Office of the Research Ethics Board
INSTRUCTIONS FOR:
APPLICATION FOR ETHICAL REVIEW
RESEARCH INVOLVING HUMAN PARTICIPANTS
(For Researchers and Supervised Researchers)
The University of Windsor Research Ethics Board (REB) undertakes ethics review of all
research involving human Participants, including funded and unfunded faculty research,
graduate research, administrative research, and research conducted on the University of
Windsor community (students, faculty, staff) by researchers not affiliated with the
University of Windsor.
The REB conducts an ethics review prior to the beginning of any research involving
human participants. The REB examines the ethics components of the research, such as:
sound methodology, possible risks to the participants, recruitment of participants,
consent from the participants, confidentiality or anonymity for the participants, the way in
which the data is handled, and how feedback can be provided for the participants.
Please note that if the Research Ethics Board (REB) identifies problems within the
application or the research, you will be contacted in order that changes can be made.
The review process may take one week or several weeks depending on a number of
factors. There is a broad range of research activities and disciplines that must undergo
the research ethics review process, and we recognize that one form cannot ask
questions completely appropriate for all research. For those questions that are not
appropriate, please answer N/A. Please note that it is the responsibility of the
applicant(s) to ensure that all relevant sections are completed.
Incomplete applications will be returned to the applicant(s).
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SECTION A – PROJECT OVERVIEW
TITLE OF THE RESEARCH PROJECT
For funded research, please ensure that the title is the same as that of the grant
application. Where more than one ethics protocol is required to cover the research of a
specific project, please use the title plus subtitle or other form of identification.
PROJECT START AND END DATES
Project start and end dates can be interpreted in several ways. In some traditions,
engagement with the participant group may start before the beginning of data collection,
and end significantly later than the end of data collection. Therefore, the start date
should refer to the beginning of a formal recruitment process, or, in the case where there
is no formal process, the commencement of the informed consent process and data
collection. Completion of a study can be defined as the point in which data analysis has
been completed in order to answer the original research question(s).
BRIEF JUSTIFICATION
Researchers are asked to provide a rationale as to the level of review that is appropriate
for the project. In presenting the justification, the level of risk associated with the
group(s) to be studied and the specific methods should be noted in sufficient detail to aid
the board in determining the level of review that is proportionate to the risks associated
with the project.
SECTION B – GENERAL INFORMATION
1., 2. INVESTIGATOR INFORMATION
The Principal Investigator is the researcher who assumes primary responsibility for
conduct of the research. This may not be the same researcher who serves as PI on the
grant, nor the PI on the overarching project, if it is multi-centered. In the case of
graduate student research, if the project will serve as the thesis or degree-fulfilling
requirement, the graduate student will normally be the PI.
Post-doctoral fellows and Visiting Professors may serve as PI on the ethics protocol.
However, in these cases, a faculty member must sign as the “Faculty Sponsor” of the
project. The Faculty Sponsor, like the Faculty Supervisor, takes responsibility for
ensuring that the PI conducts the research project ethically, in accordance with the REBapproved protocol.
Undergraduate course-based research should be reviewed by the appropriate Delegated
Ethics Review Committee (typically departmental ethics committees), unless the
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research is funded or entails more than minimal risk. Please see your department or
faculty Undergraduate Coordinator to determine what this process entails. Projects from
departments that do not have undergraduate committees are sent to the REB.
3. LOCATION(S) WHERE THE RESEARCH WILL BE CONDUCTED:
If the research is to be conducted at a site requiring administrative approval/consent (e.g. in
a school), please include all draft administrative approval/consent letters. It is the
responsibility of the researcher to determine what other means of approval are required, and
to obtain approval prior to starting the project. If you are unsure, please contact the office
of the REB.
Field research outside of Canada normally requires ethics review by a board or
committee within that jurisdiction. Please see http://www.hhs.gov/ohrp/international/ to
determine what process is in place in the country where the research is to take place. In
cases where there is no ethics review process, a letter by a relevant body (e.g. NGO,
University) stating that there is no ethics review process that covers the participants but
that the research is culturally and ethically acceptable is required. In situations where
authorities’ knowledge of the research to be conducted could potentially put the
researcher and/or the participants in danger, it may be preferable not to seek
administrative consent. Please explain these circumstances in the protocol submission
form.
4. OTHER RESEARCH ETHICS BOARD APPROVAL
Please indicate all research sites and additional ethics reviews. This may include other
institutions/sites that are collaborating in the research, and/or other institution/sites
where the research will be conducted.
