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How to Apply for Data or Biological Material from SAMINOR


Researchers can apply to use research data and biological material from SAMINOR. It is also possible to apply for access to re-contact participants for new data collection (e.g. additional questionnaires or clinical measurements). We encourage you to contact SAMINOR early in the planning phase for advice and guidance.

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There is no specific rule regarding the order in which applications should be submitted to SAMINOR, the Ethical Committee for Sami Health Research, and REK (Regional Committee for Medical and Health Research Ethics). However, we recommend applying to SAMINOR first to ensure that the project does not overlap with ongoing or planned projects. Additionally, the project board may require adjustments to the variable list. It is also possible to apply to SAMINOR, REK, and the Ethical Committee for Sami Health Research simultaneously. However, a positive decision from REK and the Ethical Committee for Sami Health Research must be submitted to SAMINOR before an agreement can be made with the project and materials can be released.

What Can You Apply For?

Researchers can apply for:

  • Data from SAMINOR's health registry.
  • Access to analyze biological material.
  • Access to data from qualitative interviews.
  • Access to re-contact participants for new data collection.

Data is provided in a de-identified format, meaning without directly identifiable information. Anonymized datasets can also be provided.
In some cases, it may be relevant to link data to other registries.

Who Can Apply?

Applications for the use of data from SAMINOR must be submitted by the project leader. The project leader must be affiliated with a research institution in Norway and, as a general rule, have at least associate professor competence (PhD or equivalent).

For students and PhD candidates, this usually means that the main supervisor submits the application for access to data.

The project leader is responsible for ensuring compliance with the agreement made with SAMINOR and must ensure that all project members also adhere to these obligations.

How to Apply?

SAMINOR's online application form must be used. The form does not require login. The form cannot be saved during the process, and it is not possible to share the form with others while filling it out. Therefore, read the entire guide and have all information and attachments ready before completing the form. Relevant attachments can be uploaded in the form or sent later to saminor@uit.no.

After submitting the form, you will receive an automatic confirmation from Nettskjema that the form has been submitted. We will also send you a copy of the completed form with information about the further processing of your application.

The requirements for applications and criteria for allocation and use of data, biological material, and re-contacting participants are described in the following documents (Norwegian only):

What to Include in the Application

The applicant must indicate the project type (PhD project, postdoctoral project, research project, student project, or other).

 

Data and analysis rights are restricted to a specific period. The project leader must specify the desired timeframe in the application. This cannot exceed the timeframe approved by REK and the Ethical Committee for Sami Health Research.

 

All processing of personal data must have a legal basis in Article 6 of the General Data Protection Regulation (GDPR).

When applying for access to directly or indirectly identifiable health or personal data, you must have a legal basis in accordance with the GDPR. In research projects, relevant legal bases may include:

  • Consent (Article 6(1)(a))
  • Public interest (Article 6(1)(e))

For processing special categories of personal data, such as health data, one of the conditions in Article 9(2) must also be met.

The project leader is responsible for ensuring that the processing of health and personal data in the project complies with the requirements of the GDPR and other regulations.

All projects at UiT involving the processing of personal data must be reported to Sikt's Data Protection Services for research. Sikt's Data Protection Services can also provide advice and assistance in finding the best solutions for the project and ensuring that the project has a legal processing basis.

Projects affiliated with other institutions must follow the procedures of their respective institutions.

According to the Personal Data Act, the institution responsible for the research must assess the need to conduct a Data Protection Impact Assessment (DPIA). The project leader is responsible for ensuring that a DPIA is conducted if required. If a DPIA is required, SAMINOR data cannot be released until the DPIA has been completed.

All applications must include a research protocol/project description. This must be uploaded as an attachment. 

