February 2024 SOCRA Source Journal - Journal - Page 41
emergency department is a suboptimal setting for children with
psychiatric crises because of the
stressful environment and the
way emergency departments
function. Visits are unscheduled
and the children may be
upset and frightened as are
their parents/caregivers. Their
behavior is already challenging,
and they are distressed. All
these issues threaten the ability
of a researcher to obtain fully
informed consent.
RESEARCH AND CLINICAL
CARE
The purpose of clinical research
is to generate evidence
for improving outcomes. If
recruitment fails to reach
the target sample size, the
study may be underpowered
and misinterpreted as
having negative results. The
research questions will remain
unanswered. In order to
evaluate potentially improved
therapies, more pediatric
participants must be enrolled in
research studies.
Clinical research differs from
clinical care, which is devoted
exclusively to enhancing the
well-being of individuals.
Clinical research focuses more
broadly on improving the
human condition. The boundary
between research and clinical
innovation often is less sharp.
Some children with mental
disorders remain unrecognized
and untreated. They do not
have access to appropriate
services.
Behavioral health research is
different from clinical research
(Table 2). The level of risk may
be psychologically higher.
Children may be emotionally
dysregulated or potentially
violent. Balancing risks and
benefits are key to the ethical
conduct of research involving
children. Commonly held
perceptions about research
participation may be a problem.
Mistrust of the research
community is sometimes
pervasive among many ethnic
minority groups.
Behavioral health research
may involve sensitive
and private information.
Researchers must consider
confidentiality in clinical care
for adolescents, particularly
regarding contraception,
reproductive healthcare, and
high-risk behaviors. Although
parents have rights, certain
information cannot be shared
with them. Private information
should remain private.
Adolescents often lose interest
in participating in behavioral
research if they believe that
confidential information could
be disclosed to their parents.
THE ETHICAL CONDUCT OF
RESEARCH
The Nuremberg Code, the
Declaration of Helsinki, and
the Belmont Report comprise
the ethical basis for conducting
research. Informed consent
for human research subjects
was first officially advocated in
the Nuremberg Code (1947),
which requires the voluntary
consent of research participants.
Children cannot give informed
consent and were, therefore,
implicitly excluded from
research. The Nuremberg Code
did not include any provision for
proxy consent.
The Declaration of Helsinki
(1964) noted that informed
consent relies on the concept
of autonomy. It established
the priority of human subjects’
interests over those of science
and society. It noted that
under-represented populations
and vulnerable populations
in need of protection should
have access to participation in
research.
The single most important
ethical guideline is the Belmont
Report, published by the US
National Commission for the
Protection of Human Subjects
of Biomedical and Behavioral
Research in 1979. The Belmont
Report has 3 core principles:
1. Respect for autonomy
honors the decision-making
capacities of independent,
autonomous individuals.
Individuals with diminished
autonomy are entitled to
protection.
2. Beneficence requires a
duty to provide care that
promotes the overall welfare
of the patient, including
balancing risks, benefits,
and even costs, maximizing
possible benefits and
minimizing possible harms.
Above all, “do no harm.”
3. Justice is not a single
principle per se but a set
of norms that guide the
treatment of individuals
according to what is fair,
due, or owed.
These ethical principles are
woven into the rationale for the
commission’s recommendations
on research involving children.
Such research must be
conducted with careful attention
to the ethical principles of
beneficence, justice, and
respect for persons.
SOCRA SOURCE © May 2023
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