1. Research Ethics At Queen's University
  2. How to start your Ethics application

How to start your Ethics application

The basic steps for completing an ethics application are provided below.

Please refer to the Research Ethics at Queen's University page or Queen’s University Ethical Guidebook for more information. 

 Step 1:

Queen’s University uses two application platforms: 

Both platforms differ significantly in their roles and functions at Queen’s University.

TRAQ CTO

TRAQ  is an internally focused research management system, providing a unified platform for all Queen’s research proposal submissions to the REB, tracking and storing data regarding the project. This includes ethics review, financial details, and project outcomes.

Submissions to either GREB or HSREB can be submitted via TRAQ.

CTO  works on a broader scale, focusing on streamlining the approval process of clinical trials across the province. Unlike TRAQ however, CTO is not limited to a sole institution but works to improve and enhance the quality of the research environment across Ontario.

Only submissions to HSREB can be submitted via CTO.
  • Used for all single centre studies being run at Queen’s University
  • Used for multi-centre studies where the lead site is not using CTO (i.e., could be outside Ontario/international)
  • Use Queen’s University Consent form templates are found on our Guidelines / Policies / Templates page.
  • Submissions from both HSREB and GREB are submitted via TRAQ
  • Used for multi-site research studies in Ontario
  • Streamlined ethics review
  • One board of record for all centres in Ontario
  • Initial application is provincial and then each centre will submit a centre application based on the initial provincial application
  • CTO has its own consent templates
  • Only submissions from HSREB occur in CTO


 

 Step 2:

If no TRAQ account:

If no CTO account:

Since Queen’s University and its Affiliated Hospitals are CTO-qualified sites, you can sign up for your own account to use CTO Stream.

Please use a valid email as you will be required to verify your email address before accessing your account. All CTO accounts must be screened by Clinical Trials Ontario before they can be accessed. You will receive an email once this screening process is complete. 

Create CTO Stream Account 

 Step 3:

According to Ethics SOP 801, all researchers, students, staff and faculty submitting an ethics application are required to complete the TCPS2 CORE tutorial prior to commencing research.

TCPS 2: CORE-2022 (Course on Research Ethics) 

NOTE: TCPS2 CORE training takes approximately 4 hours to complete. 
NOTE: TCPS2 CORE training should be updated in accordance with SOP 801, Section 5.1.3.

 Step 4:

Students must upload a copy of their supervisor’s letter that contains the following: 

  • Title of the study
  • Date of the letter/email 
  • Supervisor signature (written or electronic)

NOTE: Ensure the supervisor is added as a supervisor in the Project Team Info tab of the TRAQ application.

 Step 5:

Submitting to Health Sciences and Affiliated Teaching Hospitals Research Ethics Board (HSREB) vs. General Research Ethics Board (GREB)

If your study includes one or more of the following elements, you must obtain a review from the HSREB:

  • Participants from any of the Affiliated Teaching Hospitals or in other health care clinics or medical settings at any point during the research
  • Conducting research or recruiting participants from any of the Affiliated Teaching Hospitals (Kingston Health Sciences Centre (KGH and HDH Sites), Kingston General Health Research Institute (KGHRI), Hotel Dieu Hospital Research Institute (HDHRI), Providence Care Centre (PCC) and Ongwanada) or in other healthcare, clinic, or medical settings
  • Pharmaceutical device, drug, or natural product(s) clinical trials
  • Medical or physical interventions, treatments, therapies, or surgeries
  • New medical techniques or technologies, deviations from standard of care
  • Using human biological material from living or deceased participants; physical exertion (beyond walking/normal daily activities)
  • Medical or dental patients, doctors, nurses, dentists, or any other health care professionals, and rehabilitation therapy
  • Accessing health or medical records
  • Using X-rays, CT scan, PET Scan, MRIs, ultrasounds, EKG or other medical tests or scans
  • Administering or ingesting any substance
  • Biobanks and large databases

If no items from this list are applicable to your study, you must obtain a review from the GREB.
 

 Step 6:

Full board review: Studies involving more-than-minimal-risk research (i.e., high-risk studies based on intervention type and vulnerability of the participant group) must be reviewed at a Full Board meeting. Full Board meetings generally occur once per month. Ethics applications are due 3 weeks in advance of the monthly meeting. Meeting dates and submission deadlines are posted on the Research Ethics at Queen's University website: 

Delegated review: Studies involving minimal risk research (i.e., low-risk studies based on intervention type and vulnerability of the participant group) are reviewed on an ongoing basis. There is no submission deadline (i.e., applications can be submitted at any time).
 

 Step 7:

Login to TRAQ or CTO and create your application. 

In TRAQ:

  • Visits the TRAQ Researcher Portal Sign On site at queensu.ca/traq/signon 
  • Log In
  • click ‘Apply New’ and select the appropriate application form under the board you have determined to apply to in Step 5 above. 

For assistance with your TRAQ application view these TRAQ resource pages HSREB Training  / GREB Training 

In CTO:

You can save and exit these applications at any time while your application is in progress. 

 Step 8:

  • Information about recruitment and consent etc have been included in the ethics application. 
  • Review the consent form, ensure it meets the basic requirements. 
  • Ensure all documents references in the application have been attached to the TRAQ/CTO file in ‘attachments’ or ‘documents’ tab.
     

 Step 9:

Submit the application.

What happens next: 

Your application will be reviewed by the Research Ethics Team. The research ethics team will contact you if clarifications/modifications are required for your application. 

Refer to the Queen’s Research Ethics Board Guidebook: Navigating Ethical Practices for Human Participant Research for more information on determining the types of REB review, risk level of a project, review cycle, and processes. 

 

Post-Approval Activity:

Post approval submissions represent subsequent submissions to the file put forth after initial approval has been granted, and may include: 

  • Requests for amendments to the original plan
  • Continuation or renewal of projects
  • Reporting unexpected occurrences (i.e. SAEs, AEs)
  • Protocol deviations
  • Privacy breaches
  • Study closures

This allows the Research Ethics Board to monitor ongoing research and ensure adherence to ethical guidelines.