| Topic: | Faculty, Staff, Students: Conduct and Responsibilities |
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| Approval Authority: | Senate |
| Approval Date: | June 27, 2013 |
| Effective Date: | June 27, 2013 |
| Last Revised: | June 27, 2024 |
1. Preamble
1.1 This policy intends to cultivate an environment in which the conduct of Research involving Human Participants, performed by faculty, staff or students of or in affiliation with York University, follows the highest ethical standards.
1.2 It seeks to promote an awareness and understanding of how the Core Ethical Principles of Respect for Persons, Concern for Welfare, and Justice are applied within the current version of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans 2 (TCPS2) as well as all applicable regulations, guidelines, and standards pertaining to human participant.
1.3 This policy acknowledges the need for continuing interpretation and refinement of applicable policies to account for changes in research methods, contexts and cultures. Ethical guidelines shall be respected and revised as necessary.
2. Purpose
The policy establishes an independent human research ethics review process charged with the task of promoting the ethical pursuit of York University’s research objectives and serves as joint protection for the researcher, the study participant and the University in order to ensure attention to various rights and responsibilities of the respective parties to the research endeavour.
Scope & Application
2.1 This policy applies to all research involving humans conducted by faculty, staff or students of, or in affiliation with, York University. This includes:
a. research involving living human participants; and
b. research involving human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells from living and deceased
2.2 This policy applies to projects undertaken at, or under, the auspices of the University, whether the project is funded and, in the case of funded research, whether the funding, in whole or in part, is administered by the University.
2.3 The review of all research involving Indigenous Peoples is exempt from this policy and is governed under the Senate policies of Indigenous Research Involving Human Participants and Indigenous Research Involving Human Participants, Procedures.
2.4 Any research activity for which this policy is silent (such as Clinical Trials, research involving human biological materials and/or human genetic research), researchers are advised to consult the relevant section of the current TCPS2 for guidance. Alternatively, researchers may consult with the Office of Research Ethics for advice and direction.
3. Definitions
Human biological materials: Tissues, organs, blood, plasma, skin, serum, DNA, RNA, proteins, cells, hair, nail clippings, urine, saliva, and other body fluids. The term also includes materials related to human reproduction, including embryos, fetuses, fetal tissues and human reproductive materials.
Human Participant: An individual whose data, biological materials, or responses to interventions, stimuli, or questions by a researcher are relevant to answering the research question(s). Also referred to as a “human participant,” and in other policies/guidance as “subject” or “research subject.”
Indigenous peoples: In Canada, the term “Indigenous peoples” refers to persons of Indian (First Nations), Inuit, or Métis descent, regardless of where they reside and whether their names appear on an official register. In Canada, a comparable term, “Aboriginal peoples” is also used in certain contexts.
Research: An undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation.
Researcher and/or Principal Investigator: Any member who conducts or advances research in that capacity or who accesses University students or staff as human research participants; any other person who conducts or advances research as connected with the University; any person who conducts research using University resources (whether research space, materials, equipment or human resources).
(The term “member” when used in this Policy and its accompanying procedures includes faculty, emeritus faculty, contract faculty, staff, administrators, students, fellows and chairs, paid and unpaid research associates and assistants and any person in a like position).
4. Policy
4.1. York University has two Research Ethics Boards (REBs): the Human Participants Review Committee (HPRC); and the Indigenous Research Ethics Board (IREB) or collectively, the REBs.
4.2. HPRC is a sub-committee of the Academic Policy, Planning and Research Committee of Senate. HPRC is empowered to ensure that all non-Indigenous research involving humans with which it is affiliated is ethical and is conducted in accordance with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans 2, (TCPS2), York University Senate Policy on Research Involving Human Participants (Policy), and its Guidelines for Research with Human Participants (Guidelines).
4.3. All non-Indigenous research involving human participants conducted by faculty, staff or students, regardless of where the research is conducted, is subject to review and approval by the HPRC in accordance with the most recent Tri- Council Policy Statement prior to the commencement of any research activities.
4.4. The HPRC will determine whether research is in compliance with applicable regulations, guidelines, and standards pertaining to human participant protection, and either recommend the approval, rejection, modification or termination of such proposed or ongoing research involving humans.
