Source: Content for table taken from Panel on Research Ethics http://tcps2core.ca
Core Modules
Module
Status
Options
Module 1: Core Principles
Completed: January 26 2012, 10:17AM
 Review
Module 2: Defining Research
Completed: January 26 2012, 10:21AM
 Review
Module 3:
Assessing Risk & Benefit
Completed: January 26 2012, 10:26AM
 Review
Module 4: Consent
Completed: January 26 2012, 10:32AM
 Review
Module 5:
Privacy & Confidentiality
Completed: January 26 2012, 10:36AM
 Review
Module 6:
Fairness & Equity
Completed: January 26 2012, 10:40AM
 Review
Module 7:
Conflict of Interest
Completed: January 26 2012, 10:43AM
 Review
Module 8: REB Review
Completed: January 26 2012, 10:51AM
 Review
Module 1: Core Principles
Completed: January 26 2012, 10:17AM
 Review
The Participant Perspective
As you can see from the previous example(s), it is important for researchers to carefully consider the
circumstances of the people they will be approaching to become participants.
Here are some examples of questions that should be asked:
 Is there a power relationship between the researcher and the participants (e.g. doctor/patient,
teacher/student, supervisor/assistant)?
 Are there any cultural norms or practices that need to be factored into the recruitment, consent, or
debriefing process?
 What are the economic circumstances of the prospective participants?
 Could there be any social repercussions of participation in this project?
 How can the privacy and confidentiality of participants be protected
Thinking Through Ethics
The recognition that research, no matter how well intentioned, can cause unanticipated harm to
participants has spurred governments around the world to set ethical standards.
In Canada, we have the 2nd Edition of the Tri-Council Policy Statement: Ethical Conduct for
Research Involving Humans. This document, commonly known as TCPS 2, is supported by the three
federal research agencies: The Canadian Institutes of Health Research (CIHR); the Natural Sciences
and Engineering Research Council (NSERC); and the Social Sciences and Humanities Research
Council (SSHRC).
Thinking Through Ethics
The foundation of TCPS 2 is the value of respect for human dignity. This value is expressed through the
three core principles listed below. View each of the principles to learn more and see examples:
 Respect for Persons
 Concern for Welfare
 Justice
Respect for Persons
The principle of Respect for Persons recognizes the intrinsic value of human beings and the respect and
consideration that they are due. The essence of this principle is that it is unacceptable to treat individuals
solely as means (mere objects or things) to an end (a research goal). The welfare and integrity of the
participant must take priority over all else in human research.
Respect for Persons includes:
 individuals or groups directly involved in research as participants
 individuals or groups involved in research through the use of their data or biological materials
How To Apply: The Principle of Respect for Persons
Individuals are generally presumed to have the ability to make voluntary and informed decisions:
autonomy. Respect for persons means respecting every individual's ability to give or refuse their consent
to participate. Their decision must be based on clear information about the foreseeable risks and potential
benefits of the study and must not be coerced or influenced.
In practical terms within the research design and REB review process, the principle of respect for persons
translates into policies governing how consent by research participants is sought.
 Consider participant autonomy in research design
 Consider factors that can diminish participant autonomy
 Consider how to respect the dignity of those lacking autonomy
Concern for Welfare
The Principle of Concern for Welfare recognizes that research participation can affect the welfare of an
individual or group in many ways. Respecting the principle of Concern for Welfare means doing your best
to ensure that participants are not exposed to unnecessary risks.
Aspects of welfare that researchers and REBs need to consider include:
 physical, mental and spiritual health
 physical, economic and social circumstances
 privacy and the control of personal information
 the treatment of human biological materials according to the consent of the donor
 the possible affect of the research on the welfare of participants' friends, family, or other groups
How To Apply: The principle of Concern for Welfare
In the context of research design and REB review, it is important to consider what is being asked of
participants from their perspective. What may be a trivial matter to a researcher may be of greater
significance to participants in different circumstances or different cultures. There may also be unintended
consequences of research participation that can be anticipated by paying attention to participants’
characteristics and circumstances.
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Consider potential impacts on participants’ physical and mental health, on their social or
economic circumstances, and on their privacy
Consult any groups that may be affected by the research to assess the risk of negative impacts
such as stigmatization and discrimination
Eliminate and/or minimize risks
Maximize benefits
Provide accurate and accessible information
Justice
The Principle of Justice refers to the obligation to treat all people fairly and equitably. Fairness is treating
all people with equal respect and concern for their welfare – it does not necessarily mean treating
everyone the same.
Equity involves the distribution of the benefits and burdens of research participation. No segment of the
population should be unfairly burdened with the harms of research. Nor should any individuals or groups
be neglected or discriminated against in the opportunity to benefit from knowledge generated by
research.
How To Apply: The principle of Justice
In research design and REB review, it is important to address the following issues:
 Who are the participants? Why this group and not others?
 Are any participant groups over- or under-represented because of their vulnerable
circumstances?
 Are there measures in place to treat people in vulnerable circumstances justly in the context of
the research?
 Is there an imbalance of power between participants and researchers?
Summary
 History has shown us that without clear guidelines to help researchers identify potential risks of
their design to participants, psychological and/or physical harm can occur.
 The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) is the
minimum standard adopted by all Canadian research institutions to protect human research
participants.
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 There are many ways of designing research so that the risks to participants are minimized and
the goal of the researcher is not compromised. 2:
Module 2: Defining Research
Completed: January 26 2012, 10:21AM
 Review
Objectives
Upon completion of this module you will be able to:
 distinguish projects that fall under the TCPS 2 definition of research from those that do not
 identify research activities that may be considered exempt from REB review
 categorize examples of studies according to whether or not they are research involving humans
requiring REB review
Introduction
What is research? Is it any attempt to answer a question? When is REB review necessary? How do we
define research participation?
TCPS 2 provides guidelines to help REBs and researchers answer these questions. Let’s start with
defining research:
"an undertaking intended to extend knowledge through a disciplined inquiry or systematic
investigation."
Quality Assurance, Testing and Performance Review
When an organization is interested in assessing or improving some aspect of its performance (e.g. job
satisfaction, safety compliance), they may conduct quality assurance or improvement studies. Similarly,
schools may test their students within normal educational requirements (e.g. to assess knowledge
retention). These activities are usually not considered research as defined by TCPS 2 and do not require
REB review.
However, a quality assurance project may also be research (or become research) requiring REB review if:
 it is not within the mandate of the organization
 it is not a condition of employment or training
 the results are intended for research purposes
 the results are later used for a research purpose
Creative Practice
Writing a play and analyzing the process; interpreting the work of a sculptor; examining the art of
filmmaking; these are all examples of creative practice.
Creative practice activities may involve some research techniques but are not normally considered to be
research as defined by TCPS 2. Different creative disciplines may have their own established ethical
practices.
When creative practice involves human participants (e.g., asking a concert audience to participate in a
focus group with the musicians), then it will require REB review.
What is Research Involving Humans?
Arguably any research that studies some aspect of humans is research involving humans. However,
according to TCPS 2 research involving humans is research that:
 involves living human participants
 involves human biological materials
Human participants (more commonly referred to simply as 'participants') are individuals whose data, or
responses to research interventions, stimuli or questions, are relevant to a research question.
When is REB review required?
There are a lot of factors involved in determining what research requires REB review. Click on the
examples below to find out which of these are considered to be research involving humans and which are
not:
 An analysis of public opinion of same-sex marriage based on census data
 A study of the rate of decomposition of white blood cells in cadavers
 A study investigating the correlation between employee satisfaction and new workstations
When is REB review NOT required?
A project that meets the TCPS 2 definition of research and involves human participants, their data, or
their biological materials generally will require REB review.
Some types of research may be exempt from REB review. View the examples below for more
information:
 Publicly Available Information
 Observation in Public Places
 Secondary Use of Anonymous Data or Biological Materials
Publicly Available Information
Usually, research based entirely on existing, stored documentary material, publications, or records,
is NOT considered to be research involving humans that requires REB review.
To qualify for an exemption from REB review, it must be demonstrated that the information required for
the project is:
 legally accessible and protected by law; or
 publicly accessible and free of reasonable expectations of privacy
Observation in Public Places
Observational research is a way of studying human behaviour under natural circumstances (e.g.
shoppers in a mall, hockey fans in an arena, passengers on a bus). If an observational research proposal
meets the following criteria, it does not require REB review:
 No staged intervention or no direct interaction with those being observed
 Those observed have no reasonable expectation of privacy; and
 No identification of specific individuals in the dissemination of results
Secondary Use of Data or Biological Materials
Sometimes information is gathered for purposes other than research (e.g. patient or school records,
biological samples, online opinion sites) and then may be discovered to have research value. Data files or
samples from one study may be useful for other research purposes on their own or when combined with
information from another study. This is called "secondary use of data".
This type of research activity does not require REB review as long as the data or samples are anonymous
and there is no way the data can be linked to the individuals who provided it.
If the nature of the research requires follow-up contact with the original study participants or providers of
the biological samples, or produces identifying information of any kind, then REB review will be required.
Summary
 As a general rule, all research involving humans, other than the specific exemptions listed in
TCPS 2 requires REB review and approval.
 Not every activity involving inquiry and/or human participation is considered to be research
involving humans that requires REB review
Whenever you have any doubt about whether a particular research project should
undergo research ethics review, seek the opinion of your REB.2:
Module 3:
Assessing Risk & Benefit
Objectives
 Upon completion of this module you will be able to:
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research
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Introduction
One of the most important and challenging tasks that REBs and researchers face is evaluating and
identifying the risks and benefits associated with participation in research. Sometimes these factors seem
identifiable and quantifiable. Sometimes the risks of a study may be elusive or the benefits overestimated.
Click on ONE (or more) of the examples below and see how well you can identify foreseeable risks and
potential benefits.
Identifying Risk & Benefit: Humanities
The proposed study is an exploration of the effect of a course on comparative religion on the attitudes of
the students towards belief systems other than their own. The course will feature a historical and issuedriven perspective on Christianity, Judaism, Islam, Wicca, Humanism, and Buddhism. Students will be
asked to write an introductory essay discussing their current knowledge of these belief systems and their
impressions of how each one would respond to specific issues (e.g. divorce, homosexuality, etc.). At the
end of the course, students will be asked to write another essay describing how their knowledge and
opinion of these belief systems has or has not been altered. A content analysis tool will be used to derive
measures of positive/negative language used in regard to each belief system. Students will be given the
option of removing their essays from the study.
