Denmark

Region Zealand Biobank (RSjBB)

The Region Zealand Biobank (RSjBB) contains biological collections from large population studies and clinical research projects, including the population survey in Næstved (BEFUS) and the Lolland Falster Study (LOFUS).  The main purpose of RSjBB is to unite different collections of blood samples in the region under one biobank. RsjBB also offers advice on planning and establishing new biological collections.

Key facts

Name of the connected EIT Health partner: Lasse Boding
Number of individuals: Total 29,650
Biobank confirmed willingness to provide samples/data for EIT Health studies: Yes
Contact person(s) and contact data
(e-mail address, tel. no) for access purposes:
Palle Lyngsie Pedersen, biobank@regionsjaelland.dk
+45 25434687
Number of samples: Total 173,084
Sample type: A collection of many different types.
Omics data: OMICS data is part of data center (in development). Currently, two studies are in the process of converting DNA into Whole genome sequence data (N > 25,000).
Website: Region Zealand Biobank (RSjBB)

General information

Type of biobank: All types of biobanks including: population-based, longitudinal, disease-specific, pediatric, samples from other specimens than human.
If longitudinal the frequency: Depends entirely on the type of the project and what is clinical relevant time points for that specific project.
Link to central portal to seek samples and data: Danish Biobank Register www.biobanks.dk
Broad consent: Depend on type of biobank. An evaluation of each sample application includes evaluation of the consent (Regional Scientific Committee). If it is not within the scope of what the participant originally gave their consent – a new consent is required if samples are to be extradited for a project.
Option to recall donors: Yes. It requires approval from the Regional Scientific Committee. Previously some projects have used data from the population-based studies as described.
Option to recall family members: Yes. It requires approval from the Regional Scientific Committee. Previously some projects have used data from population-based studies as described.

Biobank access procedure:

Major terms for access: Requirement – approval from the Regional Scientific Committee and principal investigator (PI)/RSjBB scientific steering committee. Often it is required that new data is returned to PI or Region Zealand after project has ended
Ethical and legal compliance: Required
Speed and reliability of delivery: Depend on type of request and complexity of sample withdrawal
Pricing: Depend on type of request and complexity of sample withdrawal

Quality management system:

Link to operational procedures: Link
Storage: Several – including:
a) Monitoring of temperatures using an external sensor. Data is logged at a ELPRO server.
b) A CTS system, monitoring freezer alarms, cooling system, power supply.
c) Sample positions is registered in LABWARE LIMS.
d) Service agreement and yearly service on all freezers. Scheduled defrosting of all freezers
e) Support agreements with all internal and external collaborators.
Compliance with international standards: ISO 20387:2018.
Current ISO certificates: In progress.

Data:

Clinical data linked to samples: RSjBB Labware LIMS is designed to include all relevant pre analytical data. Data includes, Time of collection (who, when and where), centrifugation, and freezing. In addition to sample type, sample collection- and biobank tube type, specimen … and many others.
Data standards: Labware LIMS standard.
Data security rules: The Danish Data Protection Act.

Biobank related service:

Research support, what type of expertise?: The expertise and support offered includes:
a) RSjBB is the continuation of many years of biobank experience. The knowledge base of the biobank includes experienced personnel recruited from Department of Clinical Biochemistry, Department of Pathology and the industry.
b) RSjBB offers secure and safe storage of samples in accordance to Danish law.
c) RSjBB participate in planning and coordination of sample collection.
d) Ensure documentation of relevant pre analytical data for on-going sample collections.
e) Collect as much relevant information as possible on biobanks included in RSjBB (sample collection guidelines, protocols, consent forms …).
f) RSjBB have contact to all sample collection sites and support both researcher as well as sample collection site.g) RSjBB offers advisory services for project who wants to use biobank samples
and subsequent management of samples.
Core facility services; what type? Link?: a) Automated pipetting facility.
b) Freezers.
Queries from national health registers: Can be arranged (SSI or data center)
Networking: a) Help researchers to find relevant collaborators – e.g. where test can be performed, DNA extracted or similarly.
b) Bring researchers with shared interests together.
c) A collection of sample stability data can be offered to researchers prior to decision on which samples is suited for analysis (published or as raw data).
d) If data is not available in quality biobanks or other biobanks may be used to retrieve relevant information.
Links to the model contract and MTA: Governance of RSjBB and MTA (in Danish) is available at
https://www.regionsjaelland.dk/Sundhed/forskning/
forfagfolk/region-sjaellands-biobank/Sider/default.aspx

English version is currently not available

IP:

IP rules, what is negotiable?: Not available.
Requirements to study results (access etc.): Not available.
Participant’s right to the information: Not available.