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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.