5. FUNDING OF THE PROJECT
It is common for one protocol to cover several grants. Please make sure to include all
agency and known funding information that the protocol will be covering.
It is also common for one grant to fund several research projects, each of which is/will be
covered by a separate ethics protocol. Please provide the number of protocols they
anticipate will be submitted in order to cover the entire funded research activity, and to
specify that this is # X of total number.
If funding changes (e.g. addition of sponsor, deletion of sponsor, change of sponsor)
during the course of research, an amendment should be submitted to the ERO to state
this.
Scholarships and fellowships are not relevant to this section unless there is a research
allowance component that involves human participants.
Please note, the REB requires the exact title under which funding was approved.
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6. CONTRACTS
If there is a funding or non-funded agreement associated with the research, please
submit one copy of the contract to the REB along with the ethics protocol.
7. REB REVIEW OF ONGOING RESEARCH
As a Canadian research institution, the University of Windsor is in compliance with TriCouncil Policy Statement 2 (TCPS2). According to Article 6.14 of the TCPS2:
“The REB shall make the final determination as to the nature and frequency of
continuing research ethics review in accordance with a proportionate approach to
research ethics review. At minimum, continuing research ethics review shall
consist of an annual status report (for multi-year research projects), and an end-ofstudy report (projects lasting less than one year).”
Therefore, at the minimum, researchers wanting to continue with a project beyond the
expiry date of their current ethics approval (normally valid for one year, dependent on
the REB’s evaluation of risk level) are required to submit an Annual Progress Report. A
study is considered to be ongoing until data analysis is complete. A Study Final Report
must be submitted once the study is closed.
8. SCHOLARLY REVIEW
The REB’s mandate is to ensure that the rights of research participants are protected.
The principle of proportionate review entails that
”In keeping with a proportionate approach to research ethics review,
the selection of the level of REB review shall be determined by the
level of foreseeable risk to participants: the lower the level of risk,
the lower the level of scrutiny (delegated review); the higher the
level of risk, the higher the level of scrutiny (full board review).”
(TCPS2)
Generally this implies that different levels of REB review for different research proposals.
Necessarily implied in this is that research proposals being reviewed by the delegated
expedited review or by executive review may be reviewed by scholars from fields other
than that of the research team.
Article 16.12 of the TCPS2 states that the REB “shall satisfy itself that the design of a
research project that poses more than minimal risk is capable of addressing the
questions being asked in the research.” The REB, in cases where scholarly review is
necessary, will be concerned with an assessment of the degree to which the research
might further the understanding of a phenomenon. Article 2.7 of the TCPS2 states: “ As
part of the ethics review, the REB shall review the ethical implications of the methods
and design [emphasis added] of the research.
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On the assumption that good research is ethical research, the REB is encouraging
researchers to view the ethics review as another opportunity to have one’s research
vetted by colleagues. In its review, the REB may make collegial suggestions that are
simply intended to aid the researcher. It is the goal of the REB that researchers will see
the review process as another opportunity to have colleagues examine one’s research.
It should be stressed that REB reviews are considered confidential and will not be
disclosed.
9. CONFLICTS OF INTEREST/DUAL ROLES
Any relationships that have the potential to impact recruitment, consent, or the
conducted of the research should be described here and how they are managed
described under Section 17/18 (Risks).
See:
Senate Policy C1: Conflict of Interest of Commitment
Windsor University Faculty Association Collective Agreement Articles 35 and 60.
TCPS 2: “Chapter 7”.
SECTION C – SUMMARY OF THE PROPOSED RESEARCH
10. RATIONALE
This section should be clear, concise, and provide just enough information to give the
reviewers an understanding of why the research is being proposed, and what research
has been done in this area. Situating the research in this way aids the REB in evaluating
the ethical components of the research, including an assessment of risk. It should be
assumed that the REB is familiar with the discipline, but may not be knowledgeable of
the specific research area being proposed. In general lengthy literature and thesis
proposals are not appropriate.
