HHS Departmental Ethics Review...below. The TCPS2 Tutorial must be done and evidence in the form of...

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

Vancouver Island University

HHS Departmental Ethics Review

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Revised October 2015 H:\HHS_Ethics_Review (Restricted)\_Forms & Guidelines\HHS Departmental Ethics Review Guidelines (rev 2015).docx

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

https://www.viu.ca/REB/TCPS.asp


https://isweb.viu.ca/policy_procedure/docshow.asp?doc_id=21090

https://www.viu.ca/REB




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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.

https://www.viu.ca/REB/ResearchvsTrainingGuidelines.asp




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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



http://www.pre.ethics.gc.ca/eng/archives/tcps-eptc/section1-chapitre1#1C1


https://www.viu.ca/REB/documents/minimalriskchecklist.pdf




http://pre.ethics.gc.ca/eng/education/tutorial-didacticiel





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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:


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

http://www.pre.ethics.gc.ca/eng/archives/tcps-eptc/section1-chapitre1/#1C1

http://www.sd68.bc.ca/edocuments/Board/policiesandproc_/3000instruction_/8specialprogram_/3871proresearch/3871_PROResearchinSchools.pdf

http://www.sd68.bc.ca/edocuments/Board/policiesandproc_/default.html




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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.

mailto:[email protected]



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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):


Minimal Risk Checklist (VIU REB) http://www.viu.ca/REB/documents/minimalriskchecklist.pdf

The TCPS 2 Tutorial Course on Research Ethics (CORE) available from:


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

http://pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/

http://www.viu.ca/policies/policies-index.asp

http://www.viu.ca/policies/policies-index.asp


http://www.viu.ca/REB/documents/minimalriskchecklist.pdf


http://www.viu.ca/REB/documents/researchconsentform.pdf

http://www.viu.ca/REB/documents/exampledebreifingform.pdf

https://www.viu.ca/hhs/documents/Statementofethicalvalues-studentsignatureformSept2010final-LEAreviewed.pdf

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

https://www.viu.ca/REB


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