Full Board Application

Studies that involve more than minimal risk to participants are reviewed by the entire Research Ethics Board (REB) and must be submitted through the full board application process.

Studies that are greater than minimal risk may include studies such as:

  • clinical trials of drugs, devices, or natural health products
  • those collecting significant personal health information
  • those studies where the participant/patient population is particularly vulnerable

Please follow these instructions to submit a full board application to the Research Ethics Board:

Compile application package

The following components are required to submit a full board application to the REB:

  1. 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.
  2. Completed REB submission checklist.
  3. Research protocol (mandatory).
  4. Patient information. If participants are under 16 years of age, assent form must be included.
  5. Consent forms. All forms should be on St. Michael’s Hospital letterhead and meet the guidelines for writing a research consent form.
  6. Questionnaires, data collection forms, and/or study instruments.
  7. Investigator’s brochure(s) / product monograph(s), if applicable.
  8. Advertisement/poster. If recruiting participants by advertisement, must use St. Michael’s Hospital letterhead.
  9. Copy of Health Canada No Objections Letter (NOL) or other regulatory approvals, if applicable.
  10. 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 completed application package to the research ethics office

  1. Provide two (2) copies of the REB Submission Checklist
  2. Provide seven (7) sets of the completed application package in hard copy to the research ethics office, located at 250 Yonge St., 6th floor.
  3. Provide thirty (30) sets of a condensed package in hard copy to the research ethics office. The condensed package includes:
    • the TAHSN application form
    • the consent form(s)
    • any participant-facing materials (e.g. posters, telephone scripts, etc.)
  4. Send an electronic copy of one (1) full package to pateld@smh.ca.

Note: If an application package is incomplete or filled out using an inappropriate form, the submission will not be accepted.

Review of application package by the Research Ethics Board

  1. On submission, your application will be pre-screened by the Administrative Assistant.
  2. Complete applications are then assigned to a Research Ethics Coordinator.
  3. 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. 
  4. 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.
  5. 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.

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