Delegated Prospective Application

Studies that collect data prospectively and are deemed to be of minimal risk over standard procedures are considered ‘delegated prospective’ studies. These studies are reviewed by a subset of the Board and are submitted to the Research Ethics Board (REB) through the delegated prospective application process.

Studies that qualify for delegated review as minimal risk research may include:

  • research with no direct patient contact (i.e. chart review)
  • database development
  • questionnaires or surveys only

Please follow these instructions to submit a delegated prospective application to the Research Ethics Board:

 Compile application package

The following components are required to submit a delegated prospective 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. Advertisement/poster. If recruiting participants by advertisement, must use St. Michael’s Hospital letterhead.
  8. Copy of peer review or any other REB approval. 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 five (5) sets of the completed application package in hard copy to the research ethics office, located at 250 Yonge St., 6th floor.
  2. Provide two (2) copies of the completed REB submission checklist in hard copy to the research ethics office.

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 will be reviewed by a delegated subset of the Board.
  3. Reviewed applications are then assigned to a Research Ethics Coordinator. 
  4. The Research Ethics Coordinator will send you a review letter. This contains the concerns related to your study that were raised during review of your application.
  5. You must satisfactorily respond to all of the items raised in the review letter prior to your study being approved.

If you have any questions, please contact your Research Ethics Coordinator. 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.

If you don’t have a Research Ethics Coordinator, please email PatelD@smh.ca.

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, 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.