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 third quarter of 2019. 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, here are 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 74 days, 20 days, and 16 days respectively.

James Feldman, MD, IRB Chair

Stephen Pelton, 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 2019
Number Days from
submission until
final determination*
Days in IRB office* Days in
investigator’s office*
New Protocols
Full-board 13 51 (1-122) 27 (1-51) 13 (0-95)
Expedited 29 3 (0-48) 3 (0-48) 0 (0-0)
Exempt 148 7 (0-119) 7 (0-119) 0 (0-0)

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

User Satisfaction January 1, 2019, through June 30, 2019

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, 2019,
and June 30, 2019 (survey response n=163, 40%). 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

These scores are generally comparable to the previous time period. The INSPIR platform (question 6)
remains our area of greatest concern. We continue to improve the INSPIR system to try to make it more

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

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



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.
82% (81%) 16% (18%) 1% (0%) 0% (0%) 2% (1%)
Q2 In reviewing this protocol,
the IRB dealt with me professionally and respectfully.
54% (63%) 6% (5%) 0%(0%) 0% (0%) 40% (32%)
Q3 Given the details of this
protocol, this review time was acceptable.
60% (66%) 31% (27%) 9% (5%) 1 % (1%) 0% (1%)
Q4 For this protocol, the IRB
focused on helping me overcome regulatory challenges rather than just pointing out regulations.
36% (44%) 11% (7%) 0% (1%) 0% (0%) 53% (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% (63%) 20% (18%) 1% (1%) 1% (1%) 16% (16%)
Q6 For this protocol, I found
the INSPIR software platform understandable and easy to use.
27% (31%) 50% (56%) 17% (11%) 5% (2%) 1% (1%)

The numbers in parentheses represent the ratings from the July-December 2018 survey.