HOW TO APPLY

​If required, initiate any required contracts or institutional agreements before submitting your CO-REB application to ensure they are fully executed prior to the start of research activities, as these processes may require additional time.

A complete submission must include the following documents:

  • General Research Application (GRA) or Application for Research Access to Health Records, Registries, and Repositories (RATHR)
  • Study Protocol
  • Ethics training certificates of study team (e.g., TCPS 2: CORE, CITI-GCP)
  • Curriculum Vitae (CV) of study team (signed and dated)

If applicable:

  • Informed Consent Form (s) (ICFs should be submitted using the CO-REB template)
  • Investigator’s Brochure (IB) or Product Monograph (PM) (for studies regulated by Health Canada)
  • No Objection Letter (NOL), Investigational Testing Authorization (ITA) or Notice of Authorization (NOA) (for studies regulated by Health Canada)
  • Supporting documentation, as applicable [e.g., detailed budget; surveys/questionnaires, scripts, interview guides, brochures, case report/data collection forms, assessment tools, recruiting advertisements, documentation from other REBs, Data Safety and Monitoring Board (DSMB) Charter]

To apply, please submit an electronic copy of your completed application to coreb@rvh.on.ca. Applications must be submitted at least 30 days prior to the next scheduled CO-REB meeting.

ONGOING REB REVIEW ACTIVITIES

The investigator is responsible for submitting any changes to the approved study to the REB as an amendment. Additionally, the investigator must report any:

  • Reports of unanticipated problems involving risks to participants or others,
  • Reports of any serious or continuing non-compliance,
  • Reports of any changes significantly affecting the conduct of the research or increasing the risk to research participants,
  • Results of any interim analysis or Data and Safety Monitoring Board (DSMB) assessments,
  • Deviations to the previously approved research,
  • Adverse events that meet the reporting criteria,
  • Reports of any privacy breaches,
  • Summary reports of any audits and inspections,
  • Other new information that my affect adversely the safety of the research participants or the conduct of the research

The Researcher is also required to submit an application for continuing review at a frequency determined by the REB. This frequency will be specified at the time of initial approval or may be revised thereafter.