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Process / pipelineethics-procedural

追溯性伦理审查

追溯性伦理审查是指伦理委员会对在获得伦理批准之前进行的研究或收集的数据进行审查和判定。这种情况发生在研究人员在未获得事先伦理审查的情况下(有意、因疏忽或由于机构的不足)收集数据,然后在分析或发表前寻求伦理批准。追溯性批准通常是不被鼓励的;法规和指南强烈建议进行前瞻性审查(在数据收集前获得批准)。然而,追溯性地判定研究豁免(认定已收集的数据符合其他司法管辖区类似框架下的45 CFR 46.104豁免标准)或在有具体理由的情况下追溯性批准是可能的。了解何时可以获得追溯性批准及其局限性,对于面临这种伦理和监管挑战的研究人员来说很重要。

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来源

  1. 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). link
  2. 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. link
  3. Health Research Authority. (2021). Research That Has Already Started or Data Already Collected. UK Research Ethics Service Guidance. link
  4. International Council for Harmonisation. (2016). ICH Harmonised Guideline: Integrated Addendum to ICH E6(R1). Good Clinical Practice E6(R2). link

如何引用本页

ScholarGate. (2026, June 4). Obtaining Ethics Committee Approval After Data Has Been Collected. ScholarGate. https://scholargate.app/zh/research-ethics/retrospective-ethics-approval

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ScholarGateRetrospective Ethics Approval (Obtaining Ethics Committee Approval After Data Has Been Collected). 于 2026-06-17 检索自 https://scholargate.app/zh/research-ethics/retrospective-ethics-approval · 数据集: https://doi.org/10.5281/zenodo.20539026