February 2024 SOCRA Source Journal - Journal - Page 42
TABLE 2:
THE DIFFERENCE BETWEEN BEHAVIORAL AND CLINICAL RESEARCH
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Higher psychological risk (possibly)
More mistrust of the research community
Sensitive and private information
Balancing parents’ rights and need for knowledge with adolescent needs
Parental consent required for risky behavior survey research in adolescents
Confidential surveys, with a waiver of parental consent
BEHAVIORAL RESEARCH IN
CHILDREN
There are many challenges in
conducting behavioral health
research involving children
(Table 3). There may be a
stigma attached to mental
illness and a fear of being
“judged” and pressure to
be “normal.” Sometimes a
psychiatric diagnosis is not
deemed acceptable. Sometimes
the parents believe that the
research will help their child
directly, which may not be true.
Other challenges in conducting
behavioral health research
include concerns about privacy
and confidentiality, perceived
personal irrelevance of the
research focus and treatments,
and the distractibility and
limited attention span of
participants.
Researchers must ensure that
the behavioral health research
involving children has scientific
merit. They must handle issues
related to clinical trial design,
confidentiality, participant
selection, and recruitment
appropriateness. The study
must be scientifically valuable
and necessary. The institutional
review board (IRB), who
determines whether the study
is scientifically necessary, must
have the expertise to do this. In
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order to be ethical, a study must
yield valuable knowledge, and it
must be scientifically sound.
The design should include
accepted scientific methods
and should test hypotheses
adequately in order to yield
meaningful data that are
likely to yield generalizable
knowledge. The scientific value
of longitudinal studies should
be reevaluated periodically, as
standards for scientific merit
may shift and evolve over the
course of a study. Information
gaps begin to close over time.
In terms of design issues,
if participants are likely to
have emerging symptoms
as a result of involvement in
the clinical trial, appropriate
mechanisms for following
symptom progression must be
developed and implemented.
There must be clear criteria for
disengagement and alternative
mechanisms for treatment
must be provided to potential
participants.
Both the benefits to participants
and the likelihood of benefit
must be described accurately.
Whether the protocol poses
excessive risk to participants
and whether an alternative
design may pose less risk
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must also be considered.
Researchers must consider
whether any benefits derived
from the protocol are expected
to be applicable to the specific
population being studied.
In behavioral health research,
the control group may remain
untreated. The randomization
process could potentially harm
patients, who might otherwise
receive treatment that is tailored
to their individual needs.
Confidentiality issues include
properly safeguarding
participants’ information during
the collection, storage, and
analysis stages of a study. The
issue of confidentiality poses
unique ethical issues, especially
when engaging in behavioral
health research.
Research participants must
be aware of the researchers’
potential disclosure obligations.
There may be confidentiality
limits. If a child discloses issues
that raise concerns related
to the child’s safety, such as
substance abuse, firearm use,
or child abuse, confidentiality
no longer applies. The
researcher must take the legally
appropriate action. It is vital
to inform participants that the
information they disclose will be