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 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 first 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.

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 First Quarter of 2016
Number Days from
submission until
final determination*
Days in IRB office* Days in
investigator’s office*
New Protocols
Full-board 28 38 (1-653) 27 (1-77) 12 (0-576)
Expedited 60 7 (0-253) 6 (0-59) 0 (0-239)
Exempt 111 5 (0-79) 5 (0-79) 0 (0-13)
199 8 (0-653) 7 (0-79) 0 (0-576)

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

Slide 1

 

User Satisfaction

July 1, 2015 through December 31, 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 299 surveys that were completed between July 1, 2015, and December 31, 2015 (survey response n=134, 45%). A brief description of each question is shown in the left column.

These scores are somewhat more favorable than the responses from our Jan-June 2015 survey period. Respondents this time were slightly more satisfied with the IRB’s focus on its appropriate role, the protocol review time, and the clarity of the IRB’s requests for revisions (questions 1, 3, and 5). Responses were positive but unchanged for questions 2 and 4. The INSPIR platform (question 6) remains our area of greatest concern. But respondents were generally more satified with INSPIR this time. We had made a number of changes to INSPIR in November, so perhaps these improved satisfaction scores reflect those changes.

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. 88% (77%) 10% (22%) 0% (0%) 0% (0%) 1% (1%)
Q2 In reviewing this protocol, the IRB dealt with me professionally and respectfully. 64% (63%) 4% (8%) 0% (0%) 0% 31% (28%)
Q3 Given the details of this protocol, this review time was acceptable. 75% (65%) 19% (30%) 4% (5%) 0% (0%) 2% (1%)
Q4 For this protocol, the IRB focused on helping me overcome regulatory challenges rather than just pointing out regulations. 42% (38%) 10% (14%) 0% (1%) 0% (0%) 48% (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. 60% (51%) 14% (26%) 3% (3%) 0% (0%) 22% (20%)
Q6 For this protocol, I found the INSPIR software platform understandable and easy to use. 37% (28%) 40% (50%) 16% (16%) 6% (5%) 1% (0%)

The numbers in parentheses represent the ratings from the Jan-June, 2015 survey.

Primary teaching affiliate
of BU School of Medicine