IRB Review Times and User Satisfaction

Review Times

Dear Colleagues,

To keep you up to date on how long it is taking the IRB to review various types of submissions, we update 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 August, 2014. Some types of review require that the submission be sent back and forth between the IRB and the investigator. So we also show the number of days that protocols spend in the IRB office versus in the investigator’s office. Check back next month to see our progress.

James Feldman, M.D., IRB Chair

Colin Marchant, M.D., IRB Chair

David Kaufman, Sc.D., IRB Chair

Sanford Auerbach, M.D., IRB Chair

John Ennever, M.D., Ph.D., IRB Director

Review Time for Submissions that Reached Final Determination during August, 2014
Number Days from submission until final determination* Days in IRB office* Days in investigator’s office*
New Protocols
Full-board 11 51 (31-135) 32 (20-47) 14 (0-100)
Expedited 21 4 (0-21) 4 (0-21) 0 (0-0)
Exempt 33 5 (0-36) 5 (0-36) 0 (0-20)
Amendments
Full-board 9 33 (15-63) 33 (15-57) 0 (0-10)
Expedited/Exempt 101 5 (0-73) 5 (0-38) 0 (0-36)

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

Microsoft PowerPoint - graph Dec11-Aug14

 

User Satisfaction

User Satisfaction: December 1, 2013 through June 30, 2014

Beginning on December 1, 2013, we have asked the principal investigator (PI) of each protocol that the IRB has made its final determination on (either approve, defer, or disapprove) to complete a 6-question online survey. The brief survey allows the PI to comment on various aspects of the review of that specific protocol. In the table below, we have summarized the responses of the 158 surveys that have been completed to date. A brief description of each question is shown in the left column.

We plan to use the satisfaction data to help the IRB identify areas where there is room for improvement.

 

Description Strongly Agree Agree Disagree Strongly Disagree Not Applicable
Q1 The primary role of the IRB is to protect the rights and safety of human subjects. In reviewing this protocol, the IRB was appropriately focused on this role. 60% 35% 2% 3% 1%
Q2 In reviewing this protocol, the IRB dealt with me professionally and respectfully. 73% 26% 1% 1%
Q3 Given the details of this protocol, this review time was acceptable. 56% 32% 4% 3%
Q4 For this protocol, the IRB focused on helping me overcome regulatory challenges rather than just pointing out regulations. 56% 36% 4% 3%
Q5 The IRB often requests modifications or clarifications from investigators before they can approve a protocol. For this protocol, those requests were clear, and I understood what the IRB was asking me to do. 42% 40% 4% 3% 11%
Q6 For this protocol, I found the INSPIR software platform understandable and easy to use. 16% 51% 23% 9% 0%
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of BU School of Medicine