方法对比
并排查看您选择的方法；存在差异的行会高亮显示。
| 研究中的知情同意豁免× | 伦理委员会申请流程× | |
|---|---|---|
| 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 guidelines | U.S. Department of Health and Human Services; International research oversight organizations |
| 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 46.116(c). link ↗ | U.S. Department of Health and Human Services. (2018). Protection of Human Subjects. Code of Federal Regulations Title 45, Part 46, Section 46.109. link ↗ |
| 别名 | consent waiver, waived consent, exempt from consent, research without consent | IRB application, REC application, ethics approval, protocol submission |
| 相关 | 5 | 5 |
| 摘要≠ | 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. | 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. |
| ScholarGate数据集 ↗ |
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