Research Involving Human Participants, Senate Policy on (Formerly titled: Ethics Review Process for Research Involving Human Participants Policy)

Research Involving Human Participants, Senate Policy on (Formerly titled: Ethics Review Process for Research Involving Human Participants Policy)

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.

Approval Authority: Senate

Signature: Harriet Lewis

A.  Policy

1.  Policy Statement

It shall be the policy of York University to ensure the ethical conduct of research involving human participants and to comply in full with the Tri-Council Policy Statement on Research Involving Human Participants (December 2010) as it may be amended from time to time. The policy shall apply to all Faculties and the University Libraries, and to all research involving human participants, human remains, cadavers, tissues, biological fluids, embryos, and fetuses. The policy is intended to protect the researcher and/or principal investigator, the subject and the University jointly, and protect various rights and responsibilities of the respective parties to the research endeavour.

2.  Principles and University Commitments

It is imperative that researchers strive for ethical conduct at all times. The Senate of York University affirms that researchers must respect the safety, welfare, and dignity of human participants in their research and treat them equally, fairly, and not as a means to an end. The University values and protects the academic freedom of its researchers, and the ethics review process shall not unfairly censor researchers in the conduct of their research. However, academic freedom is complemented by the requirement to respect the rights of human participants. 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. Continued awareness and debate of the topic in the research community is essential. The University’s principal reference for ethics review is the Tri-Council Policy Statement (TCPS), with which the University has agreed to comply pursuant to the Memorandum of Understanding (September 2002) between the University and the three agencies that make up the Tri-Council.

3.  Oversight and Reporting

In accordance with the Tri-Council Policy Statement, the University’s Research Ethics Board is the Human Participants Review Committee, a sub-committee of the Academic Policy, Planning and Research Committee of Senate. HPRC is charged with reviewing the ethical acceptability of all research involving human participants conducted by members of the University, and to carry out the procedures within its jurisdiction or under its auspices. All 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. HPRC’s membership, mandate, and operations shall conform to the specifications set out in the procedures that accompany this policy.

HPRC shall report at least annually to the Academic Policy, Planning and Research Committee of Senate, and in doing so shall submit Faculty and University Library reports. APPRC shall, in turn, transmit reports to Senate and make them accessible.

4.  Definitions

For the purpose of this policy and its associated procedures, and in accordance with the Tri-Council Policy Statement (current edition):

  1. research is defined as an undertaking intended to extend knowledge through a disciplined or systematic investigation and it includes pilot or preliminary research
  2. human participants are persons who provide data or information to the researcher, which are typically, not part of their professional capacity, or in the public domain
  3. researcher and/or Principal Investigator includes:
    1. any member who conducts or advances research in that capacity or who accesses University students or staff as human research participants
    2. any other person who conducts or advances research as connected with the University
    3. 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, visiting or adjunct scholars, fellows and chairs, paid and unpaid research associates and assistants and any person in a like position).

5.  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.

6.  Reference

Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, December 2010, as amended.


1. Research Ethics Board and Governance Framework

1.1  Human Participants Review Committee as the University’s Research Ethics Board

An appropriate and compliant governance structure is a fundamental element of an effective ethics review policy and process. The governance structure ensures that the 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’s Research Ethics Board is the Human Participants Review Committee, a sub-committee of the Academic Policy, Planning and Research Committee of Senate.

1.2  Overall Mandate of the Human Participants Review Committee

It is the responsibility of the institution to establish or appoint an REB or REBs to review the ethical acceptability of all research involving human participants conducted within their jurisdiction or under their auspices. All applicable research conducted by faculty, staff or students, regardless of where the research is conducted, is subject to review by the institutional REB in accordance with the TCPS.

The REB is, on behalf of the institution, mandated to review the ethical acceptability of research including approving, rejecting, proposing modifications to or termination of any proposed or ongoing research involving humans. This mandate extends to all research conducted under the auspices of or within the jurisdiction of the institution.

In keeping with the requirement that the highest body of the institution shall establish the REB, Senate has created the Human Participants Review Committee. Appointment of members of the REB (HPRC) shall be made by the Associate Vice-President, Research as delegated by the Vice-President, Research and Innovation.

