Instructions and Review Process

🔗 Instructions and Process Map for Full Board Application Review

Full Board applications must be received on or prior to the full Board meeting submission deadline to ensure the study will be reviewed at the next assigned meeting. Please visit the "Meeting and Huddle Dates" tab.

• Note: Meeting agendas fill quickly! To ensure your study will be reviewed at the next available meeting, it is best to submit the study in advance of the submission deadline date.

Investigator/study teams should note the date of the full Board meeting in their Outlook calendar as they should attempt to attend (via Microsoft Teams) for approximately 15-30 minutes to present their project and address questions from the Board. The REB Office will contact the Investigator/ study team to schedule a presentation time.

The REB will conduct a preliminary review of the full Board application to ensure the application is complete and adequate for Board Member review.

✔ Only complete applications will be added onto the meeting agenda.

❌ Incomplete applications will either be:

• Returned to the Investigator/study team to respond to the preliminary review (bubble comments) within a 24-48 hour timeframe.

  Note: Applications are assigned to the Board members approximately 12 business days prior to the REB meeting for review, therefore, Investigator / study teams must respond promptly to the preliminary review to allow the study to be added onto the agenda and sent to Board members for review.

• Returned to the Investigator/study team with recommendation to withdraw the application due to incompleteness and requirements not being met. A brand new application will need to be submitted when ready for REB review.

  Note: The REB Office is unable to assign incomplete applications onto the meeting agenda. Applications must be complete for Board members to conduct their review.

• REB may request a huddle meeting with the Investigator and study team to discuss the incomplete application.

Once the study has been reviewed by the full Board, Investigator / study teams will receive their first review letter within 5 business days of the meeting.

The Review Letter will provide a deadline for the Investigator / study team to respond by. When the Review Letter is available, Investigators/ study teams will be notified via an automated email.

🔗 Instructions and Process Map for Delegated Prospective Application Review

Delegated applications will be reviewed, and first review letter issued within approximately 2 weeks after submission.

The Review Letter will provide a deadline for the Investigator / study team to respond by. When the Review Letter is available, Investigators/ study teams will be notified via an automated email.

The REB will first conduct a preliminary review of the application to ensure the application is complete and adequate for Chair review.

✔ Only complete applications will be assigned to the Chair for review.

❌ Incomplete applications will either be:

• Returned to the Investigator/study team to respond to the preliminary review (bubble comments) within a 24-48 hour timeframe.

• Returned to the Investigator/study team with a recommendation to withdraw the application due to incompleteness and requirements not being met. A brand-new application will need to be submitted when ready for REB review.

• The REB Office may request a huddle meeting with the Investigator and study team after review and prior to issuing the review letter.

Note: The REB Office is unable to conduct a complete review of incomplete applications.

🔗 Instructions and Process Map for Secondary Use Application Review

Secondary Use applications will be reviewed and first Review Letter will be issued within approximately 1 week after submission.

The Review Letter will provide a deadline for the Investigator / study team to respond by. When the Review Letter is available, Investigators/ study teams will be notified via an automated email.

The REB Office may request a huddle meeting with the Investigator and study team after review and prior to issuing the first Review Letter.

🔗 Instructions and Process Map for Amendment Review

If there are any changes to what is currently on file with, and approved by, the OHSN-REB, the Investigator must submit an Amendment Form to the OHSN-REB. For example:

• Changes to the Principal Investigator, Co-Investigator or Research Staff members listed on file with the OHSN-REB or on the REB approved study documents;
• Changes to the REB approved ethics application/file;
• Changes to REB approved documents (i.e. Protocol, Investigator's Brochure, Product Monograph, recruitment materials, consent forms, questionnaires/surveys, other participant facing documents, etc.).

