方法对比

	追溯性伦理审查	研究中的知情同意豁免
领域	研究伦理	研究伦理
方法族	Process / pipeline	Process / pipeline
起源年份	1991	1991
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 guidelines
类型	Guideline	Guideline
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).	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).
别名	retroactive approval, post-hoc ethics approval, IRB exemption determination, delayed ethics review	consent waiver, waived consent, exempt from consent, research without consent
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 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.