S
Simon Fraser University ?
Memorandum
To: ?
Senate
From:
?
Alison Watt, Secretary
Senate Committee on Agenda and Rules
Date: ?
May 3, 2006
Subject: ?
Policy Revision:
R20.01 -
Research Ethics Review Policy
At its meeting on May 2, 2006, SCAR recommended that the following motion be placed on the
agenda for approval by Senate.
Motion:
?
"that Senate approve and recommend to the Board of Governors the
revisions to Policy R20.01 - Research Ethics Review Policy"
^^((SCV
.
40
.
Memo
To: ?
Mario Pinto, Vice-President Research
From: Daniel J. Weeks
Date:
April 26, 2006
Re:
Review of R20.01
The Committee to Review R20.01 met on April 21 2006 to consider the
public responses to the draft document placed on your website. Our final
draft document incorporating these responses is attached.
A significant number of the public comments regarding the previous version
were editorial in nature and nearly all such input was incorporated into the
• current draft. At the same time I undertook a careful (hopefully) editing of the
current revision to R20.01. In addition to correcting numerous typos (both
old and new) there is now consistency in the use of abbreviations and
acronyms. As well, the document now includes language that clarifies duties
and responsibilities of members of Departments and Schools that also apply
to members of non-departmentalized Faculties.
There were a few more significant comments that lead to more substantive
change. I have highlighted the most important items and the Committee's
response below.
Age of Consent
As we suspected the issue of age dealt with in 8.3(g) was not sufficiently
clear. In the previous version of R20.01 age was more in the context of legal
competency that consent. Although the working policy of the REB has been
to adopt 14 as the age of consent for minimal-risk protocols, the legal opinion
was that SFU could be vulnerable if we do not ask for parental consent for
participant under the age of 19. To simplify matters 8.3(g) has been
reworked to be wholly consistent with the same policy at UBC.
Accountability of the REB
In our previous submission, the Committee recommended an addition to 6.2
aimed at enhancing the opportunity for effective reconsideration of projects
.
?
initially deemed non-minimal risk and in turn, introduce even greater
accountability into the REB process. The version of R20.01 placed on the
I.
I
VPR website changed this addition. The Committee has chosen to again
propose the addition to 6.2 as it was in our original submission.
FOl, PIPA and the University Act
Our discussion with the relevant SFU experts suggests to us that clarifying
compliance with and interplay among the
Freedom of Information and
Protection of Privacy Act,
the
Personal Information Protection Act of British
Columbia
and the
University Act is
not needed. Clearly, the University
Senate cannot create any policy that contravenes any relevant legal Act.
Attempting to specify the manner in which R20.01 interfaces with such acts
serves to invite challenges to any interpretation we may offer in the text of
R20.01. We suggest that, as a matter of courtesy, the Director of the Office
of Research Ethics provide information on his websfte that may assist
applicants in considering the implications of such acts for research ethics.
Adrian Sheppard has indicated his willingness to assist the DORE in
developing this information.
.
.
0Page2
freedom of information officers, archivists. etc., or the Chief Executive
of
an organization)
do not require ethics review, to the degree that answerin
g
questions posed by the puolcs
'
itnin he ordinary duties o' the participant and are w
i thin the acceptable
'fliES 0
disclosure defined by the participants employers. ?
are
b
Researc ?
o..
?
na...iqes are referred Lo
at/-er members
of
an organization by
a public-relations officer, official spokesperson, etc., of the organization, do,not require
ethics review, to the degree that their inquiries are in keeping with the initial protocol and
?
\'.
Deteted:
ers ?
the substance
of
the interviews are aributable.
Deleted: whose
1.9 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.
2.
Researchers'
Procedural Responsibilities
2.1 In supervised research, the term "researcher is defined as including both the supervisor and
the individual(s) being supervised.
When a graduate or undergraduate student is shown as the
p
rincipal investigator on an application, the supervisor of the student is always the co-investigator.
Inserted: whose inquiries are referred to other
members of an organization by a
public-
relations officer,
official spokesperson, etc..
of
the organization, does not require ethics review,
to the degree that their inquiries are in keeping
with the initial protocol and the substance
of the
interviews are atE
:
?
--
Deleted:
es
Deleted:
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.
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.
2.4 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.
