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| {{ombox | | |title=Introduction to Quality and Quality Management Systems |
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| | text = This is sublevel1 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see [[User_talk:Shawndouglas|my discussion page]] instead.<p></p> | | |cover-color=#fffccc |
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| ==Sandbox begins below== | | ==''Introduction to Quality and Quality Management Systems''== |
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| |title_full = How could the ethical management of health data in the medical field inform police use of DNA?
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| |journal = ''Frontiers in Public Health''
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| |authors = Krikorian, Gaelle; Vailly, Joëlle
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| |affiliations = Institut de recherche interdisciplinaire sur les enjeux sociaux (IRIS)
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| |contact = Email: gaelle.krikorian@gmail.com
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| |editors = Lefèvre, Thomas
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| |pub_year = 2018
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| |vol_iss = '''6'''
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| |pages = 154
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| |doi = [http://10.3389/fpubh.2018.00154 10.3389/fpubh.2018.00154]
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| |issn = 2296-2565
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| |license = [http://creativecommons.org/licenses/by/4.0/ Creative Commons Attribution 4.0 International]
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| |website = [https://www.frontiersin.org/articles/10.3389/fpubh.2018.00154/full https://www.frontiersin.org/articles/10.3389/fpubh.2018.00154/full]
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| |download = [https://www.frontiersin.org/articles/10.3389/fpubh.2018.00154/pdf https://www.frontiersin.org/articles/10.3389/fpubh.2018.00154/pdf] (PDF)
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| | text = This article should not be considered complete until this message box has been removed. This is a work in progress. | | | text = This book should not be considered complete until this message box has been removed. This is a work in progress. |
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| ==Introduction==
| | The goal of this short volume is to act as an introduction to the quality management system. It collects several articles related to quality, quality management, and associated systems. |
| Various events paved the way for the production of ethical norms regulating biomedical practices, from the Nuremberg Code (1947)—produced by the international trial of Nazi regime leaders and collaborators—and the Declaration of Helsinki by the World Medical Association (1964) to the invention of the term “bioethics” by American biologist Van Rensselaer Potter.<ref name="PotterBio70">{{cite journal |title=Bioethics, the science of survival |journal=Perspectives in Biology and Medicine |author=Potter, V.R. |volume=14 |issue=1 |pages=127–53 |year=1970 |doi=10.1353/pbm.1970.0015}}</ref> The ethics of biomedicine has given rise to various controversies—particularly in the fields of newborn screening<ref name=VaillyTheBirth13">{{cite book |title=The Birth of a Genetics Policy: Social Issues of Newborn Screening |author=Vailly, J. |publisher=Routledge |pages=240 |year=2013 |isbn=9781472422729}}</ref>, prenatal screening<ref name="IsambertÉthique80">{{cite journal |title=Éthique et génétique: De l'utopie eugénique au contrôle des malformations congénitales |journal=Revue française de sociologie |author=Isambert, F.A. |volume=21 |issue=3 |pages=331–54 |year=1980 |doi=10.2307/3320930}}</ref>, and cloning<ref name="PulmanLesEnjeux05">{{cite journal |title=Les enjeux du clonage |journal=Revue française de sociologie |author=Pulman, B. |volume=46 |issue=3 |pages=413–42 |year=2005 |doi=10.3917/rfs.463.0413}}</ref>—resulting in the institutionalization of ethical questions in the biomedical world of genetics. In 1994, France passed legislation (commonly known as the “bioethics laws”) to regulate medical practices in genetics. The medical community has also organized itself in order to manage ethical issues relating to its decisions, with a view to handling “practices with many strong uncertainties” and enabling clinical judgments and decisions to be made not by individual practitioners but rather by multidisciplinary groups drawing on different modes of judgment and forms of expertise.<ref name="BourretDécision08">{{cite journal |title=Décision et jugement médicaux en situation de forte incertitude : l’exemple de deux pratiques cliniques à l’épreuve de la génétique |journal=Sciences sociales et santé |author=Bourret, P.; Rabeharisoa, V. |volume=26 |issue=1 |pages=128 |year=2008 |doi=10.3917/sss.261.0033}}</ref> Thus, the biomedical approach to genetics has been characterized by various debates and the existence of public controversies.
