TOR05: Research Ethics Board

The REB is the final authority, and the College may not override REB decisions reached on the grounds of ethics without a formal appeal mechanism as set out below. The policies and practices adopted by the REB are consistent with the current approved Tri-Council Policy Statement: "Ethical Conduct for Research Involving Humans" (TCPS2).

In this context, the REB is responsible for:

1.1. Developing policies regarding ethical issues relating to the use of human participants in research and experimental teaching protocols;

1.2. Reviewing all protocols requiring the participation of human participants for ethical approval;

1.3. Reviewing annually all policies regarding ethical issues relating to the use of human participants in research projects to ensure that policies remain current;

1.4. Dealing with matters concerned with human-based research referred to the REB;

1.5. Preparing an annual report for submission to the President, as outlined in policy A201: Research and Innovation;

1.6. Participating in continuing education organized by College research administrators for the College community in matters relating to ethics and the use of human participants.

2. DEFINITIONS

None.

3. MEMBERSHIP AND TERMS OF OFFICE

3.1. Composition of the Board

The Chair and the Vice-Chair will not be from the same Collective Bargaining Agreement.

Standing membership: Eight to ten members including both men and women, appointed in accordance with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2). These members, including the Chair, are appointed by the President, on recommendation from the REB Chair and a senior REB member. Institutional senior administrators may not serve on the REB.

• At least two members have expertise in relevant applied research disciplines, fields and methodologies covered by the REB;
• At least one member is knowledgeable in ethics;
• At least one member is knowledgeable in the law (but that member should not be the institution's legal counsel or risk manager). This is mandatory for biomedical research and is advisable, but not mandatory, for other areas or research;
• At least one community member with no affiliation to the College.

Every year, the chair of the REB calls for nominations within the College for committee membership from among all full-time faculty and staff. The College also advertises externally for community members. Applicants are interviewed by the REB Chair and a senior REB member, and preferred candidates are recommended to the President through the REB Chair.

3.2. Term of Membership

The normal term of office for REB members is three years, with no more than one-third of members being replaced each year; shorter or longer terms may be necessary from time to time. Members may not serve more than six consecutive years but are eligible to reapply after an interval of one year.

3.2.1. Chair

The Chair position is a three-year appointment made by a majority vote of the Board members. The Chair position may be renewed without limitation to the number of terms served sequentially or non-sequentially. The Chair's performance will be reviewed annually by the Board at the last Board meeting in June before the summer break with informal feedback provided to the Chair. Should the Chair voluntarily step down, he/she can be appointed to a non-voting 'Past-Chair' position for one year with a majority vote of the Board, or he/she can revert to a Board Member position with the time served as Chair considered towards the Members terms. The Chair can be removed at any point upon successful motion and majority vote by the Board.

3.2.2. Vice-Chair

The Vice-Chair position is a three-year appointment made by a majority vote of the active members of the REB. The Vice-Chair's performance will be reviewed annually by the Board at the last Board meeting in June before the summer break with informal feedback provided to the Vice-Chair. The Vice-Chair can be removed at any point upon successful motion and majority vote by the Board.

3.3. Role of Chair and Vice-Chair

As required by the TCPS2 Article 6.8, the REB Chair is responsible for ensuring that the REB review process conforms to the requirements of this Terms of Reference.

3.3.1. The role of the REB Chair is to provide overall leadership for the REB and to facilitate the REB review process, based on institutional policies and procedures and the TCPS2. The Chair should monitor the REB's decisions for consistency and ensure that these decisions are recorded accurately and communicated clearly to researchers in writing as soon as possible by the Chair or his or her designate. Institutions shall provide the necessary resources and adequate administrative support to enable the REB Chair to fulfill his or her responsibilities.

3.3.2. The Vice-Chair will fulfill the role of the Chair when: (1) the Chair is not available; (2) there is a conflict of interest declared by the Chair; or (3) the Chair resigns their position. The Vice-Chair will be familiar with the guidelines, policies and the procedures with respect to research ethics and the operation of the REB.

3.4. Ad Hoc Advisors

The REB Chair may and should nominate appropriate ad hoc members for the duration of a review when the REB is reviewing a project that:

• Requires particular community or research subject representation;
• Requires specific expertise not available from the regular REB members.

Such ad hoc members are not voting members of the REB but may participate in REB deliberations. However, the membership structure should be altered accordingly if this occurs on a regular basis.

4. MEETINGS AND CONDUCT OF BUSINESS

4.1. Quorum

Quorum is 50% of REB members, but decisions are adopted only if the attending members possess the range of background and expertise stipulated in section 3 above, and article 6.9 of TCPS2. Normally consensus will be sought; when required, decision will be by majority vote of the appointed members in attendance. In the case of a tie, the Chair casts the deciding vote.

4.2. Meetings

The REB meets regularly at dates and times that are publicly announced in advance (preferably for the entire academic year) to discharge their responsibilities. Normally, the REB meets monthly; however, this may not be required at certain times of year (July and August). Regularly scheduled REB meetings may be cancelled if no protocols have been received by the submission deadlines.

4.3. Record Keeping

Minutes of REB meetings are prepared and maintained by the REB. This is essential in order to demonstrate that the REB is acting fairly and reasonably; failure to do so could expose the College and the researchers to legal liability. REB minutes clearly document REB decisions and any dissents, and the reasons for them.

In order to assist internal and external audits or research monitoring, and to facilitate reconsideration or appeals, REB minutes are accessible to authorized representatives of the College, researchers, and funding agencies.

4.4. Delegated REB Review of Minimal Risk Research

Delegated review does not require face-to-face meetings of REB members. The Chair reports delegated review results to other members of the REB at an appropriate time. Delegated review is reviewed by two REB members (the Chair may be one of these). It is available only in cases that fulfill one of the following criteria:

• Research that is confidently expected to involve minimum risk (as defined in the TCPS2: "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.").
• Research projects that have already received approval by the Fanshawe College REB, have complied fully with any requirements, have an up-to-date file, and the applicant is simply renewing the ethical approval without significant changes to the ongoing research process.
• Affirmations that conditions set by the REB as conditions of approval have been met.

4.5. Faculty/School/Departmental-level Review of Minimal Risk Research

This policy requires the REB to review and approve all research involving human participants. However, the REB may delegate the ethics review of research entailing no more than minimal risk, which is carried out by students in a diploma or degree level course, to the REB School/program delegate and one REB member selected by the Chair of the REB (which may also be the Chair).

Upon completion of such reviews, the reviewing REB member must report results to the REB. Student research deemed to be beyond minimal risk must be reviewed by the REB. Department level review may not be used to review research undertaken by a student as part of a faculty member's research program.

Regardless of the review mechanism, the REB continues to be responsible for the ethics of all research involving humans within the College.

5. REFERENCES

Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2)

6. ADDENDA

None.