Abad, X., A. Bosch, and C. Navarro. 2005. Implementation of Good Laboratory Practice in a university research unit. Quality Assurance Journal 9(4):304-311.
Abdel-Fatah, H.T.M. 2010. ISO/IEC 17025 accreditation: Between the desired gains and the reality. Quality Assurance Journal 13:21-27.
Adams, C., K. Cammann, H.A. Deckers, Z. Dobkowski, D. Holcombe, P.D. LaFleur, P. Radvila, C. Rohrer, W. Steck, and P. Vermaercke. 1998. Quality Assurance for Research and Development and Non-routine Analysis. Eurachem CITAC Guide CG2. Available at https://www.eurachem.org/images/stories/Guides/pdf/rdguide.pdf (accessed October 8, 2019).
Baker, M. 2016a. How quality control could save your science. Nature 529:456-458.
Baker, M. 2016b. 1,500 scientists lift the lid on reproducibility. Nature 533:452-454.
Begley, C.G., A.M. Buchan, and U. Dirnagl. 2015. Robust research: Institutions must do their part for reproducibility. Nature 525:25-27.
Bergman, R.G., and R.L. Danheiser. 2016. Reproducibility in chemical research. Angewandte Chemie International Edition 55:12548-12549.
Berwouts, S., M.A. Morris, and E. Dequeker. 2010. Approaches to quality management and accreditation in a genetic testing laboratory. European Journal of Human Genetics 18:S1-S19.
Bond, C. 2013. The slippery slope of errors. International Journal of Pharmacy Practice 21(3):137-138.
Bongiovanni, A., G. Colotti, G.L. Liguori, M. Di Carlo, F.A. Digilio, G. Lacerra, A. Mascia, A.M. Cirafici, A. Barra, A. Lanati, and A. Kisslinger. 2015. Applying quality and project management methodologies in biomedical research laboratories: A public research network’s case study. Accreditation and Quality Assurance 20(3):203-213.
Bustin, S.A., and T. Nolan. 2016. Improving the reliability of peer-reviewed publications: We are all in it together. Biomolecular Detection and Quantification 7:A1-A5.
Casadevall, A., and F.C. Fang. 2012. Reforming science: Methodological and cultural reforms. Infection and Immunology 80:891-896.
Casadevall, A., R.G. Steen, and F.C. Fang. 2014. Sources of error in the retracted scientific literature. The FASEB Journal 28(9):3847-3855.
Casadevall, A., L.M. Ellis, E.W. Davies, M. McFall-Ngai, and F.C. Fang. 2016. A framework for improving the quality of research in the biological sciences. mBio 7(4):e01256-16, DOI: 10.1128/mBio.01256-16.
Chalmers, I., and P. Glasziou. 2009. Avoidable waste in the production and reporting of research evidence. Lancet 374:86-89.
Cochran, C. 2008. ISO 9001 in Plain English. Chico, CA: Paton Press.
Crosby, P. 1979. Quality Is Free: The Art of Making Quality Certain. New York: McGraw-Hill.
Cutler, G.C., and C.D. Scott-Dupree. 2016. Bee ecotoxicology and data veracity: Appreciating the GLP Process. Bioscience 66(12):1066-1069.
Davies, R., C. London, B. Lascelles, and M. Conzemius. 2017. Quality assurance and best research practices for non-regulated veterinary clinical studies. BMC Veterinary Research 13(1):242.
Davis, E., K. Hampson, C. Bray, K. Dixon, W. Ollier, and M. Yuille. 2012. Selection and implementation of the ISO9001 standard to support biobanking research infrastructure development. Biopreservation and Biobanking 10(2):162-167.
Deming, W.E. 1982. Out of the Crisis. Cambridge, MA: Center for Advanced Educational Services.
Dirnagl, U., and I. Przesdzing. 2016. A pocket guide to electronic laboratory notebooks in the academic life sciences. F1000Research 5:2.
Dirnagl, U., I. Przesdzing, C. Kurreck, and S. Major. 2016. A laboratory critical incident and error reporting system for experimental biomedicine. PLoS Biology 14:e2000705.
