手法を比較

	遡及的倫理審査承認	倫理委員会申請プロセス
分野	研究倫理	研究倫理
系統	Process / pipeline	Process / pipeline
提唱年	1991	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 oversight organizations
種類	Guideline	Guideline
原典	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 46.109.
別名	retroactive approval, post-hoc ethics approval, IRB exemption determination, delayed ethics review	IRB application, REC application, ethics approval, protocol submission
関連	5	5
概要	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.	Submitting a research protocol to an ethics committee (IRB, REC, or equivalent) is a mandatory procedural gateway in human subjects research. The application process requires researchers to document their study design, justify scientific rationale, disclose risks and benefits, provide participant protections (informed consent forms), and address ethical considerations. The submission includes a completed ethics application form, protocol document, consent forms, researcher CVs, and evidence of institutional support. This standardized process enables ethics committees to conduct rigorous, timely, and consistent review before research commences.