Sharing of Acceptable Performance Standards

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1 Sharing of Acceptable Performance Standards Steven M. Niemi, DVM, DACLAM Washington, DC April 21, 2015

2 For the Record The opinions in this presentation are mine alone, and may not reflect those of this venue s host, current or past employers, professional affiliations, colleagues, family or anyone else I ever met. I have no commercial or financial conflicts to declare. Vendors are named only for example purposes, and their mention does not imply an endorsement of any products or services.

3 Today s Remarks Why PS sharing is vital (literally) PS examples and outcomes A framework for PS sharing

4 (

5 In 1995 constant $ (CPI)

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7 R01-Equivalent grants, New (Type 1) Success rates, by career stage of investigator

8 What If? FY14 NIH RPG & RO1 awards $25.9B for 14,404 awards (ave $1.8M/yr) Est. animal care direct expenses ~1.67% of academic institutional research budget (~$430M) Est. 20% of $ wasted on unnecessary engineering standards and convention ( $86M, ~48 additional awards)

9 Percentage of NIH R01 Equivalent Principal Investigators of All Degrees: Age 35 and Younger vs. Age 66 and Older Fiscal Year

10 The Graying of Academic Science

11 The Graying of Academic Science

12 What About the Future? FY14 NIH new investigator awards = $250K/yr Est. animal care direct expenses ~1.67% of total academic institutional research budget ( $430M) Est. 20% of $ wasted on unnecessary engineering standards and convention ( $86M, ~215 additional 60% F&A burden)

13 Valuing Performance Standards* Financial relief: $ for science, shareholders Environmental relief: energy consumption, waste Compliance relief:

14 How to Start? Ask four simple questions: 1. Are we doing things right? 2. If so, what would be even better*? 3. Are we doing the right things? 4. If not, what would be even better*? * faster, easier, more humane, cheaper, safer, less mistakeprone, etc. (i.e., OK even if animal welfare unchanged)

15 How to Start? Ask four simpler questions: 1. What are we doing that s wasteful? 2. What are we doing that s dangerous? 3. What are we doing that s error-prone? 4. What are we doing that s stupid?

16 What s Wrong With This Picture? Air showers + rodent microisolator technique? 30 sec/shower x 10 techs x 3X/day x 260 days = $1,500/year in labor costs

17 What s Wrong With This Picture? PPE + rodent microisolator technique? or

18 Before and After

19 Standardizing the Definition of a Dirty Soiled Rodent Cage Julieanne Brandolini B.S., LAT Stefanie Gentile B.S., LAT Felisberto Pina Donna Matthews Jarrell, DVM, DACLAM Center for Comparative Medicine Massachusetts General Hospital Charlestown, MA American Association for Laboratory Animal Science 60th Annual Meeting, Denver Colorado PS # 30, November 10, 2009

20 Implications 30% of cages didn t need changing at scheduled cycles (27,000 mouse cages, 85% IVC, 15% static) Lean: labor by >8,000 hrs (4 FTE)/year Green: >242K changes/yr avoided/delayed Serene: Mice disturbed less often

21 More Animal Care Options Don t sterilize rodent barrier caging, racks Sterilize incoming bedding only Allow 20%RH in rodent barrier rooms during frigid weather Primary enclosures 30%RH Maintain 6 fresh air changes/hr Routine care for non-toxic toxic cages ABSL-1 for human cell line xenografts

22 Vet Med, Compliance Options Replace sentinel rodents with PCR swabs of inanimate surfaces IVC exhaust plenums, etc., ± exptl animals Eliminate annual review of non-usda, non-dod protocols Eliminate de novo triennial rewrite and review of USDA protocols not PHSfunded

23 How To Share & Promote PS? - PS must be evidence-based - Local IACUC approval where appropriate - Trial M&M, results must be available - Peer-reviewed publication not necessary - Need MANY examples in 1 public repository of locally adopted examples - No guarantee of applicability or external (compliance, accreditation) acceptability

24 What s Lacking: Courage

25 Suggested Repository Features Reliable, secure host and server User-friendly website, searchable content Entries by category, other, or not at all? Entries linked to pertinent section(s) of the Guide, AWA, other Share local allowances by USDA inspectors Password-restricted access? Invite suggestions from the public?

26 Repository Management 1 st filter only to avoid nonsense, screeds 2 nd filter of rotating panel of peers only to identify obvious content gaps or errors Beyond that, everything s acceptable Recruit responsible animal protectionists as panelists Invite commentary and annotations (similarly twice filtered)

27 Yes, That s Right

28 Repository Launch Logical host: ILAR Roundtable (= ROI) Funding: dues, subscriptions, donations, grants If not ILAR RT, then another NGO? Target timeframe: ASAP

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30 Sharing of Acceptable Performance Standards Steven M. Niemi, DVM, DACLAM Washington, DC April 21, 2015