2. Disclaimer
The information provided in this presentation is consistent with the current policies and guidelines laid out within our office, the Research Ethics Board, the University and the TCPS2.
The information provided here may change and may no longer be applicable. Please visit our website regularly for up to date information.
Things change, it’s important to keep up to date!
Research Ethics: Do’s & Don’ts

3. The Office of Human
Research Ethics

4. Our Responsibility
Manage the review and approval process for all research involving human participants (initial and post submissions).
Board of Record for Western and all affiliated research institutions and hospitals.
Each year we see:
1400 NEW submissions (480 Non-Medical)
1350 AMENDMENTS (250 Non-Medical)

5. Our Staff Director Erika Basile Ethics Officers
Grace Kelly, Non-Medical REB
Vikki Tran, Health Science REB
Nicole Kaniki, Health Science REB
Karen Gopaul, Health Sciences REB
Katelyn Harris, Non-Medical REB
Administrative Support
Aneesa Khan
Nicole Holme

6. Our Location Online: uwo.ca/research/ethicsBy
In Person: 5th Floor, Support Service Building

7. Our Website

8. The Tri-Council Policy Statement 2

9. TCPS2
Overarching Canadian policy framework for research with human participants.
TCPS2
TCPS2 Tutorial
Liability
Funding
Publication
Protect the Researcher / Participant / Data

10. Research Exempt from Approval
The following are examples of research that MAY be exempt from ethics approval.
Research relying on publicly available information.
Secondary use of anonymous information.
Naturalistic observation of people in public places.
Please visit Chapter 2 of the TCPS2 for more information on what requires ethics approval.
Liability
Funding
Publication
Protect the Researcher / Participant / Data

11. The Consent Process
When carrying out the consent process it should be thought of as just that.
There should be a conversation with the participant to ensure that they understand what they are being asked to do.
Consent should be obtained in a signed consent form or in documentation by the researcher using another method of consent.
Liability
Funding
Publication
Protect the Researcher / Participant / Data

12. Privacy and Confidentiality
Liability
Funding
Publication
Protect the Researcher / Participant / Data

13. How to Handle Data
All identifiers should be kept separate from the data during collection, transportation and storage.
All identifiable data must be encrypted at all times.
De-identified or anonymous data may be password protected only.
Liability
Funding
Publication
Protect the Researcher / Participant / Data

14. Step 1
Getting Started

15. Step 1:
Get
Set-Up 1 2

16. Step 2:
Who is responsible for your project?
Only Research Eligible Faculty can act as the PI on a research project being submitted to our office.
The PI is fully responsible for the conduct of the study, everything that is written in the protocol and for the student conducting the research.

17. Step 3: Which REB / Level of Review is Needed?

18. Step 4:
Is there
a deadline?

19. Log into Romeo and Create your Submission
Step 5:
Log into Romeo and Create your Submission

20. Romeo and Submission Forms
Step 2
Romeo and Submission Forms

21. ROMEO

22. ROMEO

23. Submitting Your Application
Step 3
Submitting Your Application

24. Submitting Your Application
Have you ensured that all study documents are included in the Romeo application?
Has the entire application and the accompanying documents been vetted thoroughly by your PI before being submitted? By someone external to the study?
NEW - Have you followed our templates for all of your study documents?

25. Liability
Funding
Publication
Protect the Researcher / Participant / Data

26. Submitting Your Response
Step 4
Submitting Your Response

27. Ethics Review Process – Pre Approval
Resubmitting your Application
Have you included a detailed response letter clearly stating that every recommendation was revised, where the change was made and how it was made?
Have you exported a copy of your Western Protocol (Romeo form) to Word to make TRACKED changes?
Have you resubmitted both a tracked AND clean copy of all documents that the board has requested you change?

28. Timing is Important
Please allow yourself ample time to receive approval for all submissions to the office (both new submissions and revisions).