Human Research Ethics Board
Undergraduate Student Request for Ethical Review 2015 - 2016
Please complete the form and submit it to the appropriate Department Research Ethics Committee (DREC), then
print out the first page only, sign, and send to the Research Office G290. Handwritten forms will not be accepted.
Please click here for instructions on the HREB process for students.
Click in the text fields to enter your information. Sections will expand to accommodate your entry. Click on the
check boxes to select. If a section does not apply, please answer N/A.
Signatures
Principal Investigator or Faculty Advisor
Date:
___________________________________
Received at the Research Office by
______________________________________
Date:
___________________________________
______________________________________
A. Project Summary Information
1. Student Researcher(s) (regardless of institution): Click here to enter text.
UFV Student Number: Click here to enter text.
2. Faculty Instructor/Supervisor: Click here to enter text.
3. Department or Program Click here to enter text.
Course Number and Title Click here to enter text.
4. Contact Information
Phone: Click here to enter text.
Email: Click here to enter text.
Campus: Choose an item.
If other, please type the institution’s mailing address: Click here to enter text.
5. Title of Project: Click here to enter text.
6. Institution(s) or Partners Involved in the Project: Click here to enter text.
7a. Project Period (duration of the research project – use the drop down):
Click here to enter a date. to Click here to enter a date.
7b. Data collection period (make this date 3 weeks after submission – use the drop down):
Click here to enter a date. to Click here to enter a date.
8. Granting Agency or Source of Funds: Click here to enter text.
(if deliverables are promised to the agency
please give details in Box 27)
9. Summary of Objectives, Intended Outcomes, and Dissemination of Results (two or three
paragraphs):
Click here to enter text.
B. Description of Participants
10. How many total participants are expected? Click here to enter text.
11. How many in control group? Click here to enter text.
12. Who is recruited and what are the criteria?
Click here to enter text.
13. How are participants recruited and by whom? (If initial contact is by letter, poster, or email, please include a
copy – e.g. script of email.) Click here to enter text.
14a. What participants are excluded? Click here to enter text.
14b. Please explain why these participants are excluded: Click here to enter text.
C. Project Methodology
15. Detailed summary of methodology (step by step detailed summary of methodology from
recruitment to end of study):
Click here to enter text.
16a. Who will collect the data? Please name them. Click here to enter text.
16b. What are their qualifications/credentials? Click here to enter text.
17. Where will the data gathering take place?
☐ On campus
☐ Off campus
☐ Online
Explain (e.g. where off campus or by what online means): Click here to enter text.
D. Deception
18a. Deception (if no deception is being used put N/A)
Deception undermines informed consent. Indicate below why you believe deception is necessary to
achieve your research objectives and why you believe that the benefits of the research outweigh the
cost to the participants:
Click here to enter text.
18b. What measures will you take to ensure that there is no permanent damage as a result of the
deception:
Click here to enter text.
18c. Describe how you will debrief participants in a study that involves deception: Click here to enter
text.
E. Potential Risks and Benefits:
Your research project may cause negative reactions or inconveniences to the research participants. Each person
reacts differently to experiences. It is important to foresee possible negative reactions or inconveniences to
prevent any practical problems when obtaining free and informed consent, and describe how the risks will be
managed.
Risks may include:
·
Physical (muscle pain, tiredness, weakness, nausea);
·
Psychological or emotional (self-image issues, loss of confidence, anxiety, regret for disclosing
information, disruption of routine);
·
Legal or social (risk of marginalization, being judged, being sued);
·
Economic or other inconvenience (expenses, long travel to research site, time consumed);
·
Any risks to participants greater than those the participant might encounter in everyday life.
·
Vulnerability or ability to give consent (i.e., minors).
·
Inability to ensure confidentiality or anonymity
Please supply sufficient evidence for the HREB to determine the risk level and the benefits of the research.
If an adverse event were to occur during the procedures of the protocol that was not described in this form,
the ethics checklist, and the informed consent, then an adverse event form must be completed and the
research may, but not necessarily, be put on hold if changes are needed.
Please make sure that you have obtained Biosafety approval if your research project requires it.
***Please read the TCPS2 document, Chapter 2 part B: Approach to Research Ethics Board Review for guidelines
on minimal risk and the concepts of risks and benefits.
<Except from TCPS2>
Potential Benefits
Research involving humans may produce benefits that positively affect the welfare of society as a whole through the
advancement of knowledge for future generations, for participants themselves or for other individuals. However, much
research offers little or no direct benefit to participants. In most research, the primary benefits produced are for society and
for the advancement of knowledge.
