Research Ethics Board

Mandate

It is the mandate of the REB to approve, reject, propose modifications to, or terminate any proposed or ongoing research involving human participants which is conducted within or by members of Grant MacEwan University.  The REB ensures that all research carried out by investigators meets the highest ethical standards as per the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2), and MacEwan University Policy C5052 - Ethical Review of Research with Human Participants.

Philosophy

The cardinal principle of modern research ethics is respect for human dignity. This principle aspires to protecting the multiple and interdependent interests of the person – from bodily to psychological to cultural integrity. This principle forms the basis of the ethical obligations in research.

1.0 Mandate

The MacEwan University Research Ethics Board (REB) has been established to approve, reject, propose modifications to, or terminate any proposed or ongoing research involving human participants which is conducted within or by members of Grant MacEwan University. The REB ensures that all research carried out by investigators meets the highest ethical standards as per the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2), December 2010 and MacEwan University Policy C5052: Ethical Review of Research with Human Participants.

2.0 Accountability

2.1 The REB is a standing committee of MacEwan University’s Academic Governance Council (AGC) and reports to the Associate Vice President, Academic and Research (AVPAR) as delegated by the Provost and Executive Vice President Academic (Provost/EVPA).

2.2 The Committee Chair will report annually on the committee’s activities to the AGC and submit recommendations as required for the AGC’s consideration.

2.3 The committee refers to the AVPAR any breaches of compliance with approved protocols and standard operating procedures (SOPs) or other standards of practice that cannot be corrected by the REB.

3.0 Functions and Responsibilities

3.1 To ensure that all human participant research protocols presented to the REB receive appropriate ethical review.

3.2 To monitor the ethical conduct of research by requiring researchers to report to the REB in a timely fashion:

3.2.1 any significant modifications (i.e., any modification that may lead to an increase in risk or a decrease in benefit) from the approved protocol, as well as any changes to the consent procedures in an approved protocol.

3.2.2 any adverse occurrences associated with their approved protocols.

3.3 To provide continuing review in the form of annual protocol renewals, as well as additional monitoring in specific cases as determined in an initial review.

3.4 To suspend or withdraw approval for any project that no longer complies with the approved research protocol or where the research ceases to be ethically acceptable.

3.5 To facilitate the education of members of the REB by ensuring that they are provided with a basic understanding of the principals involved in research ethics review and continuing education opportunities, as they become available.

3.6 To act as a resource to MacEwan University researchers on issues of ethics.

4.0 Committee Operations

4.1 Review Scope and Standards

4.1.1 The REB Shall:

4.1.1.1 Determine if it is the appropriate body to review the application and whether the application is within its jurisdiction or expertise.

4.1.1.2 Determine that the research is in compliance with MacEwan University Policy C5052: Ethical Review of Research with Human Participants and the TCPS 2.

4.2 Review Process

4.2.1 All protocols will undergo a preliminary review by the REB Chair to determine the appropriate level of review.

4.2.2 All decisions of the REB shall be reached by consensus whenever possible. If one or more members have a serious concern with respect to ethics, the matter is discussed further until resolution and/or the researcher is contacted for additional information. If an REB cannot achieve consensus, however, the decision shall be based on majority vote.

4.2.3 Procedures for reconsiderations and appeals are outlined in MacEwan University Policy C5052: Ethical Review of Research with Human Participants (4.11).

5.0 Composition

5.1 The REB shall consist of at least seven members, including both men and women, to be elected by the AGC:

5.1.1 At least six full-time University faculty members or academic staff
5.1.2 At least three members with expertise in relevant research disciplines, fields and methodologies covered by the REB
5.1.3 At least one member knowledgeable in ethics to guide the REB in identifying and addressing ethics issues
5.1.4 At least one member knowledgeable in the relevant law
5.1.5 For research involving students as participants, at least one member is a full-time student at the University

5.2 The REB shall consist of at least one member to be appointed by the AGC:

5.2.1 At least one community member who has no affiliation with MacEwan University.

5.3 The following members will be appointed from among current members by the AVPAR, in consultation with the exiting REB Chair:

5.3.1 The REB Chair

6.0 Terms of Appointment

6.1 Members will normally serve two (2) year terms, except for student members who may serve one (1) year terms. Terms may be renewed to a maximum of four (4) consecutive terms or eight (8) consecutive years of service.

6.2 Members wishing to serve on the REB after eight (8) consecutive years of service may reapply after a period of one (1) year after their membership has expired.

6.3 Membership will be staggered to ensure appropriate balance and to maintain continuity.

7.0 Meetings and Attendance

7.1 Frequency of Meetings

7.1.1 The REB shall meet face-to-face approximately monthly between the months of September and June. Dates are established once a year and are made available to the University community.

7.2 Quorum

7.2.1 Quorum for a meeting will consist of not fewer than five (5) members which comprise:

7.2.1.1 Two members that have expertise in relevant research disciplines, fields and methodologies
7.2.1.2 One member knowledgeable in ethics
7.2.1.3 One community representative
7.2.1.4 The REB Chair or Vice-Chair
7.2.1.5 One member knowledgeable in the relevant law (for biomedical research)
7.2.1.6 One student member (for research involving students)

7.2.2 In unexpected circumstances, or if REB members are geographically dispersed, input from members may be allowed by other technological means, such as telephone or video link.

7.3 Attendance

7.3.1 REB members will be required to attend at least seven (7) out of the ten (10) regular monthly meetings.

7.3.2 Members who fail to attend the required number of meetings will be reported to the AVPAR.


Approved by Academic Governance Council
September 18, 2012 (Motion AGC-05-09-18-2012)