SOP Title: REB Operations Suspension and Termination of Research Involving Human Subjects for Administrative Non-compliance
Number: REB SOP 211
Version Date: November 20, 2020
Approval Date: December 9, 2020
Approved By: REB

Purpose

1. This standard operating procedure (SOP) describes the Research Ethics Board (REB) procedures for
responding to suspension or termination of research involving human subjects for administrative noncompliance.

As per article 6.14 of the Tri-Council Policy Statement 2, 2018 (TCPS 2) and the Ontario Tech REB
SOP 207, continuing ethics review consisting of an annual report (Renewal Request) or end-of-study
report (Project Completion Notification) must be reported to the REB prior to study expiry. The
Principal Investigator has a responsibility to ensure that the study remains in compliance and the REB
approval does not lapse for a study. Failure to submit yearly reports prior to the expiry date will
result in administrative non-compliance. Consequences of administrative non-compliance include
suspension or termination of REB approval and freezing access to research funds for funded projects.

Definitions

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

“Non-compliance” means not following policies and procedures as outlined in the most recent TCPS 2,
and/or institutional REB policies, procedures, communications and/or the researcher’s approved REB
protocol.

Non-Compliance can range from Administrative Non-Compliance (continuing to conduct research that
has expired) to Adverse Non-Compliance, placing participants at an increased level of risk, resulting in an
adverse event involving a participant (i.e., leaving data unsecured). Note that examples provided are for
illustrative purposes only.

“Principal Investigator (PI)”, is the person who is a University member and leads a research project.
The PI is also responsible for overseeing all aspects of the research project.

“REB designate” is the Research Ethics Officer or Research Ethics Assistant who is responsible for the
coordination of activities related to research involving humans and provides support to the REB.

“Research activity(ies)” involve participant enrolment and recruitment, research interventions, data
collection and data analysis as described in the REB application.

“University” means the University of Ontario Institute of Technology (Ontario Tech).

“Suspension” means ethical approval of the research is suspended, resulting in the temporary cessation
of all study related activities. This applies to all research involving humans.

“Termination” means ethical approval of the research is permanently revoked and all study-related
activities must cease. This applies to all research involving humans

Scope and Authority 

3. These procedures apply to all research involving humans carried out under the authority of the
University. The REB Chair, REB Vice-Chair and REB designate are responsible for executing this
Procedure. This Procedure applies to all funded and unfunded research projects involving human
subjects.

4. The REB Chair, or successor thereof, is responsible for overseeing the implementation,
administration and interpretation of these Procedures.

Procedures

5. Study suspensions for administrative non-compliance

a. Prior to study expiry, the REB designate will send three courtesy renewal reminder notices to
the Principal Investigator (PI) requesting for a submission of annual report (Renewal Request)
or end-of-study report (Project Completion Notification) before the study expires.
b. If the PI does not submit renewal requests or project completion notifications to the REB prior
to study expiry, the study will result in suspension of REB approval by the REB Chair, ViceChair or designate immediately upon study expiry.
c. The REB will inform the PI promptly in writing of study suspension.
d. Suspended research files do not have active REB approval. To that end, the PI must
temporarily suspend all research activities.

5.1. The REB Chair, Vice-Chair or designate is authorized to suspend research for administrative
non-compliance.

6. Studies renewed or closed during suspension

6.1. Renewals

a. Renewals requests submitted to the REB during suspension are reviewed by the REB Chair,
Vice-Chair or designate.
b. The REB will issue continued approval at the REB’s discretion if a satisfactory rationale is
provided for the administrative non-compliance and a corrective action plan to ensure that ethical
approval does not lapse again.
c. For REB approval to be re-instated during a suspension period:
i. the REB will renew the study until the original anniversary date of the following year;
and,
ii. the PI must re-consent all study participants that were recruited into the study or had data
collected during the lapse in REB approval. If re-consent is not obtained from study
participants or permission is not obtained to use the data collected during the suspension,
the study participants cannot be included in the study and the data obtained cannot be
used.
d. The REB will promptly inform the PI of the re-instated REB approval.

6.2. Closures

a. For Project Completion Notifications submitted to the REB during study suspension, the
application will be reviewed by the REB Chair, Vice-Chair or designate for closure and the study
will be permanently closed at the request of the PI.
b. The status of the study file will be changed from “suspended” to “closed”.
c. The REB will promptly inform the PI of study closure.

7. Study terminations for administrative non-compliance
The REB Chair, Vice-Chair or designate is not authorized to terminate research for administrative
non-compliance; rather, study termination requests must be reviewed at a REB meeting where a
decision is rendered.

7.1. Studies with suspended REB approval are reviewed at the next convened REB meeting where a
decision is rendered to terminate the study,
7.1.1.Upon termination, the following will occur:
a. REB approval will be rescinded; therefore, no results collected post study expiry can be
used or published,
b. The PI must cease all research activities,
c. The institutional head the Office of Research Services will be notified that the REB
approval for a funded study has been rescinded for follow up action and communication
with the applicable departments.
7.1.2 The decision will reflect a majority vote from the REB members. Post meeting,
the REB will provide written notification to the PI that REB approval is permanently terminated
due to administrative non-compliance.

Monitoring and Review

8. 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 successor thereof, is responsible
to monitor and review these Procedures.

9. Reference

9.1. Tri-Council Policy Statement 2 (2018): Ethical Conduct for Research Involving Humans
9.2. REB SOP 207 Ongoing Review of Approved Research
9.3. REB SOP 210 Non-compliance