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| Deklaration von Helsinki× | Ethikkommission× | |
|---|---|---|
| Fachgebiet | Forschungsethik | Forschungsethik |
| Familie | Process / pipeline | Process / pipeline |
| Entstehungsjahr≠ | 1964 | 1974 |
| Urheber≠ | World Medical Association (WMA) | U.S. Federal Requirement (National Research Act 1974); International adoption by WMA and research institutions globally |
| Typ≠ | Framework | Standard |
| Wegweisende Quelle≠ | World Medical Association. (2013). World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. JAMA, 310(20), 2191–2194. link ↗ | U.S. Code of Federal Regulations, Title 45, Part 46: Protection of Human Subjects. Office of the Federal Register. link ↗ |
| Aliasnamen≠ | DoH, Helsinki Declaration | IRB, Research Ethics Committee, REC |
| Verwandt | 4 | 4 |
| Zusammenfassung≠ | The Declaration of Helsinki (1964) is the foundational international ethical code for medical research involving human subjects, established by the World Medical Association. It extended earlier principles (Nuremberg Code 1947) to include therapeutic research and formalized the physician's ethical duty to prioritize subject welfare. Updated nine times through 2013, it remains the standard adopted by major medical journals, research ethics committees, and regulatory bodies worldwide. | The Institutional Review Board (IRB) is the independent ethics committee established at research institutions to review and approve human subjects research, ensuring compliance with ethical principles and federal regulations. Created as a legal requirement by the U.S. National Research Act (1974) and now adopted globally, the IRB serves as the primary mechanism for protecting research subjects while enabling legitimate research to proceed. No human subjects research can begin without IRB approval. |
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