IRB Protocol Review Times

Dear Colleagues, We would like to keep you up to date on how long it is taking the IRB to review various types of submissions. We are going to do that by updating the table and graph below on a monthly basis. The table displays the number of days (median and range) from date of submission until date of final determination (approval or rejection) for submissions that reached a final determination in November 2012. Some types of review require that the submission be sent back and forth between the IRB and the investigator. For your interest, we show how much time submissions spend in the IRB office versus in the investigator’s office. We are not satisfied with these current review times. We are working hard to accelerate the pace and shorten these times. Check back next month to see our progress. James Feldman, M.D., IRB Chair Lynn Borgatta, M.D., IRB Chair Sanford Auerbach, M.D., IRB Chair David Kaufman, Sc.D., IRB Chair Mary Banks, IRB Director

Review Time for Submissions that Reached Final Determination during November 2012
Number Days from submission until final determination* Days in IRB office* Days in investigator’s office*
New Protocols
Full-board 14 43 (8-146) 27 (8-55) 10 (0-91)
Expedited 14 32 (4-288) 19 (4-105) 6 (0-183)
Exempt 20 19 (2-223) 12 (2-68) 2 (0-156)
Progress reports
Full-board 22 40 (3-93) 37 (3-91) 0 (0-17)
Expedited 75 50 (2-115) 50 (2-87) 0 (0-38)
Amendments
Full-board 15 21 (8-62) 20 (2-48) 0 (0-14)
Expedited/Exempt 58 12 (0-77) 11 (0-77) 0 (0-32)

* These columns show the median number of days (and range). Slide 1

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