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| In the judicial sphere, the situation is very different. Since the end of the 1990s, developments in biomedical research have led to genetic data being used in police work and legal proceedings. Today, [[forensic science]] is omnipresent in investigations, not just in complex criminal cases but also routinely in cases of “minor” or “mass” delinquency. Genetics, which certainly receives the most media coverage among the techniques involved<ref name="BrewerMedia09">{{cite journal |title=Media Use and Public Perceptions of DNA Evidence |journal=Science Communication |author=Brewer, P.R.; Ley, B.L. |volume=32 |issue=1 |pages=93–117 |year=2009 |doi=10.1177/1075547009340343}}</ref>, has taken on considerable importance.<ref name="WilliamsGenetic08">{{cite book |title=Genetic Policing: The Uses of DNA in Police Investigations |author=Williams, R.; Johnson, P. |publisher=Willan |pages=208 |year=2008 |isbn=9781843922049}}</ref> However, although very similar techniques are used in biomedicine and police work (DNA amplification, [[sequencing]], etc.), the forms of collective management surrounding them are very different, as well as the ethico-legal frameworks and their evolution, as this text will demonstrate.
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| '''Keywords''': DNA, police, ethics, genetic technologies, criminal investigations
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| ==Nature of the information and genetic data produced in the police sphere==
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| In police work in France, data produced by DNA are currently compiled and used in two different ways: first, to create files on individuals in the FNAEG or ''Fichier national automatisé des empreintes génétiques'' (national automated DNA database) and, second, in order to obtain information about perpetrators of crimes (their appearance, their origin, their kinship links to other individuals).
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| Police use of DNA has been allowed in France since the 1998 law providing for the creation of the FNAEG. A DNA profile corresponds to a “specific individual alphanumeric combination”<ref name="CabalRapport01">{{cite book |title=Rapport sur la valeur scientifique de l'utilisation des empreintes génétiques dans le domaine judiciaire |author=Cabal, C.; Le Déaut, J.-Y.; Revol, H. |publisher=Assemblée nationale |year=2001 |isbn=2111150177}}</ref> that is the numerical encoding of analysis of DNA segments. This profile is the result of analysis of DNA fragments using genetic markers. This analysis can be carried out on a minute amount of genetic material (saliva, blood, sperm, hair, contact, etc.). It identifies the presence of sequences specific to an individual that differentiate them from any other person (with the exception of an identical twin) but that are not supposed to provide any phenotypical information (about appearance, geographical origin, or diseases).{{efn|The Order of 10 August 2015 increased the number of markers analyzed to 21; policemen and analysis laboratories had three years to comply with this new requirement.}} Such profiles therefore make individuals “identifiable in their uniqueness.”<ref name="BonniolL'ADN14">{{cite journal |title=L’ADN au service d’une nouvelle quête des ancêtres? |journal=Civilisations |author=Bonniol, J.-L.; Darlu, P. |volume=63 |pages=201–19 |year=2014 |doi=10.4000/civilisations.3747}}</ref> During investigations, DNA is collected from suspects or unidentified stains left on crime scenes or people and the results of this analysis are entered into the database. Identification through the FNAEG was originally restricted to a limited number of crimes—those of a sexual nature, as part of the law relating to the prevention and punishment of sexual crimes and the protection of minors. This remit has progressively been extended to include the vast majority of crimes and offences{{efn|Act n°98-468 of 17 June 1998 relative to the punishment of sexual crimes and the protection of minors introduced article 706-54 into the Code of Criminal Procedure making provision for the creation of an automated national database to centralize the DNA profiles of persons convicted of offences of a sexual nature. The remit of the database was then extended on several occasions. In 2001, it included serious crimes against persons. In 2003, the law on internal security extended it to persons convicted of or implicated in crimes and offences against persons or property.}}, leading to the routine use of DNA in investigations.{{efn|Collecting DNA samples in investigations is now the rule. An ''ad hoc'' body of staff has been trained over the past 15 years that almost systematically processes crime scenes.}} As a result of this evolution, there has been a substantial increase in the number of persons with files in the FNAEG, more than three million as of late 2015.{{efn|This figure was provided to the French Parliament by the Ministry of the Interior following a question by parliamentarian Sergio Coronado (member of the “Ecologist” parliamentary group) (http://questions.assemblee-nationale.fr/q14/14-79728QE.htm).}}