Risks
Because research is a step into the unknown, its undertaking can involve harms to participants and to others. Harm is
anything that has a negative effect on the welfare of participants, and the nature of the harm may be social, behavioural,
psychological, physical or economic.
Risk is a function of the magnitude or seriousness of the harm, and the probability that it will occur, whether to participants
or to third parties (as outlined below). A proper ethical analysis of research should consider both the foreseeable risk and
the available methods of eliminating or mitigating the risk.
For the purposes of this Policy, “minimal risk” research is defined as research in which the probability and magnitude of
possible harms implied by participation in the research is no greater than those encountered by participants in those aspects
of their everyday life that relate to the research.
19a. What are the benefits of the proposed research to the participant and to the research
community?
Click here to enter text.
19b. What are the risks of the proposed research to the participant and to the research community?
Click here to enter text.
☐ I believe my research is minimal risk according to the TCPS2 guidelines above;
20. Describe how you have minimized risks (please put N/A if not applicable): Click here to enter text.
21. What discomfort or incapacity may the participants experience? Click here to enter text.
22. Is monetary or other form of compensation offered to participants (e.g. gift card, meal, extra
marks, etc.)?
☐ No
☐ Yes (please explain): Click here to enter text.
23. How much time will participants expend on the project? Click here to enter text.
E. Data Security and Destruction
24. Please name who will have access to the raw data: Click here to enter text.
25. How and where will the data be stored such that privacy and confidentiality are maintained (e.g.
locked cabinet or offices, password protected computer or drive, etc.)?
Click here to enter text.
26. Are there any other uses of the data planned beyond those stated in Box 9? If yes, please explain.
Click here to enter text.
27a. Will the raw data be destroyed?
☐Yes
☐No (please explain) Click here to enter text.
27b. If yes, how will all forms of the raw data be destroyed? Click here to enter text.
27c. Approximately when will the raw data be destroyed (month/year)?
Click here to enter text.
28a. How will participants be able to withdraw from your study? Click here to enter text.
28b. What will happen to their data? Click here to enter text.
29. Will any identifiable data be available to non-participants?
☐ No
☐ Yes (explain): Click here to enter text.
30. What are the plans for feedback to the participants (e.g. final report, summary, nothing)?
Click here to enter text.
31. Please check what your project will use:
☐ Questionnaire (attach a copy)
☐ Interview (attach a copy)
☐ Observations
☐ Test Instruments (attach a copy if possible)
☐ Review of records
☐Other (please describe) Click here to enter text.
G. Funding – skip to section H if there is no funding
32. Name of organization or source of funds:
☐ Internal
☐ External
33. Funds administered by: Click here to enter text.
34. Status: Choose an item.
35. Peer Review: ☐ Yes
☐ No
36. Start Date (use drop down): Click here to enter a date.
End Date (use drop down): Click here to enter a date.
H. Informed Consent
37. Who will consent (check all that apply)?
☐ Participant
☐ Parent/Guardian
38. How will consent be obtained – verbally, written, constituted by completion of survey, etc?
Click here to enter text.
39a. Have you covered all possible uses of data in the informed consent?
☐ Yes ☐ No
39b. If no, please explain: Click here to enter text.
40a. Will the participants have difficulty giving truly informed consent (consent cultural norms and
populations who are vulnerable due to age, language, mental ability and literacy)?
☐ No
☐Yes – explain Click here to enter text.
40b. If participants are unable to give consent, who is giving consent on their behalf?
Click here to enter text.
41. If this project is carried out at institutions other than UFV, guidelines at all universities must be
adhered to. A copy of consent and/or ethics approval of the other institutions(s) must be attached
(check all that apply).
☐ Hospital
☐ School (from School Board/Principal)
☐ Provincial Government Agency
☐ Other (give details below)
Click here to enter text.
42. Participant consent is required for all projects. Use the example consent form (found at
www.ufv.ca/research/forms) and this checklist to ensure you include everything you need in your
consent form. Check items in the following list to ensure that the consent or information letter
contains all required items.
