Request for Course Designation 2017-2018as a Human Research Ethics Board Approved Course. For all courses with research projects or studies involving human participants.
Where there is a "Help" heading, please refer to the Course Designation Help document found here.
Please save and complete the form. Submit the completed form to the Research Office by email:.
Click in the text fields to enter your information, and click on the check boxes to select. Sections will expand to accommodate your entry. If a section does not apply to you, please answer N/A.
Instructions:- When designing a course or assignment for ethics review, remember that it needs to be minimal risk. The Ethics Checklist can help you determine the risk level and can also be used for each project your student brings to you.
- Due to the complexity of course designations, these requests are always reviewed by the full HREB. Please check online for the deadlines for submission to the HREB meetings.
- The instructor is acting on behalf of the HREB and therefore represents research ethics on behalf of UFV. The form is intended to ensure instructors know the issues the HREB looks for when giving approval for projects. The questions in this form are designed to provoke thoughts about potential ethical issues that come up in research.
- The HREB is guided by the UFV Policy for Human Research Ethics and the Tri-Council Policy Statement. It is required that all researchers take the TCPS tutorial. Course instructors are required to keep all CORE certificates on file for HREB review.
- The ethical conduct of research involving humans is a complex and continually evolving discussion; therefore, a new Request for Course Designation will be required when the course designation expires (3 years). New courses must be reviewed at the full board level (check meeting deadlines). Course renewals may be delegated if very little has changed.
- Complete this form and email it to ong with any documents that will be used in the course and project (see Box E).
A. Contact & Course Information
Contact Name/Course DesignerClick here to enter text.
Contact Email (UFV) Click here to enter text.
Department/School Click here to enter text.
Department Head/Director Click here to enter text.
Course Information
Course Prefix & Number Click here to enter text.
Course Name Click here to enter text.
Instructors (if different from above) Click here to enter text.
Instructor Email(s) (if different from above) Click here to enter text.
Course Description (as approved by UEC) Click here to enter text.
B. Course Study/Project Information
*RENEWALS ONLY
Please describe any updates or changes to the course content since it was last approved by the HREB. Major changes may need to be approved by the full board.
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1a. Purpose and objectives of course research assignment
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1b. What are the students doing? Give examples (examples are not meant to be definitive but are meant to set the scope of the project).
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2a. Summary of participant recruitment, informed consent, data collection (briefly describe the ones checked in Box 3 below), dissemination of results, data storage, data destruction, etc.
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2b. Describe the project approval process. Describe the instruction of ethics and ongoing feedback and monitoring. Help.
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3. Check any and all of the following procedures or methods that may be used for this course. Subsequent sections will address each of these procedures and methods.
☐ Audio Tape Recording
☐ Naturalistic Observation
☐ Review of Records
☐ Digital Audio Recording (including smart phones)
☐ Other:
Click here to enter text. / ☐ Autobiography
☐ Focus Groups
☐ Participant Observation
☐ Non-Participant Observation
☐ Secondary Data Analysis
☐ Social Media / ☐ Data Linkage
☐ Interviews
☐ Questionnaire/Survey
☐ Video Recording
4. Where will the research be conducted?
☐ In Class / ☐ Outside class, on campus / ☐ Off campus
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C. Participants and Recruitment
5. For the purposes of this course-based research, describe the anticipated demographic composition (e.g. age, gender, ethnicity, employment, etc.) of the participant population.
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6. If this course-based research specifically excludes any particular demographic group, indicate why such exclusion is necessary.
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7a. Does this course-based research involve participants employed or otherwise under the jurisdiction of any agency, company, or civil service? Help
☐Yes ☐ No
7b. If yes, explain how you would seek approval from these organizations for their participation.
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8a. Will minors or members of other vulnerable groups be recruited to participate in this course research (note that course designations only allow minimal risk projects)?
☐ Yes ☐ No
8b. If yes, describe the nature of the group.
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9. When, how, and by whom will participants be recruited (e.g. random dialing, participant pools, letters, posters of invitations, social media, listservs, personal contacts, convenience, etc.)?
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10a. Is authorization needed to access the contact information from physical or online sources? Help
☐Yes ☐ No
10b. Explain how this will happen: Click here to enter text.
11a. List all physical and online locations where recruitment is likely to take place.
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11b. If recruitment is online, explain how the names and email addresses are obtained. If not, please put N/A.
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12a. Is it possible that observations made as a result of this research include data which are subject to mandatory reporting under the law (e.g. child abuse, criminal activity, etc.)?
☐ Yes ☐ No
12b. If yes, please explain the procedures you will follow to report those observations (note that this will have to be acknowledged in any and all information or consent documents associated with this research).
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13. How much time will participants (not student researchers) be asked to expend on the research?
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14a. Will monetary or other forms of compensation be offered to participants?
☐ Yes ☐ No
14b. If yes, describe the compensation.
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15a. Will this compensation also be available to those who choose not to participate or withdraw from the study?
☐ Yes ☐ No ☐ N/A
15b. If no, please explain why (note that this will have to be acknowledged in any and all information or consent documents associated with this research).
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D. Informed Consent (have students use the template found here)
16a. Will participants be given full and complete disclosure about their involvement in the research?
☐ Yes ☐ No
16b. If no, explain why not.
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17. How will consent be obtained (check all that apply)? Explain each selection below and attach the consent form or letter of information. If informed consent is being secured online or by other electronic means, explain below how participants will give consent.Help
☐ Oral
☐ Online or other electronic means / ☐ Written
☐ N/A / ☐ Passive
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18a. Does the informed consent procedure in this research make it clear that a potential participant may decline to participate without penalty or loss of benefit?
