Access process
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This page describes all the steps required to access and use biological material and data from the Janus Serum Bank.
1. Requests / assistance
The Janus Secretariat, which consists of both technical staff and researchers, has extensive experience in biobank operations and plays an important role in the bank’s daily activities. Our ambition is to serve as an advisor for researchers, both with regard to scientific questions, study design, and laboratory analyses, as well as providing assistance in improving applications when needed. Contact us at janus@fhi.no for help identifying relevant data in the Janus Serum Bank or for questions regarding the application.
2. Application to the Janus Serum Bank
Applications must be submitted electronically via the application form in the Cancer Registry’s metadata database. Incomplete applications will not be considered.
A complete application must include:
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A completed application form
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A detailed scientific protocol containing the background and objectives of the study, methodology, description of data flow (data management), data analysis plan, justification for the requested serum volume, power calculations, and planned publications
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CVs for the project leader and other key participants in the project group (maximum four pages)
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Information regarding project funding
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An approved Data Protection Impact Assessment (DPIA), or a justified assessment explaining why this is not necessary. The assessment must include a description of the legal basis for processing pursuant to Articles 6 and 9 of the GDPR
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If the project leader is based in Norway, REK approval must be attached to the application
The project leader will receive confirmation of receipt of the application from janus@fhi.no.
3. Application review
Applications to the Janus Serum Bank are reviewed by the steering committee twice a year. The steering committee conducts a scientific evaluation of all project applications to ensure optimal use of the material in the biobank. Read more about the steering committee here. Once the application has been reviewed, the applicant will receive confirmation that the project has been approved, or in cases of partial approval or conditional approval, the applicant will be asked to elaborate on or revise the application.
4. Agreement
Once the application has been approved, an agreement will be established between the Cancer Registry and the research institution affiliated with the project leader. The agreement describes the terms and conditions underlying the approval.
5. Applications for additional data
Cancer data
An application to the Janus Serum Bank only covers biological material and associated sample information (for example, where and when the blood sample was collected). To obtain access to cancer-related information (diagnostic codes, date of diagnosis, etc.), researchers must apply for disclosure of relevant variables from the Cancer Registry through Helsedata.no.
National Population Registry information
To obtain access to information such as sex, date of birth, status, status date, etc., an application for disclosure of National Population Registry data must be submitted to the Norwegian Tax Administration via email to Forskningfellespost.SKD@skatteetaten.no. For more information, see the Norwegian Tax Administration’s website.
Lifestyle-related variables
The majority of the samples in the Janus Serum Bank were collected through the Nationwide Health Surveys, in which questionnaire data and other lifestyle-related variables were collected (blood pressure measurements, height, weight, smoking habits, physical activity, diet, etc.). These variables may also be disclosed by the Cancer Registry upon application through Helsedata.no. Include the following data sources, text, and variables in the application:
Data sources
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Oslo I – The Oslo Health Study
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The 40-Year Health Surveys
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County Health Surveys in Finnmark, Sogn og Fjordane, and Oppland 1974–1988
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The Troms and Finnmark Health Study (TROFINN)
Linkage process
The study population is established in the Janus Serum Bank. The Janus Serum Bank manages and stores the linkage key. The Janus Serum Bank sends the linkage key to the Cancer Registry’s Data Delivery Unit (DUE), which discloses cancer data and lifestyle-related variables from the Cancer Registry’s copy of harmonized variables from the Nationwide Health Surveys.
Variables
Attach the requested variables from the variable list.
Other data sources
If linkage to other data sources is needed, this must also be included in the Helsedata application, and applications must be submitted to any additional data sources outside the mandate of the Norwegian Health Data Service. The Cancer Registry’s Data Delivery Unit (DUE) is responsible for forwarding the linkage key to other data sources.
6. Study population
In collaboration with the Janus Serum Bank, the researcher will establish the study population for sample selection. A data manager selects the samples, before laboratory technicians retrieve the samples from the freezer storage and aliquot them for delivery.
7. Sample delivery
Samples are delivered to the researcher without accompanying data to ensure that analyses are conducted blinded. A project-specific sample identification code, as well as information about batch and set, will be included.
8. Return of data
After laboratory work has been completed, the analysis results must be returned to the Janus Serum Bank for future reuse.
9. Data delivery and invoicing
The process of delivering data does not begin until the analysis results have been returned to the Janus Serum Bank, ensuring that laboratory analyses have been conducted blinded.
The Janus Serum Bank provides case-control status and remaining sample information to the researcher. The Janus Serum Bank sends the linkage key to the Cancer Registry’s Data Delivery Unit (DUE), which discloses cancer data. DUE is responsible for forwarding the linkage key to any additional data sources, which then deliver their data directly to the researcher.
In all research projects, directly identifiable information is replaced with a unique, project-specific code. The coding system safeguards donor privacy and prevents research misconduct.
Researchers will receive an invoice from the Janus Serum Bank for work related to handling samples and associated data. Read more about pricing for the use of samples and data from the Janus Serum Bank here. The Cancer Registry’s Data Delivery Unit (DUE) will issue invoices related to the linkage of cancer data. The Norwegian Health Data Service and any additional data sources will also invoice separately.
10. Amendments
Any changes to the project during the course of the study must be reported to the Janus Serum Bank via janus@fhi.no.
11. Project completion
At the end of the project, a final report must be submitted to the Janus Serum Bank via janus@fhi.no. Data will then be anonymized and/or deleted.