hhs departmental ethics review...below. the tcps2 tutorial must be done and evidence in the form of...
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HHS DEPARTMENTAL ETHICS REVIEW
This document is to guide faculty and students in conducting
research with human participants. It is aligned with the Tri-
Council Policy Statement and Vancouver Island Universities
Research Ethics Board Standards.
Ethics Guidelines
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Table of Contents
Table of Contents ...................................................................................................................................... 1
Ethical Review of Student Projects Involving Human Participants ..................................................... 2
Distinguishing Research from Case/Professional Skill Development ................................................................... 2
HHS Departmental Ethics Review Committee Terms of Reference (TOR) in Brief ........................................... 3
Student Tutorial – Core Principles to a REB Review .................................................................................................... 3
HHS Departmental Ethics Review Process ...................................................................................................................... 3
Table 1: Ethics Review Guidelines .................................................................................................................................. 4
Table 2: Components of the Ethics Application ........................................................................................................ 6
Table 3: Components of the Consent Form ............................................................................................................... 7
Table 4: The Departmental Review ................................................................................................................................ 7
References .................................................................................................................................................. 9
Reference Websites ................................................................................................................................................................. 9
Appendix .................................................................................................................................................. 10
Research Ethics Process - Decision Tree ........................................................................................................................ 10
HHS Faculty Decision Tree for the Ethics Process ...................................................................................................... 11
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Ethical Review of Student Projects Involving Human Participants
Please review this document prior to submitting an application for review. Your faculty member/
instructor will be able to guide you through this process. When your work is ready to submit for
review, submit two copies of the application to the Faculty Supervisor or Course Instructor. The
second copy will be forwarded by the Faculty Supervisor or Course Instructor to the HHS
Associate Dean’s office for HHS Departmental Ethics review. Be sure to retain a copy for your file.
Note: electronic copies are sufficient.
The purpose of this document is to: 1) ensure that ethical standards and principles outlined in the Tri-
Council Policy Statement “Ethical Conduct for Research Involving Humans1 are upheld in student
research within the HHS Faculty, and 2) act as a guide for HHS Faculty and Students in the Ethics Review
process.
The HHS departmental review process covers both student projects and “blanket approval” for
faculty class projects. As noted in VIU’s Research Ethics Board (REB) policy, any projects involving more
than minimal risk to human participants, vulnerable populations, or deception in the research
process must be vetted by VIU’s Research Ethics Board (REB). See: VIU Research Ethics Board. The REB
ensures that all research projects involving human beings follow standard ethical guidelines and are
subject to ethical review, whether they be student projects or faculty projects.
Many university courses include class projects and activities designed to develop research skills. VIU and
the Tri-Council require that these projects, which involve human participants, must be screened for
ethical approval prior to their start. The VIU Research Ethics Board (REB) has devised procedures by
which undergraduate course projects that involve minimal risk can be reviewed by specially constituted
Departmental Review processes to help respond to the specific needs of the Health and Human
Services instructors and students.
Course-based research activities vary in scope, but may include: having students conduct interviews,
administer standard tests, or distribute questionnaires to develop interview or questionnaire design
skills, conduct mini research projects where students pose research questions, gather data from human
participants, and analyze the data for presentation, or other activities that would be considered research
within the disciplinary traditions in which the course is being taught.
Distinguishing Research from Case/Professional Skill Development In order to determine whether the course activities require ethics approval, the instructor must first
assess whether it involves research with human participants or focuses on professional skill building
within the guiding principles of the ethical process. Thus, the instructor will decide which route to direct
the students based on the activity. Options include:
1. Research that is eligible for the Departmental Ethics review process
2. Research that is eligible for the VIU Research Ethics Board (REB)
1 https://www.viu.ca/REB/TCPS.asp
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3. Course projects focusing on professional skill building and training with awareness and respect for
ethical principles when involving human participants.
Please refer to the webpage Research vs. Training Guidelines for Undergraduate Research to assess
whether information-gathering activities within a university course are part of a research project or are
for the teaching of professional skills or pedagogic purposes. This responsibility rests with the instructor
and program specific faculty.
