Week 3 Tri-Council Policy Statement: Ethical
Conduct for Research Involving Humans
(TCPS 2) Questions and Answers
What is the participant perspective? < ANSWER >Circumstances of the people they will be
approaching to become participants
What are some questions to ask about the participants of the project? < ANSWER >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?
What are the 3 federal research agencies responsible for TCPS 2? < ANSWER >The Canadian
Institutes of Health Research (CIHR); the Natural Sciences and Engineering Research Council
(NSERC); and the Social Sciences and Humanities Research Council (SSHRC)
What is the respect for persons principle? < ANSWER >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? < ANSWER >Consider participant autonomy
in research design
Consider factors that can diminish participant autonomy
Consider how to respect the dignity of those lacking autonomy
What aspects of welfare should researchers consider? < ANSWER >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 concert for welfare? < ANSWER >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
What is fairness? < ANSWER >treating all people with equal respect and concern for their
welfare < ANSWER >it does not necessarily mean treating everyone the same
What is equity? < ANSWER >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? < ANSWER >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?
What has the Stanford Prison Experiment taught us? < ANSWER >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.
Canadian researchers are responsible for making sure that their work adheres to the guidnce
provded in TCPS2, this means? < ANSWER >Pursuing research interests without also
considering the implications of the research for participants is unethical.
The Texas Vampires incident captures a number of practices that could easily be labeled
unethical. For example, as a way to increase the sample size for the study, individuals were told
that not participating in the research could put them in danger of sudden death. Which core
principle was violated most by this behaviour? < ANSWER >Respect for persons, The use of
undue pressure in terms of rewards or scare tactics makes voluntary and informed consent
improbable if not impossible.
Consent without coercion is a cornerstone of the principle of Respect for Persons.
The purpose of the Stanford prison experiment was to understand the development of norms and
the effects of roles, labels, and social expectations in a simulated prison environment. The
simulation became so real, and the guards became so abusive, that half the prisoners were
released early due to severe emotional or cognitive reactions.
, What ethical principle could be used to make the strongest case for shutting down the study after
only 6 days rather than the planned two weeks? < ANSWER >In the researcher's words, "After
observing our simulated prison for only six days, we could understand how prisons dehumanize
people, turning them into objects and instilling in them feelings of hopelessness". In essence the
simulated Stanford prison study had done this to its volunteers. Concern for Welfare was the
primary reason for terminating the prison experiment.
How can a quality assurance project be research? < ANSWER >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
When does creative practice require REB review? < ANSWER >When it involves human
participants
What is research involving humans? < ANSWER >Involves living human participants, involve
human biological materials
When is REB review NOT required? < ANSWER >Publicly available information: legally
accessible and protected by law or publicly accessible and free of reasonable expectations of
privacy
What is observational research? < ANSWER >Studying human behaviour under natural
circumstances
When will observational research not require REB review? < ANSWER >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 dis
What is the secondary use of data or biological materials? < ANSWER >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
When will the secondary use of data not require REB review? < ANSWER >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
How does TCPS 2 define research? < ANSWER >An undertaking intended to extend knowledge
through a disciplined inquiry or systematic investigation
Why would a study on the impact of discrimination and bullying on adolescent Metis attitudes
and behaviours require a submission for REB review? < ANSWER >Doing research with
Aboriginal populations demands attention to cultural norms in every aspect of the research (see
TCPS 2 Chapter 9). For example, although TCPS 2 promotes a decision-making capacity-based
Conduct for Research Involving Humans
(TCPS 2) Questions and Answers
What is the participant perspective? < ANSWER >Circumstances of the people they will be
approaching to become participants
What are some questions to ask about the participants of the project? < ANSWER >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?
What are the 3 federal research agencies responsible for TCPS 2? < ANSWER >The Canadian
Institutes of Health Research (CIHR); the Natural Sciences and Engineering Research Council
(NSERC); and the Social Sciences and Humanities Research Council (SSHRC)
What is the respect for persons principle? < ANSWER >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? < ANSWER >Consider participant autonomy
in research design
Consider factors that can diminish participant autonomy
Consider how to respect the dignity of those lacking autonomy
What aspects of welfare should researchers consider? < ANSWER >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 concert for welfare? < ANSWER >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
What is fairness? < ANSWER >treating all people with equal respect and concern for their
welfare < ANSWER >it does not necessarily mean treating everyone the same
What is equity? < ANSWER >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? < ANSWER >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?
What has the Stanford Prison Experiment taught us? < ANSWER >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.
Canadian researchers are responsible for making sure that their work adheres to the guidnce
provded in TCPS2, this means? < ANSWER >Pursuing research interests without also
considering the implications of the research for participants is unethical.
The Texas Vampires incident captures a number of practices that could easily be labeled
unethical. For example, as a way to increase the sample size for the study, individuals were told
that not participating in the research could put them in danger of sudden death. Which core
principle was violated most by this behaviour? < ANSWER >Respect for persons, The use of
undue pressure in terms of rewards or scare tactics makes voluntary and informed consent
improbable if not impossible.
Consent without coercion is a cornerstone of the principle of Respect for Persons.
The purpose of the Stanford prison experiment was to understand the development of norms and
the effects of roles, labels, and social expectations in a simulated prison environment. The
simulation became so real, and the guards became so abusive, that half the prisoners were
released early due to severe emotional or cognitive reactions.
, What ethical principle could be used to make the strongest case for shutting down the study after
only 6 days rather than the planned two weeks? < ANSWER >In the researcher's words, "After
observing our simulated prison for only six days, we could understand how prisons dehumanize
people, turning them into objects and instilling in them feelings of hopelessness". In essence the
simulated Stanford prison study had done this to its volunteers. Concern for Welfare was the
primary reason for terminating the prison experiment.
How can a quality assurance project be research? < ANSWER >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
When does creative practice require REB review? < ANSWER >When it involves human
participants
What is research involving humans? < ANSWER >Involves living human participants, involve
human biological materials
When is REB review NOT required? < ANSWER >Publicly available information: legally
accessible and protected by law or publicly accessible and free of reasonable expectations of
privacy
What is observational research? < ANSWER >Studying human behaviour under natural
circumstances
When will observational research not require REB review? < ANSWER >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 dis
What is the secondary use of data or biological materials? < ANSWER >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
When will the secondary use of data not require REB review? < ANSWER >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
How does TCPS 2 define research? < ANSWER >An undertaking intended to extend knowledge
through a disciplined inquiry or systematic investigation
Why would a study on the impact of discrimination and bullying on adolescent Metis attitudes
and behaviours require a submission for REB review? < ANSWER >Doing research with
Aboriginal populations demands attention to cultural norms in every aspect of the research (see
TCPS 2 Chapter 9). For example, although TCPS 2 promotes a decision-making capacity-based
