The Full Review Process

SOP Title: 200: REB Operations
Number Version: REB SOP 205 The Full Review Process
Version Date: November 12th, 2012
Approval Date: November 12th, 2012
Approved By: REB
Revised and Approved: October 19, 2016

1.0 Purpose

This section describes the REB full review process.

2.0 General Procedure Statement

All research involving human participants must be submitted for REB review according to the
specified application format and process, otherwise the investigator will be notified that the REB
will not review the research activity until all required elements are submitted. No intervention or
interaction with human participants in research, including recruitment, may begin until the REB
has reviewed and approved the TCPS certificate of completion, research protocol, consent
documentation and recruitment materials.

There are four possible decision outcomes are: Approved, Clarifications Required, Deferred
(Major Clarifications, Re-submission), or Rejected. Except when the delegated review procedure
is used, these actions will be taken by a vote of a majority of the members present, except for
those members present but unable to vote in accordance with REB’s conflict of interest policies.
The decision will reflect the majority vote. In cases where a minority disagree with the vote, their
position may be communicated to the researcher in the decision letter.

When reviewed via delegated review, the REB Chair or his/her designate can take any of the
actions outlined below, except to reject a study.

3.0 Responsibility and Authority

The Chair, Vice-Chair and the REB Administration are responsible for executing this policy.

4.0 Specific Procedures

4.1 Application Process

REB staff will review each application for completeness. If there are elements missing, the
investigator will be notified.

Review Procedures
Initial applications are pre-screened for completeness and assessment of the level of risk. If the
application does not meet the criteria for delegated review, it will be reviewed by the Research
Ethics Board in accordance with the following procedures:

• The REB office will assign the study to one primary reviewer who will review the study and the application and all relevant documentation in detail. If the study involves a medical intervention, a medical doctor must also provide a review.
• The protocol may also be assigned to an additional expert (external reviewer) who is not a member of the REB if the nature of the protocol warrants the need for additional expertise.
• All materials and relevant documents are accessible by all REB members. The primary reviewers will receive notification of their assignments vie e-mail approximately one week prior to the REB meeting at which the study is scheduled to be reviewed.
• For projects reviewed by the full REB, the Principal Investigator may be requested to attend the meeting of the Research Ethics Board and if so, he/she will be given an appointment time. If the Principal Investigator is requested to attend but cannot represent the project on the specified date and cannot delegate this responsibility to a coinvestigator, the project may be deferred to the next scheduled REB meeting.
•  Discussion of the Protocol at the REB meeting is led by the primary reviewer. In accordance with SOP 101 Article 4.6, the REB may make any of the determinations outlined below in article 4.2.

4.2 REB Determinations

The REB may make one of the four following determinations as a result of its review of research
submitted for initial or continuing review: Approval, Clarifications Required, Deferral, or
Rejected.

A. Approvals: The protocol and accompanying documents are approved as submitted. Research
may begin as soon as the Principal Investigator receives a Certificate of Approval to proceed
from the REB Chair or designate. Once the Certificate of Approval has been issued, the
research may begin provided that all other Institutional requirements have been met. The one year period of approval will commence on the day the study is approved by an action of the
convened REB or the REB Chair or his/her designate.

B. Clarifications Required: The Board may decide that a Protocol may be approved provided
that certain conditions are met or required changes are made. A written explanation of the
conditions and/or modifications is sent to the Investigator by the Chair of the REB through
the REB administration. When appropriate, the communication will include written reasons
for the required modifications. When the Principal Investigator provides the Research Ethics
Board with proof that the conditions have been met and the documents have been amended,
(as confirmed by Research Ethics Administrative Staff or the REB Chair), the Certificate of
approval will be sent to the Investigator.

C. Deferral: The REB may defer a decision on any submitted research application if it does not
have sufficient information to arrive at a determination, or if the REB requires extensive
revisions to any part of the research. The application will be brought back before the full
Board for consideration after the additional information or revisions are received.

D. Rejection: The REB may reject any protocol which does not meet its standards for ethical or
scientific review and where revision is unlikely to enable the REB to reach a positive
determination. No other UOIT Institutional official or other REB may approve a study which
has been previously rejected by the UOIT REB. A researcher may request reconsideration of
a decision made by the REB and has the right to appeal the REB’s decision to the appeals
board (Trent University REB). The decision rendered by the appeals board is final.