IMPORTANT:
Principal Investigators (PI) and/or faculty supervisors are encouraged to participate actively in the Post-Approval Review (PAR) process and will be required to attend the introduction and summary meeting.
If for extenuating circumstances the PIs and/or faculty supervisors cannot attend the entire site visit, they will be asked to designate a member of the research team knowledgeable in the procedures of the protocol.
The PAR program, an extension of continuing ethics review, has been created to provide the necessary tools to ensure that all human research conducted under the auspices of University of Toronto (U of T) is done ethically and in compliance with all regulatory requirements.
The cornerstone of the program is the PAR visit; however, other components include education sessions, workshops, study management tools, and online resources. As a collegial and value-added program, researchers will be encouraged to share their experiences and expectations of the process to help foster a culture of continuous evaluation and improvement as it evolves.
PAR visits are conducted to provide individualized support to investigators conducting human research while ensuring adherence to the Research Ethics Board (REB)-approved protocol and overall good practices in research-related activities.
Feedback and observations obtained during PAR visits will provide the Human Research Ethics Unit (HREU) with on-the ground information, which may enable the HREU to identify opportunities for improving human participant protection activities at U of T.
- Ensure compliance with ethical standards, policies and regulatory requirements
- Promote human participant protection by supporting researchers in their efforts to adhere to (REB) approved protocols and good practices in human research
- Encourage constructive communications between the HREU, REB and researchers
- Help researchers prepare for external audits
- Serve as an opportunity to review and share best practices while updating our policies and guidelines
The PAR visit will involve an introduction meeting, the review of relevant study procedures/materials and a summary meeting. The duration and activities performed during each PAR visit vary depending on the complexity of the protocol, risk level and reason for the visit.
The PAR visits for international research will take place in the researcher’s office or in a meeting space.
Within 15 business days of the PAR visit, the research team will be provided with a formal written report that outlines the PAR visit observations comments, requests for clarification, recommendations and/or required corrective actions as necessary.
When a response from the study team is received, the Continuing Ethics Review Specialist (CERS) reviews the response and confirms that all issues have either been resolved or require additional clarification. Consultation with senior members of the HREU and REB will be sought as necessary. The CERS may schedule a follow-up PAR visit under special circumstances.
When the PAR visit process is complete, the research team will be provided with a close-out letter and a copy of the final report will be added to the protocol file. The final report is accessible to the REB manager, REB chair(s) and Director, HREU and if relevant, with others who have a responsibility for oversight and compliance.
Routine
All currently active REB-approved protocols are eligible to be selected for a PAR visit as part of the PAR program. However, priority will be given to projects that involve greater than minimal risk. Research sites may be selected for routine visits based on risk level, associated REB and complexity of the protocol.
Investigator-Initiated
Researchers may request a PAR visit for educational purposes or in preparation for an external audit. This can be done by contacting the CERS.
REB Requested
PAR visits may be conducted in response to concerns or complaints. In all cases, any observations that potentially indicate non-compliance with University policy may be referred for further investigation.
- Administer the PAR program
- Provide answers related to PAR
Staff
Daniel Martel
Staff
Kristina Ognjanovic
Staff
Director, Human Research Ethics
