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.
Special considerations
If you will be including in your biobank individuals whose capacity to consent may be in question (eg, minors or adults with diminished capacity) or individuals from communities that may have additional considerations (eg, 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
**Each REB may have specific requirements, verify with your REB.
Please note that Biobanks are reviewed at the full board, please see here for submission and deadline dates.
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 stand alone Page C is not submitted then alternative is PI submits multiple Study + Page C applications and that would be misleading and ineffective use of the researcher’s and REB’s time to complete Page C multiple times.
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.
Research using Biospecimen and/or data from Biobanks
Biobank sets up the infrastructure for research, they processes 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.
Figure2 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 9.8A (If no variables or only a handful of variables then this can be indicated in Box M.5.A)
| (Required) Attach to RISe Box 9.8A |
| Biobank Consent Form Template | Attached to RISe Box 9.9 if Biobank if not in RISe. This will be reviewed by CREB. | Attached to RISe Box 9.9 if Biobank if not in RISe. This will be reviewed by CREB. |
| Certificate of Ethics approval for Biobank | Attached to RISe Box 9.9 if Biobank if not in RISe. | Attached to RISe Box 9.9 if Biobank if 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