Levels of Review

Full Board

  • More than minimal risk to participants
  • Not covered under other review categories

Example: Interventions involving physical or emotional discomfort or sensitive data

Expedited

  • Not greater than minimal risk
  • Fits one of the 9 expedited review categories

Example: Collection of biospecimens by noninvasive means, research with existing documents or records collected for non-research purposes where participants are identifiable

Exempt

  • Less than minimal risk
  • Fits one of the 6 exempt categories
  • Fits additional Flex Policy* exemption

Example: Research with de-identified records, anonymous surveys

Flex Policy*

  • For studies that are no greater than minimal risk
  • For studies with no federal funding
  • Provide equivalent protections to subjects commensurate with risk level