Research Requiring Review

The guidelines outline the conditions of research projects that require review in Article 1.1 of the Tri-Council Policy Statement, which is summarized below.

All research that involves living human subjects requires review and approval by a Research Ethics Board (REB) in accordance with the Tri-Council Policy Statement, before the research is started. This includes research funded by grants, contracts and contributions, unfunded faculty research, graduate and undergraduate research and staff research. Research involving human remains, cadavers, tissues, biological fluids embryos or foetuses shall also be reviewed by the REB.

The only exceptions to this review process by the REB include:

• Research about a living individual in the public arena, or about an artist, based exclusively on publicly available information, documents, records, works, performances, archival materials or third-party interviews. Such research only requires ethics review if the subject is approached directly for interviews or for access to private papers, and then only to ensure that such approaches are conducted according to professional protocols and to Article 2.3 (Naturalistic Observation) of this Policy.
• Quality assurance studies, performance reviews or testing within normal educational requirements. Projects of this nature will be reviewed by the administrative ethics review board in accordance with Policy 8.2 - Ethics Approval for Administrative Research Projects Using Human Subjects.
• Research undertaken by students on co-op work terms outside the auspices of Wilfrid Laurier University and/or its academic programs that does not require Wilfrid Laurier University resources and is not directly supervised by Wilfrid Laurier University faculty or staff.

If a student is conducting research on a practicum that involves human participants (questionnaires, surveys, needs studies, focus groups, interviews, naturalistic observation, participant observation, etc.) and is part of an ongoing project at the practicum placement, this is the work of the agency or other employer and does not need to be ethically reviewed by the Research Ethics Board for graduate students or by the departmental ethics review committee for undergraduate students. If the student is the primary person involved in the development and implementation of some research that involves human participants at the practicum setting, then it is mandatory to complete the WLU ethics review process.

It is also mandatory to complete the WLU ethics review process if the student's research in the practicum is part of a faculty member's own research program or if the student plans to use the information collected in the practicum setting in another academic project at a later time (for example, another course, a thesis, or a paper).

The WLU Research Ethics Board

The Research Ethics Board (REB) considers matters of policy related to research with human subjects. In addition, it reviews research applications on referral from its Chair. According to the Tri-Council Policy Statement on Research with Human Subjects, the REB must review and approve all relevant research conducted by faculty, staff and graduate students. The REB is mandated to approve, reject, propose modification to, or terminate any proposed or ongoing research involving human participants which is conducted within, or by members of, the WLU community, using the considerations set forth in that Policy Statement. Research that is carried out by undergraduate students as part of their course work must be reviewed and approved by Departmental or Faculty Ethics Review Committees.

The REB is composed of at least seven faculty members from different departments/Faculties that are directly involved in research involving human subjects, a staff member in Psychology responsible for coordinating human ethics reviews, and at least one community representative. Members of the Board are appointed for a set term (2 years, ensuring rotation of members) by the Vice-President: Research. The Board is chaired by a faculty member. The Director of Research Services is an ex-officio (non-voting) member, and serves as a resource person for the REB. The Research Compliance Officer is an ex-officio (non-voting) member, and co-ordinates the ethics review process for the REB, ensures the REB is informed about any ethics policy changes on a national level, provides ethics advice to faculty and students, and serves as secretary to the REB. For all funded projects (internal or external), ethics approval must be obtained before funds are awarded. Members of the REB are subject to the university policy that relates to conflict of interest; see University Policies: Article 8.1: Conflicts of Interest, which is in keeping with Article 1.12 of the Tri-Council Policy Statement.

Current Membership

The REB will also serve as a liaison committee to review projects undertaken by members of the WLU community that are conducted within the domains of other institutions (e.g. a school, hospital, social agency). For these research settings, the REB reviews the ethical soundness of faculty and student applications to be submitted to external agencies (e.g. The Waterloo County Board of Education) whose Research Boards vet research proposals dealing with human subjects. Proposals should be submitted to the Research Office at least two and one half weeks prior to the external agency's deadline for the submission of proposals.

Proportionate Review Process

All research involving human subjects falls into one of two review categories:

1) Full Review: All research is presumptively in this category unless it meets certain exceptions, as described below. The term "full review" refers to a face-to-face review before the full Board. In such cases, the REB will allow researchers to participate in discussions about their proposals, but the researcher may not be present when the REB is making its decision. When the REB is considering a negative decision, all reasons for this decision will be made available to the researcher and a reply from the researcher will be requested. Researchers have the right to request, and the REB has the obligation to provide, reconsideration of decisions affecting a research project.

Signed informed consent is required from all subjects or their legal guardians. A sample Informed Consent Checklist and Statement is available on the web.

2) Expedited Review: Research proposals will be reviewed by the chair of the REB and at least one additional member, if the research falls into certain categories defined as "minimal risk".

The Tri-Council Policy Statement definition of "minimal risk" is as follows: "if potential subjects can reasonably be expected to regard the probability and magnitude of possible harms implied by participation in the research to be no greater than those encountered by the subject in those aspects of his or her everyday life that relate to the research then the research can be regarded as within the range of minimal risk". This definition requires a judgement by the chair and the member of the committee designated to review the proposal. In light of the proposed research, the judgement is based on such factors as:

•  the nature of the population studied (ie, children, institutionalized individuals, vulnerable populations, incompetent populations, aboriginal peoples) in light of the proposed research,
• collection of information regarding sensitive aspects of the subject's behaviour, such as drug use, sexual practices, illegal conduct, memories of a traumatic nature, etc.,
• collection of information or recording of behaviour which, if known outside of the research, could reasonably place the subject at risk of civil or criminal liability or damage the subject's social standing, financial standing, or employability,
• invasive manipulations.