Identifying Risk & Benefit: Humanities
Expert Identification of Risks and Benefits
Risks
 the students may feel pressured by the professor to let their essays be included in the study –
jeopardizing the voluntariness of consent
 participants may feel uncomfortable expressing their personal views about sensitive topics
 depending on the steps the researcher takes to safeguard their privacy and confidentiality, there
is a risk that students’ views will not remain private
Benefits
 the students may find the essays a useful means of exploring their own attitudes
 findings from the study may indicate whether this comparative religion course increases
understanding and tolerance of other belief systems
The Proportionate Approach
TCPS 2 characterizes the assessment of the foreseeable risks and potential benefits of research
participation asthe proportionate approach to REB review.
The REB considers the foreseeable risks to participants along with the potential benefits and ethical
implications of the research. Module 8 will cover REB review in more detail.
The goals of REB review are to:
ensure that participants are not exposed to unnecessary or avoidable risks
see that, on the whole, the potential benefits outweigh the foreseeable risks
help research proceed in accordance with the core principles of TCPS
Levels of Risk
Research is a step into the unknown and can pose risks to participants and others. These risks can be
trivial or profound, physical or psychological, individual or social. History offers unfortunate examples
where research participants have been needlessly, and at times profoundly, harmed by research,
sometimes even dying as a result.
The principle of Concern for Welfare imposes an ethical obligation to design, assess and conduct
research in a way that protects participants from any unnecessary or avoidable risks. An important
function of an REB review is to provide an independent assessment of foreseeable risks to participants
and how these risks may be eliminated or minimized.
Probability & Magnitude of Risk
After identifying the risks to participants in a study (e.g. physical discomfort, stress, etc.) researchers and
REBs must consider:
PROBABILITY: How likely is it that any participant will suffer any harm as a result of the study? Are
rates of harm reported in previous publications? Is there any other empirical evidence? Is this an
emerging area of research with little or no information on rates of harm? If so, are there other ways of
assessing probable harm?
MAGNITUDE: How severe could the harm be? Would it be minor (e.g. inconvenience) or major (e.g.
severe physical or psychological trauma)? Would the harm be temporary or longer lasting? Would the
harm extend to others beyond the participants, such as their family, co-workers or community?
Minimal Risk
If participants can be expected to judge that the probability and magnitude of possible harms stemming
from their involvement in a study is no greater than those encountered by the participant in
those aspects of their everyday life that relate to the research then the study may be of minimal risk.
For those individuals or groups who live with relatively high risk on a daily basis, researchers and REBs
have a responsibility to ensure that:
their circumstances are not used as a rationale to expose them to unnecessary risks
including them as participants does not increase their vulnerability.
Above Minimal Risk
When the probability and/or the magnitude of risk to participants in a study is judged to be greater than
they would encounter in their everyday lives, the research is subject to a higher degree of scrutiny. More
risk will require proportionately more provision for the protection of prospective participants.
Researchers and REBs need to agree that any unavoidable risks are justified by the potential benefits of
the research. Ultimately, it is prospective participants, in the consent process, who decide if they can
accept the risks of participating in the research.
Types of Risk
Depending on the nature of the study (e.g. sociological, psychological, observational, biomedical),
different types of risk may be assessed. Click on each of the types of risks listed below to learn more:
 Physical Harm
 Psychological Harm
 Economic Harm
 Social Harm
Physical Harm
There are many types of physical harm that can occur in a research study depending on the situation,
including harms:
 posed by the study procedures (e.g. over-exertion, exposure to allergens, injury due to use of
dangerous equipment, sensory deprivation, side-effects due to experimental treatment, etc.).
 to the participant posed by agreeing to be in the study (e.g. a survey in an unstable country
asking probing questions about political problems could result in physical harassment or
imprisonment).
REBs must be satisfied that all potential physical harms of a study have been identified and that
measures are in place to minimize their occurrence and to offer follow-up care.
Psychological Harm
Although sometimes less obvious than physical harms, the risk of psychological harms to participants
should not be treated lightly. Some of the types of psychological harms that can occur are:
 activation of PTSD from answering questions that trigger memories of a traumatic event
 depression due to perceived poor performance in an experiment or triggered by the subject
material
 feelings of betrayal and/or anger due to the discovery of an experimental deception
REBs must be satisfied that all potential psychological harms of a protocol have been identified and that
measures are in place to minimize their occurrence and to offer follow-up care.
Economic Harm
Sometimes participation in a study may have economic consequences. For example, in a study
interviewing employees of an organization, what the employee says, or their mere participation might put
their job security or career progress at risk.
This risk may be more prevalent in research involving critical inquiry, if participants are asked to provide
information about an employer or business associate that may prove damaging.
REBs will want to see that researchers have anticipated these risks as they may apply to their study, that
measures to eliminate or minimize these risks are part of the study procedure, and that unavoidable risks
are discussed with prospective participants in the consent process.
Social Harm
Studies that have very specific selection criteria or topics that are sufficiently sensitive may have the
potential to alter a person's standing in their community or social group. For example, people who agree
to participate in a study about attitudes towards a particular illness may subsequently be avoided by those
who mistakenly think they have that illness. Publication of a study that identifies a community (e.g. one
that has a high rate of drug addiction) can stigmatize the entire community.
REBs will want to see that researchers have anticipated these risks as they may apply to their study, that
measures to eliminate or minimize these risks are part of the study procedure, and that unavoidable risks
are discussed with prospective participants in the consent process.
Types of Benefits
People participate in studies for a variety of reasons. Sometimes it is for a perceived direct benefit to
themselves. Sometimes it is in the hope that the outcome of the study will benefit others in their
circumstances. When identifying potential benefits, researchers and REBs should be aware that most
research yields no identifiable benefits for participants or their groups but may contribute to our existing
body of knowledge.
Click on each of the types of benefits listed below to learn more:
 Direct
 Indirect
 Advancement of knowledge
Direct Benefits
Some studies can directly benefit participants at the time of their involvement. For example, a study of
exercise and pregnancy directly benefits participants by providing exercise classes and health
evaluations. The opportunity to assist in the advancement of knowledge or the possibility of benefiting
others can also be a source of immediate satisfaction to participants.
Incentives offered for participation (financial or otherwise) that may be perceived as benefits by
participants, are not typically considered by REBs as benefits in the context of the risk/benefit
assessment.
Indirect Benefits
Beyond the actual participants, research may benefit a group to which the participant belongs. For
example a study exploring the views of fishermen whose livelihoods were destroyed by an engineering
project that diverted their river, may or may not be of direct benefit to them but may help their community,
and may help alert engineers to the need to consult with communities in the planning of such projects.
Advancement of Knowledge
The basic desire for new knowledge and understanding is the driving force for research. Researchers can
describe the potential addition of new information to their discipline as a valuable contribution to existing
knowledge.
In most research, the primary benefits produced are the advancement of knowledge for future
generations that may positively affect the welfare of society as a whole.
Revisiting Risk & REB Review
The first exercise in this module asked you to identify foreseeable risks and potential benefits in examples
of proposed research. Now that you have learned more about the proportionate approach to review and
the importance of evaluating risks and benefits in research, you can apply that knowledge to a different
question featuring those same examples.
Click on one or more of the examples below and, considering any foreseeable risks the proposed
research holds for participants, decide if it should receive delegated or full-board review.
Balancing Risk & Benefit: Humanities
The proposed study is an exploration of the effect of a course on comparative religion on the attitudes of
the students towards belief systems other than their own. The course will feature a historical and issuedriven perspective on Christianity, Judaism, Islam, Wicca, Humanism, and Buddhism. Students will be
asked to write an introductory essay discussing their current knowledge of these belief systems and their
impressions of how each one would respond to specific issues (e.g. divorce, homosexuality, etc.). At the
end of the course, students will be asked to write another essay describing how their knowledge and
opinion of these belief systems has or has not been altered. A content analysis tool will be used to derive
measures of positive/negative language used in regard to each belief system. Students will be given the
option of removing their essays from the study.
Experts' Response: Minimal Risk
The task involved in this study is essay writing in the context of an assignment that the students would be
obligated to submit for course credit regardless of whether they choose to allow their work to be included
in the instructor’s research. As the risks of doing this assignment for the purposes of research are no
greater than the risks of doing the assignment for course credit, the study is considered to be minimal risk
and would receive delegated review.
In the context of delegated review, the foreseeable risks will be considered in relation to the potential
benefits. Reviewers may suggest ways to eliminate or reduce risks and/or to increase benefits where
possible.
Risks to Researchers
Risks in research are not always limited to participants. In some situations, researchers may also be
exposed to risks. For example, conducting research in a volatile region may put researchers at risk of
physical injury, stress, or imprisonment. Doing door-to-door or on-the-street interviews without a partner
can also expose researchers to risks (e.g. unexpected attack, theft, etc.).
Student researchers who are learning to conduct research may feel pressure from supervisors to conduct
research in unsafe situations – or may put forward a research plan that has the potential to jeopardize
their own safety without being fully aware of the risks.
Though REBs are primarily concerned with risks to participants, they may refer proposals that pose risks
to researchers to another authority within their institution. Researchers may be advised to make
arrangements for their own security, to arrange reliable contacts who can provide assistance as needed,
and/or to submit a personal safety strategy with their research plan.
Balancing Risk & Benefit
All research involves some element of risk and benefit. The concern of an REB is whether the potential
benefits of a study justify the exposure of participants to the foreseeable risks. The weighing of risks and
benefits is part of proportionate review.
Click on ONE (or more) of the case studies below. Each describes a risk/benefit scenario and lists the
risks and the benefits. Your challenge is to decide if the benefits justify the risks.
Summary
 One of the critical functions of an REB is to provide an objective assessment of foreseeable risks
and potential benefits to the prospective participants in a study.
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Risk is assessed in terms of the probability of the occurrence of harm and its possible magnitude.
Benefits of participating in research may be direct or indirect, immediate or deferred, but in each
study they must be sufficient to justify any foreseeable risks to participants.
