February 2024 SOCRA Source Journal - Journal - Page 45
consent document to assure
that it is presented in a childappropriate, conversational
manner.
ISSUES RELATED TO
INFORMED CONSENT AND
ASSENT
Issues related to informed
consent and assent are
incentives and payments,
coercion versus undue
influence, and data presentation
issues (Table 5). Researchers
must consider the ethics of
financial remuneration, which
may be more attractive to
economically disadvantaged
populations. Potential
research participants or their
parents or caregivers may
conceal information that
would disqualify them from
participating in a study in
order to receive financial
remuneration.
Typically, people of high
socioeconomic status benefit
from research, while people who
are socially and economically
challenged and disadvantaged
endure most of the risks and
burdens of participation in
research. Socioeconomically
disadvantaged individuals
are less likely to participate in
research compared to those of
higher socioeconomic status,
regardless of incentives.
IRBs are required to ensure
that the amount, method, and
timing of research payments
are not coercive and do not
present undue influence. For
disadvantaged populations,
IRBs must consider the
amount of payment that is
excessive. For a disadvantaged
population, $20 may be
coercive. Community
representatives on the IRB can
help ensure that the amount
and the method of payment is
appropriate for the population
and is not coercive.
Coercion is a situation that
involves a threat to harm
someone or to violate their
rights. Undue influence is a
situation in which an offer
of something desirable
influences decision-making in
inappropriate ways, such as an
offer the person cannot refuse.
Data must meet current ethical
standards, for example, for
authorship and disclosure of
conflicting roles and conflicts
of interest. Data must also
describe the ethical safeguards
used in the protocol and that
adequately protect participants’
identities.
STRATEGIES TO IMPROVE
PARTICIPATION
Table 6 highlights strategies
to improve participation in
pediatric behavioral health
TABLE 5
ISSUES RELATED TO INFORMED CONSENT
Incentive and payment issues:
• Ethics of financial remuneration:
◦ More attractive to economically disadvantaged populations
◦ No standards for how much is too much
◦ IRBs must ensure that incentives are not coercive and do not present undue influence
Coercion versus undue influence:
• Coercion: A threat to harm someone or violate a person’s rights
• Undue influence: An offer of something desirable influences decision-making in inappropriate
ways
Data presentation issues:
• Data must:
◦ Describe the ethical safeguards used in the protocol
◦ Meet current ethical standards
◦ Adequately protect participants’ identities
SOCRA SOURCE © May 2023
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