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

Mary Ann Laviolette, Ethics Coordinator

Ottawa Hospital Research Ethics Board (OHREB) and University of Ottawa Research Ethics Board (HREB)

Research Ethics Board Overview

- What should be reviewed by the REB?

Responsibilities

- REB Members

- REB Support Staff

- 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

• 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:

• 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

• Guidelines• Sample Consent• Confidentiality• Compensation Clauses• Signature Blocks

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

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

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 - 191Renewals - 565Terminations - 396Amendments - 1,147Consent Changes - 128Other - 159Adverse Event Reports - 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 sub-committee of the Board

Consent Form Amendments - One to two weeks

Termination Reports - One week

Adverse Event Reports - Two weeks

Contact Information

• 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

• Alison Irwin, REB Secretary

Phone: 613-798-5555, extension 19865, Email: [email protected]

For information regarding the status of all Heart Institute protocols

• 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)• 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.

• 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

• 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)

• 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: [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 Residence751 Parkdale Avenue, Suite 106

Thank you for attending