IRB Review Times and User Satisfaction

Review Times

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 every quarter. 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 during the second quarter of 2016. 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.

In addition to these median data, we would like to show the 75th percentile data.  That is, how long did the IRB take to finalize the review of 75% of all submissions.  For full-board, expedited, and exempt reviews, the 75th percentile review times were 65 days, 7 days, and 10 days respectively.

James Feldman, MD, IRB Chair

Colin Marchant, MD, IRB Chair

David Kaufman, ScD, IRB Chair

Sanford Auerbach, MD, IRB Chair

John Ennever, MD, PhD, Director, Human Research Protection Program

Review Time for Submissions that Reached Final Determination During the Third Quarter of 2016
Number Days from
submission until
final determination*
Days in IRB office* Days in
investigator’s office*
New Protocols
Full-board 27 42 (7-142) 29 (7-72) 7 (0-118)
Expedited 36 3 (0-40) 3 (0-23) 0 (0-23)
Exempt 143 2 (0-113) 2 (0-113) 0 (0-19)
206 3 (0-142) 3 (0-113) 0 (0-118)

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

Slide 1

 

User Satisfaction

January 1, 2016 through June 30, 2016

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 surveys that were completed between January 1, 2016, and June 30, 2016 (survey response n=154, 42%).  A brief description of each question is shown in the left column.  The numbers in parentheses are the responses from the previous time period (July-December, 2015).

These scores are generally comparable to the previous time period.  The INSPIR platform (question 6) remains our area of greatest concern. We continue to modify the INSPIR questions to make them easier to understand and to complete.

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

John Ennever, MD, PhD
Director, Human Research Protection Program

Thomas J. Moore, MD
Executive Director, Office of Human Research Affairs

 

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. 87% (88%) 11% (10%) 1% (0%) 1% (0%) 1% (1%)
Q2 In reviewing this protocol, the IRB dealt with me professionally and respectfully. 58% (64%) 6% (4%) 0% (0%) 0% (0%) 35% (31%)
Q3 Given the details of this protocol, this review time was acceptable. 75% (75%) 20% (19%) 3% (4%) 2% (0%) 1% (2%)
Q4 For this protocol, the IRB focused on helping me overcome regulatory challenges rather than just pointing out regulations. 41% (42%) 13% (10%) 0% (0%) 0% (0%) 45% (48%)
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. 62% (60%) 19% (14%) 2% (3%) 0% (0%) 16% (22%)
Q6 For this protocol, I found the INSPIR software platform understandable and easy to use. 34% (37%) 45% (40%) 16% (16%) 3% (6%) 1% (1%)

The numbers in parentheses represent the ratings from the July-December, 2015 survey.

Primary teaching affiliate
of BU School of Medicine