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UVic Research Ethics Application Template

This document provides a template for submitting a research ethics application to the Human Research Ethics Office at the University of Victoria. It outlines sections for including information about the research team, project details, funding sources, whether additional ethics approvals are required from other institutions, and other necessary approvals. The template is intended to help research teams collaborate in preparing their application for online submission or course-based projects and stresses that the actual application must be submitted through the university's online Research Administration Information System.

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dawn
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0% found this document useful (0 votes)
16 views24 pages

UVic Research Ethics Application Template

This document provides a template for submitting a research ethics application to the Human Research Ethics Office at the University of Victoria. It outlines sections for including information about the research team, project details, funding sources, whether additional ethics approvals are required from other institutions, and other necessary approvals. The template is intended to help research teams collaborate in preparing their application for online submission or course-based projects and stresses that the actual application must be submitted through the university's online Research Administration Information System.

Uploaded by

dawn
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd

Template – Not for submission

This is a working template of the standard application and is only intended to help with research team
collaboration in preparation for online submission or course-based projects. To submit a research
ethics application for review and approval by the Human Research Ethics Office you must login to
Research Administration Information System UVic-RAIS ([Link] and complete
the online form.

A. Research Team
If there is more than one Principal Investigator, provide their name(s) and contact information below
in Section A.3. Research team members.
1. Principal Investigator (faculty, faculty supervising a student or post-doctoral
researcher)
Principal Investigator is a faculty member, adjunct professor or sessional instructor. For more
information please see the annotated guidelines.
If the project has more than one Principal Investigator (other than you) or more than one Principal
Applicant, their names should be listed under section A.3 Research Team Members.
Name:
Principal Investigator Department:
Principal Investigator Position:

2. Principal Applicant (students & post-docs)


For further information about the distinction between the Principal Investigator and Principal
Applicant, please see the annotated guidelines.
A Principal Applicant is an undergraduate student, graduate student or post-doctoral fellow who will
be the lead researcher (for their thesis, dissertation, project, etc.) for this study. A Principal
Applicant will be granted "View and edit" access by default, and will receive notifications related to
the study. If the project has more than one Principal Applicant, the additional individuals should be
listed under section A.3 Research Team Members.
Name: Department/Faculty:
Email: Phone:
Position:
Faculty Undergraduate Ph.D. Student
Staff Master’s Student Post-Doctoral
Adjunct or Sessional Faculty (Appointment start and end dates):
Graduate secretary email (if the principal applicant is graduate student, please provide graduate
secretary's email. Leave blank otherwise):

Is the principal applicant conducting this research for their academic degree at UVic

Yes No

3. Research team members:


Individuals and organizations involved in conducting your research. This includes co-principal
investigators, additional principal applicants, co-investigators, other UVic students, assistants (paid
or unpaid), community organizations, and clients. Team members listed will have "no access" to
Template revised October 2019
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Template revised October 2019

application as a default. You cannot assign access to team members without Netlink ID. If they
need a Netlink ID go to the Affiliate Identity Management System and click on the 'Sponsor' tab to
start the process. Once you get the Netlink ID you have to re-enter their name and give access
permission to the application.
List all current research team members (including any UVic Graduate students or research
assistants who will use the received data or biological materials to fulfill UVic thesis, dissertation, or
academic requirements) and assign level of access to the application. You do not need to add the
PI or PA to this table. Inclusion here satisfies only UVic institutional requirements.

Name Role in Research Institutional Email or Phone


Project Affiliation

B. Project Information
1. Project title:
2. Anticipated duration of the project
Anticipated start date for recruitment/data collection:
The approximate start date to begin recruitment and data collection for your project should take into
account the time it will take to complete and submit this application form and the period of four to six
weeks required for ethical review. It is a violation of University of Victoria policy to begin recruitment
and data collection before receiving HREB ethics approval.
Anticipated end date for your research project:
An approximate end date for recruitment and data collection.

