General research biobank

A general research biobank is a research biobank for future research or for the storage and possible new use of human biological material when the original purpose of a specific biobank is fulfilled. A general research biobank whose purpose is thematically defined is called a thematic research biobank. A general research biobank shall be considered for approval by the Regional Committees for Medical and Health Research Ethics (REK) using a separate biobank application form https://rekportalen.no/

The research purpose is a broad/ thematic use of the material, for example cancer research, heart and lung disease research. There is normally no limit for the duration of the biobank since the purpose is prospective research.

A general research biobank shall also have a Responsible Manager:

• 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
• Only the Responsible Manager can apply for approval of a general research biobank

A general research biobank requires a strong and clear organizing. The more complex and the more interests involved the higher level of management and organizing is needed.

For access to the material in the biobank there should be clearly defined guidelines.

• The use shall be in accordance with the purpose of the biobank
• Donors have a right to receive information about the use of the material
• Research projects using the biobank shall be approved in advance by REK

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.

Oslo University Hospital has a Biobank and Registry Advisory Board that can submit cases in the event of disagreement.

A general research biobank with different stakeholders should establish an advisory board. The constellation should involve the parties with interests in the administration and conduction of the biobank.

The advisory board should:

• Give advice about the use of the material
• Evaluate applications
• Contribute to secure the interests of the donors and society
• Cooperate with other relevant parties

The members of the advisory board should be in agreement and pointed out by the leaders in the involved departments. The advisory board should be represented by 5-7 members with necessary scientific and medical expertise.