TCPS 2: CORE
Modu
Module 4: Consent
Completed: January 26 2012, 10:32AM
 Review
le 4: Consent
Objectives
Upon completion of this module you will be able to:
 understand and apply the general principles of consent
 cite the specific circumstances under which the requirement to seek consent may be altered, or
waived by an REB
 appraise the completeness and correctness of the consent process in sample cases
Introduction
The process of seeking consent for research participation is fundamental to the principle of Respect for
Persons. Prospective participants, who have the capacity to consent on their own behalf, have the
reasonable expectation that they will be treated as autonomous individuals, able to make decisions about
the risks they consider acceptable and the information they choose to share with researchers. It is the
responsibility of researchers to be aware of any additional consentguidance or regulations that apply to
their research.
The general principles of consent are that it must be:
 Free
 Informed
 Ongoing
Introduction
The process of seeking consent for research participation is fundamental to the principle of Respect for
Persons. Prospective participants, who have the capacity to consent on their own behalf, have the
reasonable expectation that they will be treated as autonomous individuals, able to make decisions about
the risks they consider acceptable and the information they choose to share with researchers. It is the
responsibility of researchers to be aware of any additional consentguidance or regulations that apply to
their research.
 Free
 Informed
 Ongoing
The Consent Process
Consent is not a single act of someone agreeing to participate in a study. It is a process that begins with
the recruitment and screening of participants and continues throughout their involvement in the research.
The consent process must be complete and should not berushed.
Click on each of the following components of the consent process to learn more:
 Recruitment
 Information
 Documenting Consent
 Debriefing (when required)
Recruitment
Prospective participants must not be recruited using materials that create a false impression of study
conditions, or the foreseeable risks and/or potential benefits of participation. Recruitment materials (i.e.
posters, emails, social media bulletins, advertisements) must provide accurate information. Some REBs
require that recruitment materials clearly state whether the study has received REB approval.
Materials that appear to offer rewards that may constitute undue influence, or that misrepresent the
conditions of the study in any way, are likely to be flagged by an REB for revision before ethics approval
can be granted.
Information
Prior to signing a consent form, prospective participants must be given a detailed description of the study
in lay languageincluding, but not limited to:
 general purpose of the study and clear description of what the participant is expected to do
 foreseeable risks and potential benefits
 alternatives to participation (e.g. other treatments, other activities)
 contact information of the researcher
 contact information of the relevant REB
 assurance that the participant can choose to end their involvement at any time
Documenting Consent
Researchers must document the consent process in some fashion: a signed consent form; a video-taped
oral consent;implicit consent; documentation of verbal consent in research field notes, etc. Whatever
means of consent is appropriate to the situation, when the researcher engages in the consent process
with a participant, the following elements must be included:
 a restatement of the purpose of the study and the provision of a clear description of study tasks
and conditions
 sufficient prompts to encourage participants to ask questions
 a reminder of their right to refuse to do anything they find disturbing or uncomfortable
 an assurance of their right to leave the study at any time without penalty
 a statement indicating that by consenting, participants do not waive any legal rights
 the provision of contact information for the researcher and the REB that approved the study
Debriefing (when required)
When a study protocol uses deception or partial disclosure, participants must be debriefed once their
involvement in the study has ended. Depending upon the complexity of the study this may be done
verbally or with the provision of a written explanation. A debriefing should include:
 clear statement of the reseach question
 disclosure of any deception involved in the study and the rationale for its use
 explanation of how the participants' data will be used to seek an answer to the question
 opportunity for participants to ask questions and/or seek clarification
 contact information for the researcher and the REB that approved the study
Keeping Consent Free
When someone consents to be a participant in a study it is important that they have done so entirely of
their own free will. Click on each example below for ways that this element of voluntariness can be
compromised.
 Incentives
 Authority/Power relationships
 Undue Influence
Incentives
When large sums of money or other unusually attractive incentives are offered for participation in a study,
this is regarded as undue inducement. People may become involved in a study because their need or
desire for the incentive may lead them to recklessly disregard the risks of participation.
People who are financially secure are less likely to feel pressure to participate based on offers of money
or other items of value. Incentives tend to place pressure disproportionately on the financially
disadvantaged.
Undue inducement need not take the form of financial reward. For example, creating the perception that
participation will improve a participant's social standing or result in their gaining favour is also considered
unethical.
Authority/Power Relationships
When prospective participants are members of organizations with authoritarian structures (such as the
military, police, or some religious groups), their consent may not be entirely voluntary. They may feel
pressure from the organization to take part in the study. Or they may have the perception that they will
benefit in some way within the organization if they agree to participate (e.g. perks, career advancement).
Conversely, when the organization is not in favour of the study, its members may feel pressure to avoid
becoming involved. Researchers are obligated to inform people of the views of the organization's
authorities and the possible consequences of participation. Confidentiality must be protected.
Undue Influence
Relationships of trust and dependency, such as doctor/patient or professor/student, can create issues in
the consent process. The perception (if not the reality) that one's treatment, evaluation, or career
advancement may be affected by consent or refusal to participate in a study can seriously compromise
the element of voluntariness.
This is a particular risk for studies involving residents in long-term care facilities or psychiatric institutions.
Researchers should be alert to whether someone feels pressured or coerced in some way by a caregiver
or other associate to participate in a study. Manipulation by friends or family members can also be a more
subtle form of undue influence on participants.
Keeping Consent Informed
The decision to participate in a study should be based on a thorough understanding of the foreseeable
risks and potential benefits of participation, as well as the purpose of the study. For consent to be
considered informed in accordance with TCPS 2, the following elements must usually be included:
 specific invitation to participate in a study
 statement of the research purpose, the identity of the researcher, the expected duration and
nature of participation, and a description of the procedures and responsibilities on the participant
 description of foreseeable risks and potential benefits
 assurance of the participant's right to refuse consent or to withdraw at any time after providing
consent
 disclosure of any apparent or actual or potential conflict of interest on the part of researchers,
their institutions or sponsors.
Capacity to Consent
Some research requires participants who may lack the necessary cognitive capacity to decide whether
or not to participate in research. In the context of research participation, the definition of capacity is not
the same as the legal definition of capacity. It refers to the ability of prospective participants to:
 appreciate the possible impact of foreseeable risks and potential benefits on their own well-being
 understand how the conditions of the research may affect them (e.g. time required, difficulty of
tasks)
 evaluate whether participation in a particular research project may or may not be in their own best
interest
 when research involves those who are not capable of giving consent on their own behalf,
researchers must seek the consent of an authorized third party.
Assessing Capacity to Consent
Assessing capacity involves determining at a particular point in time whether participants (or prospective
participants) understand the nature of the research and the corresponding foreseeable risks and potential
benefits of their participation. Capacity to consent can change depending upon:
 the complexity of the choice being made
 the circumstances surrounding the decision
 any change in the participant's condition
If a participant regains capacity at any point in time after an authorized party has provided consent, the
researcher must seek consent directly from the participant before they can continue in the study.
Assent & Dissent
Even when an individual’s authorized third party gives consent, it is important to involve the individual to
the greatest extent possible. As prospective participants they may agree (assent) or not agree ( dissent)
with their authorized third party’s decision to consent.
Many of those who lack capacity are nevertheless able to express their wishes - for example:
 children whose capacity is still developing
 adults whose capacity is diminishing or fluctuating due to illness or injury
 those whose capacity remains only partially developed (e.g. congenital conditions)
When individuals know that their capacity is likely to diminish, they may make their wishes known in the
form of a research directive.
Alterations to Consent
According to TCPS 2, research may only begin if prospective participants, or authorized third parties,
have given their consent to participate. There are, however, circumstances under which the requirement
can be altered or waived.
Click on each example below to see whether consent must be sought:
 Observing children in a daycare setting
 Conducting an online survey about voting intentions
 Analyzing trial transcripts to assess truthfulness of witnesses
Observing Children in a Daycare Setting
This would be considered naturalistic observation. The children themselves could not be approached
for permission without jeopardizing the research. However, their parents or guardians and the daycare
administration would have to give their consent to allow the researcher access to the observation site.
The researcher would also need to address concerns about how the data will be used, and how the
privacy of the children and their families will be protected at all stages of the research.
Conducting an Online Survey About Voting Intentions
Whether a survey is conducted in person, over the phone, by mail, or online, the same consent
procedures apply. The researcher would have to provide information regarding the purpose of the
research, as well as the proper contact information in case of questions or concerns. Online consent
forms need to spell out the key points the participant must be aware of before offering a clickable choice
to agree and begin the study, or to disagree and not do the study.
Analyzing Trial Transcripts to Assess Truthfulness of Witnesses
Normally, a trial transcript is a public record and as such can be used without the consent of the people to
whom it refers. However, in some cases court proceedings may be sealed for a period of time and there
may be restrictions on usage to protect the identity of minors and/or endangered persons.
Acceptable Alterations of Consent
The consent process may be altered (waived, delayed, presented in a different format) with REB approval
if all of the following conditions apply:
 research involves no more than minimal risk
 waiver or alteration is unlikely to have a negative effect on participants’ welfare
 it would be impossible or impracticable to do the research without the waiver or alteration


whenever possible, participants will be provided with all information pertinent to their consent at
the earliest possible opportunity, and will be given the option to withdraw their consent
waived or altered consent does not involve a therapeutic, clinical, or diagnostic intervention
Observational Research
When the goal of the study is to find out how people normally behave in a specific environment, it can be
argued that approaching them for consent would compromise their normal behaviour. However, because
those being observed would be participating in research without their knowledge or consent, a request to
waive the consent procedure is not taken lightly. Researchers must satisfy REBs that:
 the research question cannot be addressed by any other means involving a consent procedure
 those being observed will not be exposed to any risks beyond what they would normally
experience in their daily lives
 those being observed do not have some expectation of privacy (e.g. a members-only support
group, a funeral)
 there is no risk that those observed could be identified in the dissemination of results
 observational research that guards against identification of participants, is not staged, and does
not violate expectations of privacy may be exempt from REB review.
Critical Inquiry
Some research seeks knowledge that may critique or challenge an organization (e.g. a hospital,
government, interest group or corporation). The consent of the organization (e.g. its governing body) is
not required for this type of research.
This allows research to be conducted on matters that might otherwise stay hidden, such as institutional
sexual abuse, or a government policy of silencing dissident scientists. Critical inquiry research can yield
important knowledge and insights on many social issues. REBs may need to adjust their risk-benefit
analysis accordingly.
