FORM 8

REB Protocol Review Form

Date: Number:

Title:

Principal Investigator: Reviewer:

Reviewers Recommendation: Approved Minor Revisions Major Revisions

There are ethical/medical issues which require discussion by the full Committee: YES NO

REVIEWERS: Please initial each page of the proposal and submit reviewed proposal with completed checklist
to the Office of the VP, Education.

PLEASE COMPLETE CHECKLIST, MAKE COMMENTS OR SUGGEST MODIFICATIONS AS REQUIRED

INVESTIGATORS
Identification of investigators
Comments:
VCC Contact Information
Comments:
Start and end date
Comments:
Source of funding and budget submitted
Comments:
PURPOSE
Purpose clearly stated in lay terms
Comments:
METHODS AND PROCEDURES
Smallest acceptable sample size
Comments:
Tests and procedures clearly explained
Comments:
Risks and benefits of participating clearly explained
Comments:
Explanation of the circumstances under which the investigator may terminate a research participants
participation with or without the research participants consent
Comments:
Data/sample storage and security appropriate
Comments:

Vancouver Community College

Research Ethics Board 1 of 4 May, 2013
Protocol Review Form
Length of time raw data kept
Comments:
Provision made to ensure proper handling of clinically significant information obtained in the course of the
study (e.g. positive pregnancy test, determination of an underlying medical condition)
Comments:
Steps being taken to offset impact of an adverse event
Comments:

DESCRIPTION OF POPULATION

Proposed advertising included

Comments:
Recruitment done at “arms-length” and free of pressure/coercion
Comments:
Subject selection equitable (e.g. male/female, inclusion of race and ethnic minorities)
Comments:
Rational provided for collection of sensitive demographic data (e.g. race, ethnicity, socio-economic status,
etc.
Comments:
Inclusion/exclusion criteria and rational with adequate safeguards
Comments:
PROJECT DETAILS
Qualifications of Investigators
Comments:
BEHAVIORAL STUDY
If study uses observational research, is it necessary to obtain consent
Comments:
Where the object of the research is a pre-formed group, are adequate procedures in place to minimize the
perception of coercion to participate
Comments:
Procedures described for when:
 An institution/power relationship between researcher and participant
 Third parties may be exposed to loss of confidentiality/anonymity and procedures to protect third
party confidentiality/anonymity
 Procedures that cause discomfort, fatigue, distress, induce embarrassment, humiliation or any other
negative emotional state
 Questions that are personal, sensitive or potentially upsetting
 Social risks
Comments:
Debriefing and feedback statement
Comments:
CLINICAL STUDY
Amount of blood/tissue/bone obtained
Comments:
Samples used only for the test specified
Comments:
When samples are destroyed
Comments:

Vancouver Community College

Research Ethics Board 2 of 4 May, 2013
Protocol Review Form
Samples are:
 Anonymous
 Anonymyzed
 Identified
Comments:
Use of types of radiation
Comments:
PROTOCOL CONSENT REVIEW
Consent on letterhead
Comments:
Consent form simply written, language at grade 6-8 or at a comprehensive level to research participants
Comments:
Information matches protocol
Comments:
Introduction
 explains study
 invites participation
 explains participation is voluntary
Comments:
Study description with purpose and benefit
Comments:
Participants’ involvement and conditions described
Comments:
Alternative treatments described where applicable
Comments:
Conditions of participation and amount of participants will be updated on new information that could effect
consent described
Comments:
Assurance and limits of the research participants’ anonymity and how accomplished
Comments:
Participant contact information re questions about:
 study
 adverse effects of participation
 concerns for REB chair
Comments:
Unambiguous statement that the research participant may decline to enter, refuse individual
questions/procedures or withdraw from the study AT ANY TIME without any consequences and consent
requested for retention of data.
Comments:
Statement ACKNOWLEDGING receipt of the consent form including attachments
Comments:
Statement agreeing to participate
Comments:
Signature of research participant CONSENTING to participate in the study
Comments:
Signature of witness
Comments:

Vancouver Community College

Research Ethics Board 3 of 4 May, 2013
Protocol Review Form
 IF BEHAVIORAL STUDY PLEASE COMPLETE THE FOLLOWING:
Participant debriefing and feedback procedures described when:
 research is above delegated review
 involves deception or concealment
 research participant discloses personally or culturally sensitive information
 research participant may become stressed or upset
Comments:
Procedures for solicitation of research participants are strictly voluntary and sensitive to issues of:
 a captive or dependent population
 a relationship of power over the research participants
 where participation is solicited as part of a person’s employment or education role
 a person’s decision to withdraw will not jeopardize their standing with that institution
Comments:
If potential risks or discomforts are anticipated, or the study is of a sensitive nature, is information on the
availability of counselling provided?
Comments:
IF STUDY PARTICIPANTS ARE CHILDREN PLEASE COMPLETE THE FOLLOWING:
Is research being conducted as part of the K-12 curriculum?
Comments:
Risk to child psychologically/physically?
Comments:
Ways to reduce stress to child
Comments:
Provisions made for comforting a distressed child
Comments:
When concealment/deception used - steps taken to clarify post study?
Comments:
Measures in place to address unforeseen consequences
Comments:
Plans for reporting results to parents and children
Comments:
Consent Review Form and verbal explanation simply spoken language at 2-3 years below child’s grade and no
greater that grade 6-8 level
Comments:
Plans to receive and address child’s questions
Comments:
Opportunity for child to provide written and informed on right to withdraw from study at any point without
negative consequences?
Comments:
Plan to obtain parental consent
Comments:
Plan to obtain third party consent
Comments:
Describe incentives offered
Comments:
Plan to maintain anonymity and confidentiality for all research participants
Comments:

Vancouver Community College

Research Ethics Board 4 of 4 May, 2013
Protocol Review Form