Application must be made to the Ottawa Hospital Research Ethics Board if you are planning any research that will involve human subjects. The following list will provide you with basic information on the various applications and forms available.
Request for Ethics Review
An OHREB Application must be submitted for review and approval by all members of the Ottawa Hospital Research Ethics Board. An approval letter must be obtained before the research begins.
Duration of Approval
Maximum duration of approval is one year. The OHREB may specify a briefer period. Annual renewal of protocols is a minimum frequency.
Advertisements, Letters to Physicians
Promotional material for studies, including letters and advertisements must be approved by the OHREB prior to use. This includes print and electronic (e.g., radio, TV, Email, web-based) communication.
Newspaper advertisements and posters should include the Ottawa Hospital logo, a contact name and a telephone number. The following statement should also be included “This research study has been approved by the Ottawa Hospital Research Ethics Board.”
The Principal Investigator’s name should not be included in the ad. The College of Physicians & Surgeons of Ontario prohibits the use of the physician’s name in any communication offering a product or service to the public. Please refer to their website for additional information. http://www.cpso.on.ca/policies/legislation/default.aspx?id=1768
Please refer to the “Bilingualism in Clinical Research: Advertising to Potential Subjects” policy in this section.
Chart Review
A completed Chart Review Form must be submitted to the Ottawa Hospital Research Ethics Board for review by the Chairperson or their delegate. OHREB approval must be received before the research begins.
Applications for chart review are usually approved within one to three business days, if the application is complete upon submission, and all signatures provided. Signatures must be original.
Expedited Review
To qualify for expedited review, research must involve no more than minimal risk to human subjects, and fall within one of the categories established by the Department of Health and Human Services.
An OHREB Application must be submitted for review and approval by the Chairperson of the Ottawa Hospital Research Ethics Board or their delegate. If the Chairperson does not agree that the research qualifies for expedited review, the investigator will be asked to submit the application to the Ottawa Hospital Research Ethics Board for full review.
Applications for expedited review are usually approved within two to four weeks of submission, if the application is complete and all signatures provided. Signatures must be original.
Annual Renewal
If research is ongoing, it is the responsibility of the investigator to ensure that approval of the study does not lapse. An Annual Renewal Form should be provided to the Ottawa Hospital Research Ethics Board approximately two months prior to the expiry date. This will allow the Chairperson or their delegate sufficient time to contact the investigator if there are any questions or concerns about the progress of the study.
PLEASE NOTE: Research participants cannot be enrolled into a study if ethics approval has lapsed.
Amendments
If there are any changes to the original Ethics application or company protocol, the investigator must notify the Ottawa Hospital Research Ethics Board as soon as possible. An Amendment Form should be completed, and an approval letter obtained prior to implementing any changes.
Changes to Consent Form and/or Information Documents
Any change to an approved consent form and/or information document must be submitted for review and approval by the Ottawa Hospital Research Ethics Board. The investigator may only use the revised forms once they have received an approval letter and a validated copy of the revised documents from the Ottawa Hospital Research Ethics Board.
Unexpected Adverse Events/Serious Adverse Events
Unexpected adverse events should be reported to the Ottawa Hospital Research Ethics Board within 15 days of the event or notification of the event by the sponsor to the investigator at this institution.
Serious and unexpected adverse events should be reported to the Ottawa Hospital Research Ethics Board within seven days of the event, or notification of the event by the sponsor to the investigator at this institution.
When the event is fatal or life threatening, reporting should be immediate when possible and, in any event, within seven days after notification of the event.
An Adverse Event Form must be completed and submitted to the Ottawa Hospital Research Ethics Board.
Terminations
Upon completion of the research, the investigator must submit a Termination Form to the Ottawa Hospital Research Ethics Board for review. This instructs the OHREB to close the file. If patients or subjects undergo continued, periodic assessment after completion of a study intervention, or if continued correspondence about the study is anticipated (e.g. adverse event reports) the study must be kept open. Patient follow-up should be complete before the termination is submitted.
Bilingualism in Clinical Research: Advertising to Potential Subjects
The Ottawa Hospital is a bilingual institution. Details of its policy statement on bilingualism can be found in the Administrative Policy and Procedure Manual, Official Languages Policy, NO. Adm. 1.25. Access to clinical research should be open to individuals of both official languages. The Research Ethics Board encourages investigators to make studies available to people who speak either official language, and in certain studies may insist on that. For more information, contact Mary Ann Laviolette, Ethics Co-ordinator for the Ottawa Hospital Research Ethics Board at 761-5072.
Advertising for the purpose of this statement is defined as any material, written, verbal, or electronic, used to inform the public or define sub-population (such as a clinic clientele) about a study, and or to solicit for their participation.
Advertising must take place in both official languages, and must be equitable. Equivalent advertisements must be used in equivalent media, and must be contemporaneous.
Websites set up centrally for multi-centre studies may be exempt form this policy if there is no direct linkage to an Ottawa Hospital website. The underlying principle is that of equivalence in terms of access.