SOP Series: SOP 200 REB Operations
SOP Title: REB SOP 214: Preapproval Review Process
Version Date: July 7, 2020
Approved: July 15, 2020

Purpose

1. The purpose of these procedures is to describe the Research Ethics Board (REB) preapproval
process. This process will allow Principal Investigators to seek approval for a standard research
procedure that can be applied across similar studies. For illustrative purposes, this may include,
but is not limited to, research programs that conduct several studies utilizing standard research
procedures involving specialized equipment, recruitment of a unique population, and/or standard
data collection procedures. The application process will require the completion of a preapproval
application and a stand-alone document (e.g. Standard Operating Procedure or protocol) that will
describe in detail the proposed standard research procedures. The REB will review the
preapproval application according to the principles of the most recent version of the Tri-Council
Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2), institutional
policies & requirements, and applicable regulations. Once approved, the Principal Investigator
(PI) can cite and append the preapproval process to subsequent REB applications. This will
facilitate a harmonized review process and eliminate the need to answer the same questions about
procedures and methods each time a new REB application is submitted.

Definitions

2. For the purposes of these Procedures the following definitions apply:

“Affiliated” means individuals who:
a. hold academic and/or clinical appointments at the University ,
b. are employed at the University, or
c. Retired University faculty.

“Delegate” is assigned responsibility by the REB Chair for decision-making to provide ethics
review support to the University REB.

“Principal Investigator (PI)” is affiliated with the University and is the lead of the research
team who has overall responsibility for the ethical conduct of the study/procedures and for the
actions of any member(s) of the research team. The PI is responsible for communicating any
changes to the study/procedures, material incidental findings, new information, and/or
unanticipated events to their own REB as well as to local site researchers for multi-site studies,
who must then inform their respective local REBs.

“REB Administration” includes the Research Ethics Officer and/or REB delegate who provides
operational support to the University research ethics framework and REB.

“REB” refers to the Research Ethics Board authorized by the University.

“Tri-Council Policy Statement 2: Ethical Conduct for Research Involving Humans
(TCPS2)” is the joint policy of Canada’s three federal research agencies – the Canadian Institutes
of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada
(NSERC), and the Social Sciences and Humanities Research Council of Canada (SSHRC). This
policy outlines ethical norms relevant to the conduct of research involving humans.

“University” refers to Ontario Tech University.

Scope and Authority

3. These procedures apply to all preapproval applications involving human participants or human
biological materials where a PI seeks approval for a standard research procedure that can be
applied across similar studies.
4. The REB Chair (or delegate) and REB Administration are responsible for
executing, overseeing the implementation, administration and interpretation of these procedures,
as well as to ensure that the research ethics review related to the procedures are compliant with
the applicable policies, regulations and guidelines.

Procedures

5. Preapproval Submission Requirements

5.1. Principal Investigators shall complete the REB’s Preapproval Application and must
append either a Standard Operating Procedures (SOP) or protocol, whichever the PI
deems appropriate for application, and supporting documentation if any, as part of
the submission. The PI will decide if a SOP or protocol will be used for the
submission.

5.2. The SOP/protocol must include an identification number assigned by the PI and a
version date.

5.3. REB applications must include all individuals who are permitted to cite the
preapproved SOP/protocol on REB submissions.

5.4. A recommended format of the SOPs may include the following elements:
a. Title,
b. SOP identifier and version date,
c. Purpose,
d. Definitions of terms, if applicable.
e. Scope and authority which defines whom or what the particular set of procedures
applies and who defines the roles and responsibility for overseeing the
implementation, administration and interpretation of the SOP.
f. Procedures which outline in a step-wise fashion the proposed standards,
procedures and/or practices. The procedures shall define the roles
responsibilities for executing the activities within the procedure.
g. References and related documents.

