Human Participants (IRB)
University policy and federal law (45 CFR 46) require that all research involving living human subjects be reviewed and approved by an institutional review board (IRB). Universities and other research institutions agree to follow the federal regulations through a written assurance with the Office of Human Research Protections (OHRP),U.S. Department of Health and Human Services (HHS). The assurance document is called the Federalwide Assurance (FWA).
By signing its FWA, the University has commited itself to upholding the Code of Federal Regulations and the ethical principles of the Belmont Report for all research involving human subjects conducted by University faculty, staff, and students. As defined by 45 CFR 46, the Common Rule, there are three levels of appropriate human subjects review: exempt from the HHS policy; expedited review; and full board review. The level depends on the nature of the research, who the subjects will be and how much risk they will experience. For information on how to decide which type of review may be required, see the IRB section.