May samples be stored abroad?

The Biobank Act allows samples to be sent to a legal entity within or outside the country in order for a certain action to be performed. For example, an action can be analysis, reformatting, or storage.

However, these may only be actions that fall within the scope of the purpose. For example, if the purpose is a specific research project, it may only be actions that fall within that project that are to be carried out.

If samples have already been collected and you then wish to store samples abroad, you need to look at what is stated in the existing ethical approval from the Swedish Ethical Review Authority, information for research subjects/persons, biobank agreements and MTA. If the action storage abroad is not covered in the existing biobank agreement and the MTA/equivalent needs to be updated. An application for a substantial change is probably also required to the Swedish Ethical Review Authority (which will also decide on the requirements that will apply in terms of information and consent).