The Office of Research Ethics October 11, 2013 Office of Research Ethics

What We Do The Office of Research Ethics manages the approval and monitoring process for the use of humans in research at the University and its affiliated hospitals and research institutes. Presentation Title Here

Why We Exist To protect the research participants and make sure that they’re not exposed to any unnecessary harms, risks or discomforts. To protect the researchers and students carrying out the research. Presentation Title Here

Tri-Council Policy Statement 2 (TCPS2) TCPS2 is a guideline created by the Interagency Agency Panel on Research Ethics for the Tri-Council Agencies(CIHR, NSERC and SSHRC). To be eligible to receive and administer research funds from the Agencies, institutions must agree to comply with Agency policies, the TCPS2 being one of those policies. Researchers funded by the Agencies are expected to adhere to the TCPS2.

Is Ethics Approval Needed? All research involving humans conducted by faculty, staff or students at Western or its affiliated hospitals or research institutes must be reviewed by a University-sanctioned review board. At that point the board will decide if approval is needed, if this is in question. Presentation Title Here

Please remember… This includes ALL research. If you are not sure, please contact us and ask. You must obtain ethics approval BEFORE you begin your research. Retroactive approval will not be given under any circumstances. Presentation Title Here

Boards and Review Level Presentation Title Here

Boards and Review Levels HSREB Full Board Delegated 1 (chart review) Delegated 2 (minimal risk) NMREB Full Board Delegated (minimal risk) Department Here

Delegated Review Research that is deemed minimal risk or lower Minimal Risk: 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.

Delegated Review Level 1 Research which includes for example chart reviews, database or registry creation, analysis of tissue samples. Generally speaking research which does not involve participant contact.

Delegated Review Level 2 Research which includes contact with patients, participants in the form of focus groups, questionnaires, surveys, etc. Generally low risk patient / participant contact.

Full Board Review Default requirement for research involving human participants. Research using human participants at more than minimum risk. Examples of research requiring full Board review : – research using deception; –research using vulnerable persons; –intervention studies; –clinical trials; –device studies; –etc. These studies are reviewed bi-monthly by the full REB

Post-Review Process Presentation Title Here

Post-Review Processes Revisions FYI DSMB Serious Adverse Events Continuing Ethics Reviews Updated Approvals Protocol Deviations Protocol Violation End of Study Reports

Office Procedures & Processes Presentation Title Here

Deadlines The HSREB Full Board and Delegated Level 2 board have deadlines which must be adhered to. Please see our website for deadlines. Keep in mind the deadline is 12 noon on the deadline day. The HSREB Delegated Level 1 board does not have deadlines. The protocols can be submitted at anytime and are reviewed within 2 weeks.

Ethics Review Process Submission of the Protocol and all necessary documentation by the deadline date into Romeo. Pre-reviewed by the office. Reviewed by the board. Sent to the researcher for response by . Response from the researcher in Romeo. Approval – *do NOT start your research until your approval is physically in your hands* Department Here

ROMEO Our online, in-office database and protocol submission system. All protocols are now submitted via ROMEO. There are workshops offered or one-on-one training is also available. Please contact us if you would like assistance in obtaining your username and password.

Consent Process Presentation Title Here

The Consent Process The Consent Process should be thought of as a process, not just a letter and a form that the potential participants signs. The Letter of Information/Consent should not cause the potential participant to: –Feel overwhelmed by institutional approval –Fear loss of benefits, employment or educational status –Feel an obligation to participate –Believe there will be financial gain

The Consent Process This can happen in a number of ways: –Written Consent (Letter of Information + Consent to sign) –Implicit Consent (Letter of Information + Completion of Survey) –Implicit Verbal Consent (Telephone Script + Agree to Interview) You still need a Letter of Information/Consent or script for ALL of these forms of consent. Please see our templates. Participants must be told exactly what is going to happen to them (full disclosure)

Who We Are Department Here ROLENAMEPHONE Ethics Officer Erika Basile86764 Ethics Officer Vikki Tran80242 Ethics Officer Grace Kelly84692 Administrative Assistant Julie Pfeiffer86811 Administrative Assistant Becky Ament84691

Where We Are We are located in suite 5150, Support Services Building, University of Western Ontario Presentation Title Here