3. Is this application linked to one that has been recently submitted to the UVic Human Research
Ethics Board?
Yes No
Provide further information about the linked application(s).
4. Geographic location(s) of the study:

5. Keywords to categorize your research:

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C. Project Funding
1. Have you and/or research team members (their names must be listed under section A.3.
Research team) applied for or been awarded funding for this project? Yes No
This information is used to permit the release of funds and to ensure proper reporting of research
ethics approval to funding agencies. Please ensure the information is this table is corrected.
a. If yes, please complete the following:
Funding Institution Exact title Account Funding Comments
Source holding funding used in holder status
funding
application

2. Will this project receive funding from the US National Institutes of Health (NIH)?
Yes No
If yes, provide further information:

3. If you are a faculty member and have indicated above that you have applied for funding, have
you submitted a Research Application Summary Form to the Grants or Contracts unit in the Office
of Research Services?
(you must submit a research application summary form to the grants or contracts office every time
you apply for funding. Provide explanation if you have not done so.)
Yes No
a. If no (for each entry), please explain why as this is a requirement of the Office of Research
Services. We may not be able to process your ethics application until this has been addresses.
Please contact UVic research ethics liaison.

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D. Multi-Jurisdictional Research
Effective January 1, 2019, research ethics applications for all studies that involve UVic and one or
more institutions listed below, must be submitted through the Provincial Research Ethics
Platform (PREP), and can no longer be submitted through UVic-RAIS. If your study involves one or
more institutions listed below, please contact HRE office ethics@[Link], 250-472-4321 or 250-472-
4545 for more information, before proceeding with the rest of the application.
1. Does the proposed project require Research Ethics Board (REB) approval from one (or more) of
the institutions that are part of BC Ethics Harmonization Initiative, listed below?
Harmonization (a single coordinated review with the other institution(s) listed) may apply if you will
be conducting research under the auspices of any of the institutions listed (involving staff, patients,
health records, sites and/or recruitment through their sites, including recruitment via poster
placement), as well as when members of your research team consist of faculty, staff and students
from the BC institution(s) listed below. Please check with UVic HRE office if you are not sure
whether your study will need to go through harmonized review.
Yes No
If ‘Yes’:
a. check all the BCEHI REBs involved in this research:
University of Victoria Simon Fraser University
University of Northern British Columbia University of British Columbia - Behavioural (BREB)
Island Health University of British Columbia – Clinical (CREB)
Northern Health Interior Health
Providence Health Care Fraser Health
BC Cancer Agency Children and Women’s Hospital
Vancouver Coastal Health First Nations Health Authority
Langara College British Columbia Institute of Technology
University of British Columbia – Okanagan Thompson Rivers University
Camosun College Kwantlen Polytechnic

2. Does the proposed research require Research Ethics Board (REB) approval from other ethics
board(s) not part of BCEHI?
Yes No

If 'Yes':
a. list the other research ethics board(s) from which you or your research team members have
sought approval or will seek approval
(Attach proof of having applied to other research ethics board(s). Please forward approvals upon
receiving them. Be assured that UVic ethics approval may be granted prior to receipt of other
research ethics board approvals.)

3. If you have answered “yes” to D.1 and/or D.2 above, please indicate your role in multi-
jurisdictional research project (Check all that apply)

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Recruiting participants
Collecting data
Analyzing data (with or without identifiers) collected by you and/or UVic research team members
Analyzing data that contains identifiers: Data to be collected by non-UVic research team
members as outlined in this application.
Analyzing data that does not contain identifiers: Data to be collected by non-UVic research team
members as outlined in this application.

Dissemination of result via publications, reports, conferences, internet, etc.


Other (explain):

E. Other Approvals and Consultations


1. If additional request(s) for permission, approval are required please complete the section below
(check all that applies).

Please check all that apply:


School District, Superintendent, Principal, Teacher. Please list the school districts or
schools:
Health Authorities outside BC involving staff, patients, health records, sites and/or
recruitment through their sites (including recruitment via poster placement)
Other regional government authority, please explain:
Community Group (e.g., formal organization, informal collective), please explain:
Other Research Ethics Board (REB) Approval, please explain:
UVic Biosafety Committee Approval. Attach your Biosafety Approval, or your
correspondence with the Biosafety Committee, to this application. Note that Research Ethics
Approval is contingent on Biosafety Approval.
Other Approval, please explain:

Comments:

Please upload proof of having made request(s) for permission or any permission/approval
documents that you received. Please forward approvals upon receiving them. Be assured that
ethics approval may be granted prior to receipt of external approvals.

F. Scholarly Review
1. What type of scholarly review has this research project undergone?
External Peer Review (e.g., granting agency)
Supervisory Committee or Supervisor—required for all student research projects
None
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Other, please explain:

G. Researcher(s) Qualifications
1. In light of your research methods, the nature of the research, and the characteristics of the
participants, what training, qualifications, or personal experiences do you and/or your research
team have (e.g., research methods course, language proficiency, committee expertise, training
on the equipment to be used)?

