Research Submission Requirements
SOP Title: 200: REB Operations
Number. Version: REB SOP 201 Research Submission Requirements
Version Date: April 22, 2013
Approval Date: April 22, 2013
Approved By: REB
Revised and Approved: October 18, 2017
1.0 Purpose
This standard operating procedure outlines the required documents and supporting information
required from investigators for REB submission and review.
2.0 General Procedure Statement
REB members often rely solely on the documentation submitted by investigators, or other parties,
for initial and continuing review. Therefore, this material must provide REB members with
enough information about a study to assess if it adequately meets the REB’s criteria for approval.
A submitted protocol will be scheduled for REB review only when the REB Administration
determines that the information and materials submitted present an adequate description of the
proposed research.
3.0 Responsibility and Authority
The Chair, Vice-Chair and the REB Administration are responsible for executing this SOP.
The President, through the UOIT Research Ethics Board has authorized the UOIT REB to review
research involving human participants conducted by faculty, staff, and students under the
auspices of the University of Ontario Institute of Technology.
4.1 Specific Procedures
4.2 The Application Process
The UOIT REB requires that applications for initial and continuing review of research involving
human participants be submitted to the REB Administration
4.2.1. Submission Requirements for Initial Review
Submission requirements for initial review are outlined on the REB Application form and the
accompanying REB Application and Website. All sections of the application
form, including all required accompanying documentation, must be completed or the application
will not be reviewed. The principal investigator and all co-investigators must submit a certificate
showing completion of the latest TCPS 2 tutorial. Student investigators and research assistants
require understanding of the TCPS requirements and are strongly encouraged to complete all
TCPS 2 education and training modules.
It is strongly encouraged that PIs with questions or concerns set up an appointment to discuss
these concerns with the Research Ethics Officer in advance of submission. The Officer will
require a minimum of one week to examine any new applications.
4.1.2 Submission Requirements for Continuing Review
During the term of the approval, investigators must inform the REB about any changes to the
study. Investigators must send a Change Request Form and any revised documents to the REB
Administration. All revisions should be highlighted. Revisions cannot be implemented until the
REB has granted approval.
4.1.3 Submission Requirements for Clarification Letters
During the review process, reviewers may require additional information or clarification from
investigators. Requests will be sent to investigators (the PIs), via email, in the form of
clarification letters. Investigators are required to address each clarification separately within the
clarification letter, revise any documentation affected by the clarification, and return all
documents to the REB Administration. All responses and revisions should be highlighted. In very
rare cases, investigators may be required to meet with reviewers to answer questions or explain
the details of the study.
4.1.4 Reporting Unanticipated Problems or Events
Investigators must report all serious and unexpected study-related events to the Chair of the REB
and the REB Administration as soon as is reasonably possible but no longer than two (2)
business days after the problem. The obligation to report extends to the discovery of any new
information that might adversely affect the safety or well-being of participants. Reports must
include a completed Adverse/Unanticipated Events Notification (available on IRIS) and any
relevant documentation. Investigators may be required to meet with a member of the REB to
discuss the event and/or changes required to minimize risks.
4.1.5 Annual Renewals
Prior to the relevant REB approval expiration date, investigators requesting renewal of an
approved research project must submit either a completed Renewal Request (if the study is ongoing; available on IRIS) or a Project Completion Notification (if the study has ended; available
on IRIS). If a renewal request is not submitted by the expiration date, the study will be suspended.
4.1.6 Submission Deadlines
REB applications can be submitted at any time. However, in order for an application to be sent to
the next full board meeting for review, it must have been received by the REB Administration ten
(10) business days before the meeting date.
