Swedish legislation demand traceability of biobank samples. To fulfil the requirements, national and/or local biobank agreements have been compiled. If samples are taken within health care, a biobank agreement between the county council and Karolinska Institutet and KI Biobank is required. Information about the agreements is found below or via the home page of Biobank Sweden (www.biobanksverige.se), where the national templates can be found. For questions and advice, please contact email@example.com.
Before starting a sample collection at KI Biobank, a service agreement must be signed between the principal investigator and KI Biobank. KI Biobank helps prepare this agreement from a standard template.
Sample responsibility transfer contract
When the legal responsibility for a sample collection should be transferred from one responsible organization to another (for instance from the county council to Karolinska Institutet), a sample responsibility transfer contract must be established.
When different responsible organizations are involved in the sample collection, the legal responsibility can be transferred to the organization responsible for the research using a multicenter agreement. The multicenter agreement facilitates the handling, as it is enough that one agreement is established with a Regional Biobank Centre (RBC) instead of one agreement with each responsible organization. Find more information about the RBC’s on www.biobanksverige.se. A small fee is charged for preparing a multicenter agreement.
If the legal responsibility remains with the first responsible organization but the samples are stored by one or several other responsible organizations, special regulations such as a “storage agreement” should be established.
Material Transfer Agreement (MTA)
When samples are to be sent outside the responsible organization, which has the legal responsibility, a Material Transfer Agreement (MTA) shall be established. An MTA-template has been developed for KI Biobank in collaboration with the lawyers at KI. The MTA must be approved and signed by all parties before samples are allowed to be sent from KI Biobank.
Sample collections in different institutions
Apart from the samples which are stored centrally at KI Biobank, there are also sample collections at some of KI’s different institutions. These include sample collections, which have been handed over from a responsible organization within the health and medical services to Karolinska Institutet, samples taken from healthy volunteers or donors outside the health and medical services or samples taken abroad.
For sample collections at these different institutions the sample quality and traceability must be secured without risk to the integrity of the sample donor. According to national guidelines this means that the sample collections must be registered in a biobank with adequate documentation in a quality system. To secure this, a registration form for new sample collections must be completed and sent to firstname.lastname@example.org.
Registration of a new sample collection