方法对比

	研究中的知情同意豁免	研究方案中的风险-效益评估
领域	研究伦理	研究伦理
方法族	Process / pipeline	Process / pipeline
起源年份	1991	1979
提出者	U.S. Department of Health and Human Services; International research ethics guidelines	U.S. Department of Health and Human Services; International research ethics community
类型	Guideline	Framework
开创性文献	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).	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.
别名	consent waiver, waived consent, exempt from consent, research without consent	risk-benefit analysis, risk-benefit calculation, risk-benefit justification, harm-benefit ratio
相关	5	5
摘要	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.	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.