When can the 9-month exemption be applied?

Samples that are analysed within 9 months of sampling and destroyed immediately following analysis are not covered by the Biobank Act. Both conditions need to be met. This means that if a research study instructs a healthcare provider to take samples for the study that meet the requirements of the exemption rule, there is no need for an agreement with a biobank. On the other hand, an ethical approval from the Swedish Ethical Review Authority or a permit in accordance with the EU regulation on clinical trials/performance studies is required, as well as agreements with clinical trial units. The research principal is responsible for ensuring that both requirements of the exemption rule are followed, i.e. that samples may not be stored for a longer period of time than 9 months after sampling and that samples are destroyed immediately following analysis. Biobank Sweden recommends that an MTA/equivalent is established, if samples that are covered by the exemption rule and are to be sent for an action. However, this is not a requirement under the Biobank Act.