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AURIA PROMA EXTRANET ONLINE PREANALYSIS REQUEST

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The Scientific Steering Committee

Requests for samples and data are processed by Auria Biobank’s Scientific Steering Committee, which is in charge of the scientific evaluation of research projects involving the biobank.

The Scientific Steering Committee evaluates especially:

• the scientific level of the research (theoretical grounds and methods to be used, etc.)
• the significance and ethics of the research
• the amount of material requested in relation to the number of samples in biobank and criteria for selecting the samples
• the resources of the research project
• how the project fits in with the biobank’s area of research

The Scientific Steering Committee may request that the application be supplemented with a statement by a regional ethics committee, as referred to in the Medical Research Act, or other additional statements. Any research carried out by the biobank itself is also evaluated according to the same criteria.

Decision

Auria Biobank’s Director makes the decision on whether to assign samples/data for biobank research on the basis of a statement by the Scientific Steering Committee.

Pursuant to the Biobank Act, Auria Biobank can restrict access to samples and data, especially if

• the intended use goes against the biobank’s defined research area, the consent that forms the grounds for processing the sample, or legal requirements
• the ethical or scientific level of the intended use cannot be verified
• the professional or scientific qualifications of the applicant cannot be verified
• the applicant’s prerequisites to comply with laws and the biobank’s guidelines and agreements cannot be verified
• the material that is being requested is limited, so its use is being prioritised for very significant research
• the material that is being requested is the original research subject of the researcher who collected the material, and assigning it for another purpose would jeopardise this primary use
• the research plan that is being presented in the request overlaps with research that is already being conducted or which has already ended
• use of the material that is being requested in the manner presented would jeopardise the protection of privacy
• an ongoing intellectual property rights protection process would be jeopardised, or
• the researcher has previously failed to fulfil his or her agreement with Auria Biobank

Preliminary meeting, agreement on the assignment of samples/data

Following a positive decision on the assignment of samples and data, a preliminary meeting with the applicant is arranged to agree on the details of how the project will be implemented and to provide a preliminary cost assessment.

A Material Transfer Agreement (MTA) concerning the assignment of samples and data is drawn up together with the researcher’s background organisation, and the costs are confirmed. The background organisation may be a Finnish or international research institution or company.

After signing the MTA, the samples and data can be handed over.

When the research ends, the results of the sample analysis and/or raw data is returned to the biobank in accordance with what is specified in the MTA.

The results of the research must also be published, depending on the research, for example in a scientific magazine.