A Biocultural Ethics Approach 65
Dignity, requiring that research involving humans be conducted in a way that
is sensitive to the inherent worth of all human beings and gives every person
due respect and consideration (Canadian Institutes for Health (CIHR) et al.,
2018, p. 7). Respect for Human Dignity is expressed through three complementary and interdependent core principles, including Respect for Persons, Concern for
Welfare and Justice, described as follows:
Respect for Persons – recognizes the intrinsic value of human beings and offers
the respect and consideration they are due. It incorporates dual moral obligations to respect autonomy and to protect those with developing, impaired
or diminished autonomy. An important mechanism for respecting participants’ autonomy in research is the requirement to seek their “free, informed
and ongoing consent”, described in more detail subsequently ( Canadian
Institutes for Health (CIHR) et al., 2018, p. 7).
Concern for Welfare – refers to concern about the quality of a person’s experience of life in all its aspects, including the impact of factors such as physical,
mental and spiritual health, as well as physical, economic and social circumstances. It involves preventing or minimizing potential harms and finding an
acceptable balance of risks and benefits involved in participation (Canadian
Institutes for Health (CIHR) et al., 2018, pp. 7–8).
Justice – refers to the obligation to treat people fairly and equitably. Fairness
entails treating all people with equal respect and concern. Equity requires
distributing the benefits and burdens of research participation in such a
way that no segment of the population is unduly burdened by the harms of
research or denied the benefits of the knowledge generated from it (Canadian
Institutes for Health (CIHR) et al., 2018, p. 8).
TCPS2 and The Consent Process
TCPS2 (Canadian Institutes for Health (CIHR) et al., 2018, pp. 27–48, Chapter
3) includes a 21-page chapter devoted to “The Consent Process” that applies to
all research involving humans (not just research involving Indigenous peoples),
and is based on the underlying principle of Respect for Persons, interpreted as
respect for an individual’s agreement or refusal to participate. TCPS2 Chapter 3
(Canadian Institutes for Health (CIHR) et al., 2018, pp. 27, 35) avoids FPIC as a
term and instead describes consent as “free, informed and ongoing”, noting that
“free” and “voluntary” are used interchangeably. The consent of participants is
required “prior” to engaging in research, except under certain circumstances
(Canadian Institutes for Health (CIHR) et al., 2018, pp. 27, 35) but the word
“prior” is not directly linked with “free, informed and ongoing”. The guidance
on consent gives substantial detail about the expectations inherent in the three
elements of voluntary, informed and ongoing as follows:
Voluntary – TCPS2, Article 3.1 (Canadian Institutes for Health (CIHR)
et al., 2018, p. 28) requires that consent be given freely or voluntarily and be able to
Dignity, requiring that research involving humans be conducted in a way that
is sensitive to the inherent worth of all human beings and gives every person
due respect and consideration (Canadian Institutes for Health (CIHR) et al.,
2018, p. 7). Respect for Human Dignity is expressed through three complementary and interdependent core principles, including Respect for Persons, Concern for
Welfare and Justice, described as follows:
Respect for Persons – recognizes the intrinsic value of human beings and offers
the respect and consideration they are due. It incorporates dual moral obligations to respect autonomy and to protect those with developing, impaired
or diminished autonomy. An important mechanism for respecting participants’ autonomy in research is the requirement to seek their “free, informed
and ongoing consent”, described in more detail subsequently ( Canadian
Institutes for Health (CIHR) et al., 2018, p. 7).
Concern for Welfare – refers to concern about the quality of a person’s experience of life in all its aspects, including the impact of factors such as physical,
mental and spiritual health, as well as physical, economic and social circumstances. It involves preventing or minimizing potential harms and finding an
acceptable balance of risks and benefits involved in participation (Canadian
Institutes for Health (CIHR) et al., 2018, pp. 7–8).
Justice – refers to the obligation to treat people fairly and equitably. Fairness
entails treating all people with equal respect and concern. Equity requires
distributing the benefits and burdens of research participation in such a
way that no segment of the population is unduly burdened by the harms of
research or denied the benefits of the knowledge generated from it (Canadian
Institutes for Health (CIHR) et al., 2018, p. 8).
TCPS2 and The Consent Process
TCPS2 (Canadian Institutes for Health (CIHR) et al., 2018, pp. 27–48, Chapter
3) includes a 21-page chapter devoted to “The Consent Process” that applies to
all research involving humans (not just research involving Indigenous peoples),
and is based on the underlying principle of Respect for Persons, interpreted as
respect for an individual’s agreement or refusal to participate. TCPS2 Chapter 3
(Canadian Institutes for Health (CIHR) et al., 2018, pp. 27, 35) avoids FPIC as a
term and instead describes consent as “free, informed and ongoing”, noting that
“free” and “voluntary” are used interchangeably. The consent of participants is
required “prior” to engaging in research, except under certain circumstances
(Canadian Institutes for Health (CIHR) et al., 2018, pp. 27, 35) but the word
“prior” is not directly linked with “free, informed and ongoing”. The guidance
on consent gives substantial detail about the expectations inherent in the three
elements of voluntary, informed and ongoing as follows:
Voluntary – TCPS2, Article 3.1 (Canadian Institutes for Health (CIHR)
et al., 2018, p. 28) requires that consent be given freely or voluntarily and be able to