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Criteria for REB Approval

SOP Title: 200: REB Operations
Number. Version: REB SOP 202: Criteria for REB Approval
Version Date: April 22, 2013
Approval Date: April 22, 2013
Approved By: REB
Revised and Approved: September 21, 2016

1.0 Purpose

This standard operating procedure describes the minimal requirements that all research proposals that
involve human participants must meet in order to be approved for conduct at, or under the auspices
of, the University of Ontario Institute of Technology.

2.0 General Procedure Statement

All research proposals that intend to enrol human participants must meet certain criteria before study related procedures can be initiated. The criteria are based on the guiding ethical principles of the TriCouncil Policy Statement 2 and principles that are unique to UOIT (e.g., UOIT REB Policy).

3.0 Responsibility and Authority 

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

4.0 Specific Procedures

4.1 Minimal criteria for approval of research

In order for a research project to be approved, at minimum, the REB must find that:

a. The Principal Investigator (or members of his/her team) has the credentials to conduct or
supervise the research.

b. There are no conflicts of interest that will compromise the safety or well-being of
participants.

c. Risks are minimized and mitigated to participants and researchers.

d. Risks to participants are reasonable in relation to anticipated benefits. In evaluating risks and
benefits, the REB will consider only those risks and benefits that may result from the
research (as distinguished from risks and benefits of therapies those participants would
receive even if not participating in the research).

e. Selection of participants is equitable. In making this assessment, the REB will take into
account the purposes of the research and the setting in which the research will be conducted.

f. Recruitment methods respect the privacy of individual participants.

g. Informed consent will be sought from each prospective participant or the participant’s legally
authorized representative, and adequately documented, in accordance with the TCPS and
appropriate local, provincial, or national guidelines or regulations.

h. Where appropriate, the research plan makes adequate provision for on-going monitoring of
the data collected to ensure the safety of participants.

i. There are appropriate provisions to protect the privacy of participants and to maintain the
confidentiality and security of data.

j. Additional safeguards are included when participants are likely to be vulnerable to coercion
or undue influence.

4.2 REB Assessment

The assigned Primary Reviewer will provide a clarification letter in full through IRIS that will be
available to the REB Chair or Vice Chair for review and comment.

4.3 Collaborative Research Arrangements

For cases involving multi-institutional, multi-site or collaborative research, please refer to SOP
206 (Multi-jurisdictional Research).