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REB-App Guideline
You will find, as you proceed through this form, that some questions do not seem to
apply to your research. Please be aware that there is a wide range of disciplines which
use this form to apply for ethics clearance. If something does not apply – please feel
free to choose the n/a option, or explain in a text box.
Tri-Council Policy Statement: Ethical Conduct for Research Involving
Humans, 2nd Edition (TCPS2)
The questions asked in the REB-App are drawn from the TCPS2. There is an online
tutorial – the CORE tutorial - discussing the TCPS2 which anyone can take. Create a
new account using your University email address so completion can be tracked by the
ethics office. This tutorial is highly recommended.
Filling out your REB-App:
As you fill out the REB-App you will see this symbol:
It means that there is an information entry in the table below that corresponds to that
question.
Find the entry using the section letter and question number.
The notes provide further information about the question, and the Tri-Council Policy
Statement quotation (in italics) will provide a reference to the section of the TCPS2
which generated the question.
Section A
“To be eligible to receive and administer research funds from the Agencies, institutions
must agree to comply with a number of Agency policies set out as schedules to a
Memorandum of Understanding (MOU) between the Agencies and institutions.2 This
Policy is referenced in Schedule 2 to that MOU. Institutions must therefore ensure that
research conducted under their auspices adhere to this Policy.” [TCPS2, p.5]
Section A, Question 1
Choose a short, unique title. You do not have to duplicate your grant or thesis title.
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Section A, Question 2
Include everyone who will have access to identified data or direct contact with the
participant.
The Principal Investigator is defined as the individual who has ultimate responsibility for
the conduct of the study.
The Principal Investigator will receive all communications from the Ethics Office, and
can opt to have some or all of the research team receive these communications as well.
In the case of graduate level research, the Principal Investigator must be the faculty
advisor/supervisor of the graduate student.
If you need more than 8 rows, press TAB in last box, a new row will be generated.
Section A, Question 3
The REB will attempt to respond to urgent timelines, but cannot promise that a
response can be provided in less than the normal two week period.
Section A, Question 4.1
You may need to obtain REB approval from another institution if you are involving their
employees, students, or facilities. Approval from the University of Guelph REB will not
be withheld, but research should not begin until such approval is in place, and the U of
G REB has been provided with a copy of the approval notice.
Article 6.1
“Institutions shall establish or appoint REB(s) to review the ethical acceptability of all
research involving humans conducted within their jurisdiction or under their auspices,
that is, by their faculty, staff or students, regardless of where the research is conducted,
in accordance with this Policy.”
Section A, Question 4.2
If you are undertaking research outside of Canada, you will need to do at least one of
the following:




Obtain ethics approval from an REB/IRB in that country
Liaise with an institution (University or NGO, for example) in that country which
can review your work to ensure that it is culturally appropriate
Liaise with individuals from the country who can help to guide your research
Explain to the REB what other mechanism you will use to ensure that your
research is culturally appropriate.
TCPS2, Article 8.3,(a), and Application
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IRBs registered with OHRP can be searched.
International Compilation of Human Research Standards
Section A, Question 5
Knowing the level of research helps the REB reviewers to determine the degree of risk.
Section A, Question 6
The university has agreed not to release funds until all permissions are in place. This
section allows the Office of Research to link the project with the funding so that Grants
can release funds as appropriate. If funds are required before it is possible to submit an
ethics application, see Guideline 4-G-001
Part of informed consent is telling the participant “the identity of the funder or sponsor”
[TCPS2, p. 30; Article 3.2]
Section A, Question 6.3
This information is collected to help determine conflict of interest issues and to ensure
consistency between the contract or agreement and the ethics application. Some issues
will be dealt with both in the ethics application and in the contract. It is important that the
ethics office work with contracts office staff to ensure consistency
[TCPS2, p.91, 163-165; Article 11.10 and 11.12]
Section A, Question 7
The REB takes a proportionate approach to the interpretation of this article. If the work
under review has been peer reviewed elsewhere (for example during the funding
process, or by a graduate committee) then the REB will not usually comment on the
methodology. In addition, if the project is minimal risk, the REB will usually not make
methodological comments. If the project is higher than minimal risk, the REB may
require external peer review. See guideline 4-G-009
Article 2.7 “As part of research ethics review, the REB shall review the ethical
implications of the methods and design of the research” [TCPS2, p.20 and application]
Section A, Question 8
The REB is charged with dealing with conflict of interest at the institutional level, within
the REB itself, and at the level of the research team. COI is usually most effectively
dealt with through disclosure. [TCPS2, Chapter 7]
Section A, Question 8.1
Disclose actual, perceived, or potential COI within the research team.