11. METHODS
This section should include all methods to be used in the study, with respect to human
participants and biological materials. This begins with a description of the procedure(s)
to be followed, presented in a step by step fashion. Tables, figures and timelines may be
useful when the study is complex or uses multiple methodologies. It is not necessary to
describe standard tests or procedures (e.g. DNA analysis, MRI scans, Beck’s
Depression Inventory, etc.). All measures/instruments/equipment/etc. used must be
described in sufficient detail that their purpose is clear, and relevance to the project is
evident. It is the responsibility of the researcher to obtain the proper permission
to use certain standard instruments in their research. If this is necessary, please
ensure that this is done before using any such instruments in your research. In
cases where publishers do not allow for instruments to be copied, it is the responsibility
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of the researcher to obtain “review only” copies or to bring the instrument to the REB for
evaluation.
Please include copies of non-standard tests, interview schedules, etc.
For naturalistic or participant observation, describe the setting, kinds of information and
interactive and observational procedures that you anticipate using.
12. DECEPTION
Deception may pose additional risks, and may require consideration as to what the
debriefing process should include. Deception should, whenever possible, be through
omission (leaving details out), not commission (providing false descriptions). Studies
involving deception require justification for the need for deception.
It has been the experience of the REB that issues in the application often stem from a
lack of clarity in the Methodology section. It is in the researcher’s or in the research
team’s best interest to be clear about each and every method used in the project.
Incomplete answers in this section may result in the application being returned to the
researcher since it would be difficult for the REB reviewers to assess the project in terms
of respect for human dignity, welfare of the participants, and justice.
13. PARTICIPANTS/INFORMANTS OR DATA SUBJECTS
This information should help the REB to establish not only who the
participants/informants will be, but also what potential vulnerabilities, if any, they may
have. For personal information, this section should provide details on how the
information will be extracted or collected and what it will contain. The degree of
identifiability should also be discussed (e.g. names, postal codes or parts thereof, OHIP
numbers, etc.).
Psychology researchers making use of the Psychology Participant Pool should indicate
this in this section.
14. RECRUITMENT
It is understood by the REB that methods of recruitment differ by discipline, with some
not having any formal recruitment whatsoever. If there are any extenuating
circumstances as to why a certain method (formal or informal) is to be used, please
include this in the description. Please describe all steps in the recruitment, and distinct
types of recruitment that will occur. Please remember to include contact scripts (e.g.,
phone, email, etc.), advertisements (e.g., posters, online, flyers, newsletter, etc.), or any
other mechanism being used to recruit or to introduce the study to (potential)
participants. The University logo and letterhead ought to be used. Also include a
statement to the effect that your study has received REB clearance (Note: The REB
does not “approve” projects but grants clearance). It is understandable that in some
cases the researcher, prior to the submission of the protocol, will know potential
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participants.
15. EXPERIENCE
Research with human participants can only be conducted ethically when the research
team’s abilities are equal to the needs and expectations of the participant. Therefore, a
brief description of the research team’s experiences and/or ability to conduct the
research is required.
Please note that what is of interest is the experience with the specific methods used in
the protocol. For example, if online surveys are being used then the research team’s
experience with online surveys must be discussed. If the researcher is a student, the
degree of supervision, by the faculty supervisor and/or on-site supervisor should be
included.
Please note: (1) the REB requires a brief description for each and every member of the
research team (2) a bibliography or CV excerpt will not suffice.
16. COMPENSATION/INCENTIVE
If compensation is offered, it should not provide undue influence in an individual’s
decision to participate in the research, nor should it be a simple token; participants
should be duly compensated for time spent participating in the study. When participants
represent a particular profession, compensation per time spent may be appropriate.
Justification for the amount of compensation to be offered to participants should be
provided.
It is expected that whenever possible, participants who withdraw will receive partial
compensation.
For Psychology researchers only making use of the Psychology Participant Pool
particular attention must be paid to the allocation of the bonus points. The REB
understands that the Psychology Participant Pool serves as an important component in
the education of psychology majors. To that end and to ensure consistency, the REB
requests Psychology researchers using the pool to use the following:
“Participants will receive X bonus points for Y minutes of participation towards the
psychology participant pool, if registered in the pool and enrolled in one or more eligible
courses.”
(NOTE to researchers planning to use the pool: Credit awarded per time involved in the
study must coincide with current Psychology Participant Pool policy, available on the
Psychology Department web page: www.uwindsor.ca/psychology; Additional
compensation above bonus points must be justified and must coincide with Pool policy).
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SECTION D – DESCRIPTION OF THE RISKS AND BENFITS
17. POSSIBLE RISKS
In order to assist researchers in evaluating possible risks of harm for participants, these
have been separated into types of risk: physical, psychological/emotional, social,
dual/multiple relationship, data security, and deception. Deception may pose additional
risks, and may require consideration as to what the debriefing process should include.
