Quality and Basic Biomedical Research
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.
KeywordsConscious management QPBR GXP Organisation Resource management Validation Documentation Storage Products Research environment Health and safety Publications Ethics
- 1.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.
- 2.A guide to the Project Management Body of Knowledge (PMBOK® guide). Project Management Institute (PMI). 2017.Google Scholar
- 4.Davies R. Good Research Practice: it is time to do what others think we do. Quasar-RQA. 2013;124:21–3.Google Scholar
- 5.Pentland A. The new science of building great teams: Harv Bus Rev; 2012.Google Scholar
- 6.RQA working party on quality in non-regulated research. Guidelines for quality in non-regulated scientific research booklet. RQA. 2008.Google Scholar
- 8.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.
- 9.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.
- 10.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.
- 11.ESF: the European code of conduct for research integrity. http://www.esf.org/fileadmin/Public_documents/Publications/Code_Conduct_ResearchIntegrity. Accessed 13 Sep 2017.
- 12.Universitat de Barcelona: code of good research practices. 2010. http://diposit.ub.edu/dspace/handle/2445/28544. Accessed 13 Sep 2017.
- 13.Universitat Autònoma de Barcelona: quality policy. 2015. http://www.uab.cat/web/research/itineraries/uab-research/quality-policy-1345681372276.html. Accessed 13 Sep 2017.
- 14.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.
- 15.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.
- 17.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.
- 18.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.
- 19.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.
- 21.WHO: laboratory biosafety manual. 3rd ed. 2004. http://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf?ua=1. Accessed 18 Sep 2017.
- 22.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.
- 23.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.