How to Identify a Biobank Sample
A biobank sample is a human identifiable sample taken for purposes covered by the Biobank Act. Biobank samples range from fluids such as blood, serum, plasma, and saliva to fecal samples and tissue samples such as biopsies, tumors, and excised organs. The new Biobank Act is effective from July 1, 2023. From then on, all identifiable/traceable samples taken from humans, including those taken outside of healthcare, are covered.
This is in accordance with the Biobank Act (2023:38). A sample is a biobank sample if it is a human sample that is identifiable (traceable) to a donor and is collected, preserved, or used for the purposes listed below.
- Healthcare, treatment, or other medical purposes within the healthcare provider's operations
- Research
- Product manufacturing
- Education, quality assurance, or development work within the framework of any of the purposes specified in 1–3) and to investigate injuries under the Patient Injury Act (1996:799).
The new Biobank Act has an expanded scope. This means that even samples taken outside of healthcare are covered. The law applies retroactively. Samples covered by the Biobank Act must always be established in a biobank. Existing healthcare sample collections (e.g., in clinical pathology, clinical microbiology, etc.) within Region Uppsala are organizationally tied to Uppsala Biobank (the joint biobank of Region Uppsala and Uppsala University).
Samples not covered by the Biobank Act and therefore not considered biobank samples are as follows:
- Samples that are completely de-identified, i.e., they are no longer traceable to the donor via code or similar means.
- Samples that have been processed to a considerable degree and are a result or product.
- Samples that have been discarded immediately after analysis and not stored for more than 9 months after sampling.
- Samples that have been taken outside the borders of Sweden.
- Tissues and cells intended for transplantation, assisted reproduction, and drug manufacturing.