Deception should, whenever possible, be through omission (leaving details out), not
commission (providing false descriptions).
If the research does involve greater than minimal risk, it is important for the researcher to
contemplate the best way to manage or minimize it.
18. USING THE RISK MATRIX
The risk matrix should be understood as a broad heuristic to help researchers frame risk
factors for standard research ethics issues such as free and informed consent, privacy
and confidentiality, and inclusion-exclusion criteria, as well as any special considerations
such as relevant professional qualifications of the research team members. By locating a
protocol on the matrix, researchers can determine both the review type (i.e. delegated
expedited or full) and level of continuing review (e.g. annual renewal or small possibility
of site visit) appropriate to a project.
Determining Risk Level and Review Type
To evaluate risk for a protocol, consider:
1. Group vulnerability—i.e., any pre-existing vulnerabilities associated with proposed
participant groups, e.g., relating to pre-existing physiological or health conditions,
cognitive or emotional factors, and socio-economic or legal status.
Researchers are reminded that group vulnerability may be inherent (e.g., young children,
members of the military, prisoners), or be tied to the specific procedures used in the
research. In the former, there is a ‘main effect’ of vulnerability on the conduct the
research. In the latter, the vulnerability of the group is contingent on the type of research
being conducted (the group would not be vulnerable if a different type of research were
to occur).
2. Research risk—i.e., the probability and magnitude of harms participants may
experience as a result of the proposed methods to be used and types of data to be
collected, e.g., relating to physiological or health issues such as clinical diagnoses or
side effects, cognitive or emotional factors such as stress or anxiety during data
collection, and socio-economic or legal ramifications such as stigma, loss of
employment, deportation, or criminal investigation (e.g., in the event of duty to report
intent to cause serious harm, subpoena, or breach of confidentiality).
Researchers are expected to adhere to the TCPS 2 when identifying that the risk
associated with any research risk is ‘minimal’. The REB will examine arguments
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regarding the level of risk with care.
The factors should be summarized with overall assessments of group vulnerability and
research risk by locating the protocol in the matrix below.
Research Risk
Low
Medium
Minimal
Group Vulnerability
Low
Medium
High
1
1
2
1
2
2
2
2
3
High
2
3
3
The Chair of the REB will take the researchers’ assessments of group vulnerability and
research risk into account in order to make the final decision regarding which review
type would be appropriate for a protocol.
Assessing risk may to some degree be affected by discipline-specific considerations—
e.g., forensics, kinesiology, psychology, and nursing may involve work with participants
in clinical settings, with attendant requirements for oversight and team qualifications.
Departments will likely want to work with the REB to decide how best to handle different
levels of risk. Additional online resources may also be helpful, including:
www.pre.ethics.gc.ca/english/
The risks associated with the research are described in Section 18b. The ways in which
these risks are mitigated is described in Section 18c.
The REB assumes that some level of risk is associated with all research, and expects
that risks that may reasonably arise due to the research (no matter how minimal they
may appear) will be described.
19. POSSIBLE BENEFITS
Whenever possible, benefits should be first felt by the participants in the study. “Society”
may refer to the community in which the research was conducted, Canada, Western
society, etc. The term is used vaguely here for the researcher to explain benefits
applicable to his/her research.
It is important that possible benefits listed are realistic. If there is no benefit to the
participant, this should be expressed.
SECTION E – THE INFORMED CONSENT PROCESS
20. THE CONSENT PROCESS
Obtaining informed consent is a process.
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Obtaining consent involves more than providing a form to read.
While the default is written consent, the REBs understand that many disciplines and
cultures do not accept written consent as appropriate. It is the quality of the consent
process, not the format that is most important.
Article 3.12 of the TCPS2 states “Evidence of consent shall be contained either in a
signed consent form or in documentation by the researcher of another appropriate
means of consent.” Moreover, “In some types of research, and for some groups of
individuals, written consent may be perceived as an attempt to legalize or formalize the
consent process and therefore may be interpreted by the participant as a lack of trust on
the part of the researcher. In these cases, oral consent, a verbal agreement or a
handshake may be required, rather than signing a consent form. In some cultures, the
giving and receiving of gifts symbolizes the establishment of a relationship comparable
to consent.”
Informed consent is an on-going process that starts with the researcher's first contact
with the individual and continues through study completion/subject withdrawal, and
beyond. Any verbal exchange about the study, the written informed consent form and
any other written documentation given to participants should provide adequate
information for the participant to make an informed decision about his/her participation.