1.3  Specific Roles and Responsibilities

The University-wide Human Participants Review Committee serves the York research community in at least the following three ways:

    • contributing to the education of members on research ethics
    • conducting independent, multi-disciplinary review of research proposals and
    • overseeing the ethics review conducted by the Faculty, Department, School and Graduate Program review bodies

The HPRC shall discharge the following specific duties:

    1. conduct ethics reviews within the context of the University's responsibility to ensure that the research meets high scientific and scholarly standards
    2. delegate Graduate theses and dissertations to the Graduate Theses and Dissertation Ethics Review Committee for review and approval and oversee that review process
    3. delegate course-related, non-funded, minimal risk research (including MRP's and   Comprehensive Examinations) to the relevant Faculty, Department, School or Graduate Program ethics review body for review and approval and oversee that review process
    4. terminate any research that it considers to be threatening or causing distress to the participants, deviates from the approved Protocol, or has not been approved by the appropriate body
    5. provide Faculties and Libraries with the resources necessary to enable them to become familiar with and adhere to this Senate Policy
    6. act as an advisory body for the University, educating the community on ethics in research and providing guidance on the ethics review policy, processes and procedures
    7. provide resources (outreach and education) to the Faculties and Libraries so as to enable them to provide the necessary education and advice to research assistants and students about the relevant aspects of ethics in research and the need to treat participants ethically and respectfully

The HPRC’s primary responsibility, however, is to ensure, 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. Through both financial and in-kind support from the Office of Research Ethics and the Associate Vice-President Research, the HPRC shall have the requisite financial and administrative support to ensure that it has both the autonomy and resources to fulfill its responsibilities.

1.4  Membership

The composition of the HPRC shall reflect the University’s commitment to gender equity. The term of service for members on HPRC is three years, with the expectation that – ideally - one-third of the membership will be appointed each year so as to ensure continuity and consistency of membership.

At a minimum, the TCPS requires that an REB must be comprised of 5 members, including both women and men. 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 REB membership exceeds the minimum standard. This is consistent with the TCPS which provides that “institutions may need to exceed the minimum REB membership requirements in order to ensure adequate and thorough reviews, reasonable workload for REB members or to respond to other local, provincial/territorial and/or federal legal requirements.”

The HPRC shall consist of at least one member from each Faculty and one member from the University Libraries. The Faculty of Liberal Arts & Professional Studies shall provide at least 2 members to the HPRC in light of the wide range of disciplines represented and the significant number of faculty members within LA&PS. This composition must be maintained at all times in order to ensure compliance with this policy and the current TCPS.

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. At a minimum, the committee shall be comprised of at least 2 members with expertise in relevant research disciplines, fields and methodologies of the proposals under review by the HPRC; at least one member knowledgeable in ethics; and   at least one member knowledgeable in the relevant law (the member shall not be the institution’s legal counsel and/or risk manager).

In addition, HPRC shall have:

    • a community representative who has no affiliation with the University
    • the Associate Deans of the Faculty of Graduate Studies (ex-officio, for purposes of graduate research review)

The following shall provide HPRC with support and advice where relevant as non-voting members:

    •  the Senior Manager and Policy Advisor, Office of Research Ethics
    • the University Privacy Officer
    • the Biological Safety Officer
    • the Vivaria Supervisor  and/or University Veterinarian(s)

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 HPRC 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 HPRC and therefore do not count towards quorum nor do they vote on REB decisions.

1.5  Chair and Vice-Chair of HPRC

The Chair of HPRC shall be appointed by the Associate Vice-President, Research and the Vice-Chair on the recommendation of Committee members. The Chair should, generally, serve for a term of one year. However, in the event that a suitable Chair is not available, the Chair may serve more than one year.

1.6  Substitute Membership

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.

1.7  Training

REB 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. Training shall be provided by the Office of Research Ethics. New members will be provided with the resources necessary to undertake their responsibilities as REB members effectively, efficiently and appropriately. In addition to the training provided by ORE, HPRC members are expected to complete the TCPS online tutorial. On-going training will be provided to members of the HPRC through education and outreach activities where relevant and necessary.

1.8  HPRC 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 REB 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 HPRC where applicable.

1.9  HPRC Meetings, Quorum and Attendance

The HPRC shall meet regularly and a minimum of 4 - 6 times annually for the purposes of discharging its responsibilities. At least once yearly, a meeting of the HPRC may be convened for the purposes of reviewing 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.  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.

