| Topic: | Faculty, Staff, Students: Conduct and Responsibilities |
|---|---|
| Approval Date: | June 29, 2024 |
| Effective Date: | June 29, 2024 |
Purpose: This SOP outlines the terms of reference for the Human Participants Review Committee (HPRC).
Responsibility: the Associate Vice-President, Research and Innovation, Director, ORE; Manager, Advisor, Coordinator, ORE; members of Human Participants Review Committee (HPRC)
1. Composition of the HPRC Membership:
1.1. The HPRC must be comprised of at least five members (TCPS2, 2022). Its membership shall have representation across Faculties at the University and be diverse in gender with appropriate representation from racialized and other distinct communities.
1.2. The HPRC shall minimum consist of:
1.2.1. a Chair (1) with experience in research ethics;
1.2.2. a Vice Chair (1) with experience in research ethics;
1.2.3. at least one member from each Faculty (The Faculty of Liberal Arts & Professional Studies shall provide at least 2 members to the HPRC to reflect the wide range of disciplines represented and the size of its faculty complement);
1.2.4. at least one (1) member from the University Libraries;
1.2.5. at least one (1) member knowledgeable in ethics theory, knowledge, and practice;
1.2.6. at least one (1) member knowledgeable in relevant law (cannot be legal counsel or risk management representative for the University);
1.2.7. at least one (1) community representative who has no affiliation with the University;
1.2.8. the Associate Dean of the Faculty of Graduate Studies (ex-officio, for purposes of graduate research review);
1.2.9. Director, Office of Research Ethics, (non-voting reviewer);
1.2.10. Manager, Office of Research Ethics (non-voting reviewer);
1.2.11. Policy Advisor, Office of Research Ethics (non-voting reviewer);
1.2.12. Research Ethics Review Coordinator (non-voting reviewer);
1.2.13. the University Privacy Officer, the Biological Safety Officer, the Vivaria Supervisor and/or University Veterinarian(s) shall provide HPRC with support and advice where relevant as non-voting members.
1.3. The above noted composition is the minimum requirement. Given the broad range of disciplines and disparate nature of research conducted by York University researchers, to better address the complex needs of ethics review processes York’s HPRC membership exceeds the minimum standard.
1.4. The HPRC shall make use of ad hoc advisors in the event that it lacks specific expertise and/or to assist with excessive workload. Ad hoc reviewers shall not be counted in quorum for the HPRC, nor be allowed to vote.
1.5. The Chair of the HPRC shall be appointed by the Associate Vice-President, Research, on the recommendation of Committee members. The Chair should, generally, serve for a term of one year. However, if a suitable Chair is not available, the Chair may serve more than one year.
1.6. The term of service for members on the HPRC is three years, with the expectation that one-third of the membership will be appointed each year to ensure continuity and consistency of membership.
1.7. Each Faculty and the University Library shall recommend candidates to the Associate Vice-President Research and shall nominate replacement candidates promptly should a vacancy arise to ensure continuity of representation. Faculty member appointments shall be consistent with the principles of Guidelines and Procedures for Senate Nominations.
1.8. A roster of substitute members may be appointed by the Associate Vice-President, Research, to ensure continuity and compliance of the ethics review process in the event of illness and/or other unforeseen circumstances which prevent a quorum of membership of the committee and/or a lack of appropriate representative disciplines for the purposes of review.
2. Training of the HPRC membership:
2.1. The HPRC members are required to have the relevant expertise and training to undertake appropriate ethics review of research involving human participants. Consequently, each new member of the HPRC shall receive relevant training as it relates to research ethics policy and research ethics review procedures and processes.
2.2. Training shall be provided by the Office of Research Ethics (ORE). New members will be provided with the resources necessary to undertake their responsibilities as HPRC members effectively, efficiently and appropriately.
2.3. In addition to the training provided by ORE, the HPRC members are required to complete the TCPS2 online tutorial. On-going training will be provided to members of the HPRC through education and outreach activities where relevant and necessary.
