Directed to consumer genetic testing. Perspective from the Ethics commission of the Spanish Society for Human Genetics

Pàmpols Ros, Teresa; García Sagredo, José Miguel; Pérez Aytés, Antonio; Díaz de Bustamante, Aranzazu
doi:10.1016/j.medcle.2019.06.006
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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">Over the last two decades&#44; a large number of companies have been launched&#44; offering genetic tests to consumers who can access them directly without professional supervision&#59; they advertise through all kinds of media and the product is known as Direct to Consumer Genetic Testing &#40;DTC-GT&#41;&#46; The most frequent biological sample used is saliva&#44; collected using a kit that the company provides&#46; These kits can be purchased online or in pharmacies&#44; and come in a box&#44; with the name of the test on it and all the necessary instructions&#46; Once the sample is collected&#44; the kit is the sent back to the company which extracts the DNA and carries out the genetic test&#44; the results are sent to the customer by email or a private&#44; secure site on an internet website&#46;<a class="elsevierStyleCrossRefs" href="#bib0155"><span class="elsevierStyleSup">1&#8211;3</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Tests that are not directly related to health are offered and advertised&#44; such as genealogy&#44; ancestor and ethnicity studies&#59; they invite the customer to participate in social networks in search of an identity&#44; in a plural world&#44; using their newly acquired genetics data&#44; paternity tests or family relationships&#59; there are even partner compatibility and infidelity tests&#44; tests related to behaviour and tests analysing children&#39;s talent and athletic skills are also offered&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">Of the 246 companies analysed for a reference study&#44;<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">2</span></a> more than one hundred offered health-related tests&#58; diagnostic tests for monogenic disorders&#44; carrier detection tests and&#44; although it is still scientifically premature to authenticate this information&#44; genetic testing related to nutrition &#40;nutrigenic&#41; or ageing and even markers of skin characteristics&#59; these last tests often offer&#44; together with the results&#44; personalised recommendations on diets&#44; cosmetics and lifestyles&#44; and are sometimes accompanied by the sale of corresponding products&#46; But the greatest development of DTC-GT over the last decade has been to focus the tests on&#58; response to medicines &#40;pharmacogenetics&#41;&#59; exploring the polygenic risk for common diseases such as asthma&#44; diabetes or stroke&#59; susceptibility to diseases such as breast and ovarian cancer&#44; Alzheimer&#39;s disease and genomic association profiles in general&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">DTC-GT companies have established collaborations with highly respected microchip companies such as Affymetrix and Illumina&#44; as well as with global software firms such as Microsoft and Google&#44; with a shared interest in DNA for their big data and the opportunities in the emerging electronic health data market&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">DTC-GT has been considered one of the great inventions of the 21st century and attracted powerful investors&#46; The company 23andMe uses a disruptive innovation model and in 2015 was given the prestigious title of a unicorn &#40;private companies whose value exceeds 1 billion dollars&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0165"><span class="elsevierStyleSup">3</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">DTC-GT contributes to the commercialisation of medicine and has resulted in changes in the doctor-patient and individual&#8211;health system relationships&#46;<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">4</span></a> This study will explore the technological and social environment that has facilitated their emergence&#59; the ethical considerations surrounding them&#59; best professional practices and the legal considerations regarding this field&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">The technological and social context that has facilitated the emergence of Direct to Consumer Genetic Testing</span><p id="par0035" class="elsevierStylePara elsevierViewall">The main technological and social factors facilitating the emergence of DTC-GT&#44; especially those offered for health purposes&#44; include the evolution of technology&#44; internet accessibility and a belief that technology should be a consumer good &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0040" class="elsevierStylePara elsevierViewall">Socially&#44; DTC-GT companies convey the idea that genomic knowledge is not scary but fascinating and emphasise that individuals have the right to know their genome&#46; The tests are presented as a new trend towards a collaborative science that promotes consumer empowerment and a more active role of individuals who are able to control their health&#44; democratising the public&#39;s access to privileged scientific information&#46; They encourage consumers to share their personal