Human Research Ethics Board
Application for Ethics Approval for
Human Participant Research	

The following application form is an institutional protocol based on the
Tri-Council Policy Statement on the Ethical Conduct for Research Involving Humans
Instructions: 
1.	Download this application and complete it on your computer. Hand written applications will not be accepted. The ethical review process takes 4 - 6 weeks.
2.	Use the Human Research Ethics Board Guidelines to complete this application. Note: This form is linked to the guidelines. Access links in blue text by hitting CTRL and clicking on the blue text.
3.	Submit one (1) original and two (2) copies of this completed, signed application with all attachments to:  Human Research Ethics, Administrative Services Building (ASB), Room B202, University of Victoria, PO Box 1700 STN CSC, Victoria BC  V8W 2Y2 Canada
4.	If you need assistance, contact the Human Research Ethics Assistant at (250) 472-4545 or ethics@uvic.ca
5.	Please note that applications are screened and will be returned to the applicant if incomplete (e.g. missing required attachments, signatures, documents).
6.	Once approved, a Request for Renewal must be completed annually for on-going projects for continuing Ethics approval.  
 A.	Principal Investigator
If there is more than one Principal Investigator, provide their name(s) and contact information below in Section B, Other Investigator(s) & Research Team.
Last Name:      	First Name:      	
Department/Faculty:      	Email:      
Phone:      	Fax:      
Mailing Address including Postal Code:     
(if different from Dept/Faculty) 	
Title/Position:
	 Faculty	 Undergraduate	 Ph.D. Student 
	 Staff	 Master’s Student 	 Post-Doctoral
Students: Provide your Supervisor’s:	
Name:      	Email:      
Department/Faculty:      	Phone:      
Graduate Students: Provide your Graduate Secretary’s email address:      
B.	Project Information
Project Title:      
Anticipated Start Date:      	Anticipated End Date:      
Geographic location(s) of study:      
Keywords:	1.      	2.      	3.      	4.      

Is this application connected/associated/linked to one that has been recently submitted?  Yes	 No
If yes, provide further information: 

Other Investigator(s) and Research Team:
(Include co-investigators, students, employees, volunteers, community organizations. The form will expand.)
Contact Name	Role in Research Project	Institutional Affiliation	Email or Phone	
     	     	     	     	
     	     	     	     	
	     	     	     	
For Faculty Only: Graduate Student/Research Assistant who will use this data to fulfill UVic thesis/ dissertation/ academic requirements. 

Student/Research Assistant	Email or Phone	
     	     	
     	     	
C.	Agreement and Signatures
Principal Investigator and Student Supervisor affirm that:
•	I have read this application and it is complete and accurate.
•	The research will be conducted in accordance with the University of Victoria regulations, policies and procedures governing the ethical conduct of research involving human participants.
•	The conduct of the research will not commence until Ethics approval has been granted.
•	The researcher(s) will seek further HREB review if the research protocol is modified.
•	Adequate supervision will be provided for students and/or staff.
Principal Investigator	Student’s Supervisor

Signature	Signature

Print Name	Print Name

Date	Date

Chair, Director or Dean 
I affirm that adequate research infrastructure is available for the conduct and completion of this research.

Signature

Print Name

Date

D.	Project Funding
Have you applied for funding for this project?	 Yes	 No
Has notice of award been received?	 Yes	 No
If yes, please complete the following:
Source(s) of Project Funding	Project Title used in Funding Application(s)	
     	     	
     	     	
     	     	
     	     	
Will this project receive funding from US Funders (e.g. NIH)?             Yes	  No
If yes, provide further information: 

E.	Level of Risk
The Tri-Council Policy Statement (TCPS) definition of “minimal risk” is as follows:
The research can be regarded as within the range of minimal risk if potential participants 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 participant in those aspects of his or her everyday life that relate to the research. The designation of minimal or non-minimal risk affects the way the application is reviewed not the substance of the ethical review.”
Based on this definition, do you believe your research qualifies as “minimal risk” research?	
	 Yes		 No
Explain your answer by referring to the level of risk stated in the TCPS definition:
     	
