Principles of access

This summary is provided to give a brief guidance for researchers who are thinking of applying for access to THL Biobank’s Material. It does not replace any part of the entire agreement as defined in the General Terms of Access.

Summary

General Terms of Access to THL Biobank Resources

THL Biobank owns its biological samples and related data (later referred to as Material). THL Biobank claims no ownership to new intellectual property invented or developed solely by or for the Researcher in connection with the project.

Access can be granted to research plans that pursue high scientific quality and impact, are performed in an ethical manner by reputable researchers with an established scientific record; and correspond with the research areas of THL Biobank. THL Biobank is open to researchers from both academic organisations and private sector.
Research areas of THL Biobank

The whole research group must abide by the General Terms of Access.

Only the principal investigator or main researcher of the project, affiliated to a certain institute, is entitled to apply for THL Biobank’s Materials. Researcher should allow 3 weeks for the application review process.

The electronic application shall include: name, affiliation and scientific qualifications of the PI; list of the institutes and researchers involved in the project including their role in the project; detailed research plan and timetable; ethical aspects of the project; short public description of the project; detailed requests for samples and data; data management plan; funding information and invoice address. Research plan, research agreement, ethical approval documents and details of requested variables may be attached when relevant.

The Material Transfer Agreement (MTA) shall be concluded between THL Biobank and the  institutes or organizations involved in the project, not with individual persons. The MTA includes standard appendices regarding General Terms of Access, Data Protection, and Safety and Information Security.

Main criteria for approval of research project: the project is clear and specifically defined and limited in scope; the analysis plan is scientifically compelling and coherent; the Material requested is available for sharing; the project proposal does not fully overlap with on-going projects; the requested data and analysis plan do not compromise the confidentiality of sample donors.

Any access to national register-based data is dependent upon access approval by the relevant registry officials (i.e. Findata) and THL Biobank cannot give any guarantee of the approval of the applications nor of the costs or time period needed for the processing of the applications.
The Researcher shall comply with the Finnish laws, and if applicable, any local laws or IRB/ethics committee opinion.

The Researcher may not use the Material for any other purposes than described in the Application, or share it with any other party without a written approval of THL Biobank.

Secure data access, such as passwords, firewalls, etc., must be in place to ensure that the shared data are kept secure. THL Biobank data should be accessed using only computers provided and maintained by researcher’s organizations, the use of personal computers to access or analyze the Material is prohibited.

The data provided for research projects do not contain any individual identifiers, but are coded (pseudonymised). Data users shall preserve the confidentiality of the data in outputs and publications and to ensure that sample donor’s identity is never disclosed. It is forbidden to match or attempt to match individual records to any other data outside the project.

The research group should aim to publish the research results based on THL Biobank’s Material in peer-reviewed scientific journals shortly after the completion of the Project. The Biobank and the study participants must be appropriately acknowledged in the publication(s).

The research group must offer to THL Biobank all individual level results emerged from the project, such as assay and analysis data (“raw data”), supplied with appropriate documentation. These research results will be made available for other researchers via the standard biobank application process.

The cost for accessing THL Biobank’s Materials depends on what is being accessed, the value of the collaboration and returning raw data and/or analysis results to THL Biobank. Academic research projects are charged based on a cost-recovery scheme to cover costs for administration and project implementation. Project specific estimation of the costs may be requested before applying.