Every year, a large number of biological samples are placed in biobanks. The purpose is usually clinical and benefits the sample provider, but these samples can also be used for research. Swedish legislation determines the purposes for which a biobank may be set up and how the samples may be used.
Biobanks in Medical Care Act (in Swedish)
Research on human blood, tissue etc. normally requires ethical permission. The requirement applies to research concerning studies of biological material taken from a living person and which can be traced to that individual, or concerning studies of biological material which has been taken from a deceased person for medical purposes and can be traced to that individual. The left hand column contains links to sections which describe the ethical review procedure in more detail.
The sample provider must have consented to the storage of the sample in a biobank. The sample provider is to have been previously informed of the intent and purpose or purposes for which the biobank may be used. If the sample provider is underage and has not yet reached the age and maturity required to take a decision on the issue, the legal guardian is to consent to the storage of the sample. If the sample originated from a foetus, the mother’s consent must be obtained. In cases where the sample is taken from a deceased person, special provisions apply (Chapter 3 Section 4 Biobanks in Medical Care Act (2002:297)).
If the aim of storing the sample changes after the sample has been collected, an ethical review board must take a decision on what rules are to apply with regard to information and consent. Please note that the ethical review is required even in cases where the sample provider consented to research.
The sample provider has the right to withdraw consent at any time. If the sample provider thereby objects to all future use of the sample, the sample is to be immediately destroyed or anonymised (so that the sample can no longer be linked to the sample provider).
The Health and Social Care Inspectorate (IVO) supervises the biobanks to ensure compliance with the Biobanks in Medical Care Act and related regulations. The principal responsible for setting up a biobank (e.g. Region Skåne or Lund University) must report the fact to IVO. Any release of samples must also be reported to IVO.
The Swedish National Biobank Council runs a web portal about biobanks. It provides information on relevant regulations, forms and links. The portal also features examples of how research volunteer information can be presented, including instructions to researchers.
Do you have any questions regarding research ethics regulations?
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