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Section A, Question 8.2
Seeks to determine a conflict between the interests of the sponsor, and of members of
the research team (such as the balance between protection of sponsor’s IP and the
need for graduate students to publish)
Section A, Question 8.3
Seeks to determine a conflict between the interests of the sponsor and the interests of
the research or the participants themselves [TCPS2,Article 3.2 Application (e), p. 31]
Section A, Question 8.4
Seeks to determine a conflict between a member of the research team and the
participants. This can also be discussed as a potential for ‘undue influence’ or ‘coercion’
by the research team. [TCPS2, Article 3.1(a),p. 28-29]
Section A, Question 8.5
Expands on the response to Question 8.1, making clear that any employment on the
part of the researcher may place them in a position of COI (or power over) the
participant.
Section A, Question 8.6
Expands on the response to Question 8.1
Section A, Question 9
In order to determine the level of risk to the participants, the REB needs to determine
the experience that the principal investigator, and the rest of the research team, have
with the procedures being proposed – whether they are typical of the social sciences
and humanities, or of the natural and physical sciences.
Section A, Question 9.1
Examples of the type of response being sought here include










Experience with overseas research
Experience with focus groups
Experience with in-depth interviews
Experience working with vulnerable groups
Experience collecting personal health information
Experience with venipuncture
Experience administering galvanic vestibular stimulation
Experience with chiropractic techniques
Experience facilitating workshops.
Experience as a personal trainer.
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Section A, Question 9.2
The REB needs to know what each member is doing. Is the student taking blood or is
the phlebotomist? Is the faculty member leading the focus group, or someone hired to
do so from outside the research team? Attach any pertinent formal qualification.
Examples of the kinds of qualifications/certificates being referred to here are Good
Clinical Practices training, Medical Laboratory Technologist Certificate, training in
Clinical Psychology, etc.
Indicate ‘yes’ under “Contact with Identified Data” if the individual will be involved in the
collection, entry, and/or analysis of the data, or have access to the data.
Indicate ‘yes’ under “Direct Participant Contact” if the individual will be in direct contact
with the research participant at any point during the research process. This contact
does not need to be face-to-face, but includes electronic or other communication.
Indicate ‘yes’ under “CORE Tutorial Completed” if the individual has taken the CORE
tutorial on the TCPS2. This tutorial provides an applied approach to the guidance
provided in TCPS 2. This self-paced course is a media-rich learning experience that
features interactive exercises and multi-disciplinary examples. CORE consists of eight
modules ranging from Core Principles to REB Review. It is designed primarily for the
use of researchers and REB members – though anyone may take this course and print
their own certificate of completion.
IT IS STRONGLY ADVISED THAT PRINCIPAL INVESTIGATOR AND ALL OF
THE RESEARCH TEAM MEMBERS COMPLETE THE TCPS2 TUTORIAL
Section A, Question 9.3
The principal investigator is ultimately responsible for the actions of research team
members. This question probes how the research team leader will ensure that team
members are adequately prepared. Not all suggestions in the list will be pertinent to all
projects. Please discuss your project, and your team members in the space provided.
[TCPS2, p.22-24]
Section B, Question 2
This section is where you provide broad overview of what will happen during the course
of the research project. Provide a summary from the perspective of the participant. For
example:
 Participants will be recruited with flyers and invited to contact the research team
 Focus groups will be run to determine general viewpoints about the particular
topic area
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 Information from focus groups will inform an online survey. This will be submitted
to the REB once final questions are determined.