2. Tri-Council Policy Statement - TCPS2 CORE Tutorial requirements


All UVic graduate students conducting research with human participants for their UVic project,
thesis or dissertation are required to complete the Course on Research Ethics (CORE Tutorial)
and provide evidence of ethics training by uploading a CORE completion certificate under this
section.
List all current UVic graduate students (also listed under A.2 and A.3) involved in this research
project for their UVic project thesis or dissertation, and upload their Course on Research
Ethics (CORE) tutorial certificate(s), if available. This CORE certification is required as of
September 1, 2020 for new applications - see the human research ethics web page for more
information.
Name Email Role in the project CORE Tutorial
completion date

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H. Research Involving Indigenous Peoples of Canada (Including First Nations, Inuit and
Métis)
The TCPS 2 (Chapter 9) is designed to serve as a framework for the ethical conduct of
research involving Aboriginal (including First Nations, Inuit and Métis) or Indigenous peoples,
regardless of where they reside or whether or not their names appear on an official register. Its
purpose is to ensure, to the extent possible, that research involving Indigenous peoples is
premised on respectful relationships and encourages collaboration and engagement between
researchers and participants.

This Policy acknowledges the role of the community in shaping the conduct of research that
affects First Nations, Inuit, and Métis peoples. The nature and extent of community
engagement should be determined through discussion with, and under the advisement of, the
relevant community, taking into account relevant characteristics and protocols and the nature of
the research.

The University of Victoria Indigenous Plan recognizes that research with Indigenous
communities or involving Indigenous peoples must be conducted in a respectful and culturally
appropriate manner, following protocols regarding entering community sites, engaging with
communities, Elders and Knowledge Keepers, acknowledging cultural knowledge and cultural
property, and disseminating research findings.
([Link]
IndigenousPlan_Final.pdf)

1. Conditions of the Research

1a. Will you be conducting research that is situated on any of the following kinds of lands
or waterways: First Nation reserves, Indigenous settlements, Indigenous lands under
self-government agreements, territories with Indigenous land claims agreements, or
other lands designated by Federal, Provincial, or local governments as Indigenous
territory?
No

Yes, provide details:

1b. Do any of the criteria for participation include belonging to an Indigenous nation,
community, group of communities, or organization, including urban Indigenous
populations?
No

Yes, provide details:


1c. Does the research seek input from participants regarding Indigenous cultural heritage,
cultural practices, artifacts, Indigenous or traditional knowledges, or distinct
characteristics of Indigenous experience or reality?
Yes No

1d. Will Indigenous identity or membership in an Indigenous community or group (e.g.


Métis Nation) be used as a variable for the purposes of analysis?
Yes No

1e. Will the results of the research make specific reference to Indigenous communities,
homelands and/or waterways, peoples, languages, histories or cultures?
Yes No
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2. Indigenous Engagement

2a. Processes and protocols for engagement differ across communities, organizations,
committees, and groups, as well as across different research contexts.
Describe the process that you have followed with respect to Indigenous engagement.
Include any documentation of collaboration (e.g. formal research agreement, letter of
approval, email communications, advisory committee, mentorship, etc.) and the role or
position of those consulted (e.g. Elder, Knowledge Holder, governing body, Chief,
etc.), including their names, if appropriate.

2b. Explain how Indigenous community members will be meaningfully involved throughout
the research process, from research design to knowledge sharing. Outline the plan, as
developed with the community, for the outcomes of the research, including research
data ownership, sharing, storage, and governance.

2c. If you have answered “yes” to any of the questions in H.1 but have not yet engaged
with the community, committee, organization, or group, please explain why not and
outline how you plan to conduct a study that respects Indigenous communities and
participants in the absence of prior engagement.

I. International Research
1. Will this study be conducted in a country other than Canada?
Yes No
If yes, describe how the laws, customs and regulations of the host country will be addressed
(consider research Visas, local Institutional Research Ethics Board requirements, etc.):

J. Description of Research Project


1. Purpose and Rationale of Research
Briefly describe in non-technical language:
a. The research objective(s) and question(s)

b. The importance and contributions of the research

c. If applicable, provide background information or details that will enable the HREB to
understand the context of the study when reviewing the application.

