Costs of Implementing Quality in Research Practice

O. Meagan Littrell, Claudia Stoeger, Holger Maier, Helmut Fuchs, Martin Hrabě de Angelis, Lisa A. Cassis, Greg A. Gerhardt, Richard Grondin, Valérie Gailus-Durner

Research output: Chapter in Book/Report/Conference proceedingChapterpeer-review

2 Scopus citations


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.

Original languageEnglish
Title of host publicationHandbook of Experimental Pharmacology
Number of pages25
StatePublished - 2020

Publication series

NameHandbook of Experimental Pharmacology
ISSN (Print)0171-2004
ISSN (Electronic)1865-0325

Bibliographical note

Funding Information:
The Good Research Practice (GRP) Resource Center at the University of Kentucky (UK) is a research support unit under the office of the UK Vice-President for Research. In the context of experimental life sciences, it is particularly important to note that UK is also an academic healthcare center. The UK Albert B. Chandler Medical Center is located in the health sciences campus and is comprised of six colleges of biomedical sciences (dentistry, health sciences, medicine, nursing, pharmacy, and public health) as well as the clinical facilities associated with UK HealthCare. These include the UK Chandler Hospital, Kentucky Children’s Hospital, UK Good Samaritan Hospital, Markey Cancer Center, Gill Heart Institute, Kentucky Neuroscience Institute, and Kentucky Clinic, which collectively support research, education, and healthcare. The Chandler Medical Center is 1 of only 22 academic medical centers in the United States that house 3 nationally recognized federally funded centers: a National Cancer Institute-designated cancer center, an Alzheimer’s Disease Center funded by the National Institute on Aging, and the Kentucky Center for Clinical and Translational Science funded as part of the NIH’s Clinical and Translational Science Award Consortium.

Publisher Copyright:
© The Author(s) 2019.


  • Automation
  • Cost of quality (CoQ)
  • Documentation
  • German Mouse Clinic (GMC)
  • Good laboratory practice (GLP)
  • ISO 9001
  • Quality management system (QMS)
  • Reproducibility

ASJC Scopus subject areas

  • Biochemistry
  • Pharmacology, Toxicology and Pharmaceutics (all)


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