Ethics Communication Bulletin

June 2022

Process Updates: 

  • The Office of Research Ethics Compliance is in the early phases of implementation of the new Human Ethics Module with our new vendor Cayuse . We hope to implement this new system by winter 2023. Refer to queensu.ca/vpr/resources/TRAQ2 for more information. 
  • The HSREB has created a new Case Report Application form that is now available when you log into TRAQ. This is a very short checklist to help expedite the review process for these types of applications. There are also associated Case Report Guidelines and a Case Report Consent Form Template available for use on the HSREB page. NOTE: The use of the Case Report Consent Form Template is now mandatory. 

  • CHEER logoThe HSREB recently underwent re-qualification through Clinical Trials Ontario (CTO) to maintain status as a qualified Board of Record in Ontario. Additionally, the HSREB underwent qualification through the CHEER Qualification Process – The Canadian Collaboration for Child-Health – Efficiency and Excellence in the Ethics Review of Research (CHEER) , which is a Pan-Canadian initiative to help streamline the ethics review process to enhance and expedite child health research across Canada. 
  • As of May 11, 2022, the Ethics Office will not be issuing PDF letters for Protocol Deviation Acknowledgements or Serious Adverse Event Acknowledgements for all remaining studies in the TRAQ system. Also, the Serious Adverse Event - Multi-Event Reporting Form has been revised to no longer require the addition of the REB review date/signature of the HSREB Chair. Instead this information will be communicated via email from TRAQ. If you require records for auditing purposes refer to the email communication or in TRAQ select ‘Shared Communications’ and click the ‘preview’ icon. Study teams can also confirm the status of events in TRAQ via the ‘Event Info’ in the ‘Note(s)’ box. Emails can be saved as PDFs and/or be printed for study records. As a reminder this process is also in effect for all renewals and study closures as of March 8, 2021. 
  • Health Canada has reduced the retention period for clinical trial records for drugs and natural health products from 25 years to 15 years under the Food and Drug Regulations and Natural Health Products Regulations. This change took effect on February 11, 2022. Read more about this change .
  • There have been some staffing updates in the Ethics Office over the last year. With Dr. Andrew Winterborn stepping down as Director of Research Ethics Compliance, Dr. Kelly Blair-Matuk, Associate Director, VPR has stepped in to provide some administrative support. We have also gladly welcomed the assistance from Zoe Moon and Christine Beswick, our new HSREB Ethics Coordinators, who recently joined the team in 2022. Miranda Miller, Ethics Coordinator, will be returning from maternity leave in July 2022.

Training Updates: 

  • There is a new version of the CORE Tutorial that was released in January 2022. We encourage all researchers to complete this new version: https://tcps2core.ca/welcome . If you have completed a previous version of the CORE tutorial we will still accept this as equivalent ethics training. We may be making the new version of CORE-2022 mandatory when we move to the new TRAQ system but we will communicate this requirement well in advance.

Standard Operating Procedure (SOP) Updates:

  • The HSREB has implemented a new version of SOPs as of January 6, 2022. View HSREB SOP Updates.
  • GREB will be revising the SOPs after moving to the new TRAQ system. 

Resource Updates: 

HSREB

2021 by the numbers

January 1 - December 31, 2021 HSREB GREB
Total New Apps 519 332
New Quality Assurance/Quality Improvement/Program Evaluation Screening Tool 10 6
COVID-19 Apps 45 21
New Clinical Trials 41 N/A
New Health Canada Regulated 17 N/A
Annual Renewals 1443 542
Amendments (incl. team change requests) 1493 468
Local & non-local Serious Adverse Events, Adverse Events  106 4
Protocol Deviations 130 7
Study Closures 350 76