the office of research ethics october 11, 2013 office of research ethics
TRANSCRIPT
The Office of Research Ethics
October 11, 2013
Office of Research Ethics
What We DoThe 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.
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Why We ExistTo 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.
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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.
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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.
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Boards and Review Level
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Boards and Review LevelsHSREB
• Full Board• Delegated 1 (chart review) • Delegated 2 (minimal risk)
NMREB• Full Board• Delegated (minimal risk)
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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
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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
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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 email.• Response from the researcher in Romeo.• Approval – *do NOT start your research until
your approval is physically in your hands*
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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
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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
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ROLE NAME PHONE EMAIL
Ethics Officer Erika Basile 86764 [email protected]
Ethics Officer Vikki Tran 80242 [email protected]
Ethics Officer Grace Kelly 84692 [email protected]
Administrative Assistant Julie Pfeiffer 86811 [email protected]
Administrative Assistant Becky Ament 84691 [email protected]
Where We Are• We are located in suite 5150, Support Services
Building, University of Western Ontario
• http://www.uwo.ca/research/ethics/
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