Please see the REB website for best practices and examples of consent forms.
21. CONSENT BY AN AUTHORIZED 3rd - PARTY
In Canada, there is no definitive age below which parental/guardian consent is required
in order to participate in research. Whenever children (under 18 years of age) are to be
included as participants, the researcher must consider the risk of the research, the
maturity level of the children, and any potential risks versus benefits associated with
parental knowledge of the research (e.g. research looking at drug use in youth).
Adolescents under the age of 18 and who do not live with their parents can consent for
themselves. Similarly, university students are considered to be adults, whether or not
they live out of the home.
If an adult participant is not competent to formally consent, a surrogate decision maker
can do so. However, the research should be explained to the participant, and given the
opportunity to provide assent or dissent.
Assent from children should also be obtained, as even very young children can be made
to understand simple explanations of what the research involves and determine whether
they want to participate or not.
Consent by an authorized 3rd party is often required when research, including
recruitment, is being done through a school board. For instance, in Windsor-Essex
County, the two English language boards require parental/guardian consent along with
participant assent regardless of the risk level and grade/age level of student participants.
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22. POST-STUDY INFORMATION/FEEDBACK/DEBRIEFING
Deception is considered a risk, as it can negatively impact on a participant’s feelings of
trust in the study, in the researcher, and in the research. Therefore, whenever deception
is to be used, it is important that debriefing be done so as to provide the participant with
an opportunity for real informed consent. The participant should also be re-consented,
or asked whether they wish to have data withdrawn, after debriefing.
It is important that participants have access to study findings. For some populations, it
may not be appropriate for providing feedback of results only to be accessible in a
scholarly journal article format. Please describe the format by which participants can
access findings (newsletter, copy of thesis material, etc.), and how they will be notified of
this.
Some disciplines have a common practice of providing post-study information at the
conclusion of data collection from a participant. A rationale of the process and a
description of this form of debriefing are required.
Study results, communicated to participants, should be brief and user friendly
summaries of the research results. In most instances, detailed journal publications or
theses need not be communicated to the participants. Study results should be
conveniently located (e.g., study results on the REB website) and participants should not
have to contact the researcher to access the results.
23. PARTICIPANT WITHDRAWAL
What actions constitute withdrawal should be listed. This may include actions of noncompliance by the participant, leading the researcher to withdraw the participant from
the study. If participants cannot withdraw after a certain point for any reason (e.g. delinking of data), this should be explained. Generally, in studies where participants are
anonymous to the researcher, participant withdrawal is not possible.
If the methodology involves Focus Groups, participants must be informed that since
Focus Groups are group events, participants cannot withdraw any information they have
contributed to the study prior to their withdrawal.
Researchers are reminded that there is typically a point in time beyond which withdrawal
is no longer possible. For example, can withdrawal occur once a paper has been
published?
SECTION F – SAFEGUARDS FOR PROTECTING PARTICIPANTS AND DATA
24. CONFIDENTIALITY/ANONYMITY
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Confidentiality pertains to the data; anonymity pertains to the individual. Anonymity is to
be differentiated from de-identified data. Specifically, for an anonymous participant,
information collected from participants never had identifiers associated with it (e.g.,
anonymous surveys) and risk of identification of the individuals is low or very low. Deidentified data is information that is irrevocably stripped of direct identifiers, a code is not
kept to allow future re-linkage, and risk of re-identification of individuals from remaining
indirect identifiers is low or very low. When a participant can be identified, what steps
will be taken to ensure that the participants’ data will be kept in confidence? This section
should describe the researcher’s plan for ensuring confidentiality. Things to consider:
• Use of pseudonyms and/or linkages, labels, generics (e.g., "a small town in north
Ontario”) and aggregates (e.g., suppression of small cell sizes?).
• Who may access data?
• Where will data be stored? How will data be secured? How long will data be
retained?
• Will data be destroyed? If so, when, and how?
In some instances when the participants are identifiable, researchers may not be able to
ensure confidentiality. Participants will need to be informed of any constraint on
confidentiality. When interviewing participants in their official capacity (e.g., politician,
judge, celebrity, etc.), it may be difficult to offer confidentiality when “on record.” A
researcher might, on the other hand, indicate that “off record” comments can be
confidential.
