Abstract
In Chap. 3, we have seen how any organisation can apply a management model that follows total quality management principles and implement a quality management system with the aim of improving effectiveness and efficiency. International guidelines for certification and accreditation are dedicated to specific fields only and did not include basic scientific research at the time of their drafting. To effectively apply quality principles to this field, we need to find the relevant references and translate and transfer the terms and directions. Starting from the definition of quality in biomedical research and the citing of the most important references for that field, Chap. 4 illustrates how quality is applied in the running of scientific projects, giving directions and practical examples for most aspects of quality management, from organisation and documentation to physical resources and ethics.
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- 1.
See Sect. 4.4.1.
- 2.
See Sect. 4.4 below.
- 3.
Rebecca L. Hegstad-Davies, Associate Professor, Director, Quality Central Department of Veterinary Population Medicine, University of Minnesota College of Veterinary Medicine.
- 4.
Widely known model by Belch&Belch.
- 5.
See Sect. 4.5.5.1.
- 6.
Cell Therapy Enterprise Technical Leader, GE Healthcare, Knoxville, Tennessee, USA.
- 7.
The code is requested to be applied by contractors of DEFRA, the FSA, NE, VMD, AHVLA, MMO, Fera, FC, the UK Devolved Administrations, BBSRC and NERC.
- 8.
- 9.
Head of the Servei de Qualitat de la Recerca, Quality Assurance Agency, Universitat de Barcelona.
- 10.
See Sect. 4.3.1.2.
- 11.
See Sect. 4.5.3.1 below.
- 12.
See Chap. 2—Total Quality Management: The Requirements.
- 13.
See Sect. 4.5.3.2.
- 14.
See also [14].
- 15.
- 16.
See also Sect. 4.5.3.
- 17.
See Sect. 4.5.5 below.
- 18.
See Chap. 5—Design of Experiment.
- 19.
See Sect. 4.5.3.2.
- 20.
Albert Einstein, Letter on his 75th birthday, 1954, reported on his Memorial Statue at the National Academy of Science, Washington DC, USA.
- 21.
San Raffaele Scientific Institute, Italy.
- 22.
Antonella Bongiovanni, Marta Di Carlo and Luca Caruana.
- 23.
See Introduction–Acknowledgements..
- 24.
Francesca De Leo, Marinella Marzano and Caterina Manzari.
- 25.
For Lean management and related tools, see Chap. 5—Lean Management.
References
WHO: WHO-TDR handbook: quality practices in basic biomedical research. 2010. http://www.who.int/tdr/publications/documents/quality_practices.pdf?ua=1. Accessed 13 Sep 2017.
A guide to the Project Management Body of Knowledge (PMBOK® guide). Project Management Institute (PMI). 2017.
Robins MM, Scarll SJ, Key PE. Quality assurance in research laboratories. Accred Qual Assur. 2006;11:214–23. https://doi.org/10.1007/s00769-006-0129-5.
Davies R. Good Research Practice: it is time to do what others think we do. Quasar-RQA. 2013;124:21–3.
Pentland A. The new science of building great teams: Harv Bus Rev; 2012.
RQA working party on quality in non-regulated research. Guidelines for quality in non-regulated scientific research booklet. RQA. 2008.
Eaker S, et al. Concise review: guidance in developing commercializable autologous/patient-specific cell therapy manufacturing. Stem Cells Transl Med. 2013;2(11):871–83.
UK Government: joint code of practice for research (JCoPR). 2015. https://www.gov.uk/government/publications/joint-code-of-practice-for-research-jcopr. Accessed 13 Sep 2017.
RQA: quality systems workbook. 2013. https://www.therqa.com/assets/js/tiny_mce/plugins/filemanager/files/Publications/RQA_Quality_Systems_Workbook.pdf. Accessed 18 Sep 2017.
Research Councils UK: RCUK policy and guidelines on governance of good research conduct. 2017. http://www.rcuk.ac.uk/documents/reviews/grc/rcukpolicyguidelinesgovernancegoodresearchconduct-pdf/. Accessed 13 Sep 2017.
ESF: the European code of conduct for research integrity. http://www.esf.org/fileadmin/Public_documents/Publications/Code_Conduct_ResearchIntegrity. Accessed 13 Sep 2017.
Universitat de Barcelona: code of good research practices. 2010. http://diposit.ub.edu/dspace/handle/2445/28544. Accessed 13 Sep 2017.
Universitat Autònoma de Barcelona: quality policy. 2015. http://www.uab.cat/web/research/itineraries/uab-research/quality-policy-1345681372276.html. Accessed 13 Sep 2017.
Tanner R. Motivation—applying Maslow’s hierarchy of needs theory. 2017. https://managementisajourney.com/motivation-applying-maslows-hierarchy-of-needs-theory/. Accessed 13 Sep 2017.
US Food and Drug Administration: analytical procedures and methods validation for drugs and biologics. 2015. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm386366.pdf. Accessed 13 Sep 2017.
Annesley TM. Who, what, when, where, how, and why: the ingredients in the recipe for a successful methods section. Clin Chem. 2010;56(6):897–901.
US Food and Drug Administration: guidance for industry-good laboratory practices-questions and answers. 2007. http://www.fda.gov/downloads/ICECI/EnforcementActions/BioresearchMonitoring/UCM133748.pdf. Accessed 13 Sep 2017.
US Food and Drug Administration: 1981 questions & answers-good laboratory practice regulations. 2007. http://www.fda.gov/ICECI/Inspections/NonclinicalLaboratoriesInspectedunderGoodLaboratoryPractices/ucm072738.htm. Accessed 13 Sep 2017.
OECD: OECD series on principles of good laboratory practice (GLP) and compliance monitoring. 1995–2006. http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm. Accessed 13 Sep 2017.
Dance A. Authorship: who’s on first? Nature. 2012;489:591–3. https://doi.org/10.1038/nj7417-591a.
WHO: laboratory biosafety manual. 3rd ed. 2004. http://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf?ua=1. Accessed 18 Sep 2017.
UCL: UCL code of conduct for research. 2013. http://www.ucl.ac.uk/srs/governance-and-committees/resgov/code-of-conduct-research. Accessed 13 Sep 2017.
Cambridge University: research integrity. 2015. http://www.research-integrity.admin.cam.ac.uk/sites/www.research-integrity.admin.cam.ac.uk/files/integrity_leaflet_1115.pdf. Accessed 13 Sep 2017.
Freedman LP, et al. The economics of reproducibility in preclinical research. PLoS Biol. 2015;13(6):e1002165. https://doi.org/10.1371/journal.pbio.1002165.
Bongiovanni A, et al. Applying quality and project management methodologies in biomedical research laboratories: a public research network’s case study. Accred Qual Assur. 2015;20(3):203–13. https://doi.org/10.1007/s00769-015-1132-5.
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Lanati, A. (2018). Quality and Basic Biomedical Research. In: Quality Management in Scientific Research. Springer, Cham. https://doi.org/10.1007/978-3-319-76750-5_4
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DOI: https://doi.org/10.1007/978-3-319-76750-5_4
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