genomic data in order to collect data sets that increase information output&#44; promoting new approaches to genomic research&#44; motivating the exchange of experiences among consumers and creating a social network to further develop the market&#46;<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">5</span></a> Underlying this is the idea of a new way of representing genes as digital big data that can be read&#44; uploaded and shared online by consumers and companies&#46; They feed &#8216;genetization&#8217;&#44; a term which suggests that genes can entirely determine one&#39;s health and life processes&#44; often associated with notions of individualised health and disease&#44; underestimating scientific aspects such as epigenetics and environmental and social aspects and solutions&#59; the deterministic representation of genes in DTC-GT company websites promotes the neoliberal notion of health as an individual responsibility&#46;<a class="elsevierStyleCrossRef" href="#bib0165"><span class="elsevierStyleSup">3</span></a></p><p id="par0045" class="elsevierStylePara elsevierViewall">Among the social aspects of the commercialisation of genomics we must mention the DTC-GTE market and DTC-GTE companies&#8217; economic policies&#46; The majority of the DTC-GTE market is dominated by US&#44; European and UK companies&#46; Certain Spanish companies &#8211; and foreign companies based in Spain &#8211; have wide-ranging business models that include official logos as guarantees and many Spanish pharmacies offer and sell genetic tests&#46;<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">6</span></a> Online purchases of genetic tests through the online shopping giant Amazon &#8211; curiously as a Christmas gifts &#8211; has reached remarkable proportions and a certain ancestor genetic test was one of the top five best-selling products on <span class="elsevierStyleItalic">Black Friday</span> in 2017&#46; The ancestor testing market is considerable as it collects a large volume of samples and data&#44; and the participation of the users who have carried out DTC-GT tests has significant commercial value as they provide data and can be used as research subjects&#46; For example&#44; Genentech paid &#36;60 million for the genome sequence of 3000 users with Parkinson&#39;s&#46;<a class="elsevierStyleCrossRef" href="#bib0185"><span class="elsevierStyleSup">7</span></a></p><p id="par0050" class="elsevierStylePara elsevierViewall">The socio-technological landscape is changing rapidly&#44; and watching how genomics is integrated into <span class="elsevierStyleItalic">mobile digital health or mHealth</span> and its role &#8211; as well as the role of other markers &#8211; in personalised&#47;precision medicine is of interest&#46; Additionally&#44; the public&#39;s response&#44; and health-professionals&#8217; criticism of this situation&#44; as well as the growing concern about the risks of overdiagnosis will heavily influence the path that it take&#46;<a class="elsevierStyleCrossRef" href="#bib0165"><span class="elsevierStyleSup">3</span></a></p><p id="par0055" class="elsevierStylePara elsevierViewall">The expansion of DTC-GT has been accompanied by corresponding academic research into its ethical&#44; legal and social implications&#46; In Spain DTC-GT is unambiguously legally restricted&#44; as is shown below&#44; but the companies that sell and operate them are very active and an interesting debate has been established between these companies and geneticists<a class="elsevierStyleCrossRef" href="#bib0190"><span class="elsevierStyleSup">8</span></a> to which the Asociaci&#243;n Espa&#241;ola de Gen&#233;tica Humana &#91;Spanish Society for Human Genetics&#93; &#40;AEGH&#41; Ethics Commission would like to contribute with this study&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Ethical considerations regarding Direct to Consumer Genetic Testing</span><p id="par0060" class="elsevierStylePara elsevierViewall">The ethical and philosophical debate regarding the principal of autonomy is a central theme in this discussion&#44;<a class="elsevierStyleCrossRefs" href="#bib0170"><span class="elsevierStyleSup">4&#44;9</span></a> since the freedom of people to manage their life processes and their health must be respected&#46; This value must be reconciled with protecting people&#39;s rights from the damage that these technologies may cause&#44; while ensuring that these limitations do not behave overly paternalistic or infringe the expression of individual rights&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">Autonomy requires adequate and accurate information about the test prior to taking it&#44; as well as the consequences of the results&#44; so that the person taking it can form an factual judgement and make independent use of this right&#58; the practical way of expressing moral autonomy is basing it on informed consent&#46; Autonomy and independence can be seriously compromised if the company does not offer clear or appropriate information about the test and the value of the diagnostic and predictive results&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">Furthermore&#44; individual autonomy has an extrinsic limit&#44; that of not causing harm to third parties&#44; for example family members&#44; whose right