Sample and data access process in Finnish Clinical Biobank Tampere (FCBT)

The application for the materials of Finnish Clinical Biobank Tampere (FCBT) is made as follows:

1. Feasibility and Access requests

The feasibility request shall examine whether biobank samples and/or related data are suitable for such research and whether samples and/or data are available. A feasibility request is made by filling in a request form in the Fingenious ® system maintained by The Finnish Biobank cooperative FINBB. Simple feasibility requests are free of charge, but more expensive work can be subject to a fee agreed in advance.

After the feasibility request, the actual request for the transfer of samples and data ("access request") will be made in the same system. The following documents are always needed as attachments to the request:

• Study protocol
• Principal Investigator´s CV
• Record of data processing
• Data protection impact assessment
  • The Fingenious service contains a document base covering the last two documents. Similar documents from the researcher's own organisation can also be used.

The need for other permits and documents (e.g. data permit and the favourable statement of the Ethics Committee) depends on the type of research and the material to be handed over. We are pleased to help you with your application and answer any questions you may have. You can contact tel. +358 (0)3 31165205, biopankki@pirha.fi or +358 (0)44 473 9462 (Enni Makkonen, Service Co-ordinator).

2. Checking of the application

The biobank will check the received application and, if necessary, request further details on the application or its appendices. Once the application and its appendices are in order, the application will proceed for evaluation by the FCBT´s Scientific Steering Group.

3. Assessment by the Scientific Steering Group

The Scientific Steering Group asesses the application. The application material ("access request") must be submitted 14 days before the meeting. The meeting schedule of the Steering Broup can be found here. 

The Scientific Steering Group will assess

• the scientific level, significance and ethics of research
• the size of the requested material in relation to the total number of samples and the criteria for sample selection
• resources of the research project (if there are prerequisites for carrying out the research)
• project belonging to the biobank´s research area.

4. Access decision

The Director of Finnish Clinical Biobank Tampere will make the decision to release the material based on the statement of the Scientific Steering Group. Biobank may restrict the release of samples and data based on the Biobank Act.

According to the Biobank Act, the reasons for the restrictions are:

• the intended purpose conflicts with the research area defined by the Biobank, the consent on which the processing of the sample is based, or the conditions laid down by law.
• it is not possible to ascertain the ethical or scientific level of the intended use
• it is not possible to ascertain the applicant's professional or scientific competence
• the applicant's ability to comply with the laws or Biobank instructions and agreements cannot be ensured
• the material subject to the access request is limited, in which case its use will be prioritised for highly significant research
• the research plan that is the subject of the access request overlaps with an already ongoing or completed research
• the described use of the subject matter of the access request may endager the protection of privacy
• the ongoing process of protecting intellectual property rights would be endangered
• the researcher has previously neglected his/her agreement with Finnish Clinical Biobank Tampere

The applicant will be informed of the decision and, if the decision is positive, preparations for the transfer of samples and data can be started.

5. A material transfer agreement

After a positive decision, a material transfer agreement (MTA) will be prepared. The MTA is concluded with the background organisation, and the final costs are estimated at the same time.

In connection with the preparation of the MTA, an initial meeting will be arranged to agree on practical matters related to the release of the samples and/or data.

6. Material collecting and release

The details of releasing the material will be discussed at the initial meeting. Once the entity and details have been mutually agreed between the biobank and the researcher, the biobank will start collecting the samples and/or data, after which the material will be handed over to the research. Samples and/or data related to the samples shall, as a rule, be provided to the research as encrypted.

7. Return of results to Finnish Clinical Biobank Tampere 

Raw data and the results analysed from the samples will be returned to Finnish Clinical Biobank Tampere in accordance with practices to be agreed separately. The results analysed from the samples increase the research value of the sample collection. The results of the research are published by a research group, and Finnish Clinical Biobank Tampere is mentioned in the research publication.

Samples and data are applied through the Fingenious ® service

All feasibility and access requests for Finnish Clinical Biobank Tampere are made in the Fingenious ® service.