According to the policy statement, "Research governed by this Policy may begin only if prospective subjects, or authorized third parties, have been given the opportunity to give free and informed consent about participation..." This consent should ordinarily be obtained in writing. Where there are "good reasons" for not recording consent in writing, the procedures used to seek free and informed consent shall be documented.

Scholarly Review as Part of Ethics Review

In all cases of research that poses more than "minimal risk", the REB shall satisfy itself that the design of a research project is capable of addressing the questions being asked in the research. In cases of funded peer-reviewed research, the review by the agency will constitute review of scholarly merit. In cases of research that has not been peer-reviewed (including contract or contribution research), the researcher(s) will be requested to provide two names (one internal to the University and one external to the University) of arms-length expert in the field who could provide an assessment of the scholarly merit of the proposed research.

In consideration of harms/benefits analysis of the proposal it is important for reviewers to note Article 1.5 (d) of the Tri-Council Statement: "Certain types of research, particularly in the social sciences and the humanities may legitimately have a negative effect on public figures in politics, business, labour, the arts or other walks of life, or on organizations. Such research should not be blocked through the use of harms/benefits analysis or because of the potentially negative nature of the findings. The safeguard for those in the public arena is through public debate and discourse and, in extremis, through action in the courts for libel."

Review Procedures for Ongoing Research

The Tri-Council Policy Statement stipulates that: "Ongoing research shall be subject to continuing ethics review. The rigour of the review should be in accordance with a proportionate approach to ethics assessment". In compliance with this policy, continuing review will consist of the submission of a succinct annual status report to the REB by July 1 of each year in cases of "minimal risk" research. This policy pertains to all faculty research and doctoral student research. The REB shall be promptly notified when data collection for a project concludes. In the case of a master's student's research, the annual report form may be completed and signed at the time of the thesis defence.

In cases of greater than "minimal risk", as part of the research proposal submitted for REB review, the researcher shall propose to the REB the continuing review process deemed appropriate for the project that is consistent with Article 1.13 (c) of the Tri-Council Policy statement.

Multi-Centred Research and Research Approved at Another Institution

As collaborative research between faculty members, staff, or students at different institutions, and perhaps with community partners, become more common, there is a desire that researchers are not unnecessarily hindered in their research by several ethics reviews by several research ethics boards. However, the Research Ethics Board (REB) at Wilfrid Laurier University has an obligation to ensure that research undertaken by faculty members, staff, and students of the University is appropriately reviewed and approved, and adheres to accepted ethical norms for research that involves human participants as set out in "Laurier Policy and Procedures for Research Involving Human Subjects".

If a research project has been reviewed and approved by a research ethics board, or equivalent body, at another institution, the chair of WLU's REB will review the project. If all ethics concerns have been addressed or if only minor changes are required, then the chair may approve the research project. However, at the chair's discretion, a review (full or expedited) by WLU's REB may be required.

If a research project has not been reviewed by a research ethics board, or equivalent body, at another institution, or if the institution's ethics policy does not comply with the guidelines set out in Laurier's policy, then WLU's REB must undertake a review (full or expedited) of the project.

In situations where WLU faculty members, staff, or students are part of a multi-centred research project, WLU's REB, through its chair, may cooperate with the research ethics boards, or equivalent bodies, at the other centres or institutions in the ethics review process in order to reduce the number of separate reviews that are necessary. In such situations, WLU's REB must ensure that the research has been appropriately reviewed and approved, and adheres to accepted ethical norms for research that involves human participants as set out in "Laurier Policy and Procedures for Research Involving Human Subjects".

Meetings and Attendance

The REB will meet as necessary, and at least quarterly, to review expedited review decisions and to review proposals that are deemed greater than "minimal risk". For "full" reviews, a quorum will consist of 60% of the committee, and a majority vote will determine the decision, with the Chair of the committee only voting in the case of a tie. Minutes of these meetings will be available in the Office of Research Services.

The REB will submit an annual report to SCRAP by September 1, concerning the number of proposals reviewed in each category (expedited review, full review, continuing review), a generic description of ethics issues/concerns that have been addressed in the past year, and, if necessary, recommendations concerning changes to this policy or the procedures for conducting an ethics review.

Appeals

In cases when a researcher and the REB can not reach agreement through discussion and reconsideration, the decision will be reviewed by an appeal board, which will operate in a similar manner as the REB. The Vice-President: Academic will appoint the 5-member standing appeal board, at least one of whom must be from outside the WLU community, upon recommendation of the Vice-President: Research. Members will be chosen for their experience in research ethics, and should be former REB members, but they must not be current members of the REB. Decisions of the appeal board are final.

Departmental or Faculty Ethical Reviews

Departmental or Faculty Ethics Review Committees must review and approve undergraduate students' course-related activities that involve human participants that are deemed "minimal risk", including undergraduate thesis research. If the departmental or Faculty committee deems a project to be of greater than "minimal risk", it must be reviewed by the University REB. Departmental Ethics Review Committees must not review and approve undergradute student research that is part of a faculty member's own research program; such research must be approved by the University REB.

Departmental Ethics Review Committees will operate according to the Tri-Council Statement on "Ethical Conduct for Research Involving Humans". The Departmental Ethics Review Committee shall consist of least two persons who will be replaced with alternates when they are associated with the project under review. The chairpersons of the Departmental Ethic Review Committees will provide information to the chairperson of the University REB by forwarding an Annual Report by July 1, summarizing the membership on the committee, the committees' activities, and any problems encountered when reviewing projects. Members of the University's REB will be available as resource and support persons for the Departmental Ethics Review Committees.

Decisions by a Departmental Ethics Review Committee may be appealed to the University Research Ethics Board. In order to avoid a conflict of interest, any member of the Research Ethics Board who participated in the decision by the Departmental Ethics Review Committee can not hear the appeal.