Balancing Research With

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Office of Research Ethics
Director Hal Weinberg. 778 782 6593
Ethics Officer Barb Ralph 778 782 3447
Ethics Assistant Janet Yule 778 782 5719
Ethics Office Assistant 778 782 5236
Balancing Research With Ethical Considerations
http//www.sfu.ca/vpresearch/ethics/
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Review Procedures
Electronic Copy Application
Minimal Risk
Non Minimal Risk
Medical Review
Modifications
DORE Miminal Risk Approvals
No Approval
Monthly Report on DORE approvals of Minimal Risk
Approval
No Approval
Appeal on Procedure
U. Victoria
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Research Ethics Appeal Board
Researchers have the right to request, and the
REB has an obligation to provide, a
reconsideration of a negative decision.
Researchers may appeal decisions of the Research
REB to the Research Ethics Appeal Board within 15
working days. 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 REB.
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New On-Line Application Forms
New On-Line Application Forms http//researchethi
cs.its.sfu.ca8181/ General Information Studies
Document Consent Form for Adults Consent Form
for Minors and Persons Not Competent Information
Document for REB Supplementary Information and
Documents Check List
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New On-Line Application Forms
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New On-Line Application Forms
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New On-Line Application Forms
New Study and Protocol Development
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New On-Line Application Forms
Main Information Page
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New On-Line Application Forms
Two Primary Documents to Upload in pdf Format
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New On-Line Application Forms
The Check List
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New On-Line Application Forms
Help Files
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New On-Line Application Forms
Polices and Templates of the REB and TCP
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New On-Line Application Forms
Two Critical Documents That Must Be Uploaded as
PDF
Study Details and Consent Document(s)
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New On-Line Application Forms
Help For What Must Be Included in Consent Document
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Research Ethics Board 8 faculty members elected
by faculty, with one from each of the Faculties
of Applied Sciences, Business Administration,
Education, Science, Health Sciences, Faculty of
Communication, Art and Technology, and two from
the Faculty of Arts and Social Sciences 2
members to be elected by Senate, from the
university community at large (these may include
faculty and staff) 1 student member and one
alternate to be elected by Senate 2 members
elected by Senate, from the community outside of
the university Every two years, Senate will
approve a list of individuals with medical
degrees and/or law degrees qualified to serve on
the REB
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Research Ethics Board
The REB will normally meet at least once per
month with no more than six weeks between
meetings, unless there is no business to
transact. Policy or procedural matters will be
discussed at the open session of the meeting
ethics applications will be discussed in the
closed session A quorum of the REB 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). The REB has the authority to establish
its own procedures and internal policies that do
not conflict with those established by Senate and
to make recommendations to Senate for revisions
to the Policy.
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Members of Research Ethics Board
Director Office of Research Ethics (ex-officio,
non-voting) Faculty Members Dr. Simon
Verdun-Jones (Chair), Criminology Dr. Ted
Kirkpatrick, School of Computing Science Dr.
Haumei Han, Faculty of EducationDr. Jerry
Sheppard, Faculty of Business Administration
Dr. Denise Zabkiewicz, Faulty of Health
Sciences Dr. Mary-Ellen Kelm - Faculty of
Arts Dr. Robert Young, Department of
Chemistry (Vacant) Communication, Art _at_
Technology   University Community at Large Dr.
Kim Bartholomew, Psychology Ms. Bergen
Butterfield, Student   University Student
Member Mr. Sean Robertson, Student
Representative   Community Members from Outside
the UniversityMs. Margit Nance, Deputy
ChairDr. Laurence Turner, M.D.
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Policy R20.01
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 participants. 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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Requirements for Ethics Review
Research involving living human participants
occurs when data are derived from Information
that is collected through intervention or
interaction with a living individual (e.g.,
interviews, questionnaires, observations taken
that are noticeable by the individual)
Secondary sources/non-public sources (e.g.,
interviews about a living individual, company
personnel records, student records collected by
an educational institution) Identifiable
private information about a living individual.