☐ Yes ☐ No
18b. If no, explain why not.
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19a. Does the informed consent procedure in this research include information on the right of the participant to withdraw without penalty or loss of benefit?
☐ Yes ☐ No
19b. If no, explain why not.
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20a. Does the research involve the consent of participants who are not legally, mentally, or otherwise competent to give informed consent? Help
☐ Yes ☐ No
20b. If yes, explain who will give informed consent and by what method.
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21a. Is the researcher or person recruiting participants in a position of authority or trust towards potential participants? Help
☐ Yes ☐ No
21b. If yes, explain the measures the researchers will take to eliminate or minimize the possibility of coercion.
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22a. Is it possible that the research methods and/or informed consent procedure will need to be adapted or modified for specific cultural, social, or ethnic groups? Help
☐ Yes ☐ No
22b. If yes, explain.
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23a. Do the research methods or informed consent procedures require translation?
☐ Yes ☐ No
23b. If yes, explain.
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D. Potential Risks and Benefits:
Student research projects 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 (minors);
Inability to ensure confidentiality of 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 caninvolve 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 researchin 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.
24. Describe fully the benefits of the research (e.g. to the participants, to the community, to society, to the advancement of knowledge, to the student researcher).
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25a. Will participants in this research experience any physical discomfort?
☐ Yes ☐ No
25b. If yes, explain the nature of the discomfort.
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26a. Are there any possible risks to participants greater than those the participant might experience in everyday life?
☐ Yes ☐ No
26b. If yes, explain what those risks might be and any measures you are taking to minimize them.
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27a. Will participants undergo the application, use, or intervention of scientific instruments involving direct physical contact on their person?
☐ Yes ☐ No
27b. If yes, explain the nature of the contact.
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28a. Will participants in the research experience any mental, psychological, or emotional discomfort?
☐ Yes ☐ No
28b. If yes, explain the nature of the discomfort.
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29a. Will participants in the research experience any economic deprivation?
☐ Yes ☐ No
29b. If yes, please explain the nature of the deprivation.
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30a. Will participants in the research suffer social, legal, or other repercussions from participating or not participating in the study?
☐ Yes ☐ No
30b. If yes, explain the nature of those repercussions.
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F. Anonymity and Confidentiality of DataHelp
31a. Will anonymity of the data be assured?
☐ Yes ☐ No
31b. If no, explain why not.
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32a. Will confidentiality of the data be assured?
☐ Yes ☐ No
32b. If no, explain why not.
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33a. Will the research results be disclosed:
☐ In the classroom? ☐ Outside the classroom (including online)?
33b. If outside the classroom, please explain where.
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34a. Will public dissemination and disclosure of the research results be limited to aggregate anonymized data only?
☐ Yes ☐ No
34b. If no, explain why not.
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35a. Does the research method and informed consent procedure guarantee the anonymity of participants?
☐ Yes ☐ No
35b. If no, explain why not.
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36a. If there are interviews or focus groups as part of the research method, will participants be quoted in any results of the research?
☐ Yes ☐ No ☐ N/A
36b. If yes, provide details and explain the measures taken to ensure anonymity of the participants’ responses.
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37a. In the case of interviews or focus groups, will participants be given the opportunity to review their responses?
☐ Yes ☐ No ☐ N/A
37b. If no, please explain why not.
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G. Data
38a.Will anyone other than the researcher or course instructor be involved in the data collection process?
☐ Yes ☐No
38b. If yes, who they are?
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39a. Will anyone other than the researcher or the course instructor have access to the raw data?
☐ Yes ☐ No
39b. If yes, please explain.
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40. In what form will the data be collected (e.g. written records, electronic data, interview recordings, transcripts, questionnaires, etc.)?
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41. Explain how and where each data item will be stored and secured. Help
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42. How and when will the data be destroyed?Include this information on the consent form.Help
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43. If the data are to be kept longer than the duration of the course, please explain why. In addition, provide details on where the data will be kept and how it will be secured. Anticipate any secondary uses for the data in the future.
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☐ N/A
E. Documents Required for Submission (checklist provided as a reminder)
☐ Consent/letter of information forms
☐Sample surveys or questionnaires
☐ Checklist for minimal risk
☐Course syllabus / ☐Instructions
☐ Scripts
☐Official course outline
Ethics Checklist[1] 2016-2017
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.
Yes / No1. / Will persons 18 years or younger be involved in your research*?
2. / 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?
3. / Will participants be told that they can discontinue their participation at any time without penalty?
4. / 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. / Will information about your participants be obtained from third parties (i.e., someone other than the investigator)?
10. / Are the investigators or associates of the investigator in a position of power in relation to the participants?
11. / 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?
14. / 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?**
15. / 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)?**
16. / 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)?**
17. / Does your research require approval from the Biosafety officer?
18. / 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.)?
19. / Will identifiable information obtained from individual participants be disclosed to third parties (i.e., someone other than the investigator)?
20. / Could publication of the research possibly jeopardize participant privacy or confidentiality?
21. / Could publication of the research possibly harm the participants either directly or through identification with their membership group?
22. / Are there any other aspects of this study that might interfere with the protection of the well-being and dignity of the participants?
23. / 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?
24. / Will the investigator ensure that participants understand the process available to them for registering concerns or complaints?
25. / If the investigator will dispose of the raw data, once the study is completed, will it be done 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.