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Human Subjects Office Monthly Update

November 18, 2011

Human Subjects Office (HSO) metrics will be made available to the research community on a recurring monthly basis. Data will be posted mid-month to highlight figures from the month prior.

HSO TAT during October 2011
Item Volume of Items Completed in October Mean Turnaround Times
(in Calendar days)
Continuing Reviews 168 40
Amendments 229 64
Exempt Protocols 48 68
Expedited Protocols 51 62
Full Board Protocols 12 79

This chart identifies the mean length of time from submission to the Human Subjects Office (HSO) to the date that approval notification is sent to the researcher. Turnaround times for Co-investigator Updates, External reviews (CIRB, WIRB, etc.), General Information updates, and Closeout requests are not included.

HSO Throughput October 2011
Item # Received # Completed
Continuing Reviews and Closeout Requests 267 223
Amendments and Co-investigator Updates 343 349
Exempt Protocols 76 48
Expedited Protocols 41 51
Full Board Protocols 24 12

This chart illustrates the volume of items received and processed at the HSO. Once a researcher is notified of the approval or closeout, an item is considered "complete" for throughput purposes. It is important to note that not all items have the same level of complexity. Therefore, this may impact the overall throughput data from month to month. This throughput for October includes some of the backlog referenced below. There have been improvements that are not reflected in the October data. For instance, between 10/27/2011 and 11/02/2011, 148 items were received, and 281 items were completed — a significant increase in weekly throughput, and a good indication that HSO is more effectively addressing the backlog of submissions.

UPDATE ON REPORTED BACKLOG
Screener Backlog, October 20 – November 1, 2011
Date Total # up/down (v. baseline) % Change (v. baseline)
10/20 615 Baseline Baseline
10/24 749 134 22%
10/31 563 (52) (8%)
11/8 431 (184) (30%)

"Screener Backlog" includes all items that have been assigned to a screener, but have not yet been reviewed. These figures will vary based on the number of submissions on any given day. This does not reflect all of the items in the HSO queue, but only those that are awaiting screening on any given day.

On October 20, 2011, 615 items were identified as waiting for screening.  We committed ourselves to taking whatever steps were necessary to reduce this long-term backlog by 50% by December 1. As of November 8, 410 of those 615 items had been screened – a reduction of 67%. We continue to work on reviewing items as efficiently as possible to further exceed our stated goal.