A research study of humans in which the investigator deliberately modifies conditions or circumstances, e.g., by administering an experimental preventive or therapeutic regimen, in order to find out what happens. There are clearly defined ethical principles and rules that must be observed when human experiments are done. The most important rule, which is inviolable and enshrined in the Nuremberg Code, is that the informed consent of the subjects (participants) in the research study is absolutely mandatory. Therefore, research involving human subjects must undergo ethical review, by an institutional review board (IRB) in the United States and similar bodies in other countries.
Subjects: Public Health and Epidemiology.