• Mandate and Authority of the REB
• Membership of the REB
• Meeting Dates & Deadlines for REB Applications
• Research Requiring Ethics Review
• Research Not Requiring Ethics Review
• Undergraduate Course-related Research
• Expedited Review
• Definition of minimal risk of harm
• Decision-making Policies
• Appeals
• Review Procedures for on-going Projects and Research in Other Jurisdictions
• Informed Consent and Competence
• Research in Emergency Health Situations

Authority of the REB

Mount Allison University endorses the ethical principles cited in the TCPS and has mandated its REB to ensure that all research investigations involving human participants are in compliance with the TCPS. The Mount Allison University REB has jurisdiction over all research involving human participants. The REB has the authority to approve, reject, propose modifications to, or terminate any proposed or ongoing research involving human participants which is conducted within, or by members of, Mount Allison University, using the considerations set forth in the TCPS as the minimum standard.

In accordance with Article 1.6 of the TCPS, the REB will adopt a proportionate approach based on the general principle that the more invasive the research, the greater should be the care in assessing the research. The concept of proportionate review gives practical expression to the general principle that, especially in the context of limited resources, the more potentially invasive or harmful is the proposed and ongoing research, the greater should be the care in its review. A proportionate approach implies different levels of REB review for different research proposals. The different levels are: full REB review, expedited REB review, and departmental level review of undergraduate projects carried out within formal course requirements.

The TCPS requires each institution to establish an independent Research Ethics Board (REB) to help ensure that ethical principles are applied to all research involving human participants. REB members normally serve for three year terms. At Mount Allison University, the REB consists of seven members, including both men and women, of whom:

• at least two members have broad expertise in the methods or in the areas of research that are covered by the REB; at least one member is knowledgeable in ethics, so as to alert the REB to potential ethical issues and options
• at least one member has no affiliation with the institution, but is recruited by the institution from the community served by the institution.

The Research Ethics Board (REB) at Mount Allison University

Conflicts of Interest

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 decisions. In cases of disagreement over conflicts of interest, both the REB member in alleged conflict and the researcher may present evidence and offer a rebuttal concerning the nature of the conflict of interest. The other members of the REB should make a final decision regarding how to proceed.

The REB will meet monthly to review all protocols requiring the participation of human participants. The REB will require a quorum of at least two thirds of its members at all meetings concerned with the ethical approval of research proposals. Minutes of all REB meetings shall be prepared and maintained by the REB. An annual activity report from the REB will be made to the the Vice-President of Academic and Research.

Scheduled Meetings for REB

Please note that applications received five days before scheduled meetings are quaranteed consideration. Applications received later than 5 days before scheduled meeting will be reviewed at subsequent meeting unless they meet the requirement for expedited review.

The TCPS defines "research" as any "systematic investigation to establish facts, principles or generalizable knowledge." In accordance with the TCPS, the following types of research require ethics review and approval from the Mount Allison University REB before the research is started:

• Research posing more than minimal risk,
• Research by undergraduate students as part of a faculty member’s research program,
• Undergraduate thesis research.

An annual report will be delivered to the Chair of the REB at the end of the academic year, giving details of the review procedures used and listing all research projects approved during the previous twelve months.

Forms for Department Level Review of undergraduate research within course requirements are available in the FORMS section of this document, or from department heads.

• research which obviously involves no more than minimal risk of harm to the participants. The researcher is responsible for an acknowledgment of minimal risk to the REB; and
• research projects which have already received approval by the Mount Allison University REB and the applicant is simply requesting approval of minor modifications to a previously approved project.

The TCPS defines the standard of minimal risk of harm 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 risk can be regarded as within the range of minimal risk.”

The REB will meet face-to-face to review proposed research that is not delegated to expedited or department level review. REB review will 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 heir proposals, but not be present when the REB is making its decision. When the REB is considering a negative decision, it will provide the researcher with all the reasons for doing so and give the researcher an opportunity to reply before making a final decision.

Researchers have the right to request, and the REB has an obligation to provide, reconsideration of decisions affecting a research project.

In cases when researchers and the REB can not reach agreement through discussion and reconsideration, an institution should permit review of an REB decision by an appeal board.

Scholarly Review as Part of Ethics Review

In accordance with Article 1.5 of the Tri-Council Policy Statement:

1. the REB will satisfy itself that the design of a research project that poses more than minimal risk is capable of addressing the question(s) being asked in the research;
2. 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;
3. research in the humanities and the social sciences which poses, at most, minimal risk shall not normally be required by the REB to be peer reviewed; and
4. certain types of research, particularly in the social sciences and 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.

In evaluating the merit and scholarly standards of a research proposal, the REB will be concerned with a global assessment of the degree to which the research might further the understanding of a phenomenon. The primary tests to be used are ethical integrity and high scientific and scholarly standards.

Appeals

The TCPS requires that appeals of REB decisions be heard by an appeal board that meets the requirements of the Policy. The TCPS allows appeals to be heard by an REB from another institution provided the other institution is itself fully compliant with the TCPS and provided a formal written agreement between the institutions is in place. What follows is a Letter of Agreement between Mount Allison University and the University of Prince Edward Island, whereby the REB of each institution will serve as an appeal board for the other.