HHS Departmental Ethics Review Committee Terms of Reference (TOR) in Brief a. The committee’s membership will include a minimum of 4 committee members from both Health
and Human Service programs.
b. The committee will meet a minimum of 2 times per year (October and February) unless there are no
proposals to be reviewed. Proposals must be submitted three weeks prior to the established
meeting date (exceptions may be made as needed).
c. Proposals may be considered on an ad hoc basis.
d. Proposals will be reviewed and assessed by two committee members.
e. Any difference in the assessment of a proposal, between the course instructor and the committee’s
reviewers, will be resolved by the VIU Research Ethics Board (REB).
f. The members of this committee must have graduate level training in advanced research methods
(ethics, qualitative, quantitative and/or other methodologies such as interpretive, hermeneutics,
etc.).
g. An annual report (the Department research Projects (DRP) Reporting Form) of the approved projects
will be completed by the Faculty of HHS Associate Dean each year. This will be reviewed by the HHS
Dean and sent to the VIU REB.
h. The Department responsibilities and the instructors’ responsibilities related to the ethical review of
student projects will be reviewed annually.
Student Tutorial – Core Principles to a REB Review If it is determined that the project requires approval via 1 or 2 above (research involving human
participants) students must complete the TCPS 2 Tutorial Course on Research Ethics (CORE) and provide
evidence of this with a certificate of completion. It is free of charge and can be completed online at:
http://pre.ethics.gc.ca/eng/education/tutorial-didacticiel/
HHS Departmental Ethics Review Process We encourage students to engage in research with human participants. With the help of a Faculty
Supervisor, students can develop research projects that address the required ethical considerations. All
students must work with a faculty member to develop their research projects. Since this process takes
time, it is best to begin the discussion as soon as possible. If you are thinking about a project for the
end of term, begin discussing possibilities with your faculty supervisor at the beginning of term.
Applications for ethical approval for research projects which involve human participants must be
reviewed and accepted by the Course Instructor or Faculty Supervisor AND the HHS Departmental
Ethics Review Committee.
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With respect to HHS Departmental Ethics Review, all student researchers, faculty supervisors, and
Faculty (Department) reviewers must follow the steps outlined in Table 1, PART 1 or PART 2 below.
PART 1 refers to student research projects. PART 2 refers to faculty class research projects. In an effort
to streamline the review process and to encourage faculty members to develop training exercises in
research for our students, faculty members can seek "blanket approval" of class projects. In this case,
one application is submitted to include all students who will be undertaking the assignment or exercise.
Faculty must pre-determine which route they will use in their course and clarify this in the course
outline. In either case, there must be clear understanding of Research vs. Training Guidelines for
Undergraduate Research.
Table 1: Ethics Review Guidelines
GUIDELINES PART 1: Student Research Projects (one or
more students engage with different
topics)
PART 2: Faculty Class Research Projects (all
students in the class engage in the same
project)
STEP 1: Assessing
minimal risk and
vulnerable
population
ONLY projects involving minimal harm or
risk* to human participants can be
approved at the department level. All
others must be reviewed by VIU’s REB.
Students must complete a Minimal Risk
Checklist.
When studying people who are
vulnerable**, special care must be taken to
ensure that the research does not expose
members of these groups to harm. Given
the greater likelihood that research with
vulnerable groups will exceed the
threshold of minimal risk, applications for
research projects involving vulnerable
populations must be reviewed by the VIU
REB.
***Student Projects with external
organizations may require additional
approval.
ONLY projects involving minimal harm or
risk to human participants can be
approved at the department level. If there
are concerns that the project exceeds
minimal risk to human participants and
researchers, then the faculty member
requesting approval must do one of the
following: 1) revise the project so that it
meets the criteria for minimal risk; 2) forgo
the research project; 3) submit an
application to be reviewed by the Research
Ethics Board at VIU.
***Class Projects with external
organizations may require additional
approval.
