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Application for a VON Research Ethics Review
Completed applications may be submitted:
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By email to: natash.cosulich@von.ca
By Fax to 902- 755-4718
Submission must be in PDF or Word format
Supporting documents that cannot be sent electronically must be faxed or mailed.
Contact and Background Information
1. Project Title:
2. Proposed Start Date (no sooner than two weeks after review of REC):
3. Proposed Completion Date:
4. Principal Investigator
a. Name:
b. Organization:
c. Address:
d. Phone:
e. Fax:
f. E-Mail:
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g. Are you a Masters or PhD student?
Yes
No
5. Co-Investigator(s)
a. Name:
b. Organization:
c. E-Mail:
6. VON Contact Name: Must be someone from the site identified in the project
a. E-Mail:
7. Privacy Legislation: Are you aware of your obligations under the Privacy Act for
obtaining?
a. Personal Information Bank
Yes
No
b. Privacy Impact Assessment
Yes
No
8. Legal Advice:
Have you sought legal advice on the project in question?
Yes
No
9. Funding Source (if applicable)
Is there a contract for this study/project?
(If available, please provide a signed copy)
Yes
No
I confirm that all contracts and any conflicts of interest (actual, apparent, perceived, or
potential) relating to this project are disclosed here for review:
Yes
No
Date:
Name:
Overview of Project
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10. Provide a clear statement of the purpose and objectives of the project:
11. State the hypothesis, the research question, or both:
12. Provide a brief description (in lay terms) of exactly what you will be asking your
participants to do:
13. Provide a brief summary (not more than 250 words) of the mode of inquiry for the
research. Note the research design, research methods, or both, and the procedures to
be followed. Provide details about the methods and techniques of data collection and
data analysis, participant protocols/instruments, and time commitment for the
participants:
14. Describe the proposed number and types of participants to be included; if participants
are grouped, specify the number and assignment criteria for each group:
15. List participant inclusion or exclusion criteria:
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16. Please indicate whether any of the participants will be recruited fall into one or more of
the following categories:
a.
Under 18 years of age
b.
Cognitively impaired
c.
Captive or dependent and residing in an institution, e.g. prison, extended
care facility
d.
Student
e.
Employees of researchers’ organization
f.
Having language barriers, e.g. illiterate, not English-speaking, dysphasic
g.
Belonging to specific ethnic or cultural groups
17. Discuss the rationale for involving individuals from any of the groups identified above,
and describe how risks will be minimized. NOTE: please ensure that you are adhering to
requirements found in Section 2, Free and Informed Consent, Competence, of the TriCouncil Policy Statement: Ethical Conduct for Research Involving Humans (2005)
http://www.pre.ethics.gc.ca/english/pdf/TCPS%20October%202005_E.pdf
Informed Consent
18. Who will be recruiting the participants?
19. From where will the research participants be recruited?
20. Describe the procedures for recruitment:
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21. Append a copy of each information letter or script that will be used to recruit
participants.
22. Describe the procedures for obtaining informed consent for each distinct component of
your study (e.g. for interviews, questionnaires, focus groups):
23. Append a copy of each information letter, script, or consent form that will be used to
ensure that participants are giving informed consent for their participation.
24. What will occur should the capacity of the participant to give informed consent changes
during the study?
25. If compensation for participating in the research is offered, provide details:
Procedures
26. If applicable, please describe which procedures are not considered part of the routine
diagnostic/therapeutic care of clients?
27. What are you going to be doing with participants and what are you asking participants
to do?
Analysis
28. How will the data be analyzed?
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29. Will there be sub-group analysis? If so, specify.
30. What are the potential harms, discomforts and inconveniences to participants?
31. What are the potential benefits to participants?
32. What are the potential benefits to society at large?
Follow-up care
33. What will be done if harms or discomforts or the need for further follow-up and/or
referral(s) arise? In the case of treatment studies, what procedures are planned to
ensure provision of follow-up care at the end of the study or if the study is terminated
prematurely?
Data Security and Confidentiality
34. What steps will be taken to ensure the privacy, security and confidentiality of data?
Please provide details on how and where data in various formats will be stored, who will
have access to the data, when it will be destroyed, and how it will be destroyed.
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35. What are the security measures to address any arising concerns?
I certify that the above declaration is accurate and is/will be in force at the time data are
collected.
Date:
Name (Principal Investigator):