 Information from the online survey will be presented to the community in the form
of workshops.
OR
 Interested participants will respond to posters by contacting the graduate student
on the research team
 First meeting:
o Anthropometric measures
o Initial blood draw
o Distribution of food
o Provide 3 day food record and teach participants how to use it
 Second meeting
o Arrive fasted
o Provide blood sample followed by a light snack
o Bicycle to exhaustion
o Provide muscle biopsy
o Hand in 3 day food record
 Etc.
Details need only be provided here if there is no other section of the application which
addresses them.
“Article 6.11 Researchers shall submit their research proposals, including proposals for
pilot studies, for REB review and approval of its ethical acceptability prior to the start of
recruitment of participants, access to data, or collection of human biological materials.
REB review is not required for the initial exploratory phase, which may involve contact
with individuals or communities intended to establish research partnerships or to inform
the design of a research proposal. “ [TCPS2, Article 6.11, p. 76]
Examples of different ‘procedures’ would be: focus groups, interviews, blood draws,
participant observation, muscle biopsies, workshops.
Four response boxes have been provided. If more are needed, expand the last box and
itemize the procedures.
Section B, Question 3
This information is collected because the location of the research has implications for
the degree of risk, the vulnerability of the population, and the need for permission from
authorities, for example.
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Section C
Answer each question in this section for each procedure/method you are planning on
doing. If you are doing more than one procedure/method within a project, provide a
short title in Section B for each method, and then, using the same titles, respond to
each question in C using the text boxes.
Section C, Question 1
The amount of time spent with the participant, and the number of interactions with the
participant, can inform the level of risk for that participant. For example:

an 8 hour project with a subsistence farmer may negatively impact his/her ability
to provide for the family.
A 10 minute survey about sensitive topics may not allow the researcher time to
determine the impact of the project on the well-being of the participant, and provide
assistance.
Concepts of Risks and Potential Benefits [TCPS2, p. 22]
Section C, Question 2
The research project should be carried out in the language in which the participant feels
most comfortable. The REB takes a proportionate approach.



For low risk studies, the participant can choose not to participate if they are
unable to understand the research project (self-selection)
For medium risk studies, the researcher should determine that the consent
process is undertaken in a manner accessible to the participant (i.e. using a
translator and/or translated consent documents)
For high risk studies, the entire project should be conducted in the language of
choice of the participant.
[TCPS2, Article 3.2, p. 30]
and
When language barriers necessitate the assistance of an intermediary for
communication between the research team and participants, the researcher should
select an intermediary who has the necessary language skills to ensure effective
communication (see Article 4.1). The involvement of such intermediaries may raise
confidentiality issues (see Article 5.2).” [TCPS2, p. 32]
Section C, Questions 2.2.1 and 2.2.2
These questions pertain to the level of confidentiality provided to the participants (if a
interpreter is part of the local community there is more opportunity for breach of
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confidentiality) and for undue influence or coercion (if the translator is in a position of
power over the participant, or is a member of an organization which provides services to
the participant).
Section C, Question 2.2.3
Sample confidentiality agreement
Section C, Question 2.2.4
If project documents given to participants will not be made available in translation, you
must provide justification, and describe how the information will be provided to the
participants.
Section C, Question 3
This can be an approximate number, but the information is important in determining risk
– particularly risk of privacy. If you are collecting data from 3 people in a company, it
would be fairly easy to link a particular data point to one of those three. If you are
collecting data from 300, it would be very difficult to do so.
Concepts of Risks and Potential Benefits [TCPS2, p. 22]
Section C, Question 3.3
Provide justification if you are selecting one gender or another exclusively.
“Taking into account the scope and objectives of their research, researchers should be
inclusive in selecting participants. Researchers shall not exclude individuals from the
opportunity to participate in research on the basis of attributes such as culture,
language, religion, race, disability, sexual orientation, ethnicity, linguistic proficiency,
gender or age, unless there is a valid reason for the exclusion.” [TCPS2, Article 4.1, p.
