Indigenous Research Involving Human Participants, Procedures

Indigenous Research Involving Human Participants, Procedures

Topic: Faculty, Staff, Students: Conduct and Responsibilities
Approval Date: 26 January 2023
Effective Date: 1 July 2023

Procedures Governing the Indigenous Research Ethics Board

1.1 Research Ethics Board and Governance Framework

An appropriate and compliant governance structure is a fundamental element of any effective ethics review policy and process. The governance structure ensures that the relevant Research Ethics Board (REB) operates with a clear mandate, authority and accountability, within clearly defined responsibilities and with the institutional independence necessary to undertake their decision-making processes appropriately and effectively. York University has two university wide REBs – the IREB and the HPRC. The Indigenous Research Ethics Board – the IREB – reviews ALL research involving Indigenous Peoples; this includes all student and faculty-led research. The York University Research Ethics board – the HPRC – reviews ALL non-Indigenous research. York University’s Research Ethics Boards – IREB and the REB are sub-committees of the Academic Policy, Planning and Research Committee of Senate.

1.2 Overall Mandate of the IREB

The IREB, on behalf of the institution, is mandated to review all Indigenous human participant research including approving, rejecting, proposing modifications to or terminating of any proposed or ongoing research involving humans. Additionally, upon request of individual researchers, it will engage with researchers throughout the entire research process, including meeting with and providing advice from conceptualization of research through to its completion and dissemination. This mandate extends to all research conducted under the auspices of or within the jurisdiction of the institution.
In keeping with the requirement of the Tri-Council Policy Statement that the highest body of the institution shall establish the REB(s), Senate has created the Indigenous Research Ethics Board (IREB) and, for non-Indigenous Research the York University Research Ethics Board (HPRC). Appointments to the IREB shall be made by the Associate Vice-Presidents, Research who oversee research with human participants as delegated by the Vice-President, Research and Innovation upon the sole recommendation of the Indigenous Council at York University.

1.3 Membership

a. The composition of the IREB shall reflect the University’s commitment to diverse Indigenous nations and Indigenous Peoples (First Nations, Inuit, and Métis) as well as principles of diversity, equity, decolonization inclusion. In recognition of the limited number of Indigenous scholars on campus the term of service for members shall be 3 years.

b. At a minimum, the TCPS requires that a REB must be comprised of 5 members. Accordingly, the IREB shall be comprised of at least 5 faculty members including a diversity of First Nations, Inuit, and Métis Peoples and gender identities. The Indigenous Council shall nominate candidates to the Associate Vice-Presidents Research. The faculty member appointments shall be consistent with the principles of Guidelines and Procedures for Senate Nominations.

c. The IREB shall also consist of at least three external Elders/Knowledge Keepers and the Chair of the Research Responsibility Group of the Indigenous Council. This composition must be maintained at all times in order to ensure compliance with this

d. In addition, IREB shall have:

i. three Indigenous community representatives (at least one of whom will be a youth 16-19 years) who have no affiliation with the University and who will be provided an annual honourarium. The Indigenous Council shall nominate candidates to the Associate Vice-President Research.

ii. at least one Indigenous undergraduate and one graduate student each of whom will be provided an annual stipend. The Indigenous Council shall nominate candidates to the Associate Vice-President.

e. The following shall provide the IREB with administrative support and advice where relevant as non-voting members:

i. the Director, Office of Research Ethics

ii. the Manager, Office of Research Ethics

iii. the Director, Information, Privacy and Copyright

iv. the Biological Safety Officer

f. Additional members may be appointed as required to ensure that all relevant subject areas are adequately represented. Further, where full membership is not warranted or applicable, Ad Hoc Advisors may be consulted. The advice of Ad Hoc Advisors will be sought in the event that the IREB does not have the discipline specific expertise or requisite knowledge to provide appropriate review of a particular ethics protocol. It should be noted that Ad Hoc Advisors are not members of the IREB and therefore do not count towards quorum nor do they vote on IREB decisions.

