About this Medicine article
What Makes Clinical Research Ethical? by Ezekiel J. Emanuel is a Medicine article available to read on EtoBox.
Many believe that informed consent makes clinical research ethical. However, informed consent is neither necessary nor sufficient for ethical clinical research. Drawing on the basic philosophies underlying major codes, declarations, and other documents relevant to research with human subjects, we propose 7 requirements that systematically elucidate a coherent framework for evaluating the ethics of clinical research studies: (1) value-enhancements of health or knowledge must be derived from the research; (2) scientific validity-the research must be methodologically rigorous; (3) fair subject selection-scientific objectives, not vulnerability or privilege, and the potential for and distribution of risks and benefits, should determine communities selected as study sites and the inclusion criteria for individual subjects; (4) favorable risk-benefit ratio-within the context of standard clinical practice and the research protocol, risks must be minimized, potential benefits enhanced, and the potential benefits to individuals and knowledge gained for society must outweigh the risks; (5) independent review-unaffiliated individuals must review the research and approve, amend, or terminate i
It is typically read by researchers, students, and practitioners in Medicine.
- Author
- Ezekiel J. Emanuel
- Publisher
- American Medical Association (AMA)
- Published
- 2000
- Language
- EN
- Field
- Medicine (Health Sciences)