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Ottawa Hospital Research Ethics Board (OHREB) and
University of Ottawa Research Ethics Board (HREB)
Mary Ann Laviolette, Ethics Coordinator
Research Ethics Board Overview
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What should be reviewed by the REB?
Responsibilities
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REB Members
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REB Support Staff
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Researchers
What should be reviewed by the REB?
All research that involves living human subjects, human
remains, cadavers, tissues, biological fluids, embryos or
foetuses requires REB review.
(Tri-Council Policy Statement, Article 1.1)
This would also include research studies conducted by staff or
students that involve investigational drugs, surgery, medical
imaging, or other diagnostic techniques, biopsies, the taking of
blood or other specimens, the review of medical records (chart
reviews), questionnaires, interviews, and the use and/or creation
of a database for research purposes.
What doesn’t need to be reviewed by the REB?
• Quality assurance studies, performance reviews or testing within
normal educational requirements
• Studies related directly to assessing the performance of an
organization or its employees or students, within the mandate of
the organization
• The opinion of the REB should be sought whenever there is
uncertainty.
(Tri-Council Policy Statement, Article 1.1d)
Members’ Responsibilities
Preliminary review of new protocols
• 2 – 12 new studies per meeting
• Resubmissions
• Renewals and/or amendments
REB Sub-committees
• Recruited at REB meetings or upon request by Chair, Vice-Chair,
or the Ethics Co-ordinator
REB Executive
• Recruited by the Chairman
Support Staff Responsibilities
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Ethics Coordinator
Secretary for OHREB
Secretary for the HREB
Protocol Officer
Administrative Assistant
• French Translator/Reviewer - OHRI
Researchers’ Responsibilities
The Principal Investigator is responsible for ensuring that:
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Ethics approval is obtained before starting any research
Study personnel are trained and knowledgeable about the study
All amendments are approved before a change is initiated
Annual renewals are submitted in order to ensure there is no
lapse in the approval of the study
• Termination reports are submitted when the study is complete,
along with a summary of the study findings
Review Type
• Full Board Review
• Expedited Review
• Chart Review
What Documents Will Be Submitted
REB Application Forms
Study Protocol – Industry or Investigator Initiated
Questionnaires
Investigator Brochures
Case Report Forms
Consent Documents
Advertisements
Health Canada ‘No Objection Letters’
Consent Issues
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Guidelines
Sample Consent
Confidentiality
Compensation Clauses
Signature Blocks
Advertisements
What should be included
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TOH logo
“This research study has been approved by the Ottawa Hospital
Research Ethics Board”
• Must be available in English and French and published
simultaneously
What shouldn’t be included
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Physician’s Name
Undue incentives
French Documentation
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When is it required?
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Riverside Campus
General Campus
Heart Institute
Emergency
One-of-a-kind services
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What needs to be translated, or should be provided?
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Advertisements
All Consent Documents/Information Sheets
Patient Diary(s), Handbooks
Letters to patients and/or doctors
Validated French questionnaires
REB Activity Levels
1,442 active studies with 1,332 currently approved (as of September 2007)
April 1, 2006 to March 31, 2007 Activity
Approvals
Renewals
Terminations
Amendments
Consent Changes
Other
Adverse Event Reports
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191
565
396
1,147
128
159
2,229 reports with a total of
approximately 16,057 AE’s
Timelines
Application for Full Board Review - Letters of concerns or approval letters
from the REB sent within one to two weeks of the REB meeting
Additional Correspondence received prior to approval - One to two weeks
Application for Chart Review - One to three days
Application for Expedited Review - Two to four weeks
Initial Review of French Consent/Information Forms - One to two weeks
Annual Update Requests - One to five weeks. Up to five weeks if
full Board review is required. The REB can only renew a study
within 30 days of the current expiry date.
Protocol Amendments - One to four weeks. This may be longer if
the amendment has to be submitted to the full Board or to a subcommittee of the Board
Consent Form Amendments - One to two weeks
Termination Reports - One week
Adverse Event Reports - Two weeks
Contact Information
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Christine Banyard, REB Secretary
Phone: 613-798-5555, extension 14902, Email: [email protected]
For information on the status of a protocol up to and including initial approval
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Alison Irwin, REB Secretary
Phone: 613-798-5555, extension 19865, Email: [email protected]
For information regarding the status of all Heart Institute protocols
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Rima Faour, Protocol Officer II
Phone: 613-798-5555, extension 13523, Email: [email protected]
For information on the status of a protocol, or for general inquiries
Contact Information (continued)
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Patricia Sorgat, Protocol Officer
Phone: 613-798-5555, extension 14146, Email: [email protected]
For general inquiries about the status of revised consent forms/information sheets,
amendments, renewals, terminations, adverse event reports, etc.
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Jennifer Munroe, Administrative Assistant
Phone: 613-798-5555, extension 19866, Email: [email protected]
To confirm whether or not we have received correspondence, or to request a
copy of lost correspondence
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Mary Ann Laviolette, Ethics Co-ordinator
Phone: 613-798-5555, extension 15072, Email: [email protected]
For information on policy and procedural issues, problematic protocols,
compensation clauses, REB document changes, website information, etc. for
The Ottawa Hospital and the University of Ottawa Heart Institute
Contact Information (continued)
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Raphael Saginur, Chairman, OHREB
Phone: 613-798-5555, extension 14902
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Francine Sarazin, Vice-Chair, OHREB
Phone: 613-737-8899, extension 78678
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James Robblee, Chairman, HI REB
Phone: 613-798-5555, extension 14379
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Richard Davies, Vice-Chair, HI REB
Phone: 613-798-5555, extension 14729
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Janet Whyte, Manager, Clinical Research and Clinical Epidemiology, OHRI
Phone: 613-798-5555, extension 12681, Email: [email protected]
For information on and requests for clinical research space
Website
www.ohri.ca/ohreb/
www.ottawaheart.ca/UOHI/hreb/flash/home.html
Location
Civic Site, Intern’s Residence
751 Parkdale Avenue, Suite 106
Thank you for attending