Dirnagl, U., C. Kurreck, E. Castaños-Vélez, and R. Bernard. 2018. Quality management for academic laboratories: Burden or boon? EMBO Reports 19:e47143.
Ehrmeyer, S.S. 2015. The New Poor Lab’s Guide to the Regulations. Madison, WI: Westgard QC.
Ellis, T., L. Margiotta-Casaluci, T.G. Pottinger, S. Morris. R.A. Reese, J.P. Sumpter, and A.P. Scott. 2019. Immunoassays are not immune to errors: Examples from two studies of steroid output from freshwater trout farms. General and Comparative Endocrinology 285:113226.
Fahey, T.J., and A.K. Knapp. 2004. Principles and Standards for Measuring Primary Production. LTER, 288 pp. Available at https://lternet.edu/books/principles-and-standards-measuring-primary-production/ (accessed October 4, 2019).
Freedman, L.P., and J. Inglese. 2014. The increasing urgency for standards in basic biologic research. Cancer Research 74:4024-4029.
Freedman, L.P., I.M. Cockburn, and T.S. Simcoe. 2015. The economics of reproducibility in preclinical research. PLoS Biology 13(6):e1002165.
Freedman, L.P., G. Venugopalan, and R. Wisman. 2017. Reproducibility2020: Progress and priorities. F1000Research 6:604.
GBSI (Global Biological Standards Institute). 2013. The Case for Standards in Life Sciences Research: Seizing Opportunities at a Time of Critical Need. Global Biological Standards Institute. Available at https://www.gbsi.org/about/initiatives/case-for-standards/ (accessed May 8, 2018).
Giesen, E. 2015. Ethical and efficient research management: A new challenge for an old problem. International Journal of Metrology and Quality Engineering 6:406.
Goodman, A., A. Pepe, A.W. Blocker, C.L. Borgman, K. Cranmer, M. Crosas, R. Di Stafano, Y. Gil, P. Groth, M. Hedstrom, D.W. Hogg, V. Kashyap, A. Mahabal, A. Siemiginowska, and A. Slavkovic. 2014. Ten simple rules for the care and feeding of scientific data. PLoS Compututational Biology 10(4):e1003542.
Gratzer, W. 2013. Trouble at the lab. The Economist 302:774-775.
Guaspari, J. 2002. Switched-On Quality: How to Tap into the Energy Needed for Fuller and Deeper Buy-In, T. March and H. Paton, ed. Chico, CA: Paton Press. Pp. 1-190.
Henri, J., P. Sanders, H. Lelievre, and N. Cadieu. 2009. Implementation and assessment of the quality management system in research in a laboratory of the French Food Safety Agency: Application to PhD student work. Accreditation and Quality Assurance 14:207-214.
Herman, D.R., and R.W. Usher. 1994. Good research practices: A commonsense approach to ensuring quality in research facilities. Quality Assurance: Good Practice, Regulation, and Law 3(4):355-359.
Holcombe, D.G., B. Neidhart, P. Radvilac, W. Steck, and W. Wegscheider. 1999. Quality assurance good practice for research and development and non-routine analysis. Analytica Chimica Acta 393:157-165.
Hooper, J.E., H. Richardson, A.W. Maters, K.C. Carroll, and P.J. Pronovost. 2018. The Association of Departmental Quality Infrastructure and Positive Change: A Pathology Department Illustration. Academic Pathology 5. DOI:10.1177/2374289517744753.
Iacob, E. 2016. Experience of accreditation in a surface science laboratory. Accreditation and Quality Assurance 21:9-17.
IG (Inspector General). 2016. Scientific Integrity Incident at USGS Energy Geochemistry Laboratory. Report No. 2016-EAU-010. Office of Inspector General, U.S. Department of Interior, Washington, DC.
Ioannidis, J.P.A., S. Greenland, M.A. Hlatky, M.J. Khourry, M.R. Macleod, D. Moher, K.F. Schultz, and R. Tibshirani. 2014. Increasing value and reducing waste in research design, conduct, and analysis. Lancet 383:166-175.
