How to establish a research biobank

In order to store human biological material for research purposes, one must establish a research biobank. The only exception is short time storage; if the material is destructed within two months after collection, there is no need to establish a research biobank. The research project and the use of the material should neverthelss be approved by REK before the research can start.

The planning phase:

A research biobank must have a responsible person with a medical or biological higher degree, and the research biobank must be approved by REK (regional committee for medical and health research ethics) before any collection and use of the material can take place.

When establishing a research biobank, it is very important to think prospective with respect to collection, use and storage of human biological material. Is the use meant for a specific research project, or is it relevant to use the material in many research projects? Consent from the donor is the main rule for collection, use and storage of human biological material, and the information and consent form has to be in accordance with the research purpose.

A specific biobank is connected to a specific project and a specific consent limited to the scope and duration of the project. It is often the project leader who is responsible for the specific research biobank, but this function can also be fulfilled by a person who is more responsible for the operational tasks.

Procedure for establishing a specific research biobank (OUS - in Norwegian).

A general biobank for prospective use is connected to a broad consent within a thematic research area and to multiple studies. Every single research study has to be accepted by the responsible for the biobank and be approved by REK before using the biobank. REK will then consider if the purpose of the study is covered by the consent, or if there is need for more information.

The donors have a right to get informed about studies they are included in, and it is the project leader for each study that is responsible to fulfill this duty.

Procedure for establishing and organizing a general research biobank (OUS - in Norwegian)

Procedure and template for broad consent (OUS - in Norwegian).

Biobanks based on a broad consent are often more complex in size, organization and administration. It is therefore recommended to establish an advisory board/ steering committee for the biobank, with members from the involved departments.

General research biobanks are often connected to a register (Norwegian webpage).

More information (in Norwegian) 

 

The implementation phase:

When a research biobank has received all necessary approvals, the collection, storage and use of human biological material can start. Please be aware that for research biobanks based upon a broad consent, all research projects using the collected material must be pre-approved by the regional committee for medical and health research ethics (REK).

New, changed or extended use of material must be pre-approved by REK before any changing in the project can take place. If there are significant changes in the use, REK might consider that there is need for more information and a new consent from the donors.

Donors have a right to withdraw consent and participitation, and it is the project leader who is responsible to withdraw material from those donors for further research.

Procedure for accession to and handling of biobank material (OUS – in Norwegian)

Every export of human biological material shall be followed by a Material Transfer Agreement (MTA) (Deling av biobankmateriale).

OUS has a Biobank and Registry Advisory Board that can be consulted if there are questions regarding accession and use of research biobank.

Read more about general Guidelines for research ethics in science and technology issued by The Norwegian National Committee for Research Ethics in Science and Technology (2016).

More information (in Norwegian)

The termination phase:

When a research biobank is terminated, all remaining material must be destructed following the internal routines. If the material still has a high research value and there is a potential for further research, one can apply for extended use to the regional committee for medical and health research ethics (REK).

More information (in Norwegian)