STEP 2: Write the
ethics application
and include
information,
consent and debrief
information
The ethics application should be a
minimum of two pages in length and
include several components- See Table 2
below. The TCPS2 Tutorial must be done
and evidence in the form of a completion
certificate be provided. The following
forms must be completed (see Table 3 for
components):
Minimal Risk Checklist
Consent form
Debrief form
https://www.viu.ca/REB/forms.asp
The minimum two-page blanket
application should include:
(a) a description of the class assignment,
and
(b) in addition to a certificate indicating
completion of the TCPS2 Tutorial, a
description of the ethics training that will
be provided to the students.
c) any or all of the steps listed in Table 2 at
the Faculty instructors discretion to help
the HHS Departmental Ethics Review
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* Minimal Risk is defined as follows: “The standard of minimal risk is commonly defined as follows: if
potential subjects can reasonably be expected to regard the probability and magnitude of possible
harms implied by participation in the research to be no greater than those encountered by the subject
in those aspects of his or her everyday life that relate to the research, then the research can be regarded
as within the range of minimal risk. Above the threshold of minimal risk, the research warrants a higher
degree of scrutiny and greater provision for the protection of the interests of prospective subjects.
There is a similar threshold regarding undue or excessive offers of benefit. As an offer of payment in
relation to research participation exceeds the normal range of benefits open to the research subject, it
Committee make a decision about the
class project.
Faculty members should include a copy of
a blanket consent form (see Table 3 for
components) that will be used by the
students. A sample consent form is
available on the VIU website at:
https://www.viu.ca/REB/forms.asp
STEP 3: Submit the
application for
review
Two copies of the application should be
submitted to the Faculty Supervisor or
Course Instructor. The second copy will be
forwarded by the Faculty Supervisor or
Course Instructor to the HHS Associate
Dean’s office for HHS Departmental Ethics
review. Students will also retain a copy for
their files. Note: electronic copies are
sufficient.
The faculty member will submit the
assignment or exercise to the HHS
Departmental Ethics Review Committee.
Where more thorough review is deemed
necessary, applications will be forwarded
to the VIU Research Ethics Board for their
consideration.
The faculty member should keep a copy of
the approved proposal in his/her office for
one year after the end of the class project.
STEP 4: The Review See Table 4 below for the Review Process The same general review process that is
used for student projects will be used for
faculty projects (See PART 1, STEP 4 and
Table 4 below).
Should the faculty member or HHS
Departmental Review Committee feel that
the application demands a more thorough
discussion at the departmental level, or
that the application was unfairly reviewed,
the application will be forwarded to the
VIU REB.
NOTE: Once a faculty class project or
exercise has been reviewed and approved,
the project can be used for three academic
years. The intention to use an approved
research project or exercise must be
announced to the department prior to its
implementation.
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is increasingly likely to amount to an undue incentive for participation.” (TCPS, 2010).
(http://www.pre.ethics.gc.ca/eng/archives/tcps-eptc/section1-chapitre1/#1C1).
An example of a minimal risk project is interviewing people about their favourite television shows. An
example of research exceeding minimal risk is interviewing family members about their loved ones’
experience of a disease or illness for the purposes of research (as opposed to being part of the normal
work of particular professions, e.g., nurse).
** Vulnerable Population is loosely defined as: the economically disadvantaged, racial and ethnic
minorities, children, the elderly, the homeless, those with human immunodeficiency virus (HIV), and
those with other chronic health conditions, including severe mental illness. It may also include rural
residents, who often encounter barriers to accessing healthcare services. The vulnerability may be
enhanced by race, ethnicity, age, sex, and factors such as income, and absence of a usual source of care.
Health and healthcare problems intersect with social factors, including housing, poverty, and
inadequate education (Raphael, 2008).
***If you are considering research in School District 68; all research MUST be approved by the
Superintendent's Office (or delegate), and you must have a police records check. See Procedure 3871P
on SD68's web page: School District 68 - Board Information
Table 2: Components of the Ethics Application
Identification and contact
information
The name of the student(s) carrying out the project and the faculty supervisor,
including phone numbers and email addresses;
Research Title The title of the proposed research project;
Research purpose The purpose of the research;
Research Sample The intended research participants;
Recruitment Methods How participants will be recruited and, if applicable, compensated for their
participation;
Research Methods The method(s) used for gathering information (using deception is not allowed);
Training The formal training he/she has received (or is receiving) for conducting ethical
research in the health and human services;
Required
Documents/Attachments
Required: TCPS 2 Tutorial Course on Research Ethics (CORE) and the certificate of
completion. Minimal Risk Checklist; Consent form; Debrief form; Introductory
letter/script; and signed Statement on Ethical Issues. A poster or other documents
may be requested e.g., information letter for surveys.