Ioannidis, J.P.A., D. Fanelli, D. Drake Dunne, and S.N. Goodman. 2015. Meta-research: Evaluation and improvement of research methods and practices. PLoS Biology 13:e1002264.
Jena, G.B., and S. Chavan. 2017. Implementation of Good Laboratory Practices (GLP) in basic scientific research: Translating the concept beyond regulatory compliance. Regulatory Toxicology and Pharmacology 89:20-25.
Juran, J.M. 1986. Quality Control Handbook. New York: McGraw-Hill.
Krapp, M. 2001. Quality assurance in research and development: an insoluble dilemma? Fresenius’ Journal of Analytical Chemistry 371:704-713.
Kretser, A., D. Murphy, S. Bertuzzi, T. Abraham, D.B. Allison, K.J. Boor, J. Dwyer, A. Grantham, L.J. Harris, R. Hollander, C. Jacobs-Young, S. Rovito, D. Vafiadis, C. Woteki, J. Wyndham, and R. Yada. 2019. Scientific integrity principles and best practices: Recommendations from a scientific integrity consortium. Science and Engineering Ethics 25(2):327-355.
Lacalamita, R., M. Schirone, and A. Paradiso. 2008. ISO 9001:2000 applied to a research oncology laboratory: Which problems? The experience of National Cancer Institute-Bari. Annals of Oncology 19(6):1207-1208.
Lanati, A. 2018. Quality Management in Scientific Research: Challenging Irreproducibility of Scientific Results. Berlin: Springer Nature.
Leonelli, S. 2017. Global data quality assessment and the situated nature of ‘best’ research practices in biology. Data Science Journal 16(32):1-11.
Macleod, M.R., S. Michie, I. Roberts, U. Dirnagl, I. Chalmers, J.P.A. Ioannidis, R. Al-Shahi Salman, A.-W. Chan, and P. Glasziou. 2014. Biomedical research: Increasing value, reducing waste. Lancet 383:101-104.
Martinson, B.C., M.S. Anderson, and R. de Vries. 2005. Scientists behaving badly. Nature 435:737-738.
Mathur-De-Vre, R. 1997. Approach to quality system in research and development. Accreditation and Quality Assurance 2:63-68.
Meeks, P., S. Kassner, and L. Mathai. 2018. United States Geological Survey Energy Resources Program External Audit Report. Report No. NAC-0116_R1. Lakewood, CO: Neptune and Company.
MHRA (Medicines & Healthcare products Regulatory Agency), 2018. ‘GXP’ Data Integrity Guidance and Definitions. Revision 1. Available at https://www.gov.uk/government/publications/guidance-on-gxp-data-integrity (accessed October 4, 2019).
Moher, D., S.N. Goodman, and J.P.A. Ioannidis. 2016a. Academic criteria for appointment, promotion and rewards in medical research: Where’s the evidence? European Journal of Clinical Investigation 46:383-385.
Moher, D., P. Glasziou, I. Chalmers, M. Nasser, P.M.M. Bossuyt, D.A. Korevaar, I.D. Graham, P. Ravaud, and I. Boutron. 2016b. Increasing value and reducing waste in biomedical research: Who’s listening? Lancet 387:1573-1586.
Molinéro-Demilly, V., A. Charki, C. Jeoffrion, B. Lyonnet, S. O’Brien, and L. Martin. 2018. An overview of Quality Management System implementation in a research laboratory. International Journal of Metrology and Quality Engineering 9:2.
Munafò, M. 2016. Open science and research reproducibility. ecancermedicalscience 10. DOI: 10.3332/ecancer.2016.ed56.
NASEM (National Academies of Sciences, Engineering, and Medicine). 2018a. Open Science by Design: Realizing a Vison for 21st Century Research. Washington, DC: The National Academies Press.
NASEM. 2018b. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press.
