1 Multiple Reporting LinesStacy Pritt, DVM, MS, MBA, CPIA, DACAW Director, IACUC

2 Effectively manage regulatory support staff The Challenge Effectively manage regulatory support staff Support regulatory compliance, animal welfare, research, and volunteers (IACUC members) Ensure that the IACUC (committee & staff) have the appropriate resources Minimize self-imposed regulatory burden Minimize conflicts of interest

3 Separate Reporting Lines Model Single Reporting Line ModelReporting Structures Separate Reporting Lines Model Single Reporting Line Model

4 Advantages & Disadvantages for the Separate Reporting LinesSynergies with other regulatory groups Separate budget Disadvantages Lack of animal research expertise May contribute to self-imposed regulatory burden Strategic goals not aligned Synergies with other groups can include working together for process improvement and decreasing self-imposed regulatory burden, sharing costs of software licensure, access to various software systems, having consolidated training and on-boarding efforts, input on institutional research policies Meeting space access Documentation systems, administrative support Separate budget – not beholden to animal populations as IACUC protocol count may not follow trends of animal population trends Lack of animal research expertise especially for programs with small protocol counts, say less than 100, it may not be enough to have an FTE dedicated to the IACUC, no impetus for developing the animal expertise hard to develop the expertise when in a different organizational arm lack of animal expertise means that its heard for staff to do pre-review which causes a lot of burden on IACUC members and veterinarians No support to go to animal research focused meetings such as PRIMR or AALAS Not doing environmental scanning An effective director, AVP, VP could mitigate this Regulatory burden – too many things borrowed from the IRB and IBC, especially when they tend to be larger, that create self-imposed regulatory burden on the IACUC program Strategic goals not aligned – many animal research departments want to decrease regulatory burden but that could be perceived as a threat to jobs, do separate research regulatory departments have that same goal especially when many institutions tend to be research averse, animal research oversight may get short-changed for administrative support due to larger human research programs

5 Variations in Reporting StructuresResearch Administration Research Administration or Compliance may not report to the IO VPR (that may not have oversight of research compliance) IACUC Chair IACUC Office can directly report to the IO Quality Assurance (Industry) The IACUC may report into a research administration office which is separate from research compliance Many research compliance offices do not want to deal with animal research

6 Mouse centric with >67,000 cagesUTSW 300 PIs 820 Protocols IACUC Staff of 8 ARC Staff of 215 >220,000 sq. ft. Mouse centric with >67,000 cages

7 UTSW Previous & Current Organizational Structures

8 UTSW Previous & Current Organizational Structures

9 UTSW Previous & Current Organizational Structures

10 UTSW Previous & Current Organizational Structures

11 Access to campus-wide information Disadvantages Previous Structure Advantages Synergies Access to campus-wide information Disadvantages Repetition of information Lack of information Lack of goal alignment Increase in burden

12 Current Structure AdvantagesElimination of multiple lines of communication for the IACUC Alignment with ARC for goals, resources, information Allows for a separate professional path for IACUC staff Separate budget Keeps veterinarians out of compliance, but increases communication May decrease self-imposed regulatory burden Decrease self-imposed regulatory burden – multiple offices and staff members looking at all parts of the animal research processes

13 Current Structure DisadvantageFragmented research administration Have to ask for information previously provided

14 Combining the Best Approaches

15 Survey Results

16 Self-Imposed Regulatory Burden (Survey)#1 – Applying same standards to all species #2 – Disconnect between various groups (IACUC, AV, IBC) #3 – Protocol form Same rankings for both Diplomates & IACUC Admin Listserv

17 Program Size (Protocols)ACLAM Diplomates IACUC Listserv

18 Summary No “best practice”

19 Summary

20 Multiple models may work well Summary No “best practice” Multiple models may work well Unexplored topic – does program size or focus help predict which model works best? Trend towards IACUC offices reporting separately to IO Stems from compliance issues

21 Well functioning IACUC Similar risk tolerance Keys to Success Well functioning IACUC Similar risk tolerance Work to decrease self-imposed regulatory burden using the principles of process improvement and change management Create a culture of success for the PI