Terms of Reference for REB Appeals

The TCPS requires that an institution’s REB be responsible for reviewing research involving human subjects and issuing an Ethics Certificate or equivalent letter which approves the work if the guidelines for such work described in the TCPS are met. As indicated in Article 1.10 of the TCPS, in the case of a negative decision of the REB, researchers have the right to request, and REB’s have an obligation to provide, reconsideration of the decision. Appeals of REB decisions will be considered after this process is complete. Appeals of REB decisions will only be considered on procedural grounds or when there is significant disagreement over an interpretation of the TCPS.

Mechanism

In the case of a negative decision by the REB at either University, its Chair will notify its own senior administrative officer (SAO) responsible for the REB. The appeal process will be initiated when the researchers whose work the decision affects sends a request for appeal in writing to their own SAO within 30 days of receiving the final decision from the REB.

The letter of appeal shall include a copy of the original submission to the REB from the researcher(s), copies of the relevant decisions from the REB (including a written record of the REB’s decision upon reconsideration of the original decision), the reasons for the appeal, and a statement of the desired outcome.

Upon receiving the appeal, the senior administrative officer responsible for the REB will forward the request to the SAO of the appeal board’s institution along with the documentation included in the appeal mentioned above, who will then pass the information to their own REB. The appeal will be heard and a decision made by the appeal board within three (3) weeks of receiving all the relevant information. This decision will only be released to the appeal board’s SAO, who will then make the decision known to her or his counterpart at the institution where the appeal originated.

In keeping with the Section B1, Article 1.2 of the TCPS which stipulates “Institutions may refuse to allow certain research within its jurisdiction, even though the REB has found it ethically acceptable” the SAO of the appealing researcher’s own institution will then decide whether or not to ratify the appeal board’s decision. Such ratification is required before the research can proceed. The SAO will then make the decision known to both the Chair of the local REB and the researcher, in writing, including an explanation for the research not being ratified, should this occur.

• ongoing research shall be subjected to continuing ethics review. The rigour of the review will be in accordance with a proportionate approach to ethics assessment;
• as part of each research proposal submitted for REB review, the researcher will propose to the REB the continuing review process deemed appropriate for that project; and
• normally, continuing review shall consist of at least the submission of a succinct annual status report to the REB. The REB will be promptly notified when the project concludes.

In accordance with the principle of proportionate review, research that exposes participants to minimal risk or less requires only a minimal review process.

Review of Research in Other Jurisdictions or Countries

• by the REB within the researcher’s institution; and
• by the REB, where such exists, with the legal responsibility and equivalent ethical and procedural safeguards in the country or jurisdiction where research is to be done.

Free and Informed Consent

Section 2 of the TCPS describes the procedures for free and informed consent. Researchers should explain the nature of the research to participants before they take part in the study, and document their consent to participate (see Article 2.1 of the TCPS and, subject to the exception in Article 2.1 (c), Article 2.4 of the TCPS). Whenever possible and appropriate, researchers should explain to the participants, at the end of the study, the purpose of the study and exactly what transpired. In accordance with Article 2.2 of the TCPS, participants must be informed that they are free to with draw from the study at any time without prejudice.

• the research question can only be addressed using individuals within the identified group(s); and
• free and informed consent will be sought from their authorized representative(s); and
• the research does not expose them to more than minimal risks without he potential for direct benefits for them.

In accordance with Article 2.6 of the TCPS, for research involving incompetent individuals, the REB shall ensure that, as a minimum, the following conditions are met:

• the researcher shall show how the free and informed consent will be sought from the authorized third party, and how the subject’s best interests will be protected.
• the authorized third party may not be the researcher or any other member of the research team.
• the continued free and informed consent of an appropriately authorized third party will be required to continue the participation of a legally incompetent subject in research, so long as the subject remains incompetent.
• when a subject who was entered into a research project through third-party authorization becomes competent during the project, his or her informed consent shall be sought as a condition of continuing participation.

Finally, in accordance with Article 2.7 of the TCPS, where free and informed consent has been obtained from an authorized third party, and in those circumstances where the legally incompetent individual understands the nature and consequences of the research, the researcher shall seek to ascertain the wishes of the individual concerning participation. The potential subject’s dissent will preclude his or her participation.

Research in Emergency Health Situations

The REB may allow research that involves health emergencies to be carried out without the free and informed consent of the participants or of his or her authorized third party if ALL of the following apply:

• a serious threat to the prospective participant requires immediate intervention; and
• either no standard efficacious care exists or the research offers a real possibility of direct benefit to the participant in comparison with standard care; and
• either the risk of harm is not greater than that involved in standard efficacious care, or it is clearly justified by the direct benefits to the participant; and
• the prospective participant is unconscious or lacks capacity to understand risks, methods and purposes of the research; and
• third-party authorization cannot be secured in sufficient time, despite diligent and documented efforts to do so; and
• no relevant prior directive by the subject is known to exist.

When a previously incapacitated participant regains capacity, or when an authorized third party is found, free and informed consent shall be sought promptly for continuation in the project and for subsequent examinations or tests related to the study.