All research involving human participants that
proposes the systematic, controlled, empirical
and objective inquiry into natural phenomena
using currently accepted investigation
procedures, the immediate product of which is
evidence, with the objective of discovering how
that aspect of the physical world works, requires
ethics approval. Research that utilizes human
tissue may require review and approval by the
Research Ethics Board before research is started.
Research involving identifiable human remains,
identifiable cadavers, primary tissue cultures,
biological fluids, embryos, or foetuses must be
reviewed by the Research Ethics Board.
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Requirements for Ethics Review
Primary Tissue Cultures which are the mixture of
cells that grow out of or from tissue samples
taken from participants placed into culture
Secondary Tissue Cultures which are derived
from cells in Primary Tissue Culture by serial
passages and dilution, often leading to clonally
derived lines of cells having relatively uniform
properties that have adapted to growth in tissue
culture. 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 . Biological Fluids
which are fluids of human origin including blood,
mucus, perspiration, saliva, semen, vaginal
fluid, and urine.
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Requirements for Ethics Review Exclusions
Research by Adjunct Faculty that are not carried
out under the auspices of SFU 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 individual is approached directly
for interviews or for access to private papers.
The public domain includes all information that
is available under FOI (Freedom of Information)
legislation in British Columbia and Canada,
whether or not the information has been exposed
to the public. All course-based research
assignments involving living human subjects,
including Directed Studies require ethics review
and approval.
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Requirements for Ethics Review Exclusions
Research conducted by a member of the academic
staff as an Outside Professional Activity 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. 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. Public policy is defined as follows
Research protocols that require contact with
human participants as part of the study and whose
regular occupational duties involve communicating
with the public on behalf of their organizations
do not require ethics review, Research
protocols in which inquiries are referred to
other members of an organization by a
public-relations officer, official spokesperson,
etc., of the organization, do not require ethics
review. Research on ancient unidentifiable human
remains
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Informed Consent
A mandatory condition of approval from the
Research Ethics Board is that participants, or
authorized third parties, have given informed
consent about participation in the research.
Normally, all communication with research
participants 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 for
all non-minimal risk projects. The Director of
the Office of Research Ethics is authorised to
approve methods of consent for Minimal Risk
studies. The Board reviews and may amend
decisions made independently by the Director,
Chair or Deputy Chair, at their regular monthly
meetings.
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Informed Consent Documents Should Include
a) information that the participant 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 participant. In research which involves
treatment procedures, this description must
include an assessment of potential harms and
benefits of not undertaking the treatment.
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Informed Consent Documents Should Include
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.
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Informed Consent Participants who are not
Legally Competent a) free and informed consent
will be obtained from authorised
representatives. b) research is in the "minimal
risk" category, or has the potential to provide
distinct benefits to the research
participant. c) the researcher can show how the
participans best interest will be protected. d)
provision must be made for participants who are
legally incompetent to express their opinions
about participation in the research dissent on
the part of a research participant must preclude
further participation in the research, regardless
of his/her legal competency.
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Researchers' Procedural Responsibilities 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
principal investigator on an application, the
supervisor of the student is always the
co-investigator. 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. It is the
responsibility of researchers to ensure that
there is adequate lead time available for ethical
review in relation to other deadlines. 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
Services.
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Risk Analysis (a) minimal risk, which occurs
when potential participants 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 participant in those aspects
of his or her everyday life (b) non-minimal
risk, which includes applications not covered by
a) above. .
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Database Data If 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 may be 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. Database Data of
Communities If the data relate to identifiable
communities the REB must, on a case-by-case
basis, determine if the risk to communities
justifies the use of the data without approval of
those communities. Participants must be
informed of the methods for data archiving, and
provisions for ensuring security and
confidentiality of data.
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Research Ethics Appeal Board Appeals may only be
heard on the basis of a procedural error that
materially and adversely influenced the decision
of the REB, 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, the REB would then
determine whether to amend the procedures used
based on the recommendations of the appeal body
and make a final determination on the research
proposal.
