National Research Network 2012 Benchmark Report
®
The National Research Network 2012 Benchmark Report pulls together real world performance data from hospitals, universities and
government agencies across the National Research Network. It is provided as a service to the human subject research community to assist
organizations as they benchmark internal performance. The 2012 Benchmark Report includes data sampled from April 2011- March 2012. IRBNet A WIRB-Copernicus Group Company
Copyright Protected © 2013
Background Na$onal Research Network® 2012 Benchmark Report The Na'onal Research Network 2012 Benchmark Report assembles real world performance data from hospitals, universi'es and government agencies across the Na'onal Research Network (NRN). It is provided as a service to the human subject research community to assist organiza'ons as they benchmark internal performance. The 2012 Benchmark Report includes data from more than 100 randomly selected IRBs ac've on the Na'onal Research Network, sampled from April 2011 -­‐ March 2012. Anonymous selec'on was based upon tenure, volume of ac'vity, ins'tu'onal profile, completeness of data and other factors. If you have benchmark report ques'ons, comments, or want to discuss your ins'tu'on's performance, please contact the IRBNet Analy'cs team at benchmark@irbnet.org. About the Data: Ins$tu$onal Research Profile 60% of analyzed research is biomedical in nature; hospitals and universi$es report varied research focus. Overall Profile:
58% Biomedical
Hospital Profile:
85% Biomedical
University Profile:
80% Social/Behavioral
IRBNet Analytics
social / behavioral
15%
biomedical:
non-oncology
22%
social / behavioral
42%
biomedical:
oncology
36%
N = 94
National Research Network 2012 Benchmark
biomedical:
non-oncology
6%
biomedical:
oncology
14%
biomedical:
non-oncology
34%
biomedical:
oncology
51%
N = 56
social / behavioral
80%
N = 38
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Na$onal Benchmark: Days to Review and Approval by Review Type 32% of total $me to first approval by convened review is due to inves$gator errors, omissions and response to commiLee decisions (40% for expedited reviews). IRBNet National Research Network Performance Benchmarks:
Days to Review and First Approval
IRBNet Analytics
47.5
45
number of days
40
35.0
35
32.1
30
25
Administrative
and Expedited /
Convened
Review
25.3
21.1
Investigator
Response to
Committee
Decisions
20
15
22.8
10.6
10
5
0
15.2
2.5
4.8
9.5
6.5
5.7
7.4
14.0
Convened Review: Convened Review: Expedited Review: Expedited Review: Exempt Review:
Submission to
Submission to
Submission to
Submission to
Submission to
Review
Initial Approval 1 Review
Initial Approval 1 Determination 2 National Research Network 2012 Benchmark Report
1 Includes
multiple submissions when
required to obtain initial approval. 2
Investigator
Errors /
Omissions
Errors / Omissions and
investigator
responses less than 0.1
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Na$onal Benchmark: Convened Review Turnaround Time Total convened review $mes are similar across categories; universi$es issue post-­‐review leLers in 6 days. IRBNet National Research Network Performance Benchmarks:
Turnaround Time
IRBNet Analytics
Convened Review
40
number of days
Time to Letter
After Decision
30
20
11.9
12.1
11.2
6.0
14.3
15.0
6.0
Review to
Decision
14.4
Administrative
Pre-Review
7.2
Investigator
Errors /
Omissions
15.1
17.2
10
11.0
10.3
0
2.5
Average
2.2
Hospital
National Research Network 2012 Benchmark Report
7.4
10.7
2.8
2.2
University
Biomedical
4.3
Social / Behavioral
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Na$onal Benchmark: Days to First Approval by Review Type Hospitals approve new studies via convened review at a faster rate than the NRN average. IRBNet National Research Network Performance Benchmarks:
Days to First Approval
IRBNet Analytics
Convened Review Time to First Approval 60 Administrative
Pre-Review and
Convened
Review
