areas with resource needs and communicate with senior management as to the greatest risks for the animal care and use program.
Senior management should be updated on this topic regularly since
they should not be lulled into a false sense of security thinking that
what they addressed 10, 5, or even 3 years ago will help control
risks (or even keep them risk-free) in the present or future.
What happens, then, when all risks are identified and characterized? That is when the IACUC uses one of five accepted methods of risk control based upon institutional tolerance. Risk control
will be the topic of the next article for this column.
To view the additional reading for this article, go to
Stacy Pritt, DVM, MS, MBA, CPIA, DACAW, is the Director of
the IACUC at the University of Texas Southwestern Medical Center.
Currently, she serves as the Delegate to the AVMA House of Delegates
for the American Society of Laboratory Animal Practitioners.
Risk characterization is the second component of risk assessment. The framework for risk characterization is relatively simple and remains the same know matter what
industry or business and organization is in.
Severity (or impact) and likelihood (or possibility) are the
standard two measures by which risks are characterized. Both are
typically quantified by some rating system to help identify if the
risk can be ranked as high, medium, or low (or some variation
of that theme). For example, in looking at the illustration below,
an institution with a low number of USDA covered species protocols and low number of high risk procedures (as defined by the
USDA APHIS Animal Welfare Inspection Guide) may consider
USDA inspections and review of those protocols to be a low risk
event when the inspector has not reviewed any protocols for several years. However, due to new USDA requirements for inspectors and the release of a revised Chapter 7 (Research Facility
Inspection – IACUC Requirements and Protocols) of the USDA
APHIS Animal Welfare Inspection Guide in March of 2015, inspectors are now required to pull a certain number of protocols to
review during each inspection and all protocols falling into certain
pre-defined categories as defined by the USDA must be reviewed.
This changes the risk for a negative consequence (a non-com-pliant item on an USDA inspection report) during an event (a
regulatory inspection). Since the likelihood of the negative consequence has increased because the USDA inspector must review
protocols, the risk characterization for the event also increases.
In this case, the impact could be considered the same since the
protocols and procedures themselves have not changed, but one
could argue that likelihood increases as well since the inspectors
are instructed to pull certain protocols by the USDA.
Utilizing these basic exercises of risk identification and characterization, as incorporated into the tenets of risk assessment, on a
regular and ad hoc basis can be tremendously helpful to help direct
IACUC efforts. IACUC members and staff can quickly recognize