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| ==Discussion and closing remarks== | | <div class="nonumtoc">__TOC__</div> |
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| ===Discussion=== | | ==Sandbox begins below== |
| [[File:CERN Control Center.jpg|right|thumb|400px|The CERN laboratory is one of the largest physics laboratories in the world. What is its impact on society? CERN leaders have already asked (and attempted to answer) this very question.]]This guide attempted to:
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| 1. provide historical context of the laboratory to paint a picture of quickly going from a few personal labs to a network of labs embedded into the fabric of modern society;
| | ==8. Resource Management== |
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| 2. provide a framework of understanding where we could take a laboratory of most any type and find a place for it within the framework; and | | | STYLE="vertical-align:top;"| |
| | | {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0" |
| 3. examine 20 different industries, fitting the laboratories associated with them into that framework while providing a little background about their activities and underpinnings.
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| | | ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| |
| In truth, researching and writing this guide was a challenge because few have put the disparate pieces together. Instead, a review of journal articles, books, and news items revealed:
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| | | ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance |
| * material written from a technical, regulatory, and methodological perspective, with few from the sociological and anthropological perspective;
| | ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement |
| * material that takes a focused, analytical approach to laboratory activities and not so much a broader, human interest approach to those activities; and
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| * material that simply glosses over or fails to mention the relevance of laboratories to manufacturing, research and development (R&D), and analytical activities.
| | | style="padding:5px; width:500px;" | |
| | | [https://www.law.cornell.edu/cfr/text/29/1910.120 29 CFR Part 1910.120]<br /> |
| As such, it doesn't take much effort to reach a perhaps inconclusive belief that today the laboratory setting and its researchers are so interwoven into the fabric of our society — largely behind the scenes — that the average person is practically blind to them and their impact on their day-to-day life. That's not to say, however, that the impact of research laboratories on the social structure hasn't ever been discussed; rather, it's not discussed often. But it is happening. In June 2014 the Organisation for Economic Co-operation and Development (OECD) published the report ''The Impacts of Large Research Infrastructures on Economic Innovation and on Society: Case Studies at CERN'' to show "the ways in which the outcomes of publicly-funded research can benefit national economies and can affect the lives of citizens in general."<ref name="OECDTheImpacts14">{{cite web |url=https://www.oecd.org/sti/sci-tech/CERN-case-studies.pdf |format=PDF |title=The Impacts of Large Research Infrastructures on Economic Innovation and on Society: Case Studies at CERN |author=Organisation for Economic Co-operation and Development |date=June 2014 |pages=79 |accessdate=30 June 2017}}</ref> The motivation for this case study came from CERN leaders themselves, who wanted a third party to analyze the laboratory's impact on society and the economy. In that study, the authors emphasized the difficulty of that task<ref name="OECDTheImpacts14" />:
| | [https://www.law.cornell.edu/cfr/text/29/1910.134 29 CFR Part 1910.134 (m)]<br /> |
| | | [https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (h-1)]<br /> |
| <blockquote>Long-term impacts [of the activities of a laboratory] on science, the economy and society are, typically, difficult to forecast and to assess. They can even be difficult to evaluate retrospectively, since science typically advances over a broad front, with many separate but interlinked discoveries producing overall societal change. The impact of any particular scientific result is hard to separate cleanly from that of many others. In addition, it is widely acknowledged that scientific and technological progress are closely intertwined, such that certain fundamental problems cannot be tackled unless technology (even commercial technology) is sufficiently advanced.<br /> <br />Scientists who undertake basic research may not be motivated by a desire to achieve concrete societal benefits. In some cases the emergence of benefits is a long-term and highly indirect process, such as when advances in understanding provoke a "scientific crisis" that then becomes a driver for breakthrough discoveries ...</blockquote> | | [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (j)]<br /> |
| | | [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.2.3]<br /> |
| These are all important points worth noting when thinking about how laboratories affect our lives. Quantifying and qualifying is how most seek answers and rationalize their world, but doing such with laboratories and their activities is apparently a difficult task indeed. This may lend to the lack of research on laboratories and how they affect societies.
