Principles of ethical consideration required for clinical research involving children

Study Group on Regulatory Science for Early Clinical Application of Pediatric Pharmaceuticals

doi:10.1111/ped.14529

Principles of ethical consideration required for clinical research involving children

Study Group on Regulatory Science for Early Clinical Application of Pediatric Pharmaceuticals

LIT - Department of Integrated Human Sciences

Research output: Contribution to journal › Article › peer-review

3 Citations (Scopus)

Abstract

Ethical considerations are more stringent in pediatric clinical research than in research targeting adults. However, in Japan, clear guidelines have yet to be presented on the necessary ethical considerations for clinical research involving children. The “Principles of Ethical Consideration Required for Clinical Research Involving Children” provide guiding principles for ethical considerations and the essential ways of thinking that all involved in clinical research on children need to understand in advance.

Original language	English
Pages (from-to)	248-259
Number of pages	12
Journal	Pediatrics International
Volume	63
Issue number	3
DOIs	https://doi.org/10.1111/ped.14529
Publication status	Published - 2021 Mar

Keywords

children
clinical research
ethical guidelines
ethical principles
human subject protection

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1111/ped.14529

Cite this

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title = "Principles of ethical consideration required for clinical research involving children",

abstract = "Ethical considerations are more stringent in pediatric clinical research than in research targeting adults. However, in Japan, clear guidelines have yet to be presented on the necessary ethical considerations for clinical research involving children. The “Principles of Ethical Consideration Required for Clinical Research Involving Children” provide guiding principles for ethical considerations and the essential ways of thinking that all involved in clinical research on children need to understand in advance.",

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author = "{Study Group on Regulatory Science for Early Clinical Application of Pediatric Pharmaceuticals} and Kenji Matsui and Tomohide Ibuki and Shimon Tashiro and Hidefumi Nakamura",

note = "Funding Information: The authors declare no conflict of interest. The English version of the document was prepared by the Grant‐in‐Aid for Scientific Research No. 15mk0101024h0103 (The Ministry of Health, Labour and Welfare, Japan), and No. 19H01083 (Japan Society for the Promotion of Science). Publisher Copyright: {\textcopyright} 2021 Japan Pediatric Society",

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doi = "10.1111/ped.14529",

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AU - Study Group on Regulatory Science for Early Clinical Application of Pediatric Pharmaceuticals

AU - Matsui, Kenji

AU - Ibuki, Tomohide

AU - Tashiro, Shimon

AU - Nakamura, Hidefumi

N1 - Funding Information: The authors declare no conflict of interest. The English version of the document was prepared by the Grant‐in‐Aid for Scientific Research No. 15mk0101024h0103 (The Ministry of Health, Labour and Welfare, Japan), and No. 19H01083 (Japan Society for the Promotion of Science). Publisher Copyright: © 2021 Japan Pediatric Society

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Principles of ethical consideration required for clinical research involving children

Abstract

Keywords

UN SDGs

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