S.O1-55
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SIMON FRASER UNIVERSITY
University
MEMORANDUM
Secretariat
?
?
Cl
rot
0
To: ?
Senate
From: ?
Alison Watt, Director, University Secretariat
Subject: ?
Research
Ethics Policy
Date: ?
20 June, 2001
The University has had a Research Ethics Policy R 20.01 in place for many years.
In 1998, NSERC, SSHRC and MRC (now Cil-IR) developed the Tr-Council Policy
Statement: Ethical Conduct for Research Involving Humans. The Tr-Councils
indicated that universities needed to develop policies consistent with this policy
statement in order to be eligible for continued federal research grants. SFU's
policy revision followed these steps:
October 1998
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President's Task Force for Revision of the Research Ethics Policy
was established
January 2000
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President's Task Force for Revision of the Research Ethics Policy
• ?
forwarded a draft revision of the policy
February 2000
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Discussion at Senate with a decision that the Task Force's report
should be referred to an ad hoc committee.
February 2000 ?
Ad hoc committee established and started work
January 2001 ?
New revision circulated
January 2001
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Open meeting to discuss the revision, followed by further
revisions.
March 2001
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Senate discussed proposed revision and comments were referred
to the committee
June 2001
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Final revision circulated to University community
Motion
That Senate approve and recommend to the Board of Governors the
attached Policies and Procedures for Ethics Review of Research
Involving Human Subjects - June 5, 2001
0
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Attachment
POLICY AND PROCEDURES
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FOR
ETHICS REVIEW OF RESEARCH INVOLVING
?
HUMAN SUBJECTS
June 5th, 2001
Preamble:
Simon Fraser University is committed to ensuring the highest Level of ethical conduct for
research involving human subjects and to following the guidelines outlined in the Tn-Council
Policy Statement,
Ethical Conduct for Research Involving Humans,
(the TCPS).
University researchers enjoy special freedoms and privileges, which include freedom of
inquiry and the right to disseminate the results thereof, freedom to challenge conventional
thoughts, freedom from institutional censorship, and the privilege of conducting research on
human subjects with the trust and support of the general public, often with public funding.
With these freedoms come responsibilities to ensure that research involving human subjects
meets high scholarly and ethical standards, is honest and thoughtful inquiry, involves
rigorous analysis and complies with professional and disciplinary standards and
methodological approaches. Review of research proposals by a Research Ethics Board takes
into account these freedoms and responsibilities and provides accountability and quality
assurance both to colleagues and to society.
Policy:
This Policy provides a mechanism for ethics review of research involving human subjects to
protect those subjects, researchers, support staff, students, and third parties, and to
educate those involved in this type of research. Its procedures are consistent with the
educational and research mandates of Simon Fraser University and respect the academic
freedom and responsibilities of faculty members and the principle of informed consent with
respect to potential subjects. No more than three years after the implementation of this
Policy, and no more than every five years thereafter, Senate will undertake a review of the
Policy and Procedures for Ethics Review of Research Involving Human Subjects, and make
amendments should they be deemed necessary.
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1. ?
Requirement for Ethics Review
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1.1
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Ali research involving living human subjects, conducted by any employee or student of
Simon Fraser University, requires review and approval by the Research Ethics Board
before research is started, except as stipulated in 1.6, 1.7 and
1.8
below.
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1.2 ?
Research involving human remains, cadavers, tissues, biological fluids, embryos, or
foetuses must be reviewed by the Research Ethics Board.
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1.3 ?
Research involving living human subjects occurs when data are derived from:
a)
information that is collected through intervention or interaction with a living
individual (e.g., interviews, questionnaires, observations taken that are
noticeable by the individual),
b)
secondary sources/non-public sources (e.g., interviews about a living
individual, company personnel records, student records collected by an
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educational institution),
C)
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identifiable private information about a living individual.
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Page 1 of 8 -
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1.4 ?
Research about a Living individual, based exclusively on publicly available information,
documents, records, works, performances, actuarial materials, or third party
interviews, is not required to undergo research ethics review. However, such
research requires ethics review if the subject is approached directly for interviews
or for access to private papers.
