The mandate of the REB is to ensure that ethical principles are applied to all research involving human subjects. It has a role to educate researchers and to review and monitor research proposals and projects. It serves as a consultative body on research ethics and to assist in educating employees about research ethics. It has the responsibility for independent multidisciplinary review of research proposals to determine if they meet ethical requirements and to approve them to be initiated or continue.
1. Authority of the Research Ethics Board
A. The College mandates the REB to approve, reject, propose modifications to or terminate any proposed or ongoing research involving a human subject that is conducted within or by members of, the College, using the considerations set forth in this Policy, as a minimum standard.
B. The REB is an independent standing committee with terms of reference approved by Senior Management. The REB's decision to approve or deny proposals for research or standardized testing are made independently and may not be set aside without formal appeal.
2. Membership of the Research Ethics Board
A. The REB shall consist of at least five members, including both men and women, of whom:
i. at least two are faculty who possess broad expertise in the methods or in the areas of research that are covered by the REB;
ii. at least one member is knowledgeable in ethics;
iii. for biomedical research, at least one member is knowledgeable in the relevant law;
iv. at least one member has no affiliation with the College, recruited from the community served by the institution; and
v. At least one College administrator (non-voting) who will provide staff support for the REB.
B. All members will be appointed by Senior Management.
C. The REB may itself appoint up to two additional voting members of two year terms, with expertise to balance the composition of the REB.
D. The REB may from time to time also call on specialists to advise on particular proposals that require additional expertise for appropriate review.
E. Appointment to the REB is for a two year term, with terms of members overlapping. The appointment is renewable to a maximum of three terms.
F. The REB will elect a Chairperson each year from among its membership. The position is renewable.
G. Prior to serving, all members of the REB will attend a workshop or orientation session, to ensure that they have an understanding of the principles and practices of ethical review. The workshop requirement may be substituted by the on-line tutorial accessed at http://www.pre.ethics.gc.ca/english/tutorial or a similar tutorial approved by the REB.
3. Scholarly Review as Part of Ethics Review (required for Full Reviews)
A. The REB shall satisfy itself that the design of a research project that poses more than minimal risk is capable of addressing the questions being asked in the research.
B. The extent of the review for scholarly standards that is required for biomedical research that does not involve more than minimal risk will vary according to the research being carried out.
C. Research in the humanities and the social sciences which poses, at most, minimal risks shall not normally be required by the REB to be peer reviewed.
D. Certain types of research, particularly in the social sciences and the humanities, may legitimately have a negative effect on public figures in politics, business, labor, the arts or other walks of life, or on organizations. Such research should not be blocked through the use of harms-benefit 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.
E. Scholarly and ethical reviews undertaken vary between disciplines. The following mechanisms are among those that should be considered by the REB. The REB may
i. Conclude that the proposed research has already passed appropriate peer review, for example by a funding agency;
ii. Establish an ad hoc independent external peer review;
iii. Establish a permanent peer review committee reporting directly to the REB;
iv. Assume complete responsibility for the scholarly merit, which would require that it have the necessary scholarly expertise in the discipline to carry out peer review of the research in question.
F. In evaluating the merit and the scholarly standards of a research proposal, the REB should be concerned with a global assessment of the degree to which the research might further the understanding of a phenomenon, and not be driven by factors such as personal biases or preferences. REBs should not reject research proposals because they are controversial, challenge mainstream thought, or offend powerful or vocal interest groups. The primary tests to be used by REBs should be ethical probity and high scientific and scholarly standards.
4. Review Procedure
A. Proportionate Approach to Ethics Assessment
The REB uses a proportionate approach based on the general principle that the more invasive or harmful the proposed and on-going research, the greater should be the care in its review.
i. Proposals are reviewed and may be approved through one of the means listed below. Regardless of the review strategy, the REB remains responsible for the ethics of all research involving human subjects that is carried out at the College.
a. Full Review
Where a proposal poses more than minimal risk the REB will assess the harms and benefits of the proposed research project, may determine if the research design is capable of answering the research questions, and will ensure that the research procedures and materials conform to established ethical standards.
b. Expedited Review (Results of these reviews will be reported back to the full REB in a timely manner)
Where a proposal poses only minimal risk or have been approved elsewhere by a Tri-Council policy-compliant REB, the Chair (or designate) of the REB will review the proposal and its conformity to established research ethics standards and practices. Researchers may request an expedited review when submitting their proposal.
c. Local (Course) Review (Research Conducted by Students as Part of Course Requirements) (Results of these reviews will be reported back to the full REB in a timely manner)
Research which is conducted by students under the supervision of an instructor as part of an approved course outline does not need approval from the Research Ethics Board. Instead, the appropriate Faculty Education Committee will review the ethics of the generic research activities as part of its curricular review processes. The research activity must be listed in the course Curriculum Guidelines and must refer to the requirements laid out in this Policy. Faculty supervising students will ensure compliance with this Policy. Copies of appropriate generic consent forms and research ethics guidelines approved by the REB should be provided by the instructor to the students. In situations where student research activities will depart from using these forms, the faculty member should refer the matter to the REB for approval.
