How to Fill Out the Biobank Application
A new Biobank Act is in effect from July 1, 2023, along with new application forms (including L1.1 Establishment of a sample collection for research). Visit the Biobank Sweden website for the latest documents.
Feel free to send a filled-out application (Word format) to Uppsala Biobank for a pre-review before processing. This saves time during the handling process. Take a look at our three steps below when completing the application. During the pre-review, we examine the completion of the form but do not assess the substance of the case. An instruction guide for filling out the application is available: K4 Instruction for L1.1 and L1.2.
Email: info@uppsalabiobank.uu.se
Step 1: Considerations when filling out the Biobank Application, L1.1 Establishment of a sample collection for research
When filling out the application form, it's important to consider the following:
- Note that withdrawals from, for example, the pathologist's healthcare sample collection always count as existing samples, even if the sample is taken in connection with the study.
- The research principal may be, for example, Uppsala University or Region Uppsala (must always be the same as in the ethics application). Starting from July 1, 2023, it should be noted that the research principal can become the biobank principal directly. This means that newly collected samples taken at, for example, Akademiska Hospital can be established/registered in the research principal's biobank (if one exists), even if healthcare assists in the new collection. If the research principal is different from Region Uppsala or Uppsala University, use form L7 to inform Uppsala Biobank about newly collected research samples and that Uppsala Biobank should not be the responsible biobank for these samples, but the samples should be established in another principal's biobank. The form must be signed by the responsible biobank and sent to Uppsala Biobank, where the samples will be taken before the sample collection begins. If samples are to be collected within multiple regions, L7 needs to be established with each region collecting samples. If unsure, contact us for advice at the above functional address.
- The healthcare principal is Region Uppsala for samples taken within healthcare in Uppsala.
- Uppsala Biobank has registration number 827 with IVO.
- Lists of personal identification numbers should be sent securely directly to the person who will perform the sample collection, e.g., the R&D department at Clinical Pathology. If a list of personal information is to be sent electronically, it must always be encrypted.
Step 2: Should Samples be Released? (L1.2)
If samples are to be released, i.e., change the principal and responsibility, leaving Region Uppsala, fill out the release application with information about the receiving biobank. The receiving biobank also signs the release application. Uppsala Biobank has introduced electronic signatures, and if the receiving biobank also accepts digital signatures, we initiate a signing round after reviewing the application. If samples are only sent for action/analysis, no release occurs.
Step 3: Should Samples be Sent for Action/Analysis? (L2a)
If samples that are or will be established at Uppsala Biobank are to be sent for action or analysis outside the principal within Sweden or abroad, an agreement (Material Transfer Agreement, MTA form L2a) must be signed. The agreement is between the biobank manager at Uppsala Biobank and the recipient. Read more about the conditions that need to be met in the research guide at Biobank Sweden. There are three different variants of MTA depending on who is the principal of the biobank and who is the research principal: L2a1, L2a2, and L2a3. More information is available here.
Step 4: Submit the Application Electronically with Accompanying Documents
The documents that must always be submitted are:
- Application for ethical review (including any amendment applications and decisions)
- Decision from the Swedish Ethical Review Authority (EPM)
- Patient/Research participant information with consent section (not needed if EPM has approved access to existing samples without consent)
Additional documents that may need to be submitted are:
- L1a. Appendix information about existing clinical pathology and cytology biobank samples
- L1b. Appendix information about existing clinical liquid-based biobank samples
- L2a. MTA for the transfer of biological material - AGREEMENT on the transfer of biological material
Submit the unsigned application in Word format to Uppsala Biobank's address for processing biobank applications: uppsalabiobank@regionuppsala.se.