Our client’s need
The compliance officer of an elite research university needed to perform a scheduled compliance assessment of its animal research program. As university’s compliance office was understaffed, the compliance officer was looking for an outside firm to serve as an extension of the compliance office and assess compliance with animal care and use regulations by the centralized veterinary facility and by principal investigators (PIs).
Baker Tilly solution
Baker Tilly performed the compliance assessment in accordance with the Federal Sentencing Guidelines’ (FSG) elements of an effective compliance and ethics program. Specifically, we assessed compliance with each of the FSG’s elements of an effective compliance and ethics program for both animals in the care of the centralized veterinary facility and animals in the care of PIs. As part of this process, we interviewed key processes owners and personnel with governance responsibilities, reviewed relevant policies, procedures, websites, handbooks and prior audit reports, and toured animal facilities. We summarized our observations and findings in a final deliverables that also included summaries of relevant federal and state regulations and recent case studies and governmental enforcement of animal care and use compliance.
The compliance officer and senior leadership receive assurance that its animal research program had the proper processes to comply with the FSG elements. We also provided minor recommendations to enhance processes and controls within the animal research program.
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