3. Research Ethics Board
(REB)
3.1 TheREB is a committee of Senate. It is responsible for themeiy review of all research
protocols or projects covered by this Policy to ensure that they meet acceptable ethical
Is
Deleted: Research Ethics Board
3.2 The
,REB
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 latter two cases, detailed written
?
t,,Deleted: Research Ethics Board
reasons will be provided to assist researchers in the preparation of revised applications for ethics
approval.
3.3 TheEB has the responsibility to monitor on-going research and .tertmnateanyprojectthat
?
_
does not conform to ethical standards.
?
?
Dan Weeks ______________________
-
?
Deleted:
Research Ethics Board
3.4
The,EB is responsible for responding to inquiries from external agLencies with respqnsibiliY to
.
_____________________________
monitor ethics review procedures at universities.
?
-I
I, Deleted: Research Ethics Board
3.6 TheEB 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.
?
(Deleted:
Research Ethics Board
3.6
TheREB 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 JEB plus the Director of the Office of
Research Ethicswhowillbeex officio non-voting and will serve as Secretary. Membersh
ip_
qualifications shall comply with the specifications of Article 1.3 of the TCPS. The specific
membership and the terms of members will be as follows:
F
Mks 413/06 1:59 PM
tian
ks 4/3106 2:00 PM
MME
ks 413106 2:04 PM
3.
III
SFU
?
)
RESEARçkI"
-MrAT TERS
VICE-PRESIDENT, RESEARCH
SIMON FRASER UNIVERSITY
Review of R20.01—University Research Ethics Review
The proposed Policy has been through two rounds of University consultation, and the
resulting memo from the Review Committee and final draft of the proposed revision to
the Policy is now being forwarded to Senate and the Board of Governors for
consideration and approval.
The current policy is available
Mandate of the
Ad Hoc Committee to Review Policy R20.01
• ?
To review the Policy and Procedures for Ethics Review of Research Involving Human
Subjects (R20.01) and:
• assess whether revisions to the Policy are required, and if so
• provide a revised Policy for consideration.
Reporting and Approval Process
The Task Force reports to the Vice-President, Research. Recommendations of the Task
Force will be considered in accordance with normal University approval processes.
Membership of the Ad Hoc Committee
• Dan Weeks, (Committee Chair), Department of Psychology, SFU
• Bruce Brandhorst, Department of Molecular Biology and Biochemistry, SFU
• John Dickinson, School of Kinesiology, SFU
• David MacAlister, (Lawyer), School of Criminology, SFU
• David MacLean, Faculty of Health Sciences, SFU
• Simon Verdun-Jones, (Lawyer), School of Criminology, SFU
• Camilla Sears, PhD Candidate, School of Criminology, SFU
• Bruce Landon, Instructor, Department of Psychology, Douglas College
• Rob Woodbury, School of Interactive Arts & Technology, SFU Surrey
Page
updated:
April 26, 2006
.
"A
SIMON FRASER UNIVERSITY ?
Policies and Procedures
•
??
University Research Ethics Review (R20.01)
Date: October 1, 1992
Number R 20.01
Revision Date: December 13, 2001
Revision No.:A
Ethics Review
of Research Involving Human Subjects
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 Tr-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
for
the protection of privacy
and
for
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.
Click here for instructions on accessing the electronic Ethics Applications
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.
1. Requirement for Ethics Review
1.1 All research involving living human subjects, conducted by any employee or student of Simon
Fraser University, or Adjunct Faculty of any Department, School orr.on-Departmeruaiized
Faculty
of
Simon Fraser University. Where external agencies or non-SFU researchers are
involved the aopllcant should
seek
advice from the Direct
or ofthe Office
of
Research Ethics
regarding the potential need for ethics review.
1.2
Research that utilizes human tissue may
require, review and approval by the Research Ethics
Board before research is started, except as stipulated in
1.6,
1.7 and 1.8 below ,Research
involving
Ce" , = ab e
human remains
icier' i'ao e
cadavers
primary
tissue
culture,
biological
fluids, embryos, or foetuses must be reviewed by the Research Ethics Board.
Any studies
ut i
lizing human tissue must first be reviewed by the Bic-Safety Commtttee who w;il provide the
REB with a statement as to whether the or000sed research meets these criteria and hence will
require full REB review. Dist
i nct
i
ons with respect to human !issue that are relevant to REB
revIew nciude
a.
