Establishment
The project head is responsible for establishing a project biobank and must familiarise themselves thoroughly with Chapter 6 of the Health Research Act. It is also important that the project head understands REK’s requirements regarding approval, reporting during the project, and the measures to be taken at project completion.
A person possessing a university background in medicine or biology who will be dedicated to running the biobank must be appointed to run it. The establishment of a biobank must be institutionally anchored at the faculty level, and the Faculty’s Vice Dean for Research must appoint an individual with the relevant qualifications as responsible for the biobank.
Upon its establishment, and in the event of significant changes to it, a risk assessment of the biobank must be carried out.
A dedicated research biobank contains biological material collected for aspecific research project. The purpose of the biobank is described in consent documentation which participants sign prior to project start.
At the end of the project, the research biobank must be destroyed. Alternatively, the researcher may apply to REK for permission to repurpose the biobank.
A general research biobank contains biological material collected without being tied to a specific research project. This means that the biobank’s purpose or analyses have not yet been fully determined, or that the material is intended to be used in several research projects that are not necessarily related.
Such use is described in simplified consent documentation referred to as “broad consent.” Research participants who donate biological material must have consented in advance. They are entitled to access up‑to‑date information about the research activities related to the general research biobank to which they belong. The project head is, however, not required to provide individual feedback to each project participant.
Access to and disclosure of material and data
Requests from other researchers for access to material stored in research biobanks must be submitted in writing and answered in writing. A refusal for access to material stored in a research biobank must be justified.LEN
Before granting access to the biobank, the project head must ensure that the applicant has satisfactory procedures for handling and storing the material. The project head must also ensure that REK has granted permission for the material to be accessed and that a written agreement is entered into with the external party.
The pre-approval of REK is required to transfer human biological material into, or out of, Norway.
Human biological material may not be submitted to insurance companies, employers, prosecuting authorities, or courts, even if the material originates from individuals who have provided their consent.
Ressurser
- Several Norwegian biobanks have developed Best Practice for Norwegian Biobanks in a document detailing best practices for the establishment and operation of human biobanks. The document includes detailed guidance and templates.
- Act on Medical and Health Research (Health Research Act) – Chapter 6: Research Biobanks and Research Involving Human Biological Material. Read here for an overview of the Act.
- REK-Portal