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| Proses Aplikasi Komite Etik× | Registrasi Uji Klinis× | |
|---|---|---|
| Bidang | Etika Penelitian | Etika Penelitian |
| Keluarga | Process / pipeline | Process / pipeline |
| Tahun asal≠ | 1991 | 2005 |
| Pencetus≠ | U.S. Department of Health and Human Services; International research oversight organizations | World Health Organization; International Committee of Medical Journal Editors |
| Tipe≠ | Guideline | Requirement |
| 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 ↗ | World Health Organization. (2005). Ensuring that Studies Are Prospectively Registered. International Clinical Trials Registry Platform (ICTRP) Statement. link ↗ |
| Alias≠ | IRB application, REC application, ethics approval, protocol submission | trial registration, prospective registration, ClinicalTrials.gov, trial registry |
| 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. | Clinical trial registration is the prospective documentation of a trial's key information (hypothesis, design, population, outcomes) in a public registry before enrollment begins or results are known. In 2005, the World Health Organization established the requirement that all clinical trials be registered in an internationally recognized registry before participant enrollment. The International Committee of Medical Journal Editors (ICMJE) made registration a condition for publication in major medical journals in 2005, updated in 2015. Primary registries include ClinicalTrials.gov (U.S.), ISRCTN (UK), EudraCT (EU), and others operating under WHO oversight. Registration serves to prevent selective outcome reporting, reduce publication bias, and enhance research transparency. |
| ScholarGateSet data ↗ |
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