66 Kelly Bannister
withdraw at any time. In withdrawing consent, the participant can also request
his or her data be withdrawn, to the extent possible, given the methods of data
collection and storage that were used (e.g. individual data may be impossible
to identify if anonymity was used or if information was collected from a group
without attribution to individuals). The consent process is required to make clear
at the onset whether or not withdrawal of data is possible and individuals “should
not suffer any disadvantage or reprisal for withdrawing” (Canadian Institutes for
Health (CIHR) et al., 2018, p. 29). Participants should also be made aware that
“it is impracticable, if not impossible, to withdraw results once they have been
published or otherwise disseminated” (Canadian Institutes for Health (CIHR)
et al., 2018, p. 29).
Methods of participant recruitment are seen as “important elements in assuring
(or undermining) voluntariness” since “undue influence, coercion or the offer of
incentives may undermine the voluntariness of a participant’s consent” ( Canadian
Institutes for Health (CIHR) et al., 2018, p. 28). Undue influence and manipulation are seen as potentially arising in situations related to power relationships
and positions of authority where individuals “may feel constrained to follow the
wishes of those who have some form of control over them” and where “control may be physical, psychological, financial or professional”. Likewise, paying
attention to existing relationships of trust and dependency is advised as “any
relationship of dependency, even a nurturing one, may give rise to undue influence even if it is not applied overtly” (Canadian Institutes for Health (CIHR)
et al., 2018, p. 28).
Informed – TCPS2, Article 3.2 (Canadian Institutes for Health (CIHR)
et al., 2018, p. 30) requires “full disclosure of all information necessary for making an informed decision to participate” and offers a lengthy list of elements to
include in plain language, such as:
• Purpose, nature and expected duration of research activities, as well as the
identity and contact information of a qualified designated representative of
the research institution “who can explain scientific or scholarly aspects of
the research”;
• Assurance that there is no obligation to participate, that participants may
withdraw at any time without penalty or prejudice to pre-existing entitlements, and that information relevant to continuing or withdrawing will be
provided throughout the project;
• Identities of research proponents (individuals, institutions, partners) and
funders of the research;
• Responsibilities of all parties involved, including participants;
• What information will be collected from or about participants and for what
purposes;
• Anticipated uses of data;
• Who will have access to information collected and the identity of participants;
• How privacy and confidentiality will be protected;
withdraw at any time. In withdrawing consent, the participant can also request
his or her data be withdrawn, to the extent possible, given the methods of data
collection and storage that were used (e.g. individual data may be impossible
to identify if anonymity was used or if information was collected from a group
without attribution to individuals). The consent process is required to make clear
at the onset whether or not withdrawal of data is possible and individuals “should
not suffer any disadvantage or reprisal for withdrawing” (Canadian Institutes for
Health (CIHR) et al., 2018, p. 29). Participants should also be made aware that
“it is impracticable, if not impossible, to withdraw results once they have been
published or otherwise disseminated” (Canadian Institutes for Health (CIHR)
et al., 2018, p. 29).
Methods of participant recruitment are seen as “important elements in assuring
(or undermining) voluntariness” since “undue influence, coercion or the offer of
incentives may undermine the voluntariness of a participant’s consent” ( Canadian
Institutes for Health (CIHR) et al., 2018, p. 28). Undue influence and manipulation are seen as potentially arising in situations related to power relationships
and positions of authority where individuals “may feel constrained to follow the
wishes of those who have some form of control over them” and where “control may be physical, psychological, financial or professional”. Likewise, paying
attention to existing relationships of trust and dependency is advised as “any
relationship of dependency, even a nurturing one, may give rise to undue influence even if it is not applied overtly” (Canadian Institutes for Health (CIHR)
et al., 2018, p. 28).
Informed – TCPS2, Article 3.2 (Canadian Institutes for Health (CIHR)
et al., 2018, p. 30) requires “full disclosure of all information necessary for making an informed decision to participate” and offers a lengthy list of elements to
include in plain language, such as:
• Purpose, nature and expected duration of research activities, as well as the
identity and contact information of a qualified designated representative of
the research institution “who can explain scientific or scholarly aspects of
the research”;
• Assurance that there is no obligation to participate, that participants may
withdraw at any time without penalty or prejudice to pre-existing entitlements, and that information relevant to continuing or withdrawing will be
provided throughout the project;
• Identities of research proponents (individuals, institutions, partners) and
funders of the research;
• Responsibilities of all parties involved, including participants;
• What information will be collected from or about participants and for what
purposes;
• Anticipated uses of data;
• Who will have access to information collected and the identity of participants;
• How privacy and confidentiality will be protected;