Topic

Post-Approval Review (PAR) Program - Human Ethics

Who is this for?

The Post-Approval Review (PAR) Program is for researchers at the University of Toronto (U of T), primarily faculty and graduate students.

Research conducted at the Toronto Academic Health Science Network (TAHSN) hospital will not be eligible for a visit if the protocol has been approved by the hospital Research Ethics Board (REB).

What do I need before I can begin?

Research should recognize that the Post-Approval Review (PAR) Program is a routine process that can be conducted at any time to any project. For more information, please watch the PAR informative video.

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.

Overview

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.

PAR Program Benefits

  • 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

PAR Visit Process

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 Quality Assurance Analyst (QAA) 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 QAA 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.

Types of PAR Visits

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 QAA.
 

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.

Forms & Downloads

VPRI Role

  • Administer the PAR program
  • Provide answers related to PAR

VPRI Contact

Staff

Joshua Van Ry

Quality Assurance Analyst – Human Research
Research Oversight & Compliance Office (ROCO)
(416) 946-5606

Staff

Rachel Zand

Director, Human Research Ethics
Research Oversight & Compliance Office (ROCO)
(416) 946-3389

Other Resources

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