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Human Subjects Division (HSD)

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IRB Review and Determinations/Actions

Does all research receive the same review?

Research is reviewed according to the potential level of risk to subjects and federal regulatory guidelines. Research that:

  • Poses more than minimal risk to subjects undergoes a review process that involves the full IRB committee.
  • Is considered minimal risk according to the federal regulations and can be reviewed using an expedited process in which the IRB application is assigned to a subcommittee of the IRB.
  • Qualifies for exempt status under one or more of the federally-defined categories receives administrative review.

Note: Full IRB and Minimal Risk review use the same criteria for approval.

 

What can the IRB do?

The IRB has the authority to make specific determinations:

  • that activity IS or IS NOT research.
  • Human subjects ARE or ARE NOT involved, and
  • that research qualifies for Exempt Status.

The IRB also has the authority to take the following actions related to human subjects research:

  • Approve
  • Conditionally Approve
  • Defer
  • Disapprove
  • Require corrective actions
  • Suspend or terminate parts or all of a study

 

How long does review take?

Key Performance Metrics of the IRB review process, including turn-around times and other measures, are posted quarterly to the HSD website.

Change Notes

  • Noted 07/30/2010 @ 10:38am
    Keyword newly added.
    - selsayed