SOP Series: SOP 300 Board of Record (BOR)
SOP Title: SOP BOR 301 Coordinated Initial and Ongoing Review Process for Durham College and the University of Ontario Institute of Technology
Version date: December 21, 2017
Approved: January 17, 2018

1.0 Purpose

This Standard Operating Procedure (SOP) describes the initial and ongoing review process for
research studies involving human participants that have been accepted for ethical review through the
Durham College (DC) and The University of Ontario Institute of Technology (Ontario Tech) Board of
Record (BOR) coordinated review process.

2.0 General Procedure Statement

All research projects involving human subjects require Research Ethics Board (REB) approval prior
to study initiation at the institution where the research project is led. The BOR coordinated review
process will streamline ethics review between DC and Ontario Tech so that an ethics submission is only
required at one institution. Under the DC-Ontario Tech BOR coordinated review process, a BOR
designation will be assigned to either the DC or Ontario Tech REB. This is a decision that will be mutually
agreed upon by each REB. To qualify for a BOR coordinated review, a project team member
(e.g. Principal Investigator or Co-Investigator) must be affiliated with DC and/or Ontario Tech. REB
submissions will be made to the assigned BOR. The BOR that will carry the responsibility for the
initial review, approval and ongoing ethical review of the study.

3.0 Responsibility

The REB Chairs, Vice-Chairs and REB administrators are responsible for executing this SOP.

4.0 Definitions

4.1 Board of Record (BOR) is the REB of the institution where the main research activities will be
led. The BOR will be responsible for the ethics review, approval and ongoing review of the
study. BOR is assigned to DC or Ontario Tech by the REB Chair(s).

4.2 Delegated Research Ethics Board (DREB) is the REB of the institution that defers the ethics
review, approval and ongoing review of the study to the BOR.

4.3 REB administrator: Research Ethics Officer at Ontario Tech or Finance and Ethics Compliance
Coordinator at DC who provides administrative support and liaises with the research community
and REB.

4.4 Principal Investigator (PI) is responsible for completing the Ontario Tech or DC REB application. The
PI must be affiliated with DC and/or Ontario Tech.

4.5 Project team member can be the PI or Co-Investigator named on the REB application.

4.6 Research activity(ies) are considered participant enrolment, research interventions and data
collection.

5.0 Specific Procedures

5.1 Initial Applications Submitted to the REB

Ethics applications involving DC and Ontario Tech are screened and assessed for risk by the REB
administrator upon receipt. If the application has been deemed as minimal risk research by the
REB and qualifies for BOR coordinated review, the receiving REB will promptly notify the other
REB. If an application has been deemed as above minimal risk by the REB, the project team
member will be notified that a separate application must be submitted to other institution.

5.2 BOR Assignment

Once a project has been deemed as eligible to undergo a BOR coordinated review, each REB will
work together to assign a BOR. The BOR will be assigned to the REB of the institution where
the research will be led. The other institution that defers REB review to the BOR, will be
considered as the Delegated REB (DREB) and will accept the decisions of the BOR. To
illustrate, if the PI’s home institution is DC, and the project will involve participants at Ontario Tech, the
BOR will be assigned to DC given that DC is the PI’s primary affiliation. In this case, Ontario Tech will
be assigned as the DREB. As another example, if the PI is cross appointed with DC and Ontario Tech
and the project will involve participants at each institution, a mutual decision will be made
between the REBs as to which institution will be assigned as the BOR.

When Ontario Tech is the BOR, the PI will be notified by the REB administrator that the DC REB
External Researcher Institutional Permission Request Form is required and must be submitted to
DC prior to study initiation.

5.3 BOR Review Process and Records Management

The BOR will be responsible for all aspects of the initial and ongoing review of applications
undergoing a BOR coordinated review process. The BOR REB administrator functions as the
principle point of contact for the researchers and will provide administrative support for the BOR
coordinated review process. The application will be reviewed and approved according to the
designated BOR’s review pathway. All initial and post review activities such as the REB review
decision letter, responses to the decision letter, issuing of study decisions, ongoing continuing
review and study consultations will be overseen by the BOR. Each REB reserves the right to
conduct an independent research ethics review of any research involving humans at any time.

All BOR decisions will be communicated in writing to the PI. Documentation surrounding the
initial and post review activities will be managed and retained by the BOR. A copy of the BOR
initial study decision letter will be given to the DREB for informational purpose.

5.4 BOR Ongoing Review

The ongoing review, post approval activities (e.g. change requests and yearly progress reports)
monitoring and follow-up reporting of anticipated issues and non-compliance will be overseen
and managed according to the designated BOR’s SOPs and policies.

When DC is the BOR, all ongoing review activities will be managed according to DC’s REB
Protocol #404 (Ongoing REB Review Activities). Likewise, when Ontario Tech is the BOR, ongoing
review activities will be managed according to Ontario Tech’s REB SOP 207 Ongoing Review of
Approved Research.

5.5 Monitoring and Review

These procedures will be reviewed as necessary and at least every three years (unless another
timeframe is required for compliance purposes). The Chair, Vice-Chair and REB administrators
are responsible to monitor and review these procedures.

6.0 References

6.1 DC REB External Researcher Institutional Permission Request Form

6.2 Ontario Tech REB SOP 207: Ongoing Review of Approved Research

6.3 DC REB Protocol #404: Ongoing REB Review Activities