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?
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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”
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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
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Inspections and program reviews
Review and approve animal activities
Comply with the AWAR
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What about the “Should’s”?
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Reduction should not be the rationale for animal reuse
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All Program personnel training should be documented
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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.
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Pharmaceutical grade chemicals and other substances should be
used when available.
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PAM should be tailored to institution size and complexity
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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.
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Regulatory Creep; Hmm - Self Imposed Regulatory Burden
What is the Cost?
“The Cost of Self-imposed Regulatory Burden in Animal Research”*
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What is the true cost of risk aversion?
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Striving for “perfection” is fine, but is it a reality?
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Has the concern about public perception and the goal of achieving
perfection lead to an overly burdensome expectation?
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Consider the benefit to be gained when implementing a compliance
operation.
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* The FASEB Journal (www.fasebj.org), Vol. 28 August 2014
Any Pressure?
Risk of loosing granted funds
PETA
Society expectations
Any Pressure ?
They say YES!!
1.
Report of the National Science Board - http://www.nsf.gov/pubs/2014/nsb1418/nsb1418.pdf
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2.
Federal Demonstration Partnership (FDP) 2012 Faculty Workload Survey
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3.
The institutions’ interpretation of the regulations.
Change regulations not satisfying the goal (humane care) and focus on science
Harmonize and streamline requirements
Preparing protocols for initial review
Completing annual and three year protocol renewals
Completing protocol modifications
Training and Record Keeping
Federation of American Societies for Experimental Biology
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Lack of coordination of regulations across agencies (OLAW and the USDA)
Inconsistent interpretation of regulations
Streamline to minimize regulatory burden and promote science
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What’s Problematic?
The PI’s say:
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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.
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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.
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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.
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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.
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Really? Even modifications?
What? GEU’s IACUC meets only monthly?
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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.
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It’s time for the semi-annual inspection. The IACUC Administrator schedules
two IACUC members to visit with the PI during the inspection rotation.
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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
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How about this group?
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Annual report for all submissions – 76%
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Complete re-writes for de novo reviews – 90%
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How often is DMR used – 62%
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Congruency review on all (not just PHS) – 38%
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More staff needed – 62%
Thoughts?