F.	Scholarly Review
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	
 Other, please explain:
     	
G.	Other Approvals and Consultations
Do you need to seek approval from other agencies, community groups, First Nations, local governments, etc?
	 Yes		 No
(Attach proof of having made request for permission or approval letter. Please forward approvals upon receiving them. Be assured that ethics approval may be granted prior to receipt of external approvals.)
If Yes, what types of other approval will you need?
 School District, Superintendent, Principal, Teacher
 VIHA or other regional government authority. If you are planning to conduct research (including recruitment via poster placement), in a VIHA facility you must use the Joint UVic/VIHA application form on the ORS website. Above minimal risk applications, please contact the Ethics Office.
 Community Group (e.g., formal organization, informal collective)
 Indigenous Organization (e.g., Treaty Group, Tribal Council) 
 Indigenous Community 
Approval from an Indigenous community or organization may be required when the research involves Indigenous people in relation to their community or organizational affiliation (whether residing in urban or reserve areas), the cultural knowledge and/or resources of Indigenous people, or where individuals speak on behalf of an Indigenous community or nation.
a.	Does your research specifically involve or include in the study’s population sample individuals from an Indigenous community or organization?
 Yes	 No
b.	Will a particular Indigenous community, group of communities, or organization be a central focus of the research?
 Yes		 No
c.	Will the cultural knowledge, resources or heritage of an Indigenous community be a central focus of the research?
 Yes		 No
d.	If you answered “yes” to questions a), b), or c) have you consulted with the Indigenous community or communities for this study?
 Yes	 No
e.	If you answered “yes” to question d), describe the process that you have followed or will follow. Include any documentation of consultations and the role or position of those consulted, including their names if appropriate.
     	
f.	If you answered “no” to question d), briefly justify your decision not to seek Indigenous community approval.
               
 UVic Biosafety Committee Approval. Please attach Biosafety Human Materials Form to this application. Note that Ethics Approval is contingent on Biosafety Approval.

 Other Approval, please explain:
     	
 H.	  Description of Research Project
1.	Purpose and Rationale of Research
Briefly describe in non-technical language: 
Please use 150 words or less. The form will expand to the length of your answers.
1a.	The research objective(s) and question(s)
     	
1b.	The importance and contributions of the research
          
1c.	If applicable, provide background information or details that will enable the HREB to understand the context of the study when reviewing the application.
     	
I.	Recruitment
2.	Recruitment and Selection of Participants 
2a.	Briefly describe the target population(s) for recruitment. Ensure that all participant groups are identified (e.g. group 1 - teachers, group 2 - administrators, group 3 - parents).
     	
2b.	Why is this population of interest?
     	
2c.	What is the desired number of participants? 
     	
2d.	What are the salient characteristics of the participants (e.g. age, gender, race, ethnicity, class, position, etc.):
     	
2e.	Provide a detailed description of your exact recruitment process. Explain:
i)	Who will recruit/contact participants (e.g. researcher, assistant, third party)
     	
ii)	List and explain any relationship between the investigator(s) and participant(s) (e.g. aquaintences, colleagues). Complete item 3 if there is a power over relationship (e.g. instructor-student, manager-employee). 
     	
iii)	Describe how recruitment will be done (e.g. in person, by telephone, letter, snowball sampling, word of mouth, advertisement) and from what source(s) will the participants be recruited. If applicable, include how contact information for participants will be obtained.
     	
iv)	Describe the steps in the recruitment process.
     	
v)	Indicate whether the permission of other bodies is required for recruitment (e.g. school boards).
     	
3.	Power-Over

If you are completing this section, please refer to the: 
Guidelines For Ethics in Dual-Role Research for Teachers and Other Practitioners
Are you or any of your co-researchers in any way in a position of authority or power over participants? Examples of a “power-over” situation include teachers-students, therapists-clients, supervisors-employees and possibly researcher-relative or researcher-close friend.
 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 power.
iii)	What safeguards (steps) will be taken to minimize inducement, coercion or potential harm.
iv)	How the dual-role relationship and the safeguards will be explained to potential participants.
     

