| Topic: | Faculty, Staff, Students: Conduct and Responsibilities |
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| Approval Date: | June 29 2024 |
| Effective Date: | June 29 2024 |
Purpose: This SOP outlines the HPRC ethics review process and procedures
Responsibility: Director, ORE; Manager, Advisor, Coordinator, ORE; members of Human Participants Review Committee (HPRC)
1. Scope of Research Ethics Review:
1.1. All University-based research involving human participants, whether funded or non-funded, faculty or student, scholarly, commercial, or consultative, is subject to the ethics review process. Research subject to review includes, but is not limited to, surveys, questionnaires, interviews, and participant observation. It should be noted that if researchers at York University reference their affiliation to the University or use any of its resources when engaging in research, they must submit their research proposal to the HPRC for research ethics review in accordance with this policy.
1.2. As per TCPS2 (2022, p. 14) research is “defined as an undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation. The term “disciplined inquiry” refers to an inquiry that is conducted with the expectation that the method, results, and conclusions will be able to withstand the scrutiny of the relevant research community”. Human participants are “individuals whose data, biological materials, or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question(s)” (2022, p. 14).
1.3. All course-based research activities involving human participants are also subject to REB review. While the primary purpose is pedagogical, they may pose possible risks to those recruited to participate in such activities, and from their perspective, such activities may appear indistinguishable from those that meet the TCPS’s definition of research (2022, p. 14).
1.4. All pilot and preliminary research activities involving human participants are also subject to HPRC review. Pilot studies are smaller versions of the main study (e.g., fewer participants, shorter duration) with the purpose of assessing the feasibility and/or inform the design of a subsequent study intended to address a research question (2022, p. 14).
1.5. The HPRC only reviews research that falls within the scope of research as defined by the Tri-Council Policy Statement; however, the HPRC is responsible for reviewing research involving human participants to determine if it is exempt from ethical review. Researchers are responsible for obtaining confirmation from the HPRC on whether or not their project is exempt from ethics review. In accordance with the TCPS, research not requiring REB review and approval include:
1.5.1. activity not defined as research or does not involve human participants as defined by the TCPS2. The key consideration when making the determination as to whether ethics review is required is to ascertain whether research is the intended purpose of the undertaking or not. Researchers are advised to consult with the Office of Research Ethics when unclear as to whether their research project requires ethics review before commencing any research activities;
1.5.2. legally and publicly accessible information or data where there is no reasonable expectation of privacy;
1.5.3. observation of people in public spaces where there is no reasonable expectation of privacy, is not epidemiological in nature, involves no direct interaction or intervention by the researcher, and dissemination does not identify specific individuals;
1.5.4. interaction with individuals who are not themselves the focus of the research (e.g., collecting information from authorized personnel about the ordinary course of their employment, organization, policies, procedures, professional practices, or statistical reports);
1.5.5. research that relies exclusively on secondary use of anonymous information, or anonymous human biological materials, so long as the process of data linkage or recording or dissemination of results does not generate identifiable information. However, when there is a reasonable prospect that this data could generate information identifiable as originating from a specific Indigenous community or a segment of the Indigenous community at large, REB review is required;
1.5.6. quality assurance and improvement studies, program evaluation and performance reviews, testing within normal educational requirements when used exclusively for assessment, management, or improvement purposes;
1.5.7. creative practice whereby an artist makes or interprets a work or works of art or studies the process of how a work of art is generated. However, research that employs creative practice to obtain responses from participants that will be analyzed to answer a research question is subject to REB review;
1.5.8. exploratory phase of a research project where the intent of the researcher is to assess the feasibility of the project, establish relationships and/or partnerships with potential participants or to inform the research design or questions. The preliminary phase of research should not be confused with “pilot studies” or “preliminary research”. Researchers are still required to submit an ethics protocol which clearly outlines activities to be undertaken in the exploratory phase of the research so as to afford the HPRC the ability to assess whether ethics review and approval of that portion of the research may in fact be required.
