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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 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.