IRB standards in the U.S. are based on those put forth by the Nuremberg Code in response to the use of humans for scientific experiments performed by the Nazis. In the U.S., the establishment of IRBs also occurred in response to unethical treatment of human subjects, such as those used in the Tuskegee Study. In that study, African American men who were infected with syphilis were not offered treatment even after it became available. IRBs are used to help prevent such abuse or neglect of human subjects in research.
Researchers must make clear the possible risks and benefits to participants. According to IRB guidelines, researchers must consider all possible harm that could befall people from participating in their research. This includes any possible physical or psychological harm or any other possible risks. Any treatment of subjects that may be considered "brutal" or "inhumane" is strictly forbidden by IRB guidelines.
According to IRB standards, all human participants must give "informed consent" for their participation. This means that participants must be given clear information about any risks that may accompany participation and what specifically is expected of participants. In addition, consent for participation must be done in a way that is non-coercive. IRB standards also have strict requirements for the language that may be used on informed consent forms, and they forbid the use of legal jargon as well as first-person language, which can be interpreted as coercive.
IRB standards require that the selection of subjects be done in a way that is democratic, giving all possible subjects an equal chance at being selected for a study. The researcher must specify what population of subjects are to be recruited, and must explicitly state why these people are being used. In addition, researchers must make sure that the selection of participants is done fairly or justly. As such, the researcher cannot show preference for people he likes or for people he feels are undesirable. Rather, the researcher should select individuals or groups that will best fulfill the purposes of the research. Researchers must make their planned methods of selection of participants explicit to the IRB, and must make efforts to avoid biases against race, class, sex, culture and disability.