The following documents and/or guidelines are intended for use by Heart Institute researchers and staff ONLY
- Submission Checklist
- Initial application forms
- HREB application (to be phased out during the fall of 2009)
- COREB application (current available and suggested for use; COREB form will replace HREB application in the Fall of 2009)
- COREB instructions
- CONSENT form
- HREB Guidance Document for writing the consent to participate in a research study form
- HREB Consent form checklist
- HREB Example consent form (to be developed)
- Appendices
- Appendix A - Clinical Services
- Appendix B - Diagnostic Services
- Appendix C - Pharmacy
- Appendix H - Financial Disclosure
- The following appendices are the same for OHREB and HREB.
- Pathology and Laboratory Medicine Impact (.doc, .xls)
- Health Records (.doc, .pdf)
- Radiation Safety & Health Physics Department
- All documents can be found on the Infonet site.
- Diagnostic Imaging Impact
- Appendix A - Clinical Services
- Other forms
- The following appendices are the same for OHREB and HREB.
- Study Renewal
To renew your study on an annual basis, you will need to complete and submit the following form 60 days in advance of the approval expiry date. If you have completed research participant enrollment, but research participants remain on follow-up, this form should be completed. If recruitment is still ongoing, submit a copy of the last approved Patient Information Sheet and/or Consent Forms. If they are being revised, attach a copy of the revised documents with all changes highlighted, and a clean final version of the revised document printed on original letterhead. Be sure to update the 'version' and 'date' on the revised form. Please ensure the HREB's contact phone number is correct. The number is 613-798-5555, extension 19865.
IT IS THE INVESTIGATOR’S RESPONSIBILITY TO ENSURE THAT STUDY APPROVAL DOES NOT LAPSE. PATIENT RECRUITMENT CANNOT CONTINUE IF STUDY APPROVAL LAPSES- Study Termination
If your study is complete, you need to inform us by submitting the following form. Please do not complete this form if patients remain on follow-up (see Annual Renewal Form).
- Adverse Event Reporting
If there has been an amendment to your study, please complete the following form. Be sure to include the appropriate revised documents. If there are changes required to the Patient Information and Consent Form because of the amendments, include a copy of the revised documents with all changes highlighted, and a clean final version of the revised document printed on original letterhead. Be sure to update the 'version' and 'date' on the revised form.
If there are any adverse events (SAEs) to report, please inform the HREB by using the following form. If there are changes required to the Patient Information and Consent Form because of these adverse events, include a copy of the revised documents with all changes highlighted, and a clean final version of the revised document printed on original letterhead. Be sure to update the 'version' and 'date' on the revised form.
- The following appendices are the same for OHREB and HREB.
- French translation Request Form
- HREB - Membership List
- HREB 2010 Website Schedule (.doc, .pdf), HREB 2009 Website Schedule