1.10  Reconsideration and Appeals

If an ethics review body (HPRC Delegated Ethics Review Committee(s)) refuses to approve the research or if the body requires amendment to the research as a condition of approval and the Principal Investigator disagrees with the proposed amendments, the Principal Investigator may request that the HPRC reconsider their decision. Upon receipt of a request for reconsideration, the HPRC is required to provide a prompt reconsideration and decision pertaining thereto. 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.

1.11  REB(s) Reporting Requirements

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.

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.

1.12  Conflict of Interest

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.). 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, REB 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, REB 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 REB in accordance with the approved Senate Conflict of Interest policy.

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.

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.

2.  Research and Ethics Review

2.1  Principles of Review

A research investigation that involves human participants should be designed to take account of the well-being of prospective participants. 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. The risks (if any) should never be excessively harmful and the risk-to-benefit ratio should be taken into consideration when proposing the research. Participants’ anonymity and confidentiality shall be fully protected, unless this right is expressly waived (or unless disclosure is authorized or required by law).

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.

Concerns regarding the ethical propriety of the research or the interpretation and application of the Senate policy should be addressed to the Sr. Manager & Policy Advisor, Research Ethics, Office of Research Ethics (ORE).

2.2  Research That Is Subject To Review

In general and with some exceptions, research involving living human participants as well as research involving human biological materials, fetuses, fetal tissue, reproductive materials and stem cells from both living and deceased individuals requires ethics review and approval by the HPRC before the research can commence. This applies to pilot and preliminary research as well. It should be clear, however, that the scope of this policy is limited to those activities defined as “research” involving “human participants”. Thus, if the activity is not defined as research or does not involve human participants as defined by the TCPS, then the project is not subject to ethics review. 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.

2.3  Research That Is Not Subject To Review

While the default consideration is that research involving human participants may be subject to ethics review, there are a number of research related activities involving human participants that are not in fact subject to review.  Given the complexity of research before the committee and the context specific ethical questions each may present, it is difficult to provide a complete list of all exemptions; however, the following is a general list of research that is not subject to review. Please note that the HPRC is the ultimate arbiter as to whether research is exempt from Ethics review.

Research that is exempt from review can be summarized as follows:

    1. research that relies entirely on publicly available information is not subject to review if,
      1. the information is legally accessible to the public and appropriately protected by law. An example would be information obtained through a PHIPPA request or
      2. If the information is publicly accessible and there is no reasonable expectation of privacy. An example would be information in a newspaper, or a website or other publishing media
    2. naturalistic observation does not generally require ethics review
    3. research that relies exclusively on secondary use of anonymous information and/or biological materials is not subject to ethics review as long as there is no potential for data linkage and/or participant identification
    4. quality assurance studies, program evaluations, performance reviews and practica are not subject to review
    5. creative practice is not subject to review; however, research that “employs creative practice” to obtain data from participants for the purposes of answering a research question IS subject to review

2.4  Multi-Jurisdictional Research

A considerable volume of research undertaken by York researchers is collaborative in nature, consisting of partnerships between and amongst many institutions and spanning numerous jurisdictions. The ethics review of collaborative research projects which span multiple jurisdictions has proved challenging from both an administrative perspective and a researchers’ time and resource perspective given the number of Research Ethics Boards by which they must be reviewed. To address the complex nature of ethics review of multi-jurisdictional research, there are a number of mechanisms available to both researchers and the HPRC. Researchers should consult with the Office of Research Ethics on potential options for alternate review models.

2.5  Qualitative Research

An ethics protocol is predicated on the assumption that the researcher has a defined set of research questions, methodology, participants etc. that can be readily documented. However, qualitative research practices are more fluid and dynamic and are thus often problematic to document appropriately. The iterative and organic research practices, common to qualitative research have, in the past, been difficult to review from a research ethics perspective.

Of particular concern for both researchers and REB members alike, are the issues of privacy, confidentiality, consent and the relationship between researchers and participants that may often be blurred in qualitative research project – in particular, participatory action research. Qualitative research is challenged by unique ethical issues as it is often difficult discern when and where the collaboration ends and the research begins. While many preliminary activities may not require ethics review, should a researcher wish to use information collected during preliminary phases, they will be required to obtain consent form the participants and ethics approval from the HPRC. Thus, given the complexity of the issues, when conducting qualitative research, researchers should consult with the Office of Research Ethics prior to the start of their research or potential recruitment of participants.

