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Storage and release of human biological material

Norsk versjon: Oppbevaring og utlevering av humant biologisk materiale

Material in research biobanks must be stored and handled appropriately, with respect for the donor of the material.The project manager must provide storage facilities for the data and project.

Regional forskningsbiobank i Midt-Norge (the regional research biobank in Central Norway) can help with issues related to administration or medical disciplines. The biobank assists researchers who are developing project ideas, applying for project approval, or collecting, recording, storing or analysing patient material and research data.

The biobank will help researchers to find solutions so that their projects comply with the relevant laws and regulations and so that personal data about patients are protected.

Human biological material cannot be released to insurance companies, a participant’s employer, prosecuting authorities or a court of law, even with the consent of the person from whom the material originates.

If the project manager wants to store material in the biobank for reuse after the original research objectives have been met, this is regarded as a new research biobank that must be approved by the REC, unless a general biobank for research has been established. In all cases, a prerequisite for use of the material in a new research project is that the REC has approved the new project.

Human biological material collected in the health service in connection with diagnosis or treatment can only be used for research purposes with consent and approval from the REC.

The REC may decide that such material may or must be used for research purposes without obtaining the patient’s consent. This may only take place if it is difficult to obtain consent and such research is of significant interest to society, and the participants’ welfare and integrity are assured. The REC may impose conditions for use of the material. People who have reserved the right to require prior approval for any use of their own biological material for research are listed in the Registry of Withdrawal from Biological Research Consent.

Discontinuation, closure or takeover of research biobanks must be approved by the REC. If material is to be destroyed, the REC must approve the procedure. An application for discontinuation or closure of a project-specific research biobank must normally be sent together with a final report to the REC, or as a separate application if applicable.

Requests from other researchers for access to material in research biobanks must be submitted in writing and answered in writing. If the request is refused, reasons for the refusal must be given. Before access to material is granted, the project manager must ensure that the party that is to have the material has adequate procedures for handling and storage. The project manager must ensure that the REC has granted permission and must enter into a written agreement (in preparation) with the external party.

Human biological material may only be sent out of Norway or brought into Norway in accordance with approval from the REC. The requirements for consent in Chapter 4 of the Health Research Act and for research involving human biological material in Chapter 7 of the Act must be fulfilled.