手法を比較

	研究プロトコルにおけるリスク・ベネフィット評価	インフォームド・コンセントの免除
分野	研究倫理	研究倫理
系統	Process / pipeline	Process / pipeline
提唱年	1979	1991
提唱者	U.S. Department of Health and Human Services; International research ethics community	U.S. Department of Health and Human Services; International research ethics guidelines
種類	Framework	Guideline
原典	The 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.	U.S. Department of Health and Human Services. (2018). Protection of Human Subjects. Code of Federal Regulations Title 45, Part 46, Section 46.116(c).
別名	risk-benefit analysis, risk-benefit calculation, risk-benefit justification, harm-benefit ratio	consent waiver, waived consent, exempt from consent, research without consent
関連	5	5
概要	A risk-benefit assessment is a systematic evaluation of the potential harms and benefits of a proposed research study, documented in ethics committee applications. The Belmont Report (1979) established the principle of beneficence—maximizing benefits while minimizing harm—as a cornerstone of research ethics. Regulatory frameworks (45 CFR 46.111 in the U.S., equivalent in other jurisdictions) require ethics committees to determine that risks are reasonable in relation to anticipated benefits before approving research. This assessment is not a simple calculation (risks + benefits) but a qualitative judgment incorporating probability, magnitude, and distribution of harms and benefits.	A waiver of informed consent permits research to proceed without obtaining prospective written or verbal consent from participants. This exception to the standard informed consent requirement applies to specific low-risk research scenarios where obtaining consent is impractical, unnecessary, or would compromise research validity. In the U.S., the regulations (45 CFR 46.116) specify four criteria that must be met for an IRB to approve a waiver; similar criteria apply in the UK (Research Ethics Committee) and EU jurisdictions. Waivers are not automatic; researchers must request them explicitly and justify them to the ethics committee, which determines whether the criteria are met.