National Research Network 2011 Benchmark Report

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1 National Research Network 211 Benchmark Report The National Research Network 211 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 211 Benchmark Report includes data sampled from April 21 - March 211. IRBNet 211

2 Background Na$onal Research Network 211 Benchmark Report The Na'onal Research Network 211 Benchmark Report pulls together 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 211 Benchmark Report includes data from 69 randomly selected ins'tu'ons ac've on the Na'onal Research Network, sampled from April 21 - March 211. Anonymous selec'on was based upon tenure, volume of ac'vity, ins'tu'onal profile, completeness of data and other factors.

3 About the Data: Ins$tu$onal Research Profile 6% of analyzed research is biomedical in nature; hospitals and universi$es report varied research focus. Overall Profile: 6% Biomedical social / behavioral 4% Hospital Profile: 89% Biomedical social / behavioral 11% University Profile: 69% Social/Behavioral biomedical: non-oncology 12% biomedical: non-oncology 24% biomedical: oncology 36% biomedical: non-oncology 35% biomedical: oncology 54% biomedical: oncology 19% social / behavioral 69% N = 69 N = 44 N = 25 National Research Network 211 Benchmark Report 211

4 Days to and Approval by Type 32% of total $me to first approval for convened review projects is due to inves$gator errors, omissions and response to commimee decisions (38% for expedited reviews). Days to and First Approval Convened : Submission to Convened : Submission to Initial Approval National Research Network 211 Benchmark Report 14.7 Expedited : Submission to 36.1 Expedited : Submission to Initial Approval 13.7 Exempt : Submission to Determination Includes multiple submissions when required to obtain initial approval. Administrative and Expedited / Convened Response to Committee Decisions Errors / Omissions 2 Errors / Omissions and investigator responses less than.1 211

5 Convened Total convened review $mes are similar across categories; universi$es issue post- review lemers in 4 days. 4 Convened Time to Letter After Decision to Decision Administrative Pre Average Hospital University Biomedical Social / Behavioral National Research Network 211 Benchmark Report Errors / Omissions 211

6 Days to First Approval by Type Hospitals approve new studies via convened review at a faster rate than the na$onal average. Days to First Approval 7 Convened 6 5 Administrative Pre- and Convened Response to Committee Decisions Errors / Omissions Average Hospital University Biomedical Social / Behavioral National Research Network 211 Benchmark Report 211

7 Number of Submissions to Obtain Ini$al Approval (Convened ) 18% of studies approved by convened review required three or more submissions to obtain ini$al IRB approval. Number of Submissions to Obtain Initial Approval number of submissions % Convened 82% National Research Network 211 Benchmark Report % 99% 1% submissions 1% 9% 8% 7% 6% 5% 4% 3% 2% 1% % % approved

8 Expedited On average, 23% of the $me to complete expedited review is consumed by inves$gator rework of errors and omissions. 25 Expedited Average Hospital University Biomedical Social / Behavioral Time to Letter After Decision Administrative/ Expedited Rework due to Errors / Omissions National Research Network 211 Benchmark Report 211

9 Expedited NRN Members complete expedited reviews in less than 15 days on average. 25 Expedited Expedited 5 Average New Continuing Other National Research Network 211 Benchmark Report 211

10 Expedited Errors and omissions average more than 5 days for new and con$nuing reviews. 25 Expedited New and Continuing Time to Letter After Decision Administrative Pre- and Expedited Rework due to Errors / Omissions Average Hospital University Biomedical Social / Behavioral National Research Network 211 Benchmark Report 211

11 Days to First Approval by Type Hospitals approve new studies via expedited review at a faster rate than the na$onal average. Days to First Approval Expedited Administrative Pre- and Expedited Response to Expedited Decisions Errors / Omissions Average Hospital University Biomedical Social / Behavioral National Research Network 211 Benchmark Report 211

12 Staffing and Workload NRN members efficiently manage large protocol workloads, with an average of only 3 Staff FTEs. Staffing and Protocol Workload Average Number of Protocols Average Number of IRB Staff (FTE) Protocols per FTE Ins$tu$ons with 1-5 Ac$ve Protocols (Expedited, Convened) Ins$tu$ons with 51-1 Ac$ve Protocols (Expedited, Convened) National Research Network 211 Benchmark Report 211

13 If you would like to automa$cally receive future copies of Na$onal Research Network Benchmark Reports you may submit your request to

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