IRB Review Levels

There are three levels of review: Full Board, Expedited and Exempt

Full Board Review

Federal regulations require that research projects involving human subjects be reviewed by an IRB. The IRB must approve or determine the project to be exempt prior to the start of any research activities. The IRB cannot provide retroactive approval or determinations for research activities that have already taken place.

IRB review and approval is required for projects that:

  • Meet the definition of research
  • Involve human subjects and
  • Include any interaction or intervention with human subjects or involve access to identifiable private information

Expedited Research

Research that involves no more than minimal risk and falls into one of the following categories may be expedited through the IRB approval process. Contact if you have any questions. 

Exempt Research

Research that falls into one of the following categories is exempt from the requirement for formal IRB approval. The research must still be submitted to and reviewed by the COMIRB office. If COMIRB agrees the research is eligible for exemption, an exempt certification will be issued.

IRB reliance is not possible for research found to be exempt. Other sites should seek exempt determination from their own IRBs.

Research enrolling prisoners is not eligible for exemption, except for research aimed at involving a broader subject population that only incidentally includes prisoners.

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