Nosek, B.A., G. Alter, G.C. Banks, D. Borsboom, S.D. Bowman, S.J. Breckler, S. Buck, C.D. Chambers, G. Chin, G. Christensen, M. Contestabile, A. Dafoe, E. Eich, J. Freese, R. Glennerster, D. Goroff, D.P. Green, B. Hesse, M. Humphreys, J. Ishiyama, D. Karlan, A. Kraut, A. Lupia, P. Mabry, T. Madon, N. Malhotra, E. Mayo-Wilson, M. McNutt, E. Miguel, E. Levy Paluck, U. Simonsohn, C. Soderberg, B.A. Spellman, J. Turitto, G. VandenBos, S. Vazire, E.J. Wagenmakers, R. Wilson, and T. Yarkoni. 2015. Scientific standards: Promoting an open research culture. Science 348:1422-1425.
Nussbeck, S.Y., P. Weil, J. Menzel, M. Bartlomiej, K. Lorberg, and B. Schwappach. 2014. The laboratory notebook in the 21st century: The electronic notebook would enhance good scientific practice and increase research productivity. EMBO Reports 15(6):631-634.
Ortner, H.M. 2000. The human factor in quality management. Accreditation and Quality Assurance 5:130-141.
Perkel, J.M. 2015. Lab-inventory management: Time to take stock. Nature 524:1-6.
Petit, J.-C., and A. Muret. 2000. A specific standard for quality in fundamental research. Accreditation and Quality Assurance 5:28-34.
Phillips, P., A. Ludtke, J. Mosley, A. Foster, D. Myers, and J. McCoy. 2018. Status of Quality Practices in USGS Laboratories. Unpublished report. U.S. Geological Survey.
Plant, A.L., L.E. Locascio, W.E. May, and P.D. Gallagher. 2014. Improved reproducibility by assuring confidence in measurements in biomedical research. Nature Methods 11:895-898.
Plant, A.L., C.A. Becker, R.J. Hanisch, R.F. Boisvert, A.M. Possolo, and J.T. Elliott. 2018. How measurement science can improve confidence in research results. PLoS Biology 16(4):E2004299.
Pohl, B., S. Simon, and P.-J. Kramer. 2008. Current experiences with a quality management system for nonclinical research and development in pharmaceutical industry. Accreditation and Quality Assurance 13(9):511-521.
Poli, M., S. Pardini, I. Passarelli, I. Citti, D. Cornolti, and E. Picano. 2015. The 4A’s improvement approach: A case study based on UNI EN ISO 9001:2008. Total Quality Management and Business Excellence 26(11):1113-1130.
Poste, G. 2012. Biospecimens, biomarkers, and burgeoning data: The imperative for more rigorous research standards. Trends in Molecular Medicine 18(12):717-722.
RQA (Research Quality Association). 2014. Quality in Research Guidelines for Working in Non-Regulated Research. L. Handy and S. Volsen, eds. Suffolk, UK: RQA.
Riedl, D.H., and M.K. Dunn. 2013. Quality assurance mechanisms for the unregulated research environment. Trends in Biotechnology 31:552-554.
Robertson, G.P., D.C. Coleman, C.S. Bledsoe, and P. Sollins, eds. 2009. Standard Soil Methods For Long-Term Ecological Research. LTER, 480 pp. Available at https://lternet.edu/books/standard-soil-methods-longterm-ecological-research/ (accessed October 4, 2019).
Robins, M.M., S.J. Scarll, and P.E. Key. 2006. Quality assurance in research laboratories. Accreditation and Quality Assurance 11(5):214-223.
Rüegg, J., C. Gries, B. Bond-Lamberty, G.J. Bowen, B.S. Felzer, N.E. McIntyre, P.A. Soranno, K.L. Vanderbilt, and K.C. Weathers. 2014. Completing the data life cycle: Using information management in macrosystems ecology research. Frontiers in Ecology and the Environment 12(1):24-30.
Sandle, T. 2014. Good documentation practices. Journal of Validation Technology 20(3):1-5.
Sené, M., I. Gilmore, and J.-T. Janssen. 2017. Metrology is key to reproducing results. Nature 547:397-399.
Smith, J.L. 2009. The History of Modern Quality. Peoria Magazine. Available at https://www.peoriamagazines.com/ibi/2009/jul/history-modern-quality (accessed October 8, 2019).
