Delegated Retrospective Application

Studies that will only be accessing retrospective data and not collecting any information prospectively are considered ‘ delegated retrospective’ studies and can be submitted to the Research Ethics Board (REB) using the delegated retrospective application process.  These studies will be reviewed by a subset of the Board.

  • In order for a study to be considered retrospective, the end date of data collection must be before the date of submission to the Research Ethics Board. 

Not sure if you’re completing the application correctly?  Keep reading to view our list of common errors in retrospective study applications.

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

Compile application package

The following components are required to submit a delegated retrospective application to the REB:

  1. Completed TAHSN research ethics application (retrospective data). All sections must be completed and all signatures, including Principal Investigator, Co-Investigators, and Division/Department/Program Head, must be obtained.
  2. Research protocol (mandatory).
  3. Data collection forms.
  4. Other approval letters, if applicable.
  5. Consent documents, if applicable.

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 an Research Ethics Coordinator, who will then contact the PI for any questions or issues that need to be addressed.
  3. Once these issues have been addressed, the Research Ethics Coordinator will recommend study approval, and the study will undergo final review by a member of the Board.
  4. If there are further questions upon final review by the Board member, the Research Ethics Coordinator will contact the PI to have these addressed.

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

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.

Common errors in retrospective study applications

The following are common errors to be aware of when submitting a retrospective study application:

  1. End date of data collection exceeds the date of submission to the REB (i.e. prospective data collection involved).
  2. If consent is not being obtained for secondary use of identifiable information, TCPS2 Article 5.5A criteria (a)-(f) must be satisfied under TAHSN 10B.
  3. If consent is not being obtained for secondary use of identifiable human biological materials, TCPS2 Article 12.3 criteria (a)-(f) must be satisfied under TAHSN 10B.
  4. The confidentiality surrounding the data is unclear or inconsistent across the application:
    • If the study data is de-identified, it means that identifiers are being collected and stored separately in a master linking log.
    • If the study data is anonymized, it means that the master linking log that was being used to link the identifiers to the rest of the study data has been destroyed.
    • If the study data is anonymous, it means that no identifiers were ever collected with the study data. 
  5. The protocol is lacking information:
    • The protocol should include background and study rationale, the study purpose and hypothesis, primary and secondary outcomes, the study methods (e.g.; data collection process, data sources to be used, sample size, date range of collection, etc.), data analysis plan, data management plan (e.g.; confidentiality surrounding the data, timepoint for data anonymization, timepoint for data destruction, etc.).