Department of Health and Human Services Rules Governing Institutional Review Boards:


Determination of Type of Review

In order to determine the type of review necessary, the chair or his/her designee screens the entire application and makes determinations as to whether the project constitutes human subjects research and, if so, the type of review required. All applications are assigned to be reviewed at a convened meeting unless (1) they meet the criteria for expedited review or, (2) they meet the criteria for exemption, as explained below.

Exempted

  • Reviewed by IRB Chair and one other member
  • Possible outcomes
    • Exemption certified
    • Certified contingent upon specific modification/clarification
    • Referred for expedited or full IRB review

Expedited

  • Reviewed by IRB Chair and at least two other members
  • Possible outcomes
    • Approved
    • Approved contingent upon specific modification/clarification
    • Referred for full IRB review

Full

  • Reviewed by full IRB
  • Possible outcomes
    • Approved
    • Approved contingent upon specific modification/clarification
    • Not Approved