The protocol can be written in Norwegian or English. A protocol template (docx format) has been made to clarify what it must contain. Feel free to download the attachment, fill it out directly in the file, and upload it as an attachment in the application form. In the protocol, the project leader must demonstrate their knowledge of SAMINOR. SAMINOR's website provides detailed information about the data collections and links to all questionnaires and published articles. It is an advantage if someone in the project group has experience using SAMINOR data. Feel free to contact one of the researchers at the Centre for Sami Health Research for potential collaboration.

An overview of planned publications, including preliminary titles, must be attached. Planned dissemination of research and popular science work should also be included in the plan.

You can find an overview of available variables in SAMINOR in the variable explorer on helsedata.no. To create and download a variable list, you must log in via ID-porten (Bank-ID, Min-ID, Buypass, or Commfides). All questionnaires are available on our website.

In the variable explorer, you can create variable lists that you download and attach to the data access application in Excel format. The file must not be edited, as this creates additional work for the data provider.

There must be consistency between the project description and the variable list. SAMINOR follows the principle of data minimization, meaning that only variables necessary for the aim will be made available. The project leader may be asked to reduce the variable list in line with this principle.

As a general rule, pre-approval from one of the Regional Committees for Medical and Health Research Ethics (REK) is required. REK approval is not required for anonymized datasets.

The decision from REK must be uploaded in SAMINOR's application form or sent later to saminor@uit.no. Pre-approval from REK has a time limit. Retaining data beyond the period specified in REK's decision is a violation of the Health Research Act. The same applies to processing information that is not in line with the aim reported to REK.

In case of changes to the project or the need to extend the timeframe, an amendment application must be submitted to REK. The decision must be sent to SAMINOR at saminor@uit.no.

Here is some information about SAMINOR that may be useful to include when filling out the REK application:

  • The data controller for SAMINOR is UiT The Arctic University of Norway, represented by the highest authority. The daily responsibility is delegated to the Centre for Sami Health Research at the Department of Community Medicine, Faculty of Health Sciences.
  • SAMINOR 1 and 2 have a license from the Norwegian Data Protection Authority with reference number 2002/1525-2.
  • SAMINOR's biobank is approved by the Regional Committee for Medical and Health Research Ethics (REK), Northern Division, with reference numbers P REK V 22/2002 (SAMINOR 1) and 2011/1840 (SAMINOR 2).
  • SAMINOR's biobank is registered in the Biobank Register with biobank number 4651.
  • Information received from SAMINOR will be de-identified. This means that researchers will not have access to directly identifiable personal information.
  • The linkage key between personal identification numbers and participant IDs in SAMINOR is stored at Statistics Norway for SAMINOR 1 and SAMINOR 2 Stage 1. The linkage key for SAMINOR 2 Stage 2 is stored on a secure server with two-factor authentication at Services for Sensitive Data (TSD) at the University of Oslo, where only a few selected staff members at the Centre for Sami Health Research have access.
  • After the project is completed, the data must be deleted. Original data from SAMINOR will continue to be stored in SAMINOR's health registry.

All SAMINOR projects must follow the Ethical Guidelines for Sami Health Research and obtain Sami collective consent from the Ethical Committee for Sami Health Research. This requirement also applies to anonymized datasets. The committee has prepared a guideline for applying for Sami collective consent.

Response to Received Application

Within a few days, the project leader will receive confirmation that the application has been received, information about when it will be processed, and whether there are any deficiencies in the application. The application must be complete before it can be processed. Processing time is typically 1–2 weeks after each meeting.

Resolution and Agreement

After review by SAMINOR's project board, the project leader will receive a decision. If the application is approved, SAMINOR will prepare an agreement for the release of data or biological material once all approvals are in place. The agreement must be signed by the project leader and a representative of the institution (usually the department head or equivalent). Materials will be released after the agreement is signed.

Fees

A one-time fee is charged for the release of data and biological material. The cost covers part of the expenses related to data release and contributes to the continued management and quality assurance of data in SAMINOR. The fees are standardized for all population surveys at ISM. See The Administrative Unit for Population-Based Health Studies' pricing.

