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When should a Material Transfer Agreement (MTA) or equivalent be established for samples covered by the Biobank Act and what should an MTA contain?

For research or clinical trials with ethical approval or permit, samples can be sent for a certain action (e.g. for analysis, reformatting and/or storage) to be carried out to a legal entity within or outside the country without it being considered a release. Samples sent to another legal entity for an action to be carried out do not cease to be part of the biobank in which they are established.

There are specific requirements for agreements and terms for a sample to be sent for an action. Agreements can be in the form of a Material Transfer Agreement (MTA).

The biobank custodian is required to draw up an agreement (MTA/equivalent) with the recipient stating the purpose of making the samples available, what will happen to samples after the action has been performed, and set as a condition for making the material available that:

  • a sample stored at the recipient must be returned or immediately destroyed or, if it is not possible to destroy it without destroying other samples, anonymised*, at the request of the biobank custodian.
  • the recipient does not use samples for anything other than the stated purpose.

It is not necessary to draw up an agreement for each sample, but an agreement between the parties may cover a large number of samples, which may have been sent at the same time or on different occasions. Biobank Sweden provides standard templates for Material Transfer Agreements. However, it is not always the case that a separate MTA needs to be used. For example, a separate MTA is not required if the agreement between the sponsor and the central laboratory already contains the information required by the Biobank Act.

*An example of when this situation arises is when a sample donor contacts the biobank and informs them that they are withdrawing their consent to the storage of samples. The responsible biobank must ensure that the wishes of the sample donor are executed even though the sample is stored at the recipient.