48] and “Women shall not be inappropriately excluded from research solely on the basis
of gender or sex.” [TCPS2, Article 4.2, p. 49] and “Women shall not be inappropriately
excluded from research solely on the basis of gender or sex.” [TCPS2, Article 4.3, p. 49]
Section C, Question 3.6
Inclusion and exclusion criteria are particular characteristics of the participant group, as
specified by the researcher.
Inclusion criteria can include:





A particular age
Membership in a group
An occupation
A medical diagnosis
General health
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 Students of PSYC*100
Exclusion criteria can include:




A particular age
A medical diagnosis
Wearing glasses
Residing in assisted living
This information is helpful for the REB to make suggestions regarding the management
of risk. For example:




if the recruitment methods are correct
if the individual screening participants is adequately trained
if appropriate permissions have been sought
if participants posing high risks, and who are not essential to the project, are not
included.
Concepts of Risks and Potential Benefits [TCPS2, p. 22]
Section C, Question 4.1
The REB reviews the recruitment process to ensure that the project is appropriately
represented and that participants are not subject to undue influence.
Typical requirements for recruitment are:







statement of U of G affiliation
statement that it is a research project
brief summary of what will be required
estimate of time requirements
contact information for one or more of the research team
incentives or reimbursements available
geographic location of the research site (if applicable)
The REB tries to be sympathetic to the need to tailor the contents of the recruitment
document to the available space, so rather than having strict requirements across all
research types, projects will have individual requirements based on level of risk,
vulnerability of the participants, and the nature of the recruitment document.
NOTE: SIGN UP SHEETS LISTING MULTIPLE NAMES WILL NOT BE APPROVED
FOR REASONS OF PRIVACY
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“The approach to recruitment is an important element in assuring voluntariness. In
particular, how, when and where participants are approached, and who recruits them
are important elements in assuring (or undermining) voluntariness.” [TCPS2, Article 3.1,
Application (a), p. 28]
Section C, Question 4.2
The physical location of the participant when they are recruited may be important. For
example, if you are recruiting individuals from an organization for an interview about a
sensitive topic, targeted recruitment in that organization may breach the individual’s
privacy.
Section C, Question 5
This information will enable the REB to determine if the incentives and reimbursements
are appropriate or if they may undermine the voluntariness of consent.
[TCPS2, Article 3.1, Application (a), p. 28 and TCPS2, Article 3.2 Application (j), p. 33]
Section C, Question 5.1
This information is required to determine the appropriateness of the incentive, and
should be provided to the participant during the consent process. Note that the plan
detailing how the draw should be managed should include:






how identifiable information for the draw will be managed and safeguarded
who will hold the identifiable information
how many draws will be done, and when
who will draw the names
how winners will be notified
how long researchers will wait for a response before contacting another winner
 that you have informed participants that their SIN number will be needed to claim
prizes over $500.
Section C, Question 5.2
If you wish to use a lottery or draw as an incentive, you must communicate to the
participant what they may win, and the likelihood that they will win this prize. You can
state the chances of winning (e.g. 1/100, 1/50), or you can state how many people are
eligible. (e.g. We estimate that there will be 500 people taking part, and there will be two
prize draws of $250). Please establish who will draw the prize, how the winner will be
notified, the number of times contact will be attempted, what will happen if the winner
cannot be reached, how personal information will be managed (how long kept and
where stored), and whether or not a SIN number will be required (only if over $500).
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Section C, Question 5.3
Financial Services require for the purposes of audit, that you record dispersal of dollars
for reimbursement or incentives. You can:
 have participants initial beside their name when you pay them
 note the gift card numbers next to the participant’s name
Please confirm with Financial Services that the method you plan to use is acceptable to
them. The REB’s concern is that participants are made aware that their personal
information will be provided to Financial Services, and that, if the payment is greater
than $500 in one calendar year, they will have to supply their SIN number.
Section C, Question 5.4
Participants should receive any incentives or reimbursements if they chose to withdraw.
These payments can be prorated based on level of participation.