K. Recruitment
1. Participant details
Provide details of your participants

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a. Briefly describe the target population(s) for recruitment. Ensure that all participant
groups are identified (e.g. group 1 - teacher, group 2 - administrators, group 3 -
parents).

b. Why is each population or group of interest?

c. What are the salient characteristics of the participants for your study? (e.g., age,
gender, race, ethnicity, class, position, etc.)? List all inclusion and exclusion criteria
you are using.

d. What is the desired number of participants for each group?

2. Recruitment and process


Provide details of your recruitment process

a) List all source(s) for information used to contact potential participants (e.g., personal
contacts, listserves, publicly available contact information, etc.). Clarify which sources
will be used for which participant groups:

b) List all methods of recruitment (e.g., in-person, by telephone, letter, snowball sampling,
word-of-mouth, advertisement, etc.) If you will be using “snowball” sampling, clarify how
this will proceed (i.e., will participants be asked to pass on your study information to
other potential participants?). Clarify which methods will be used for which participant
groups.

c) If you will be using personal and/or private contact information to contact potential
participants (as stated above), have the potential participants given permission for this,
or will you use a neutral third party to assist you with recruitment? Note that this is not a
concern when public and/or business contact information is used.

d) Who will recruit/contact participants (e.g., researcher, assistant, third party, etc.) Clarify
this for each participant group.

e) List and explain any relationship between the members of the research team (including
third party recruiters or sponsors/clients of the research) and the participant(s) (e.g.,
acquaintances, colleagues). Complete item 7 if there is potential for a power relationship
or a perceived power relationship (e.g., instructor-student, manager-employee, etc.). If
you have a close relationship with potential participants (e.g., family member, friend,
close colleague, etc.) clarify here the safeguards that you will put in place to mitigate any
potential pressure to participate.

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f) In chronological order (if possible) describe the steps in the recruitment process.
(Include how you will screen potential participants where applicable). Consider where in
the process permission of other bodies may be required.

3. Power Relationships (Dual-Role and Power-Over)

If you are completing this section, please refer to the:


Guidelines For Ethics in Dual-Role Research for Teachers and Other Practitioners and the
TCPS 2, Article 3.1 and Article 7.4.
Are you or any of your co-researchers in any way in a power relationship, including dual-
roles, that could influence the voluntariness of a participant’s consent? Could you or any of
your co-researchers potentially be perceived to be in a power relationship by potential
participants? Examples of “power relationships” include teachers-students, therapists-
clients, supervisors-employees and possibly researcher-relative or researcher-close friend
where elements of trust or dependency could result in undue influence.
Yes No Varies

If yes or varies, describe below:


i) The nature of the relationship:

ii) Why it is necessary to conduct research with participants over whom you have
a power relationship:

iii) What safeguards (steps) will be taken to ensure voluntariness and minimize
undue influence, coercion or potential harm:

iv) How will the power or dual-role relationship and associated safeguards be
explained to potential participants:

Recruitment Materials Checklist:


Upload all the documents that you think may be relevant to this section (check those that
are uploaded):
Script(s) – in-person, telephone, 3rd party, e-mail, etc.
Invitation to participate (e.g., Psychology Research Participation System Posting)
Advertisement, poster, flyer
None; please explain why (e.g., consent form used as invitation/recruitment guide)

L. Data Collection Methods


1. Data Collection
Use the following sections in ways best suited to explain your project. If you have more than
one participant group, be sure to explain which participant group(s) will be involved in which
activity/activities or method(s).
a. Which of the following methods will be used to collect data? Check all that apply.

Interviewing participants: Attach draft interview

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in-person questions
by telephone
using web-based technology (explain):
Conducting group interviews or discussions (including
focus groups)
Explain and provide the name of the web-based technology
or technologies (e.g., SurveyMonkey), and see the U.S.
Freedom Act advisory below.
If using a web program (online surveys, video
conferencing etc.) with a server located in the United
States (e.g. SurveyMonkey), or if there are other reasons
that the data will be stored in the US (e.g. use of US-
based cloud technology, sharing data with US colleagues,
etc.),you must inform participants that their responses may
be accessed via the U.S. Freedom Act. Please add the
following to the consent form(s): "Please be advised that
this research study includes data storage in U.S.A. As
such, there is a possibility that information about you that
is gathered for this research study may be accessed
without your knowledge or consent by the U.S.
government, in compliance with the U.S. Freedom Act."

