1. Mary Ann Laviolette, Ethics Coordinator Ottawa Hospital Research Ethics Board (OHREB) and University of Ottawa Research Ethics Board (HREB)

2. Research Ethics Board Overview -What should be reviewed by the REB? Responsibilities -REB Members -REB Support Staff -Researchers

3. 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)

4. 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.

5. 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)

6. 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

7. Support Staff Responsibilities Ethics Coordinator Secretary for OHREB Secretary for the HREB Protocol Officer Administrative Assistant French Translator/Reviewer - OHRI

8. Researchers’ Responsibilities The Principal Investigator is responsible for ensuring that: 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

9. Review Type Full Board Review Expedited Review Chart Review

10. 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’

11. Consent Issues Guidelines Sample Consent Confidentiality Compensation Clauses Signature Blocks

12. Advertisements What should be included -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 -Physician’s Name -Undue incentives

13. French Documentation When is it required? -Riverside Campus -General Campus -Heart Institute -Emergency -One-of-a-kind services What needs to be translated, or should be provided? -Advertisements -All Consent Documents/Information Sheets -Patient Diary(s), Handbooks -Letters to patients and/or doctors -Validated French questionnaires

14. 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-191 Renewals-565 Terminations-396 Amendments-1,147 Consent Changes-128 Other-159 Adverse Event Reports-2,229 reports with a total of approximately 16,057 AE’s

15. 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

16. 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 sub- committee of the Board Consent Form Amendments - One to two weeks Termination Reports - One week Adverse Event Reports - Two weeks

17. Contact Information Christine Banyard, REB Secretary Phone: 613-798-5555, extension 14902, Email: cbanyard@ohri.ca For information on the status of a protocol up to and including initial approval Alison Irwin, REB Secretary Phone: 613-798-5555, extension 19865, Email: airwin@ohri.ca For information regarding the status of all Heart Institute protocols Rima Faour, Protocol Officer II Phone: 613-798-5555, extension 13523, Email: rfaour@ohri.ca For information on the status of a protocol, or for general inquiries

18. Contact Information (continued) Patricia Sorgat, Protocol Officer Phone: 613-798-5555, extension 14146, Email: psorgat@ohri.ca For general inquiries about the status of revised consent forms/information sheets, amendments, renewals, terminations, adverse event reports, etc. Jennifer Munroe, Administrative Assistant Phone: 613-798-5555, extension 19866, Email: jmunroe@ohri.ca To confirm whether or not we have received correspondence, or to request a copy of lost correspondence Mary Ann Laviolette, Ethics Co-ordinator Phone: 613-798-5555, extension 15072, Email: mlaviolette@ohri.ca 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

19. Contact Information (continued) Raphael Saginur, Chairman, OHREB Phone: 613-798-5555, extension 14902 Francine Sarazin, Vice-Chair, OHREB Phone: 613-737-8899, extension 78678 James Robblee, Chairman, HI REB Phone: 613-798-5555, extension 14379 Richard Davies, Vice-Chair, HI REB Phone: 613-798-5555, extension 14729 Janet Whyte, Manager, Clinical Research and Clinical Epidemiology, OHRI Phone: 613-798-5555, extension 12681, Email: jwhyte@ohri.ca For information on and requests for clinical research space

20. Website www.ohri.ca/ohreb/ www.ottawaheart.ca/UOHI/hreb/flash/home.html Location Civic Site, Intern’s Residence 751 Parkdale Avenue, Suite 106

21. Thank you for attending