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How long does it take to get IRB approval?

We hear some crazy things about how long it takes to get a study through the IRB. We’ve heard it said, in front of a group of people, that IRB approval could take 6 months. This comment was made with no elaboration of the situation or indication that anyone called the IRB office to ask what was going on with the study.  Rather than just venting to each other within the office, we decided to go check the numbers. CLARA’s many great attributes include its ability to generate reports regarding review times and to allow research teams to see exactly where a study is in the review process.

So we present cold hard data from CLARA and let’s face it — data is the heart and soul of research.  Below are the median (half take less time, half take longer) numbers of days a study spends at the IRB, along with the range of values for each measure, broken down by type of study review. These data show the time from IRB submission to IRB approval for new studies since CLARA was instituted in April 2013. CLARA “days” include weekends and holidays, not just workdays.  The expected IRB review times are listed on the IRB website.  If for some reason you are outside the expected review times or especially the “Time on IRB side” median below, call us and we’ll figure out what the status is and why.

Please note that IRB submission is only one step in the review process, and other institutional reviews prior to IRB review may precede the IRB’s receipt of a new submission. Those other reviews, which are outside the IRB’s control, may lengthen the overall approval time. Items that are in the IRB review process will be listed in CLARA as under review by the IRB Assigner, IRB Office, IRB Pre-Review, IRB Consent Review, IRB Expedited, IRB Exempt, IRB Reviewer (Full Board Review).

Full Board Review Studies (72 Studies total)

 

Median Time (days)

Range (days)

IRB Review to Approval Time (total)

31

10 – 127

Time on IRB side

23

9 – 43

Time on PI side (e.g. PI responding to contingencies)

5

1 – 99

Expedited Review Studies (209 Studies total)

 

Median Time (days)

Range (days)

IRB Review to Approval Time (total)

13

1 – 236

Time on IRB side

10

1 – 30

Time on PI side (e.g. PI responding to contingencies)

1

1 – 211

Exempt Status Studies (59 Studies total)

 

Median Time (days)

Range (days)

IRB Review to Approval Time (total)

5

1 – 95

Time on IRB side

3

1 – 23

Time on PI side (e.g. PI responding to contingencies)

1

1 – 93