In the TCPS 2, three complementary core principles serve as the guide to ethical research
involving human participants: correct answers Respect for Persons
Concern for Welfare
Justice
Respect for Persons correct answers recognizing the intrinsic value of each individual and their
autonomy.
In the context of research, it means recognizing that participants should only subject themselves
to the risks of participation in research as a matter of choice, based on the information they need
or request to understand those risks, as well as the purpose and potential benefits of the research.
It means respecting their values and their choices to decide whether to participate, or to continue
to participate, in research.
It also means putting in place additional measures to protect those who lack the capacity to make
their own decisions.
Concern for welfare correct answers avoiding exposing participants to unnecessary risks. This
requires consideration of the physical, mental, and spiritual health of participants, as well as their
physical, economic and social circumstances.
To achieve the most favourable balance of foreseeable risks and potential benefits, researchers
and REBs must understand the impact of those risks on a person in the prospective participant's
circumstances, and on the group to which they belong
Justice correct answers dual obligation to treat persons as well as groups and communities:
1) fairly and
2) equitably.
TCPS 2 provides guidance for correct answers the ethical conduct of research involving human
participants.
For researchers in Canada correct answers compliance with the TCPS 2 is a condition of Agency
funding and a requirement for all research conducted under the auspices of an eligible institution
Where the TCPS 2 applies, it does regardless of correct answers Who carries out the research;
What the source of funding is, if any; and
Where the research is conducted.
TCPS 2 defines research as correct answers an undertaking intended to extend knowledge
through a disciplined inquiry and/or systematic investigation
disciplined inquiry correct answers inquiry that is conducted with the expectation that the
method, results, and conclusions will be able to withstand the scrutiny of the relevant research
community
, Human participants correct answers those individuals whose data, biological materials, or
responses to interventions, stimuli or questions by the researcher, are relevant to answering the
research question(s)
Research involving human participants, as defined in the TCPS 2, requires correct answers
review and approval by a REB.
The TCPS 2 definition of human participant includes correct answers human biological materials
from living and deceased individuals
what does not require REB review correct answers Activities that use techniques or methods
similar to those used in research, but do not have a research purpose do not require REB review
because they do not fall within the TCPS 2 definition of research.
For research to be ethical correct answers the potential benefits of the research should outweigh
the foreseeable risks to participants.
REBs should assess the risks by correct answers considering only those risks that are attributable
to the research. When assessing the potential benefits, they should consider only those for
participants, their community, and society.
how to determine the appropriate level of ethics review that is required correct answers REBs
should distinguish between minimal risk research and research that is greater than minimal risk
in order
Researchers have a duty to correct answers avoid, minimize, or eliminate unnecessary research-
attributable risks.
Minimal risk research correct answers research in which the probability and magnitude of
possible harms implied by participation in the research are no greater than those encountered by
participants in those aspects of their everyday life that relate to the research.
incidental finding correct answers a discovery about research participants or prospective
participants that is made in the course of research, but is outside the objectives of the research
study
what is Consent correct answers fundamental process for respecting individual autonomy. It
must be voluntary, informed, and ongoing.
consent must precede correct answers collection of, or access to, research data or biological
materials.
Consent documentation correct answers Researchers must document the process by which
individuals have consented to participate in the research.