Administering a questionnaire or survey: Attach questionnaire


or survey:
In person by telephone
standardized (one
mail back email with established
web-based* (see below) reliability and validity)
non-standardized
Other, describe: (one that is un-tested,
*If using a web program with a server located in the United adapted or open-
States (e.g., SurveyMonkey), or if there are other reasons ended)
that the data will be stored in the US (e.g., use of US-
based cloud technology, sharing data with US colleagues,
etc.), you must inform participants that their responses
may be accessed via the U.S. Patriot Act. Please add the
following to the consent form(s):
“Please be advised that this research study includes data
storage in the U.S.A. As such, there is a possibility that
information about you that is gathered for this research
study may be accessed without your knowledge or
consent by the U.S. government in compliance with the
U.S. Patriot Act. ”

Administering a computerized task (describe in 8b or attach details)


Observing participants
In 8b, describe who and what will be observed. Include where observations will take
place. If applicable, forward an observational data collection sheet for review.
Recording of participants and data using: Images used for analysis
audio video photos or slides
note taking flipcharts Images used in
data collection sheet (attach) other: disseminating results

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(include release to use


participant images in
consent materials)
Using human samples (e.g., saliva, urine, blood, hair)
Attach your Biosafety Approval, or your correspondence with the Biosafety Committee, to
this application. Note that Research Ethics Approval is contingent on Biosafety Approval.

Using specialized equipment/machines (e.g., ultrasound, EEG, prototypes etc.) or


other. (e.g., testing instruments that are not surveys or questionnaires). Please specify:
.
Using other testing equipment not captured under other categories.
Please specify: .
Collecting materials supplied by, or produced by, the participants (e.g., artifacts,
paintings, drawings, photos, slides, art, journals, writings, etc.)
Please specify: .
Analyzing secondary data or secondary use of data (Refers to information/data that was
originally gathered for a purpose other than the proposed research and is now being
considered for use in research (e.g., patient or school records, personal writings, lesson
plans, etc.).
Secondary data involving anonymized information (Information/data is stripped of
identifiers by another researcher or institution before being shared with the applicant).
Secondary data with identifying information (Data contains names and other
information that can be linked to individuals,( e.g., student report cards, employment
records, meeting minutes, personal writings).
In item 8b describe the source of the data, who the appropriate data steward is, and
explain whether (and how) consent was or will be obtained from the individuals for use of
their data.
Other:
Please specify: .

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b. Provide a sequential description of the procedures/methods to be used in your


research study.
Be sure to provide details for all methods checked in section 8a. Clarify which
procedures/methods will be used for each participant group. Indicate which methods, if
any, will be conducted in a group setting. List all of the research instruments and
interview/focus group questions, and append copies (if possible) or detailed
descriptions of all instruments. If not yet finalized, provide drafts or sample
items/questions.
If using a web program (online surveys, video conferencing etc.) with a server located
in the United States (e.g. SurveyMonkey), or if there are other reasons that the data
will be stored in the US (e.g. use of US-based cloud technology, sharing data with US
colleagues, etc.),you must inform participants that their responses may be accessed
via the U.S. Freedom Act. Please add the following to the consent form(s): "Please be
advised that this research study includes data storage in U.S.A. As such, there is a
possibility that information about you that is gathered for this research study may be
accessed without your knowledge or consent by the U.S. government, in compliance
with the U.S. Freedom Act."

c. Where will participation take place for each data collection method/procedure? Provide
specific location, (e.g., UVic classroom, private residence, participant’s workplace).
Clarify the locations for each participant group and/or each data collection method.

d. For each method, and in total, how much time will be required of participants? Clarify
this for each participant group, each data collection method, and any other research
related activities.

e. Will participation take place during participants’ office/work hours or


instructional time?

No Yes. Indicate whether permission is required (e.g., from workplace


supervisor, school principal, etc.) and how this will be obtained:
.

2. Data Collection Methods Checklist:


Make sure that you have uploaded all the documents relevant to this section. Add any other
documents that you think may be relevant to this section.
Standardized Instrument(s)
Survey(s), Questionnaire(s)
Interview and/or Focus Group Questions
Observation Protocols
Other:

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M. Possible Benefits, Inconveniences, and Risks of Harm to Participants


1. Benefits
Identify any potential or known benefits associated with participation and explain below.
Keep in mind that the anticipated benefits should outweigh any potential risks.
To the participant To society To the state of knowledge

2. Inconveniences
Identify and describe any known or potential inconveniences to participants:
Consider all potential inconveniences, including total time devoted to the research.