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1.5 ?
ALL course-based research assignments involving Living human subjects require ethics
review and approval (see section 6.3).
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1.6 ?
Certain classes of research involving human subjects are excluded from the
requirement of ethics reviewj b
4-La.
?esez.c%,
E4sc q
, acrd
ax
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%-1.
a)
research conducted by a member of the academic staff as an
Outside
Pro
f essional
Activity (see A30.04),
or by other employees or students, as
long as the research data are not collected by asserting connection or
affiliation with Simon Fraser University, and the results are not disseminated
in the public domain indicating association with Simon Fraser University, and
the research is not conducted at Simon Fraser University or using Simon
Fraser University resources,
b)
research undertaken by students outside the auspices of Simon Fraser
University and/or its academic programs (e.g., students on co-op or work
terms outside the University) that does not require Simon Fraser University
resources and is not directly supervised by Simon Fraser University faculty,
C) ?
research on ancient unidentifiable human remains.
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1.7
?
Quality assurance studies, performance reviews or testing within normal educational
requirements are not subject to Research Ethics Board review unless there is an
element of research in addition to the assessment.
1.8 Research on public policy issues, public institutions, and other matters that in a free
and democratic society can properly be considered as part of the public domain is not
required to undergo ethics review, even when interviews with individuals occupying
positions connected to such matters are involved.
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1.9
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The opinion of the Director of the Office of Research Ethics should be sought
whenever there is doubt whether or not a particular research project requires ethics
review.
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2. ?
Researchers' Procedural Responsibilities
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2.1
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In supervised research, the term "researcher" is defined as including both the
supervisor and the individual(s) being supervised.
2.2 It is the responsibility of researchers to obtain ethical approval as described in this
policy for any project, funded or not, involving human subjects before commencing
the research.
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2.3 ?
It is the responsibility of researchers to ensure that there is adequate lead time
available for ethical review in relation to other deadlines.
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2.4
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Project funds will not be released by the University to the project principals until
ethics approval for the project has been obtained and a copy of the approval is on file
in the Office of Research Ethics.
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Page 2 of 8 -
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3.
Research Ethics Board
3.1
The Research Ethics Board is a committee of Senate. It is responsible for the timeLy
review of all research protocols or projects covered by this Policy to ensure that
they meet acceptable ethical standards.
3.2
The Research Ethics Board has the authority to approve a protocol or project,
approve a protocol or project subject to modifications, or reject a protocol or
project. In the tatter two cases, detailed written reasons wilt be provided to assist
researchers in the preparation of revised applications for ethics approval.
3.3
The Research Ethics Board has the responsibility to monitor on-going research and to
terminate any project that does not conform to ethical standards.
3.4
The Research Ethics Board is responsible for responding to inquiries from external
agencies with responsibility to monitor ethics review procedures at universities.
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3.5
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The Research Ethics Board is responsible for ensuring that the research community at
Simon Fraser University is aware of the principles and practices of ethical conduct of
research and for publicizing issues that will lead to changes in its current review
process.
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3.6 ?
The Research Ethics Board provides an annual report of its activities in the previous
year to Senate at its September meeting.
3.7 There are twelve voting members of the Research Ethics Board plus the Director of
40 ?
the Office of Research Ethics who wilt be
ex
officio
non-voting and will serve as
secretary. Membership qualifications shalt comply with the specifications of Article
1.3 of the TCPS. The specific membership and the terms of members will be as follows'
a)
six faculty members elected by faculty, with one from each of the Faculties of
Applied Sciences, Business Administration, Education, and Science, and two
from the Faculty of Arts,
b)
three members to be elected by Senate, from the university community at
Large (these may include faculty and staff),
C) ?
one student member to be elected by Senate,
d)
two members elected by Senate, from the community outside of the university,
e)
the term of office for voting members of the Research Ethics Board will be
three years except for the student member who may serve for a one or two
year term. No more than two consecutive terms wilt be allowed.
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3.8
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Prior to serving, all members of the Research Ethics Board wilt attend a workshop or
orientation session, organized by the Director of the Office of Research Ethics, to
ensure that they have an understanding of the principles and practices of ethical
review.
