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Human Subjects Division (HSD)

Quick Tips from HSD

Expedited Review

Jan 10, 2012 at 12:00am

I'm in a hurry, so I want to choose Expedited Review, right?

Maybe not!

Expedited review is a review process defined by the federal regulations that allows for a research study to be reviewed by the IRB committee chair, or by one or more review members designated by the chair, rather than the full convened IRB.  Despite its name, expedited review is not necessarily quicker than review by a full IRB committee.  The most important factor for efficient review is the researcher providing complete and accurate information within the application.

Okay, so it's not necessarily quicker.  What qualifies for Expedited Review?

The UW Human Subjects Division uses Expedited Review interchangeably with Minimal Risk Review because to qualify for expedited review, a study must first meet the regulatory definition of Minimal Risk: "...the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."

In addition to being no more than minimal risk, all study procedures must fall into one or more of the research categories in this regulatory list: http://www.hhs.gov/ohrp/policy/expedited98.html.  If the procedures do not fit into this list, the study cannot receive expedited review even if it is no more than minimal risk.

Got it, but I'm always sending in the wrong number of copies. What's up with that?

Because of differences in filing systems between the minimal risk teams and the full committee teams at HSD, new applications for expedited review should be submitted as two copies only - not the three copies required for new full-IRB applications.  You should also send in two copies of modifications and status reports.

Sometimes a study under full IRB review can have expedited review of its modifications and status reports, performed by the staff of the full IRB.  If your study was initially reviewed and approved by a full IRB, all modifications and status reports must be submitted in three copies.  The review team will decide whether a given modification or status report requires full-IRB review or is expeditable.