NEW APPLICATIONS

All new applications for ethical review are to be submitted using the Researcher Information Services system (RISe). 

For assistance in submitting ethics applications, please contact Nesa Kruse, Pre and Post Review Manager or by phone at 604-806-8567

AMENDMENTS TO RESEARCH

Approved amendments expire on the expiration date for the entire study (the expiry date of the study is noted on each certificate of approval as a reminder).  An approval of an amendment does not change or extend the expiry date of the study, a separate request for annual renewal must be submitted.

Once a study is approved, updated Investigator Brochure (IB) or addendums to the IB and/or Product Monograph must be submitted as a request for amendment. This is necessary for harmonization amongst all the UBC REBs so that the current version is readily accessible in RISe application section 9 for applicable studies.

Guidance for Amendments to a Previously Approved Project

ANNUAL RENEWALS

In compliance with regulatory requirements and the UBC Office of Research Services, all ongoing projects must have a current valid ethics approval (they may not remain in an "expired" state).

RISe generates automated email reminders for annual renewal, which are sent to the Prinicipal Investigator and Primary Contact listed in the application.

• 6 weeks before the ethics approval expires
• 2 weeks before the ethics approval expires
• on the day the ethics approval expires

UBC Providence Health Care Research Ethics Board Policy: Failure to Comply with Requirement for Annual Renewal

PROTOCOL DEVIATION REPORTING (updated 29 Oct 2009)

Protocol Deviation Reporting Guidance

SERIOUS ADVERSE EVENT REPORTING (05 Nov 2009)

A new policy and guidelines was introduced 30 October 2009 for all UBC REBs regarding the criteria and method for reporting non-local (external) Serious Adverse Events (SAEs) to the REB.

Effective 30 October 2009, individual non-local (external) serious adverse events should be reported to the REB in the form of periodic summary reports, rather than submitting individual SAE reports. The periodic summary report must, at minimum, include a sponsor analysis of the significance of the adverse events or such an analysis for an independent Data Safety monitoring Board (DSMB), with (where appropriate), a discussion of previous similar events. Periodic reports should be submitted using the Request for Acknowledgement Form in RISe. Periodic summary reports may be either quarterly or six monthly, as preferred by the sponsor. All local SAE reports should also be submitted via RISe.

SAE Policy: 30 October 2009

SAE Guidance Notes: 30 October 2009