to not know may be affected&#46; Genetic data do not belong only to the individual and can also impact the family and the community&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall">The principles of non-maleficence and beneficence can be compromised because the suitability of a test that has not been prescribed by a competent&#44; trained professional in a health context is not guaranteed&#46; The scientific evidence of the tests may be insufficient and difficult to interpret by the untrained user&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">There is also a risk of self-interpretation of the results&#44; where the consumer may not properly understand their scope&#44; limitations and meanings&#46; And importantly&#44; there is often an absence of genetic counselling and follow-up after the test&#44; which should be available to provide the necessary support to correctly interpret or address the impact of results on the individual and the family <span class="elsevierStyleItalic">e&#46;g&#46;</span> confirmation of a genetic disease&#46; Certain situations&#58; prenatal tests&#44; tests for the preconceptional detection of heterozygotes and tests for the detection of severe non-treatable diseases&#44; unquestionably require genetic counselling prior to the test&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">Because samples are so easy to collect&#44; they can be obtained from vulnerable people&#44; for example minors&#44; ignoring corresponding ethical principles&#46; There is a general consensus of not applying genetic tests to minors without a medical reason or a direct benefit for their health&#44; in order to prevent a violation of their right to not knowing about genetic information&#44; and ensure they decide only when they are capable of making those decisions&#44; and of their right to autonomy by deciding whether they want to submit&#44; or not&#44; to a genetic test by sharing their genetic data on the internet&#46;<a class="elsevierStyleCrossRef" href="#bib0200"><span class="elsevierStyleSup">10</span></a> Tests associated with lifestyles&#44; for example to select a sport for the child&#44; can also easily limit their autonomy&#44; exaggerate their expectations or&#44; conversely&#44; stigmatise them&#46;<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">4</span></a></p><p id="par0090" class="elsevierStylePara elsevierViewall">The protection and treatment of genetic data and samples by the company is another controversial issue&#46;<a class="elsevierStyleCrossRef" href="#bib0205"><span class="elsevierStyleSup">11</span></a> Aspects in this area to consider include&#58; safeguarding confidential data&#59; conservation of samples&#59; ownership and subsequent use of samples after the analyses have been completed&#59; the sale of the data and samples to third parties for therapeutic research and the end use of the samples and data should the company&#47;laboratory close&#46;</p><p id="par0095" class="elsevierStylePara elsevierViewall">DTC-GT do not only represent personal decisions without further consequences&#44; the principle of fairness and justice is also relevant&#46; These tests tend to have an impact on the public health system since their results often raise doubts&#44; and users then consult their doctors to resolve them&#46; Another issue is that they cause users to request unnecessary test through advertising to professionals&#46; In short&#44; public resources are diverted&#44; affecting the sustainability and equity of the public health system&#46;<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">4</span></a></p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Considerations of best professional practices in Direct to Consumer Genetic Testing</span><p id="par0100" class="elsevierStylePara elsevierViewall">On the basis of the above&#44; offering health-related genetic tests directly to consumers without medical supervision&#44; informed consent&#44; or adequate independent genetic counselling&#44; and marketing genetic tests without proven benefits&#44; goes against all deontological standards that are the foundations of scientific and professional associations&#44;<a class="elsevierStyleCrossRef" href="#bib0210"><span class="elsevierStyleSup">12</span></a> and European geneticists strongly oppose DTC-GT&#44; with a practically unanimous opinion from clinical geneticists regarding the unacceptability of offering tests &#8211; outside the healthcare context&#44; without an appropriate doctor&#8211;patient relationship and without physical supervision in person &#8211; for non-treatable or preventable diseases and disorders with serious consequences for health&#46;</p><p id="par0105" class="elsevierStylePara elsevierViewall">The above considerations have generated numerous position articles by scientific societies and bioethics committees<a class="elsevierStyleCrossRefs" href="#bib0170"><span class="elsevierStyleSup">4&#44;12&#8211;19</span></a> that concur&#44; albeit with slight differences&#44; with the requirements outlined in <a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>&#46;</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><p id="par0110" class="elsevierStylePara elsevierViewall">The companies that offer DTC-GT tests evolve rapidly&#44; and