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| 임상시험 등록× | 연구에서의 데이터 보호 및 개인정보 보호× | |
|---|---|---|
| 분야 | 연구윤리 | 연구윤리 |
| 계열 | Process / pipeline | Process / pipeline |
| 기원 연도≠ | 2005 | 1996 |
| 창시자≠ | World Health Organization; International Committee of Medical Journal Editors | European Union; U.S. Department of Health and Human Services; International research ethics community |
| 유형≠ | Requirement | Regulation |
| 원전≠ | World Health Organization. (2005). Ensuring that Studies Are Prospectively Registered. International Clinical Trials Registry Platform (ICTRP) Statement. link ↗ | European Union. (2018). Regulation (EU) 2016/679 of the European Parliament and of the Council: General Data Protection Regulation (GDPR). Official Journal of the European Union, L 119, 1-88. link ↗ |
| 별칭≠ | trial registration, prospective registration, ClinicalTrials.gov, trial registry | research privacy, GDPR research, data security, confidentiality |
| 관련 | 5 | 5 |
| 요약≠ | 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. | Research involving human subjects generates sensitive data: medical records, genetic information, behavioral responses, economic or social information. Regulatory frameworks—HIPAA (Health Insurance Portability and Accountability Act) in the U.S., GDPR (General Data Protection Regulation) in the European Union, and parallel regulations in other countries—establish legal obligations for data protection and privacy. Researchers must implement technical and procedural safeguards to prevent unauthorized access, maintain confidentiality, and comply with participant rights (access, rectification, deletion, data portability). Understanding data protection requirements is not optional compliance; it is foundational to ethical research. |
| ScholarGate데이터셋 ↗ |
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