| | [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.1]<br /> |
| | | [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.8]<br /> |
| The American Association for the Advancement of Science has also been promoting the idea of correlating research laboratory activities with societal impacts, primarily through their science and research advocacy workshops.<ref name="AAASCat17">{{cite web |url=https://www.aaas.org/page/about-0 |title=Catalyzing Advocacy in Science and Engineering |publisher=American Association for the Advancement of Science |date=2017 |accessdate=30 June 2017}}</ref><ref name="AAASCatApr17">{{cite web |url=https://www.forceforscience.org/new-events/2017/4/21/catalyzing-advocacy-for-science-engineering-workshop |title=Catalyzing Advocacy for Science & Engineering Workshop |publisher=American Association for the Advancement of Science |date=21 April 2017 |accessdate=30 June 2017}}</ref> Speakers at these workshops have been encouraging scientists to more clearly and succinctly demonstrate the social and cultural implications of their laboratory research to lawmakers. The AAAS' thinking is essentially by making laboratory research more relatable to society and human outcomes, the difficulties of acquiring research funding will be lessened slightly.
| | [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 6.1]<br /> |
| | | [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3] |
| We also see attempts being made in other arenas. The American Society for Clinical Laboratory Science, American Clinical Laboratory Association, and Advanced Medical Technology Association have all promoted the value of the diagnostic laboratory to patient outcomes and disease prevention through various position and white papers.<ref name="ASCLSValue05">{{cite web |url=http://www.ascls.org/position-papers/177-value-of-clinical-laboratory-services/153-value-of-clinical-laboratory-services |title=Value of Clinical Laboratory Services in Health Care |author=American Society for Clinical Laboratory Science |date=July 2005 |accessdate=01 July 2017}}</ref><ref name="WolcottTheValue09">{{cite web |url=http://www.chi.org/uploadedFiles/Industry_at_a_glance/Lewin%20Report%20on%20Dx%20Tests%20(2009).pdf |format=PDF |title=The Value of Laboratory Screening and Diagnostic Tests for Prevention and Health Care Improvement |author=Wolcott, J.; Goodman, C. |publisher=The Lewin Group, Inc |date=September 2009 |accessdate=01 July 2017}}</ref> On the teaching front, Sunal ''et al.'' have published a collection of papers addressing the importance of laboratories in science teaching and learning. "In general, recent research provides evidence that students do benefit from inquiry-based laboratory and technology experiences that are integrated with classroom science curricula," they emphasize.<ref name="SunalTheImpact08">{{cite book |url=https://books.google.com/books?id=fvknDwAAQBAJ&printsec=frontcover |title=The Impact of the Laboratory and Technology on Learning and Teaching Science K-16 |editor=Sunal, D.W.; Wright, E.L.; Sundberg, C. |publisher=IAP |pages=309 |year=2008 |isbn=9781607526452}}</ref> Finally, researchers are also looking at how discoveries and innovations in laboratories — such as advances in genetic testing<ref name="VriesGenetics08">{{cite book |url=https://books.google.com/books?id=imaJDAAAQBAJ&printsec=frontcover |title=Genetics from Laboratory to Society: Societal Learning as an Alternative to Regulation |editor=de Vries, G.; Horstman, K. |publisher=Springer |pages=222 |year=2008 |isbn=9780230598775 |doi=10.1057/9780230598775}}</ref> — have and could potentially affect society, positively and negatively.
| | | style="background-color:white;" |The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure. |
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| These examples, while relatively sparse, add additional context to what has already been discussed. We begin to form a somewhat clearer idea of how laboratories of all types intersect our lives, largely on a practical scale and partially from the perspective of how laboratories and the research going on in them affect us directly. We find laboratories in numerous pockets of modern society, from the public high school chemistry lab to the private R&D laboratory developing improvements to batteries. Some affect us directly, such as when you get your blood tested at the clinical lab for symptoms related to diabetes, and others rarely affect us so directly, such as the mobile forensic laboratory. And some laboratories only affect us tangentially, for example through a scientific discovery that gets propagated slowly from lab to lab, influencing other researchers' approaches over time.
