Ethics in clinical research are indispensable for participant protection and ensuring research quality, and constitute essential knowledge for all healthcare professionals involved in clinical practice. Learning from historical case studies of unethical research, such as the Nazi human experiments and the Tuskegee Syphilis Study has led to progressive development of ethical guidelines like the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report—which presents the three core principles of respect for persons, beneficence, and justice. In Japan, incidents including the Diovan case prompted the enactment of the Clinical Research Act. The 8 requirements set forth by the U.S. National Institutes of Health (social/scientific value, scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, informed consent, and respect for subjects) serve as a key framework for modern research practice. In Japan, regulations such as the Pharmaceuticals and Medical Devices Act/Good Clinical Practice, the Clinical Research Act, and associated guidelines have been established, and require compliance tailored to the specific type of research. The practice of clinical research adhering to ethical principles forms the foundation for the advancement of medicine built on trust.
"},{"@language":"ja","@value":"臨床研究における倫理は，研究参加者保護と研究の質確保に不可欠であり，臨床に携わる全医療者が共有すべき知識である。過去のナチスの人体実験やタスキギー梅毒実験などの非倫理的な研究事例の反省から，ニュルンベルク綱領，ヘルシンキ宣言，そして「人格の尊重・善行・正義」の三原則を示すベルモント・レポートといった倫理規範が段階的に形成されてきた。国内ではディオバン事案などが臨床研究法制定の契機となった。現代の研究実施の指針としてNIHの8要件があり，社会的/科学的価値，科学的妥当性，適正な被験者選択，リスク/ベネフィット配分，独立審査，インフォームド・コンセント，被験者尊重などが求められる。わが国では，薬機法/GCP，臨床研究法，関連指針等が整備されており，研究の種類に応じた遵守が必要である。倫理原則に則った臨床研究の実践が，信頼に基づく医療の発展の礎となる。
"}],"abstractLicenseFlag":"disallow"}],"creator":[{"@id":"https://cir.nii.ac.jp/crid/1410024257280509824","@type":"Researcher","foaf:name":[{"@language":"ja","@value":"西脇 聡史"},{"@language":"en","@value":"NISHIWAKI Satoshi"}],"jpcoar:affiliationName":[{"@language":"en","@value":"Department of Advanced Medicine, Nagoya University Hospital"},{"@language":"ja","@value":"名古屋大学医学部附属病院 先端医療開発部"}]}],"publication":{"publicationIdentifier":[{"@type":"PISSN","@value":"04851439"},{"@type":"LISSN","@value":"04851439"},{"@type":"EISSN","@value":"18820824"},{"@type":"NDL_BIB_ID","@value":"000000024253"},{"@type":"ISSN","@value":"04851439"},{"@type":"NCID","@value":"AN00252940"}],"prism:publicationName":[{"@language":"en","@value":"Rinsho Ketsueki"},{"@language":"ja","@value":"臨床血液"},{"@language":"en","@value":"Rinsho Ketsueki"},{"@language":"en","@value":"Jpn. J. Clin. Hematol."},{"@language":"en","@value":"The Japanese Journal of Clinical Hematology"},{"@language":"ja","@value":"臨床血液"}],"dc:publisher":[{"@language":"en","@value":"The Japanese Society of Hematology"},{"@language":"ja","@value":"一般社団法人 日本血液学会"}],"prism:publicationDate":"2025","prism:volume":"66","prism:number":"9","prism:startingPage":"1271","prism:endingPage":"1279"},"url":[{"@id":"http://id.ndl.go.jp/bib/034338405"},{"@id":"https://ndlsearch.ndl.go.jp/books/R000000004-I034338405"},{"@id":"https://search.jamas.or.jp/link/ui/2025365292"}],"availableAt":"2025","foaf:topic":[{"@id":"https://cir.nii.ac.jp/all?q=Clinical%20research%20ethics","dc:title":"Clinical research ethics"},{"@id":"https://cir.nii.ac.jp/all?q=Participant%20protection","dc:title":"Participant protection"},{"@id":"https://cir.nii.ac.jp/all?q=Informed%20consent","dc:title":"Informed consent"},{"@id":"https://cir.nii.ac.jp/all?q=Ethical%20principles","dc:title":"Ethical principles"},{"@id":"https://cir.nii.ac.jp/all?q=Clinical%20research%20ethics","dc:title":"Clinical research ethics"},{"@id":"https://cir.nii.ac.jp/all?q=Participant%20protection","dc:title":"Participant protection"},{"@id":"https://cir.nii.ac.jp/all?q=Informed%20consent","dc:title":"Informed consent"},{"@id":"https://cir.nii.ac.jp/all?q=Ethical%20principles","dc:title":"Ethical principles"}],"dataSourceIdentifier":[{"@type":"JALC","@value":"oai:japanlinkcenter.org:2014600570"},{"@type":"NDL_SEARCH","@value":"oai:ndlsearch.ndl.go.jp:R000000004-I034338405"},{"@type":"PUBMED","@value":"41034080"}]}