Module A1 - Introduction
Abstract
In Canada, the main guidance document for the ethics of
research involving human participants is the Tri-Council
Policy Statement:
Ethical Conduct for Research Involving Humans – TCPS 2
(2018). It applies to all research involving humans,
conducted in Canada or abroad, by researchers working under
the auspices of one or more institution(s) eligible for
funding by federal agencies: i.e., the Canadian Institutes
of Health Research (CIHR), the Natural Sciences and
Engineering Research Council of Canada (NSERC), and/or the
Social Sciences and Humanities Research Council (SSHRC).
Respect for human dignity
Research is meant to enhance our understanding of the
world. It is therefore essential to the advancement of
society. Because research explores the unknown, it
generally carries some risk. For research involving humans
to be ethical, it is necessary that human participants in
research understand those risks and freely choose to
participate in the research. More broadly, the ethical
conduct of research requires that human participants be
treated with dignity, from the recruitment process to the
sharing and dissemination of research results. Respect for
human dignity is the fundamental value that lies at the
heart of the TCPS 2. It is expressed concretely through
three core principles.
The core principles
In the TCPS 2, three complementary core principles serve as
the guide to ethical research involving human participants:
Respect for Persons
Concern for Welfare
Justice
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Respect for Persons
Respect for Persons means 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
Participation in research can have an impact on the welfare
of a person or a group to which that person
belongs. Concern for Welfare means 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.
When designing and reviewing proposed research, researchers
and research ethics boards (REBs) must consider the
principle of Concern for Welfare from the perspective of a
potential participant. 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.
For more details on: risks in research – see Module A3; the
concept of vulnerability in research – see Module A5.
Justice
Justice refers to a dual obligation to treat persons as
well as groups and communities: 1) fairly and 2) equitably.
Treating persons fairly implies according them equal
respect, but not necessarily treating everyone in the same
way. Sometimes it is the failure to take differences into
account that can create or reinforce inequities. In those
circumstances, differences in treatment may be justified.
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Treating persons equitably implies a fair distribution of
the burdens and the potential benefits of the research.
When designing or assessing the ethics of a proposed study,
the core principle of Justice requires researchers and REBs
to consider participant selection criteria (i.e., exclusion
and inclusion criteria).
Some questions that merit consideration include:
Why choose this group of prospective participants, and
not a broader or a narrower one?
Is there a sound rationale for who is included in and
excluded from participation in the research?
Who will be exposed to the risks, and who will
experience the possible benefits?
For more details on fairness, equity, and appropriate
selection in research – see Module A5.
Justice also requires that researchers and REBs consider
the imbalance of power that may exist between participants
and researchers. Researchers may have or be perceived to
have authority over participants. This imbalance of power
can undermine the autonomy of participants and negatively
affect their welfare. Therefore, ensuring Justice is a
means of supporting the other core principles.
Like Respect for Persons and Concern for Welfare, the core
principle of Justice underscores the need to view proposed
research from the perspective of participants.
Balancing ethics and law
Researchers are expected to be aware of and to respect the
laws and regulations in their jurisdiction as they relate
to research involving humans. This includes not only
federal and provincial or territorial laws and regulations,
but also those that may apply in the countries or regions
where the research is being conducted, if outside of
Canada.
In general, compliance with both ethics guidance and the
law does not pose a problem. Researchers may face
situations, however, where there are discrepancies between
the requirements of the law and the recommendations arising
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from the ethics principles included in the TCPS 2. For
example, a legal obligation for certain professionals to
report a communicable disease to the competent health
authority may conflict with a researcher’s ethical duty of
confidentiality, which is a condition of a participant’s
consent to take part in research.
Where researchers face a conflict between legal obligations
and ethics considerations, they will have to think
carefully about how to resolve the conflict prior to
recruiting participants. For instance, they should ask
themselves: Can such conflicts be anticipated and can the
research be designed to avoid them? To help resolve any
conflicts that arise or are anticipated between legal
obligations and ethics considerations, researchers should
consult with colleagues, their REBs, or any relevant
professional body, and if necessary, they should seek
independent legal advice.