Where students are carrying out research that is part of a faculty member's own research program, this research proposal must be reviewed by the REB as in the Full Review procedure or the Expedited Review procedure outlined earlier.
d. Review Procedure for On-going Research
i) Ongoing research shall be subject to continuing ethics review. The rigor of the review will be in accordance with a proportionate approach to ethics assessment.
ii) As part of each research proposal submitted for REB review, the researcher shall propose to the REB the continuing review process deemed appropriate for that project.
iii) Normally, continuing review should consist of at least the submission of a succinct annual status report to the REB. The REB shall be promptly notified when the project concludes.
iv) Beyond scrutinizing reports, the REB will not normally carry out the continuing ethics review, except in specific cases where the REB believes that it is best suited to intervene. For research posing significant risks, the REB should receive reports on the progress of the research project at intervals to be predetermined. These reports should include an assessment of how closely the researcher and the research team have complied with the ethical safeguards initially proposed.
v)In accordance with the principle of proportionate review, research that exposes subjects to minimal risk or less requires only a minimal review process. The continuing review of research exceeding the threshold of minimal risk, in addition to annual review might include:
a) formal review of the free and informed consent process;
b) establishment of a safety monitoring committee;
c) periodic review by a third party of the documents generated by the study;
d) review of reports of adverse events;
e) review of patients' charts; and
f) a random audit of the process of free and informed consent.
ii. To undergo REB review, researchers will submit to the REB:
a. The research proposal, in sufficient detail to permit the REB to make an assessment of its ethical acceptability;
b. Experimental protocol (where appropriate);
c. Informed consent statement and forms (as necessary). Normally, subjects must be given a copy of the informed consent form which they have signed;
d. Copies of questionnaires and research instruments (where appropriate);
e. Statement of formal acknowledgement and/or approval of any agencies or companies whose co-operation is needed to conduct the research or whose support is being or is provided in connection with the research (where applicable);
f. Copies of any ethical guidelines, other than those approved by the REB, used in preparing the proposal;
g. Such other material or information as the REB may request.
B. Meetings and Attendance
i. The REB will meet regularly and as needed to review requests and carry out REB business. It is necessary for members to attend and participate in face to face meetings.
ii. A quorum for committee purposes for a full review is at least 4 members. Where possible, the REB will reach decisions by consensus; otherwise a simple majority will prevail. The Chair will not vote, except in the event of a tie.
iii. The Administrator of Reference will arrange the meetings, distribute relevant documents and organize the recording and distribution of minutes. He/she will also ensure that all minutes, and relevant records are maintained securely.
C. Record Keeping
i. Minutes of all REB meetings shall be prepared and maintained by the REB. The minutes shall clearly document members in attendance, the REB's 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, the minutes are accessible to authorized representatives of the College, researchers and funding agencies.
ii. The REB will prepare and maintain adequate documentation of REB activities, including the following:
a. Copies of all research proposals reviewed, certificates of approval, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports by researchers and reports of injuries to subjects;
b. Records of continuing review activities;
c. Copies of all correspondence between the REB and the researchers;
d. A list of REB members; and
e. Written procedures for the REB.
iii. The required records will be retained for three years, and records relating to research that is conducted will be retained for at least three years after completion of the research.
D. Decision Making
i. The REB review shall be based upon fully detailed research proposals or, where applicable, progress reports. The REB will function impartially, provide a fair hearing to those involved and provide reasoned and appropriately documented opinions and decisions. The REB will accommodate reasonable requests from researchers to participate in discussions about their proposals, but not be present when the REB is making its decision. When the REB is considering a negative decision, it shall provide the researcher with all the reasons for doing so and give the researcher an opportunity to reply before making a final decision.
ii. Final decisions in the full review that are based on consensus or majority quorum (i.e. at least 4 members present) will be adopted only if the members attending the meeting possess the range and background outlined in the policy.
iii. The REB will notify the researchers in writing of its decision to:
a. Approve the proposed research activity as submitted; or
b. Require minor modifications of the proposed research activity. The resubmitted proposal will be reviewed by the Chair and the Vice Chair of the REB; or
c. Require significant modifications or additional information or major revisions. The resubmitted proposal will be reviewed by the REB; or
d. Disapprove the proposed research activity.
e. The REB will submit an annual report to Senior Management listing the number of proposals reviewed, approved and denied.
i. Researchers have the right to request, and the REB has the obligation to provide, reconsideration of decisions affecting a research project.
ii. The REB will be guided by principles of natural and procedural justice in their decision-making. Such principles include providing a reasonable opportunity to be heard, an explanation of the reasons for opinions or decisions, and the opportunity for rebuttal, fair and impartial judgment, and reasoned and written grounds for the decisions.
Researchers have the right to appeal a decision taken by the REB by submitting in writing their reasons to the Chair. Such appeals will then be submitted to the Research Ethics Board of the University of the Fraser Valley with which Douglas College has a formal agreement to perform this function. The decision of that Research Ethics Board shall be final.
G. Conflicts of Interest
i. If the REB is reviewing research in which a member of the REB has a personal interest in the research under review (e.g., as a researcher or as an entrepreneur), conflict of interest principles require that the member not be present when the REB is discussing or making its decision. The REB member may disclose and explain the conflict of interest and offer evidence to the REB provided the conflict is fully explained to the REB, and the proposer of the research has the right to hear the evidence and to offer a rebuttal.
ii. Disclosure of the conflict of interest will comply with the Douglas College Conflict of Interest Policy.