Pnmary Tissue Cultures which are
t
he mixture
of
cells that grow out of or from tissue
samples taken from
p
articipants placed into culture,
b.
Secondary Tissue Cultures Which are denved from cells in Pnrnary Tissue Culture by serial
passages and d,iutlon, often leading to clonally derived lines of cells fla
y
ing relatively
uniform properties that have adapted to growth in tissue culture. Once characterized and
.
-Effla
n
Weeks 11/13105 12:46 PM
c.
described in the public domain, these cultures may be considered Established
Cell
Lines
that can be maintained or stored indefinitely. Established Cell Lines con normally be
obtained commercially
or as a gift, but identifying informat
i on about the donor is not
provided with the cells. REB approval is not required for the use
of
human secondary
tissue cultures (providing appropriate ethical approval was obtained for creation of the
primary culture) nor for the use of established cell lines.
c.
Biological Fluids which are fluids of human origin including blood, mucus, perspiration,
saliva, semen. vaaina/ fluid. and urine.
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 educational institution),
c.
identifiable private information about a living individual.
1.4 Research
in the public domain
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 :I?:v.::..i$ approached directly for interviews or for access to private papers. ?
-
The
pubi
c do"ia,r nci..4es all rforr r 'a ion that is avai ac
e
under FO! (Freedom of Information
leg/slation in British Columbia and Canada, whether or not the information has been exposed to the
?
,
Del eted: subject
pubic.
1.5
All course-based research assignments involving living human subjects:.c:c:r..):e'v:
require ethics review and approval (see section 6.3).
1.6 Certain classes of research involving human subjects are excluded from the requirement of
ethics review by the Research Ethics Board at SFU:
a. research conducted by a member of the academic staff as an
Outside Professional 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 undertaken by Adjunct Faculty outside the auspices of Simon Fraser Unlversirj
?
_________________________________
and/or
i'
s academic programs that does not require Simon Fraser University resources
d research on ancient unidentifiable human remains. ?
(Formatted: Bullets and Numbering ?
J
1.7
Protocols that do not propose the systematic, controlled. empincal and object!ve in q
uiry into
natural
p
henomena using currently accepted tnvesrgauon procedures, the mmedate product of
which is evidence. with the objective of discovering how that aspect of the pn vslcal world works, do
not require ethics approval, ?
- -
Deleted: Quality assurance studies,
performance reviews or testing within normal
1.8 Research on public policy issues, public institutions, and other matters that in a free and
?
educational requirements are not subject to
democratic society can properly be considered as part of the public domain is not required to
?
Research Ethics Board review unless there is
undergo ethics review, even when interviews with individuals occupying positions connected to
?
an element of research in addition to the
such matters are involved.
Public poi;cy s defined as follows: ?
assessment
a.
Research protocols that require contact with human part,coants as part of the study and
whose regular occucationol duties involve communicatin g with the public on behalf of their
organzat:ons (such as public relat,ons officers, official spokespersons, dotoma tic offlc,a!s,
fl
(.
1
1'
Deleted:
Research Ethics Board
Deleted:
Ethics Board
Deleted:
Research Ethics Board
.
a.
sevenfacutty members elected by faculty, with one from each of the Faculties of Applied
Sciences Business Administration Education,Science
and Hea' 1'
Sciences
and two from
the Faculty of Arts
and Social Science.
?
cwebelt
six
b.
at
ieaa:
tw,rnembers to be elected by
Senate.Irorn
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 .
-
--------- - - - - - - - - - - - - - - - - - - - - -
-
f. ?
VItO! ?
0)
?
Cuc&
?
a. Chd5S a
r- ? ,
g.r; ?
a;s':: ?
0' 0)
ao;ve
does no)
Xii
?
a ft) /f
4
cudl a pe'son axth
a
''aioe q
ea, ienata ?
a!iapzoLntaL;on . ?
/
i:
It. the term of office for voting members of the
,REB
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
will be allowed.
L in the event that member of the JE8 is unable to attend itmeeting, the
?
•.'roithaPE:
has the authority to appoint a temporary replacement
?
to
act in place of the regular member until the regular member returns or until an election can :
?
.
Deleted: Research Ethics Board
be held.
?
•.Dan Weeks
413106 2M PM
LDeleted: Research Ethics Board
*
Deleted:
its
3.8
Prior to serving, all members of theREB will attend a workshop or orientation session,
organized by thepirecorof
the Office
of
ResearcI'E ics
to ensure that they have an
?