REBs and researchers need to consider the possible effects of critical inquiry on participants and ensure
participants know:
 The organization’s view of the research
 The potential risks of participation
 Their privacy will be safeguarded to the fullest extent
Waiver of Parental/Guardian Consent
In most cases, obtaining parental consent for a child or minor to participate in research is a reasonable
and necessary procedure. But there are some circumstances in which this may be at odds with the
interests of the minor participant:
 A study of children using counseling services without parental consent or knowledge - requiring
the children to get parental consent to fill out a survey evaluating the service would breach their
right to confidentiality.
 A study of girls and women aged 14–24 regarding contraception and sexual activity. There are
several issues here - in several provinces, girls under 18 may seek medical advice, prescriptions
and/or treatment related to contraception and reproductive health without parental consent.
Requiring that their parents provide consent for a study on similar issues may be a violation of
participants’ privacy. Within the same participant pool there may be girls who
are emancipated minors who do not have to get third-party consent. Asking non-emancipated
participants of the same age and experience to seek parental consent may be inconsistent with
the principle of Justice. It also breach their right to privacy.
Deception & Debriefing
In some studies, the quality of the data depends on the participants being unaware of the true research
goal. A consent procedure that is not fully informed may be allowed as long as the tasks that the
participants will be asked to perform are clearly described, and the deception is revealed and explained to
participants at the earliest opportunity. See the example below:

A study investigating the effect of questioning style on eye-witness testimony does not tell
participants they will be asked to recall information about a film they see at the beginning of the
experiment. The researcher also does not tell them their responses are expected to differ
depending on the type of questions they are asked about the film. When each participant is
finished they are told about the purpose of the study and given an opportunity to refuse consent
retroactively. Researchers may also give participants the option of removing their data.
Individual Medical Emergencies
A man who has suffered a severe stroke is brought into a hospital by a neighbour who saw him fall. If he
can be given an experimental treatment within the next hour, a great deal of damage to his brain may be
prevented. A standard treatment may revive him but will not prevent the brain damage. The hospital
cannot reach any member of his family who could provide authorized third-party consent. Can the
treatment still be given in the absence of consent?
In this type of situation, where the delay necessary to seek third-party consent could seriously
compromise the unconscious or incapacitated individual’s health, it is possible to act without consent if
the following conditions are observed:
 The research addresses the emergency needs of the individual and does not conflict with any
applicable legal or regulatory requirements
 An REB has approved an emergency no-consent procedure in advance of the research in
accordance with the criteria specified inTCPS 2 Article 3.8
Summary
 Free, informed, ongoing consent is a critical part of Respect for Persons in the context of human
participation in research.
 The voluntariness of consent can be compromised by disproportionate incentives, power
relationships and undue influence.
 The researcher is obligated to provide as much information as individuals need to make a fully
informed choice to consent or refuse to participate.
 The consent process may be altered or waived if the REB is satisfied that the rationale for doing
so is consistent with the criteria specified in TCPS 2.
Module 5:
Privacy & Confidentiality
Completed: January 26 2012, 10:36AM
 Review
Objectives
Upon completion of this module you will be able to:
 describe what is meant by identifiable information
 identify situations in which an REB may allow research without consent of individual participants
 generate strategies for safeguarding participants' privacy and confidentiality
Introduction
Many areas of research, such as epidemiology, history, genetics and psychology, depend on access to
personal information. The use of personal information in research can lead to major advances in
knowledge and quality of life.
When participants provide personal information in the context of a study this creates a trust relationship
between participant and researcher. Researchers have a duty to treat personal information respectfully
and confidentially.
In addition to accepted ethical principles TCPS 2, researchers must also be aware of the laws governing
privacy and confidentiality in the jurisdiction where the research will be conducted (e.g. PHIPA; PIPEDA ).
Definitions
The terms privacy and confidentiality are related but different. Each term carries with it implications for
researchers and participants.
Privacy
The state of being free from intrusion or interference by others. Individuals have privacy interests in
relation to their bodies, personal information, expressed thoughts and opinions, personal communication
with others, and the spaces they occupy.
Confidentiality
Researchers have an ethical obligation to keep anything participants reveal to them in confidence – that
is, not sharing this information in such a way that would identify participants, and protecting it from
unauthorized access, use, disclosure, modification, loss or theft. Fulfilling the ethical duty of confidentiality
is essential to the trust relationship between researcher and participant, and to the integrity of the
research project.
Expectations of Privacy
Participants may reasonably expect that any personal information given in a research study that could be
used to identify them will:
 not be linked to other information about them (e.g. health, employment, or educational records)
without their consent
 not be made available to anyone except those involved in collecting, analyzing, or monitoring the
data for that research project
 be stored securely until no longer needed and then be destroyed
 not be released to anyone outside the study, unless permission to do so has been explicitly
granted
Degrees of Identifiability
Researchers and REBs need to consider whether the type of information being gathered and used in a
study could be used to identify participants. TCPS 2 provides the following categories as a guide to help
researchers and REBs assess the potential identifiability of participants in the context of a research
proposal:
 Directly identifying information
 Indirectly identifying information
 Coded information
 Anonymized information
 Anonymous information
Information Security
Researchers are responsible for maintaining the extent of confidentiality promised to their participants.
Institutions are required by TCPS 2 to support their researchers’ promise of confidentiality.
Information security refers to the physical, administrative, and technical measures institutions and
researchers can use to protect participant information.
Click each of the stages of research conduct below to learn about the ways in which participant privacy
can be safeguarded throughout the life of a research project:
 Recruitment
 Consent Process
 Data Collection and Analysis
 Data Storage
 Sharing of Findings
Recruitment
When potential participants respond to a research advertisement the researcher may collect their names,
phone numbers and/or email addresses in order to contact them about study details. All such contact
information must be kept apart from the data and stored in a secure place.
Institutions should have policies governing who may have access to personal information about
participants throughout the life of a research project.
Consent Process
When written consent is obtained, the consent form should be separate from participants' contact
information and other information collected from them during the study. This procedure is also appropriate
for the documentation of any non-written consent process (e.g. field notes). The separation of identifying
information from coded or anonymized data is fundamental to safeguarding participant privacy and
confidentiality.
Data Collection and Analysis
One effective strategy to maintain the confidentiality of data during its collection and analysis is assigning
a code to the information obtained from each participant. Once it was common practice to use
participants' initials but in small communities, or in cases where an individual has unusual initials, this is
not a sufficient safeguard. A better standard practice is to assign an alphanumeric code to each
participant’s data (e.g. A01, A02 ... Z99).
The key to the code must be kept in a secure place (e.g. a locked cabinet or a password-protected file)
away from the data set. The researcher in charge of the project is ultimately responsible for controlling
access to the data coding key.
Data Storage
During and after data analysis any personal information obtained from participants must be stored
securely. The selection of security measures should take into account the nature, types and state of the
data, its content, mobility, and vulnerability to unauthorized access. In the case of online data,
researchers and REB members need to be aware of relevant online privacy laws and site terms of use
and consider if the data is more vulnerable to third party viewing.
Typically, data in paper form should be kept in a locked cabinet not accessible to anyone outside the
study. Data in digital form should be encrypted and password protected.
The duration of data storage depends on the research discipline, the research purpose, and the kind of
data involved (e.g. sensitive personal data, biological samples, anonymized data, etc.).
Sharing of Findings
Data can be presented in aggregate form (percentages, means, etc.) that does not infringe on
participants' privacy or confidentiality. Descriptions of participants in papers or presentations that give too
many identifying details (e.g. location, ethnicity, rare blood type, etc.) may expose participants to
unwanted public attention.
Unless participants have specifically consented to being identified, researchers must avoid exposing them
to the risk of identification in any dissemination of research results.
Keeping Confidentiality
Confidentiality applies to information obtained directly from participants or from other researchers or
organizations that have a legal obligation to safeguard personal records. When there is a breach of
confidentiality this can cause harm to:
 the trust relationship between the researcher and the research participants
 other individuals/groups affiliated with participants
 the credibility of the research institution
 the reputation of the research community
When a third party seeks access to confidential data of participants, it is the researcher's duty to maintain
participants' confidentiality. It is the duty of the REB and the institution to support the researcher to uphold
this principle. This may involve resisting requests for access, such as opposing court applications
seeking disclosure.
Extent of Confidentiality
Researchers are required to maintain their promise of confidentiality to participants to the extent permitted
by ethical principles and/or law. However, there are instances when it is in the public interest to breach
confidentiality (e.g. protection of health, life, and safety). For example, when researchers working with
children discover that one of their participants may be the victim of abuse they are bound by law to
inform the appropriate authorities.
It is the role of the REB to balance possible conflicts between the public interest in research that uses
personal information and the privacy of the individual participants.
If there is a possibility that participants' data will not be completely secure, then researchers should let
participants know during the consent process the extent of the confidentiality that can be promised (in
accordance with the law) and whether information could be released to government agencies, research
sponsors or a regulatory agency, etc.
Secondary Use of Data
Sometimes data collected for one study is used for another research purpose. For example, a study of
eating habits may make use of school records to draw a link between nutrition and academic
performance. Information originally collected for quality assurance or program evaluation may turn out to
be relevant to a research question.
Privacy concerns arise if secondary use of the data poses a risk of re-identification to the original study's
participants. If there is a possibility that the original participants could be identified through dissemination
or data linkage, their consent to include their data in any new study is required. TCPS 2 does allow an
exception to this requirement if specific conditions are met and the REB agrees with the rationale for
seeking the exception.
Follow-up Contact
When using secondary data that does not contain identifiable information it is sometimes necessary for
the researcher to access contact details to do follow-up interviews with participants. Whenever possible, it
is preferable that re-contact with participants be carried out by the custodian of the original data set as
some people may not be comfortable being contacted by someone unrelated to the original study.
Researchers need to seek consent from individual participants for any new data collection. It is important
that researchers ensure that these participants have every opportunity to consent or refuse the use of
their data in a subsequent study.
The core principles underlying respect for privacy oblige researchers to be cautious in the creation and
use of databases. Even when databases do not contain directly identifiable information, the linking of two
or more databases can combine to create identifiable information – posing a risk to participants'
confidentiality.
Minding Your P & C
Click on one of the interactive case studies below. Each describes a study in which participants' privacy
or confidentiality could be threatened in some way. Your challenge is to come up with several ways to
safeguard participants' personal information.
Summary
 Participants expect that any personal or identifying information they provide in the context of a
research study will be kept confidential by the researcher.