When conducting qualitative research, there may be circumstances in which written consent will not be appropriate. Researchers, who wish to use a consent process other than a written consent process, must clearly explain their rationale for using an alternative consent process and their strategies for documenting consent. Concern for the welfare of the participants should be paramount.

Observational research studies in public places where there is no reasonable expectation of privacy are not subject to review. Further, where the observational research does not involve the identification or potential identification of the participants in the results, is not staged by the researcher, is non-intrusive and/or where no personal information is collected, ethics review is not required. However, if people have a reasonable or limited expectation of privacy, researchers must submit a protocol to the HPRC or relevant ethics review body for review as ethics review and approval may be required. When in doubt, the Office of Research Ethics should be consulted for advice as to applicability and/or need for ethics review.

2.6  Exploratory Phase

Research ethics review is not generally required for the 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.

2.7  Scholarly Review and Research Ethics Review

For research that has not undergone peer review, it is at the discretion of the HPRC to require the scholarly review of the proposed research so as to ensure that the ethical implications of the methods and design of said research have been fully considered. Scholarly review may be undertaken by an ad hoc, independent peer-review committee or by a subcommittee of delegates of the HPRC so long as the delegates have the relevant expertise to review the proposed research

2.8  Privacy and Confidentiality

The privacy and confidentiality of data supplied by research participants as a consequence of their participation in research projects is of paramount concern to both institutions and researchers alike. Researchers have an obligation to protect information from unauthorized access, use, disclosure, modification, loss or theft. As a consequence, safeguards must be in place to protect the security of research related data and in particular that data which contains personal identifiers. It is the responsibility of both researchers and institutions therefore to have the necessary physical, administrative and/or technical security measures in place to provide the necessary protection that this data requires. At a minimum, researchers are required to provide both the HPRC (via the ethics protocol) and potential participants (via the Informed Consent Form) a detailed description of the proposed measures for the protection of the data collected through the full research cycle: collection, use, dissemination, retention and/or disposal. Potential disclosure requirements must be clearly outlined in both the ethics protocol submitted to the HPRC for review as well as in the informed consent form administered to potential participants.

The privacy and confidentiality of data garnered through research activities are addressed in separate Data Security Guidelines. Researchers are advised to consult the Data Security Guidelines prior to the completion and submission of ethics protocols.

2.9  Secondary Use of data

While the secondary use of non-identifiable data is not subject to ethics review, research involving the use of identifiable data for secondary purposes or for purposes other than that for which it was originally collected, is subject to ethics review with some exceptions. Research which involves secondary analysis of identifiable information for which consent has not been obtained, may be approved if the following 6 criteria are met:

    1. the data is essential to the research
    2. its use is unlikely to negatively impact the welfare of the individuals
    3. the researchers will take all necessary measures to protect the privacy of the individual(s) and to safeguard the information
    4. the researchers will comply with all known previously expressed preferences re future data use
    5. it is impossible or impracticable to obtain consent and
    6. the researchers have obtained any other necessary permission for secondary use of information for research purposes

Similarly, should a researcher wish to engage in data linkage, permission will be sought from the HPRC prior to conducting the linkage.

3.  Research Ethics Review

3.1  Ethics Review Processes

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 (the institutional REB) for research ethics review in accordance with this policy.

In general, the following general principles apply to the ethics review process:

    1. review procedures should ensure that there is accountability by way of a paper trail from the researcher to HPRC to the relevant research oversight body of Senate
    2. ethics review should be seen as an integral part of a research process
    3. reviews should be conducted in an efficient and timely manner
    4. ethics reviews are undertaken within the context of a proportionate approach to review
    5. decisions of the HPRC are based on consensus; where consensus is not possible, the HPRC may decide via a majority vote with dissenting opinions noted in the record

3.2  Full Review

All research that is subject to ethics review must be approved by the appropriate ethics review body before the research may begin. 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. The HPRC shall conduct either a full or delegated review, depending on the level of risk, the status of the research, or whether the research is more appropriately reviewed by an alternate review committee. Unless otherwise exempted, full board review is the default review process.

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. 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.)

3.3  Delegated Review

There are a number of types of research that are not subject to full board review but rather subject to a delegated review process. Research that meets the criteria for delegated review is universally minimal risk research. Thus, research that is more than minimal risk is always subject to full board review. 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. The following sections describe the type of research subject to and respective Research Ethics Boards that conduct delegated ethics reviews of research involving human participants.

