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 2015. 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.

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, 2015
Number Days from submission until final determination* Days in IRB office* Days in investigator’s office*
New Protocols
Full-board 4 43 (24-69) 32 (13-35) 16 (2-34)
Expedited 15 11 (0-101) 11 (0-38) 0 (0-63)
Exempt 33 7 (0-26) 7 (0-26) 0 (0-0)
Amendments
Full-board 9 21 (10-83) 21 (10-40) 0 (0-43)
Expedited/Exempt 60 9 (0-38) 9 (0-33) 0 (0-24)

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

Dec11-August15

User Satisfaction

January 1, 2015 through June 30, 2015

When the IRB makes a determination on a new protocol (either approve, defer, or disapprove), we ask the principal investigator (PI) to complete a 6-question online user satisfaction survey. This brief survey allows a PI to comment on various aspects of the review of that specific protocol. In the table below, we have summarized the responses from the 216 surveys that were completed between January 1, 2015 and June 30, 2015 (survey response rate = 51%). A brief description of each question is shown in the left column.

These scores are very similar to the responses from our July-December, 2014 survey. Respondents this time were slightly more satisfied with the IRB’s focus on protecting subjects and the IRB’s respectful behavior (questions 1 and 2).  They were slightly less satisfied with review times (question 3), although actual review times were very similar in the two survey periods. The INSPIR platform remains our area of greatest concern. We are in the process of modifying the INSPIR application to address some of the complaints users have made. We hope that will lead to greater user satisfaction in our next survey.

Thanks to all of you who cooperated by filling out this survey.

Tom Moore, MD

Director, Office of Clinical Research

 

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. 77% 22% 0% 0% 1%
Q2 In reviewing this protocol, the IRB dealt with me professionally and respectfully. 63% 8% 0% 0% 28%
Q3 Given the details of this protocol, this review time was acceptable. 65% 30% 5% 0% 1%
Q4 For this protocol, the IRB focused on helping me overcome regulatory challenges rather than just pointing out regulations. 38% 14% 1% 0% 46
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. 51% 26% 3% 0% 20%
Q6 For this protocol, I found the INSPIR software platform understandable and easy to use. 28% 50% 16% 5% 0%
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of BU School of Medicine