“The participant should not suffer any disadvantage or reprisal for withdrawing nor
should any payment due prior to the point of withdrawal be withheld. If the research
project used a lump-sum incentive for participation, the participant is entitled to the
entire amount. If a payment schedule is used, participants shall be paid in proportion to
their participation. “[TCPS2, Article 3.1, Application (b), p. 29]
Section C, Question 5.5
Any additional expenses should be declared here and during the consent process.
Section D
In this section, describe how you will obtain consent for each procedure you are
undertaking.
You may be obtaining consent for all procedures at once (this is common in health
based research).
You may be interacting with different groups of participants at different times, and
asking them to participate in different types of research – each requiring its own consent
process.
You may be obtaining written consent OR oral consent for the same interview set,
depending on the geographic location or availability of the participants. In this case, fill
out both the written consent section AND the oral consent section.
[TCPS2, Chapter 3, The Consent Process, p. 27]
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Section D, Question 1
Note that it is seldom the case that a waiver of informed consent is granted. If you feel
that you can justify each of (a) to (e), please describe in the space provided.
If applying for a waiver of prior consent, describe in detail how each of the following
conditions are met:
The following must all be true:
(a) The research involves no more than minimal risk to the participants;
(b) The lack of the participant’s consent is unlikely to adversely affect the welfare of the
participant;
(c) It is impossible or impracticable to carry out the research and to answer the research
question properly given the research design, if the prior consent of the participant
is required;
(d) Whenever possible and appropriate, after participation, or at a later time during the
study, participants will be debriefed and provided with additional pertinent
information in accordance with Articles 3.2 and 3.4, at which point they will have
the opportunity to refuse consent in accordance with Article 3.1; and
(e) The research does not involve a therapeutic intervention, or other clinical or
diagnostic interventions.
From alteration of informed consent TCPS2 Article 3.7, p. 37
Section D, Question 2
Written consent (i.e. the participant signs the bottom of the consent form indicating that
they agree to participate) is the most common form of documentation of consent. If you
do not think it is appropriate to require written consent, provide a justification for another
method of documenting consent
[TCPS2, Article 3.12, p. 44]
Section D, Question 2.1
Informs the REB about what documents will be used to obtain written consent. A
consent form has consent information, plus an included signatures section. An
information letter has only consent information, with the signature section separate.
Either can be used.
Section D, Questions 2.2 and 2.3
Deals with the logistics of obtaining consent, and can have an impact on undue
influence and privacy.
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Section D, Questions 2.4 and 2.5
Has the individual obtaining consent obtained the appropriate training? The level of
training will be proportionate and based on the degree of risk of the project.
Section D, Question 2.6
This is a checklist, meant to alert to researcher to the documents to be attached with the
application form. Documents which will be provided to participants will be printed on U
of G letterhead or show a U of G logo.
Section D, Question 2.7
Participants should have sufficient time to read the consent form (or have it read to
them), to engage in a discussion about the consent process and the research project,
and have any questions answered. Again, the amount of time required will be
dependent on the complexity of the project, the level of risk, and the capabilities of the
participants.
Section D, Question 3
Oral Consent must be obtained using a script (to be submitted) . Written documentation
must be provided to the participant.
Section D, Question 3.1
Informs the REB about what documents will be used to obtain oral consent.
Section D, Questions 3.2 and 3.3
Deals with the logistics of obtaining consent, and can have an impact on undue
influence and privacy.
Section D, Questions 3.4 and 3.5
Has the individual obtaining consent obtained the appropriate training? The level of
training will be proportionate and based on the degree of risk of the project.
Section D, Question 3.6
This is a checklist, meant to alert to researcher to the documents to be attached with the
application form. Documents which will be provided to participants will be printed on U
of G letterhead or show a U of G logo.
Section D, Question 3.7
Participants should have sufficient time to read the consent form (or have it read to
them), to engage in a discussion about the consent process and the research project,
and have any questions answered. Again, the amount of time required will be
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dependent on the complexity of the project, the level of risk, and the capabilities of the
participants.
Section D, Question 4
Consent is assumed or implied solely by the actions of the participant (e.g. through the
return of a completed questionnaire).