4.5. Researchers have a reconsideration and appeal route on a decision of the HPRC on the grounds of alleged breaches to the established research ethics review process, or any elements of the HPRC decision that are not supported by the TCPS2.
Non-Compliance
4.6. Failure to comply with York University’s policies and procedures may prevent approval of pending ethics applications and/or may result in current studies being revoked. As warranted by the severity of circumstances, HPRC may also
send notification of such failure to comply to the Vice-President Research and Innovation, the researcher’s Dean, Chair or Director, Institute Heads, and appropriate funding and licensing agencies.
4.7. Failure to comply with this policy may result in the revocation of grant funding.
5. Roles and Responsibilities
The Vice-President Research and Innovation responsible for:
a. the implementation of this Policy and may establish procedures, and guidelines pursuant hereto from time-to-time regarding any matters set out in this Policy.
The Associate Vice-President, Research, is responsible for:
a. the appointment of members of the HPRC as delegated by the Vice-President,
Research and Innovation; and
b. providing to the HPRC necessary and sufficient financial and administrative resources to fulfill its regulatory duties.
The Human Participants Review Committee (HPRC) is responsible for:
a. approving any research that it deems to comply with the applicable regulations, guidelines, and standards pertaining to human participant protection;
b. rejecting, proposing modifications to, or terminating any proposed or ongoing research involving humans it deems to be noncompliant with the applicable regulations, guidelines, and standards pertaining to human participant protection, or
c. ensuring, through the review and approval of research ethics protocols, that researchers respect the safety, welfare and dignity of human participants in their research and treat them equally and fairly and not as a means to an end;
d. delegating graduate theses and dissertations to the Graduate Theses and Dissertation Ethics Review Committee for review and approval and overseeing that review process;
e. delegating course-related, non-funded, minimal risk research (including MRPs) to the relevant Faculty, Department, School or Graduate Program ethics review body for review and approval and overseeing that review process; and
f. The HPRC may be designated as another institution’s REB of Record or, conversely, another institution’s research ethics board for the review of multijurisdictional minimal risk research. In each case, the designated REB acting as the Board of Record carries out the mandate of the designating institution’s REB provided it meets and maintains acceptable research ethics review qualification or accreditation standards.
The Indigenous Research Ethics Board is responsible for:
a. the ethics review process of all Indigenous research involving human participants including their lands, materials, human remains, cadavers, tissues, biological fluids, embryos, and fetuses and researchers in all Faculties and the University Libraries conducting such research. Please see the Senate policies of Indigenous Research Involving Human Participants and Procedures on Indigenous Research Involving Human Participants.
York University’s Office of Research Ethics (ORE) is responsible for:
a. providing support for research ethics, integrity, compliance, and training in alignment with best practices and the Division of the Vice President Research & Innovation’s overall strategic imperatives;
b. providing secretariat to the HPRC and advising on current and emerging national and international research ethics (humans/animals/biological agents) and integrity policies and procedures (regulatory requirements, compliance issues, training and best practice systems for administering animal and human research ethics including governance arrangements, sanctions, and research integrity matters, etc.) to university leadership and researchers;
c. developing and maintaining guidelines and procedures governing the ethics review process to ensure consistency with evolving provincial, federal and international research ethics requirements, and responsiveness to changing societal values and evolution in research ethics; and
d. delivering educational programs and materials to students, staff and faculty involved in research with humans.
6. Review
The Academic Policy, Planning and Research Committee is responsible for the review of this policy every five years at a minimum.
| Legislative History: | Approved by Senate on 24 June 1993; Amendments approved by the Senate Committee on Research on 11 April 2001; Concurrence of the Academic Policy and Planning Committee received on 14 June 2001; Amendments approved by Senate on 28 June 2001; Amendments approved by Senate on May 23, 2002; Revised and Replaced by Senate on June 19, 2003. Revised and Replaced by Senate on June 27, 2013; Revised and Approved by Senate on June 27, 2024 |
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| Date of Next Review: | May 2029 |
| Related Policies, Procedures and Guidelines: |