Terms of Reference for Research Ethics Board of Seneca College ...

Seneca Research Ethics Board
Terms of Reference
Adopted: 2012
I. Research Ethics Board Mandate
The Research Ethics Board (REB) is mandated by the President of Seneca College to approve,
reject, propose modifications to, or terminate any proposed or ongoing research involving
human participants based on their assessment of the compliance with this Ethics Policy and Tri-
Council standards of any research conducted under the auspices of the College as well as
research conducted on the premises of the College. This mandate includes ensuring that ethical
principles are applied to all research involving human subjects. The REB may be called upon to
serve as a consultative body on matters related to research ethics.
II.
Authority of the Research Ethics Board
The REB is a standing committee of the Office of Research & Innovation at Seneca College and is
mandated 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 the Tri-Council Policy, as a minimum standard.
The REB Terms of Reference are approved by the Dean of Applied Research & Scholarship at
Seneca College.
The Dean of Applied Research & Scholarship has the authority to appoint or dismiss REB
members upon the recommendation of the College Executive, Academic Deans, the REB
committee, and/or her/his own good judgement.
III.
Structure, Membership & Tenure of the Research Ethics Board
The REB shall consist of at least six (6) members appointed by the Dean of Applied Research &
Scholarship at the College upon recommendation by of the College Executive, Academic Deans,
the REB committee, and/or her/his own good judgement.
Of the minimum six (6) members of the REB; one (1) shall serve as Chair; one (1) member shall
serve as Vice-Chair; and one (1) member shall be an ‘external’ who has no affiliation with the
College, recruited from the community served by the institution
With the exception of the Chair, all members shall be responsible for reviewing, assessing, and
evaluating any proposed or ongoing research proposals submitted to the REB and rendering
their assessment of its compliance with Tri-Council Research Ethics Standards. REB Members
shall be responsible for conducting Full Board Reviews and Delegated Reviews (Expedited
Reviews), as deemed appropriate and allocated by the REB Chair
Members shall attend and participate in all meetings of the REB
Each Faculty at the College shall have at least one (1) representative as a member on the REB
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At least five (5) members shall be Seneca faculty members who possess a broad competency in
research ethics
No member shall be an Administrator at the College
Each member shall be appointed to a three year term, renewable up to a maximum of 2 terms.
The Committee will do its utmost to ensure responsible succession planning by staggering
member replacement in order to ensure a good representation of new and experienced
members.
The REB may, at its discretion, invite individuals with competence in special areas to assist in the
review of issues which require expertise beyond or in addition to that available on the REB.
These individuals may not vote with the REB.
As needed, the Dean may appoint additional voting members to the REB for three year term,
with expertise to balance the composition of the REB
All members of the REB are required to have completed the TCPS 2 CORE Tutorial and file their
CORE completion certificate with the Office of Research and Innovation at Seneca College.
With the exception of the Chair of the REB, all Seneca Faculty members on the REB shall be
compensated on their SWF in order that they may carry out their duties associated with the REB
The College shall ensure a staff support person is available to support the REB in its
administrative duties.
IV.
Chair of the REB
The REB Chair shall be responsible for the leadership and administration of the Research Ethics
Board; including circulating protocols to other REB members for review; deciding whether a
protocol requires delegated (expedited review) or full review; issuing requests for additional
information or revisions to applicants, attending and Chairing REB meetings, and other
administrative matters related to the operations of the REB
As necessary and appropriate, the Chair may also be involved in reviewing protocols.
The Chair shall be a Seneca Faculty member
V. Vice-Chair of the REB
The Vice-Chair shall assist the Chair in the execution of his/her duties and will replace the Chair
if she/he is temporarily or permanently unable to execute his/her duties.
The Vice-Chair shall be responsible for planning and scheduling meetings of the REB
The Vice-Chair shall be involved in reviewing protocols
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The Vice-Chair shall be a Seneca Faculty member
VI.
