Access to the diagnostic biobank (includes histological slides, paraffin blocks, frozen tissue/cells, blood samples, autopsy samples) for research purposes is only given to research projects with prior approval from the Norwegian Regional Ethics Committee (REC). You will find more information about how to apply for REC approval here: https://rekportalen.no/
Once you have REC approval, you can send an application to the Department of Pathology requesting access to the diagnostic biobank and research services.
- For access to the diagnostic biobank for research purposes, please fill out the application form Søknad om tilgang til humant biologisk material fra biobank (Norwegian) / Application for access to human biological biobank material (English) and send it to the department’s biobank coordinator Paula De Angelis; email: firstname.lastname@example.org or email@example.com. All requests for access to the diagnostic biobank/associated research services will be registered electronically so that the department of pathology maintains an overview of the number of such requests annually as well as the type and amount of material requested.
- Requests for collaboration with pathologists when microscopic evaluations of existing and prospective histological slides are required will be handled in the same way as requests for access to the diagnostic biobank. Interested researchers must use the same application forms as in section "1". This applies to internally- and externally-initiated research projects.
- Requests for material for quality control testing/evaluation (e.g. antibody testing) and for educational purposes do not need REC approval, but interested parties are still required to apply to the department of pathology using the same application forms as in section "1" with a description of the type of diagnostic material needed.
- All other types of internal and external research projects requesting the involvement of the department's personnel/infrastructure/resources/lab services (but that do not need access to the diagnostic biobank) must fill out a collaborative agreement form: Søknad Samarbeidsavtale Forskningsprosjekter (Norwegian)/ Application Collaborative Agreement Research Projects (English) and send it to firstname.lastname@example.org or email@example.com.
- The department of pathology is also involved in clinical research studies that are initiated and sponsored by industry (‘oppdragsforskning’ or ‘contract research’). More information about the procedures involved in setting up a clinical research study, and contact information for the department’s coordinators of clinical studies can be found here: https://forskerstotte.no/oppdragsforskning and https://forskerstotte.no/filer/oppdragsforskning/docs/Kontaktinformasjon_serviceavdelinger_20200326.pdf
- If a patient (or the patient’s representative) requests access to his or her biopsy material (e.g. in cases where a second opinion is desired), the material will be personally delivered to the patient or the patient representative following completion of the form Utlevering av prøvemateriale til privatpersoner (Delivery of sample material to private persons).
The department’s Biobank Steering Committee will evaluate all requests (internal, external, national, international requests—academic and commercial) to access and use specific material from the diagnostic biobank for research purposes. The department will make every effort to approve research projects that wish access to patient material, with some few exceptions where the amount of said patient material is minimal. When requests are approved by the Steering Committee, the department’s Joint Research Support lab will provide the requested biobank material/service. If tissue sections from paraffin blocks are requested, the relevant blocks will be retrieved and sectioned. If researchers are interested in tissue microarray creation from existing paraffin blocks, tissue microarrays can be produced by the Joint Research Support lab. The Biobank Steering Committee will evaluate/approve the use of existing paraffin blocks (donor blocks) for tissue microarray creation, taking into consideration the status and quality of the donor paraffin blocks. For price information for the services required, please email firstname.lastname@example.org or email@example.com.
The Biobank Steering Committee will also evaluate whether other types of research projects that wish to utilize the department's infrastructure/resources/personnel/lab services, can be approved. The Committee will also evaluate requests for collaborations with pathologists.
It must be emphasized that the prices for the different services provided by the department’s Joint Research Support section (and the Molecular Diagnostics section) must be factored into overall project budgets when applying for research support from different granting agencies (see price list for academic customers; commercial customers—please double the list prices).
There are specific hospital procedures for sharing of biobank material (deling av biobank material) that can be found on the OUS research biobank webpage: https://forskerstotte.no/biobanker. The information is in Norwegian, but can be summarized as follows: import and export of biobank material (paraffin blocks, tissue sections, DNA, etc.) for research purposes requires prior REC approval, consent from the department/biobank owner, and an agreement between the parties regulating use of the material (Collaborative Agreement or Material Transfer Agreement).
A Collaborative Agreement Research Projects form or a Material Transfer Agreement should be filled out. If all parties actively participate in a research project, then a Collaborative Agreement should be filled out. However, if the involved parties only supply material without being actively involved in the research project, a Material Transfer Agreement should be filled out. If biobank material is to be sent abroad, the project leader must have a formalized agreement with the foreign institution. Export and handling of biobank material must occur in accordance with applicable Norwegian laws and regulations. REC approval is necessary even if the research projects have anchoring and approval abroad. If there is doubt about whether the approval and consent are sufficient for material export, REC should be consulted.