number of days
50 40 30 32.1 34.0 32.4 30.7 38.6 Investigator
Response to
Committee
Decisions
20 10 0 12.7 10.6 9.2 4.3 4.7 4.8 5.1 Hospital University Biomedical Social / Behavioral 10.6 9.3 4.8 Average National Research Network 2012 Benchmark Report
Investigator
Errors /
Omissions
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Na$onal Benchmark: Number of Submissions to Obtain Ini$al Approval (Convened Review) 82% of studies approved by convened review required two or less submissions to obtain ini$al IRB approval. IRBNet National Research Network Performance Benchmarks:
Number of Submissions to Obtain Initial Approval
IRBNet Analytics
Convened Review
1800
95%
82%
1400
99%
100%
90%
80%
70%
1200
60%
1000
50%
800
41%
40%
600
% approved
number of submissions
1600
100%
30%
400
20%
200
10%
0
0%
1
2
National Research Network 2012 Benchmark Report
3
4
5+
submissions
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Na$onal Benchmark: Expedited Review Turnaround Time On average, 38% of the $me to complete expedited review is consumed by inves$gator rework of errors and omissions. IRBNet National Research Network Performance Benchmarks:
Turnaround Time
Expedited Review
25
20
Time to Letter
After Decision
3.6
5.8
number of days
IRBNet Analytics
6.3
8.5
5.4
15
Administrative/
Expedited
Review
10
17.3
15.2
15.8
13.5
15.1
5
5.7
4.6
7.4
7.0
Investigator
Rework due to
Errors /
Omissions
3.5
0
Average
Hospital
University
National Research Network 2012 Benchmark Report
Biomedical
Social / Behavioral
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Na$onal Benchmark: Expedited Review Turnaround Time NRN Members complete expedited reviews in 15 days on average. IRBNet National Research Network Performance Benchmarks:
Turnaround Time
IRBNet Analytics
Expedited Review
number of days
25
20
15
Expedited
Review
25.5 10
15.2 13.8 13.5 Continuing Review Other
5
0
Average
New
National Research Network 2012 Benchmark Report
IRBNet A WIRB-Copernicus Group Company © 2013
Na$onal Benchmark: Expedited Review Turnaround Time Errors and omissions average 7 days for new and con$nuing reviews. IRBNet National Research Network Performance Benchmarks:
Turnaround Time
Expedited Review – New and Continuing Review
25
1.6
2.8
3.6
4.5
number of days
Time to Letter
After Decision
1.1
20
Administrative
Pre-Review and
Expedited
Review
15
10
5
23.1
21.4
IRBNet Analytics
22.1
19.8
19.4
11.2
8.0
7.4
4.2
6.6
Investigator
Rework due to
Errors /
Omissions
0
Average
Hospital
National Research Network 2012 Benchmark Report
University
Biomedical
Social / Behavioral
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Na$onal Benchmark: Days to First Approval by Review Type Hospitals approve new studies via expedited review at a faster rate than the NRN average. IRBNet National Research Network Performance Benchmarks:
Days to First Approval
Expedited Review -­‐ Time to First Approval 40 35 IRBNet Analytics
Administrative
Pre-Review and
Expedited
Review
number of days 30 25 21.5 21.1 19.3 22.9 19.8 20 Investigator
Response to
Expedited
Decisions
15 10 5 6.5 8.4 7.5 2.3 5.7 Investigator
Errors /
Omissions
7.4 7.4 7.6 8.0 6.5 Average Hospital University Biomedical Social / Behavioral 0 National Research Network 2012 Benchmark Report
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Na$onal Benchmark: Staffing and Workload NRN members efficiently manage large protocol workloads, with an average of less than 2 Staff FTEs. IRBNet National Research Network Performance Benchmarks:
Staffing and Protocol Workload
IRBNet Analytics
Ins$tu$ons with 100-­‐500 Ac$ve Protocols (Expedited, Convened) Ins$tu$ons with 501-­‐2000 Ac$ve Protocols (Expedited, Convened) Average Number of Protocols 153 684 Average Number of IRB Staff (FTE) 1.5 1.8 Protocols per FTE 105 372 National Research Network 2012 Benchmark Report
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A WIRB-Copernicus Group Company
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