Research on human tissue

Research where new tissue samples are collected

If you, or others on your behalf, will collect tissue samples from living or deceased persons through physical interventions, you must begin by obtaining an ethical review approval from the Swedish Ethical Review Authority. You can read about this here. There is a need for consent to the taking and (if applicable) preservation of the samples.

In some situations the Biobank Act (biobankslagen, 2023:38) applies to the samples, see information here. If the samples are subject to the Act, this means that they must belong to and be established in a biobank. There must be an agreement with a biobank, see more information here.

Under certain circumstances, the requirements of the Biobank Act do not apply, for example if the samples have been deidentified (as to no longer be traceable), or if they are destructed within nine months from being collected or immediately after being analysed.

Research on existing tissue samples

If you are going to use already collected tissue samples from living or deceased people in your research, and these samples can be linked to the people in question, you need to apply for ethical review. Read more here. The ethical review will include an assessment of whether you need to obtain renewed consent from the sample donors in order to use the samples in the research.

Note that blood samples or blood component samples obtained from Komponentlabbet at Karolinska University Hospital are considered identifiable as they are delivered in coded (pseudonymised) form. Even if you as a researcher remove the codes and thus anonymize the samples, ethical review is required as identified samples were initially processed. You can find information about this here.

Note that blood samples/blood components that are stored for more than nine months, or that are stored for less than nine months but are not destroyed immediately after analysis, are subject to the Biobank Act, which requires that the sample collection be established in a biobank (see information above).

If you are going to use existing samples from a biobank in your research, you will find useful information on the Biobank Sweden website.

An MTA may be needed for the transfer of samples

If samples are to be transferred between different research principals (for example between different universities), this must be done in a controlled and legal manner. A Material Transfer Agreement (MTA), and possibly additional agreements, are often required.

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