Practical guidance
Q. Who is responsible for the TCPS 2?
The Social Sciences and Humanities Research Council
(SSHRC), the Natural Sciences and Engineering Research
Council of Canada (NSERC); and the Canadian Institutes of
Health Research (CIHR) (the Agencies) - Canada’s three main
research funding agencies - developed the TCPS in 1998 in
order to have a single source of guidance for research
ethics. Based on shared principles, the guidance is
intended to be flexible enough to apply to the different
approaches and practices of all research disciplines. In
2001, they jointly established two bodies responsible for
the TCPS.
The Secretariat on Responsible Conduct of Research
(SRCR) drafts, revises, interprets, and helps to implement
the TCPS. It responds to questions from researchers and
REBs about how to interpret and apply the TCPS. It
identifies emerging ethics issues and proposes changes to
the TCPS to keep it current. It conducts consultations with
the research community to ensure the relevance and accuracy
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of TCPS guidance. SRCR supports and collaborates with the
Panel on Research Ethics.
The Panel on Research Ethics (PRE) provides expert,
independent advice and strategic guidance on the content of
the TCPS. It considers novel ethics questions or issues,
and reviews the guidance or interpretations proposed by
SRCR. PRE consists of 12 independent members reflecting a
broad range of expertise and research experience. They are
appointed by the Presidents of the Agencies. PRE serves as
an advisory body to the Agencies on research ethics issues.
Q. Who has to follow the TCPS 2?
Anyone who conducts research under the auspices of an
eligible institution must comply with the TCPS 2. This is
true regardless of the source of the research funding,
including self-funded or non-funded research. It also
applies regardless of where the research is conducted.
An eligible institution is one that has entered into an
agreement with the Agencies: the Agreement on the
Administration of Agency Grants and Awards by Research
Institutions. By signing the Agreement, institutions have
committed, among other undertakings, to complying with all
Agency policies, including the TCPS 2. Fulfilling the terms
of the Agreement makes an institution eligible to receive
and administer Agency funds. In general, universities,
colleges and affiliated hospitals as well as research
institutes/centres in Canada are eligible institutions.
Some organizations that are not eligible institutions have
nevertheless adopted the TCPS 2 voluntarily.
Accountability for compliance with the TCPS 2
The Tri-Agency Framework: Responsible Conduct of Research
(RCR Framework) describes the responsibilities of
researchers, institutions and the Agencies themselves in
maintaining appropriate standards of responsible conduct of
research. Responsible conduct of research is a broad term
that encompasses the integrity and accountability of
researchers, in their professional relations with
colleagues, funders, research participants, as well as the
public. One of the key aims of responsible conduct of
research is to ensure the validity and accuracy of the
research record.
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Compliance with Agency policies, including the TCPS 2, is
one of the requirements of the RCR Framework. Researchers
who fail to comply with the TCPS 2, whether intentionally
or not, are therefore in breach of the RCR Framework. The
Agencies have the authority to exercise the recourses set
out in the RCR Framework. Depending on the severity and
impact of the breach, these range from a letter of
awareness, to ineligibility to apply for or to hold Agency
funding for a period of time (or permanently, in the most
serious matters). Any recourse by the Agencies would be in
addition to any disciplinary action taken by the
researcher’s institution. The RCR Framework also sets out
how institutions must respond to allegations of breach of
RCR responsibilities by researchers. The RCR Framework
takes effect from the moment a researcher applies for
funding and continues through the conduct of research to
the dissemination of results.
Summary
TCPS 2 provides guidance for the ethical conduct of
research involving human participants.
It is based on respect for human dignity, which is
expressed through three core principles:
Respect for Persons;
Concern for Welfare;
Justice.
For researchers in Canada, 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:
Who carries out the research;
What the source of funding is, if any; and
Where the research is conducted.
Researchers should anticipate, and must attempt to
resolve, any conflicts that arise between ethics
considerations and legal obligations.
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Failure to comply with the TCPS 2 may result in a
recourse taken by the researcher’s institution, and by
the Agencies.
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