3. Level of Risk

The TCPS 2 definition of “minimal risk research” is as follows:


“Research in which the probability and magnitude of possible harms implied by
participation in the research is no greater than those encountered by the participant in
those aspects of their everyday life that relate to the research.”
Based on this definition, do you believe your research qualifies as “minimal risk research”?

Yes it is minimal risk. No, it is not minimal risk.


Explain your answer with reference to the risks of the study and the vulnerability of the
participants:

4. Estimate of Risks of Harm


Consider the inherent foreseeable risks associated with your research protocol and
complete the table below by putting an X in the appropriate boxes. Be sure to take into
account the vulnerability of your target population(s) if applicable:

Potential Risks of Harm Very Possibly Likely


unlikely

i) Emotional or psychological discomfort, such as feeling


demeaned or embarrassed due to the research

ii) Fatigue or stress

iii) Social risks, such as stigmatization, loss of status,


privacy and/or reputation

iv) Physical risks such as falls

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v) Economic risk (e.g., job security, salary loss, etc.)

vi) Risk of incidental findings (See Article 3.4 of the


TCPS 2 for more information)

vii) Other risks:

5. Possible Risks of Harm


If you indicated in Item 12 (i) to (vii) that any risks of harm are possible or likely, please
explain below:
13a. What are the risks? (i.e., elaborate on risks you have identified above)

13b. What will you do to try to minimize, mitigate, or prevent the risks?

13c. How will you respond if the harm occurs? (i.e., what is your plan?)

13d. If you have indicated that there is a risk of Incidental Findings (vi) please outline your
proposed protocol for information and/or action.

13e. If one or more of your participant groups could be considered vulnerable please
describe any specific considerations you have built into the protocol to address this.

6. Risk to Researcher(s)
14a. Does this research study pose any risks to the researchers, assistants and data
collectors?

14b. If there are any risks, explain the nature of the risks, how they will be minimized, and
how you will respond if they occur.

7. Deception
Will participants be fully informed of everything that will be required of them prior to the start
of the research session?
Yes No (If no, complete the Request to Use Deception form on the
ORS website)

N. Incentives, Reimbursement and Compensation


1. Is there any incentive, monetary or otherwise, being offered for participation in the
research (e.g., gifts, honorarium, course credits, etc.)
Yes No
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If yes, explain the nature of the incentive(s) and why you consider it necessary. Also
consider whether the amount or nature of the incentive could be considered a form of
undue inducement or affect the voluntariness of consent. Clarify which participant groups
will be provided with which incentives.

2. Is there any reimbursement or compensation for participating in the research (e.g., for
transportation, parking, childcare, etc.)
Yes No
If yes, explain the nature of reimbursement or compensation and why you consider it
necessary. Also consider whether the amount of reimbursement or compensation could
be considered a form of undue inducement or affect the voluntariness of consent. Clarify
which participant groups will be provided with which kind of reimbursement or
compensation.

3. Explain what will happen to the incentives, reimbursement or compensation if participants


withdraw during data collection or any time thereafter (e.g., compensation will be pro-
rated, full compensation will be given, etc.)

O. Free and Informed Consent


Consent encompasses a process that begins with initial contact and continues through to the
end of the research process. Consult Article 3.2 of the TCPS 2 and Appendix V of the
Guidelines for further information.

1. Participant’s Capacity (Competence) to Provide Free and Informed Consent


Capacity refers to the ability of prospective or actual participants to understand relevant
information presented about a research project, and to appreciate the potential
consequences of their decision to participate or not participate. See the TCPS 2, Chapter 3,
section C, for further information.
Identify your potential participants: (Check all that apply.)

Competent Non-Competent
Competent adults Non-competent adults:
A protected or vulnerable population (e.g., Consent of family/authorized
inmates, patients) representative will be obtained
Assent of the participant will be
obtained (note that assent of the
participant is always required)
Competent youth aged 13 to 18: Non-competent youth:
Consent of youth will be obtained and Consent of parent/guardian
parental/guardian consent is required,
due to institutional requirements (such Assent of the youth will be obtained
as school districts) or due to the (note that assent of the participant is
nature of the research (e.g., risks, always required)
etc.)
Consent of youth will be obtained,
parents/guardians will be informed
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Consent of youth will be obtained,


parents/guardians will NOT be
informed
Other, explain:
Competent children under 13 (who are Non-competent children (young children
able to provide fully informed consent): and/or children with limited abilities to
Consent of child will be obtained and provide fully informed consent):
consent of parent/guardian will be
obtained Consent of parent/guardian