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| | | [https://www.law.cornell.edu/cfr/text/21/820.198 21 CFR Part 820.198]<br /> |
| ===Closing remarks===
| | [https://www.law.cornell.edu/cfr/text/42/493.1233 42 CFR Part 493.1233]<br /> |
| The introduction posed questions such as "Why should I care that a laboratory was somehow involved in a product's creation?" and "How is a laboratory involved with the ink pen on my desk or water I drink?" Through the previous examples and the contents of this guide, the goal has been to 1. help readers answer those questions, and 2. help paint a picture showing how laboratories have, within a couple of centuries, rapidly transformed from somewhat rare place of individual study and notoriety to ubiquitous location for analysis, research, development, quality control, and calibration efforts that drive society forward towards new frontiers. Hopefully this guide has been successful on both fronts.
| | [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf E.U. Commission Directive 2003/94/EC Article 13]<br /> |
| | | [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (j)]<br /> |
| What will the future hold for the humble laboratory, and how will its status within the fabric of our society change, if at all? Optimistically, they will increasingly be viewed as spaces that assist scientists with rational and safe discoveries that provide benefits for the whole of society. Laboratories and their denizens will undoubtedly also continue to play important roles in maintaining the safety and well-being of the populace, from product quality control to disease tracking and analysis. Technologies such as cloud computing and data management systems may further streamline how laboratory research data is produced, handled, and stored<ref name="Saliah-HassaneLabAtHome11">{{cite journal |title=Lab@Home: Remote laboratory evolution in the Cloud Computing Era |journal=Proceedings of the 2011 ASEE Annual Conference & Exposition |author=Saliah-Hassane, H.; Saad, M.; Ofosu, W.K. et al. |pages=22.995.1-22.995.13 |year=2011 |url=https://peer.asee.org/18691}}</ref>, and data sharing policies — if they can overcome some inherent challenges<ref name="MarcusNew17">{{cite web |url=https://www.statnews.com/2017/06/06/data-sharing-rules-disappoint/ |title=New science data-sharing rules are two scoops of disappointment |author=Marcus, A. |work=STAT |publisher=Boston Globe Media |date=06 June 2017 |accessdate=01 July 2017}}</ref> — may positively shape laboratories even further. In the end, one way or another laboratories will continue to play a pivotal role in society, obvious or not.
| | [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0] |
| | | | style="background-color:white;" |The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility. |
| ==References==
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| {{Reflist|colwidth=30em}}
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| | | [https://www.law.cornell.edu/cfr/text/7/331.15 7 CFR Part 331.15]<br /> |
| <!--Place all category tags here-->
| | [https://www.law.cornell.edu/cfr/text/9/121.15 9 CFR Part 121.15]<br /> |
| | [https://www.law.cornell.edu/cfr/text/21/211.25 21 CFR Part 211.25]<br /> |
| | [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (f)]<br /> |
| | [https://www.law.cornell.edu/cfr/text/42/73.15 42 CFR Part 73.15]<br /> |
| | [http://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3]<br /> |
| | [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-1-1]<br /> |
| | [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.2.1]<br /> |
| | [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.1]<br /> |
| | [https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Guidelines]<br /> |
| | [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.1.2–3]<br /> |
| | [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 10] |
| | | style="background-color:white;" |The system shall allow training sessions to be scheduled for personnel. |
| | |- |
| | | style="padding:5px; width:500px;" | |
| | [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (f)]<br /> |
| | [http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. B]<br /> |
| | [http://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7]<br /> |
| | [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-1-2]<br /> |
| | [https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Guidelines] |
| | | style="background-color:white;" |The system should provide access to relevant training materials to personnel attending training sessions. |
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| | |} |
| | |} |
