Data disclosure process of Finnish Clinical Biobank Tampere (FCBT)

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

1. Preliminary reports and requests for sample and data disclosure

The preliminary study shall examine whether biobank samples are suitable for such research and whether samples are available. A request for preliminary investigation is made by filling in a request for preliminary investigation ("feasibility request") into the Fingenious ® system maintained by THE Finnish Biobank cooperative FINBB. Simple preliminary studies are free of charge, but more expensive work can be subject to a fee agreed in advance.

After the preliminary assessment, a genuine 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 for extradition:

• Research plan
• Principal Researcher CV
• Data Protection Policy
• 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. the granting and use of patient data and the favourable opinion 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 4739745 (Leena Viiri, Service Co-ordinator).

2. Documentary check 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 Biobank Science Steering Group of Tampere.

3. Application for assessment by the Scientific Steering Group

The Scientific Steering Group assessed that an application had been received. The material must be submitted 14 days before the meeting. The meeting schedule of the steering group can be found here. 

The scientific steering group will assess

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

4. Decision on the disclosure of material

The Director of Finnish Clinical Biobank Tampere will make the decision to hand over the material based on the opinion of the scientific steering group. A biobank may restrict the disclosure 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 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 whether the intended use is ethical or scientific
• 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 request for extradition is limited, in which case its use will be prioritised for highly significant research
• the research plan that is the subject of the request for extradition overlaps with an already ongoing or completed research
• the use of the subject matter of the request for extradition as described endangers 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. Drawing up a transfer agreement

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

In connection with the preparation of the extradition agreement, an initial meeting will be agreed to agree on practical matters related to the handover of samples and/or data and possible handling of samples.

6. Picking up/collecting and handing over material

The details of extracting and handing over 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 sample and data materials, after which the material (s) will be handed over to the research. Samples and/or information related to samples shall, as a rule, be provided in coded form.

8. 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 in question.

Samples and data are retrieved through the Fingenious ® service

All preliminary studies and applications for sample and data disclosure from Finnish Clinical Biobank Tampere are made in the Fingenious ® service.