3.9 On an annual basis, the Research Ethics Board will elect a Chair and a Deputy Chair
who will act in the absence of the Chair. These persons will be faculty members of
Simon Fraser University who have served on the Research Ethics Board previously,
normally for at least two years.
3.10 The Research Ethics Board will normally meet at Least once per month with no more
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than six weeks between meetings, unless there is no business to transact.
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3.11 A quorum of the Research Ethics Board for meetings at which applications involving
non-minimal risk will be considered, is the Chair or Deputy Chair plus six of the voting
members (i.e., seven in total).
3.12 The Research Ethics Board has the authority to establish its own procedures and to
make recommendations to Senate for revisions to the Policy.
4.
Research Ethics Appeal Board
4.1 ?
Researchers have the right to request, and the Research Ethics Board has an
obligation to provide, a reconsideration of a negative decision. Researchers may
appeal decisions of the Research Ethics Board to the Research Ethics Appeal Board
within 15 working days.
4.2 ?
The Research Ethics Appeal Board will be the University of Victoria's Human Research
Ethics Committee (HREC). The decisions of the HREC shall be final and binding in all
respects for any appeal lodged against a decision of the Research Ethics Board.
4.3 ?
Appeals may only be heard on the basis of a procedural error that materially and
adversely influenced the decision of the Research Ethics Board, including real or
reasonably apprehended bias, including epistemological bias, or undeclared conflict-
of-interest on the part of one or more members of the Research Ethics Board. The
Research Ethics Appeal Board will first determine whether a procedural error, bias or
a conflict of interest (as described above) occurred, and if so, theResearch Ethics
Appeal Board would then proceed to hear the case and make a final determination on
the research proposal.
5.
Director of the Office of Research Ethics
5.1 ?
The Director of the Office of Research Ethics reports to the Vice-President
(Research).
5.2 ?
The appointment of the Director of the Office of Research Ethics will be made by the
Vice-President (Research) after receiving advice from a search committee comprising
the Research Ethics Board. The Director of the Office of Research Ethics will have
experience in research involving human subjects and will hold a doctoral degree.
5.3 ?
The duties and responsibilities of the Director of the Office of Research Ethics
include, but are not limited to:
a)
being responsible for research ethics education programs at Simon Fraser
University in conjunction with the Research Ethics Board,
b)
assisting researchers in the preparation of applications for submission to the
Research Ethics Board,
C) ?
reviewing all applications submitted to the Research Ethics Board for the
completeness of these applications and their compliance with this Policy,
d)
advising the Research Ethics Board with respect to the category of risk (i.e.,
minimal, in-coursestudent, or non-minimal) of an application,
e)
approving minimal risk applications, and providing summaries of such approvals
to the Research Ethics Board,
f)
acting in an
ex
officio non-voting capacity as Secretary to the Research Ethics
Board
g i ?
managing the Office of Research Ethics,
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Page 4 of 8 -
h)
undertaking other duties assigned by the Research Ethics Board, such as
monitoring, data collection, and communication with other universities and
granting councils.
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6. ?
Review Process
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6.1 ?
Applications to the Research Ethics Board may be placed in one of three categories by
the Director of the Office of Research Ethics. These categories are:
a)
minimal risk;
which occurs when potential subjects can reasonably be
expected to regard the probability and magnitude of possible harms incurred
by participating 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,
b)
in-course student;
which applies to undergraduate and graduate courses that
require or allow students to participate in research projects as part of the
training or for assessment,
C) ?
non-minimal risk;
which includes applications not covered by a) and b)
above.
All studies designed to determine the consequences for individuals and communities of
specific preventative or therapeutic measures and/or invasive procedures, and
studies concerning human health-related behaviour and/or experiences in a variety
of circumstances and environments are considered non-minimal risk.
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6.2 ?
An application that is categorized by the Director of the Office of Research Ethics as
minimal risk will be reviewed by the Director. If the Director is satisfied that the
S
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?
application meets the standards established in this policy, the Director shall approve
the application on behalf of the Research Ethics Board. If the Director is not satisfied
that the application meets the standards of this policy, the application may be
returned to the applicant for revisions, or forwarded to the Board for consideration.
