How to Submit to the Research Ethics Board (REB)

Submitting new information for studies already approved by the REB

New Submissions (proposals)
When submitting a new proposal to the Toronto Rehab Research Ethics Board (the Rehabilitation Medicine and Science REB of the University Health Network (UHN)), please submit an electronic copy by e-mail directly to TRI-REB@uhn.ca. The required documents are as follows:

1) Completed Application Form (TAHSN Human Subjects Research Ethics Application - MS Word form PDF format)

All relevant signatures (investigators and Department Head) should be obtained prior to submission. If the proposal involves recruitment of patients or staff, the relevant Department Head at Toronto Rehab or UHN should sign. Pages which include signatures can be sent electronically in PDF format or mailed by inter-departmental mail
Prior Ethics/Scholarly Review: If the study has undergone peer review or review at other REBs, include any relevant review comments from them in your application. Indicate if the proposal will also be reviewed by one of the University of Toronto or TAHSN Research Ethics Boards.

2) The research protocol (research plan or research proposal).

Please note that the application form is not a substitute for the protocol. The protocol should discuss all the relevant topics and must also include specific details if using Personal Health Information. (See link to Guidelines Protocol)

3) Informed Consent Documents, if applicable:

Informed Consent Documents should meet the following criteria before submission: Grade 6 - 8 reading level, avoid or explain jargon or academic language, and a font size 11 point or larger, especially for older adults.
See link for headings in a typical Informed Consent Document. (Some Sponsors have particular requirements about Informed Consent topics.)
Studies that propose to omit the usual requirement to inform and seek consent from participants (e.g. retrospective chart review) must demonstrate that applicable requirements have been met. (e.g. TCPS2 Article 3.7 and PHIPA Section 44, 3)

4) All relevant study documents for ethics assessment (e.g. questionnaires, data collection forms, study introductory letters, telephone scripts, focus group questions or themes, ads, budgets). For investigational drug studies, include the Investigator’s Brochure or Product Monograph.

5) A cover letter (optional) can help describe any unusual conditions about the study, to help the REB reviewer put the study in context.

Please note that if the research proposal needs funding to be carried out appropriately and safely, then the funding must be secured before submitting the proposal for ethics review.

REB Meeting Schedule
The Toronto Rehab Research Ethics Board normally meets on the fourth Wednesday of each month. Consult the Meeting and Deadline Dates Notice 2012. Investigators are welcome to attend a portion of the REB meeting, if they wish. (Studies of minimal risk are reviewed by delegated process, not by the full board.)

REB review fee
The REB review fee for ethics assessment will be invoiced to the sponsor. The review fee is to help offset the work of the ethics review and is not payment for approval. (The REB review fee is waived for studies funded by internal sources, non-profit granting agencies, or government agencies.)

Contracts Negotiation
Contracts negotiation is handled by Research Administration, including Data Sharing Agreements.

Submitting new information for studies already approved by the REB
The REB is responsible for overseeing all aspects of the study, once it is approved. Any new information (such as adverse events, amendments to the Protocol or Informed Consent documents, protocol deviations or violations, annual status updates must be submitted to the REB for ethics review, on a timely basis.

The following forms should be submitted electronically by e-mail to: TRI-REB@uhn.ca.

Amendment and/or Administrative Changes – see Guidelines and submit the Amendment and/or Administrative Changes Form
Change in Study Personnel Amendment – see Guidelines and submit the Change in Study Personnel Amendment Form
Annual Renewal – submit the Annual Review Form to request renewal of an active protocol prior to 2 weeks before the expiry date of the study.
Notice of Late Submission of the Annual Renewal – submit the Notice of Late Submission of the Annual Review Form if the annual renewal form is submitted less than 2 weeks before or after the expiry date of the study
Study Completion and Termination – submit the Study Termination Form if you would like to close/terminate an active protocol.
Unanticipated Problem Reporting – see the UHN website and submit the UHN REB Unanticipated Problem Reporting Form