Compliance, how does your institution interpret the “Gray Area” – Total Risk Aversion? Bill Greer Penn State University

What do we need to think about? 1. What do we have to do? 2. Where’s the “so-called” gray area - Is it the “Should’s”? 3. Why do we do what we do? 4. What’s influences decisions about “regulation interpretations”? 5. What are we doing? 2

What do we have to do? How about the musts? “Must indicates actions that are imperative and mandatory duty or requirement for providing human animal care and use.” 40 plus “you must” Each institution MUST establish and maintain an OHSP. The institution MUST develop methods for reporting and investigating animal welfare concerns The use of restraint devices MUST be justified in the animal use protocol Facilities MUST have a disaster plan Animals MUST have enough space to express their natural postures and posture adjustments Don’t forget the PHS Policy Inspections and program reviews Review and approve animal activities Comply with the AWAR 3

What about the “Should’s”? Reduction should not be the rationale for animal reuse All Program personnel training should be documented Public members “should” not be laboratory animal users, affiliated in any way wit the institution, or members of the immediate family who is affiliate with the institution. Pharmaceutical grade chemicals and other substances should be used when available. PAM should be tailored to institution size and complexity 4

Gray Area – the opportunity for Flexibility “Performance standard” means a standard or guideline that, while describing a desired outcome, provides FLEXIBILITY in achieving this outcome by granting discretion to those responsible for managing the animal care and use program, the researcher, and the IACUC. The performance approach requires professional input, sound judgment, and a team approach to achieve specific goals (Guide, page 6). “ Should ” indicates a strong recommendation for achieving a goal; however, the Committee recognizes that individual circumstances might justify an alternative strategy (Guide page 8). Point being – don’t forget about the flexibility (the gray area) that allows you to implement the best strategies for your situations. 5

Regulatory Creep; Hmm - Self Imposed Regulatory Burden What is the Cost? “ The Cost of Self-imposed Regulatory Burden in Animal Research ”* What is the true cost of risk aversion? Striving for “ perfection ” is fine, but is it a reality? Has the concern about public perception and the goal of achieving perfection lead to an overly burdensome expectation? Consider the benefit to be gained when implementing a compliance operation. * The FASEB Journal ( Vol. 28 August 2014www.fasebj.org 6

Any Pressure? Risk of loosing granted funds PETA Society expectations

Any Pressure ? They say YES!! 1. Report of the National Science Board The institutions’ interpretation of the regulations. Change regulations not satisfying the goal (humane care) and focus on science Harmonize and streamline requirements 2. Federal Demonstration Partnership (FDP) 2012 Faculty Workload Survey Preparing protocols for initial review Completing annual and three year protocol renewals Completing protocol modifications Training and Record Keeping 3. Federation of American Societies for Experimental Biology Lack of coordination of regulations across agencies (OLAW and the USDA) Inconsistent interpretation of regulations Streamline to minimize regulatory burden and promote science 8

What’s Problematic? The PI’s say: Regular Use of DR process rather than full review Regulatory Drift Insufficient administrative support

Maintaining Compliance Efficiently Semi-Annual and Three Year Reviews: Great Eastern University has a robust research program that involves PHS funded projects involving primarily mice, but at times USDA covered species. Since the AWAR and the PHS Policy differ as it relates to review requirements, GEU adopted the following policy. To secure ongoing IACUC approval for animal use activities, all PI’s must prepare and submit to the IACUC an annual report of activities for each approved protocol. To secure ongoing IACUC approval for animal use activities, all PI”s must rewrite and submit ongoing research activities at the end of three years. 10

Protocol Review Process GEU has traditionally reviewed all of their protocols using the full committee review process. The logic is everyone should have an opportunity to comment on it during a public forum and this opportunity should be documented in the meeting minutes. Really? Even modifications? What? GEU’s IACUC meets only monthly? 11

Maintaining Compliance Efficiently We do it right, because we do it twice! – What? A PI acquires approval from the IACUC to conduct a novel surgery that involves temporarily ligating a pulmonary vein, which causes cardiac damage similar to that experienced after a heart attack. Upon approval the committee asks the AV to monitor the procedure and report to the IACUC as necessary. It’s time for the semi-annual inspection. The IACUC Administrator schedules two IACUC members to visit with the PI during the inspection rotation. The project is very invasive and new; consequently the PAM decides to conduct a PAM visit with the PI. – maybe we do it 3X’s 12

How about this group? Annual report for all submissions – 76% Complete re-writes for de novo reviews – 90% How often is DMR used – 62% Congruency review on all (not just PHS) – 38% More staff needed – 62%

Thoughts?