ETHICAL ASPECTS IN CLINICAL TRIALS IN CHILDREN
Journal
Македонски медицински преглед = Macedonian Medical Review
Date Issued
2021
Author(s)
Arnaudov, Dimitar
Gjinovska Tasevska, Elena
Abstract
Conducting clinical trials in children has particular importance
as they strive to provide optimal care and therapy
for this specific group of patients, but their implementation
is still complex. This is often due to the lack
of agreed-upon research objectives, unresolved questions
about informed consent, and the general perception that
children are a vulnerable group of subjects. For providing
the best clinical care for pediatric subjects, it is
important to conduct careful, effective research that has a
scientific basis to answer important clinical questions.
The main challenge of pediatric research is the risk
and therefore the question arises whether the purpose
of the research justifies the risks associated with the
study? The four ethical principles should serve as a
framework in the process of conducting clinical trials
in children: benefacere, justice, respect for personality
and confidentiality. One principle is no more or less
important than the others, so all four must be taken
into account when conducting a research. The ethical
principle of "respect for personality" is the basis for
the process of informed consent. It is a legal document
by which the patient voluntarily agrees to participate
in a research. The informed consent must be signed by
child's legal guardian(s) and this step cannot be delegated
to other family members or friends unless there is a
legal basis. However, with proper planning and monitoring
the study process, a research can be conducted in
children even though they are considered as a vulnerable
population.
as they strive to provide optimal care and therapy
for this specific group of patients, but their implementation
is still complex. This is often due to the lack
of agreed-upon research objectives, unresolved questions
about informed consent, and the general perception that
children are a vulnerable group of subjects. For providing
the best clinical care for pediatric subjects, it is
important to conduct careful, effective research that has a
scientific basis to answer important clinical questions.
The main challenge of pediatric research is the risk
and therefore the question arises whether the purpose
of the research justifies the risks associated with the
study? The four ethical principles should serve as a
framework in the process of conducting clinical trials
in children: benefacere, justice, respect for personality
and confidentiality. One principle is no more or less
important than the others, so all four must be taken
into account when conducting a research. The ethical
principle of "respect for personality" is the basis for
the process of informed consent. It is a legal document
by which the patient voluntarily agrees to participate
in a research. The informed consent must be signed by
child's legal guardian(s) and this step cannot be delegated
to other family members or friends unless there is a
legal basis. However, with proper planning and monitoring
the study process, a research can be conducted in
children even though they are considered as a vulnerable
population.
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