Specific research biobank

Prior approval by the Regional Committees for Medical and Health Research Ethics (REK) is required for research biobanks.

A specific research biobank is linked to a specific research project. It has the same duration as the project, must be described in the project's protocol and shall be part of the ordinary project application to REK. Applications must be sent to REK in electronic format from https://rekportalen.no/.

The manager responsible for the research biobank must have a higher level of medical or biological education. The Responsible Manager shall be appointed by the Research Manager.

All amendments that affect the conditions for approval of a project must be assessed by REK. Examples given are; the project's purpose or duration, new methodology, changes in safety, integrity or welfare of participants, change of responsible person or organization, changes to the storage and processing of personal health information or biological material. REK will decide whether the project's approval shall continue under the new conditions. The form used to apply for approval of project amendments can be found at https://rekportalen.no/.

All use of human biological material and health information for research purposes must be approved before collection and use of the material. Register and submit an electronic application here: meldeskjema.

For further information about biobanking see Biobanking in Practice.