Procedures of the REB
Researchers shall submit their research proposals for REB review and approval to the REB Chair
prior to the start of recruitment of participants, access to data, or collection of human materials
The REB Chair shall use a proportionate approach to determine the appropriate level of REB
review by assessing the level of foreseeable risk to the participants; where the lower the level of
risk, the lower the level of scrutiny (delegated/expedited review); the higher the level of risk,
the higher the level of scrutiny (full board review)
Where Full REB review is determined, the REB Chair will circulate the research proposal to all
members of the REB for review and assessment; following which the REB shall normally meet
face to face to review and adjudicate the proposed research. Where a face to face meeting is
not possible or when exceptional or exigent circumstances limit the feasibility of face to face
deliberations, teleconferencing or use of other technologies may be regarded as necessary to
discharge this responsibility
Where Delegated/Expedited REB review is determined, the REB Chair shall delegate the protocol
for ethics review to one (1) or two (2) members of the REB according to his/her assessment of
the level of risk, complexities, and complications of the proposed research
Delegated REB reviewers shall be selected from the REB membership. Delegated reviewers may
refer projects back to the full REB if they determine that full board review is required. Where
delegates consider a negative decision, this decision shall be referred to the Full REB for further
review and endorsement before communicating the decision to the researcher
Research proposals will be considered as being eligible for Delegated/Expedited REB review by
the Chair when:
• The research projects must be no more than minimal risk; defined as: If potential
participants 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 research can be regarded as within the range of minimal risk.
• The research participants must be drawn from the general adult population, capable of
giving free and informed consent, and may not include vulnerable subjects such as
children, persons who are not legally competent to consent, mentally incompetent
persons, prisoners, legal wards or the therapeutically dependent.
• In general, the projects should not involve any highly personal, sensitive or incriminating
topics or questions which could place participants at risk or cause embarrassment.
• The projects must not manipulate behaviour of participants beyond the range of
“normal” classroom activity or daily life.
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• In general, the projects should not involve physically invasive contact with the research
participants.
• The projects should not withhold key information that could influence a participant’s
decision to participate in the research.
• The projects should not involve the kind of deception that had a participant known
about it in advance they likely would not have agreed to participate.
VII.
REB Decision Making
The REB shall function impartially, provide a fair hearing to the researchers involved, and
provide reasoned and appropriately documented opinions and decisions
The REB shall make decisions on the ethical acceptability of research in an efficient and timely
manner, and shall communicate all approvals and refusals to researchers in writing (print or
electronic means)
In the event that a minority within the REB membership considers a research project unethical,
an effort should be made to research consensus. In such cases, consultation with the researcher
and the Dean of Applied Research and Scholarship, external advice or further reflection should
be called upon. If disagreement persists, the majority position (50% + 1) will stand and the
minority position will be communicated to the researcher in writing
The REB's decision to approve or deny proposals for research or standardized testing shall be
made independently and may not be set aside by the College without formal appeal
VIII.
REB Meetings, Attendance, and Quorum
The REB shall have regular face to face meetings to discharge their responsibilities. The meeting
schedule shall be determined by the Chair and Vice-Chair in consultation with the REB
membership and shall occur at least once every two months. Where a face to face meeting is
not possible or when exceptional or exigent circumstances limit the feasibility of face to face
deliberations, teleconferencing or use of other technologies may be regarded as necessary to
discharge responsibilities
Quorum for meetings and Full REB reviews shall be 70% of the REB membership
Motions and decisions shall be carried with a majority; being 50% + 1 in agreement
IX.
REB Record Keeping
Minutes of all REB meetings shall be prepared and maintained by the REB, with assistance from
a staff support person appointed to the REB by the College
The minutes shall clearly document members in attendance, the REB's decisions and any
dissents, and the reasons for them
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In order to assist internal and external audits or research monitoring and to facilitate
reconsideration or appeals, the minutes shall be accessible to authorized representatives of the
College, researchers and funding agencies
The REB shall prepare and maintain adequate documentation of REB activities, including the
following:
• 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;
• Records of continuing review activities;
• Copies of all correspondence between the REB and the researchers;
• A list of REB members;
• Written procedures for the REB
The required records will be retained for three years, and records relating to research that is
conducted shall be retained for at least three years after completion of the research
X. Course-Based Student Research
Course based student 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 ethics review shall be undertaken by a non-REB Member Delegated
Reviewer from the student’s school, faculty, or department but NOT by the instructor teaching
the course.
