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IRB Review Times and User Satisfaction

For information on how long it is taking the IRB to review various types of submissions, the table and graph below are updated every quarter. The table displays the number of days (median and range) from date of submission until date of final determination (approval or disapproval) for submissions that reached a final determination during the fourth quarter of 2023. Since some review processes require that the submission be sent back and forth between the IRB and the investigator, the number of days that submissions spend in the IRB office and the number of days that submissions spend in the investigator’s office are also presented.

James Feldman, MD, IRB Chair

Stephen Pelton, MD, IRB Chair

David Kaufman, ScD, IRB Chair

Sanford Auerbach, MD, IRB Chair

Jamie Merrill, MPH, CIP, IRB Director

Review Times for Submissions that Reached Final Determination During the Fourth Quarter of 2023
Number of reviews Median days
(range) from
submission
until final determination
Median days (range) in IRB office Median days (range) in
investigator’s office
New Submissions
Full-board 9 51 (7-493) 30 (7-53) 12 (0-442)
Expedited 23 11 (0-70) 11 (0-70) 0 (0-0)
Exempt 118 11 (0-55) 11 (0-55) 0 (0-0)

The 75th percentile data, which is how long the IRB takes to finalize the review of 75% of all submissions by type of review are also calculated for each quarter. For the fourth quarter of 2023 the results are: 64 days for full-board, 23 days for expedited, 74 days for ceded reviews, and 23 days for exempt reviews.

User Satisfaction July 1, 2023, through December 31, 2023

When the IRB makes a determination on a new submission (either approve, 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 July 1, 2023 and December 31, 2023 (survey response n=115, 32%). A brief description of each question is shown in the left column. The numbers in parentheses are the responses from the previous time period (January 1, 2023 to June 30, 2023).

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 user-friendly.

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

Jamie Merrill, MPH, CIP
IRB Director

Description Strongly Agree Agree Disagree Strongly Disagree
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.
89% (85%) 9% (14% 2% (1%) 1% (0%)
Q2 In reviewing this protocol,
the IRB dealt with me professionally and respectfully.
90% (93%) 10% (7%) 0% (0%) 0% (0% )
Q3 Given the details of this protocol, this review time was acceptable. 52% (53%) 38% (32%) 6% (8%) 3% (7%)
Q4 For this protocol, the IRB focused on helping me overcome regulatory challenges rather than just pointing out regulations. 89% (82%) 11% (14%) 0% (3%) 0% (0%)
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.
74% (71%) 24% (27%) 2% (2%) 0% (0%)
Q6 For this protocol, I found the INSPIR software platform understandable and easy to use. 48% (41%) 38% (48%) 9% (8%) 5% (3%)

The numbers in parentheses represent the ratings from the January-June 2023 survey.