手法を比較

	研究におけるインフォームド・コンセント	ヘルシンキ宣言
分野	研究倫理	研究倫理
系統	Process / pipeline	Process / pipeline
提唱年	1947	1964
提唱者	Multiple (Nuremberg Code 1947 first principle; formalized in Belmont Report 1979, Declaration of Helsinki 1964; US Common Rule 45 CFR 46)	World Medical Association (WMA)
種類	Guideline	Framework
原典	U.S. Department of Health and Human Services. Code of Federal Regulations Title 45, Part 46: Protection of Human Subjects. Federal Register.	World Medical Association. (2013). World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. JAMA, 310(20), 2191–2194.
別名	Research Consent, Informed Consent Process	DoH, Helsinki Declaration
関連	4	4
概要	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.	The Declaration of Helsinki (1964) is the foundational international ethical code for medical research involving human subjects, established by the World Medical Association. It extended earlier principles (Nuremberg Code 1947) to include therapeutic research and formalized the physician's ethical duty to prioritize subject welfare. Updated nine times through 2013, it remains the standard adopted by major medical journals, research ethics committees, and regulatory bodies worldwide.