Course based research is defined as minimal risk research that occurs within the context of a
specific course offering and that involves an assigned research activity, the key objective of
which is to allow students to learn about the research process. This includes class projects for
research methods courses as well as projects for any course that requires students to undertake
research that involves human subjects and protocols such as interviews, testing, observations,
video, or audiotape
XI.
Non-REB Delegated Reviewers of Course-Based Research
Non-REB Delegated Reviewers shall be appointed by their respective School Chair for Course-
Based Research protocol reviews
Non-REB Delegated Reviewers for Course-Based Research shall complete the TCPS 2 CORE
Tutorial and send their completion certificate to their Chair, the Dean of Applied Research and
Scholarship, and the Chair of the REB
Non-REB Delegated Reviewers for Course-Based Research shall be responsible for reviewing
and approving Course-Based Research protocols for their respective Schools
Non-REB Delegated Reviewers for Course-Based Research may receive SWF allocation to enable
them to execute these duties; as determined by their respective Chair, Dean, or supervisor
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XII.
Procedures for non-REB Delegated Review of Course-Based Student Research
Instructors and students shall submit their proposals for Course-Based Research review and
approval to the non-REB Delegated Reviewer of their respective School and their School Chair
prior to the commencement of their Course-Based Research activities. Commencement of
Course-Based Research activities is contingent upon approval by Non-REB Delegated Reviewer
assigned to the protocol
In cases of Course-Based Research, where the research questions and methodology will be
similar across all students in the class (general), a single ethics protocol submission form shall be
submitted for the Course to the non-REB Delegated Reviewer of their respective School as well
as their School Chair
In cases of Course-Based Research, where the research methodology, questions, or activities will
vary significantly with each student or student team (specific), then the instructor shall submit
an individual protocol for each set of activities (or student team) to the non-REB Delegated
Reviewer of their respective School as well as their School Chair
Where a single Course-Based ethics protocol (general) has been approved; this approval shall
stand for the Course for three (3) years under the condition that the research questions,
methodologies, and information gathering activities remain the same
Where multiple Course-Based ethics protocols (specific) have been approved for the same
course; this approval shall stand for the Course for three (3) years under the condition that the
research questions, methodologies, and information gathering activities remain the same
XIII.
Decision Making of Non-REB Delegated Reviewers of Course-Based Research
Non-REB Delegated Reviewers shall review, approve, reject, or propose modifications to any
proposal for Course-Based Research. These decisions will be based on their assessment of the
compliance of the protocol with this Ethics Policy and Tri-Council standards of any research
conducted under the auspices of the College
Non-REB Delegated Reviewers of Course Based Research shall function impartially, provide a fair
hearing to the researchers involved, and provide reasoned opinions and decisions
Non-REB Delegated Reviewers of Course Based Research shall make decisions on the ethical
acceptability of research in an efficient and timely manner, and shall communicate all approvals
and refusals to researchers (instructors and/or students) in writing, in print or electronic means
In the event that a Non-REB Delegated Reviewers of Course Based Research considers a project
unethical, the protocol shall be referred by the non-REB Reviewer to the Chair of the REB.
Non-REB Delegated Reviewers of Course Based Research may refer any protocol to the Chair of
the REB with good cause
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Decisions of non-REB Delegated Reviewers shall be made independently and may only be set
aside upon formal appeal by the applicant, the students, or the respective Chair or Dean to the
Chair of the REB
XIV.
Record Keeping of Non-REB Delegated Reviewers of Course-Based Research
Non-REB Delegated Reviewers shall send an electronic or print copy of their CORE completion
certificate to the Chair of their School, the Dean of Applied Research and Scholarship, and the
Chair of the REB
Non-REB Delegated Reviewers shall communicate to researchers in writing (print or electronic)
all decisions on the ethical acceptability of research in an efficient and timely manner
Non-REB Delegated Reviewers, in collaboration with their respective School Chairs, shall clearly
document and disseminate decisions, approvals, issues, reports of injuries, and TCPS CORE
certifications within the School to the Dean of Applied Research and Scholarship as well as the
Chair of the REB
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