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Posted on January 13, 2020 at 8:49 AM

Children are not small adults. This is a phrase we say in
pediatrics on a regular basis. The reason for such an absurd comment is that we
are constantly faced with medical decisions that force us to rely on adult data
to inform our practice. Pediatric patients face unique diseases and metabolize
medications differently from adults. Their ability to recover from injury is
often superior to their adult counterparts and thus the Quality Adjusted Life
Years can be substantially different.  I
argue that we have an ethical imperative to conduct pediatric research because 1.
research brings forth generalizable knowledge for the good of the pediatric
population and 2. because research guides clinical practice and the physician
has a duty to provide the best possible care to the patient.

Research in human subjects is justifiable if it satisfies the
following conditions: 1. A goal of valuable knowledge, 2. A reasonable prospect
that the research will generate the knowledge that is sought, 3. The necessity
of using human subjects, 4. Favorable balance of potential benefits over risk
of the subjects, 5. Fair selection of subjects and 6. Measures to protect
privacy and confidentiality. This list does not suggest any condition that
could not be applied to pediatric research subjects as they all promote
fairness, beneficence and non-maleficence. Typically, we do not consider
clinical research as something that provides significant benefit to the individual
subject. Generally, a clinical trial is initiated with equipoise on the
efficacy for if not met with equipoise, there would be no need for the study as
the outcome would already be known. Thus, if a clinical trial were to test the
efficacy of a given medication, the human subject could benefit from being in
the trial if the medication works OR could suffer from side effects and receive
no benefit from participation. So, although there is potential for individual
benefit after participating in the study, the main purpose is to benefit future
patients and add to the general knowledge of the topic. A utilitarian approach would
look at the potential consequences of pediatric research and determine it to be
right or wrong based upon the balance of good or bad. Pediatric research must
go through the same pathways as adult research with all human subjects’ trials
needing to have a careful justification that the benefits outweigh the risks.
Utilitarian theory is focused on value and thus the best action is the one who promotes
the most good for all involved. This is precisely the goal of research.
Research is conducted to affect change and improve care across a larger
population. Through clinical practice, a physician may help hundreds to
thousands of patients over the course of a career. However, through research,
that same physician could affect the lives of thousands to millions of patients
over the course of her life and far beyond. Therefore, in a carefully planned
and executed pediatric clinical trial where the potential benefits outweigh the
risks, the outcomes could be exponentially beneficial to the pediatric
population, thus supported by a Utilitarian approach.

The physician takes an oath to promote the patient’s best
interest and to avoid harm. Currently, the majority of treatments we provide to
pediatric patients are not evidenced based because no clinical trials have been
conducted to test that hypothesis. Therefore, each day we care for pediatric
patients without evidence of treatment safety nor effectiveness, we are
potentially causing harm. Pediatric researchers support a Kantian theory where
morality is judged by their motives. Thus, if a researcher wants to conduct a
clinical trial only for the fame from discovering the essential element and not
because of a desire to promote good, this would not be a moral-worthy endeavor.
Therefore, if we examine the physician’s obligation to her pediatric patient, a
duty-based ethical theory would tell us to treat each of them with the best
possible practice available. Research guides our clinical practice and help to
ensure that we are minimizing harms and maximizing benefits. If we support a
Kantian approach, in order to satisfy our obligations, we must utilize the
available data to make the best possible decisions, and thus, the available
data must come from clinical trials on pediatric patients to ensure scientific
rigor.

One objection to pediatric research is that these patients are
considered a vulnerable population, incapable of independent informed consent
and at risk of exploitation. Due to this fear, special protections have been
placed on pediatric research leaving an even more limited pool of subjects in
which to study. This is justified by some stating that we should proceed with
caution and only permit research when the potential for benefit is extremely
likely. However, if the criteria are too narrowed, we risk excluding potential
participants from research and unjustly diffusing the risks to a non-uniform
population. Rights Theorists would protect the pediatric patient against oppression,
unequal treatment, etc. Therefore, upholding the decision to conduct pediatric
research allows for the rights of all patients to be upheld and for providers
to contribute to the overall body of science, thus practice safer and more
effective medicine to the benefit of all patients. When we practice medicine on
children without data, we are unnecessarily exposing them to the same risks we
fear and are doing so without the oversight and protection imbedded in clinical
trials.

In
conclusion, I support that pediatric research is both essential and ethical as
it 1. generates a generalizable body of knowledge to the benefit of the
pediatric patient of the future and 2. clinical practice is best guided by
empirical data conducted through research. Clinical ethics outlines our
responsibilities as physicians to our patients including veracity, privacy,
confidentiality, and fidelity while upholding our role as a clinician. In
contrast, research ethics contributes to the greater good by promoting
generalizable knowledge for all future patients.

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