COVID-19 Research Evaluation Committee (CREC) Approval Process – FAQ’s

All COVID-19 related research (whether new studies or amendments to existing studies) must be reviewed and approved by the COVID-19 Research Evaluation Committee prior to being submitted for Unity Health REB, CTO or Contracts review. This memo outlines the details.

1. How do I submit my COVID-19 research project for CREC approval?

The Principal Investigator must complete and submit the new COVID-19 Study Impact Approval Form to Elizabeth.Huggins@unityhealth.to prior to REB submission. CREC will evaluate your application form and will endeavour to notify the PI and the REB of the decision within 3 business days. If your project is approved by the CREC, you can then submit to the REB for review. No COVID-19 study will be permitted to begin without both CREC and REB approval. Approval from CREC does not guarantee that your project will be approved by the REB.

St. Michael’s COVID-19 Study Impact Approval Form (version: April 30,2020)

St. Joseph’s COVID-19 Study Impact Approval Form (version: May 27, 2020)

Providence COVID-19 Study Impact Approval Form (version: April 30, 2020)

Please ensure a separate Study Impact form is submitted for any site where research will be happening. Resource/service approval is different for each site.

2. Who is on CREC?

The Vice-President of Research & Innovation will chair the CREC. Other members are representatives of Li Ka Shing Knowledge Institute, Keenan Research Centre, Office of Research Administration, and Research Ethics Board, plus ad hoc members with other expertise (e.g., pandemic research and clinical trials) as required.

3. Why is REB and ORA/contact approval alone no longer sufficient for COVID-19 research studies?

Due to the growing number of COVID-19 related research studies, the VPRI needs to determine the feasibility of implementing every COVID-19 project at each site. Specifically, the Committee will ensure that the resources needed to complete the study are available. Once the COVID-19 project is approved by CREC, you must submit your application to REB or CTO for review and approval as you normally would.

4. If an amendment to an approved study is being considered, do I need to resubmit to the CREC?

If the amendment has material changes, you need to complete the documents below and submit it to Elizabeth.Huggins@unityhealth.to   

  •  Amendment form
    • If Unity Health REB – Unity Health REB Amendment Form
    • If CTO and Unity Health is the Board of Record – CTO Provincial Amendment Form
    • If CTO and Unity Health is NOT the Board of Record – CTO Centre Amendement Form
  • Brief summary of the changes proposed
  • Description of substantive changes to the resources required (e.g. clinical impact, funding, PPE, interventions)
  • Approvals from impacted clinical departments/resources (this can be an email confirmation)

5. How frequently does CREC meet?

The Committee meets twice weekly. Please note your submissions must be complete and verified prior to Committee review. The verified submissions will be sent for Committee review 1 business day prior to the meeting. If your submission isn’t verified as complete prior to the next meeting day, it will be scheduled for the following meeting.

Meeting schedule:

Thursday April 30 3:30 pm

Tuesday May 5 3:00 pm

Thursday May 7 11:00 am

Tuesday May 12 11:00 am

Friday May 15 11:00 am

Tuesday May 19 1:00 pm

Friday May 22 3:00 pm

 

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