신생아 임상연구에서의 Good Clinical Practice (Good Clinical Practice in Neonatal Clinical Research)

서지정보

· 발행기관 : 대한신생아학회
· 수록지 정보 : Neonatal medicine / 15권 / 2호 / 119 ~ 122페이지
· 저자명 : 박민수

초록

Clinical research is a necessity, not an option, for developing better and new medicines
and therapeutic modalities. But in the course of clinical research, there are rules and guidelines
that should be followed to ensure the due respect for persons, beneficence, and justice for
persons who voluntarily participate in the research as described in the Belmont Report. Good
Clinical Practice ( GCP) is an “international scientific and ethical quality standard for designing,
conducting, recording, and reporting”clinical trials. T he main purposes of GCP would
be to protect rights, safety, and well-being of trial subjects, in compliance with the principles
of Declaration of Helsinki, and to assure that the data obtained from clinical trials are credible.
In order to achieve these, investigators must be fully aware of the meanings as well as actual
procedures involved in the research and should make the best effort to comply with GCP.
For those individuals who belong to vulnerable populations, such as neonates, in addition to
the general principles of GCP, further measures to ensure added protection should be
implemented. It is our duty to develop and provide better care through clinical research even
for neonates. But in doing so, we have to make sure that the importance of protecting the
rights, safety, and well-being of the subjects supersede the interests of science and society.
(J Korean SocNeonatol 2008;15:119-122)

영어초록

Clinical research is a necessity, not an option, for developing better and new medicines
and therapeutic modalities. But in the course of clinical research, there are rules and guidelines
that should be followed to ensure the due respect for persons, beneficence, and justice for
persons who voluntarily participate in the research as described in the Belmont Report. Good
Clinical Practice ( GCP) is an “international scientific and ethical quality standard for designing,
conducting, recording, and reporting”clinical trials. T he main purposes of GCP would
be to protect rights, safety, and well-being of trial subjects, in compliance with the principles
of Declaration of Helsinki, and to assure that the data obtained from clinical trials are credible.
In order to achieve these, investigators must be fully aware of the meanings as well as actual
procedures involved in the research and should make the best effort to comply with GCP.
For those individuals who belong to vulnerable populations, such as neonates, in addition to
the general principles of GCP, further measures to ensure added protection should be
implemented. It is our duty to develop and provide better care through clinical research even
for neonates. But in doing so, we have to make sure that the importance of protecting the
rights, safety, and well-being of the subjects supersede the interests of science and society.
(J Korean SocNeonatol 2008;15:119-122)

참고자료

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