If forwarded to the Board, the Chair or Deputy Chair has the authority to grant
approval for minimal risk proposals without a meeting of the Research Ethics Board, or
to refer it to the next meeting of the Research Ethics Board. Summaries of all
approvals by the Director, Chair or Deputy Chair will be brought to the next regular
meeting of the Board. The Board may review and amend any decisions made
independently by the Director, Chair or Deputy Chair.
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6.3 ?
A department wishing to offer an undergraduate or graduate course that requires or
allows students to participate in research projects involving human subjects will
submit to the Director of the Office of Research Ethics:
a)
a description of the course,
b)
the course outline,
C) ?
a general description of the type(s) of research projects that are Likely to be
part of the course,
d)
the means by which the students in the course are made familiar with
appropriate ethical standards, with copies of printed materials,
e)
the means by which students submit their research plans to the instructor(s),
f)
the means by which those plans are assessed and approved by the
instructor(s),
g)
the means by which the conduct of the in-course student research projects is
monitored,
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h) ?
and other relevant information.
When the Director of the Office of Research Ethics is satisfied that this course poses
only minimal risk to research subjects and student participants and otherwise meets
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Page
5
of 8 -
the standards established in this policy, she/he will grant approval for the course to
be designated as a "Research Ethics Board approved course". A summary of such
approvals will be forwarded to a regular meeting of the Research Ethics Board. This
designation will remain with the course as Long as the course description and the
general method of teaching the course do not change (i.e., there is no need for the
course to be approved each time it is offered if it does not change).
If approval is not given, the application will be returned to the department with an
explanation and appropriate suggestions. In order for a course to be offered as a
designated "Research Ethics Board approved course", the instructor of the course
must sign a statement to the effect that he/she undertakes to include ethical issues
related to the research projects in the subject matter of the course. The instructor
will also take all reasonable efforts to ensure that his/her students comply with the
terms of the approval in carrying out the research. If the instructor deems a
research project to involve an element of greater than minimal risk, it is the
responsibility of the instructor to ensure that the project be changed to conform
with minimal risk or to be submitted to the Research Ethics Board for full review.
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6.4 ?
Research proposals designated non-minimal risk must be reviewed for scholarly merit.
Scholarly merit involves a global assessment of the degree to which the research
might further the understanding of the phenomenon being studied. The primary test
of scholarly merit is the application of scholarly standards and methodological
approaches appropriate to the discipline(s) of the researcher(s). Proposed research
that has been submitted to a recognized granting agency (e.g., SSHRC, CIHR, NSERC)
for funding under peer review will be considered to have scholarly merit if the work is
funded. Projects that are not approved for funding through peer review must be
reviewed locally for scholarly merit before submission to the Research Ethics Board. A
description of the project will be sent to two qualified reviewers by the Director of
the Office of Research Ethics. One reviewer will be chosen by the applicant(s) and
the other by the Chair or Deputy Chair of the Research Ethics Board in consultation
with members of the Research Ethics Board who have experience in the discipline of
the applicant(s) or the project. If the decision of the two reviewers is not
unanimous, the Chair of the Research Ethics Board wilt consider the views of the two
reviewers and cast the deciding vote.
6.5 When a project has been determined to have scholarly merit, it will be reviewed by
the Research Ethics Board. Normal outcomes of the review process are:
a)
when a majority of the Research Ethics Board votes to approve the research
protocol, approval will be granted and the research may be initiated,
b)
when the Research Ethics Board identifies problems such that ethical approval
cannot be granted, the problems will be communicated to the applicant(s) in
writing,
C) ?
when a majority of the Research Ethics Board does not vote to approve the
research protocol, and attempts to address ethical problems have been
unsuccessful, the Chair or Deputy Chair will disallow the research on ethical
grounds.
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7.
?
Risk Analysis
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7.1
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Researchers should assess
all
reasonably foreseeable risks involved in, and benefits
expected to arise from research projects. Researchers involved in greater than
minimal risk research projects should be prepared to document reasonably
foreseeable risks and benefits.