Recruitment Materials Checklist:
Attach all documents referenced in this section (check those that are appended):
 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) 
     
J.	Data Collection Methods
4.	Data Collection
For community-based research, autobiographical or observational research, please see Appendix III of the Guidelines. 
4a.	Which of the following methods will be used to collect data? Check all that apply.
 Interviewing participants:
 in-person
 by telephone
 using web-based technology (explain)
 Conducting group interviews or discussions (including focus groups)	 Attach draft interview questions	
 Administering a questionnaire or survey:
 In person	 by telephone	
 mail back	 email	
 web-based           Other, describe:      	 Attach questionnaire or survey:
 standardized (one with established reliability and validity)
 non-standardized (one that is un-tested, adapted or open-ended)	
 Administering a computerized task (describe in 4b)	
 Observing participants
[In 4b,  describe who and what will be observed. Include where observations will take place.]	
 Recording of participants using:	
 audio	 video	 photos or slides
	 Images used for analysis

 Images used in disseminating results [include release to use participant images in consent materials]	
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).
 Secondary data involving anonymized information (Information/data is stripped of identifiers by another researcher or institution before being shared with the applicant).  May be eligible for Application for a Waiver from Full Ethical Review)
 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 4b describe the source of the data, and explain whether and how consent was obtained from the individuals for use of their data.	
 Using human samples (e.g., saliva, urine, blood, hair)
Ensure that you apply to the Biosafety Committee for the storage and use of biological materials. Also, complete the Human Materials Form, have it signed and attach it to your application. If using human tissue only, skip to 7g-8, 11-end.	
 Other, specify:      

4b.	Provide a sequential description of the procedures/methods to be used in your research study.
List all of the research instruments and interview/discussion questions, and in an appendix provide copies of all instruments. If not yet available, provide drafts or sample items/questions. For multi-method or other complex research, 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.
     	
4c.	Where will participation take place? (Provide specific location, e.g., UVic classroom, private residence, participant’s workplace)
     	
4d. 	How much time will be required of participants?
     

4e. 	Will participation take place during participants’ office hours or instructional time? If so, indicate whether other permission (e.g. from workplace supervisor) is required.
     	

Data Collection Methods Checklist:
Attach all documents referenced in this section (check those that are appended):
 Standardized Instrument(s)
 Survey(s), Questionnaire(s)
 Interview and/or Focus Group Questions
 Observation Tools 
K.	Possible Inconveniences, Benefits, Risks and Harms to Participants
5.	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 state of knowledge
     	
6.	Inconveniences
Identify and describe any known or potential inconveniences to participants:
Consider all potential inconveniences, including time devoted to the research.
     	
7.	Estimate of Risks 
Could this study involve the following? Please answer each question by putting an X in the appropriate boxes:
7a.	Could a participant feel demeaned or embarrassed during their participation in the research?
Very unlikely	Possibly	Likely
7b.	Could a participant feel fatigued or stressed due to the research?
Very unlikely	Possibly	Likely
7c.	Could a participant experience any other emotional or psychological discomfort as a consequence of participation?
Very unlikely	Possibly	Likely
7d.	Is there any social risk, possible stigmatization, loss of status, privacy and/or reputation?
Very unlikely	Possibly	Likely
7e.	Are there any physical risks?
Very unlikely	Possibly	Likely
7f.	Could a participant experience any economic risk? (e.g. job security, job loss)
Very unlikely	Possibly	Likely
7g.	Do you see any chance that participants may be harmed in any other way?  (e.g. risk to community)
Very unlikely	Possibly	Likely

8.	Possible Risks 
If you indicated in Item 7 (a) to (g) that any risks are possible or likely, please explain below:
8a.	What are the risks?
     	
8b.	What will you do to try to minimize or prevent the risks?
     	
8c.	How will you respond if the risk of harm occurs? (e.g. what is your plan?)
     	
