Carleton University Research Ethics Boards Terms of Reference

1.     Purpose and Mandate

1.1.   Overview

As delegated by the President, the Vice-President (Research and International) is responsible for the implementation of policies and procedures governing research ethics and compliance. Carleton University endorses the principles cited in the Tri-Council Agreement on the Administration of Agency Grants and Awards by Research Institutions, and has mandated its regulatory committees to ensure that all research investigations are in compliance with that document, other Tri-Agency Rules and Guidelines, and applicable research ethics standards and regulations.

These Terms of Reference, and any amendments hereto, require the approval of the Vice President (Research and International).

In accordance with the norms and standards developed and refined by the Tri-Councils (CIHR, NSERC and SSHRC) and contained in the Tri-Council Policy Statement; Ethical Conduct of Research Involving Humans, as updated from time to time (TCPS), as well as other authoritative sources and standards, and including applicable laws and regulations, notably applicable Federal and Ontario privacy legislation.  In its decision-making and other review activities, the REBs shall apply and promote the principles of diversity, inclusion and engagement in research.

1.2.   Standard Operating Procedures

Day-to-day operations, policies and procedures of the REBs shall be as described in Standard Operating Procedures (“SOPs”) which shall guide the processes of the Office of Research Ethics, the REBs and REB Chairs and Members.  The rules and procedures set forth in the SOPs shall be, to the extent permitted by the TCPS, applied with flexibility and judgment to permit streamlined and ethically appropriate decision making by the responsible persons.

2.     Carleton University Research Ethics Boards

2.1.   Structure

The REB shall report to the Vice-President (Research and International).

Research ethics review at Carleton University shall be carried out within a structure of two or more Boards (collectively, “the REB”), with review responsibilities as provided in the SOPs.

2.2.   Scope of Authority

The Carleton University Research Ethics Boards shall review the ethical acceptability of all research involving humans or human biological materials conducted within the University’s jurisdiction or under its auspices and, in particular, shall have authority with respect to the following research studies:

1. Research carried out, as Principal Investigator or Co-Investigator, or is facilitated by, any Carleton University faculty, staff, post-doctoral fellow, visiting scholar, adjunct faculty, or student (“Members of the Carleton Community”) regardless of where the research is conducted, and
2. Any research involving participants, or prospective participants, who are Members of the Carleton Community, or former Members of the Carleton Community.

This authority includes both funded and unfunded research; research projects carried out in courses of instruction, and contracted research where the researcher is identified as a Member of the Carleton Community.

“Research” shall include, as a minimum, those activities defined as such by the TCPS and those more fully described in the SOPs.

2.3.   Mandate

• 2.3.1. The research ethics review process at Carleton is built upon the guiding core ethical principles discussed in the TCPS2, of respect for persons, concern for welfare, and justice. The application of these core principles is intended to achieve balance between the necessary protection of participants and the legitimate requirements of research and academic freedom through a transparent, accountable, and fair process for review and monitoring of the ethical acceptability and conduct of research.

• 2.3.2. In pursuance of this fundamental mandate, the REB shall:

• Provide impartial, fair, informed, and balanced review, using a proportionate approach, in accordance with the requirements of the TCPS, the SOPs, and established research ethics standards.
• Ensure the post-clearance monitoring of ongoing projects and requests for changes in previously cleared research projects to ensure compliance with the terms and spirit of the original project clearance and evolving circumstances.
• In reviewing an ethics protocol, the REB may clear (approve), reject, or require revisions to a proposed research project, or suspend or withdraw its previous clearance of a project.

2.4.   Functions and Responsibilities

• 2.4.1. Unless determined by the REB to be exempt under the TCPS or the SOPs, all proposals for research involving human participants within the REB Scope of Authority must be submitted for review and approval by the REB before any research activities may commence.
• 2.4.2. An REB’s clearance applies to the ethical acceptability of the research and does not, in itself, constitute authorization by Carleton University for the research to proceed.

2.5.   Independence

The REB operates independently in decision-making with respect to its mandate and under the current TCPS. All other entities and offices shall respect the independence, accountability and authority delegated to the REB and may not override a decision of an REB to clear, reject, or require changes to a research protocol, or to suspend or withdraw its clearance, except in accordance with the appeals procedure described below.