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Page 6 of 8 -
p
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7.2 ?
Researchers should employ methods that avoid or reduce possible risks, and maximize?
benefits in keeping with disciplinary and epistemological norms and standards.
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7.3 ?
Researchers should consider possibilities that exist with respect to possible:
a)
physical harm,
b)
psychological harm,
C)
?
injury to reputation or privacy,
d) ?
breach of any relevant law.
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7.4 ?
Researchers should consider not only the likelihood of a given risk, but also
parameters such as its duration and the likely reversibility of its impact should it
materialize.
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7.5 ?
Benefits include specific advantages to subjects, to third parties, or to society or a
segment thereof, and any general increase in human knowledge. Benefits may arise
from advantages or increases in knowledge that are actively sought by the
researcher or as by-products of the research (e.g., serendipitous events).
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7.6 ?
In projects involving more than minimal risk it is the responsibility of both
researchers and the Research Ethics Board to balance risks and benefits. Projected
benefits should outweigh reasonably foreseeable risks. With regard to non-minimal
risk, the more incalculable the risks or the less tangible the benefits, the more
cautious must researchers and the Research Ethics Board be.
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7.7 ?
The Research Ethics Board should be satisfied that the research design and proposed
implementation procedures are consistent with sound research standards and with
accepted standards of disciplinary conduct and practice.
7.8 The Research Ethics Board must always be conscious of the importance of academic
freedom for researchers, particularly where risks are the subject of informed
consent, or will devolve upon the researchers personalty. Nothing in this section is
intended to diminish researchers' rights to engage in critical inquiry and disseminate
that information, even though analysis of this sort of might be considered "harmful"
to the interests involved.
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8. ?
Informed Consent
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8.1 ?
A mandatory condition of approval from the Research Ethics Board is that subjects,
or authorized third parties, have given informed consent about participation in the
research. Normally, all communication with research subjects will be in writing, unless
circumstances of the research prevent this. The Research Ethics Board must
approve methods of communication which are not in written form.
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8.2 ?
Normally, researchers must provide the following information to subjects or
authorized third parties:
a)
information that the subject is being invited to participate in a research
project,
b)
an understandable description of the research, the identity and institutional
affiliation of the researcher, contact information, the duration, the nature of
participation, and a description of research procedures,
• ?
c) ?
an understandable description of reasonably foreseeable harms and benefits
that may result from participation as a research subject; in research which
involves treatment procedures, this description must include an assessment of
potential harms and benefits of not undertaking the treatment,
- Page 7 of 8 -
d)
an assurance that subjects are free to avoid participation or to withdraw
from participation at any time,
e)
an understandable description of the type(s) of data to be collected, the
method(s) of data collection (e.g. interview, video recording), the purpose(s)
for which the data will be used, and Limits on the use, disclosure and retention
of data,
f)
anticipated secondary uses of identifiable data collected during the research,
and anticipated Linkages of data with other data about research subjects,
g)
methods for data archiving, and provisions for ensuring security and
confidentiality of data.
8.3
?
Individuals who are not Legally competent may be asked to become research subjects
only if all the following conditions are satisfied:
a)
the research requires the participation of individuals who are not Legally
competent (e.g., studies of children),
b)
free and informed consent will be obtained from authorized representatives,
following procedures outlined under 8.2a through 8.2g (above),
C) ?
research is in the "minimal risk" category, or has the potential to provide
distinct benefits to the research subjects,
d)
the researcher can show how the subjects' best interest will be protected,
e)
the same provisions defined in 8.2a through 8.2g (above) will be extended to
the research subjects, should they become legally competent during the
course of the research,
f)
provision must be made for subjects who are legally incompetent to express
their opinions about participation in the research; dissent on the part of a
research subject must preclude further participation in the research,
regardless of his/her legal competency.
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Page 8 of 8 -
.
FILE No. 314 07/09 '01 08:30 ID:PRESIDENTS' OFFICE SFU
?