Other, explain: Assent of the child will be obtained


(note that assent of the participant is
always required)

2. Means of Obtaining and Documenting Consent and/or Assent:

Check all that apply, consider all of your participant groups, attach copies of relevant
materials, complete item 19:
Signed consent (Attach consent form(s) - see template available )
Verbal consent (Attach verbal consent script(s) - see template available.)
Explain in 19 why written consent is not appropriate and how verbal consent will be
documented.
Letter of Information for Implied consent (e.g., anonymous, mail back or web-based
survey. Attach information letter, see template)
Signed or Verbal assent for non-competent participants (Attach assent form(s), or
verbal assent script(s)).
Explain how verbal assent will be documented in 19.
Other means. Explain in 19 and provide justification.
Consent will not be obtained. See TCPS 2 Articles 3.5 and 3.7. Explain in 19.
Signed consent from the parents/guardians for youth/child participants (Attach consent
form(s)).

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Explain how parents/guardians will provide informed consent for child/youth participants
in 19.
Information letters for the parents/guardians of youth/child participants (Attach
information letter(s)). If consent will not be obtained from parents/guardians and the
parents/guardians will not be informed, explain why not in 19.
3. Informed Consent
Describe the exact steps (chronological order) that you will follow in the process of
explaining, obtaining, and documenting informed consent. Ensure that consent procedures
for all participant groups are identified (e.g., group 1 - teachers, group 2 – parents, group 3
– students). Be sure to indicate when participants will first be provided with the consent
materials (e.g., prior to first meeting with the researcher?). If consent will not be obtained,
explain why not with reference to the TCPS 2 Articles 3.5 and 3.7.

4. Ongoing Consent
Article 3.3 of the TCPS 2 states that consent shall be maintained throughout the research
project. Complete this section if the research involves interacting with participants over
multiple occasions (including review of transcripts, etc.), has multiple data collection
activities, and/ or occurs over an extended period of time.
Will your research occur over multiple occasions or an extended period of time (including
review of transcripts)?
Yes No
If yes, describe how you will obtain and document ongoing consent. If consent procedures
differ for each group or activity, please clarify each group or activity that you are referring to.

5. Participant’s Right to Withdraw


Article 3.1 of the TCPS2 states that participants have the right to withdraw at any time and
can withdraw their data and human biological materials.

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a. Describe what participants will be told about their right to withdraw from the research at any
time (i.e., who to contact and how). If compensation is involved, explain what participants
will be told about compensation if they withdraw. If you have different participant groups
and/or different data collection methods, clarify the different procedures for withdrawing as
necessary.

b. What will happen to a person’s data if s/he withdraws part way through the study or after the
data have been collected/submitted? If applicable, include information about visual data
such as photos or videos. If you have different participant groups and/or different data
collection methods, clarify the different procedures for withdrawing as necessary. Ensure
this information is included in the consent documents.
Participant will be asked if he/she agrees to the use of his/her data. Describe how this
agreement will be documented:

It will not be used in the analysis and will be destroyed.


It is logistically impossible to remove individual participant data (e.g., anonymously
submitted data).
When linked to group data (e.g., focus group discussions), it will be used in summarized
form with no identifying information.

Free and Informed Consent Checklist:


Please make sure that you have uploaded all the documents relevant to this section. Add
any other documents that you think may be relevant to this section.
Consent and Assent Form(s) – Include forms for all participant groups and data gathering
methods
Letter(s) of Information for Implied Consent
Verbal Consent and Assent Scripts

P. Anonymity and Confidentiality


1. Anonymity
Anonymity means that no one, including the principal investigator, is able to associate
responses or other data with individual participants.
a. Will the participants be anonymous in the data gathering phase of research?
Yes No

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b. Will the participants be anonymous in the dissemination of results (be sure to consider
use of video, photos)?
Yes
Maybe. Explain below.
No. If anonymity will not be protected and you plan to identify all participants with
their data, provide the rationale below.

