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INTEGRATING QA PRINCIPLES WITH BASIC ELEMENTS OF A RESEARCH PROGRAM PROMOTES QUALITY SCIENCE IN A NON-GLP RESEARCH LABORATORY
Citation:
Lilly, M., K. Gold, AND R.R. Rogers. INTEGRATING QA PRINCIPLES WITH BASIC ELEMENTS OF A RESEARCH PROGRAM PROMOTES QUALITY SCIENCE IN A NON-GLP RESEARCH LABORATORY. U.S. Environmental Protection Agency, Washington, D.C., EPA/600/J-95/058.
Description:
Much of the research conducted at the U.S. Environmental Protection Agency's (EPA's) Health Effects Research Laboratory (HERL) located in Research Triangle Park, NC, involves "pilot" and small-scale acute toxicity assessments conducted over short periods of time. onsequently, the time and cost for extensive quality assurance (QA) can become prohibitive. A efforts within HERL are shifting from traditional QA activities, often seen by researchers as hindering scientific creativity, to the integration of QA principles with current research practices. A personnel provide assistance to HERL researchers on QA issues that arise in the development of studies that are planned, designed, conducted, and documented according to sound scientific practices. ey aspects of the planning and design phases which receive special emphasis in HERL QA include (1) ensuring adequate consideration is given to the anticipated end use of the data, (2) encouraging appropriate consideration for alterative approaches such as in vitro techniques, modeling, or a combination, and (3) seeking statistical consultation when appropriate. enefits may include more data from smaller numbers of animals, less repetition of efforts due to improper planning or mistakes, and fewer replicates required to achieve desired statistical power. hus, the collaborative efforts of QA personnel and researchers in integrating QA principles into HERL's research program have the potential to lead to improved research practices and study results, and to a more conscientious, efficient, and productive use of resources, including laboratory animals.