Amendment Application

If changes are needed in the project—such as new variables, changes to research questions, new project collaborators, or an extension of the project period—an amendment application must be submitted to SAMINOR. Use SAMINOR's application form. Changes to the agreement require approval from the Ethical Committee for Sami Health Research and REK (if relevant). Confirmation of approved extensions from REK and the Ethical Committee for Sami Health Research must be sent to SAMINOR before SAMINOR can approve the amendment application. Applications for extensions must be submitted via SAMINOR's application form well before the end date to ensure the application is processed before the agreement expires. Retaining data beyond the agreed period is a breach of the agreement.

Linking SAMINOR Data with Data from Other Sources

It is possible to link (combine) SAMINOR data with information from other registers or research projects. Such linking is possible using participants' personal identification numbers.

To link SAMINOR data to other registers, approval must be obtained from:

  • Regional Ethical Committee (REK)
  • Sami collective consent from the Ethical Committee for Sami Health Research

For registers not covered by the Health Research Act, notification must be sent to Sikt (formerly NSD), and in some cases, a decision on exemption from confidentiality must be obtained. Each project must apply for this individually.

The project leader must apply to the owners of the relevant registers for access to data and is responsible for ensuring that agreements with these are valid at all times.

The project leader submits applications to the various register owners for access to data and permission to link. Once responses are received, the case number and contact person at the register owners must be sent to SAMINOR. Statistics Norway (SSB) stores the linkage key for SAMINOR 1 and SAMINOR 2 Stage 1.

For these two datasets, the following applies: SAMINOR sends a list of relevant participant IDs to SSB, including case numbers and contact persons at the register owners. SSB creates a project-specific identification number (PID) for each participant. SSB sends the linkage bridge between personal identification numbers (FNR) and PID to the relevant register owner(s). The register owner(s) link the relevant data, delete the FNR, and send the data file to the project leader. SSB sends the linkage bridge between PID and SAMINOR's participant IDs to SAMINOR. SAMINOR sends the data file with PID to the project leader, who can then link SAMINOR data to the relevant register data via PID.

For SAMINOR 2 Stage 2: SAMINOR creates a project-specific identification number (PID) for each participant. SAMINOR sends the linkage bridge between personal identification numbers (FNR) and PID to the relevant register owner(s). The register owner(s) link the relevant data, delete the FNR, and send the data file to the project leader. SAMINOR sends the data file with PID to the project leader, who can then link SAMINOR data to the relevant register data via PID.

Anonymised Datasets (Primarily for Student Projects)

It is possible to apply to SAMINOR for access to anonymised datasets. Anonymisation involves removing the possibility of identifying individuals in a dataset. It should not be possible to trace the data back to the individual (re-identification).

When personal data is anonymised, it is no longer considered personal data, and its processing falls outside the scope of the Personal Data Act. For anonymised datasets, it is not necessary to apply to REK or conduct a Data Protection Impact Assessment (DPIA). Since REK applications and DPIAs can be time-consuming processes, anonymised datasets are recommended for student projects. Collective consent from the Ethical Committee for Sami Health Research is still required for anonymised datasets.

  • The number of variables should be as few as possible, typically no more than around 20. This is assessed on a case-by-case basis and depends on the variables requested.
  • As a general rule, variables should be categorised/grouped in such a way that re-identification is not possible. For example, age is often grouped into 5- or 10-year intervals.
  • Extreme values are either set to missing or truncated at an appropriate level.
  • The possibility of re-identification is assessed on a case-by-case basis. Generally, this depends on the number and type of variables. If the variables include easily recognisable external characteristics, place of residence, or occupation, the likelihood of re-identification increases. Measurement values such as blood pressure, cholesterol, etc., cannot identify individuals, but extreme values for height, weight, and BMI may enable identification in some cases. This may also apply to rare diagnoses, medications, or the use of illegal substances.