9.	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.)
L.	Compensation
10.	Compensation
10a. Is there any compensation for participating in the research (e.g. gifts, honorarium, bonus points, reimbursement for transportation, parking, childcare, etc.)?
 Yes	 No
If yes, explain the nature of the compensation and why you consider it to be necessary: 
Also consider if the amount of compensation could be considered to be a form of inducement.

10b. Explain what will happen to compensation if participants withdraw during or anytime after data collection (e.g. compensation will be pro-rated, full compensation will be given, etc.).	
M.	Free and Informed Consent
The following questions address the competence of participants to give consent, the process used in your research to obtain consent, ongoing consent, and the participants’ right to withdraw. Consult Appendix V of the Guidelines for further information.
11.	Participant’s Capacity (Competence) to Provide Free and Informed Consent
Identify your prospective participants: (Check all that apply.)
Competent	Non-Competent	
 Competent adults
 A protected or vulnerable population (e.g.,       
     inmates, patients)	 Non-competent adults:
      Consent of family/authorized      
           representative will be obtained
      Assent of the participant will be obtained	
 Competent youth
 Youth 13 to 18: consent of youth will be obtained, and parental consent is required due to institutional requirements (e.g. school districts)
 Youth 13 to 16: consent of youth will   
      be obtained, parents will be informed
 Youth 13 to 16: consent of youth will 
      be obtained, parents will NOT be  
      informed
 Youth 17 to 18: consent of youth will 
      be obtained, parents will not be  
      informed
	 Non-competent youth:
       Consent of parent/guardian
       Assent of the youth will be obtained	
 Competent children
 Children under 13: consent of 
      parent/guardian will be obtained, and 
      child consent will be obtained
 Other, explain:      

	 Non-competent children:
       Consent of parent/guardian
       Assent of the child will be obtained	

12.	Means of Obtaining Consent: 									(Check all that apply, attach copies of all consent materials, complete item 13)
 Signed consent. (Attach consent script(s) and consent form(s) - see template available on ORS Website)
 Verbal consent. (Attach information letter(s). Explain below why written consent is not appropriate and how verbal consent will be documented.)
 Implied consent (e.g. anonymous, mail back or web-based survey. Attach information letter, see template)
 Other means. (Explain below and provide justification.)
 Consent will not be obtained. (Please see TCPS Chapter 3. and explain below)
Explain consent procedure if “verbal consent,” “other” or “consent will not be obtained”:
     	
13.	Informed Consent
Describe the exact steps you will follow in the process of explaining and obtaining informed consent.
     
	
14.	Ongoing Consent 
Ongoing consent is required for research that occurs over multiple occasions and/or multiple research activities and/ or extended periods of time (i.e., more than one point of contact, including second interviews, review of transcripts, etc.)
14a. Will your research occur over multiple occasions or an extended period of time?
 Yes	 No
14b. If yes, describe how you will obtain and document ongoing consent:
     	
15.	Participant’s Right to Withdraw
Free and informed consent requires that participants have the right to withdraw at any time without consequence or explanation.
Describe what participants will be told about their right to withdraw from the research at any time.
     	
16.	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.
 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. Include this agreement in the consent form.
 It will be used in the analysis if the participant agrees to this. Describe how this agreement will be obtained:
     	
Free and Informed Consent Checklist:
Attach all documents referenced in this section (check those that are appended):
 Consent Form(s) – Include forms for all participant groups and data gathering methods
 Letter(s) of Information for Implied Consent 
 Verbal Consent Script 
N.	Anonymity and Confidentiality
17.	Anonymity
Anonymity means that no one, including the principal investigator, is able to associate responses or other data with individual participants.
17a.	Will the participants be anonymous in the data gathering phase of research?
 Yes	 No
17b.	Will the participants be anonymous in the dissemination of results (be sure to consider use of video, photos)?
 Yes	 No

18.	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).
18a.	Will the confidentiality of the participants and their data be protected?
 No - If confidentiality will not be protected, explain why. If you are asking the participants to waive their right to confidentiality (you plan to identify them with their data), explain what steps will be taken to respect their privacy, if any.
		     

