手法を比較

	ベルモント報告書	研究におけるインフォームド・コンセント
分野	研究倫理	研究倫理
系統	Process / pipeline	Process / pipeline
提唱年	1979	1947
提唱者	National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (US DHEW)	Multiple (Nuremberg Code 1947 first principle; formalized in Belmont Report 1979, Declaration of Helsinki 1964; US Common Rule 45 CFR 46)
種類	Framework	Guideline
原典	National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Department of Health, Education, and Welfare.	U.S. Department of Health and Human Services. Code of Federal Regulations Title 45, Part 46: Protection of Human Subjects. Federal Register.
別名	Belmont Principles, Three Ethical Principles	Research Consent, Informed Consent Process
関連	5	4
概要	The Belmont Report (1979) is the foundational US ethical framework for human subjects research, established by the National Commission following the Tuskegee Syphilis Study scandal. It articulates three core principles—Respect for Persons, Beneficence, and Justice—that form the basis for institutional review and regulatory oversight of human research globally. Every researcher conducting human studies must understand and apply these principles.	Informed consent is the cornerstone of ethical human subjects research, requiring researchers to disclose material information about a study and obtain voluntary agreement from subjects before participation. Established as the first principle of the Nuremberg Code (1947) and formalized in subsequent ethical frameworks (Declaration of Helsinki 1964, Belmont Report 1979), informed consent protects subject autonomy, enables risk-benefit assessment, and creates accountability. Effective informed consent requires far more than obtaining a signature—it demands clear communication, genuine comprehension, and authentic voluntariness.