14. Long-term storage of research data

When the project is completed, the project manager must ensure that the research data are anonymized or deleted, unless REK has approved continued storage. The project manager must ensure that copies of the data are handled in the same way.

A copy of the complete anonymized data may be kept. Anonymization is usually achieved by deleting the identifier. If this is not done, all information that could directly or indirectly identify a specific person must be removed from the research data. Procedures for safe storage of personal data and human biological material are available.

For storage of human biological material, specific regulations apply.

The project manager keeps track of who has access to the research data in each project. This information must always be available to the person/entity responsible for research. When research data are kept in long-term storage (passive data), strict restrictions on access to research data must be enforced.

Storage obligation
To enable audit and oversight, in some cases there may be an obligation to store the research data.

  • REK may decide that the research data must be stored for up to 5 years after the project is completed.
  • For clinical trials of medicines with human subjects, all source data must be available at each trial site for at least 15 years after the final report is available.
  • Contractual terms and conditions may also specify storage for longer periods. Retention of certain health data may be necessary under the regulations for health records or the Archives Act.
  • When students or project team members leave the project, the project manager must ensure that the research material they have collected or have had access to is securely stored.

Source data or other research data and documents must not be deleted if the regulatory authorities have open issues associated with the research project, or if the project manager or project team members are under investigation by the committee for misconduct in research (Uredelighetsutvalget for forskning).

Possibility of retention
It may be desirable to archive research data in personally identifiable form to enable follow-up studies or study of related research questions based on the same data sample. In this case, the project manager must write a new research protocol and application to REK for approval. If the objective of an approved project is changed substantially, notification of changes or a new application must also be submitted to REK.

Long-term storage of electronic data is also possible at external organizations that are approved for this purpose, such as Norwegian Social Science Data Services (NSD) or Statistics Norway (SSB).

Only digital versions retrieved from this website are valid.

Version 1.0. Date: 1 January 2012