604 2914860
Resaa
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and
of
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July 6, 2001
PAGE 2
Pdc1e
r
du
fr'
Dr. Bruce P. Clayman
Vice-Presjdezit Research
Simon Fraser University
BURNABYECV5A 1S6
Fax: (604) 291-4860
Dear Dr. Clayman:
Thank you for sending us
the
revised policy governing
the ethics review of research
presented
involving humans
to Senate
at
for
Simon
approval
Fraser
on
University
July 9
,
2001,
(SFU), which we understand
Will
be
account
Statement
The
of
the
revised
federal
in future
Ethical
SFIT
fun'ling
revisions
policy
Conductfor
Ag
meets
e
of
ncies.
the
the
Aesea,ch
SFU
Enclosed
general
policy.
In
requirements
arc
You
Someobservations
ing Humaj&s
of the
(TCPS)
Tn-Council
that
and
could
the
Policy
be
expectations
taken into
The federal tliMing Agencies are conunrned to promoting research that is ethically
sound, and intend to continue to work closely with research institutions on this matter.
Sincerely,
Thérôse
Do Orooto
Policy Analyst
C.C. ?
C1MRjt
C.C.
NSERCAimMe MoteftJi
Enclosure
50 ALBERT
STREET
?
350. RUE
ALBERT
OTTAWA
P0
BOX 1810
ON
KIP
STN
604
B
??
OTTAWA
CP 1810 SUCC
ON KIP
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604
?
www.&? m.c* ?
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FILE No. 314 07/09 '01 08:30 ID:PRESIDENTS' OFFICE SFU
?
604 2914860
?
PAGE 3
SIMON FRASER UNIVERSITY
?
July
7,
2001
?
C
ETHICS REVIEW OF RESEARCH INVOLVING HUMANS
The following comments are based on the revised "Policy and Procedures for Ethics
Review of Research Involving Human Subjects" dated
June 1, 2001,
The policies and procedures for ethics review meet
the
federal funding Agencies'
requirements
described in Section 1 and 2 of the
Tri.Cowwil Policy Statement: Ethical
Conduct for Research hivolving Humans (TCPS).
Some of the comments that were provided on an earlier version (see below) have not
been addressed by
the
institution, but could be taken into account in future revisions:
Article
Couuiwnt
of TC?S
1.1
SFtJ Policy 16 c) exempts research on ancient unidentifiable human
remains
from ethics review. Following the advice of the Tr-Council Advisory Group
on this matter (ref.
our letter
of
March 29, 2001), researchers should
seek the
R.EB's
opinion on whether ethics review is required for a particular project.
e.g.. in accordance with SPU Policy 1.9.
1.1
SPU Policy 1.8 specifics that research on public policy issues and public
institutions, among other matters
In
the public domain,
is
not required
to
undergo
ethics
review,
even when
it
involves interviewing individuals.
However, TCPS Article 1.1 c) requires research to undergo ethics review if any
person is approached directly for interviews or access to private papers.
Individuals who are approached to participate in a
research project about their
organisation, whether a corporation or a
government, have a right to give free
and informed Consent
(see
also discussion on TCPS pages 2.2 and 2.4). The
purpose of the ethics review for such research is only to ensure that the
interviews
are
conducted according to professional protocols.
1.7
SFTJ Policy 3.11 defines aquoruni as the Chair (or Deputy Chair) plus six of
the voting members. Thc quorum rule should also take into account the
range
of expertise and background stipulated in Article 13: members present should
have expertise in the methods or areas of research; knowledge in ethics; include
a representative of the community who has no affiliation with the institution;
and for biomedical research 1
knowledge in the relevant law.
1.11
The
agreement with the University of Victoria to have their REB
serve
as
SPU's
appeal
committee
(ref. SPU Policy 4.2) should be documented.
1.12
SFU Policy 4.3 makes reference to "undeclared conflict-of-interest on the part
of one or
more members
of
the
Research
Ethics Board",
It
would
be useful to
clarify what constitutes a conflict of interest for an R.EB member.
Alternatively,
if
guidc1icR on
conflicts
of
interest are described
in
another institutional policy,
it could be a cross-referenced.
1.14
The SPU Policy could
address the requirements for multi-centred research and
research that is conducted outside the jurisdiction or country of the institution.
0.
