Author Affiliations: Department of Clinical Bioethics, Warren G. Magnuson Clinical Center, National Institutes of Health, Bethesda, Md.
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 it; (6) informed consent—individuals
should be informed about the research and provide their voluntary consent;
and (7) respect for enrolled subjects—subjects should have their privacy
protected, the opportunity to withdraw, and their well-being monitored. Fulfilling
all 7 requirements is necessary and sufficient to make clinical research ethical.
These requirements are universal, although they must be adapted to the health,
economic, cultural, and technological conditions in which clinical research
Emanuel EJ, Wendler D, Grady C. What Makes Clinical Research Ethical?. JAMA. 2000;283(20):2701-2711. doi:10.1001/jama.283.20.2701