1. Purpose
The purpose of this procedure is to ensure that the necessary approvals have been obtained prior to the establishment and use of research biobanks at UiO containing human biological material and that the necessary written agreements are arranged prior to any research on human biological material collected by the health services, or or that is acquired or made available from biobanks managed by institutions that are responsible for biobanks other than UiO. Furthermore, the procedure shall ensure that human biological material is handled and stored according to current regulations and also ensure that the human biobank material which is no longer in use, is not destroyed before REK has given approval.
2. Scope
This procedure applies to all research activities that use research biobanks (that include human biological material). This includes human biological material which has been collected at the clinics of UiO for research purposes. When using human biobank material from partner institutions or other parties, such use must be set down in agreements that take into account the procedures at both UiO and partner institutions. These procedure doesn't apply to human biological material obtained from commercial parties. It is important to ensure that the material has been made available in a lawful manner.
This procedure also doesn't apply to biological material that is not of human origin or material that is not biological (examples in footnote).
3. Responsibilities
The representative of the institution responsible for research
is responsible for:
- research biobanks at his/her unit and for appointing a qualified person in charge of each biobank (a manager)
- keeping a register of all biobanks at his/her unit, including the location of the biobanks and allocating serial numbers to newly established biobanks
- ensuring that the necessary agreements are in place for the use of biobank material from partners
- ensuring that the necessary agreements are in place when releasing biobank material to partners
- following up with third parties in the event of refusals of applications from project managers at UiO concerning access to third-party biobanks
The manager of the research biobank:
- is responsible for preparing and submitting applications for a general research biobank
- must ensure that materials in research biobanks are stored and handled properly
- shall assess and manage the risks associated with biobanks, including implementing the necessary risk mitigation measures
- is responsible for applying for termination, closure, transfer or acquisition of a research biobank from REK
- is responsible for considering and responding to requests from third parties concerning access to material in UiO’s research biobanks
- is responsible for entering into agreements with partners concerning the release of human biological material from biobanks managed by UiO and for which of the biobank manager in question is responsible
The qualified person in charge of the biobank may also take on the role of Principal Investigator.
The Principal Investigator (Project Manager)
is responsible for:
- obtaining approval from REK for the establishment of the project-specific research biobank
- obtaining approval from REK for reuse of an existing research biobank
- obtaining approval from REK for research on material collected within the Health Services
- following the routine for The Norwegian Institute of Public Health on identification of patients registered in the reservation register
- keeping the manager of the research biobank informed about the project’s progress
- following up the withdrawal of consent
- disclosing to the manager of the research biobank all requests about access, delivery or use
- informing the relevant biobank manager of any material collected from partner institutions
- entering into agreements with partner institutions concerning project-specific use of human biological material from biobanks created by other biobank managers or in the event of ongoing receipt of material from external institutions. This applies to both national and international partners and other parties and may be part of or a supplement to a cooperation agreement applicable to the project as a whole.
For further description of the Principal Investigator’s role and responsibilities, see also Procedure description 02.
4. Appointment of a biobank manager
Each research biobank must have a manager with a higher education degree in medicine or biology. Responsibilities and qualifications must be internally documented at the unit designated to be the entity responsible for research.
5. Establishment of a research biobank and new or expanded use of an existing research biobank
The establishment of a research biobank must be approved by REK. When the approval is available, the new research biobank must be registered in the Unit’s overview of biobanks and in Forskpro with a unique biobank number consisting of the DF? or ID code from UiO finance system and the unit’s own serial number.
5.1 Application for a research biobank as part of a research project
When a research biobank is established as part of a specific research project, this must be described in the project's research protocol. The application for the establishment of a research biobank will be a part of the project application to REK, prepared and handled by the Principal Investigator. The establishment of the research biobank will be assessed as part of the total REK-assessment, and a separate description is not required.
5.2 Application for a research biobank unrelated to a specific research project (general research biobank)
Before establishing a general research biobank, an approval from REK is needed. The application for establishing a general research biobank must be prepared and managed by the UiO’s Biobank Manager. The competent person must be appointed by the representative of the institution responsible for research before the application for the establishment of the general research biobank is submitted.
