All research studies conducted at St. Joseph’s Health Centre that involve staff, patients or community members require prior approval by the Research Ethics Board. The Board reviews all protocols conducted within the Health Centre or by Health Centre staff and physicians. The Board is responsible for ensuring that all protocols are of high scientific merit; are ethically sound; respect the privacy and rights of all participants; comply with all regulations; and are monitored.
You may wish to read the Human Subjects Research Application Guidelines to assist you with your submission. If your study involves a retrospective chart review, please see the SJHC REB Chart Review Application Form.
Investigators, research coordinators and residents: please complete the Tri-Council Policy Statement (TCPS2) Tutorial and include the certificate with your submission.
Is it Research or Quality?
If you are not sure whether your project requires REB review, please see our Research versus Quality Improvement Guideline & Checklist by clicking the document below. The guideline describes the difference between research and QI and includes a checklist that will help you with the determination. Upon completing the checklist, please print and keep for your records.
REB Applications, Forms and Guidelines
To initiate new study protocols at the Health Centre, an application form must be submitted to and approved by the Research Ethics Board. The submission will be reviewed at the monthly REB meeting; REB responses and recommendations will be distributed within approximately two weeks following the meeting. Please note: if the purpose of the submission is to receive approval to post external study advertisements at SJHC, the SJHC application form must be completed and all study documents must still be provided.
Annual Renewal (please mark your calendars!): For ongoing studies, annual renewal forms must be submitted 11 months from the anniversary of REB approval; this is the researcher’s responsibility. If approval lapses, study procedures must stop. Upon study closure, final reports are required. See forms and guidelines below:
DO NOT FAX OR E-MAIL FORMS
- SJHC Human Subjects Research Application Form (Word Doc)
- Human Subjects Research Application Guidelines
- SJHC REB Retrospective Chart Review Form (Word Doc)
- Sample Consent Form (Word Doc)
- Consent Form Guidelines (PDF).
- Consent Form Guidelines (Word Doc)
- Annual Renewal / Final Report Form (Word Doc)
- SJHC REB – Amendment and Administrative Form – March, 2015 (Word Doc)
- Change in Personnel Form (Word Doc)
- External SAE Summary Form (Word Doc)
- Internal SAE Form (Word Doc)
- Protocol Violation Reporting Form (Word Doc)
- Safety-Reporting Flowchart
- Guideline for the Post-Discharge Contact of Patients
- SJHC Confidentiality Policy
- Approval Process
2017 REB Meeting Dates
Note: The submission deadline is 4 weeks prior to meeting dates. Hard copies submissions are required; e-mail submissions are not accepted.
- March 20, 2017
- April 24, 2017
- May 29, 2017
- June 19, 2017
- July 17, 2017
- September 18, 2017
- October 23, 2017
- November 20, 2017
- December 11, 2017
Submission to the Research Ethics Board
Please submit your hard copy forms and associated documents to the REB Coordinator at the address below. The deadline for receiving submissions for REB review is four weeks prior to the meeting date. You may wish to confirm final details with the REB Coordinator). Please note that original signatures are required by the REB.
Submission Cover Letter: With your submission, please include a cover letter addressed to the REB Chair, Mr. Michael Heffer, c/o REB Coordinator, Rm 6S604a, describing your project and what it is you are requesting (e.g. approval for a new protocol, approval for annual renewal, etc.).
Responding to an REB Conditional Approval letter: Once your study has been reviewed and you are prepared to respond, please follow these steps:
- Please respond in the form of a letter, addressed to the REB Chair, in Question & Answer format, ensuring responses are clear and complete. The REB Coordinator can send you the conditions via e-mail.
- Please submit modified study documents only. Changes to documents must be tracked or highlighted.
- A hard copy is required. Usually, one copy will suffice but the REB coordinator may require more – please ask.
REB Regulations & Guidelines
- Research Ethics Board Standard Operating Procedures (Opens In New Tab)
- ICH – Good Clinical Practice (GCP) Guidelines (Opens In New Tab)
- Tri-Council Policy Statement (Opens In New Tab)
- The Personal Information Protection and Electronic Documents Act (PIPEDA) (Opens In New Tab)
- Personal Health Information Protection Act, 2004 (PHIPA) (Opens In New Tab)
- Health Canada – Therapeutic Products Directorate (Opens In New Tab)
- Safety Reporting – Excerpt from SJHC REB Standard Operating Procedure – December 2015 (Opens In New Tab)