Ethical review of research involving human subjects: when and why is IRB review necessary?

Requirements for ethical review of research involving human subjects are based on widely accepted international standards that are implemented by various national regulations and institutional policies. In the United States, most human research is reviewed by institutional review boards (IRBs) applying federal standards. Researchers may not realize the variety of studies that should be submitted for review. Studies involving interventions must be reviewed regardless of whether these are standard interventions, nonmedical interventions, or retrospective studies. Quality improvement activities require IRB review if the results may be published. Research use of information from medical records or of biomedical specimens requires review unless no identifiers are recorded. Review must be sought at least annually and whenever the research changes. Even human research that is technically exempt from Federal regulations usually needs to have that exemption certified by someone other than the researcher. Copyright 2003 Wiley Periodicals, Inc.