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| New techniques have also emerged in recent years. It is now possible to obtain indications about an individual's physical appearance based on a sample of his/her DNA<ref name="KayserImproving11">{{cite journal |title=Improving human forensics through advances in genetics, genomics and molecular biology |journal=Nature Reviews Genetics |author=Kayser, M.; de Knijff, P. |volume=12 |issue=3 |pages=179–92 |year=2011 |doi=10.1038/nrg2952 |pmid=21331090}}</ref><ref name="KayserForensic15">{{cite journal |title=Forensic DNA Phenotyping: Predicting human appearance from crime scene material for investigative purposes |journal=Forensic Science International Genetics |author=Kayser, M. |volume=18 |pages=33–48 |year=2015 |doi=10.1016/j.fsigen.2015.02.003 |pmid=25716572}}</ref>: the analyses in question provide statistical information on eye, hair, and skin color, etc. These techniques are more exploratory and aim not to match DNA with an identity by comparison but to determine the characteristics of the perpetrator of a crime. These data result from [[Data analysis|analysis]] of several dozen DNA markers that, unlike the FNAEG's data, are selected deliberately so that they can provide information about a person's physical appearance. They are therefore aimed at “generating a suspect”<ref name="M'charekBeyond13">{{cite journal |title=Beyond Fact or Fiction: On the Materiality of Race in Practice |journal=Cultural Anthropology |author=M'charek, A. |volume=28 |issue=3 |pages=420–42 |year=2013 |doi=10.1111/cuan.12012}}</ref> but because the information about this person's features are incomplete (e.g., a person with blue eyes, fair skin, light brown hair, and of European “bio-geographical” ancestry), they define “target populations of interest” to guide police investigations.<ref name="CaliebePredictive18">{{cite journal |title=Predictive values in Forensic DNA Phenotyping are not necessarily prevalence-dependent |journal=FSI Genetics |author=Caliebe, A.; Krawczak, M.; Kayser, M. |volume=33 |pages=e7–e8 |year=2018 |doi=10.1016/j.fsigen.2017.11.006}}</ref> Several private and public laboratories in France now produce what professionals often refer to as “DNA photofits”; it is estimated that several dozen such analyses have been carried out since 2014 as part of investigations.
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| ==Footnotes==
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| {{reflist|group=lower-alpha}}
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| ==References==
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| {{Reflist|colwidth=30em}}
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| ==Notes==
| | ;1. What is quality? |
| This presentation is faithful to the original, with only a few minor changes to presentation. In some cases important information was missing from the references, and that information was added. Footnotes were originally numbered but have been converted to lowercase alpha for this version.
| | :''Key terms'' |
| | :[[Quality (business)|Quality]] |
| | :[[Quality assurance]] |
| | :[[Quality control]] |
| | :''The rest'' |
| | :[[Data quality]] |
| | :[[Information quality]] |
| | :[[Nonconformity (quality)|Nonconformity]] |
| | :[[Service quality]] |
| | ;2. Processes and improvement |
| | :[[Business process]] |
| | :[[Process capability]] |
| | :[[Risk management]] |
| | :[[Workflow]] |
| | ;3. Mechanisms for quality |
| | :[[Acceptance testing]] |
| | :[[Conformance testing]] |
| | :[[Clinical quality management system]] |
| | :[[Continual improvement process]] |
| | :[[Corrective and preventive action]] |
| | :[[Good manufacturing practice]] |
| | :[[Malcolm Baldrige National Quality Improvement Act of 1987]] |
| | :[[Quality management]] |
| | :[[Quality management system]] |
| | :[[Total quality management]] |
| | ;4. Quality standards |
| | :[[ISO 9000]] |
| | :[[ISO 13485]] |
| | :[[ISO 14000|ISO 14001]] |
| | :[[ISO 15189]] |
| | :[[ISO/IEC 17025]] |
| | :[[ISO/TS 16949]] |
| | ;5. Quality in software |
| | :[[Software quality]] |
| | :[[Software quality assurance]] |
| | :[[Software quality management]] |
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| <!--Place all category tags here--> | | <!--Place all category tags here--> |
| [[Category:LIMSwiki journal articles (added in 2018)]]
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| [[Category:LIMSwiki journal articles (all)]]
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| [[Category:LIMSwiki journal articles on forensic science]]
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| [[Category:LIMSwiki journal articles on health informatics]]
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