When focus groups are used in research the following statement or a statement of a
similar nature needs to be included in the confidentiality section of the Letter of
Information and the Consent Form:
"The focus group is a group event. This means that while confidentiality of all the
information given by the participants will be protected by the researchers
themselves, this information will be heard by all the participants and therefore will
not be strictly confidential.”
When the researcher or the research team does not know the participants’ identity, then
participants can be considered to be anonymous. (Note: signed consent forms will have
an impact on anonymity.)
The ethical conduct of research extends beyond the active collection of information, to
the complete lifecycle of the information that is gathered. This includes how the
information will be used, and how the data will be handled up to the point of destruction.
Increasingly researchers are choosing to archive data, publish data sets, and share data
with colleagues. Research participants must be informed if data may be used for other
purposes in the future. Researchers wishing to use data for other purposes must consult
REB guidelines and/or consult with the REB as to whether ethical review is needed for
the new use of the data.
25. PRIVACY REGULATIONS
Please see relevant regulations, including:
Personal Health Information Protection Act (PHIPA):
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http://www.e-laws.gov.on.ca/DBLaws/Statutes/English/04p03_e.htm
Personal Information Protection and Electronic Documents Act (PIPEDA):
http://www.privcom.gc.ca/legislation/02_06_01_e.asp
and Health Insurance Portability and Accountability Act (HIPAA):
http://www.hhs.gov/ocr/hipaa/privacy.html
Patriot Act (US): http://www.epic.org/privacy/terrorism/hr3162.html
Clinical Trial Registration: http://www.icmje.org/clin_trialup.htm
SECTION G – CONTINUING REVIEW OF ONGOING RESEARCH
The risk matrix should be understood as a broad heuristic to help researchers frame risk
factors for standard research ethics issues such as free and informed consent, privacy
and confidentiality, and inclusion-exclusion criteria, as well as any special considerations
such as relevant professional qualifications of the research team members. By locating a
protocol on the matrix, researchers can determine both the review type (i.e. expedited or
full) and level of continuing review (e.g. annual renewal or small possibility of site visit)
appropriate to a project.
Level of Continuing Review
Each of the three risk levels is also associated with a more rigorous program of
continuing review. Generally, the three levels of continuing review can be summarized
as follows:
Level 1: All protocols extending beyond one year require annual renewal in the form of a
brief summary report (Progress Report) commenting on:
• any changes to the protocol, forms, or personnel (e.g., status as students or
employees)
• number of participants currently in the study, or who have completed the study, or
who withdrew (including their reasons for withdrawing)
• any ethical concerns arising
• researchers should submit a Final Report when data analysis has been
completed in order to answer the original research question(s)
Level 2: In addition to being subject to Level 1 review, mid- and high-risk protocols have
a small chance of receiving a routine site visit, including review of:
• REB’s file documenting the approval process
• researcher’s consent files documenting participant consent and eligibility
Level 3: in addition to being subject to Level 1 review, and having a small chance of
being subject to Level 2 review, high-risk protocols have a small chance of receiving a
routine site visit, including review of:
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• researcher’s data files documenting adherence to or deviation from protocol,
reporting of adverse/unanticipated events, and data quality; this may include audio
or video recordings, electronic or paper records, field notes, etc.
• under unusual circumstances, continuing review may also include direct contact
with the research process (i.e., observing the consent or study procedures) if the
researcher has received permission from the participant to do so, and the REB
determines that the risks to participants do not outweigh the benefits. Under
similar circumstances, continuing review may also include contacting participants
during or after participation (e.g., by phone, or by appending relevant questions to
study protocols); relevant questions may include how they were recruited, who
they interacted with and in what capacity, whether they were given an opportunity
to ask questions, whether they felt pressure to participate or continue, whether
they are satisfied with their experience as a participant, and whether they have any
other questions or comments. Such procedures, however, are not expected to be
the norm.
The risk matrix and explanation/justification will be taken into account when determining
which category of Continuing Review the research will fall under (Level 1, 2 or 3). The
University of Windsor REB will make the final decision of the risk level, and will
determine the program of Continuing Review that will be followed. This determination
will be communicated to the researcher in the ethics approval letter.
SECTION H – SIGNATURES
Signatures are required from:
Faculty researcher including Adjunct appointments
Principal Investigator
Post-Doctoral Fellow or
Visiting Professor PI, Faculty Sponsor
Graduate Student PI, Faculty Supervisor
Research supervisors are reminded that they are ultimately responsible for the conduct
of the research, and in ensuring that the research is conducted as described in the
application.
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