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Personal Data in Health Research

USN has an agreement with Sikt – the service provider for the knowledge sector – to pre-assess all student and faculty research projects at USN making use of personal data. This means that all such projects must be submitted to Sikt for a data protection assessment. Sikt must issue a recommendation before any project can begin.

Helseikon

Notification Form

See Sikt’s website for more information if you are unsure whether you need to submit a notification form.

Once Sikt has assess the notification you have submitted, its approval will serve to document that the project will lawfully process personal data. Sikt registers all projects it assesses for USN in a dedicated database, and in the event of an inspection by the Norwegian Data Protection Authority, USN can document how it has used personal data in student and faculty research projects.

The project manager is responsible for ensuring the project is filed with Sikt. In the event of student projects, it is the supervisor’s responsibility to apply to Sikt. An application must be filed with Sikt no later than 30 days before data collection is to begin to ensure that the assessment of a project is completed before any personal data is collected. Sikt must first assess a project before any personal data can be processed. 

If there are significant changes to the project, a change notification must also be submitted to Sikt. The requirement to notify Sikt also applies to student projects at both bachelor’s and master’s levels. Both the student and the supervisor are responsible for assessing whether it is necessary to collect personal data to complete the student's project.

P.S. When preparing a notification form, it is also important to consider the reuse of research data. For example, it may be appropriate to use public interest as the legal basis for processing personal data in research projects, and, if possible, to develop a plan for data sharing and reuse. For more on this, see DHP: Research Data Management Plan.  

Resources

Security and Risk Assessment

Personal data must be protected. When completing the notification form to Sikt, you must describe what you consider to be the risks associated with your processing and storage of personal data, and what measures you plan to take to reduce the risk of unauthorised access.

Common security measures include, for example:

  • Storing personal data separately from other data
  • Continuously anonymising the data
  • Using storage solutions with restricted access

The level of security required depends on the volume and sensitivity of the personal data. For more information about USN’s storage solutions for research data, see the library’s webpages on research data.

In addition, you must assess the risks related to the data processing itself:

  • Confidentiality: Prevent unauthorised access to the data
  • Integrity: Prevent unintended or unauthorised alteration of the data
  • Availability: Ensure the data is not lost and remains accessible to persons whose access is authorised 

Data Protection Impact Assessment (DPIA)

For larger research projects, a Data Protection Impact Assessment may be required. A DPIA must be conducted for projects that process personal data where the rights and freedoms of individuals could be at risk. This may include projects that process sensitive personal data on a large scale.

The assessment helps prevent undesirable incidents or deficiencies in the processing of personal data. Measures to protect research data must be proportionate to the actual risks identified in the risk assessment. Key factors in the risk assessment include the scope of the project, the sensitivity of the data, and the project’s duration.

Sikt’s data protection services usually assist with these assessments and provide support, but the data controller makes the final decisions after the Data Protection Officer has provided comments. The decision must be documented and uploaded as an attachment to the notification form to Sikt.

Resources - Security and Risk Assessments

 

Questions about the Quality Assurance System for Health Research?

The Department of Research, Innovation, and Library Services manages the Quality Assurance System for Health Research at USN. The quality assurance system is reviewed and updated as needed. If you have suggestions for improvements or notice that content is missing, feel free to report it to forskningsetikk@usn.no. We will reply to your email.

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