If the proposed changes represent more than minimal risk, the Amendment submission must be reviewed by the REB at a Full Board meeting. Examples of Amendments that may be classified as more than minimal risk include:

• Significant changes to study design (for example, addition or new study population or addition of new treatment arm).
• New risk information that is substantial or involves risk to the participant and/or risk/benefit ratio of the study
• Increase in physical and/or psychological risk/discomfort to participants
• Increase in risks to privacy/confidentiality
• Increase in dosage or frequency of investigational product
• Reduced safety monitoring
• New/additional genetic testing or tissue banking where genetic testing may/will be performed

The amended research may not be implemented prior to REB approval, except when necessary to eliminate immediate hazards to participants. If changes are made to eliminate immediate hazards, the Researcher must notify the REB immediately.

IMPORTANT: Changes to the study may affect the institution's Contracts Office, Grants Office and/or departments (i.e.: departmental impacts). It is the Principal Investigator's responsibility to notify all applicable parties of changes to the approved research throughout the life of the study.

The OHSN-REB Amendment Form must be submitted electronically via IRIS. See IRISGuide for guidance documents.

🔗 Instructions and Process Map for Continuing Review (coming soon)

Studies are usually approved for a maximum duration of one year. The date of REB expiry is listed on all REB approval/acknowledgement letters. It is the responsibility of the Investigator to ensure that approval of the study does not lapse. According to regulations, the REB is not permitted to provide an extension for the study should ethics approval lapse.

If the research is ongoing, a Continuing Review Form must be submitted to the OHSN-REB according to the Full Board meeting submission deadlines AND at least 40-45 days prior to the expiry date of the study. This will allow the Chairperson or their delegate sufficient time to contact the Investigator/study team if there are any questions or concerns about the progress of the study.

The Full Board submission deadlines and meeting dates can be found on our website by clicking on the Meeting & Huddle Dates tab.

The Continuing Review Form is to renew what is currently approved only. If there has been a departure from the approved research an Amendment Form must be submitted to the OHSN-REB.

IMPORTANT: If ethics approval lapses, research activities, including the enrollment of new participants, must be suspended until ethics approval has been re-instated. If there is a lapse in ethics approval, the Researcher must document the reasons for the lapse and identify the steps taken to prevent future lapses.

The OHSN-REB Continuing Review Form must be submitted electronically via IRIS. See IRISGuide for guidance documents.

🔗 Instructions and Process Map for Reportable Event Review (coming soon)

The Investigator is responsible to report reportable events to the REB of Record (e.g., OHSN, OCREB, or a qualified Board of Record (BOR) appointed by CTO) according to that board's SOPs.

The REB must receive and review any new information generated throughout the course of the research that might affect the rights, safety and well-being of research participants.

Prior to submission, please review the following for more information and for reporting timelines

• N2 CAREB SOP 404
• OHSN-REB N2 CAREB SOP 404 Addendum
• Appendix 1: Summary of Reporting Timelines in Calendar Days

When submitting Reportable Events to the OHSN-REB, each event must be submitted individually (one Main Reportable Event Form and Section Form per event).

For example, if there is a local adverse event and protocol deviation that need to be reported, the following must be submitted:

• Main Reportable Event Form + Local SAE Section Form AND
• Main Reportable Event Form + Protocol Deviation Section Form

The OHSN-REB Reportable Events Form must be submitted electronically via IRIS. See IRISGuide for guidance documents.

🔗 Instructions and Process Map for Study Closure Review (coming soon)

Upon completion of the research, and prior to study expiry, the Investigator must submit a Study Closure Form to for the REB to close the study file.

The ICH Guideline for Good Clinical Practice (1996) clearly indicates in section 14.3 – Final Report(s) by Investigator that "upon completion of the trial, the investigator, where applicable, should inform the institution; the investigator/institution should provide the IRB/IEC with a summary of the trial's outcome, and the regulatory authority(ies) with any reports required" (p. 20).

Prior to submitting a Study Closure Form, please ensure that this is your FINAL submission to the OHSN-REB for your protocol, i.e. all participant follow-up is complete, the sponsor has confirmed (where applicable) the database has been locked, all queries have been resolved. Study Closure Forms should not be submitted unless the study is finished at all centres (where applicable).

Once a file is closed with the OHSN-REB:

• The file cannot be re-opened; if the research for a closed file is to continue, a new application will need to be submitted.
• The file is sent offsite for the archive period; if it needs to be retrieved, a $100 file retrieval fee will apply.

The OHSN-REB paper-based Study Closure Form will be accepted via email to REBAdministration@ohri.ca. until June 1, 2022; see the 'Forms' tab of the OHSN-REB website to access the paper- based form. After June 1, 2022, the Study Closure Form must be submitted electronically via IRIS; see IRISGuide for guidance documents.

1. CTO Stream (e.g., non-oncology related, and oncology related via OCREB)
2. OHSN-REB & CHEO-REB Harmonization
3. OHSN-REB & The Royal Ottawa Health Care Group (ROHCG)-REB Harmonization
4. OHSN-REB & Bruyère-REB Harmonization
5. OHSN-REB clarification on the harmonization process for research at both TOH/OHRI and UOHI/OHIRC

Please visit the IRISGuide REB Education Catalogue – Introduction to the REB Harmonization Process to learn about the REB harmonizations available to you to support collaborations across the province of Ontario via CTO Stream and within Ottawa institutions (e.g., CHEO, ROHCG, Bruyère and TOH/UOHI).

Note: It is important to continuously visit the IRISGuide for updates regarding the REB harmonization processes prior to submitting an REB application if you plan to conduct collaborative research within Ottawa and/or Ontario.

Harmonization streamlines the ethics review and approval process, allowing researchers to submit a single ethics application for multi-jurisdictional research involving two or more Research Ethics Boards. Harmonization also standardizes the review processes among Research Ethics Boards, ensuring review quality and compliance with national standards. Harmonized review models are used for both minimal risk and above minimal risk research.

OHSN-REB is proud to work with collaborative partners in supporting a province wide harmonized system of ethics reviews. If you are planning to conduct a multi-site study in Ontario and/or Ottawa, we encourage investigators and study teams to submit through CTO Stream.

Ottawa & area CTO participating sites:

The Ottawa Hospital (TOH), University of Ottawa Heart Institute (UOHI), Children’s Hospital Eastern Ontario (CHEO), Royal Ottawa Health Care Group (ROHCG), Bruyère, Montfort Hospital, Winchester District Memorial Hospital, University of Ottawa, and Hawkesbury Hospital are all participating sites in CTO Stream and support streamlined research ethic reviews.

In addition to CTO above, OHSN-REB has collaborated further with CHEO REB, ROHCG REB, and Bruyère REB to support streamlined ethics reviews for the following:

• If you plan to conduct a study with one of the sites’ independently.
• If you are an investigator with a cross-appointment for research with responsibilities to report to both REBs.
• If your study will include follow up visits or tests at one of the sites.

We encourage you to submit a REB Harmonization Survey which enables the start of communication between both REBs to guide you with a streamlined ethics submission. The survey must be submitted prior to any REB submission.

Currently, there are three separate REB Harmonization agreements in place which enables the investigator to communicate with two REBs at the same time, upfront, and prior to the ethics submission:

1. OHSN-REB and CHEO-REB Harmonization
2. OHSN-REB and ROHCG-REB Harmonization (The Royal)
3. OHSN-REB and Bruyère-REB Harmonization

• If you are planning to conduct the study at three or more sites, please submit through CTO Stream.

Note: We are currently working on a fourth REB harmonization with uOttawa.

The Ottawa Hospital and University of Ottawa Heart Institute has been participating in CTO Stream since April 2016. In addition, OHSN-REB has been a qualified Board of Record reviewing CTO Stream REB applications since 2016. To date, OHSN-REB has reviewed and approved over 160 research studies, both interventional and observational, within the CTO Stream REB application system which involves approving research for lead site and multiple participating sites (primarily for participating Ontario hospital institutions).

Please visit the Clinical Trials Ontario website for a list of participating sites across Ontario and for more information on how “Streamlined Ethics Review” can be accomplished via the CTO Stream REB application.

In 2019 CHEO REB and OHSN REB entered into an REB harmonization agreement to streamline ethics review for studies occurring at both CHEO and TOH/UOHI.

What does this mean for researchers?

Studies falling under the jurisdiction of both CHEO-REB and OHSN-REB (e.g., due to investigator affiliation, or study activity at both sites) will no longer require two separate ethics applications. CHEO-REB and OHSN-REB work collaboratively to review and approve research studies using one ethics application and a single Board of Record (BOR) is assigned.

What is the process for requesting research studies to be reviewed under the agreement?

• Investigators or study teams must complete the REDCap survey called, REDCap Survey for TOH/UOHI & CHEO REB Harmonization.
• Once submitted, the survey will be reviewed by both REBs to determine the following:
  • Which REB will be the Board of Record for the study?
  • Which REB application system will be used to submit the REB application?
    • IRIS REB Application (OHSN-REB)
    • ROMEO REB Application (CHEO-REB)
    • CTO Stream REB Application
  • Which REB(s) will require a Registration Form?
    • IRIS Registration Form in the CRRF (TOH/UOHI)
    • CHEO Registration Form
• For all harmonization requests under the CHEO-REB & OHSN-REB Harmonization agreement, you must select, “Submit project under CHEO and OHSN-REB Harmonization Agreement” option in the intake form of the IRIS Clinical Research Registration Form (CRRF) regardless of whether the decision has been to submit a full REB application or registration only.

The investigator or study team member who completed the survey will be informed of the REBs’ decisions outlined above via an automated email.

Note: If your study plan includes additional sites to CHEO, TOH/UOHI, then a submission via CTO Stream is encouraged.

In spring 2024, ROHCG-REB and OHSN-REB entered into an REB harmonization agreement to streamline ethics review for studies occurring at both The Royal Ottawa Health Care Group (ROHCG) and TOH/UOHI.

What does this mean for researchers?

Studies falling under the jurisdiction of both ROHCG-REB and OHSN-REB (e.g., due to investigator affiliation, study activity at both sites, follow up or tests at the site, etc.) will no longer require two separate ethics applications. ROHCG-REB and OHSN-REB work collaboratively to review and approve research studies using one ethics application and a single Board of Record (BOR) is assigned.

What is the process for requesting research studies to be reviewed under the agreement?

• Investigators or study teams must complete the survey called, OHSN-REB and ROHCG-REB Harmonization survey.
• Once submitted, the survey will be reviewed by both REBs to determine the following:
  • Which REB will be the Board of Record for the study?
  • Which REB application system will be used to submit the REB application?
    • IRIS REB Application (OHSN-REB)
    • ROHCG REB Application (The Royal REB)
    • CTO Stream REB Application
  • Which REB(s) will require a Registration Form?
    • IRIS Registration Form in the CRRF (TOH/UOHI)
    • ROHCG Registration Form (The Royal REB)
• For all harmonization requests under the ROHCG-REB & OHSN-REB Harmonization agreement, you must select, “Submit project under a General and OHSN-REB Harmonization Agreement” option in the intake form of the IRIS Clinical Research Registration Form (CRRF) regardless of whether the decision has been to submit a full REB application or registration only.

The investigator or study team member who completed the survey will be informed of the REBs’ decisions outlined above via an automated email.

Note: If your study plan includes additional sites to The Royal and TOH/UOHI, then a submission via CTO Stream is encouraged.

• Announcement for ROHCG-REB and OHSN-REB Harmonization Agreement which includes the steps to the process for submission and review.
• Here is the link to the process map for research studies that fall under jurisdictions of both ROHCG-REB and OHSN-REB.

In summer 2024, Bruyère REB and OHSN REB entered into an REB harmonization agreement to streamline ethics review for studies occurring at both Bruyère and TOH/UOHI.

What does this mean for researchers?

Studies falling under the jurisdiction of both BRI-REB and OHSN-REB (e.g., due to investigator affiliation, or study activity at both sites) will no longer require two separate ethics applications. BRI-REB and OHSN-REB work collaboratively to review and approve research studies using one ethics application and a single Board of Record (BOR) is assigned.

What is the process for requesting research studies to be reviewed under the agreement?

• Investigators or study teams must complete the survey called, OHSN-REB and Bruyère REB Harmonization survey.
• Once submitted, the survey will be reviewed by both REBs to determine the following:
  • Which REB will be the Board of Record for the study?
  • Which REB application system will be used to submit the REB application?
    • IRIS REB Application (OHSN-REB)
    • BREB REB Application (Bruyère REB)
    • CTO Stream REB Application
  • Which REB(s) will require a Registration Form?
    • IRIS Registration Form in the CRRF (TOH/UOHI)
    • BREB Registration Form (Bruyère REB)
• For all harmonization requests under the Bruyère-REB & OHSN-REB Harmonization agreement, you must select, “Submit project under a General and OHSN-REB Harmonization Agreement” option in the intake form of the IRIS Clinical Research Registration Form (CRRF) regardless of whether the decision has been to submit a full REB application or registration only.

The investigator or study team member who completed the survey will be informed of the REBs’ decisions outlined above via an automated email.

Note: If your study plan includes additional sites to The Royal and TOH/UOHI, then a submission via CTO Stream is encouraged.

• Announcement for Bruyère-REB and OHSN-REB Harmonization Agreement which includes the steps to the process for submission and review.
• Here is the link to the process map for research studies that fall under jurisdictions of both Bruyère REB and OHSN-REB.

OHSN-REB acts as the Board of Record (BOR) for both TOH/OHRI and UOHI/OHIRC.

Important! Although the REB is harmonized and able to review REB applications on behalf of both institutions, it is important to remember that OHRI (Ottawa Hospital Research Institute) and OHIRC (Ottawa Heart Institute Research Corporation) are separate institutes. Each institute follows its own Clinical Research Standard Operating Procedures and has its own Clinical Research Administration, as well as its own Compliance, Finance, Contracts/Legal, Privacy Office, Data Analytics, and Human Resources Offices.

The link below to the document called “Guidance for Clinical Research involving Cross-Institutional Collaboration between TOH/OHRI and UOHI/OHIRC”, outlines scenarios of collaboration and the processes required for the following types of cross-institutional collaboration:

1. Study involves participant involvement at both TOH (The Ottawa Hospital) and UOHI (University of Ottawa Heart Institute).
2. OHRI or OHIRC Investigator requires Epic data from the other institute.
3. OHRI or OHIRC Investigator access to Cross-Institute ‘Permission to Contact’ lists.
4. OHRI and OHIRC Investigator requires access to a database being maintained outside of Epic at the other institute (e.g., research, clinical, or quality improvement database).

Link: Guidance for Clinical Research involving Cross-Institutional Collaboration between TOH/OHRI and UOHI/OHIRC

If are planning to conduct research at both TOH and UOHI, we strongly recommend requesting a huddle meeting with the REB manager to discuss the plan. Requests for huddle meetings are accepted via REBAdministration@ohri.ca.

OHSN-REB is currently working with uOttawa REB to support a new/updated REB harmonization review process. In the interim, if you wish to discuss collaborative research between uOttawa, TOH/UOHI, please send a request to meet with both REB managers at OHSN-REB and uOttawa REB via REBAdministration@ohri.ca.

OHSN-REB supports collaborative discussions virtually via MS Teams. If you would like to discuss any REB harmonization initiatives prior to the submission of the survey, we welcome your request via REBAdministration@ohri.ca.

Please provide a summary for the discussion and list the members you wish to attend the virtual meeting. The list of attendees could consist of:

• REB Chair, Manager, Research Ethics Coordinator at OHSN-REB and/or External REB
• REB Chair, Manager, Research Ethics Coordinator at external site
• Contracts Manager or Contracts Officer
• Facilitators or Quality Team from the institution(s)
• Investigator and/or study team from local and participating site(s).