Retrospective Ethics Approval
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.
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- 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). · URL
- U.S. Department of Health and Human Services, Office for Human Research Protections. (2010). Retrospective Collection and Codification of Existing Data and Specimens. OHRP Guidance. · URL
- Health Research Authority. (2021). Research That Has Already Started or Data Already Collected. UK Research Ethics Service Guidance. · URL
- International Council for Harmonisation. (2016). ICH Harmonised Guideline: Integrated Addendum to ICH E6(R1). Good Clinical Practice E6(R2). · URL
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