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

The Office of Human Research Ethics

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)

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

Our Location Online: uwo.ca/research/ethics By Email: ethics@uwo.ca In Person: 5th Floor, Support Service Building

Our Website

The Tri-Council Policy Statement 2

TCPS2 Overarching Canadian policy framework for research with human participants. TCPS2 http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/ TCPS2 Tutorial http://www.pre.ethics.gc.ca/eng/education/tutorial-didacticiel/ Liability Funding Publication Protect the Researcher / Participant / Data

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

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

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

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

Step 1 Getting Started

Step 1: Get Set-Up 1 2

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.

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

Step 4: Is there a deadline?

Log into Romeo and Create your Submission Step 5: Log into Romeo and Create your Submission https://grant3.vm.its.uwo.ca/Romeo.Researcher/

Romeo and Submission Forms Step 2 Romeo and Submission Forms

ROMEO

ROMEO

Submitting Your Application Step 3 Submitting Your Application

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? http://www.uwo.ca/research/services/ethics/nonmedical_reb/NMREB_Templates.html

Liability Funding Publication Protect the Researcher / Participant / Data

Submitting Your Response Step 4 Submitting Your Response

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?

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