1.4 Chair and Vice-Chair

The Chair of IREB shall be appointed by the Associate Vice-Presidents Research, as delegated by the Vice-President Research and Innovation, on the sole recommendation of the Indigenous Council. The Vice-Chair will be chosen on the recommendation of IREB Committee members. The Chair should, generally, serve for a term of three years with a possibility of renewal if or as needed.

1.5 Substitute Membership

A roster of substitute members to the IREB may be appointed by the Associate Vice- Presidents, 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.

1.6 Training

IREB members shall receive relevant training as it relates to research ethics policy and research ethics review procedures and processes.

Training shall be provided by the Office of Research Ethics in conjunction with the Indigenous Council. New members will be provided with the resources necessary to undertake their responsibilities as IREB members. In addition to the training provided by Office of Research Ethics (ORE) & Indigenous Council (IC), IREB members are expected to complete the TCPS online tutorial. On-going training will be provided to members of the IREB through education and outreach activities where relevant and necessary.

1.7 IREB Standard Operating Procedures and/or Guidelines

In order 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 IREB operations. SOPs shall be developed, reviewed and updated, where applicable, on a regular basis. All relevant SOPs will be developed by and housed in the Office of Research Ethics and subject to review and/or approval by the IREB where applicable.

1.8 IREB Meetings, Quorum and Attendance

The IREB shall meet periodically and a minimum of 1 - 2 times annually for the purposes of discharging its responsibilities. At least once yearly, a meeting of the IREB may be convened for the purposes of reviewing SOPs, and other operational and reporting documents where appropriate and applicable. Additional and emergency meetings of the IREB 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. Quorum must include the Chair, at least one Elder, one community member and 3 additional members.

1.9 Reconsideration and Appeals

If an ethics review body refuses to approve the research or if the body requires amendment to the research as a condition of approval and the lead researchers or Principal Investigator disagrees with the proposed amendments, the Principal Investigator may provide a rationale for reconsideration of the IREB decision. Upon receipt of such a request, the IREB is required to provide a prompt reconsideration and decision pertaining thereto. Should the IREB and the researcher fail to come to an agreement with regards to the committee’s decision, the researcher may appeal the ethics review body’s decision to the Indigenous Research Ethics Board Appeal Committee (IREBAC) which shall conduct an ethics review of the research Protocol and the procedures followed by the body that conducted the first review. The appeal body is an ad hoc committee. Membership of the IREBAC shall be drawn from past members of the predecessor Indigenous Research Ethics Advisory Committee (pre- 2023) and/or the Indigenous Research Ethics Board. However, members of the IREB whose decision is under appeal shall not serve on the appeal committee.

Decisions of the Indigenous Research Ethics Board Appeal Committee are final and binding.

1.10 EB(s) Reporting Requirements

The IREB is required to provide an annual report to the Indigenous Council and to Senate via the APPRC for the purposes of information and oversight. The report shall include a list of all IREB approved protocols, an overview of IREB operations, education and outreach activities, a report on activities of the Committee and the Office of Research Ethics, and any other relevant matters.

1.11 Conflict of Interest

a. 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 halt 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.). In addition to researcher conflict of interest, there may be institutional conflicts of interests, as well as IREB members’ conflict of interest. Just as all researchers are required to state clearly any and all real or perceived conflict of interest on ethics protocols, so too IREB members are bound to the same disclosure and are 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, IREB members will be reminded that they are required to recuse themselves from deliberations of any such research protocols. To manage institutional conflicts of interests, any real, potential or perceived institutional conflicts of interest should be reported to the relevant REB in accordance with the approved Senate Conflict of Interest policy.

b. 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 IREB and research participants alike, in as much detail as possible. Researchers are required to minimize or manage identified conflicts and provide the IREB 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 IREB may require researchers to provide a copy of their budget so that it may be examined for inappropriate payments or unexplained

c. Researchers should be aware that the IREB 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 IREB 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 26 January 2023
Related Policies, Procedures and Guidelines: Indigenous Research Involving Human Participants