2. Confidentiality
Confidentiality means the protection of the person’s identity (anonymity) and the protection,
access, control and security of his or her data and personal information during the
recruitment, data collection, reporting of findings, dissemination of data (if relevant) and after
the study is completed (e.g., storage). The ethical duty of confidentiality refers to the
obligation of an individual or organization to safeguard entrusted information. The ethical
duty of confidentiality includes obligations to protect information from unauthorized access,
use, disclosure, modification, loss or theft.
a. Are there any limits to protecting the confidentiality of participants?
No, confidentiality of participants and their data will be completely protected
Yes, there are some limits to the researcher’s ability to protect the confidentiality
of participants (Check relevant boxes below.)
Limits due to the nature of group activities (e.g., focus groups): The
researcher cannot guarantee confidentiality
Limits due to context: The nature or size of the sample from which
participants are drawn makes it possible to identify individual participants
(e.g., school principals in a small town, position within an organization)
Limits due to selection: The procedures for recruiting or selecting participants
may compromise the confidentiality of participants (e.g., participants are
identified or referred to the study by a person outside the research team)
Limits due to legal requirements for reporting (e.g., legal or professional)
Limits due to local legislation such as the U.S.A. Patriot Act (e.g., when there
will be data storage in the United States). When using USA based data
instruments and data storage systems researchers are responsible for
determining if this applies.
Other:

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b. If confidentiality will be protected, describe the procedures to be used to ensure the


anonymity of participants and for preserving the confidentiality of their data (e.g.,
pseudonyms, changing identifying information and features, coding sheet, etc.) If you
will use different procedures for different participant groups and/or different data
methods be sure to clarify each procedure.

c. If there are limits to confidentiality indicated in section 24a. above, explain what the
limits are and how you will address them with the participants. If there are different
procedures for different participant groups and/or different data collection methods, be
sure to clarify each procedure.

Q. Use and Disposal of Data


1. Use(s) of Data
a. What use(s) will be made of all types of data collected (field notes, photos, videos,
audiotapes, transcripts, etc.)?

b. Will your research data be analyzed, now or in future, by yourself for purposes other
than this research project?
Yes No Possibly
If yes or possibly, indicate what purposes you plan for this data and how will you obtain
consent for future data analysis from the participants (e.g., request future use in
current consent form)?

c. Will your research data be analyzed, now or in future, by other persons for purposes
other than explained in this application?
Yes No Possibly

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e. If yes or possibly:
i) Indicate whether the data will contain identifiers when it is provided to the other
researchers or whether it will be fully anonymous (note that “fully anonymous”
means that there is no identifying information, links, keys, or codes that allow the
data to be re-identified).

ii) How will you obtain consent from the participants for future data analysis by other
researchers? (If the data will be transferred in fully anonymous form, this request for
future use can be made in the current consent form. If the data will contain
identifiers or links/keys/codes for re-identification, consider requesting permission to
contact the participants in the future, to obtain consent for the use of the data at that
time).

2. Commercial Purposes
a. Do you anticipate that this research will be used for a commercial purpose?
Yes No

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b. If yes, explain how the data will be used for a commercial purpose:

c. If yes, indicate if and how participants will benefit from commercialization.

3. Maintenance and Disposal of Data


Describe your plans for protecting data during the project, and for preserving, archiving, or
destroying all the types of data associated with the research (e.g., paper records, audio or
visual recordings, electronic recordings, coded data) after the research is completed:
a. means of storing and securing data (e.g., encryption, password protected computer
files, locked cabinet, separation of key codes from raw data etc.):

b. location of storing data (include location of data-storage servers if using web-based


technology):

c. duration of data storage (if data will be kept indefinitely, explain why this is necessary
and state whether the data will contain identifiers or links to identifiers):

d. methods of destroying or archiving data. If archiving data, please describe measures


to secure or protect the data. If the archiving will involve a third party (e.g., library,
community agency, Aboriginal band, etc.) please provide details:

4. Dissemination
How do you anticipate disseminating the research results? (Check all that apply)
Thesis/Dissertation/Class presentation
Presentations at scholarly meetings Published article, chapter or book
Internet (Students: Most UVic Theses are posted on “UVicSpace” and can be accessed
by the public)
Media (e.g., newspaper, radio, TV)
Directly to participants and/or groups involved. Indicate how: (e.g., report, executive
summary, newsletter, information session):
Other, explain:

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R. Conflict of Interest
a. Apart from a declared dual-role relationship (Section K, item 7), are you or any of the
research team members in a perceived, actual or potential conflict of interest regarding
this research project (e.g., partners in research, private interests in companies or other
entities)?
Yes No
b. If yes, please provide details of the conflict and how you propose to manage it:

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