In-Person Human Participant Research
Applications requesting to restart existing or new in-person human participant research either on campus or in a hospital setting are no longer required. Please refer to Queen’s University COVID-19 Vaccination Policy regarding mandatory vaccination requirements for in-person University Activities.
Visit queensu.ca/vpr/covid-19 for the most up-to-date information related to COVID-19.
TRAQ users with an active ethics account (HSREB/GREB) are being contacted by the Office of Research Ethics Compliance regarding the proposed changes to the Panel on Research Ethics: Proposed Guidance for Public Consultation, Interpretation and Implementation of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2 2018).
The Office of Research Ethics Compliance will be drafting a response to send on behalf of the Research Ethics Boards and Queen’s University. We invite anyone from the Queen’s University research community who wishes to collaborate in this response to send written comments via email to Jennifer Couture, Manager Research Ethics Compliance no later than September 20, 2021.
These documents (hyperlinked below) touch on the following themes:
COVID- 19 Update - Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans TCPS 2 (2018) – 2020APR29
The Tri-Council released a statement for Research ethics review during COVID-19 publicly declared emergency. The update reminds REBs that even in a public emergency situation, full REB review is still required, and ethics clearance must not be bypassed. REBs can refer to the TCPS 2018 Chapter 6, Section D, Articles 6.21, 6.22 and 6.23.
Health Canada, FDA, OHRP COVID-19 Updates
- FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency Guidance for Industry, Investigators, and Institutional Review Boards
- OHRP Guidance on Coronavirus | HHS.gov - Research Guidance on Coronavirus
- Health Canada - Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors
Research Ethics Policy Updates
The HSREB has revised the Fee Policy, for more information view the HSREB Fee Policy webpage.
Standard Operating Procedures
The following SOPs were updated to reflect changes in ethics training requirements due to implementing mandatory ethics training as of December 2, 2019.
The following resources were created to help researchers navigate virtually due to COVID-19.
- Virtual Research Guidelines
- Verbal Consent Script Template for Regulated Studies (WORD 44 KB)
The Ethics office is making an update to processing annual renewals and study closures. As of March 8, 2021, annual renewal letters will no longer be generated for GREB and HSREB. Instead this information will be communicated via email only. 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 annual renewal or study status in TRAQ via the ‘Event Info’ in the ‘Note(s)’ box.
In order to improve processing times, the HSREB will be moving forward with processing Serious Adverse Events (SAEs) and Protocol Deviations (PDs) through an official email acknowledgment. If your study sponsor requires a letter, indicate so in the shared comments.
Indigenous Community Research Partnerships (ICRP) Training Resource is an online open education training resource . The Group for Ethics and Engagement in Indigenous Community Research Partnerships (EIP), author of the training resource, consists of partnerships with Indigenous and non-Indigenous researchers, and Queen's University Arts and Science Online, the Centre for Teaching and Learning, and the Office of Indigenous Initiatives . It is designed to assist researchers who are new to research in partnerships with Indigenous communities, or who are researchers-in-training, to:
- Operationalize required regulatory policy requirements and research directives;
- Ensure equitable inclusion of Indigenous and Western-oriented knowledge in research systems;
- And, in the case of Indigenous-specific enquiry, to privilege or give primacy to Indigenous ways of knowing and doing;
The ICRP training is available online and on-demand and can be taken as a Queen's Certificate (available to those with a Queen's netID) or as an Open Access educational resource available to the public. The training resource is in the form of four modules, with a fifth module designed specifically for the Queen's University local context (coming soon!). The training resource is designed to be completed at your own pace. A certificate of completion will be issued to those who register and complete the training resource.
|New Application and Events||HSREB||GREB|
|New Research Applications||596||345|
|New COVID-19 Applications||89||46|
|New Clinical Trial Applications||41||N/A|
|New Health Canada Regulated Applications||16||N/A|
|Amendments, adverse events, protocol deviations, study closures||1957||358|