Compile application package
The following components are required to submit a full board application to the REB:
- Completed TAHSN research ethics application. All sections must be completed and all signatures, including Principal Investigator, Co-Investigators, and Division/Department/Program Head, must be obtained.
- Completed REB submission checklist.
- Site Impact Forms (for studies taking place at St. Joseph’s Health Centre or Providence Healthcare)
- Research protocol (mandatory).
- Consent forms. All forms should be on institutional letterhead and meet the guidelines for writing a research consent form. If participants are under 16 years of age, a separate assent form must also be included.
- Questionnaires, data collection forms, and/or study instruments.
- Investigator’s brochure(s) / product monograph(s), if applicable.
- Advertisement/poster. If recruiting participants by advertisement, must use institutional letterhead or hospital logo(s).
- Copy of Health Canada No Objections Letter (NOL) or other regulatory approvals, if applicable.
- Copy of peer review or any other REB approvals. If the study has been approved elsewhere, a copy of the approval letter is required.
Submit the application package to the research ethics office for screening
Provide one complete copy of your application for screening. Please submit both of the following:
- A single hard copy to the research ethics office, located at 250 Yonge St., 6th floor.
- An electronic copy to Dharmista.Patel@unityhealth.to, with the subject line “PI Last Name – New Full Board Submission”.
Please consider submitting your applications well in advance of your planned meeting date, in the event that screening clarifications are requested. If clarification requests are not addressed prior to the deadline for a meeting, your application will not be scheduled for review at that meeting.
Note: If an application package is incomplete or filled out using an incorrect form, the submission will not be accepted for screening and will be returned to you.
Screening of the application package by the Research Ethics Office
- Your application will be screened by a Research Ethics Coordinator for completeness and accuracy
- All TAHSN questions must be answered
- The information must be provided in lay language where indicated
- The information in the TAHSN must be consistent with the information in the protocol and consent form
- All documents required for review must be submitted in hard copy and matching electronic copy
- If your application is incomplete or inaccurate, the Research Ethics Coordinator will contact you about revising the application and providing missing information or documents.
- Once an application has been determined to be complete, it will be scheduled to a Board meeting.
- You will be asked to provide the screened documents in hard copy to the research ethics office, located at 250 Yonge St., 6th floor. This will include:
- two (2) copies of the REB Submission Checklist
- five (5) sets of the complete application package
- ten (10) sets of a condensed package. The condensed package includes:
- the TAHSN application form
- the consent form(s)
Review of application package by the Research Ethics Board
- Prior to the Board meeting, the Research Ethics Coordinator may send you preliminary questions from the reviewers. You are asked to respond to the questions in advance of the Board meeting to facilitate the review of your study at the meeting.
- After the meeting (within one week) you will receive your review letter. This contains the concerns related to your study that were raised by the Board during review. You must satisfactorily respond to all of the items prior to your study being approved.
- Your Research Ethics Coordinator will be identified in your review letter and will be the point of contact between you and the Board and will work with you through the review and approval process.
Approval of research ethics application
Once the review is complete and all concerns have been addressed, your application will be approved for a maximum of one year, and your approval letter will be available for pick-up in the research ethics office.
Note: This approval pertains only to the research ethics components of your study. Please ensure that all other institutional approvals and contracts have been established prior to beginning your research.
Changes, amendments, annual renewals to your study
As your study progresses, please make sure to keep the REB informed of any amendments, changes, or annual renewals to your study. In addition, please ensure your annual renewals are submitted prior to the expiry of your current approval.