-
-
..PIeted s
understanding
of the principles and practices of ethical review.
The 1 ,vorkshop equiremeo
?
be
substituted by the
on-/rae
tutorial accessed at http :,
?
.re.etflicsoc.ca/engIrsflutonai or a
?
'.. ?
leted:
Senate Committee on Agenda and
similar tutorial approved by the REB.
?
,
Rules
or
3770M
V111cus
W.111
3.9
On an annual basis,
theF.EB
will elect a Chair and a Deputy Chair who will act in the absence
?
LDeleted:
Research Ethics Board
of the Chair. These persons will be faculty members of Simon Fraser University who have served
on the
REB
previously, normally for at least two years.
?
j
Deleted:
Director of the Office of Research
3.10
TheEBwlnorrnay meet at least once per month with no more than six weeks between - -
meetings, unless there is no business to transact.
?
d ll
cy crorocec i
u
ral
matters will be
discussed
at
the open sess
i
on of the meeting: ethics appl;catrons
Wi/i
be discussed in
the
closed session,
3.11
A quorum of the
,,REB ?
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 ES has the authority to establish its own procedures
and Thtesnai policies that do not
conflict with those established
by
Senate
and to make recommendations
to Senate for revisions to .
the Policy.
4. Research Ethics Appeal Board
three
Deleted:
one of whom shall be a registered
lawyer familiar with the law related to ethics.
and one
Inserted:
one of whom shall be a registered
lawyer familiar with the law related to ethics,
and one
Deleted:
Research Ethics Board
'5'
_L_
Deleted:
4.1 Researchers have the right to request, and theES has an obligation to provide, a
reconsideration of a negative decision. Researchers may appeal decisions of the ResearchEB
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?EB.
._ ......................................................................
1 ]
2-.
S
4.3
Appeals may only be heard on the basis of a procedural error that materially and adversely
'
?
Deleted: Research Ethics Board...Researth
influenced the decision of the REB including
al
re
or reasonably apprehended bias including
/ ?
/ (Ethics Appeal Board
?
proceed to hear ?
ri
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
or
of
the Office of Researc
procedural error, bias or a conflict of interest (as described above) occurred, and if so, the
REB
would
Me appeal
then
determine
bodynd
make
whether
a final
to emend
determination
the procedures
on the research
used based
proposal.on
the recommendations
0.
I
?
ior
FiR
of the Office of Research
ch
Ethics Board... Director
of
the
5. ?
Director
of the Office
of
Research
Ethics
(DORE)
-
a
rch
Ethics ?
.
F2
______________________________
:
?
•-'
!!MLsi;JtiuI1.1ti;
5.1
The
POPE
reports ..the Vice-President (Research).
..
.
;ted:
Director
of
the Office of Research ?
j
5.2 The appointment of thePgRE will be made by the Vice-President (Research)after receiving -
ii I __________ ____
?
________________
?
__
t[eiete: Research Ethics Board
involving
advice from
human
a search
subjects
committee
and will
comprising
hold a doctoral
the
REB.
degree.
ThepQrt will have experience in research
i
lDeleted:
Research Ethics Board
5.3 The duties and responsibilities of thepORE include, but are not limited to:
. iDeleted: Research Ethics Board
a. ?
being responsible for research ethics education programs at Simon Fraser University in
-
.'
conjunction with the FEB,
IDeleted:
Research Ethics Board
b. ?
assisting researchers in the preparation of applications for submission to the
J
EB,
;1,'
1 ?
il
Deleted:
Research Ethics Board
c. ?
reviewing all applications submitted to the,EB for the completeness of these applications
and their compliance with this Policy,
/
Deleted:
Research Ethics Board
d.
?
advising the
REB
with respect to the category of risk (i.e., minimal, in-course student, or
IDan Weeks 4/3/06 2:06 PM
non -minimal)ofanapplication, ?
-
&Deleted:ReseamhEthicsBoard
e. ?
approving minimal risk applications, and providing summaries of such approvals to the
la1
00i6
ai'l
Deleted:
Research Ethics Board ... Director of
FEB
...
.
the Office of Research Ethics ?
=3
[3
f.
?
acting in an ex officio non-voting capacity as Secretary to the
f-?EB
.
1.
