Abstract
Using standardized guidelines in preclinical research has received increased interest in light of recent concerns about transparency in data reporting and apparent variation in data quality, as evidenced by irreproducibility of results. Although the costs associated with supporting quality through a quality management system are often obvious line items in laboratory budgets, the treatment of the costs associated with quality failure is often overlooked and difficult to quantify. Thus, general estimations of quality costs can be misleading and inaccurate, effectively undervaluing costs recovered by reducing quality defects. Here, we provide examples of quality costs in preclinical research and describe how we have addressed misconceptions of quality management implementation as only marginally beneficial and/or unduly burdensome. We provide two examples of implementing a quality management system (QMS) in preclinical experimental (animal) research environments - one in Europe, the German Mouse Clinic, having established ISO 9001 and the other in the United States, the University of Kentucky (UK), having established Good Laboratory Practice-compliant infrastructure. We present a summary of benefits to having an effective QMS, as may be useful in guiding discussions with funders or administrators to promote interest and investment in a QMS, which ultimately supports shared, mutually beneficial outcomes.
Highlights
The mention of certified or standardized laboratory requirements to other scientists is often met with apprehension, a skeptical expression, and concerned questions about taking on additional bureaucracy and time-consuming paperwork in addition to introducing what is perceived as unnecessary limits for creative and innovative scientific freedom
We present a summary of benefits to having an effective quality management system (QMS), as it may be useful in guiding discussions with funders or administrators to promote interest and investment in a QMS, which supports shared, mutually beneficial outcomes
Efforts for implementing a QMS might be more tricky in an academic setting in a university than in a mouse clinic performing highly standardized tests and procedures, the ISO 9001 standard gives a framework for introducing more quality-relevant aspects in preclinical research and helps enormously with team mindset
Summary
The mention of certified or standardized laboratory requirements to other scientists is often met with apprehension, a skeptical expression, and concerned questions about taking on additional bureaucracy and time-consuming paperwork in addition to introducing what is perceived as unnecessary limits for creative and innovative scientific freedom. We want to dispel misconceptions that implementing quality management in research practice is only marginally beneficial or too burdensome and costly to justify. The treatment of quality costs is misleading and incomplete if regarding only the costs of “doing something” – in this case implementing quality management. This approach, known as “omission bias,” ignores the fact that “not doing something,” i.e., not implementing quality management, comes with costs, some clear and many others hidden or absent from general estimations. We hope to have made a convincing case for taking a long-term approach to promoting quality, where the costs are comparatively minor and the benefits exceed initial “activation energy” and commitments needed for implementation. We present a summary of benefits to having an effective QMS, as it may be useful in guiding discussions with funders or administrators to promote interest and investment in a QMS, which supports shared, mutually beneficial outcomes
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