2. Research Ethics Review Process and Procedures:
2.1. Principles of Research Review:
2.1.1 Respect for human dignity is the underlying value of ethics review. Per TCSP2 respect for human dignity is expressed through three core principles: Respect for Persons, Concern for Welfare, and Justice.
2.1.2 Respect for persons recognizes the intrinsic value of human beings (including their data and biological materials) and incorporates the dual moral obligation to respect autonomy while protecting those with developing, impaired, or diminished autonomy. Respecting autonomy requires participants’ free, informed, and ongoing consent and choice. Human participants should be clearly, fairly, and fully informed of the research objectives, procedures, foreseeable risks, and potential benefits. Their decision to participate should be fully voluntary (TCPS2 2022: 6).
2.1.3 The welfare of a person is the quality of that person’s experience of life in all its aspects (physical, mental, and spiritual health, economic, and social circumstances etc.). Researchers and HPRC should aim to protect the welfare of participants, and, in some circumstances, to promote that welfare in view of any foreseeable risks associated with the research (TCPS2 2022: 7). The risks (if any) should never be excessively harmful, and the risk-to-benefit ratio should be taken into consideration when proposing the research. Research design should be especially sensitive to ethical issues when the research involves not legally competent individuals and vulnerable populations as well as when it involves risky procedures, deception, or withholding of information. Participants’ anonymity and confidentiality shall be fully protected, unless this right is expressly waived (or unless disclosure is authorized or required by law).
2.1.4 Justice refers to the obligation to treat people fairly and equitably. Equity requires distributing the benefits and burdens of research participation in such a way that no segment of the population is unduly burdened by the harms of research or denied the benefits of the knowledge generated from it. Historically some groups of people have been either excluded or inappropriately targeted in research. As such, the recruitment process should be based on inclusion and/or exclusion criteria that are justified by the research question (TCPS2 2022: 8).
2.2. Research Ethics Review Procedures:
2.2.1. All researchers must complete and submit the relevant Protocol Form for ethics approval to the appropriate ethics review body. The review shall be conducted according to the principles and procedures set out in this document.
2.2.2. Research that is subject to ethics review and that is not approved may not be undertaken. Researchers found to have conducted research without ethics approval and/or contrary to an approved ethics protocol may face serious sanctions (please see the Tri-Agency Framework for Responsible Conduct of Research and the YUFA collective Agreement, sub-section 11.03-9 for further information as to the implications of non-compliance with this policy.)
2.2.3. The appropriate level of review is determined by the nature of the research and the level of risks or foreseeable risks to the participants. Ultimate determination of the appropriate level of review rests with the HPRC. Pursuant to the TCSP2 Article 6.1, the default requirement for research involving human participants is ethics review by the full HPRC.
2.2.4. Full Ethics Review - At York University, research that poses greater than minimal risk to participants is reviewed by the full HPRC. TCPS2, Chapter 2, defines minimal risk as: “research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in those aspects of their everyday life that relate to the research”. Further, negative decisions by Delegated Review committees, that is, a decision to not approve a protocol before the committee, must be referred to the HPRC for full review. The HPRC will communicate the result of the final review.
2.2.5. HPRC-Delegated Ethics Review - The TCPS2 describes a “proportionate approach” to the ethics review and clearance process for minimal risk research, Article 6.12. Under this approach, York’s HPRC delegates authority to individual members of the HPRC, including non-voting members such as the Director, ORE and/or Manager and Coordinator, ORE (each a “Reviewer”) for ethics review and clearance of research that poses no more than minimal risk to participants. New submissions of minimal risk research, amendments and annual renewals of approved minimal risk research shall be reviewed by no less than two delegated reviewers. Where delegated reviewers decide that a protocol should not be approved, the protocol will be referred to the HPRC for full board review.
2.2.6. Graduate Theses and Dissertations Research Ethics Review - Ethics review of research that is conducted for the purposes of completion of graduate theses or dissertation that is minimal risk and/or is not funded (please consult the Faculty of Graduate Studies for further information as to what constitutes “funded research” in a graduate context) will be conducted by the delegates of the HPRC, namely, the Chair/Vice-Chair HPRC and Associate Dean(s), Research, Faculty of Graduate studies. Where delegated reviewers decide that a protocol should not be approved, the protocol will be referred to the HPRC for full board review.
