Principles of ethical consideration required for clinical research involving children

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

Research output: Contribution to journalArticlepeer-review

3 Citations (Scopus)


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 languageEnglish
Pages (from-to)248-259
Number of pages12
JournalPediatrics International
Issue number3
Publication statusPublished - 2021 Mar


  • children
  • clinical research
  • ethical guidelines
  • ethical principles
  • human subject protection


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