3.4  HPRC-Delegate Ethics Review

Minimal risk, funded research minimal risk changes to approved research and annual renewals of approved minimal risk research shall be reviewed by delegates of the HPRC via a delegated review process involving no less than two members of the committee. Delegates may be full or non-voting members of the HPRC; however, all must have the requisite knowledge and expertise to conduct appropriate ethics reviews. Where delegated reviewers decide that a protocol should not be approved, the protocol will be referred to the HPRC for full board review.

3.5  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. All graduate student PIs must complete the TCPS tutorial to establish that they have completed the necessary education component and attach their certificate of completion to their protocols. Protocols will not be accepted for review unless a valid TCPS tutorial certificate is attached.

3.6  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.

All Faculty/Departmental level Ethics Review committees are required to establish review procedures according to the guidelines set out above and approved by the HPRC. Further they are required to:

    1. review all course-related, non-funded, minimal risk research proposals (including MRP's and Comprehensive Examinations) that are subject to ethics review according to the criteria set out in this document
    2. report to the HPRC by July 30th of each year on the research proposals (name of Principal Investigator and topic or research title) reviewed and the decisions made for the 12 month period ending June 30th and
    3. obtain a written statement from the instructor or supervisor confirming that the Principal Investigator (s) has been advised that all human participants in the research must have either signed a written consent form or have provided oral consent for their participation in the research.  The Principal Investigator must also be advised that consent forms shall be retained by the Principal Investigator for two years following the completion of the research. All student PIs must complete the TCPS tutorial to establish that they have completed the necessary education componen.

3.7  Ongoing Review

Ethics approval is a fluid process that requires ongoing review and monitoring.  Consequently there are a number of processes and procedures that must be undertaken in order to ensure continued compliance (of the ethics protocol) with this policy.

3.7.1 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.

 3.7.2 Progress Reports

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.

3.7.3 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.

3.7.4 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.

3.7.5 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.

3.8 Consent

Respect for persons, as noted in the introduction, is a core principle of research ethics.  In respecting persons, researchers understand the dual moral obligations to respect autonomy and to protect those with developing, impaired or diminished autonomy.  An important mechanism for respecting participants’ autonomy in research is the requirement to seek their free, informed and ongoing consent.

3.8.1 Principles of Informed Consent

Ethical research involving humans requires free and informed consent. To that end, all potential human participants (e.g. interviewees, research subjects, community members, etc.) have the right to be informed of:

    1. the nature of the research (hypotheses, goals and objectives, etc.)
    2. the research methodology to be used (e.g., medical procedures, questionnaires, participant observation, etc.)
    3. a complete description of risks and benefits
    4. that their participation is entirely voluntary and thus they have the right not to participate, not to answer questions, and/or to terminate participation at any time without prejudice (e.g., without academic penalty, withdrawal of remuneration, etc.)
    5. their right to anonymity and confidentiality
    6. when relevant, whether or not the permission of the organization with which they are associated (e.g. employment, profession) has been sought and/or obtained
    7. the right to withdraw their biological data should they choose to withdraw from the study; where such withdrawals are not possible, researchers must make this clear on the consent form;
    8. information about potential commercialization of the research
    9. potential or real conflicts of interest
    10. where applicable, to be debriefed (via a debriefing document) of any deception or partial disclosure used in the study
    11. data security and management and any other issues of which the participants should be aware that is relevant to specific protocols and research projects

Free and informed consent from participants, subject to a few exceptions, should be obtained prior to the commencement of research. No research may proceed with anyone who has refused to consent to participate. It is the responsibility of the Principal Investigator to ensure that the approved consent process is adhered to at all times.  Further, the Principal Investigator is required to ensure that all members of his or her research team similarly adhere to the approved consent process. The manner in which a Principal Investigator obtains informed consent may be restricted as a result of the nature of the research, status of the participants, and culturally-specific norms. Regardless of the method used, the principles of informed consent must be met and documented; however, the reviewing bodies shall be flexible in how that consent is obtained where circumstances warrant.