[TCPS2, Article 3.12, p. 45]
Section D, Question 4.1
Informs the REB about what documents will be used to obtain oral consent.
Section D, Questions 4.2 and 4.3
Deals with the logistics of obtaining consent, and can have an impact on undue
influence and privacy.
Section D, Questions 4.4 and 4.5
Has the individual obtaining consent obtained the appropriate training? The level of
training will be proportionate and based on the degree of risk of the project.
Section D, Question 4.6
This is a checklist, meant to alert to researcher to the documents to be attached with the
application form. Documents which will be provided to participants will be printed on U
of G letterhead or show a U of G logo.
Section D, Question 4.7
Participants should have sufficient time to read the consent form and have any
questions answered. Again, the necessity to provide time to have questions answered
will depend on the complexity of the project, the level of risk, and the capabilities of the
participants.
Section D, Question 5
Proxy consent is obtained from a parent or legal guardian if the participant lacks “the
capacity, either permanently or temporarily, to decide for themselves whether to
participate”.
[TCPS2, Article 3.9, p. 41]
Section D, Questions 5.1 and 5.2
How have you established that the participant lacks the capacity to make their own
decision to consent? The MMSE or Mini Mental State Exam is commonly used to
establish competence in cases where competence is in question, but should not be
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automatically used at a certain age. If you plan to use the MMSE, see Guideline 3-G010.
Section D, Questions 5.3 and 5.4
The TCPS2 asks that “the researcher involves participants who lack the capacity to
consent on their own behalf to the greatest extent possible in the decision-making
process”. The most common way of involving the participant is to obtain their assent.
For guidance, please refer to Guideline 3-G-003.
Section D, Questions 5.5 and 5.6
These are checklists, meant to alert to researcher to the documents to be attached with
the application form and to key information from the TCPS2 which must be taken into
account during this type of research project.
Section D, Question 5.7
This question invites a discussion of special needs which participant might have in order
to access information during the consent process. The researcher could discuss the
following here, or discuss issues unique to their research project:







language barriers
literacy barriers
physical competence
mental competence
cultural issues
community or group consent
consent or lack of consent during critical inquiry
Section D, Question 6
See Guideline 1-G-020
[TCPS2, Article 3.7, Application, p. 37]
Section D, Question 6.3
The debriefing or second consent form should include:
 a full explanation of why participants were temporarily led to believe that the
research, or some aspect of it, had a different purpose, or why participants
received less than full disclosure
 give details about the importance of the research
 discuss the necessity of having to use partial disclosure or deception, explaining
why these research procedures were necessary to obtain scientifically valid
findings
 express concern about the welfare of the participants (apologize)
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 remove any misconceptions that may have arisen
 re-establish any trust that might have been lost
Section D, Question 7
Researchers are responsible for ascertaining and complying with the laws, regulations,
or customs of the jurisdiction where the research will take place. In some cultures,
community consent is required prior to obtaining individual consent. This question gives
the researcher the opportunity to discuss unique requirements for their project, and how
these requirements will be addressed.
[TCPS2, Chapter 1, p. 12, and Article 8.3 (b), p. 102 and Article 9.11, p. 122]
Section D, Question 8
[TCPS2, Article 3.1, Application (a), p. 28]
Section D, Question 9
Consent shall be maintained throughout the research project. Researchers have an
ongoing duty to provide participants with all information relevant to their ongoing
consent to participate in the research.
[TCPS2, Article 3.3, p. 33]
Section D, Question 10
Discussion should occur here, and within the research team regarding the appropriate
response to a disclosure which might warrant a breach of confidentiality. The principal
investigator should be involved in any response, and the REB should be notified
[TCPS2, Article 5.1, Application, p. 58 and Article 5.2, p. 59]
Section D, Question 11
Examples include:
 “participants shall be free to withdraw their consent to participate in the research
at any time, and need not offer any reason for doing so”
 “participants should not suffer any disadvantage or reprisal for withdrawing”
 “nor should any payment due prior to the point of withdrawal be withheld”
 Note that there are cases when withdrawal is not possible or very difficult:
o Anonymous research
o Focus groups or other types of group research where one
voice/contribution would be difficult to separate from another
o When data has been anonymized and added to a data pool
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[TCPS2, Article 3.1, Application (b), p. 29]
Also: “consent form should set out any circumstances that do not allow withdrawal” [p.