Clarity and Dissemination When, how, and to what extent the nature, purposes and results of the research
will be explained to participants;
Transparency The anticipated risks and benefits for research participants
Processes used A description of how informed consent will be obtained
Data Storage How the data will be treated once the project is completed
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Table 3: Components of the Consent Form
Table 4: The Departmental Review
Research Goals A brief overview of the research goals and objectives
Explain Importance and
Relevance
Why participants are being asked to participate in the research
Define Parameters How much of their time will be required
Participants own volition That the research is voluntary, and the participant may withdraw at any time
without reason or penalty
Anonymity and confidentiality A statement which promises anonymity and confidentiality (if this is promised),
and that all data will be encoded for their protection
Data access and storage How respondent information will be used, who has access to it, How it will be
stored, and when it will be destroyed
Risks and Benefits A statement of the possible risks and benefits for participating in the research
(e.g., physical, psychological, social, economic, and legal)
Contact Information Contact numbers of student researcher, faculty research supervisor. Contact
information should also include the Research Ethics Manager at VIU (email:
[email protected], phone: 350-753-3245, ext. 2665). The latter is important if
participants have concerns about their treatment in the research.
Faculty Instructor or
Supervisor ensures application
is submission ready
The instructor should monitor and review the application, make suggestions or
edits, and sign off on the proposal prior to its submission to the faculty Review
committee.
Reviewer assesses Minimal
Risk and Vulnerable
population
(STEP 1 in Table 1 above)
The application is reviewed by two independent Faculty (Departmental)
Reviewers from the HHS Departmental Ethics Review Committee. These
individuals are not the instructor of the course. If the Faculty Reviewer feels
that the topic is such that assessment of minimal risk requires specialized
expertise, then the reviewer may request to the HHS Associate Dean that the
proposal be reviewed by another Faculty member who has the appropriate
substantive expertise to assist with the assessment of minimal risk.
Potential outcomes of the
review process
Approval
Approval subject to request for minor revisions. Should there be a request for
revisions, it is the responsibility of the student and Faculty Supervisor or
Course Instructor to address the revisions and resubmit the revised proposal
to the HHS Departmental Ethics Review Committee through the HHS Associate
Dean’s office.
A request for the Associate Dean to review the proposal.
Rejection
Rejection with the suggestion to develop a proposal to go to VIU’s Research
Ethics Board (if, for example, the project exceeds minimal risk).
Time Bound Nature Every effort will be made to review proposals in a timely manner, e.g., within 1-
2 weeks of receiving the application.
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Storage The Course Instructor or Faculty Supervisor will keep one copy of approved
proposals (electronic/hard) on file for one year in his/her VIU office. The
location is to be confidential and secure.
Destruction Data will be securely destroyed, e.g., paper confidential shredding, electronic
deleted.
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References
Raphael, D., (2008). Introduction to the social determinants of health. In Social Determinants of Health:
Canadian Perspectives. (pp. 2-19). (2nd ed.). Toronto, ON: Canadian Scholars' Press.
Reference Websites Tri- Council Policy Statement “Ethical Conduct for Research Involving Humans
http://pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/
Policy 31.03 Research Involving Humans Vancouver Island University accessible
From: http://www.viu.ca/policies/policies-index.asp , Revised Nov 26, 2009
Procedure 31.03.001, http://www.viu.ca/policies/policies-index.asp , Revised Nov 26, 2009
Minimal Risk definition from Tri-Council Policy site (TCPS):
http://www.pre.ethics.gc.ca/eng/archives/tcps-eptc/section1-chapitre1#1C1
Minimal Risk Checklist (VIU REB) http://www.viu.ca/REB/documents/minimalriskchecklist.pdf
The TCPS 2 Tutorial Course on Research Ethics (CORE) available from:
http://pre.ethics.gc.ca/eng/education/tutorial-didacticiel/
Sample Consent Form: http://www.viu.ca/REB/documents/researchconsentform.pdf
Sample Debrief Form: http://www.viu.ca/REB/documents/exampledebreifingform.pdf
Statement on Ethical Issues: https://www.viu.ca/hhs/documents/Statementofethicalvalues-
studentsignatureformSept2010final-LEAreviewed.pdf
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Appendix
Research Ethics Process - Decision Tree
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HHS Faculty Decision Tree for the Ethics Process
VIU Research Ethics Board
Minimal Risk Checklist