2.6.   Proportionate Review

Ethics review shall be proportionate to the level of risk to participants and researchers. To the extent that risk is greater, review of research protocols shall be more detailed and subject to greater scrutiny.

2.7.   REB Membership and Composition

The REB shall be multidisciplinary in nature and composed of individuals who have a demonstrated interest in research ethics.  The membership of each of the REBs shall, at a minimum, comply with current TCPS policy regarding numbers and composition, and the SOPs.

• 2.7.1. Chair: A Chair of an REB is appointed by the Vice-President (Research and International) for a period of 2 years, renewable for further terms of two years, or otherwise in the discretion of the Vice-President (Research and International). The Chair of an REB shall preside at the REB meetings and generally supervise all of its ongoing activities. The duties of the Chair also include, but are not limited to, those duties described in the SOPs.
• 2.7.2. Vice-Chair:  A Vice-Chair of an REB is appointed by the Vice President (Research and International) for a period of two years, renewable for further terms, or otherwise in the discretion of the Vice-President (Research and International).  The Vice-Chair of the REB shall undertake the role and responsibilities of the Chair while absent, and act as delegated decision-maker and signatory for the Chair as needed.  The duties of the Vice-Chair also include, but are not limited to, those duties described in the SOPs.
• 2.7.3. Members:   Members shall be appointed by the Vice President (Research and International). The term of the members shall be set by the terms of appointment and be renewable for further terms in consultation with the REB Chair.  The duties of the Members shall be as provided by the SOPs. Members who consistently or repeatedly are unable or unwilling to meet these responsibilities may be removed as members of the Board by the Vice-President (Research and International), in consultation with the Chair(s).
• 2.7.4. REB Sub-Committees: The REB may establish such permanent or ad hoc sub-committees as it considers necessary to undertake special or ongoing tasks relating to the review of proposed research at Carleton, and any matters incidental to such review.
• 2.7.5. Departmental Sub-Committees:  The REB may establish department-, school-, or faculty-based sub-committees to review undergraduate and course based projects conducted by students of that department, school or faculty that are low risk or primarily pedagogical in nature and do not otherwise require REB review under the TCPS.

2.8.   Meetings

• 2.8.1. Frequency: Meetings will be held monthly at a time to be publicized in advance.  Scheduled meetings may be cancelled by the Chair if there is insufficient meeting business.  At the discretion of the Chair, guests may be invited to attend the meeting of the REBs.
• 2.8.2. Remote Participation using Electronic Technology: Meetings shall normally be held in person but may be held by teleconference, videoconference, or other technological means, when circumstances warrant.  Any member joining a meeting by such electronic means shall be provided with all meeting materials for prior review and be included in determining quorum for the meeting.
• 2.8.3. Quorum:  REB meeting quorum shall be not less than that required by the TCPS and shall, at a minimum, be greater than 50% of voting members (not counting alternate members if any).
• 2.8.4.  Minutes: The REB shall keep and maintain minutes of all duly convened REB meetings.

3.     Research Ethics Review

3.1.   Categories of Review

The REBs may undertake the categories of review as more fully described in the SOPs, including but not limited to:

• new study submissions of various categories of research,
• amendments and addenda to approved studies,
• continuing review of approved studies,
• applications for course-based and pedagogical research,
• renewals, closures and withdrawals of studies, and
• applications for release of research funds prior to study clearance.

Such categories of review, and requirements for their review including the submission forms to be used, shall be as more fully described in the SOPs.

3.2.   Determinations of Exemption

The Chair may, consistent with the provisions of the TCPS, determine that a proposed project is exempt from review or does not meet the definition of research involving human participants in the TCPS.  Such determinations may be delegated to the Vice-Chair, another REB member or members, a sub-committee of REB members, to members of the Office of Research Ethics, or otherwise as provided in the SOPs.

3.3.   Delegated Review for Minimal Risk Studies

For each new study submitted for review, the Chair shall determine whether the project poses at most minimal risk to research participants, and if so is eligible for delegated review.  Delegated review of research projects may be done by the Chair, Vice-Chair, another REB member or members, or a sub-committee of REB members, or by members of the Carleton University Office of Research Ethics, or otherwise as provided in the SOPs.