Deleted: that relate to the research...,
g. ?
managing the Office of Research Ethics,
h ?
undertaking other duties assigned by the
? EB
such as monitoring, data collection and
Deleted
?
4
?
n-course student
communication with other universities and granting councils
-
?
-
Deleted:
?
>course;
which
applies to
6.
?
Review
Process
.
?
undergraduate and graduate courses that
require or allow students to participate in
ft
6.1 Applications to the
?
EB
maybe placed in one of three categories by the pO.t. These
research projects as part
of
the training orf
assessment,
categories are:
--
a.
?
minimal risk;
which occurs when potential subjects can reasonably be expected to regard
Inserted:
<*>course
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
/ ?
Deleted:
and b)
everyday Iife
T , ?
.
?
.
non minimal risk
which includes applications not covered by a)bove
Formatted ?
Bullets and Numbring
Deleted:-
All
studies designed to determine the
6
2Jf the pORE is satisfied that the application meets the standards ?
- established in
consequences for individuals and communities
this policy, the POPE
... ?
shall
...................................................................................
approve the application on behalf of the ,REB.
?
If
.... ?
the
............................-
.PORE is
not
of specific preventative or therapeutic measures
satisfied that the application meets the standards ?
.......... the application may be returned
. ?
and/or invasive procedures, and studies
". ?
I concerning human health-related behaviour
forwarded
to the applicant
to the
for
FEB,
revisions
the Chair
or forwarded
or Deputy
to
Chair
theREB
has the
for considerationauthority
to grant
?
approval for minimal
If
?
-
risk
and/or experiences in a variety of ?
flTfl
all
proposals
approvals
without
by the
a
pORE,
meeting
Chair
of the
or
RE
peputy_Car
8,
or to refer
will
it to
be
the
broughtjo
next meeting
the next
of the
regular
FEB.
meeting
Summaries
of theof
. ?
(
,
peleted:
An
application
_
that
is
cstegoriz(j
EB
The?EB
may review and amend any decisions made independently by thepORE Chair or
th
?
I
,, ?
e ?
. ?
is
po
icy
Deputy Chair.
I
.
Deleted:
Board ... Board... Research Etr(jj
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'n;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 FORE: -
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iDeleted:
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,
h.
and other relevant information.
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Dan Weeks 413/06 11:26 AM
Dan Weeks 4/3/062:08 PM
Deleted: Research Ethics Board
DarrWeeks4/31062:08PM -
Deleted: Director of the Office of Research
Ethics
Dan Weeks 413/06 2:09 PM
Dan Weeks 4/3106 2:09 PM
Dan Weeks 413/06 2:09 PM
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Dan Weeks 4/3106 2:09 PM
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Deleted: Research Ethics Board
Deleted: Research Ethics Board
Deleted: Research Ethics Board
Deleted: D
Deleted: ORE
Inserted: O.PE
-
Deleted:3
or school
Deleted: Director of the Office of Research
Deleted: of the Department or Director of the
School
Inserted: of the Department or Director of the
:' School.
Although the application of course approval may be submitted by toe current instructor of the
coarse it r"us be aoorovedb, Me C'ar.
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'o..""
?
When theOREis /
satisfied that this course poses only minimal risk to research subjects and student participants and
otherwise meets the standards established in this policy, she/he will grant approval for the course
to be designated as a "Research Ethics Board approved course".
If the course is designated
minimal riska
summary of such approvals will be forwarded to a regular meeting of the
REB.
This '- -
Deleted: Director of the Office of Research
Deleted: A
Deleted: Research Ethics Board
.
q
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) Hovvever. the C17a1r p cec"or
?
'r ?
e
-i
e ?
Is - -
responsible for ensuring the maintenance of the agreement for the course when the instructcr(s of
that course chengei. If the course is designated non-minimal risk it shall be fo,'warded to the REB
fora decision.
If approval is not given, the application will be returned to the department with an explanation and
appropriate suggestions
or contingencies.
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
or the CORE
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
tobe submitted totheeREBforfullreview.
Course applications shall be considered in closed meetings of the RES. After approval the course
application and approval shall be in the public domain.
S.
___________________________________________
)isAnaysis ?
...
7.1 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.
7.2 Researchers should employ methods that avoid or reduce possible risks, and maximize
benefits in keeping with disciplinary and epistemological norms and standards.