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Director of the Office of Research Ethics 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-course
student, 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) managing the Office of Research
Ethics. 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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Research Ethics Board The Research Ethics Board
is responsible for responding to inquiries from
external agencies with responsibility to monitor
ethics review procedures at universities. 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. The Research Ethics
Board provides an annual report of its activities
in the previous year to Senate.
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Internal Policies
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 an application for
course approval with the exception of a thesis,
honours thesis, dissertation and directed
studies. These will be dealt with under the
normal avenues of the REB. The REB considers the
student researcher of every thesis conducted at
Simon Fraser University to be the Principal
Investigator of the thesis project. All projects
in Directed Studies courses, involving human
subjects, must be submitted for individual review
each time the course is offered. The
interpretation of public domain includes all
information that is subject to FOI (Freedom of
Information) provincial, federal and SFU policy,
whether or not the information has been exposed
to the public. If students are approached or
tested on school grounds, permission of the
school district is required.
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Internal Policies
Signed consent forms do not have to be used in
all circumstances. If the researcher proposes
to not use a signed consent form the application
should include an explanation of why. When
written or other forms of documented consent is
acquired as part of the research protocol, it is
the responsibility of the researcher to maintain
those records for a period of 1 year after the
research has been completed, and it is the
responsibility of the supervisor to ensure this
for graduate student or undergraduate student
research. The DORE is authorized to approve
non-written consent procedures in minimal risk
applications
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Internal Policies
For minimal risk protocols only, persons greater
than or equal to 16 years of age and less than 19
years of age may in some circumstances consent to
participate as a research subject in the absence
of parental consent, subject to specific approval
by the REB in that instance. Persons under the
age of 16 may not participate as research
subjects in either minimal or non-minimal risk
protocols, without parental consent. Persons
greater than or equal to 19 years of age are
considered adults and may consent to participate
as research subjects in both non-minimal and
minimal risk protocols. All persons registered
at SFU as students are considered adults. The
DORE will evaluate all research that proposes to
use the internet in accordance with the five
requirements below, with respect to the level of
risk a) The method of giving informed
consent b) The method of communicating data
between respondent and researcher c) The method
of storing data d) Who will be able to
legitimately access the data and why? e) How
were the names and email addresses of the
potential respondents collected.
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Internal Policies
Public Policy is defined as follows a)
Research protocols that require contact with
human participants in the study, whose regular
occupational duties involve communicating with
the public on behalf of their organizations (such
as public relations officers, official
spokespeople, diplomatic officials, freedom of
information officers, archivists, etc. or the
Chief Executive of an organization) do not
require ethics review, to the degree that
answering questions posed by the public are
within the ordinary occupational duties of the
subject. b) Researchers whose inquiries are
referred to other members of an organization by a
public relations officer, official spokesperson,
etc. for 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 attributable. c)
As per the Tri-Council Panel on Research Ethics
recommendation, interviews with elected officials
are exempt from ethics review to the degree that
such interviews are part of their ordinary
obligations to communicate with the public. The
same exemptions apply to declared candidates for
public office.
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Internal Policies
Applications that are considered by the Director
of the Office of Research Ethics to utilize or
involve medical procedures, or which may have
medical implications, will be sent to the
Director, Office of Research Ethics (DORE) with a
request that the DORE ask one of the persons
shown below, or others at the applicants
discretion, who is a licensed MD to Designate
the protocol as Minimal Risk, or Designate the
protocol as Non-Minimal Risk, or Designate the
protocol as one that needs external or internal
review, and suggest who might be approached to do
the review. The researcher must confirms that
the equipment used in the protocol of
the.application for Ethics Approval for human
research has been certified by CSA or other
acceptable national or international agencies,
and meets Medical Devices Regulations. If the
equipment has not been certified as safe or the
PI does not know if the equipment has
certification the researcher must contact
the Environmental Health and Safety (EHS) Office
and DORE for guidance on the certification and
approval process Application.
