TPH Research Ethics Review Policy and Process
The Toronto Public Health Research Ethics Review (RER) Policy outlines the TPH Research Ethics Review Criteria. It also describes the five step TPH RER Process:
- Pre-screening Assessment, if necessary, to determine if the project requires TPH RER
- Organizational Assessment for relevance, feasibility, scientific merit, if necessary; and privacy and information management issues
- REB review
- Review Outcome Notification, and
- Ethics Monitoring and Completion.
The Project Lead may be required to complete a Project Summary Form to enable the Research Coordinator to determine if projects meet the TPH Research Ethics Review (RER) Criteria. If the project requires TPH RER the Principal Investigator should submit a signed TPH RER Application Form and all relevant attachments to firstname.lastname@example.org:
- Tri-Council Policy Statement (2): Ethical Conduct for Research Involving Humans (2014) tutorial completion certificate(s) (Required for Principal Investigator(s) and Investigator(s))
- Completed Informed Consent Checklist
- Copies of relevant REB approvals
- Documentation of previous scientific review(s)
- Information/forms which will be read to/by potential participants (e.g., recruitment scripts, flyers, posters, ads, information sheets, consent forms, letters, emails, website text)
- Data collection/extraction/debriefing instruments
Research applications receive a TPH organizational assessment for relevance, feasibility, scientific merit, and privacy and information management issues. TPH will not duplicate previous assessments of scientific merit unless there is a good reason to do so. Projects which receive all organizational approvals are reviewed by the REB. If TPH discloses personal health information, personal information, or aggregate information to a Principal Investigator, a signed Research Agreement is required before a project can start.
The TPH REB uses a Proportionate Assessment Approach to RER when reviewing research proposals. Thus, the level of scrutiny of a research proposal is related to its level of risk. Minimal risk projects receive a Delegated REB review. Projects which are more than minimal risk receive a Full REB review. The TPH REB meets monthly.
Following review by the REB the REB Chair sends the Principal Investigator a letter containing the initial REB decision and any comments. Research proposals should not require more than three rounds of revisions before a final REB decision is made.
REB approval is valid for one year from the date of the approval letter. Projects that extend beyond one year require Annual Renewal until completion. All approved research projects are monitored by the REB until completion (i.e., data collection, data analysis, and contact with project participants is finished and/or use of their data is no longer required and an End of Research Project Reporting Form has been submitted to the REB). The nature and frequency of REB monitoring is determined by the REB and is related to project’s level of risk.