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Human Subjects

Regulatory Flexibility

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.

Regulatory Flexibility Options
IU’s regulatory flexibility options include additional Exempt categories and extended approvals. To be eligible for these flexibility options, research must meet the following requirements:

  • All research procedures are minimal risk,
  • The research is not directly or indirectly funded by any federal agency,
  • The research is not subject to FDA regulations, and
  • The research is not subject to VA research regulations.

Depending on the particular flexibility initiative, additional restrictions may also be in place. For example, research subject to HIPAA and research enrolling prisoners cannot be reviewed as exempt even if it would otherwise qualify. The specific parameters of each flexibility initiative are fully described in the SOPs.

Additional Exempt Categories

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Extended Approval

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Determining Whether Your Study Qualifies for Exempt Flex Review

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How to Submit a Study for Exempt Flex Review

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What If My Eligibility for Flexibility Changes After Approval?

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