The primary set of federal regulations governing IRB review of human subjects research is the Common Rule, 45 CFR 46. An institution indicates its commitment to comply with the Common Rule via its Federalwide Assurance (FWA). When completing the FWA, the institution elects whether it will apply the Common Rule to all human subjects research conducted by the institution or only to human subjects research supported by the federal government. Institutions are permitted to “uncheck the box” indicating that the requirements of the Common Rule may not be applied to research that is not federally funded or regulated. IU elected to “uncheck the box” in 2010. Currently, all institutions for which IU IRB serves as the IRB of record have “unchecked the box” on their FWA.
If an institution has unchecked the box, it has flexibility to apply human subjects protections commensurate with risk rather than applying the federal regulations to all research. Most important, flexibility is not a lessening of protection offered to human subjects but rather the application of protections that are different from but equivalent to the protections offered by the Common Rule. The SOPs detail the equivalent protections applied to research approved under the flexibility initiatives. This includes consideration of the ethical principles of the Belmont Report, assessment of risks to subjects, and ensuring appropriate protections for subject privacy and confidentiality.