2.2.7. Graduate and Undergraduate Course-related Research (including MRPs) Ethics Review - Course-related, non-funded, minimal risk research proposed by students in Departments, Schools or Graduate Programs, with the exception of theses and dissertations, are subject to review by the relevant Faculty/Departmental level Ethics Review committee. Departmental/Faculty level review committees must be comprised – at a minimum – of two members.
2.2.8. Administrative Review - For minimal risk research and/or protocols that have undergone a delegated review by another REB, administrative reviews will be conducted by a member of the Office of Research Ethics (Director, Manager, Policy Advisor or Coordinator – with oversight from Sr. ORE rep).
2.2.9. Annual Renewals - At a minimum, research that extends beyond one year and/or the expiry date of the certificate of ethics approval must be renewed. Researchers must submit an application for renewal of ethics approval prior to the expiration of the approval certificate in order to maintain on-going compliance.
2.2.10. Progress Report - Research that is more than minimal risk may require and be subject to greater post approval monitoring to ensure the continued protection of participants rights and researcher’s responsibilities. Consequently, the HPRC may require researchers to provide more frequent progress reports on the status of their research than that of the standard Annual Renewal application. The need for progress reports will be project specific and determined on a case-by-case basis. The need for and number of progress requirements are the discretion of the HPRC.
2.2.11. Amendments to Protocols - Researchers are required to complete and submit an amendment application outlining any proposed changes to their approved protocol, to the HPRC in as timely a manner as possible. Approval for said changes must be received prior to the continuation of the research. Researchers may not proceed with their proposed amended research until such time as the proposed amendments have received ethics approval. Substantive changes to approved protocols may be required to undergo full committee review and the subsequent submission of a new protocol.
2.2.12. Adverse and Unanticipated Events - Researchers are required to report any unanticipated or adverse events to the HRPC as soon as possible, or immediately if the risk to the participants of the event is significant. Documentation of said events must be submitted to the Office of Research Ethics as soon as possible and should include a description of the event or issue and how the researcher has addressed the matter. The HPRC will review reports of adverse or unanticipated events and may, as a consequence, require the researchers to amend their protocols to prevent future recurrences.
2.2.13. End of Project Reporting - Researchers are required to complete an “End of Project Report” so as to notify the HPRC of the completion of their research project.
2.2.14. Incidental Findings - Researchers are obligated to ensure that participants are provided with the information necessary to maintain consent to participate. Thus, should information become known or available that may have an impact on participants or may impact their continued participation in the project, researchers are required to inform the participants as soon as possible. Similarly, should it become known to researchers that there are new potential significant risks to participants or substantial benefits, participants must be informed of the changes immediately. Similarly, any material incidental findings (i.e. findings that have been interpreted as having significant welfare implications for the participant, whether health-related, psychological or social) may be required to be disclosed to the participants. The Office of Research Ethics must receive documentation of any changes to the risks to or benefits for the participants or any material incidental findings of which researchers become aware and/or that have been disclosed to participants.
2.2.15. Confidentiality: All information provided by Principal Investigators is confidential and shall be retained in the files of the Office of Research Ethics on that basis to the fullest extent possible by law.
2.3. Reconsideration and Appeals:
2.3.1. A researcher may request reconsideration of a decision made by the HPRC within 30 days of receiving notice of the HPRC’s decision. The onus is on researchers to justify the grounds on which they request reconsideration and to indicate any alleged breaches to the established research ethics review process, or any elements of the HPRC decision that are not supported by the TCPS2. The HPRC shall review the reconsideration request and respond to the researcher within 30 days of receiving the request.
2.3.2. Should the HPRC 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 York Ethics Appeal Committee which shall conduct an ethics review of the research Protocol and the procedures followed by the body that conducted the first review. Decisions of the York Ethics Appeal Committee are final and binding.
| Legislative History: | Approved June 29 2024 |
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| Date of Next Review: | June 2029 |
| Related Policies, Procedures and Guidelines: | Research Involving Human Participants |