Definitions
As per TCPS2:
Biobank- An organized collection of searchable human biological materials stored for one or more specific or future unspecified research purposes. It may also include associated information about individuals from whom biological materials were collected.
Repository – A data repository or biobank with a known governance framework that “must ensure safe storage, preservation and curation of the data” and human biological materials
TCPS 2 Article 3.13 posted in Jan 2023 guidance on Biobanks, Research registries and broad consent. It is recommended that Biobank and Research registry teams review this article.
Custodianship: Responsibility for safe keeping of biospecimens and associated data and control of their use and eventual disposal in accordance with the terms of the consent given by the participant and as regulated by the Research Ethics Board. Custodianship implies some rights to decide how the biospecimens are used and by whom, and also the responsibility for safeguarding the interests of participants.
UBC CREB: Please note that the term "study" should not be used when referring to the biobank in the RISe application nor in attached documents.
Special considerations
If you will be including in your biobank individuals whose capacity to consent may be in question (e.g., minors or adults with diminished capacity) or individuals from communities that may have additional considerations (e.g., an Indigenous community), please contact your REB office to discuss prior to submission.
UBC policy on Mandatory Biobanking
Participants cannot be required to agree to the biobanking of their biospecimens for future research as a condition of entry into a study. Consent for future undefined research on biospecimens must be obtained separately from the main study consent by way of a separate consent form or a separate section for Optional Biobanking within the Main Consent form. See policy here
CREB Application Requirements:
Table1 Table 1
*Templates available here
**Reference SOPs can be found here, create SOPs specific to your biobank
1 Click section "RISe application" below and see paragraph 1 for additional info
Please note that Biobanks are reviewed at the full board at CREB, please see here for submission and deadline dates.
Each REB may have specific requirements, verify with your REB.
UBC as Contributing Site
If UBC is a contributing site, then the expectation is the lead/custodian site provides the following information to UBC CREB for review:
Biobank Protocol: A supplementary document may be attached to address these requirements. At minimum, information such as Governance and Management, Biospecimen & Data, Access and Release, Final Biospecimen and Data Disposition. De-identification of data and if applicable, de-identification of imaging such as MRIs prior to transfer by the team should be provided. See Biobank Protocol template for descriptions.
SOPs: Individual SOPs are not required to be submitted, however a list of SOPs should be submitted in Application Box 9.8.A.
When to submit separate stand alone Biobank application (Page C only)?
If you have multiple studies that will contribute to 1 biobank then you should submit a separate application to cover the Biobank component.
Each study that will be contributing to the Biobank would reference the Biobank RISe H# in boxes 4.3A & 4.3B and vice versa (Biobank reference the study for these boxes).
Figure1 Figure 1
If a standalone Page C is not submitted then the alternative is to have the PI submit multiple Study + Page C applications, this would be misleading and an ineffective use of the researcher’s and REB’s time.
If the Study is approved prior to the Biobank component, then UBC CREB may request that the Biobank component is submitted as a separate application.
Similarly, if you will have multiple studies that will be using data/biospecimens from the biobank, then a stand alone Biobank application would be recommended. Note, UBC CREB reserves the right to request that a stand alone Biobank application is submitted instead of a Biobank (Page C) + Study (Pages 5-8) combination application.
Research using Biospecimen and/or data from Biobanks
A biobank sets up the infrastructure for research, they process samples for storage, they do not conduct the research. Research studies are covered under separate applications. The following diagram demonstrates how UBC will review research using Biospecimen and/or data from biobanks.
Figure 2
*Data does not include physical biospecimens but may include imaging.
Table2 Table 2
| Page M (Biospecimen primarily +/- Data) | Page A (Data Only) | |
| RISe Application |
|
|
| Requirements | Study Protocol attached to RISe Box 9.1.A Contents include:
| Study Protocol attached to RISe Box 9.1.A Contents include:
|
| Data variable form | Attach to RISe Box 9.8.A (If no variables or only a handful of variables then this can be indicated in Box M.5.A)
| (Required) Attach to RISe Box 9.8.A |
| Biobank Consent Form Template | Attached to RISe Box 9.9 if Biobank is not in RISe. This will be reviewed by CREB. | Attached to RISe Box 9.9 if Biobank is not in RISe. This will be reviewed by CREB. |
| Certificate of Ethics approval for Biobank | Attached to RISe Box 9.9 if Biobank is not in RISe. | Attached to RISe Box 9.9 if Biobank is not in RISe. |
Material/Data transfer agreements (MTA/DTA)
| MTA/DTA: May be required by sending or receiving institution. If required, attached signed agreement to RISe Box 9.9. | DTA: May be required by sending or receiving institution. If required, attached signed agreement to RISe Box 9.9. |
| Website | For more info on Page M see here
| Coming soon |
Questions/Feedback? Please email Elmira.Chan@ubc.ca
Revised: Feb 3, 2026