3. HPRC Meetings, Quorum and Attendance:
3.1. The HPRC shall meet regularly and a minimum of 4 - 6 times annually for the purposes of discharging its responsibilities.
3.2. At least once yearly, a meeting of the HPRC may be convened for the purposes of reviewing Standard Operating Procedures (SOPs), reports of delegated review processes (including Graduate Theses and Dissertation Ethics review committees and Faculty/Departmental level Ethics Review Committees) and other operational and reporting documents where appropriate and applicable.
3.3. Additional and emergency meetings of the HPRC can be convened at the request of the Chair or members of the Committee for the purposes of reviewing research that is problematic, contentious or for which a consensus decision cannot be reached via regular review processes.
4. HPRC Standard Operating Procedures and/or Guidelines:
4.1. To ensure consistency of decision-making processes as well as to ensure accountability of said processes, wherever possible, Standard Operating Procedures (SOPs) or Operations Guidelines should be developed and implemented as they speak to HPRC operations. SOPs shall be developed, reviewed and updated, where applicable, on a regular basis.
4.2. All relevant SOPs will be developed by and housed in the Office of Research Ethics (ORE) and subject to review and/or approval by the HPRC where applicable.
5. HPRC and Delegated Ethics Review Committee(s) Reporting Requirements:
5.1. The HPRC is required to provide an annual report to Senate via the APPRC for the purposes of information and oversight. The report shall include a list of all HPRC approved protocols, Faculty annual reports (and delegated reviews), an overview of REB operations, education and outreach activities, a report on activities of the Committee and the Office of Research Ethics, and any other relevant matters.
5.2. Delegated Ethics Review Committees (Graduate Theses and Dissertation Committee and Faculty/Departmental Level Review Committees) are required to provide regular reports to the HPRC with regards to decisions rendered on protocols submitted to said committees. At a minimum, said committees are required to provide a list of all protocols and/or projects and/or courses that have received ethics approval on an annual basis. Those protocols which have not received approval must similarly be reported to the HPRC along with the rationale for the decision of the committee.
6. Conflict of Interest:
6.1. Any conflict of interest that exists or may appear to exist as it relates to any of the researchers must be described, even though this need not preclude the continuance of the research. A conflict of interest may exist if there is potential benefit to the researcher(s) beyond the professional benefit from academic publication or presentation of the results (and consequent honoraria, royalties, etc.).
6.2. In addition to researcher conflict of interest, there may be institutional conflicts of interests, as well as REB members’ conflict of interest. As a consequence, while researchers are required to state clearly any and all real or perceived conflict of interest on ethics protocols submitted to the committee for review, HPRC members are similarly required to state any real or perceived conflicts of interest they may have with regards to a particular protocol before the committee for review. To better manage such conflicts, HPRC members will be required to recuse themselves from deliberations of said protocols. To manage institutional conflicts of interests, any real, potential or perceived institutional conflicts of interest should be reported to the HPRC in accordance with the approved Senate Conflict of Interest policy.
6.3. While it is preferable that conflicts of interest be avoided, in those cases where a conflict of interest cannot be avoided, researchers must declare said conflicts to the REB and research participants alike, in as much detail as possible. Researchers are required to minimize or manage identified conflicts and provide the REB with a detailed description of how such conflicts will be managed. For those instances where there may be a financial conflict of interest, researchers shall disclose all kinds and amounts of payment to the researchers by sponsors, commercial interests and consultative or other relationships. Where concerns are raised with regards to potential financial conflicts of interest, the REB may require researchers to provide a copy of their budget so that it may be examined for inappropriate payments or unexplained expenses.
6.4. Researchers should be aware that the REB can determine, upon review of the stated conflict of interest and proposed method for management of same, that the researcher withdraw from the research or that others on the research team who are not in a conflict of interest make research-related decisions. Further, the REB has the discretion to prohibit certain kinds of payment and the discretion to refuse to approve a protocol for which it feels the implications of the conflict of interest are too significant and/or cannot be managed effectively.
| Legislative History: | Approved June 29, 2024 |
|---|---|
| Date of Next Review: | June 2029 |
| Related Policies, Procedures and Guidelines: |