The following two methods of informed consent are the most common and are generally acceptable:

Informed Consent Form:

The default consent process requires a written informed consent form.  A written informed consent form is the standard for research involving human participants and it is the one required to be used routinely.  The written consent form includes the minimum principles outlined above, and require the participants’ or their representative'(s) signature(s).

Verbal statement:

Only in specific circumstances, such as where written communication is not feasible (children, illiterate adults, certain communities) or appropriate (politically volatile situations), may researchers relay the principles outlined above verbally.  The verbal consent script must be provided to the relevant ethics review Committee for review and approval.

3.8.2 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.

 3.8.3 Departures from General Principles of Consent

There are certain research situations in which the common principles of informed consent may not be appropriate or practical and thus a departure from the general principles of consent may be justified.  In order for a departure from the general principles of consent to be approved, all of the following 5 criteria must be met:

      • the research must be minimal risk
      • the participants’ welfare is unlikely to be impacted
      • it is impossible or impracticable to carry out the research if prior consent is required;
      • wherever possible, participants may be briefed at a later date and provided the opportunity to consent or refuse consent and;
      • the research does not involve a therapeutic intervention or other clinical or diagnostic interventions

Further, in exceptional circumstances such as individual medical emergencies, departure from general principles of consent may also be justified.  However, such exceptions are made only in those cases where the research to be conducted addresses the emergency needs of the individuals involved and conforms to established ethics review processes as approved by the HPRC.

 3.8.4 Consent and Capacity

Researchers must ensure that participants have the capacity to consent and must therefore be aware of all the regulatory and legal requirements as they speak to capacity.  Further, researchers are required to provide a mechanism by which those that do not have the capacity to consent or a limited capacity to consent have the means to participate where appropriate and applicable so as to ensure that they are not unjustly excluded from the benefits of the research or included where not appropriate. Such mechanisms can include third party consent, substitute consent or research directives.  Regardless of the mechanism used to obtain consent, the researcher must provide sufficient detail to the HPRC to assess whether the rights of the participants who do not have the capacity to consent or have limited capacity to consent have been sufficiently protected.

3.9 Risk (Participants, Researchers)

Risk is a function of the magnitude of the harm that may befall participants or others as a result of their participation in a particular research project.  The HPRC is required to review proposed research as outlined in the respective ethics protocols in the context of both the foreseeable risks of the research and the available methods of eliminating or mitigating the risk. The level of review – full review or delegated review and the concomitant level of scrutiny associated with each – is dependent on the determination of the level of risk. Given the proportionate approach to the analysis of risk in the ethics review process, magnitude or seriousness of harm and probability of occurrence of harm, are the primary considerations.  It should be noted that, in general, consideration of risks to researchers are beyond the purview of the HPRC.  However, should members of the committee be concerned about the safety of researchers – and in particular, student researchers – the appropriate body within the University may be contacted for further review, comment and direction.

3.10 Participants – Inclusion and Exclusion criteria

Researchers are required to provide detailed description of their recruitment processes, potential research participants and the related inclusion and exclusion criteria. Researchers which exclude a particular group shall provide a rationale for their exclusion. Wherever possible and relevant, equal gender representation should be sought in all participant groups. Similarly, accommodations – including necessary alternative consent processes -  should be made so as to afford the inclusion of minors, the elderly and other vulnerable groups in research projects, wherever possible. Researchers whose participant groups may include those of limited capacity to consent, the elderly, minors and other vulnerable groups should generally be limited to research that is minimal risk.

4. Research Involving Aboriginal Peoples

In recognition of the complex nature of research involving Aboriginal peoples and mindful of the need to ensure that appropriate sensitivity to cultural and community rights, roles and responsibilities are employed in all research projects conducted under the auspices of York University, separate Research Ethics Review Guidelines for Research Involving Aboriginal People as well as a Research Ethics Review Checklist have been developed.   An advisory group comprised of Aboriginal researchers, students and scholars representing a wide range of communities was created in 2010 and formalized as a consulting advisory committee in 2011 for the purposes of providing advice and recommendations on research ethics protocols, and research ethics policies and procedures as they relate to research involving Aboriginal peoples.

Researchers conducting research involving Aboriginal peoples and/or within or about Aboriginal communities are required to consult the Guidelines prior to submitting an ethics protocol to the HPRC for review.

5. Research Not Covered by This Policy and Procedures

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 TCPS for guidance.  Alternatively, researchers may consult with the Office of Research Ethics for advice and direction.