30]
Section E, Question 1
Please review the discussion of risk and the definition of risk and harm starting on page
22 of the TCPS2.
“Harm is anything that has a negative effect on the welfare of participants, and the
nature of the harm may be social, behavioural, psychological, physical or economic”
A thorough estimate of potential risk should be made for each type if intervention
proposed.
[TCPS2, Chapter 1, p. 9 and Chapter 2, p. 22]
Section E, Question 1.2
Use sub-headings to itemize risks and to discuss how they will be mitigated, or avoided.
Section E, Question 2
The REB will examine your estimation of the risk of harm, and balance this with the
benefits as outlined in this section. In order for the project to go ahead, the benefits
must outweigh the risks of harm to the participants. Your project may not present risks
of harm to the participants.
Once the REB has established the level of risk, through information provided by the
research team, a proportionate approach to review will be adopted. Higher risk projects
will receive more scrutiny (i.e. full board review) than lower risk projects (i.e. delegated
review).
[TCPS2, Chapter 2, p. 24 and Article 2.9]
Section E, Question 2.1
“researchers should ensure that participating individuals, groups and communities are
informed of how to access the results of the research. Results of the research should be
made available to them in a culturally appropriate and meaningful format”
This normally refers to aggregate results. It may not be appropriate or possible to
provide individual results if the work is experimental and the individual results will not
have meaning, for example.
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Section E, Question 2.2
When providing individual results of a clinical nature, provide population norms where
possible, and indicate that the values were not obtained from a medical laboratory and
should not be used for diagnosis. Invite the participant to discuss the results with the
research team or their physician.
[TCPS2, Chapter 4, p. 53]
Section F, Question 1
Indicate all that apply and then break down the response for each method or procedure
you will be using in the text box below.
Note that if you are collecting identified information, and have permission to publish the
identity of the participant, many of the data security questions will not apply. It may still
be important to safeguard the data against loss or corruption.
[TCPS2, Chapter 5, Section A, Page 56]
Section F, Question 2
Indirect identifiers are context dependent. They will alone, or in combination identify an
individual in a particular context. Researchers should familiarize themselves with the
participants’ community and environment in order to understand what will or will not
identify. This can be particularly challenging in different cultural contexts.
Guideline 1-G-002 contains a list of identifiers according to the US HIPAA document
Section F, Question 4
Incidental Findings [TCPS2, Article 3.4, p. 34]
Section F, Question 5
Most research data must be stored for a period of time, even after dissemination. The
REB is not concerned with the duration of this storage period – this is usually
established by a particular discipline or journal requirements – but must ensure that the
period of storage is communicated to the participant. In addition, the REB must ensure
that the proposed storage method is appropriately secure.
[TCPS2, Article 5.3, p. 60 and Article 5.4, p. 61]
University of Guelph Encryption Policy
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Section F, Question 6
Secondary use of anonymous information does not require ethics review. This does
NOT include anonymized information. Secondary use both with and without consent
requires submission
[TCPS2, Article 2.4, p. 19 and Chapter 5, Section D, p. 62]
Section F, Question 7
The answer to this question will inform the level of risk to the participant, and the level of
security need for the data, and calls for speculative judgement on the part of the
researcher and the REB.
[TCPS2, Article 5.3, Application (d), p. 60]
University of Guelph Encryption Policy
Section F, Question 8
Audio and video recordings are considered identified data.
Section F, Question 9
Re-linkage can render anonymized data identifiable, counter to previous consent
agreements. Plans for re-linkage should be disclosed in the initial application, or in a
subsequent ‘secondary use’ application.
[TCPS2, Article 12.2, p. 171]
Section F, Question 9.2.1
If the transcriber is not a member of the research team, they will have to sign a
confidentiality agreement. Care must be taken to safeguard the transfer of identified
data to and from the transcriber.
