Guidance and supervision of biobanks at Fimea

Steering and supervision of biobanks at Fimea

Fimea's task is to steer and supervise biobanks. As part of this supervision, Fimea regularly inspects biobanks. For implementing biobank regulation, Fimea has the right to inspect the premises and operations of biobanks as well as any relevant documents. As part of biobank inspections, assessment is also made of the implementation of the right to self-determination, protection of privacy, and transparency in the use of biobank samples.

An inspection record is drawn up for each inspection, and a copy of this is sent to the biobank owner and the person responsible for the biobank within 30 days of the inspection. The custodian of the biobank must immediately initiate any measures needed to address identified deficiencies and inform Fimea of the measures to be taken and of the timetable for their implementation within 30 days of receiving the inspection report.