| Forms & Guidelines |
See RISe webpage on this website. |
| BCCA Department Head Approval |
BCCA Department Head Approval must be obtained prior to submission to REB
When you "submit" a new application in RISe it is not sent directly to the REB, it is first electronically routed to the BCCA Department you select in RISe for Dept. Head review/approval. It is not until the BCCA Department Head approves the study in RISe that it will appear in the REB in-box. Please be sure to allow enough time for your Department Head to review/approve the submission in order to meet the REB deadlines. The REB does not track the Department Review. It is the Principal Investigator's responsibility to follow-up with their Department Head to ensure the study is reviewed/approved in time for an REB deadline.
How can you track this? You can track your submission in RISe by looking at the "state". When you see the state change from "Department Review" to "REBA Screening" this indicates the REB has received the study.
Instructions for Departmental Reviewers: Help Document #3 on our REB webpage. |
Level of REB review
|
Expedited (delgated) or Full Board Review?
Expedited (Delegated) Review means a review by the Chair only and there is no deadline for submission. Expedited Review only applies to "minimal risk" projects, otherwise, full board review is required. To avoid delay and missing deadlines please be sure to check the criteria for minimal risk projects that qualify for expedited review.
For Clinical projects:
Guidance Notes for Minimal Risk Studies (Mar 1, 2011)
For Behavioural projects see
Guidance Notes on BREB Application (Section 4.6) (May 2011) |
| Deadlines for Full Board Meetings |
Deadlines and Meeting schedule |
Consent Templates |
Submissions to the BCCA REB must use the BCCA Informed Consent Templates The main consent should contain information about the requirements that are mandatory in order to participate. Optional testing should not be included in the main consent, instead use the optional consent template. |
| Contact Letters, Handouts, Advertisements |
Submit as individual documents with a version date. If these are BCCA generated; submit on BCCA letterhead. These will be listed on the approval certificate. Refer to the BCCA policy for Subject Handouts and advertisements. |
| Protocol Required |
All applications must include a protocol.
Elements of a protocol are noted in the RISe application in Section 5.1B (Summary of Proposal). Also see Characteristics of a Project  which explains what the BCCA REB looks for in any project submitted for review/approval. |
Expanded Access Protocols (EAP)
|
EAP Guidelines-V1-2005-March-12 .pdf file |
Elements Required of a Pilot or Feasibility Study
|
Elements Required of a Pilot or Feasibility Study .pdf file |
| Combined Phase I/II Clinical Trials |
Guidelines for Applications for Combined Phase I/II Clinical Trials
|
| Mandatory Tissue Collection |
Mandatory Tissue Collection |
| Tissue Banking |
BCCA REB Guidance for Biobanks (Feb 10, 2012)
Guidance Notes for Tissue Collection and Banking (Feb 11, 2009)
Guidance re Human Tissue Banks V1 (March 2005)
|
| Scientific Peer Review and Health Canada |
For projects that require Health Canada approval, the BCCA REB will only issue the certificate of approval when the Health Canada No Objection Letter is received for the initial protocol. This also applies to subsequent amended protocols. If a project is a medical device trial that requires Health Canada approval - please contact the REB Admin.
Also refer to the BCCA Scientific Peer Review requirements. |
| Registration of Clinical Trials for Publication |
For details see BCCA REB "Policies" web page re "Registration of Clinical Trials for Publication" |
| Clinical Trials Agreement (CTA) |
The REB refers to the legal contract as a CTA. This refers to the legal contract between the Sponsor, Principal Investigator and Institution. A certificate of approval will be issued only upon receipt a completed copy of the CTA for review/approval. For details refer to Clinical Trials Agreement (CTA) |
Fee for Ethical Review
|
A Certificate of Approval will be issued only upon receipt of the REB Fee if applicable. For full details refer to: BCCA Fee for Ethical Review |
| Health Canada Research Ethics Board Attestation (REBA) Form |
Since October 1, 2003 the UBC BCCA REB Certificates of Approval include the REB certification statement as well as all of the required REB contact information for the UBC BCCA REB office, the Chairs, and REB signature, which is accepted by Health Canada in lieu of the "REB Section" of the (REBA) attestation form. Submission of REBA forms to the UBC BCCA REB is therefore not required.
If you require a signed statement for your sponsor, one is attached below
BCCA REB Letter re HC REBA Form Not Required
|
| US Affiliated Studies |
The BCCA REB will only issue the certificate of approval upon approval of the project and completion of administrative requirements.
REB requirements for US affiliated studies |
| REB Certificate of Approval |
The BCCA REB will only issue the certificate of approval upon approval of the project and completion of applicable administrative requirements.
See Certificates of Approval policy |
|
Back to top
|
Questions?
Other questions and answers may also be found under "FAQs Frequently Asked Questions"or "Policies"
Contact the REB Administration (REBA) by email reb@bccancer.bc.ca or see Contacts page.
Additional information about submitting amendments, annual renewals, etc. are posted on the REB website: REB Homepage
|