7.3 Researchers should consider
.iir:J ?s!
a.
physical harm
to the participants or third parttes,
b.
psychological harm
to the participants or tl.ird parties,
c.
injury to reputation or privacy
of the participants or third parties,
or
or Director
Research Ethics Board
Deleted: 6.4
Research proposals designated
non-minimal risk trust 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
descnplion 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 Dettuty
Chair of the Research Efi
Inserted:. A description of the project will be
bent to two qualified reviewers by the
.
D .,,
Deleted: 6.5 When a project has been
determined to have scholarl
y
merit, it wil rim
Inserted:
?
if the application has not been
( ,
completed after one year of being sent (
7.
-
LDeleted: possibilities that exist ?
red to)
Deleted:
d. breach of any applicab!eis
iL.
.-
?
relevant toda
e
-oa ?
'
?
cor1r"un1/.
iDeleted: alan relevant law
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. ?
.
( , Inserted:
than
7.5 Benefits include specific advantages to subjects, to third parties, or to society or a segment ?
[jnseited:
thereof, and any general increase inhuman knowledge Benefits may arise from advantages or
increases in knowledge that are actively sought by the researcher or as by-products of
the
De
l
ete
d:
risk
••. .
?
- .......-
research (e.g., serendipitous events).
?
__________________________________
7.6 In projects involving more than minimal risk it is the responsibility of both researchers and the
REB
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
,REB
be.
- .....................
7.7
in a project involving more than minimal risk t'ne$EB
should
e_
satisfied _that the research - -
design and proposed implementation procedures are consistent with Sound research standards
?
'..,
and with accepted standards of disciplinary conduct and practice.
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/0.
.
7.8 The
REB
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
?
-
personally. Nothing
in
Policy R20.01
is
intended to inhibit the rights of researchers,to
engage in
critical inquiry and disseminate that information
Informed Consent
Informed consent may be obtained in different
ways:
a.
expressed opt-in
by written, oral or by the conduct of the Participant. such as returning a
questionnaire This type of consent must be voluntary. informed, unambiguous, obtained
before beginning the research and may be withdrawn at any time, and unless there is
exp
iicit consent at the time of data collection, there will be no further collection of additional
data, no further analysis of the data initially collected and there will be removal of the data
from the database to the extent possible.
b.
implied,
which must be voluntary, with opt-out provisions where consent is assumed
because the participant does not opt out. Participants may be notified of the research in
writing by various means including, brochures. letters, media, announcements and
advertisements of the research and of the provisions for opting out. Opt-out opportunities
include written, oral or conduct, such as leaving the research site.
c.
oral,
which is acceptable where written documentation is culturally unacceptable, or where
there are good reasons for not recording opt-in
or
opt-out in writing, using a form that the
participant signs. An oral procedure should be managed and documented, indicating how
the opt-in and opt-out provisions were conducted.
d.
Wren research participants desire anonymity and personal data can be collected without
the researchers present (such as the use of a self-administered questionnaire) individuals
could indicate consent by filling out and mailing back an anonymous questionnaire to the
researcher. Documentation of the consent should be done separately in order to prevent
linking research participants to their data or the results of analyses.
.
8.1
A mandatory condition of approval from the REB is that subjects, or authorized third parties,
have given in formed consent about participation in the research. The REB must approve methods
of communication which are not in written form. The REB may approve consent procedures which
do not include, or which alter, some or all of the elements of informed consent set forth above, or
waive the requirement to obtain informed consent, provided that the REB finds and documents
that;
a.
the research ,nvoives no more than min
i
mal nsk to the participants.
b.
the waiver or alteration Mill not affect the rights and welfare of the participants
c.
the research could not be-Practically carried out without the waiver or alteration,
d.
whenever poss
i
ble and appropriate. participants will be provided with additional pettnent
information after participation
e.
the waived or altered consent does not involve a therapeutic intervention
f.
if an approved protocol
does not require written consent, the researcher has keot a record
of who has been ,nterviewed or who has participated
8.2 Normally, researchers must provide the following information to
participants
or authorized third - -
parties: ?
- -- ?
.
Deleted:
subjects
a.
information that the subject is being invited to participate in a research project,
b.
an understandable description of the research
goals,
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,
.
1/.
d.
an assurance that
participants
are free to avoid participation or to withdraw from
participationatantime,
--
---'------------ ---
---•••-• ---------
e.
an understandable description of the type(s) of data to be collected, the method(s) of data
?
