February 2024 SOCRA Source Journal - Journal - Page 39
JOURNAL ARTICLES
Challenges in Behavioral
Research
Involving Children
Muhammad Waseem, MD, MS, CHSE-A
Professor Emergency Medicine and Pediatrics,
Weill Cornell Medicine
Research Director Emergency Medicine,
Lincoln Medical Center,
Bronx, New York
Muhammad Waseem, MD, MS, CHSE-A
Abstract: Children are an inherently vulnerable population. They lack the autonomy and decision-making
capacity to effectively, ethically, and legally provide consent to participate in clinical research. Mental
health issues in children are numerous and make the issue of voluntary consent even more complex.
The recruitment of children into behavioral health research studies poses a challenge in terms of the
requirement for parental consent on their behalf. This article highlights barriers to the participation of
children in behavioral health research and includes strategies that can help to improve their recruitment
and retention in these studies.
Disclosure: The author has no financial interests, professional relationships, or conflicts of interest
associated with any products or devices discussed in this article.
BACKGROUND
Mental health conditions are
common in society and are
becoming increasingly prevalent
in emergency departments.
Many emergency departments
are seeing an influx of patients
with behavioral and mental
health issues. Children with
mental health issues account for
5% of emergency department
visits. This has become a
serious public health issue
with considerable long-term
consequences. Unfortunately,
data about children with
behavioral issues is limited.
Children are a vulnerable,
marginalized, and difficult
population (Table 1). They are
inherently vulnerable because
of their emotional immaturity
and incomplete cognitive
development. Children have a
dependent status; they depend
on somebody else for their care
and do not have legal status as
decision-makers.
Acknowledging this
vulnerability is critical in
ensuring that clinical research
is conducted in an ethically
appropriate environment. A
blanket exclusion of children
from clinical trials limits the data
and may therefore increase
their vulnerability. Children
need the best, most effective,
and least coercive therapeutic
interventions. Researchers
must balance the need to
recruit children for behavioral
research while simultaneously
balancing risk and benefit
and the provision of adequate
protection.
Children with behavioral issues
are part of a marginalized
population and too often
are under-represented in
certain ethnic, disadvantaged,
and medically underserved
communities. Children with
behavioral issues may struggle
with family dysfunction,
relational conflicts, domestic
violence, and exposure to
many other social challenges.
Childhood exposure to violence
in any form is often associated
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