Solis-Rouzant, P. 2012. Experience of implementing ISO 15189 accreditation at a university laboratory. eJIFCC 26(4):270-273.
Steneck, N.H. 2006. Fostering integrity in research: Definitions, current knowledge, and future directions. Science and Engineering Ethics 12(1):53-74.
Toker, L., M. Feng, and P. Pavlidis. 2016. Whose sample is it anyway? Widespread misannotation of samples in transcriptomics studies. F1000Research 5:2103.
Trotter, A.M., R. Calabrese, L. Huang, and A.P.U. Krumenaker. 2012. Best quality practices for biomedical research in drug development. Journal of GXP Compliance 16(4):13.
USGS (U.S. Geological Survey). 2018. U.S. Geological Survey Instructional Memorandum IM OSQI 2018-01. Quality Management System for USGS Laboratories. Available at http://www2.usgs.gov/usgs-manual/im/im-osqi-2018-01.html (accessed October 8, 2019).
Vermaercke, P. 2000. Sense and nonsense of quality assurance in an R&D environment. Accreditation and Quality Assurance 5(1):11-15.
Vermaercke, P., F. Verrezen, and S. Boden. 2000. Implementing quality assurance in an R&D environment at the Belgian Nuclear Research Centre – SCK CEN. Accreditation and Quality Assurance 5(1):21-27.
Volsen, S.G., and M.M. Masson. 2009. A novel audit model for assessing quality in non-regulated research. Quality Assurance Journal 12(2):57-63.
Volsen, S.G., J.M. Kent, and M. Masson. 2004. Quality: An old solution to new discovery dilemmas? Drug Discovery Today 9(21):903-905.
Westgard, J., and S. Westgard. 2014. Basic Quality Managment Systems. Madison, WI: Westgard QC, 290 pp.
WHO (World Health Organization). 2006. Handbook: Quality Practices in Basic Biomedical Research. Available at https://www.who.int/tdr/publications/training-guideline-publications/handbook-quality-practices-biomedical-research/en/ (accessed October 8, 2019).
WHO. 2010a. Quality Practices in Basic Biomedical Research (QPBR) training manual: Trainee. Available at https://www.who.int/tdr/publications/training-guideline-publications/qpbr-trainee-manual-2010/en/ (accessed October 8, 2019).
WHO. 2010b. Quality Practices in Basic Biomedical Research (QPBR) training manual: Trainer. Available at https://www.who.int/tdr/publications/training-guideline-publications/qpbr-trainer-manual-2010/en/ (accessed October 8, 2019).
WHO. 2016. Guidance on Good Data and Record Management Practices. WHO Technical Report Series, No. 996, Annex 5. Available at https://www.who.int/medicines/publications/pharmprep/WHO_TRS_996_annex05.pdf (accessed October 8, 2019).
Wiggins, A., R. Bonney, E. Graham, S. Henderson, S. Kelling, G. LeBuhn, R. Littauer, K. Lotts, W. Michener, G. Newman, E. Russell, R. Stevenson, and J. Weltzin. 2013. Data Management Guide for Public Participation in Scientific Research. DataONE: Albuquerque, NM. Available at https://www.dataone.org/sites/all/documents/DataONE-PPSR-DataManagementGuide.pdf (accessed October 4, 2019).
Wilkinson, M.D., M. Dumontier, I.J. Aalbersberg, and 50 coauthors. 2016. The FAIR Guiding Principles for scientific data management and stewardship. Scientific Data 3(1):160018 doi:10.1038/sdata.2016.18.
Zapata-García, D., M. Llauradó, and G. Rauret. 2007. Experience of implementing ISO 17025 for the accreditation of a university testing laboratory. Accreditation and Quality Assurance 12(6):317-322.
Ziemann, M., Y. Eren, and A. El-Osta. 2016. Gene name errors are widespread in the scientific literature. Genome Biology 17:177.
Zimmerman, R. 2010. 10 Best Practices of Good Laboratories. Standardization News 38:24-31.