3.4.   Administrative Review

The Chair shall undertake delegated, administrative review of new studies otherwise subject to the REB review in which the primary research site is an outside institution and the project has approval of such outside institution’s REB or similar research ethics review committee.

3.5.   Effect of Delegated and Administrative Review

Decisions made by delegated and administrative review are valid decisions of the REB.  Completed delegated and administrative reviews shall be reported to the next occurring meeting of the REB for information and comment.

3.6.   Full Board Review

All other submissions of new proposed studies shall be reviewed by the full REB at a properly constituted meeting, as more fully described in the SOPs.

3.7.   Changes to Protocol

• 3.7.1. Study changes to protocol, being study amendments and addenda, shall be reviewed by delegated review by the Chair, the Vice-Chair, another REB member, a sub-committee of REB members or members of the Office of Research Ethics, or otherwise as set forth in the SOPs.  However, where an amendment or addendum materially affects the risks to participants or significantly alters participants’ rights or welfare, such amendment or addition shall be referred for review by the full REB.
• 3.7.2. A Change to Protocol shall not be instituted by any researcher until it is given clearance by the REB, except if undertaken to prevent serious harm.

3.8.   Ongoing/Continuing Review

• 3.8.1. After a research proposal has been cleared by the REB, the REB shall maintain ethics oversight of the research through a continuing review process and shall require such ongoing reporting as is provided in the SOPs.
• 3.8.2. The REB may withdraw or suspend its approval from any project that does not comply with the approved Protocol or that has been identified as posing new or significant increases in the level of risk to research participants not identified in the cleared REB application.  When the REB withdraws or suspends its approval, the activities of the research project shall cease immediately, and the study investigators shall take appropriate steps, approved or imposed by the REB, to correct the breach and to ensure that the interests of the study participants are not adversely affected as a consequence of such actions.

3.9.   Renewal/Closure

New studies and renewals may be cleared for at most one year and the status of each cleared study is therefore subject to renewal annually or sooner as determined at the time of initial or renewed clearance.  Upon expiry of the study approval period, studies must be renewed, failing which the REB approval shall lapse.

Active studies shall be closed at the request of the Principal investigator once all activities involving research participants have been completed including compiling and analyzing study data.

3.10.  Harmonization of Multi-Institutional Review

On the advice of the REB, the Vice-President (Research and International), on behalf of Carleton University, may enter into Agreements with other institutions to facilitate and harmonize the review and clearance of any research project(s) that fall under the jurisdiction of the REB and also any other REB(s) or equivalent research ethics review committee(s).  In particular, such Agreements may permit the REB to accept reviews, undertaken by an external REB, of the ethical acceptability of such research projects, on such terms and conditions as may be provided in such Agreement and the SOPs.

3.11.  REB Members’ Conflict of Interest

Any REB member having a conflict of interest, as described in the SOPs, with respect to any research project, or any other member believing that another member has such a conflict of interest, shall declare that conflict to the Chair as soon as possible and if a conflict is determined to exist, the member shall be recused from participating in deliberation and voting on that project.   However, in the discretion of the Chair, such recused member may stay in the meeting to provide further information and comment about the proposed study, prior to being excused while the Board conducts its final discussion and voting.

3.12.  Appeals

The principal investigator of a study reviewed by the REB may appeal the decision of the REB by sending a written request for reconsideration to the Chair of the REB.  When reviewing the appeal received from a principal investigator, the REB will follow the procedures outlined in the SOPs.

4.     The Office of Research Ethics (ORE)

4.1. Composition and Duties

The ORE shall be staffed by the Director of Research Ethics, Research Ethics Coordinators, and such other staff as may be engaged from time to time.

The ORE shall:

1. Provide administrative support to the Chair and REB members in the discharge of the REB mandate.
2. Prepare and maintain comprehensive records, including all documentation related to the project protocols submitted for review, attending all Board meetings, preparing minutes of REB decisions taken at meetings and undertaking other work regarding processing of research ethics applications.
3. Perform such other functions as more fully described in the SOPs.

4.2.  Delegation of Routine Tasks and Approvals

On the advice of the Chair(s), the REB may delegate routine tasks and approvals to the REB Coordinators or other ORE staff, and the terms of such delegated powers shall be provided in the SOPs.