February 2024 SOCRA Source Journal - Journal - Page 40
TABLE 1:
CHILDREN IN RESEARCH
Vulnerable:
• Emotional immaturity or incomplete cognitive development
• Do not have legal status as decision makers
• A blanket exclusion from clinical trials:
◦ Limits their autonomy
◦ May further increase their vulnerability
• Children need the best, most effective, and least coercive therapies
• Balance the need to recruit while providing adequate protection
Marginalized:
• Under-representation of certain ethnic communities
• Disadvantaged populations
• Impoverished communities
• Under-represented and under-served neighborhoods
• Family dysfunction, conflicts, and domestic violence
• Many more social factors
Challenges – These issues increase their vulnerability:
• Psychologically driven; multifaceted
• Cognitive impairments, learning disabilities, and academic challenges
• Emotionally charged, volatile, and dysregulated
• Violent, aggressive, and agitated
• Defiant, angry, and oppositional
• Psychiatric diagnoses and acute mental health crisis
• Safety concerns: Suicidal intent or self-harm
with behavioral and emotional
health difficulties.
Children with behavioral
issues are part of the special
needs population. The author
often sees children in the
emergency department who
are emotionally challenged and
exhibit cognitive impairment.
They are emotionally charged,
volatile, and dysregulated
and may be aggressive,
agitated, and upset and
display their feelings by being
oppositionally defiant. Some
children who come to the
40
emergency department may
be experiencing a behavioral
or mental health crisis. They
may be at risk of self-harm or
harm from others. All these
issues increase the vulnerability
of children. Researchers must
consider how to best approach
and enroll children in research,
keeping in mind their safety and
the safety of people who are
enrolling them.
THE SCOPE OF THE
PROBLEM
There is a paucity of pediatric
clinical trials, and many trials
SOCRA SOURCE © May 2023
involving children are small,
thereby threatening their
statistical validity. In real life,
physicians extrapolate from
what is known to be effective
for adults to children; however,
this approach may not be valid.
Many children receive off-label
medications, which may pose
undue risks. Many treatments
have not been sufficiently tested
on children. Treatments that
have been tested in children
are necessary in developing
effective treatment for children.
There is a rising crisis in
emergency departments. The