[TCPS2, Article 5.3, p. 60 and Article 5.4, p. 61]
Section F, Question 10
The period of long term data storage may be determined by disciplinary or publication
requirements.
Section G Question 1
The REB requires the submission of a status report annually, and may require more
frequent reporting based on the level of risk involved in the project.
[TCPS2, Article 2.8, p. 21 and Article 6.14, p. 79]
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Section G, Question 2
Incidental findings are defined as “Unanticipated discoveries made in the course of
research that are outside the scope of the research” [TCPS2, p. 193]
Adverse events are occurrences with an undesirable outcome for the participant.
Both types of events may be serious or minor in nature, and may have immediate or
long term effects.
The purpose of this reporting is to:
 Ensure that the researcher proceeds appropriately with any external reporting
which may be necessary (e.g. to Health Canada in the case of a clinical trial, or
to Child and Family Services in the case of alleged child abuse).
 Provide advice and guidance to the research as requested
 Ensure that any changes are made to the research protocol to reduce the
likelihood of future adverse events within that project
 Act as an educational tool for the REB to ensure more complete reviews
(possibly limiting or helping the researcher prepare for adverse events and
incidental findings).
“Researchers shall report to the REB any unanticipated issue or event that may
increase the level of risk to participants, or has other ethical implications that may affect
participants’ welfare.” [TCPS2, Article 6.15, p. 81]
“Depending on the nature of the issue, and in consultation with researchers, REBs may
require that researchers adjust their procedures to prevent its recurrence during the
research project.” [p. 81]
Section G, Question 3
Please add any other information you think is pertinent, but was not requested
anywhere else in the ethics application form.
Section H
The last page must be submitted in hard copy or a scanned electronic signature added.
Supplement I: Biological Specimens to be Collected from Participants
Question I.3
What tests will be run or parameters measured?
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Question I.14
Long term storage of samples increases the likelihood that future findings may reveal
important information which could affect the health and well-being of the donor. A plan
should be in place, and participants should be consulted, regarding future contact and
the provision of information to the participant.
Question 1.15
A material transfer agreement is required for any human material (tissue, bodily
fluids,etc). See a material transfer agreement template at the Catalyst Centre
Supplement II: Contracts and Industry Sponsored Research
Include this supplement only if your protocol requires a contract to be drawn up with a
sponsor or funding agency.
Supplement III: Secondary Use of Data
Include this supplement only if your protocol discusses secondary use of a data set. In
addition to this Supplement, please fill out the REB-App, Section A, Section B, Section
D (from the perspective of the participants who originally donated the data/tissue,
Section E (from the perspective of loss of privacy, inadvertent identification of data),
Section F and Section G.
Question III.4
[TCPS2, Article 2.4 and Application, p. 18 and TCPS2]
[TCPS2, Chapter 5, Section A, Type of Information, p. 56 and Section D, p. 62, Consent
and Secondary Use of Identifiable Information]
Include discussion of the other types of approvals or permissions which might be
needed before researchers access previously collected information for research
purposes.
Supplement IV: Cross Cultural
This Supplement is primarily focused on submissions dealing with Aboriginal or First
Nations peoples of Canada. However, Chapter 9 of the TCPS2 can also be applied to
isolated or identifiable communities (such as participants in foreign countries). Any
researcher proposing to work with participants in foreign countries must include this
section. Some research involves a researcher doing work in, and with, individuals and
communities whose cultures are distinct enough from that of the researcher to warrant
particular care – in the planning, conduct and dissemination of the project.
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Special consideration will be given when reviewing the protocol to ensure that the work
is ethically sound as well as culturally appropriate.
IV.20
Provide the amount in Canadian dollars, and discuss how long it would take participants
in another country to earn this amount of money (if there is an economic disparity).
“In considering the possibility of undue influence in research involving financial or other
incentives, researchers and REBs should be sensitive to issues such as the economic
circumstances of those in the pool of prospective participants, the age and capacity of
participants, the customs and practices of the community, and the magnitude and
probability of harms”
[TCPS2, Article 3.1(a) application, p. 28]