5.5. A recommended format of the protocol may include the following elements:
a. Title,
b. Protocol identifier and version date,
c. Rationale and background which outlines the reasons for the proposed
preapproval,
d. Objectives,
e. Design,
f. Methodology,
g. Safety considerations,
h. Follow up,
i. Data management and statistical analysis,
j. Quality assurance,
k. Expected outcomes.

5.6. The PI shall submit completed preapproval applications, SOPs/protocols and
supporting documentation through the IRIS Research Portal.

6. Review and Approval Process of Preapproval Submissions

6.1. The REB Administration shall promptly screen for completeness of new preapproval
applications received through the IRIS Research Portal using the Pre-Submission
REB checklist. Applications that are assessed as complete will be accepted for
review. Incomplete applications will be returned to the PI for correction.

6.2. Accepted applications are assigned to the next available REB meeting and shall be
reviewed according to the procedures outlined in REB SOP 205 (The Full Review
Process).

6.3. REB determinations about the preapproval application are made according to
procedures outlined in REB SOP 205 (The Full Review Process).

6.4. During the review process, the REB may require additional information or
clarification from investigators. The REB shall send clarification and/or decision
letters to the PIs via email.

6.5. Occasionally, the PI may be required to meet with reviewers to answer questions or
explain the details of the preapproval application.

6.6. The PI is required to address each clarification separately, revise the preapproval
application and supporting documentation to satisfactorily address the ethical
concerns raised during the review. The PI must emphasize in the clarification
response where the revisions were made in the application and provide clean and
tracked copies of all revised documents. The PI shall resubmit the clarification
response in the IRIS Research Portal.

6.7. Once all clarifications have been satisfactorily addressed, the REB shall email a
decision letter to the PI.

6.8. In rare instances when a preapproval application does not receive ethics approval or
conditional approval based on the ethical acceptability of the principles of the
TCPS2, the PI is entitled to a reconsideration by the REB according to Article 6.18,
TCPS2 2018 and the procedures outlined in REB SOP 212 (Process for
Reconsideration or Appeal of Decisions of the REB). If the reconsideration does not
resolve the disagreement, the PI may appeal the REB decision in accordance to these
procedures according to Article 6.19, TCPS2 2018 and REB SOP 212 (Process for
Reconsideration or Appeal of Decisions of the REB).

6.9. The PI is responsible for obtaining other institutional, multi-institutional and/or
regulatory approvals/permission that are applicable to the preapproval process prior
to implementing the preapproval SOP/protocol.

7. Ongoing Reviews of Preapprovals

7.1. All preapproved research procedures cited in REB applications are subject to
continuing research ethics review under the Tri-Council Policy Statement 2 Articles
6.14, 6.15 , 6.16 and the procedures outlined in REB SOP 207 (Ongoing Review of
Approved Research).

7.2. The PI shall submit an annual report (renewal) or end-of-procedures report (closure)
to the REB through the IRIS Research Portal prior to pre-approval expiry.

7.3. The PI shall also submit to the REB reports of unanticipated issues, and requests for
changes to approved procedures through the IRIS Research Portal. Proposed
revisions to preapproved procedures must be reviewed and approved by the REB
prior to implementation.

8. Preapproved procedures in new REB applications

8.1. When using preapproved procedures in new REB submissions, the REB file number,
version date, number and title of the SOP/protocol must be cited in sections of the
REB application where appropriate.

8.2. The approved SOP or protocol must be attached to the REB submission as an
appendix.

Monitoring and Review

9. These Procedures will be reviewed as necessary and at least every three years (unless another
timeframe is required for compliance purposes). The REB Chair (or delegate), REB
Administration and/or REB delegate, or successor thereof, is responsible to monitor and review
these Procedures.

Related Policies, Procedures & Documents

10. Pre-Submission REB checklist
REB SOP 205 (The Full Review Process)
REB SOP 207 (Ongoing Review of Approved Research)
REB SOP 212 (Process for Reconsideration or Appeal of Decisions of the REB)
Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2018)