^Deleted; subjects
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,
?
a
f.
anticipated secondary uses of identifiable data collected during the research, and
anticipated linkages of data with other data about research subjects.
it a database is used
by an investigator as secondary data, and the use of that data is not consistent with the
use to which the participant consented, explicitly or implicitly.
.
or if the information to the
participant at the time of consent did not inform the participant that the data maybe used
for other purposes in the future than the use for which they consented, then the data must
be anonymous and published in an aggregate form and no attempt must be made to
contact the original providers of the data. If the data relate,to de ifjn/ie communities the
REB mast on a case-by-case basis determine
if
the ns o communities is fies t
he use
cfthe data without approval ofthose communities ,
Deieted:s
g.
methods for data archiving, and provisions for ensuring security and confidentiality of data.
h.
when intentional deception is a necessary component of initial instructions and information
to par t
icipants, participants must be de-brie fed immediately after their participation and
given the opportunity to opt-out. Opting out will mean that the data collected cannot be
used for analysis or retained, and that the individuals participation and decision to opt-out
will remain confidential.
L
when students are to be approached or tested on school grounds, permission of the school
district is required
j.
prior to conducting research activities and where applicable, participants must be advised
whether employers, and/or government agencies have given permission, denied
permission, or have not been a p proached for permission, to include their employees to
take part in the study
8.3 Individuals who are not legally competent, o'h
?
re
/;:ie
spay be asked to become research subjects only if all the
-
following conditions are satisfied
Deieted: or under legal
guardianship
a.
b free
the
and
research
informed
requires
consent
the participation
will be obtained
of
from
?
individual
?
.
\'.
I
ns
erted: or under legal guardianship
authorized representatives following procedures
- -- ?
-.--- - -
outlined under
8.2a
through 8.2g (above),
?
I
e^a
?
sludil
c. research is in the "minimal risk" category, or has the potential to provide distinct benefits to
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i,.ofchildren. incarcerated persons)
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 8.29 (above) will be extended to the research
c;&rt,
should they become legally competent during the course of the research,
f.
provision must be made fOr,
'/Jcr:itl;
who are legally incompetent
or subject
to
legal
guardianship
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.
g.
the age of majority in British Columbia is 19 years of age and parental consent is required
for subjects younger than 19. Written consent from parents or legal guardians (as well as
authorization from appropriate school authorities) is normally re
q uired for research in the
public schools. Consistent with
8(r?,
an opportunity must be given to the individual to
refuse to participate or withdraw at anytime. A copy of what is written or said to the
individual must be included for review by the REB. The REB considers minors attending
University, who are
17
to 18 years of age to be emancicated adults for the pu
r
p oses of
minima/-risk research. Parent or guardian consent
will
generally only oe required ;f the
Inserted: or
are subiect to
1_
Inserted: . incarcerated persons
""'Dv ?
"''.,
ME
LDeleted :
subjec
Deleted: subjects
ii
research study is deemed non-minimal risk or represents an invasion of the family's right to
privacy. In either case. justification must be provided in the application for ethics review.
The REB may make an exception to these requirements on a case-by-case basis, but the
.
?
investigator must provide adequate justification in the ap p
lication for ethics review (e.g. the
child no longer lives with parent or guardian, there is no invasion of privacy or sensitive
issue involved. etc.).
9. International Projects
When a protocol r
e
quires collaboration with universities, agencies or individuals in other countries.;
a.
T-e RE, in conjunction with the Office of Research Services,
sh!i
'rmy reiire
.pnfi ma ion by the
nLv sjs_aercLeoL Ird!vidualsofcorrpsaflc2 !'
t t -
the Tri-ouncil statement as pe,1 of a contract between Simon Fraser University and the
collaborating university, agency or individual.
b.
The REB may review the protocols and responsibility of those international universities.
agencies or individuals.
c.
The REB may accept the decision of an international university, or agency as a substitute
for their own review if the procedures adopted by that university, agency or individual
require compliance of protocols with the Tri-ouncii or simiiar policy, as determined by the
REB.
the REB shall
Inserted:
Confirmation by the collaborating
universities, agencies or individuals of
compliance with the Tn-Council statement as
part of a contract between Simon Fraser
University and the collaborating university,
agency or individual.
The REB may review the protocols and
responsibility of those international universities.
.
.
/3.
