Updated:  Dec 7, 2011

UBC BCCA Research Ethics Board

REB Fees

There are three BCCA REB Fees.  These fees are applicable only to studies that are sponsored by for-profit agencies.  Click on the links below for details regarding these fees.

• Ethical Review Fee    
• SAE Review Fee       
• Annual Renewal Fee 

The Principal Investigator (PI) is responsible for payment of all applicable REB fees. The REB will issue invoices or statements to the PI.  The PI is responsible for communicating the fee requirements with their sponsor and for making arrangements for prompt payment to the REB.

 Ethical Review Fee

The fee for the initial ethical review is $3,000 CAD (Canadian Dollars). See criteria below.

This fee covers only the initial ethical review of a new project and subsequent amendments.

This fee does not cover Serious Adverse Event reporting, which will be billed separately (refer to SAE Review Fee) or Annual Renewal Fees.

Criteria
The fee for ethical review applies only to research that receives its funding from a for-profit agency (i.e., pharmaceutical/medical devices company) or other for-profit organization.

Fee Waiver Criteria
The following types of funding are excluded from the fee requirement:

i. Cooperative groups (i.e; NSABP);
ii. National Cancer Institute of Canada Clinical Trials Group
iii. Grant from a non-profit organization, for example, CIHR, NIH or a cancer-specific foundation
iv. BCCA internal

The fee may be waived in other circumstances if requested in writing with an explanation.

The BCCA REB will issue an invoice to the PI with a request to arrange for prompt payment (refer to Mechanisms for Submitting Fee below). It is the responsibility of the Principal Investigator to ensure payment of this invoice and for communicating this requirement to the Sponsor.

A Certificate of Approval will be issued only upon approval of the project and completion of applicable administrative requirements (see Certificates of Approval policy ), one of these being receipt of the REB Review Fee. 

(Effective January 30, 2008) If the Clinical Trial Agreement (the legal contract) is received and approved by the REB and it includes a clear statement that the sponsor is bound by the legal agreement to pay the $3000 REB fee, the REB will issue the certificate pending receipt of payment (providing all other provisos have been satisfied). The language must be clear and easily identified in the contract. An example of preferred wording is below. The REB will accept other language with clearly similar intent. However, in situations where such language is not clearly evident in the legal contract the REB will continue to withhold the certificate of approval until the payment has been received.

Example of wording for the CTA:

"Ethics Committee Fee
A payment of $3,000 for the initial ethics committee review will be issued by [sponsor name] upon receipt of the appropriate invoices from the institution.

Note:  If an approval is issued under these conditions, payment is due within 30 days from the date of the REB approval.  The REB reserves the right to withhold review of subsequent amendments or renewal until payment is received.

Refund:  The initial review fee may be totally refunded 'upon request' if the study is withdrawn prior to review.  A refund is not automatically issued upon withdrawal.  To request a refund the Pincipal Investigator must notify the REB by email and include an explanation for the withdrawal. The email must include the REB #, project title, and mechanism for refund such as the BCCA account into which the refund should be transferred or identification of the designate to whom the cheque is to be made payable.

Memo re implementation of the annual renewal fee 

The SAE Review Fee is $20 CAD (Canadian Dollars) per report until January 1, 2012.

New  BCCA REB Discontinuing SAE Dbase and SAE Fees effective Jan 1, 2012 

The following instructions continue to apply until January 1, 2012;

Criteria
1) The SAE fee applies only to clinical trial studies for which the BCCA REB is the ethics Board of record and that are sponsored by for-profit agencies.

2) Until the project has both REB approval and is "activated" SAE reports constitute updates to the Investigator's Brochure (background information) and can be sent to the REB in a fashion similar to submitting safety letters (either with the original application, or as a request for acknowledgment) to the BCCA REB under that project in RISe.

3) Once the project has REB approval and is "activated"; SAEs must be reported using the BCCA REB SAE database located within the PHSA/BCCA network and is subject to the SAE review fee.

4) The data coordinators enter the SAE's into the BCCA REB SAE database, which generates an immediate acknowledgement.

5) Projects where the researcher and/or the project data coordinator do not have access to the PHSA/BCCA network, are being managed on a case by case basis with regard to the SAE reporting process and billing. The researcher or data coordinator should contact the REB administration office for these particular projects (see Contacts).

6) Effective October 30, 2009 the REB implemented a new method of reporting individual external (non-local) SAE reports. As a result, the cost to sponsors may be minimized by providing periodic summary reports (quarterly or six monthly) in lieu of individual reports that do not meet the requirement for individual reporting (see Adverse Events webpage). The periodic summary report will be counted as a single document subject to a $20 fee for the entire report.

Specifically, each of the following will constitute an SAE document and incur a $20 fee:

• A quarterly or 6-monthly summary report submitted via RISe.
• An SAE report, local or external, submitted via the SAE database
• An SAE follow-up report, local or external, submitted via the SAE database
• An SAE report or follow-up report, local or external, submitted via RISe for those who have specifically been granted permission to use the RISe system because they cannot be granted access to the BCCA REB SAE database.

7)  The REB will issue a statement by email on a quarterly basis for the preceding 3 months. The statement is payable within 30 days of receipt of the email statement. It is the responsibility of the Principal Investigator to ensure payment of this invoice and for communicating the fee requirement to the Sponsor.  (Refer to Mechanisms for Submitting Fee below).

The key information here is that if a project meets the above criteria, the SAE fee will be billed separately from the REB review fee and annual fee, and the researcher and sponsor should be prepared to pay the SAE statement in full within 30 days of receipt of the statement.  If a project meets the above criteria but the researcher or data coordinator do not have access to the PHSA/BCCA network, they should contact the REB administration office.
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