Rendering data anonymized by assigning codes and keeping contact information and consent
forms apart from data are standard procedures for safeguarding participants' privacy.
In cases where the public interest outweighs concern for individual privacy (e.g. possible child
abuse) breaches of confidentiality may be necessary.
Module 6:
Fairness & Equity
Completed: January 26 2012, 10:40AM
 Review
Objectives
Upon completion of this module you will be able to:
 identify possible vulnerable circumstances of participants
 assess the appropriateness of inclusion and exclusion criteria to a research question
 address issues of fairness and equity in sample research designs
Introduction
How do we decide who may participate in a study and who may not? How do we ensure that participants
are treated fairly and equitably?
History has taught us that without adequate oversight, individuals and groups can be included in research
without consideration of the ways in which they may be vulnerable. Conversely, past research has also
unfairly excluded participants, making it inappropriate or unsafe to apply the results to members of
excluded groups.
The fair distribution of potential benefits and the equitable treatment of all research participants is a
matter of concern to all researchers, REBs, institutions and sponsors of research.
When any individual or group is unfairly treated in the context of research, the entire research community
suffers. Public trust in researchers and their institutions is broken. Society as a whole suffers because
inequitable participation in research compromises the reliability and usefulness of research results. Good
research is ethical research.
Understanding Vulnerable Circumstances
In applying the principle of Justice to research design and review, it is important for researchers and REB
members to understand vulnerable circumstances from the perspective of the participant. This is
particularly important when a study involves people whose ability to provide consent free of influence or
coercion may be compromised.
Click through the historical examples below to learn more about how the vulnerable circumstances of
participants have been overlooked or abused in the past:
 MKULTRA
 The Yanomami
 Dorothy Proctor
 Tuskegee Syphilis Study
Creating Vulnerable Circumstances
With the development of modern research ethics guidance and education, the extreme instances of
mistreatment of participants in vulnerable circumstances are largely a thing of the past. However, there
are subtle ways in which a study can create conditions that make participants vulnerable – or worsen
existing conditions. Even the most well-intentioned research designs can have inadvertent negative
effects on these participants. Click on the examples below to learn more:
 Watch your Language
 Avoid Misunderstandings

Be Careful of Context
Watch Your Language
A researcher is interviewing people in an area known for its poor access to education and low literacy
levels. They are told that their stories about their experiences in the local school system will be heard by a
government task force that wants to improve educational opportunities in their area. Before doing the
interview, each participant is given a consent form that begins:
This study, an assessment of this region's level of educational disenfranchisement, will seek to establish
each individual's intensity and longevity of engagement with the school system.
Click HERE to see this sentence in clear and simple language. You may Click HERE to see the original
version.
Using unsuitable language in recruitment, information, consent and debriefing documents is one of the
most common mistakes researchers make. Aside from being difficult to understand, this sort of language
can make participants feel too uncomfortable to admit they don't fully understand the study causing them
to give uninformed consent. Conversely, a lack of understanding may cause people to refuse to
participate in research that may be in their interests. This violates the principle of Respect for Persons.
Avoid Misunderstandings
A team of researchers spend a week talking to elderly people in an assisted care home about their quality
of life. They have permission from the administration to approach people and ask if they would like to do
the study. Those who agree to be interviewed are taken to a room that has been set aside for the study
for about an hour at a time.
A few days later the daughter of a participant calls the researchers. She tells them that each person they
interviewed is being treated differently by the staff and the other residents because of a rumour that each
person taken into the study room has been diagnosed with senile dementia. This is causing the
participants a great deal of distress. How could this have been avoided?
Be Careful of Context
A researcher is using a well-established intelligence test to assess the average intelligence of children
in a cross-section of a large city's neighbourhoods. The results indicate that, on average, Black and
Hispanic children scored lower on the intelligence test than Caucasian children, and Asian children
scored higher than Caucasian children. The results, consistent with other studies, are used by some to
speculate that intelligence is genetic and that some races are naturally more intelligent than others –
igniting a storm of controversy.
A closer look at IQ tests revealed them to be culturally biased, that is, the scenarios and question content
are more familiar to people raised in a white middle-class family than to people from other cultural
backgrounds. And, the "normative" scores were derived from the scores of people from white, middleclass families.
Efforts have been made to create "culture free" IQ tests but there is still much controversy over the use
and applications of IQ tests in general. If you are interested in exploring some examples of standard and
alternative IQ tests click HERE.
Varying Vulnerable Circumstances
As the pendulum swung away from inappropriate inclusion of participants in vulnerable circumstances to
an emphasis on protection, research ethics policy reflected a concern for "vulnerable populations."
Women, children, and the elderly, as well as mentally ill, institutionalized and impoverished people, were
all considered to be vulnerable populations in need of special protection in the context of research.
TCPS 2 takes the view that categorizing people in this manner fails to consider the nature and stability of
each participant’s circumstances in the context of specific research. Anyone may be in vulnerable
circumstances at some time in their lives. These circumstances may be long-term, short-term, or perhaps
only in the context of a specific research project. Click on the examples below to learn more:
 Minors
 Brain Injury Survivors
 Students
Inappropriate Exclusion
The consideration of participants' vulnerable circumstances in the context of research design and review
should not lead to the inappropriate exclusion of individuals or groups. Historically, women, children, the
elderly and those who lack capacity to consent have been routinely excluded from research (particularly
health research). Sometimes these exclusions were due to an over-protective attitude on the part of
researchers and REBs. Sometimes they were due to a desire for expediency and the assumption that
results from one group (males aged 18 – 35) could be adapted to other groups.
Exclusions that are not justified by the research question violate the principle of Justice by denying the
excluded groups the benefits of research participation. TCPS 2 requires that individuals not be excluded
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. The intent of this directive is a more inclusive practice of research
leading to a more just distribution of research benefits across the whole of society.
Out in the Cold
In 2007, the U.S. and Canadian governments called for all cold and cough medicines promoted for use in
infants to be pulled from the market. This was in response to reports of children suffering side-effects
(and several deaths) from the use of common over-the-counter cold medications.
Physicians had long been concerned about the use of these drugs as they have never been tested on
children. Rather than include children in the clinical trials, manufacturers of the medications decided to
estimate dosages for children based on data from trials with adult participants.
After having conducted a review of cough and cold medicines intended for children, Health
Canada currently advises parents not to give these medications to children under the age of six and has
required the manufacturers to label the products accordingly.
Click HERE to read a news report on this issue.
Expecting the Worst
For women who are pregnant and on medication for a pre-existing condition – or who develop a condition
during pregnancy that requires medication – there is usually very little their doctor can tell them about
how that medication is going to affect their child.
The majority of clinical trials for medications do not include pregnant women among their participants.
Researchers and REBs have traditionally shown a reluctance to include pregnant and/or nursing mothers
in any research that may pose a risk to the fetus or infant. Some studies exclude women for fear that they
may get pregnant during a study. The result is a lack of information about the safety of medications many
pregnant and nursing women need (e.g. for epilepsy, anxiety, heart condition, thyroid disease).
TCPS 2 recognizes that there are ways to safely conduct research with pregnant and nursing women that
is consistent with the core principles. The Policy also requires that these prospective participants not be
excluded from research solely on the basis of reproductive capacity, pregnancy, or breastfeeding.
To learn more about this issue, click HERE.
Including Incapacity
Research involving participants who lack capacity to consent is necessary to ensure that the results
benefit those with the same source of incapacity. Here are some examples of research that could not be
done without the participation of people lacking capacity to consent:
 monitoring long-term effects of a new drug for Alzheimer's disease on people experiencing its
early stages
 comparing different educational approaches to helping children with autism learn to express
themselves
 assessing the effect of community employment on the well-being of intellectually disabled adults
TCPS 2 recognizes the fairness and equity of the appropriate inclusion of people who lack cognitive
capacity, and provides specific guidance to researchers and REBs.
Missing the Mark
Sometimes, researchers exclude participants who represent the very population they are trying to help.
Using exclusion criteria to maximize the success of the research – that is, accepting only participants
whose behaviour, opinions, or mental or physical characteristics are likely to support a hypothesis – is a
built-in bias of researchers and their support staff that needs to be addressed at the design, review, and
recruitment stages of research.
For example, an analysis of the inclusion and exclusion criteria of studies investigating the efficacy of
psychiatric treatment for alcohol abuse, compared the participants who passed the recruitment screening
with the real-world population of people in need of treatment for alcohol abuse. It was revealed that
African-Americans, low-income earners, and individuals with more severe alcohol, drug, and psychiatric
problems were disproportionately excluded from the research, while white, economically stable, highfunctioning individuals were disproportionately included.
The exclusion criteria effectively denied the potential benefits of the research to the populations in need of
those benefits. Click HEREfor a news report on the study.
Who's In and Who's Out?
In the design stages of a study, researchers have to decide who to include and who to exclude in their
recruitment of participants. They create a list of inclusion criteria and a list of exclusion criteria. These
criteria are based upon the research question, the available participant population, and the goals of the
research.
At the review stage, it is the REB’s responsibility to examine the research proposal and determine if the
inclusion and exclusion criteria are justified by the research question in accordance with the core
principles of TCPS 2.
Click on the examples below to try your hand at generating appropriate inclusion and exclusion criteria:
 Work station Comparison
 Learning Disability Assessment
 Effects of Frequent Body Scans
Work Station Comparison
Research Questions: Are there any measurable differences in user posture, alertness, fatigue, and
subjective well-being between users assigned to the prototype, "WorkRite station" and users assigned to
a standard work station?
Method: Participants will be randomly assigned to work at either a standard work station or a WorkRite
station for a two hour period each day for two weeks. Participants will be assigned routine tasks and
video-taped while they perform them to provide data for posture and alertness measures. After each
session they will complete a well-being questionnaire.
And Benefits for All
Participants may form expectations in regard to the potential benefits of their involvement in a study. It is
important that the consent materials provide an accurate description of potential benefits and that
researchers talk to prospective participants to ensure they have a clear understanding.
Recall from Module 3 that benefits may be direct (e.g. participants learn new information relevant to their
lives) or indirect (e.g. results from the study of the effects of a drug on one group of participants can be
used to improve the safety and efficacy of the drug for others). Benefits may be specific to individuals
(e.g. improved recovery from depression) or spread out within a community (e.g. access to training,
establishment of services) or society in general (advancement of knowledge).
