Multicenter Studies

The multicenter principle was introduced to simplify the application process and to comply with the requirements of the biobank law regarding traceability in research projects and clinical trials that involve sample donors and patients from multiple healthcare regions in Sweden. With the new biobank law (effective from July 1, 2023), the multicenter principle is removed. Therefore, the same application form is used for multicenter studies as for single-center studies (L1.1). For changes to previous multicenter applications, form N2 Application for Amendment of Agreement under the Multicenter Principle is used. Contact the Regional Biobank Center Middle Sweden for questions regarding changes to multicenter applications.

Email: rbc@rbcmellansverige.se

National Review Procedure for Access to Existing Samples from Multiple Biobanks

Applies according to the biobank law 2002:297 valid until June 30, 2023 (the page will be updated shortly). There have been requests from researchers and companies for a simplified procedure for applications for access to existing samples from biobanks with a common review of the application. The processing of biobank agreements is sometimes time-consuming for the individual biobank because the application is often incomplete or not filled out correctly. Therefore, a new national review procedure has been developed. It involves the researcher/company sending their biobank application (including attachments) regarding existing samples to RBC Middle Sweden, if the ethical review has been/will be conducted in Uppsala. RBC offers advice, reviews the application documents, and also provides contact information for the relevant biobanks to which the application should be sent for a decision after review. This procedure means that other biobanks do not need to go through the review step but can directly assess whether sufficient material, etc., is available.