Chapter 3: Ethical Research
Ethical Research In Canada
The Tri-Council and Its Policy Statement
• In Canada, researchers and institutions adhere to the Tri-Council Policy Statement:
Ethical Conduct for Research Involving Humans. “Tri-Council” is a common way to refer
to the three federally funded research granting agencies: the Canadian Institutes of
Health Research (CIHR), the Social Sciences and Humanities Research Council of Canada
(SSHRC), and the Natural Science and Engineering Research Council of Canada (NSERC).
• In 1998 the Tri-Council published the ﬁrst Tri-Council Policy Statement (TCPS), which
became the ﬁrst standard Canadian Ethics Code to guide all research involving humans,
and replacing all guidelines developed by some individual agencies as early as the
Historical, Legal, and International Context
• The Nuremberg Code, which was developed in response to horriﬁc human
experimentation during WWII, was a catalyst for modern international debate and
policies for respecting human dignity in medical and behavioural research.
Core Principles Guiding Research with Human Participants
• The aim of research ethics codes generally, including the TCPS, is to ensure that
research is conducted in a way that respects the dignity and inherent worth of all human
beings. Three basic ethical principles express the value of ensuring human dignity, and
are speciﬁed in the TCPS and other documents: respect of persons, concern for the
welfare, and justice.
- To show respect for persons, researchers must respect the autonomy of research
participants, and protect those who have “developing, impaired or diminished
autonomy.” Respecting autonomy means enabling people to choose participation freely
and without interference.
- To show concern for welfare, researchers must attempt to minimize risks associated
with participating in research, while maximizing the beneﬁts of that research to
individual participants and to society.
- To show justice, researchers must treat people fairly and equitably by distributing the
beneﬁts and burdens of participating in research.
Designing Research To Uphold The Core Principles
Promote Concern for Welfare by Minimizing Risks and Maximizing Beneﬁts
The principle of concern for welfare refers to the need for research to maximize
beneﬁts and minimizing any possible harmful effects of participation.
• In decisions about the ethics of research, we must calculate potential risks and beneﬁts
that are likely to result; this is called a risk-beneﬁts analysis.
Risk of Physical Harm: Some procedures could conceivably cause some physical harm
to participants. For example, researchers have administered alcohol to investigate the
effects of intoxication on decision making, and have deprived people of sleep during
different sleep phases to investigate the effects of attention. The risks in such
procedures require that great care be taken to make them ethically acceptable. • Rick of Stress: Participants may experience psychological stress during research. For
example, participants might be told that they will deliver a speech in front of an
evaluative audience, receive a few minutes to prepare the speech, and go on to deliver
• Risk of Losing Privacy and Conﬁdentiality: Another risk is the loss of expected privacy
Promote Respect for Persons Through Informed Consent
• The TCPS principle of respect for persons states that participants are treated as
autonomous; they are capable of making deliberate decisions about whether to
participate in research.
• The key way to apply this principle is informed consent: potential participants in a
research project should be provided with all information that might inﬂuence their
decision about whether to participate.
Informed Consent Form: Potential participants are usually provided with some type of
informed consent form that contains the information they need to make their decision.
The content will typically cover:
1) The purpose of the research
2) Procedures that will be used, including time involved
3) Risks and beneﬁts to the participants and in general
4) Any compensation
5) How conﬁdentially will be protected
6) Assurance of voluntary participation and permission to withdraw
7) Contact information for questions about the research and about the ethics of
• Researchers do not need to tell participants exactly what is being studied, but the
consent form must include all information that could affect a participant’s choice to
• Autonomy Issue: informed consent seems simple enough; how