Summary
 Researchers and REBs must consider the possible vulnerable circumstances of participants in
the context of specific research.
 Over-protectionist attitudes or built-in recruitment biases can lead to the inappropriate exclusion
of individuals or groups from participation in research.
 Care must be taken to avoid inappropriate inclusion of particular populations or groups such that
they bear a disproportionate burden of research participation without necessarily being able to
enjoy its benefits.
 Researchers and REBs must navigate between the dangers of imposing unfair burdens on
particular participants, groups and communities, and overprotecting them.
Module 7:
Conflict of Interest
Completed: January 26 2012, 10:43AM
 Review
Objectives
Upon completion of this module you will be able to:
 identify real, perceived or potential conflicts of interest that may affect the ethical conduct of
research
 describe typical conflicts of interest that should be addressed in COI policies for institutions,
REBs, and researchers
 generate strategies for eliminating, minimizing or managing conflicts of interest
Introduction
If you were in a study comparing the user-friendliness of two different but similar computer programs and
you heard later that the researcher had invested money in one of them, would you trust the outcome of
the study? How would it look to you if the only physician-researchers reporting positive results of a new
drug had all been through a clinical trials training program sponsored by the maker of that drug? If your
application for research ethics approval was rejected and you knew that researchers who disagree with
your hypotheses sat on the REB, would you have concerns about whether they were involved in the
decision?
Conflict of interest or even the appearance of a conflict of interest (COI) can damage the trust
relationships the research community depends on – between REBs, researchers, participants, sponsors,
institutions, professional associations, and society. The heart of effective research is the ability to engage
in fair assessments and interpretations without the influence of personal, institutional, or financial
concerns.
The Need for Conflict of Interest Policies
Ideally, conflicts of interest (COI) would be easy to avoid. Some types of COI are foreseeable but not
avoidable; others can arise unexpectedly as circumstances change. For these reasons, TCPS 2 requires
that institutions have COI policies to help researchers, REBs and administrators identify, eliminate,
minimize, or manage any
real, perceived, or potential conflict of interest that may affect the ethical conduct of research.
These policies need to deal specifically with each of the following types of COI:
 Institutional COI
 REB member COI
 Researcher COI
Institutional COI
Institutions, such as universities, colleges, and hospitals, have a number of interests (e.g. financial,
reputational, educational and ethical) that may come into conflict with one another. For example, an
institution may set a goal to become renowned for a particular type of research and find that the potential
sponsors they seek require more control over data ownership and dissemination of results than the REB
or researchers think is appropriate.
Just the appearance of a conflict of interest can affect an institution's reputation among the research
community and the general public. In developing an institutional COI policy, openly and transparently with
input from its research community, an institution needs to address the following questions:
Questions to Inform Institutional COI Policy
 How can real, perceived and potential COI that may affect the ethical conduct of research be
identified, eliminated, minimized, or managed?
 How can the responsibilities of individuals or the administrative structure of the institution be
designed or changed to eliminate or minimize COI?
 Generate strategies for eliminating, minimizing or managing conflicts of interest
 When should institutional COI be disclosed to the REB?
 When should the REB disclose institutional COI to researchers and require that it be disclosed to
participants during the consent process?
 How can the institution ensure its researchers are able to conduct independent research without
interference from institution funders?
 How can institutions ensure their researchers will be supported by their administration in the
event of aconflict with a research sponsor who is also a funder of the institution?
REB Member COI
The institution and the public rely upon REBs to review research proposals for their consistency with
TCPS 2 core principles, without being influenced by personal or professional interests. To maintain this
trust, REB members must be aware of, and fully disclose, any real, perceived or potential conflict of
interest they may have.
Usually, REB members who have a COI with a particular research proposal are not assigned to review it
and are not present for any discussion or vote regarding its ethical acceptability.
To see examples of REB member COI click HERE.
Examples of REB Member COI
 Their own research projects are under review by their REB.
 They are a co-investigator on a proposal under review.
 They are in a supervisory or mentoring relationship with a graduate student applicant.
 They have interpersonal or financial relationships with the researchers named in a proposal.
 They have personal or financial interests in the sponsor of the research project.
 They may be personally or professionally affected by the research.
Researcher COI
Researchers need to be aware of real, perceived and potential conflicts of interest that may compromise
their independence or objectivity and report them to the REB in their application for research ethics
review. For any identified COI, researchers must demonstrate how the conflict can be eliminated,
minimized or managed to ensure the ethical conduct of the research.
Pressures to delay or withhold results or to use questionable recruitment strategies are some possible
outcomes of COI. Click on the examples below of the most common types of researcher COI to learn
more:
 Interpersonal
 Dual Roles
 Financial
Researcher COI: Interpersonal
Researchers' conflicts of interest may arise from interpersonal relationships (e.g. family, colleagues, or
community relationships). If a spouse or family member, colleague or friend stands to benefit from the
outcome of a study, the researcher has a conflict of interest that needs to be minimized or managed. For
example, a researcher's evaluation of several natural health products includes one that his spouse’s
company represents.
While it may not be possible to eliminate all conflicts of interest, researchers are expected to identify,
minimize or otherwise manage their individual conflicts in a manner that is satisfactory to the REB.
Researcher COI: Dual Roles
Researchers often have dual roles in academic and other professional settings. Having responsibilities as
both a researcher and a therapist, a caregiver, a teacher, a consultant, an employer, or other role can
lead to conflicts of interest.
To ensure that the trust relationships that go with these responsibilities are safeguarded, researchers
need to clearly identify potential conflicts of interest between their roles and plan in advance how to
manage COI when it happens.
For example, researchers who are recruiting for a study should either avoid recruiting students who
depend on their good will for career advancement, or should have another member of the research team
conduct the recruitment and the study itself.
Researcher COI: Financial
A real or perceived financial conflict of interest can destroy trust in researchers and in all of their previous
work. Unfortunately, it has been established that financial incentives can distort researchers’ judgement in
regard to the ethical design and conduct of research.
It is the responsibility of researchers to disclose and document all kinds and amounts of financial
incentives (sponsorship, salary, fee per participant, equipment, other resources, gifts, etc.) in their
application for REB approval. In addition to identifying all financial COI, researchers must demonstrate in
their proposal how they intend to minimize or manage these conflicts.
The REB will examine research budgets and payment provisions as part of their review to ensure that
there are no inappropriate payments to be made or other unexplained expenses. For example, if a
sponsor of a study is offering large incentives for researchers to recruit quickly, there is a risk to
participants of inappropriate inclusion, coercion, or undue influence.
Full disclosure of any financial COI can help researchers and REBs work together to manage real,
perceived and potential COI and ensure that research is conducted in accordance with the core principles
of TCPS 2.
Assessing Conflict of Interest
Once conflict of interest is identified, it must be assessed for its potential to create divided loyalties that
may distract researchers, REBs, and institutions from the primary concern for the welfare of participants.
Even the appearance of a conflict of interest can inflict damage on the reputation of the researcher and
the research community.
Here are two ways of assessing whether real or perceived conflicts of interest exist:
 Ask yourself whether an outside observer, aware of your personal or private interests, would
question your ability to make objective decisions about the research.
 If allegations of a conflict of interest were made public, ask yourself if people would be convinced
by the facts of the matter that the ethical conduct of the study was not threatened, or, if suspicion
of conflict of interest would linger.
Eliminate, Minimize, Manage
Once a conflict of interest is identified and determined to be a real, perceived or potential threat to the
ethical conduct of interest, the next step is to choose one of the following strategies:
 Eliminate
 Minimize
 Manage
Eliminating COI
Researchers may be able to eliminate COI by adjusting the research design. For example, if there is a
concern that a researcher's role as an instructor may interfere with the voluntariness of consent from
student participants, the recruitment and conduct of the experiment can be delegated to research
assistants who have no power relationships (as course markers or tutors) with prospective participants.
Institutions can eliminate the potential for COI by ensuring that people responsible for promoting research
are not also involved in research ethics oversight. REBs can eliminate COI by assessing the potential
COI of prospective REB members, and screening out those who would be prohibited from reviewing
much of the time due to their real, perceived or potential COIs.
Minimizing COI
If a COI cannot be eliminated, there may be a way to minimize it. For example, an REB member who is
prohibited from reviewing a research proposal because she is the advisor of the applicant may still be
allowed to give the other members of the REB sufficient information about the discipline to help them in
their evaluation.
An institution that receives an offer of funding from a company that is also sponsoring individual research
projects can ensure that the agreement includes language that allows the institution to support their
researchers in the event of any conflict with the sponsor, without affecting the funding agreement. If a
researcher discovers that one of his research assistants does have a power relationship with potential
participants, he can assign that RA to data entry or data analysis rather than recruitment and testing.
Managing COI
A COI that cannot be eliminated or minimized may be managed. Institutional policies should ensure that
the measures prescribed to manage COI reflect the level of risk posed to the ethical conduct of the
research as well as to scientific credibility. Some institutions establish independent COI committees for
this purpose.
One way of managing COI is to disclose it. For example, institutions should disclose an institutional COI
to the REB if it may affect an area of research or a specific research project. REB members are required
to disclose any COI that may interfere or be seen to interfere with their objectivity as reviewers.
Researchers may be required to disclose financial COI to participants in their consent process.
The disclosure of COI serves the core principles of TCPS 2 by making the process of dealing with
conflicts transparent and open to scrutiny.
Summary
 A conflict of interest occurs when one or more interests or responsibilities of an individual or an
institution are incompatible, such that one cannot be satisfied without compromising another.


Often conflicts of interests need not damage the trust relationships involved in research as long
as they are openly identified and dealt with. Attempts to conceal conflicts of interest, even minor
conflicts, may cause more damage than the conflict itself.
There are ways to eliminate, minimize, and manage conflicts of interest so that participants are
protected and the integrity of the study, the researcher, and their associates are not affected.
Module 8: REB Review
Completed: January 26 2012, 10:51AM
 Review
Objectives
Upon completion of this module you will be able to:
 Understand the roles and responsibilities of REBs and researchers
 Describe the research ethics review process
 Recognize common errors and omissions in REB review applications
Introduction
As you learned in Module 2: Defining Research, all research involving humans (other than the specified
exemptions) must receive REB review. Most REBs are made up of volunteers from an institution’s
research faculty as well as people from the surrounding community.
