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| {{ombox | | |title=Introduction to Quality and Quality Management Systems |
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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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| ==How is this framed legally, politically, and ethically?==
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| The legal framework surrounding how the police and justice system use DNA analysis was devised to follow the creation of the FNAEG. For this reason, and in order to defuse fears and criticisms, the law only allows analyses using “non-coding” DNA so as to meet the initial objective of allowing identification without providing information about individuals. French law only provides the police DNA for identification purposes “within the framework of investigative measures or the preparation of a case during a judicial proceeding,”{{efn|Art. 16.11 of the Civil Code}} in cases of missing persons{{efn|Art. 26, Domestic Security Guidance and Planning Act n° 95-73 of 21 January 1995}}, or, more recently, in the context of familial searches to allow “searches for persons directly related to [an] unknown person” who has left a stain at a crime scene (i.e., without determining phenotype).{{efn|This possibility was written into law in 2016 in article 796-56-1-1 of Act n° 2016-731 of 3 June 2016 strengthening provisions for the fight against organized crime, terrorism, and their financing, and improving the efficiency and guarantees of the criminal procedure.}}
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| Concerning the so-called “DNA Photofit” technique, in June 2014, France's highest court, the Court of Cassation, ruled admissible an expert report charged with providing “all useful elements relating to the suspect's visible morphological characteristics” based on stains collected after a rape in an investigation into a series of sexual assaults in Lyon between October 2012 and January 2014. The Court of Cassation's authorization of this practice in DNA analysis was the first in France. For judges and prosecutors, there is now set a legal precedent allowing them to authorize “DNA Photofits” when they consider this could help an investigation.
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| In legal terms, the emerging of new technical possibilities and their practical use create conflicting and parallel regimes. On one hand, “DNA Photofits” do not correspond to the legal frameworks devised in the 1990s. It does not provide identification, per se, but is rather an “assistance to the investigation,” as it uses coding DNA. One another hand, as science evolves, the law is falling out of step with the technical and scientific reality. New knowledge shows that some of the markers used by the FNAEG may in fact allow further information to be obtained about people regarding their predisposition to certain diseases, their genetic pathologies, and their “ethnic origin” (by continent or sub-continent).{{efn|For example, according to a study by the Telethon Institute of Genetics and Medicine, D2S1388, one of the markers used by the FNAEG, plays a determining role in the transmission of pseudohyperkalaemia, a rare genetic disease.<ref name="CarellaASecond04">{{cite journal |title=A second locus mapping to 2q35-36 for familial pseudohyperkalaemia |journal=European Journal of Human Genetics |author=Carella, M.; d'Adamo, A.P.; Grootenboer-Mignot, S. et al. |volume=12 |issue=12 |pages=1073–6 |year=2004 |doi=10.1038/sj.ejhg.5201280}}</ref> In 2011, a publication by Chinese researchers highlighted the association between marker D21S11-28.2 and coronary heart disease.<ref name="HuiNovel11">{{cite journal |title=Novel association analysis between 9 short tandem repeat loci polymorphisms and coronary heart disease based on a cross-validation design |journal=Atherosclerosis |author=Hui, L.; Jing, Y.; Rui, M.; Weijian, Y. |volume=218 |issue=1 |pages=151–5 |year=2011 |doi=10.1016/j.atherosclerosis.2011.05.024 |pmid=21703622}}</ref> A team of Portuguese researchers<ref name="PereiraPop11">{{cite journal |title=PopAffiliator: online calculator for individual affiliation to a major population group based on 17 autosomal short tandem repeat genotype profile |journal=International Journal of Legal Medicine |author=Pereira, L.; Alshamali, F.; Andreassen, R. et al. |volume=125 |issue=5 |pages=629–36 |year=2011 |doi=10.1007/s00414-010-0472-2 |pmid=20552217}}</ref> has developed an online calculator capable of correlating certain markers used in the FNAEG's DNA samples with individual affiliation to population groups (Sub-Saharan Africa, Eurasia, East Asia, North Africa, Near East, North America, South America, and Central America).}} Moreover, whereas at the FNAEG's inception it was considered unacceptable for the police to use medical information, certain professionals in police or justice now recognize that this information (whether genetic or not) can be useful in investigations (providing information about wanted persons' need for medication or healthcare, or about their physical appearance, etc.). Although there are no changes in the legal framework on this matter, the idea is spreading and the red line is, to some extend, and for some of the professionals, fading.
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| It is thus obvious that police uses of DNA data providing information about individuals' characteristics raise novel politic-ethical issues.<ref name="M'charekSilent08">{{cite journal |title=Silent witness, articulate collective: DNA evidence and the inference of visible traits |journal=Bioethics |author=M'charek, A. |volume=22 |issue=9 |pages=519-28 |year=2008 |doi=10.1111/j.1467-8519.2008.00699.x |pmid=18959734}}</ref><ref name="MacLeanForensic14">{{cite journal |title=Forensic DNA phenotyping in criminal investigations and criminal courts: Assessing and mitigating the dilemmas inherent in the science |journal=Recent Advances in DNA and Gene Sequences |author=MacLean, C.E.; Lamparello, A. |volume=8 |issue=2 |pages=104-12 |year=2014 |pmid=25687339}}</ref> In particular, it brings into play the issue of what constitutes private data<ref name="ToomApproaching16">{{cite journal |title=Approaching ethical, legal and social issues of emerging forensic DNA phenotyping (FDP) technologies comprehensively: Reply to 'Forensic DNA phenotyping: Predicting human appearance from crime scene material for investigative purposes' by Manfred Kayser |journal=Forensic Science International Genetics |author=Toom, V.; Wienroth, M.; M'charek, A. et al. |volume=22 |pages=e1–e4 |year=2016 |doi=10.1016/j.fsigen.2016.01.010 |pmid=26832996}}</ref>—for certain geneticists, where “DNA Photofits” are concerned, externally visible characteristics do not fall into this category because they are visible.<ref name="KayserForensic15" /> Generally, as stated by some professionals during interviews, the question is “to know until where to go. And where to stop.“ Regarding the FNAEG and French law, in a case heard in June 2017, the European Court of Human Rights (ECHR) ruled that “interference with the applicant's right to respect for his private life had been disproportionate.”{{efn|Case of Aycaguer V. France, 22 June 2017, 8806/12, ECHR, Court (Fifth Section)}} The ECHR judgment ruled against France and underscored that French law regarding DNA date storage should be differentiated “according to the nature and seriousness of the offence committed."{{efn|See legal summary, available at [https://goo.gl/FcyuUM https://hudoc.echr.coe.int/eng#{%22itemid%22:[%22002-11703%22]} }}
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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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| [[Category:LIMSwiki journal articles (added in 2018)]]
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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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