 Yes, completely
Yes, with limits (Check relevant boxes below.)
	Limits due to the nature of group activities (e.g. focus groups) the researcher can not 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)
	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
	Other:

18b.	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). 
     	
18c.	If there are limits to confidentiality due to the methods (e.g. group interview), sample size or legal requirements (e.g. reporting child abuse) so that you cannot guarantee confidentiality, explain what the limits are and how you will address them with the participants:
     	
O.	Use and Disposal of Data
19.	Use(s) of Data
19a.	What use(s) will be made of all forms of data collected (field notes, photos, videos, audiotapes, transcripts, etc.)?
     	
19b.	Will your research data be analyzed, now or in future, by yourself for purposes other than this research project?
 Yes	 No	 Possibly
19c.	If yes or possibly, how will you obtain consent for future data analysis from the participants (e.g. request future use in current consent form)?
     	
19d.	Will your research data be analyzed, now or in future, by other persons for purposes other than explained in this application?
 Yes	 No	 Possibly
19e.	If yes or possibly, by whom and how will you obtain consent from the participants for future data analysis by other researchers (e.g. request future use in current consent form)?
     	
20.	Commercial Purposes
20a.	Do you anticipate that this research will be used for a commercial purpose?
 Yes	 No
20b.	If yes, explain how the data will be used for a commercial purpose:
     	
20c.	If yes, indicate if and how participants will benefit from commercialization. 
     	
21.	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:
21a.	means of storing data (e.g., a locked filing cabinet, password protected computer files):
     	

21b.	location of storing data:
     	

21c.	duration of data storage (if data will be kept indefinitely, explain):
     	

21d.	methods of destroying or archiving data:
     	
22.	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	 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: 
     	
P.	Researchers
23.	Conflict of Interest
23a.	Apart from a declared dual-role relationship (Section I, item 3), 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
23b.	If yes, please provide details of the conflict and how you will manage it:
     	
24.	Researcher(s) Qualifications	
In light of your research methods, the nature of the research and the characteristics of the participants, what training or qualifications do you and/or your research team have (e.g. research methods course, language proficiency, committee expertise)?
     	
25.	Risk to Researcher(s)
25a.	Does this research study pose any risks to the researchers, assistants and data collectors?
     	
25b.	If there are any risks, explain the nature of the risks, how they will be minimized, and how they will be responded to if they occur.
     	
Q.	Further or Special Questions
26.	Multiple Site Research
26a. 	Does this project involve collection of data at multiple sites within Canada requiring the approval of other sites, bodies or organizations (e.g., other ethics board(s))?
 Yes	 No
26b.	If you responded Yes to 27a. above, list the sites, bodies or organizations:
      	
27.	International Research
27a.	Will this study be conducted in a country other than Canada?
 Yes	 No
27b.	If yes, describe how the laws, customs and regulations of the host country will be addressed:
     	

Attachments*

*Ensure that all applicable attachments are included with all copies of your application. 
Incomplete applications will not be processed and will be returned to the applicant.

Information for Submission
•	Applications may be printed and submitted double-sided
•	Do not staple the original application with original signatures
•	The two photocopies may be individually stapled or clipped
•	Do not staple or clip the individual appendices

Title and label attachments as Appendix 1, 2, 3 etc. and attach the following documents (check those that are appended):

Section I - Recruitment Materials:
 Script(s) – in-person, telephone, 3rd party, e-mail, etc.
 Invitation to participate 
 Advertisement, Poster, Flyer 

Section J - Data Collection Methods:
 Standardized Instrument(s)
 Survey(s), Questionnaire(s)
 Interview and/or Focus Group Questions
 Observation Tools 

Section M - Free and Informed Consent:
 Consent Form(s) – Include forms for all participant groups and data gathering methods
 Letter(s) of Information for Implied Consent 
 Verbal Consent Script 

 Approval from external organizations (or proof of having made a request for permission)
 Permission to gain access to confidential documents or materials
 Request to Use Deception form
 Human Materials Form
 Other, please describe: