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Instructions and Review Process

The OHSN-REB review process requires a collaborative team effort! The REB Office works in collaboration with the Investigator and study team, Contracts Office, Facilitation, Privacy Office and IT.

The Clinical Research Registration Form (CRRF)

A Clinical Research Registration form (CRRF) must be submitted for all studies whether applying locally in IRIS or in CTO Stream. Researchers/staff can access the CRRF through their IRIS homepage.

Institutional approval is required prior to starting a study. Institutional approval is obtained by completing the three tabs of the CRRF: Departmental Notification, Ethics and Contracts.

Local IRIS System

The local OHSN-REB electronic application can be found in IRIS. You must have a TOH account in order to apply through the IRIS system.

Clinical Trials Ontario System (CTO Stream)

For multi-centre studies in Ontario, applications can be submitted through the Clinical Trials Ontario system called CTO Stream. For more information about CTO Stream, please see the "Application and Submission Process" tab of the OHSN-REB website.

Local IRIS Applications

Please use the OHSN-REB consent form templates available in the "Guidance and REB Templates" tab of the OHSN-REB website. The REB will return applications if the consent form was not created using the applicable template.

CTO Applications

Clinical Trials Ontario (CTO) has their own consent form templates which can be found on their website. It is mandatory to use the templates. CTO will send applications back to the applicant did not create the consent form using the applicable template. In addition, CTO will not assign a Board of Record to review the project until the consent forms follow the CTO templates.

🔗 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.

For all study types, the maximum duration of ethics approval is one year. The date of REB expiry is listed on all REB approval/acknowledgement letters.

Note, the REB may determine that the research requires continuing review more frequently than once per year by considering the following:

  • The nature of any risks posed by the research,
  • The degree of uncertainty regarding the risks involved,
  • The vulnerability of the participant population,
  • The projected rate of enrolment and estimated research closure date,
  • Whether the research involves novel interventions,
  • The REB believes that more frequent review is required.

Continuing Review Forms are mandatory and must be submitted between 40-45 days prior to the study's expiry date. For good study management, the expiry date for the study should be noted in the Investigator and study team's Outlook calendar with a reminder set 60 days prior to expiry.

The REB will send an automated email reminder 60 days prior to study expiry date and the expiry dates can also be found on the right-hand side of Investigator and study team's IRIS homepages, in the "IRIS Ticker" section.

🔗 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

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.