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| Proses Aplikasi Komite Etik× | Penolakan Persetujuan Setelah Penjelasan (Informed Consent) dalam Penelitian× | |
|---|---|---|
| Bidang | Etika Penelitian | Etika Penelitian |
| Keluarga | Process / pipeline | Process / pipeline |
| Tahun asal | 1991 | 1991 |
| Pencetus≠ | U.S. Department of Health and Human Services; International research oversight organizations | U.S. Department of Health and Human Services; International research ethics guidelines |
| Tipe | Guideline | Guideline |
| Sumber perintis≠ | 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 ↗ | 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 ↗ |
| Alias | IRB application, REC application, ethics approval, protocol submission | consent waiver, waived consent, exempt from consent, research without consent |
| Terkait | 5 | 5 |
| Ringkasan≠ | 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. | 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. |
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