☐ UFV Letterhead
☐ Title of the project
☐ Identification of investigators including phone numbers
☐ Assurance of confidentiality and description of how
☐ If any questions contain sensitive subject matter, a statement forewarning participants must be
included
☐ Details of compensation, if applicable
☐ A statement of the participant’s right to refuse to participate or withdraw at any time (for research
conducted at schools, state what will happen to children whose parents do not consent)
☐ A place for the participants signature if written consent is obtained
☐ Brief but complete description in lay language of the purpose of the project and all procedures
☐ Statement of risks and benefits
☐ Statement of time required of participant
☐ Offer to answer questions and to provide debriefing
☐ A statement that they may contact Adrienne Chan, Associate Vice-President of Research,
Engagement, and Graduate Studies at UFV, 604-557-4074 or Adrienne.Chan@ufv.ca if they have any
concerns regarding their rights or welfare as a participant in this research.
☐ A place for the date consent was given (if written consent if obtained)
☐ A statement that the ethics of this research project have been reviewed and approved by the UFV
Human Research Ethics Board
44. Attachments. Check and attach all that apply. A missing document may hold up your application.
☐ Hospital Ethics Committee Consent ☐ Deputy Minister Consent
☐ Questionnaire
☐ Observation description
☐ Project or thesis proposal
☐ Informed Consent/Letter of Information
☐ School Consent
☐ Interview
☐ Test instruments
☐ Recruitment tools (letter, poster, telephone or personal contact script, etc.)
☐ Other (give details below)
Click here to enter text.
Ethics Checklist1 2015-2016
Instructions: Please left click to select the appropriate answer. Note: If you are uncertain which
answer best pertains to your project you MUST check the highlighted response.
If you have selected any highlighted response, please provide comments to clarify your choice, referring
to the checklist number.
Yes
1.
2.
4.
Will persons 18 years or younger be involved in your research*?
Will participants be informed of the nature of their involvement in the
collection of data and all features of the research that reasonably might be
expected to influence willingness to participate?
Will participants be told that they can discontinue their participation at any
time without penalty?
Will the participants’ right to withdraw their data be respected?
5.
Does the study involve concealment from and/or deception of the participants?
6.
Will deception be used to obtain agreement to participate?
7.
Will participants in your study be aware that they are participants?
8.
Will participants or their guardians be asked to sign consent forms?
9.
11.
Will information about your participants be obtained from third parties (i.e.,
someone other than the investigator)?
Are the investigator or associates of the investigator in a position of power in
relation to the participants?
Is any coercion exerted upon the participants to participate?
12.
Is confidentiality of the participants’ identities positively ensured?
13.
Will the investigator ensure all the promises made to the participants are
fulfilled?
Does the study involve physical stress (or the participants’ expectation thereof),
such as those that might result from heat, noise, electric shock, pain, drugs,
alcohol, or deprivation of sleep, food, or drink?**
Does the study involve mental, psychological or emotional discomfort in the
participants (e.g., fear, anxiety, loss of self-esteem, shame, guilt,
embarrassment, becoming aware of personal weakness)?**
3.
10.
14.
15.
1
Adapted from SFU Ethics Checklist, Dept. of Psychology
No
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
Will all necessary measures be taken to protect the physical safety of
participants (from dangers such as faulty electrical equipment, poor grounding,
lack of oxygen, falls, traffic and industrial accidents, the possibility of hearing or
vision loss, and so forth)?**
Does your research require approval from the Biosafety officer?
Does the study involve participants who are legally, mentally or otherwise not
in a position to give their valid consent to participate (e.g., minors, hospital
patients, etc.)?
Will identifiable information obtained from individual participants be disclosed
to third parties (i.e., someone other than the investigator)?
Could publication of the research possibly jeopardize participant privacy or
confidentiality?
Could publication of the research possibly harm the participants either directly
or through identification with their membership group?
Are there any other aspects of this study that might interfere with the
protection of the well-being and dignity of the participants?
Will the investigator make all efforts to ensure a return to normal relationship
among and between participants and investigator once the collection of data
has been terminated?
Will the investigator ensure that participants understand the process available
to them for registering concerns or complaints?
Will the investigator dispose of the raw data, once the study is completed, in a
way that will safeguard the participants’ right to confidentiality?
*University students could be 18 years or younger, but they are assumed to be able to give free and informed
consent. Regardless, the box must be checked yes.
** If an adverse event occurs during this project, an Adverse Event form must be completed and submitted to the
Research Office by emailing research.ethics@ufv.ca . An adverse event is considered to be any undesirable
experience or response that was not expected and not stated in the informed consent or the original Request for
Ethical Review. This includes anything emotional, psychological, or physiological.
If you have selected any highlighted response, please provide comments (below or on separate page)
to clarify your choice, referring to the checklist number.
Click here to enter text.
Please save and submit the completed form to the Research Office by email: research.ethics@ufv.ca