Clinical Research: Ethical or Unethical?
Clinical Trials, Drug Development, Pharmaceutical Excipients and Drug Formulation, Pharmaceutical Research and Development
Everybody believes 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,
The aspects which make Clinical Research Ethical:
Value: enhancements of health or knowledge must be derived from the research;
Scientific validity: the research must be methodologically rigorous.
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.
Favorable risk-benefit ratio: within th...
