Supervision of biobanks
All biobanks are supervised by the authorities. Finnish Medicines Agency Fimea guides biobanking activities in Finland and supervises that biobanks observe the Biobank Act and other regulations and operate in accordance with their quality systems. Fimea also maintains the National Biobank Register which contains information about all Finnish biobanks, including descriptions of their research areas. The Data Protection Ombudsman supervises that data protection regulations are observed.
The National Committee of Medical Research Ethics (TUKIJA) will evaluate the ethicality of the activities of each biobank, particularly from the perspective of sample donors. A positive statement from TUKIJA is a condition for establishing a biobank. For its statement, TUKIJA must examine the biobank's action plan and its consent procedures to determine whether the activities of the biobank meet the conditions concerning the protection of privacy and self-determination laid down in the Biobank Act or elsewhere in legislation. Statements issued by a regional ethics committee and Valvira on the use of samples for biobank research are a prerequisite for the transfer of old samples to a biobank. The decision to transfer the old samples collected in THL is made at the Ministry of Social Affairs and Health.
