A Biocultural Ethics Approach 67
• Measures for disseminating results and whether participants will be identified directly or indirectly;
• All reasonably foreseeable risks and potential benefits that may arise from
participation;
• Any possibility of findings being commercialized;
• Any real, potential or perceived conflicts of interest on the part of the
researchers, their institutions or the research sponsors;
• Information about any payments, including incentives for participants,
reimbursement for participation-related expenses and compensation for
injury;
• A statement that, by consenting, participants have not waived any rights to
legal recourse in the event of research-related harm; and
• The identity and contact information of an appropriate arms-length
individual who may be contacted regarding ethical issues arising (e.g.
ombudsperson).
TCPS2 requires that language not be a barrier to the consent process, which
may require “an intermediary who has the necessary language skills to ensure
effective communication” (Canadian Institutes for Health (CIHR) et al., 2018,
p. 31).
7
Adequate time and opportunity are required for this initial phase of the
consent process to ensure mutual understanding, which will depend on many
factors, such as complexity of information and likelihood of harms.
Ongoing – TCPS2, Article 3.3 (Canadian Institutes for Health (CIHR)
et al., 2018, p. 33) speaks to the ongoing nature of consent as encompassing a
process that begins with initial contact and carries through to the end of the
participants’ involvement in a project. It involves “an ongoing duty” to provide
participants with all information relevant to their ongoing consent to participate.
It highlights the researcher’s “ongoing ethical and legal obligation to bring to
participants’ attention any changes to the research project that may affect them”,
including “changes to the risks or potential benefits of the research” to give participants “the opportunity to reconsider the basis for their consent in light of the
new information”.
TCPS2 (Canadian Institutes for Health (CIHR) et al., 2018, p. 47) also
requires that consent be documented, noting that “written consent in a signed
statement from the participant is a common means of demonstrating consent, and
in some instances, is mandatory” but there are many other ethically acceptable
means of providing consent. These might include oral consent or other verbal
agreements, intentional physical gestures such as a handshake, or exchange of
gifts, which can symbolize “the establishment of a relationship comparable to
consent”. These alternative processes for demonstrating consent are intended for
circumstances where there are valid reasons for not documenting consent in
writing (e.g. in a signed consent form), not as options for convenience of the
proponents of research. The procedures that are used to seek consent must be
documented, and it is recommended that a “written statement of the information
• Measures for disseminating results and whether participants will be identified directly or indirectly;
• All reasonably foreseeable risks and potential benefits that may arise from
participation;
• Any possibility of findings being commercialized;
• Any real, potential or perceived conflicts of interest on the part of the
researchers, their institutions or the research sponsors;
• Information about any payments, including incentives for participants,
reimbursement for participation-related expenses and compensation for
injury;
• A statement that, by consenting, participants have not waived any rights to
legal recourse in the event of research-related harm; and
• The identity and contact information of an appropriate arms-length
individual who may be contacted regarding ethical issues arising (e.g.
ombudsperson).
TCPS2 requires that language not be a barrier to the consent process, which
may require “an intermediary who has the necessary language skills to ensure
effective communication” (Canadian Institutes for Health (CIHR) et al., 2018,
p. 31).
7
Adequate time and opportunity are required for this initial phase of the
consent process to ensure mutual understanding, which will depend on many
factors, such as complexity of information and likelihood of harms.
Ongoing – TCPS2, Article 3.3 (Canadian Institutes for Health (CIHR)
et al., 2018, p. 33) speaks to the ongoing nature of consent as encompassing a
process that begins with initial contact and carries through to the end of the
participants’ involvement in a project. It involves “an ongoing duty” to provide
participants with all information relevant to their ongoing consent to participate.
It highlights the researcher’s “ongoing ethical and legal obligation to bring to
participants’ attention any changes to the research project that may affect them”,
including “changes to the risks or potential benefits of the research” to give participants “the opportunity to reconsider the basis for their consent in light of the
new information”.
TCPS2 (Canadian Institutes for Health (CIHR) et al., 2018, p. 47) also
requires that consent be documented, noting that “written consent in a signed
statement from the participant is a common means of demonstrating consent, and
in some instances, is mandatory” but there are many other ethically acceptable
means of providing consent. These might include oral consent or other verbal
agreements, intentional physical gestures such as a handshake, or exchange of
gifts, which can symbolize “the establishment of a relationship comparable to
consent”. These alternative processes for demonstrating consent are intended for
circumstances where there are valid reasons for not documenting consent in
writing (e.g. in a signed consent form), not as options for convenience of the
proponents of research. The procedures that are used to seek consent must be
documented, and it is recommended that a “written statement of the information