REB reviewers are expected to read research proposals from the point of view of a prospective
participant. Are the risks clearly explained? Is there enough time provided for the consideration of
consent? Are there sufficient measures to safeguard confidentiality? They look closely at whether there is
anything that does not comply with TPCS 2 or other relevant policies.
Researchers and REBs are expected to work together to ensure that all approved research is of the
highest ethical standard.
The REB Mandate
Research Ethics Boards (REBs) are mandated by their institution to assess whether the research
proposals they review are ethically acceptable according to TCPS 2.
Any institution that is eligible to receive federal research funding is obligated to provide support (funding,
space, personnel) to at least one REB or to make arrangements to have their research proposals
reviewed by another TCPS 2 compliant REB.
The goal of an REB is to represent the interests of participants by assessing the foreseeable risks, ethical
implications, and potential benefits of each proposal they review. Researchers can consult with REB staff
at the design phase of their project, while they are preparing their application for REB review, and during
the review process.
Researchers are expected to work with their REB to resolve ethical issues in their research in accordance
with the core principles of TCPS 2.
Ethical Research Design
Having an in-depth understanding of TCPS 2 can help researchers design proposals in accordance with
the core principles right from the beginning. Researchers generally find that incorporating research ethics
considerations into their research design improves their proposal and ultimately strengthens the quality of
their research. Taking the time to do this can reduce the frustration that researchers sometimes
experience will the REB review process.
Researchers should include the time necessary for REB review in the overall research plan. Treating
REB review as an expected and valuable step in the research process can reduce or eliminate
unnecessary delays in the conduct of research.
The REB must ensure that any research they approve is consistent with the core principles of TCPS 2.
They are responsible, along with the researcher and the institution, for the ethical acceptability of the
research they approve.
Click on each element of research design at right to review the ethical issues that need to be considered
before submitting a proposal for REB review.
Inclusion & Exclusion Criteria
After deciding upon the research question, one of the next steps is deciding what participants are needed
to address it. This leads to the formulation of inclusion and exclusion criteria for the recruitment process.
In accordance with the Principle of Justice, the inclusion and exclusion criteria must be relevant to the
research question. REBs will want to see justification for any exclusion of participants based on
characteristics like gender, language, culture, ethnicity, age or disability. If your research depends on the
inclusion of people in vulnerable circumstances (e.g. as a function of illness, mental disability or
immaturity, poverty, etc.), you will need to show that you have carefully considered the relationship
between their circumstances and your research question. Individuals should not automatically be
excluded due to assumptions made about their vulnerability.
Assessment of Risks & Benefits
Keeping the participants you will be recruiting in mind is important to the assessment of risks and
benefits. What may be a minor risk to you may represent a greater risk to them. For example, being seen
going into the study area may not be an issue on a university campus in Canada, but it may be very risky
for participants in a controversial study in a politically unstable region.
The REB will want to see a thorough and realistic account of the foreseeable risks and potential benefits
to participants in your study. Some studies offer incentives or compensation for participation but these do
not count as benefits. In fact, as you may recall from Module 3: Assessing Risk & Benefit, if the incentives
offered for participation are too great, they may be flagged as a source of undue influence that could lead
some participants to recklessly disregard risks they would not normally take.
Protecting Privacy & Confidentiality
The context of your study will determine the extent of confidentiality you can offer your participants. In the
context of a survey of passers-by in a mall that collects no identifying information (e.g. name, address, full
date of birth) participants can be assured that their responses will remain anonymous. However, in the
context of a focus group, participants can only be assured that the researcher will keep their responses
confidential and that the other participants will be asked to not discuss each other’s responses outside the
group.
The REB will want to see that the promises of confidentiality with respect to safeguarding participant
privacy are appropriate given the study recruitment and consent procedures, the conduct of the study,
and the plans for dissemination of results. As you may recall from Module 4: Consent, there are instances
in which some participants prefer to be recognized for their contributions to the research. If this is the
case in your research, you will need to document explicit consent for participant identification.
Recruitment Procedures
How you approach people to participate in your study is an important element of its ethical acceptability.
The REB will be checking to see if the language of your recruitment materials is accurate and appropriate
to the desired participant group, and, if the direct or implied promise of incentives or benefits is misleading
or amounts to undue influence.
For an example of a radio ad that would not likely be approved, click HERE
REB members will also look at your method of recruitment. For example, If you will be using social media
to recruit, you will need to include a copy of any text or images you intend to post. It is up to researchers
to be aware of any privacy legislation that applies to their research, as well as any copyright and/or
intellectual property rights protections or restrictions, to obtain appropriate permission to post material,
and to ensure all recruitment materials are complete and accurate.
Consent Procedures
The consent process should be appropriate to the language, culture and literacy level of your prospective
participants. Regardless of how you document consent, REB reviewers will want to see that your
procedures meet the requirements for free, informed and ongoing consent, such as an accurate
description of:
 The research purpose and proposed use of data collected
 Foreseeable risks and potential benefits
 Extent of confidentiality promised
 Requirements of the study (e.g. duration, frequency, nature of tasks and/or measures)
 Withdrawal procedure
 Extent of incentives
 Data management (access and safeguards)
 Plans for provision of new information
 Plans for dissemination of results
As you will recall from Module 4: Consent, participants must be provided with the contact information of
(at minimum) the researcher in charge of the study and the REB that approved it. REBs will also want to
see that participants are given enough time to consider their decision and have ample opportunity to ask
questions or seek further information about the study.
Study Materials
Depending on the nature of your research, study materials may include questionnaires, task instructions
or scripts, interview scripts, readings, video or audio stimuli, drawings or photographs, websites, and
debriefing scripts. The general rule is:
If a participant will read/hear/view it
the REB needs to read/hear/view it
If there are any questionnaire items, interview topics, graphic, video or audio material or other stimuli that
may be upsetting to participants, reviewers will want to see your rationale for including them and what
measures you plan to take to offset the risk of causing your participants any emotional or psychological
distress.
As with your recruitment and consent processes, REB reviewers will want to see that any instructions
provided to participants are clear, and respectful of their culture, language and literacy and that sufficient
time is allotted for questions and consideration.
Withdrawal
In the consent process, participants must be assured that they can choose to end their involvement in the
study at any time. Similarly, during the conduct of the research, whenever new information is presented
that requires the researcher to re-affirm participants’ consent, they must be reminded that they may
choose to withdraw from the study.
In some studies, particularly those involving deception, REBs may require researchers to give participants
the option of removing their data from the study if they decide to withdraw. Whether withdrawal of data is
possible will depend upon how data are entered and identified. Whether withdrawal of data as an option
is warranted depends upon the nature and type of information collected, and the extent of deception (if
relevant).
Data Management
Researchers must provide a description of how they plan to collect, enter and store data for the life of the
research project and beyond. The primary question underlying this description is: How will you protect
participants' identities?
Some typical elements of a data management strategy are:
 Method of data collection (e.g. paper, computer, online, recordings, physiological measures,
photographs, etc.)
 Format of data for analysis and storage (e.g. with or without identifying information intact, coded,
anonymized, etc.)
 Duration and method of data storage (e.g. hard-copy, digital files, location and access)
 Method of protecting stored data (e.g. door locks, computer passwords, encrypted files, limited
access)
 Provisions for data sharing (e.g. secure physical transport, encrypted digital transfer, data shared
only in aggregate form)
Dissemination
In your plans for presenting or publishing the results of your research, you must indicate how any
promises of confidentiality made to participants will be respected. You must also indicate how participants
will be able to access the results of the study they were involved in. Here are some examples of the
questions you should address in your research proposal:
 What will be disseminated?
 Are there participant identification issues?
 How will your dissemination plan affect the community?
 How will your participants learn of the study results?
REB Review
As you will recall from Module 2, all research involving humans requires REB review (unless it qualifies
for a specific exemption from review). This includes pilot studies involving any participant who is not part
of the research team. It does not include exploratory work, such as consulting with a community or
relevant individuals to obtain permission to conduct research, or to inform the design of a research
proposal.
TCPS 2 advocates a proportionate approach to REB review. In practice, this means that the REB as a
whole, and each REB member, is required to consider the foreseeable risks, ethical implications and
potential benefits of each research proposal in their evaluation of its ethical acceptability.
The first element of REB review is deciding what level of review your research proposal should receive.
Typically, minimal riskproposals will be assigned to delegated review and higher-risk proposals will be
assigned to full-board review.
Delegated Review
A delegated review normally involves one or two members of the REB with appropriate expertise who are
assigned to assess the research proposal. Their decision to approve the proposal is reported to the Chair
for release of approval notification. If the delegated reviewers are considering rejecting the proposal, it
must be referred back to the full board for decision.
In the case of course-related research conducted by students, the responsibility for research ethics
review may be delegated tonon-REB members such as the student’s department, faculty, or equivalent
authority.
Full-board Review
All proposals receiving full-board review are made available to all REB members who are expected to be
prepared to comment on them at the meeting and to come to a decision to accept (with or without
specified revisions) or reject each proposal.
A full-board review begins with the assignment of the proposal to a small number of REB members for
review (typically two but this may vary according to institutional policy). The reviewers present their
assessment and recommendations to the entire board at an REB meeting.
Scholarly Review
The REB's primary concern is the ethical acceptability of a research proposal, and, where appropriate,
whether it meets the scholarly standards of the relevant discipline. If your research has already received
appropriate peer-review, the REB will not normally carry out any further scholarly review. Researchers
are expected to provide evidence of previous scholarly review in their proposal.
For some types of research, such as clinical trials, there is a regulatory requirement that the REB
evaluate the scientific aspects of the proposal. If it is evident that a proposal before the REB is in need
of scholarly review, TCPS 2 advocates:
 the establishment of an ad hoc independent peer review committee
or
 having members of the REB with the necessary expertise assume responsibility for the scholarly
review
REB Review: Common Errors
Before submitting your research proposal for REB review, consider the following common errors most
likely to result in requests for revisions and how to avoid them:
 Too Much Jargon
 Inconsistent or Missing Information
 Omission of Risks
 Failure to Identify Measures to Deal with Risk
 Misidentification of Benefits
 Misidentification of Deception
 Inadequate debriefing
 Failure to identify data security measures
REB Review: Communication
Put yourself in the place of an REB reviewer. Imagine taking on the responsibility to ensure any research
you recommend for approval respects the core principles of TCPS 2. Keeping in mind that the REB is
there to help your research meet the highest ethical standards, here are some tips for working with the
REB during the review of your proposal:
 Respond to any requests for clarification thoroughly
 If you are asked to make reasonable revisions to your study to conform to ethical standards -- do
them quickly and thoroughly so that you may keep your application on track to REB approval
 If you do not understand or disagree with a revision request, seek clarification from the reviewer
In the event of an unresolvable disagreement between yourself and the REB regarding the ethical
acceptability of your proposal, you may seek reconsideration, and if that fails, an appeal. Carefully
examine the substance of your argument and whether it is supported by TCPS 2 and/or institutional
policy.
