation with external researchers, including those working in the health industry, is encouraged.
More details can be found on our website.
Contact person(s) and contact data
(e-mail address, tel. no) for access purposes:		 Lovice Sutherland, Manager support Radboud Biobank; Peggy Danders, Head of Radboud Biobank, readboudBiobank@radoudumc.nl, +31243668977
Number of samples:
Sample type: DNA, serum, plasma, tissue, urine and faeces – depending on the specific patient group. The Radboud Biobank catalogue provides real time information about the content of the Radboud Biobank
Website: www.radboudumc.nl/radboudbiobank
Website:

General information

Type of biobank: The Radboud Biobank is a hospital integrated biobank, i.e. all disease groups and clinical departments are represented. It stores all types of disease samples. The Radboud Biobank catalogue provides real time information about the content of the Radboud Biobank. Clinical/disease specific
If longitudinal the frequency: The clinical department is responsible for the details regarding the frequency.
Link to central portal to seek samples and data: https://catalogue.bbmri.nl/menu/main/app-molgenis-app-biobank-explorer/biobankexplorer
Broad consent: Yes. Prepare documents link
Option to recall donors: Yes
Option to recall family members: No

Biobank access procedure:

Major terms for access: Access information. Scientific researchers, who are not necessarily linked to the disease-based biobank,are invited to submit their research proposals. The research proposal has to be approved by the Institutional Review Board (IRB).This committees will assess whether the study objective fits the scope of the disease-based biobank and its informed consent procedure. Note: External applicants or those requesting samples collected by a colleague need to set up a collaboration with the Radboudumc researcher who collected the samples.
Ethical and legal compliance: Each research application is reviewed by the Institutional Review Board (IRB). After the IRB has approved the research application and the head of a sub-biobank also agrees to the intended delivery, the Radboud Biobank delivers the data and requested biomaterials to the researchers. Prior to the release, a standard Material (or Data) Transfer Agreement must be signed, which states that the biomaterial will not be used for other purposes than the original agreement, will not be delivered to third parties, remaining biomaterial will be destroyed, and that feedback will be provided regarding the findings, profits and publications. Furthermore, new information that becomes available through scientific analyses will be added to the Radboud Biobank database.
Speed and reliability of delivery: After the Institutional Review Board (IRB) has approved the research application and the head of a sub-biobank also agrees to the intended delivery, the Radboud Biobank delivers the data and requested biomaterials to the researchers.
Pricing: Researchers using the samples and clinical data pay a fee per sample, which is based on the nature and quantity of the requested samples, and on the affiliation of the applicants. In addition, a fixed administrative fee is charged for each delivery. All revenues are used as return of investment.

Quality management system:

Storage: Biomaterial and associated clinical data are stored using unique codes. The key connecting these codes to patient identifiers is kept by the owner of the specific disease-based biobank. The software package for the research database produces the unique code also noted on the application form accompanying the biomaterial. The Radboud Biobank laboratory technician enters the same code in the laboratory sample management software system. Each month, the Radboud Biobank functional manager synchronizes the research database and the sample management system using study numbers. Pseudonymisation is mandatory since hospital patient identifiers do not adequately protect patient privacy. All relevant documents can be found on our website; for additional information, please contact RadboudBiobank@radboudumc.nl
Compliance with international standards: Sample handling and storage are based on standard operating procedures (SOPs). These procedures are based on (inter)national standards.The sample handling is embedded in the quality management system of all cooperating laboratories, i.e. Department of Laboratory Medicine, Human Genetics or Pathology. Process control is based on the department’s detailed Standard Operating Procedures (SOPs). All cooperating laboratories are accreditaded / cerfified.
Current ISO certificates:

Data:

Clinical data linked to samples: The Radboud Biobank requires some basic data for the catalogue, however, the department responsible for a specific disease-based biobank has defined a minimal dataset. This dataset comprises patient information collected in the context of routine daily clinical practice, among which are base-line data (patient history, physical examination, diagnostic investigations, imaging, pharmacy) and data obtained during the follow-up treatment of the patient. The clinical department is responsible for the details regarding the data. To facilitate follow-up, connections to existing medical registries are actively sought. This includes, for example, links to registries for vital status, cause of death, hospitalization, cancer diagnoses and pathology records.
Data standards: The Radboud Biobank requires some basic data for the catalogue, however, the department responsible for a specific disease-based biobank has defined a minimal dataset. This dataset comprises patient information collected in the context of routine daily clinical practice, among which are base-line data (patient history, physical examination, diagnostic investigations, imaging, pharmacy) and data obtained during the follow-up treatment of the patient.
Data security rules: The Radboud Biobank guarantees the privacy of the participants. Biomaterial and associated clinical data are stored using unique codes. The key connecting these codes to patient identifiers is kept by the owner of the specific disease-based biobank. The software package for the research database produces the unique code also noted on the application form accompanying the biomaterial. The Radboud Biobank laboratory technician enters the same code in the laboratory sample management software system. Each month, the Radboud Biobank functional manager synchronizes the research database and the sample management system using study numbers. Pseudonymisation is mandatory since hospital patient identifiers do not adequately protect patient privacy.

Biobank related service:

Research support, what type of expertise?: The Radboud Biobank offers researchers the opportunity for storage and management of biomaterial of research projects such as clinical trials, cohort studies and patient control studies.
Core facility services; what type? Link?:
Queries from national health registers:
Links to the model contract and MTA: Each disease-based biobank is responsible for drafting a contract whereby the Department of Valorisation negotiates the contract. MTA link, DTAlink

IP:

IP rules, what is negotiable?: https://www.radboudumc.nl/en/research/radboud-technology-centers/radboud-biobank/about/apply-for-use-of-biobank-data#74927
Requirements to study results (access etc.):
Participant’s right to the information: The Radboud Biobank is a non-commercial scientific initiative of Radboud university medical center. For some studies it is important to collaborate with commercial companies and institutions. The results of such cooperation can become the property of that cooperation partner. The results can also be used for further commercial developments, such as patents. However, all research results benefit healthcare. Donors will not acquire ownership rights in the results and they will not be able to claim any future financial benefit. Of course, the rights of the donors, are also guaranteed in commercial cooperation.
Number of access contracts with industry: 0

COVID-19 samples:

Access to biological samples from patients with COVID-19?

  • Serum
  • Full blood (for RNA extraction)
  • EDTA-Full blood (for DNA extraction)
  • EDTA-Plasma
  • Citrate-Plasma
  • PBMC (Peripheral Blood Mononuclear Cells)
  • Nasopharyngeal aspirate
  • Tracheal aspirate
Contact person(s) and contact data (e-mail address, tel. no) for access purposes