5.3 Application for storage and reuse of existing research biobank
After the original research objectives have been completed, any further storage of the material in the existing research biobank should be regarded as establishing a separate biobank and must be approved by REK. UiO’s biobank manager is responsible for handling the applications.
5.4 Application for use of human biological material collected by the health services for research purposes
Human biological material collected by the health services in connection with diagnosis s or patient treatment can only be used for research purposes if approved by REK. The application for approval should be submitted by the Biobank Manager, who must be appointed by the representative of the institution responsible for research before the application is submitted to REK. If the relevant material is not collected by UiO, but by some other institution responsible for research, then there must be a written agreement concerning the transfer and use of this material for research purposes at UiO.
6. Transfer of human biological material between partners
Transfer of material to and from UiO must be approved by REC. In connection with individual research projects, this will be included as part of the application to REK, which will be submitted and managed by the project manager.
6.1 Transfer of human biological material between national partners
If human biological material is transferred to another institution from a biobank managed by UiO or if UiO receives human biological material from another institution that manages a biobank, a written agreement concerning the release and use in research must be in place, see Appendix 5.2. Furthermore, a data transfer agreement, see Appendix 6.3 or a data processing agreement, see Appendix 6.4, must be entered into with the recipient.
6.2 Transfer of human biological material to and from other countries
The person responsible for the biobank will be responsible for submitting and managing applications to the REK concerning the transfer of human biological material from general research biobanks to other countries.
When releasing human biological material to countries within the EEA, the principal investigator must also enter into a data transfer agreement, see Appendix 6.3 or data processing agreement, see Appendix 6.4, with the recipient in addition to submitting an application to the REK.
When releasing human biological material to countries outside of the EEA, the principal investigator must also obtain written assurance that the data controller and/or data processor in the country to which the human biological material will be transferred guarantees the same level of protection for data as required under the GDPR and that the research participant has consented to and has been informed that data will be disclosed to countries outside of the EEA in addition to submitting an application to the REK.
The Principal Investigator must also ensure that there is a valid legal basis for the transfer pursuant to Chapter 5 of the GDPR.
7. Handling of withdrawal of consent
If the research subject’s consent for use of human biological material, which is not anonymous or part of other processed biological material, is withdrawn, the research on this material must cease immediately. The relevant biological material must be destroyed within 30 days, unless otherwise is decided and documented. Destruction must be documented. If the project is a clinical trial using medicinal products, the collected data will not be deleted, but further data collection must stop.
8. Termination, closure or transfer of research biobank
Termination, closure or transfer of the research biobank must be approved by REK. Application of termination or closure of a project-specific research biobank (See section 5.1 of this procedure) is normally sent with a final report to REK (See Procedure description 2 for the Principal Investigator), but can also be sent separately. Application for termination or closure of a general research biobank (See section 5.2 of this procedure) is sent along with the final report for the last project or separately.
9. Handling requests for third party access
Requests from other researchers for access to human biological material l in the research biobanks at the UiO must be available in writing, and answered in writing by the Biobank Manager. A rejection of this request must be justified. Before access is granted, the representative of the entity responsible for research at UiO must ensure that the receiver of the material has adequate procedures for handling and storage. Before the material is transferred, the representative of the entity responsible for research at UiO must ensure that approval has been granted by REK and that a written agreement on access is worked out.
Release must be certified and the conditions must be specified in the written agreement. See Appendix 5.2.
10. Handling of request for access to a third party
A request from researchers at UiO for access to biological material in the third party research biobanks must be in writing from the Principal Investigator, and a written response must be claimed. Rejection of such a request and a possible appeal to REK must be followed up in collaboration with the representative of the entity responsible for research at UiO. See Appendix 5.2.
11. Legal basis
- LOV-2008-06-20 no 44 Act on medical and health research (Health Research Act)
- FOR-2009-07-01-955 Regulations on the organization of medical and health research
- LOV-2018-06-15-38 Act on the Processing of Personal Data
12. Appendices
5.2. Elements of the contract for supply of biological material from UiO
6.3 Data Transfer Agreement (Word)
6.4 Data Processing Agreement (Word)
5.3. The Norwegian Public Health Institute's routine for the identification of patients recorded in reservation register (in Norwegian)