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| Pristanak informisanog lica u istraživanju× | Belmont Report× | |
|---|---|---|
| Oblast | Etika istraživanja | Etika istraživanja |
| Porodica | Process / pipeline | Process / pipeline |
| Godina nastanka≠ | 1947 | 1979 |
| Tvorac≠ | Multiple (Nuremberg Code 1947 first principle; formalized in Belmont Report 1979, Declaration of Helsinki 1964; US Common Rule 45 CFR 46) | National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (US DHEW) |
| Tip≠ | Guideline | Framework |
| Temeljni izvor≠ | U.S. Department of Health and Human Services. Code of Federal Regulations Title 45, Part 46: Protection of Human Subjects. Federal Register. link ↗ | National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Department of Health, Education, and Welfare. link ↗ |
| Drugi nazivi | Research Consent, Informed Consent Process | Belmont Principles, Three Ethical Principles |
| Srodne≠ | 4 | 5 |
| Sažetak≠ | Informed consent is the cornerstone of ethical human subjects research, requiring researchers to disclose material information about a study and obtain voluntary agreement from subjects before participation. Established as the first principle of the Nuremberg Code (1947) and formalized in subsequent ethical frameworks (Declaration of Helsinki 1964, Belmont Report 1979), informed consent protects subject autonomy, enables risk-benefit assessment, and creates accountability. Effective informed consent requires far more than obtaining a signature—it demands clear communication, genuine comprehension, and authentic voluntariness. | The Belmont Report (1979) is the foundational US ethical framework for human subjects research, established by the National Commission following the Tuskegee Syphilis Study scandal. It articulates three core principles—Respect for Persons, Beneficence, and Justice—that form the basis for institutional review and regulatory oversight of human research globally. Every researcher conducting human studies must understand and apply these principles. |
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