Continuing Review
Once your proposal has received REB approval, your relationship with the REB is not over. In addition to
initial review, the REB is obligated to provide continuing review of all research they approve. Normally,
the level of continuing review will be determined by the REB at the time of initial review depending upon
the level of risk the study poses to participants.
Click on the links below to learn more about the researcher responsibilities for each component of
continuing review:
 Annual status report
 End of study Report
 Requests for change
 Unanticipated issue reports

Additional continuing review
Continuing Review: Annual Status Report
Initial REB approval is valid for up to one year from the date of approval. If your study is expected to take
more than one year, you must submit an annual status report to the REB to be reviewed for continuation
of your REB approval.
Annual status reports may receive full-board or delegated review depending upon the level of continuing
review required by the REB at the time of initial review (or as adjusted since). Annual reports should have
enough information to allow REB reviewers to determine whether the research may continue. You may
use your annual report to propose minor changes to the research design or study materials (e.g. adding a
question item, changing contact information, adding a new member of the research team). For more
significant changes, follow your REB’s request for change procedure.
Reviewers may recommend or deny the renewal of research ethics approval depending on their
assessment of its continued ethical acceptability.
Continuing Review: End of Study Report
If your study is completed within one year, your end of study report will also be your 'annual status report'.
For studies that exceed a year in duration, end of study reports are submitted in addition to annual status
reports.
End of study reports are necessary to allow REBs to close the file on completed research and maintain
accurate records of research they have approved. These reports should include a summary of the
findings of the research if possible, and indicate how participants may gain access to the results of the
study.
For some studies, the end date is difficult to determine (e.g. longitudinal studies). In these situations
researchers should work with their REB to determine an end date and an appropriate level of continuing
review.
Continuing Review: Requests for Change
In the course of conducting research, you may discover that you need to make changes to your original
research design. Very minor changes, such as changing contact information in the consent procedure
can be implemented as needed and reported in your annual status report. More significant changes like
adding a new task, testing a different age group, or substantial changes to questionnaires or stimuli
require a formal 'request for change' (also known as an amendment) to your REB.
Requests for Change can be submitted at any point during the conduct of your research. Depending on
the level of continuing review assigned at the time of initial review (or since), the request for change may
receive full-board or delegated review. Researchers are expected to provide an account of how the
requested change may affect foreseeable risks and potential benefits and include copies of study
materials that will need to reflect the requested change (e.g. recruitment, consent, and/or debriefing
materials, instructions, etc.).
When a request for change would result in research that is substantially different from the proposal
originally approved by the REBs, reviewers may recommend that it be considered a new study, requiring
its own application for initial REB review. Carrying over REB approval to what is essentially a new study
may lead to insufficient scrutiny of foreseeable risks to participants, jeopardizing their welfare as well as
the integrity of the researcher, the REB and the institution.
Continuing Review: Unanticipated Issues
When something happens in your research that may affect the welfare and safety of participants or has
other ethical implications you must report it to the REB. Examples of unanticipated issues include
unforeseen side effects of a medication or natural health product, unintended stimulation of traumatic
memories, or a breakdown in the partnership between a research team and a community. Single
incidents that are unlikely to re-occur such as the inadvertent sharing of participant data also need to
reported.
Some unanticipated issues may not be directly related to the research itself, but they must still be
reported so that the REB can independently make that assessment. Depending on the nature of the issue
REBs may require that you adjust your research procedures to prevent its recurrence.
Any unanticipated issue that increases the level of risk to participants or has other ethical implications
should be reported to the REBwithout delay. Changes that are necessary to eliminate an immediate
risk(s) to the participants may be implemented as needed, but must be reported to the REB at the earliest
opportunity.
Continuing Review: Additional
When the foreseeable risks are high, or when there other ethical implications of the research that warrant
a higher level of scrutiny, REBs can require more frequent reports on the conduct of the research after it
has been approved. The REB can also require one or more site visits to observe the conduct of the
study and to review the study materials in use at the research site.
Reconsideration & Appeals
In most cases, REBs and researchers can resolve ethical issues in research design so that the research
can proceed with REB approval. If one of your research proposals does not receive ethics approval or
you find the revisions requested by the REB compromise the feasibility or integrity of your research, you
can ask the REB to reconsider the proposal and their decision.
It is up to you to justify your request for reconsideration by identifying specific problems with the REB
review process, or any inconsistency between the REB decision and TCPS 2.
The REB is expected to have policies and procedures in place to deal with requests for reconsideration
fairly and promptly. If the reconsideration process does not result in REB approval for the proposal, you
may seek a formal appeal. Click on the links below to learn more:
 The appeal mechanism
 Authority of the appeal committee
 The appeal process
The Appeal Mechanism
Institutions are expected to have written policies to guide the establishment of an appeal process as
needed by researchers who wish to appeal an REB decision. The policies should make clear that the
appeal process can only be invoked once the reconsideration process has been completed and the REB
has issued its final decision on the ethical acceptability of the research proposal.
Your institution may have one or more of the following appeal mechanisms in place:
 a permanent appeal committee that is activated as needed
 an ad hoc appeal committee that is formed as needed and exists only for the duration of an
appeal
 an agreement to bring appeals to the REB of another institution
 an appeal committee that is shared with one or more institutions
In any case, the appeal committee must have a membership that reflects the range of knowledge and
expertise of the standing REB. Members of the REB whose decision is being appealed may not serve on
the appeal committee.
Authority of the Appeal Committee
The purpose of an appeal committee is to review negative decisions made by an REB. The institution
must empower the appeal committee to approve, reject, or require modifications to the research proposal
in question. Its decision on behalf of the institution is final. If the appeal committee rules in favour of the
researcher, then the REB must treat the proposal like any other they have approved themselves.
When an appeal committee upholds the decision of the REB to reject a proposal as ethically
unacceptable, researchers may still have recourse to judicial review.
The Appeal Process
You can launch an appeal for procedural or substantive reasons. As in the reconsideration process, it is
up to you to justify your request for an appeal by identifying any problems with the REB review process or
any elements of the REB decision that are inconsistent with TCPS 2.
You and a representative of the REB must have an opportunity to speak before the appeal committee.
Neither of you may be in the room during the appeal committee’s discussion and decision- making.
The decision of the appeal committee must be communicated in writing to the researcher(s) and REB. At
all times, the people involved in the appeal process are expected to treat each other with respect and
work towards a resolution whenever possible.
Research in Publicly Declared Emergencies
When an emergency situation presents extraordinary risks to the general public, an authorized public
official (e.g. mayor, premier, prime minister) may declare it a public emergency. The SARS crisis is one
example of a publicly declared emergency. Civil disorder, environmental disasters, and releases of biohazards may also trigger the declaration of a public emergency.
An official declaration gives special responsibilities and powers to authorities to help them deal with the
emergency (e.g. the regulation or prohibition of travel, the establishment of emergency shelters, orders of
evacuation or quarantine). The exercise of these powers is limited in time and extent by law at the
municipal, provincial, territorial and federal level.
It has been widely recognized in the wake of recent crises that institutions need to plan for the review and
conduct of research in the context of a publicly declared emergency. REBs are expected to uphold the
core principles of TCPS 2 with the support of their institution. Researchers are expected to maintain the
highest ethical standards in any research that must be reviewed and conducted during a publicly declared
emergency.
Preparedness Plans
TCPS 2 recommends that REBs work with researchers and institutions to develop a comprehensive
preparedness plan for the review and conduct of research during a publicly declared emergency. The
plan should anticipate the pressures, constraints, priorities and challenges to the quality and timeliness of
REB initial and continuing review of research.
Some researchers may expect the REB to lower the usual level of scrutiny of research proposals under
emergency conditions. However, it is even more important that REBs maintain their commitment to
proportionate review at these times than under normal circumstances.
As a researcher, it is important that you take even greater care to ensure any proposal to conduct
research associated with the emergency is consistent with the core principles of TCPS 2. Keep in mind
that you as a researcher, and your participants may be in vulnerable circumstances due to the
emergency.
Emergency REB Policies & Procedures
Once a public emergency has been declared, the provisions of the emergency preparedness plan for
REB review come into effect. As soon as the emergency is declared over, normal operating procedures
must be re-instated.
Researchers may find that the REB has to make adjustments to its basic operations such as changing
their meeting schedule, making alternate arrangements for receiving research proposals and
communicating with researchers. If your proposal is not time-sensitive or essential (with respect to the
emergency) it may not be reviewed until after the emergency is over.
If your research can only be conducted during the emergency or is urgent in any other way, it is up to you
to make the case for priority review to your REB.
Limiting Requests for Exceptions
During times of emergency, REBs should carefully consider any requests for exceptions to the principles
and procedures of TCPS 2. The purpose of the REB is to preserve respect for the core principles of this
Policy: Respect for Persons, Concern for Welfare, and Justice under any circumstances.
Any exception to research ethics principles and/or REB procedures must be demonstrably justified by the
researcher. If there is justification for an exception, the researcher must work with the REB to ensure that
it presents the narrowest application and least intrusive means necessary in order to preserve maximum
respect for human rights and ethical principles - particularly in light of theincreased vulnerability of
people in emergency circumstances.
One way that researchers can plan ahead for anticipated requests for exceptions to TCPS 2 principles
under emergency conditions is to develop a pre-planned emergency research proposal and have it
reviewed by the REB before an emergency occurs. This allows the priority of the research, the anticipated
emergency conditions, and the welfare of participants to be considered carefully and without the pressure
of an actual emergency.
Summary
 REBs are mandated by the Federal Government through the three major research funding
agencies to uphold the ethical principles outlined in TCPS 2.
 REB review involves a proportionate approach in which the foreseeable risks to participants are
weighed against the potential benefits.
 Researchers and REBs are expected to work together to ensure that the design and conduct of
all approved research is of the highest ethical standard.