方法对比

	追溯性伦理审查	研究中的数据保护与隐私
领域	研究伦理	研究伦理
方法族	Process / pipeline	Process / pipeline
起源年份	1991	1996
提出者	U.S. Department of Health and Human Services; International research ethics community	European Union; U.S. Department of Health and Human Services; International research ethics community
类型	Guideline	Regulation
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).	European Union. (2018). Regulation (EU) 2016/679 of the European Parliament and of the Council: General Data Protection Regulation (GDPR). Official Journal of the European Union, L 119, 1-88.
别名	retroactive approval, post-hoc ethics approval, IRB exemption determination, delayed ethics review	research privacy, GDPR research, data security, confidentiality
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.	Research involving human subjects generates sensitive data: medical records, genetic information, behavioral responses, economic or social information. Regulatory frameworks—HIPAA (Health Insurance Portability and Accountability Act) in the U.S., GDPR (General Data Protection Regulation) in the European Union, and parallel regulations in other countries—establish legal obligations for data protection and privacy. Researchers must implement technical and procedural safeguards to prevent unauthorized access, maintain confidentiality, and comply with participant rights (access, rectification, deletion, data portability). Understanding data protection requirements is not optional compliance; it is foundational to ethical research.