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What's New  

Merger of The Ottawa Hospital and the Heart Institute's REB Process

The Ottawa Hospital Research Ethics Board (OHREB) and the Human Research Ethics Board (HREB) have merged into one Board. The new name of the merged REB is 'Ottawa Health Science Network Research Ethics Board' (OHSN-REB).

**IMPORTANT** Your research consent forms must be updated with the new REB name at the time your renewal or amendment submission (whichever comes first).

In addition, the first page and the final signature page should be on OHSN-REB letterhead if you are recruiting across sites (e.g. at both TOH and UOHI). If you are recruiting from only one institution (e.g. TOH only) you may use the new OHSN-REB letterhead or your institution's letterhead.

  If any other research documents contain one of the old REB names, they too must be revised with the new name and submitted at the time of renewal (e.g. posters that state, "This research study has been approved by the Ottawa Hospital Research Ethics Board (Human Research Ethics Board)."

 Valid Until Dates

The OHSN-REB no longer requires that a "valid until" date to be added to the bottom of all approved informed consent forms. Each initial approval, continuing review and consent form amendment approval letter will indicate the name and version date of the consent form(s) currently approved for use.

In addition, copies of the OHSN-REB approved informed consent form(s) will no longer be sent back with the approval letters.  

New Consent Form Template and Guidance Documents

The OHSN-REB has created a new consent template and guidance document. Please click on the consent tab for further information.

Unanticipated Problems/Adverse Event Reporting

SOP number OH309 (Safety Reporting Requirements for Research Involving Human Participants) has been renumbered and can now be found under the REB SOPs as number 1003. This SOP describes a significant change to SAE reporting and those who submit information not in line with this SOP will have their submission rejected for resubmission in the correct format.

Reminder about unanticipated problems/adverse event reporting:

The following local AEs/ADRs ordinarily should NOT be reported to the REB:

• SAEs/SADRs that are considered expected as defined by the protocol and/or IB or PM
• SAEs that are considered not related to the investigational product or research procedures, whether the event is expected or not.
• AEs/ADRs that are non-serious, whether expected or not

External (non-local) serious AEs/ADRs or Unanticipated Problems should only be reported to the REB in the form of periodic safety update reports accompanied by information that is meaningful and useful to the REB. The content of the safety report should include at a minimum a sponsor analysis of the significance of the event or an analysis from the DSMB, with (where appropriate) a discussion of previous similar events, and a position statement as to whether any changes are required to the approved documents. These periodic reports should be submitted to the REB no later than fifteen days after receipt by the investigator and summarized during the continuing review application process.