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Internal Policies
Approval of Assistants to Amend Projects.
Background Several Faculty who are the PI for
many approved projects have assigned assistants
to administer the project, and to insure
compliance with provisions of the approval. These
faculty are frequently in transit to
international conferences or have obligations
that make it difficult for them to respond to
requests by the ORE for approval of minor changes
to the protocol of minimal-risk studies. In
several cases it is critical that the amendments
be approved expeditiously. Therefore The PI
be authorized to approve the authority of
'Assistants' to the PI who may request
minimal-risk amendments to a minimal-risk study.
Minimal-risk amendments to minimal-risk studies,
requested by the Assistants, and approved by the
DORE, be sent to the PI by email as notification.
Implementation of the amendments can begin
without prior approval of the PI. Letters by the
PI authorizing (2) will be included in the file
of the project and reported to the REB as
information at their monthly meetings
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British Columbia Legislation
The Personal Information Protection Act (PIPA)
sets out how B.C. organizations, including
corporations, sole-proprietorships, partnerships
and non-profit organizations, may collect, use
and disclose personal information about
individuals (including administration in teaching
organizations, and spin-off companies).  The
Freedom of Information and Protection of Privacy
Act (FOIPPA) creates specific information and
privacy rights regarding information that is
collected or controlled by public bodies in B.C.
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FOIPPA
Accountability An organization is responsible
for personal information under its control and
shall designate an individual or individuals who
are accountable for the organization's compliance
with the following principles. Identifying
Purposes The purposes for which
personalinformation is collected shall be
identified by the organization at or before the
time the information is collected. Consent The
knowledge and consent of the individual are
required for the collection, use or disclosure of
personal information, except when
inappropriate. Personal Information Protection
and Electronic Documents Act (PIPEDA). Applies to
the collection, use and disclosure of personal
information related to the operations of a
federal work, undertaking or business (e.g.,
banks, airlines, telecommunications
companies). Since 2002, universities performing
human subject research must comply with the
Personal Information Protection and Electronic
Documents Act (PIPEDA).
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FOIPPA
Limiting Collection The collection of personal
information shall be limited to that which is
necessary for the purposes identified by the
organization. Information shall be collected by
fair and lawful means. Limiting Use, Disclosure,
and Retention Personal information shall not be
used or disclosed for purposes other than those
for which it was collected, except with the
consent of the individual or as required by the
law. Personal information shall be retained only
as long as necessary for fulfilment of those
purposes. Accuracy Personal information shall be
as accurate, complete, and up-to-date as is
necessary for the purposes for which it is to be
used. Safeguards Personal information shall be
protected by security safeguards appropriate to
the sensitivity of the information. Openness An
organization shall make readily available to
individuals specific information about its
policies and practices relating to the management
of personal information. Individual Access Upon
request, an individual shall be informed of the
existence, use and disclosure of his or her
personal information and shall be given access to
that information. An individual shall be able to
challenge the accuracy and completeness of the
information and have it amended as appropriate.
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FOIPPA
Challenging Compliance An individual shall be
able to address a challenge concerning compliance
with the above principles to the designated
individual or individuals for the organization's
compliance. Exemptions Personal information
collected, used or disclosed solely for
journalistic, artistic or literary purposes or
permission could infringe on the informations
accuracy where such data can contribute to a
legal investigation or aid in an emergency where
peoples lives and safety could be at stake and if
disclosure aids, in times of emergency, matters
of legal investigation, or facilitates the
conservation of historically important records.
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What is the US Patriot Act?
Summary of Critical Provisions

• Gives government the power to access any data
  base, personal, business, political and social
  without a court order including
• Includes medical records, tax records and
• books purchased, financial records,
• membership in clubs or societies, use of
  Internet
• Includes the power to break into a home and
  conduct secret searches without telling the
  resident for weeks, months, or indefinitely.
• Prohibits anyone from disclosing to anyone that
  the information has been accessed.