השוואת שיטות

	הסכמה מדעת במחקר	ועדת הלסינקי
תחום	אתיקה במחקר	אתיקה במחקר
משפחה	Process / pipeline	Process / pipeline
שנת המקור	1947	1974
הוגה השיטה	Multiple (Nuremberg Code 1947 first principle; formalized in Belmont Report 1979, Declaration of Helsinki 1964; US Common Rule 45 CFR 46)	U.S. Federal Requirement (National Research Act 1974); International adoption by WMA and research institutions globally
סוג	Guideline	Standard
מקור מכונן	U.S. Department of Health and Human Services. Code of Federal Regulations Title 45, Part 46: Protection of Human Subjects. Federal Register.	U.S. Code of Federal Regulations, Title 45, Part 46: Protection of Human Subjects. Office of the Federal Register.
כינויים	Research Consent, Informed Consent Process	IRB, Research Ethics Committee, REC
קשורות	4	4
תקציר	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 Institutional Review Board (IRB) is the independent ethics committee established at research institutions to review and approve human subjects research, ensuring compliance with ethical principles and federal regulations. Created as a legal requirement by the U.S. National Research Act (1974) and now adopted globally, the IRB serves as the primary mechanism for protecting research subjects while enabling legitimate research to proceed. No human subjects research can begin without IRB approval.