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Principles of ethical consideration required for clinical research involving children

Kenji Matsui1, Tomohide Ibuki2, Shimon Tashiro3

  • 1Division of Bioethics and Healthcare Law, The National Cancer Center Japan, Tokyo, Japan.

Pediatrics International : Official Journal of the Japan Pediatric Society
|February 27, 2021
PubMed

Insights

Ethical standards for pediatric clinical research in Japan are being clarified. New guiding principles address crucial ethical considerations for studies involving children, ensuring better protection and oversight.

Area of Science:

  • Pediatric clinical research ethics
  • Bioethics in Japan

Background:

  • Ethical considerations in pediatric research are more rigorous than for adult research.
  • Japan currently lacks specific, comprehensive guidelines for pediatric clinical research ethics.

Purpose of the Study:

  • To present guiding principles for ethical considerations in pediatric clinical research.
  • To outline essential ethical frameworks for researchers involved in studies with children in Japan.

Main Methods:

  • Development of ethical principles based on existing ethical research standards.
  • Dissemination of guidelines for researchers and stakeholders in pediatric clinical research.

Main Results:

  • Introduction of "Principles of Ethical Consideration Required for Clinical Research Involving Children".
  • Establishment of a foundational document for ethical conduct in pediatric studies.

Conclusions:

  • The new principles aim to standardize and strengthen ethical practices in pediatric clinical research in Japan.
  • These guidelines are essential for all personnel engaged in clinical research involving children.

Keywords:
childrenclinical researchethical guidelinesethical principleshuman subject protection

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