Procedures must be used that are consistent with good research design and do not expose subjects to unnecessary risk. If the subject is a patient, the study must be designed and conducted in a way that does not adversely affect the patient's progress. Informed consent is obtained and documented from each subject or the subject's legal representative. Selection of subjects is fair and equitable, and there are safeguards to protect subjects, such as the mentally retarded, who may not be able to look out for their own interests. Risks to subjects are reasonable in relation to expected benefit to those subjects and the importance of the knowledge that may be gained.
Provisions exist to protect the privacy of subjects and to maintain data confidentiality.
IRBs also ensure that appropriate additional safeguards are in place to protect the rights and welfare of vulnerable populations, such as women, children, prisoners, those with mental disabilities, and persons who are economically or educationally disadvantaged. Sometimes these inspections yield evidence of problems, such as in 1993 when FDA imposed penalties on a large California university IRB for infractions that included failure to report deaths. Researcher and subject should discuss the study and the subject's role in it until both are satisfied that the subject can make an informed decision about whether to participate. In July 1993, FDA released new guidelines for including women and minorities in clinical research. The guidelines promote recruitment of women and minority participants and foster understanding of cultural nuances.