方法对比

	追溯性伦理审查	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 community	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 46.101(b).	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	retroactive approval, post-hoc ethics approval, IRB exemption determination, delayed ethics review	risk-benefit analysis, risk-benefit calculation, risk-benefit justification, harm-benefit ratio
相关	5	5
摘要	Retrospective ethics approval is the ethics committee's review and determination regarding research conducted or data collected before ethics approval was obtained. This situation arises when researchers collect data without advance ethics review (intentionally, out of oversight, or due to institutional gaps) and then seek ethics approval before analysis or publication. Retrospective approval is generally disfavored; regulations and guidelines strongly recommend prospective review (approval before data collection). However, retrospective determination of exemption (finding that data already collected meets exempt criteria under 45 CFR 46.104, similar frameworks in other jurisdictions) or retrospective approval with specific justifications may be possible. Understanding when retrospective approval can be obtained—and its limitations—is important for researchers facing this ethical and regulatory challenge.	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.