09. Exemption Review

09. Exemption Review

09. Exemption Review

Exempt studies are so named because they are exempt from some of the federal regulations (refer to §46.101). However, they are not exempt from state laws, institutional policies, or the requirements for ethical research.  UAB policy does not allow investigators to self-exempt their human subjects research.  Instead, determining if a project is exempt is an administrative review process handled by the Office of the IRB.
Only the IRB can assign Exempt status.
In order to obtain an exempt designation, the investigator must
  • Determine that the proposed research activity fits entirely within one or more of the six categories of exemption.
  • Obtain departmental Protocol Oversight Review.
  • Maintain all current IRB Human Subjects training.
  • Submit an IRB Exemption Review Application. 
  • Fully describe the project so that the exemption criteria are clearly addressed, the reviewer can understand (i.e., lay language) the project being proposed, and the procedures and methodology are complete.
  • Respond to requests for further information from the reviewer
NOTE:  Any changes, additions, and deletions after the IRB exempt determination must be approved by the IRB before implementation of the changes.
There are no deadlines for submission
of an Application for Exemption Review.

Decision Trees 

OHRP has published decision trees to help in determining whether a research proposal fits the criteria for Exempt, Expedited, or Full review. The charts are available online to help investigators determine whether their proposed research may be eligible for exemption.

 

Form

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