to address criticism and pressure from government agencies such as the <span class="elsevierStyleItalic">Food and Drug Administration</span>&#44; some have changed their delivery model so that users must first obtain approval from a professional contracted by the company before placing the order&#59; however this not establish an adequate doctor&#8211;patient relationship with the consumer&#46;<a class="elsevierStyleCrossRef" href="#bib0165"><span class="elsevierStyleSup">3</span></a> There are companies that offer information on their websites&#44; telephone assistance and genetic counselling by professionals contracted by the company&#44; sometimes at an additional cost&#46; Although telephone medical supervision may be a valuable tool in a previously established doctor&#8211;patient relationship&#44; European clinical geneticists consider it to be unacceptable in the context of presymptomatic tests for a disease with high penetrance&#44; predictive tests for a disease with average penetrance of 50&#8211;60&#37; and for the diagnosis of carriers&#46;<a class="elsevierStyleCrossRef" href="#bib0250"><span class="elsevierStyleSup">20</span></a></p><p id="par0115" class="elsevierStylePara elsevierViewall">Some reviews highlight that propaganda often puts more emphasis on the benefits than on the side effects&#59; ignores scientific evidence and clinical utility of the tests&#59; is not adequately informative&#59; does not explain that the tests have little predictive power and do not adequately calibrate the genetic risk&#46;<a class="elsevierStyleCrossRefs" href="#bib0255"><span class="elsevierStyleSup">21&#44;22</span></a> In general&#44; the commercialisation of these tests often do not often satisfy the above requirements&#46; DTC-GT companies&#8217; monitoring of international guidelines on confidentiality&#44; privacy and secondary use of data is also inconsistent&#46;<a class="elsevierStyleCrossRefs" href="#bib0255"><span class="elsevierStyleSup">21&#44;23</span></a></p><p id="par0120" class="elsevierStylePara elsevierViewall">The legal complexity and length of contracts signed with electronic commerce companies can be overwhelming&#44; and reading and accepting those terms is not always obligatory&#46; For this reason&#44; establishing more specific regulations to adequately protect consumers is essential&#46;<a class="elsevierStyleCrossRefs" href="#bib0160"><span class="elsevierStyleSup">2&#44;3</span></a> The user must be aware that they send data and samples that will be processed&#44; stored and shared in another country&#44; and that their genetic data not only belongs to them&#44; but also to their relatives and sometimes even their social group&#46;</p><p id="par0125" class="elsevierStylePara elsevierViewall">The progressive implementation of informed consent before carrying out any tests and a request for consent to use the data and samples in research is essential&#44; including documentation adapted to minors&#46; An informed consent for the massive genomic sequencing tests offered by some companies deserves special consideration&#46; On this basis&#44; a review of the ethical aspects&#44; storage policy and future uses of the data and samples that companies offering exome and genome sequencing have access to&#44; concluded that these companies did not&#58; provide enough information regarding the treatment of data and samples in their use in research and consequences resulting from that&#59; offer pre-test genetic counselling&#59; give sufficient information on benefits and risks&#59; adequately address the treatment of incidental findings&#44; and were potentially misleading&#46;<a class="elsevierStyleCrossRef" href="#bib0205"><span class="elsevierStyleSup">11</span></a></p><p id="par0130" class="elsevierStylePara elsevierViewall">It is thus important to examine the behaviour of companies and ensure they are aware of and adhere to generally accepted ethical standards or at least those that are aspired to by the scientific and professional community&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Legal considerations and regulations on Direct to Consumer Genetic Testing</span><p id="par0135" class="elsevierStylePara elsevierViewall">The genetic tests and the genetic information obtained with it have significant individual&#44; family and socioeconomic repercussions and their ethical&#44; legal and social implications are extremely relevant&#46;<a class="elsevierStyleCrossRefs" href="#bib0270"><span class="elsevierStyleSup">24&#44;25</span></a> The protection of the rights of people in regard to genetics&#47;genomics has generated a large number of declarations&#44; documents and legal provisions&#44; especially since the beginning of the human genome project in 1990&#46; In Europe alone&#44; approximately 80 varying legal documents on genetic testing have been enacted&#46;<a class="elsevierStyleCrossRef" href="#bib0280"><span class="elsevierStyleSup">26</span></a> The 1997 the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine &#40;Oviedo Convention&#41; and its 2008 Additional Protocol on Genetic Testing for Health Purposes are especially relevant&#46;</p><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Spanish legal framework for genetic testing</span><p id="par0140" class="elsevierStylePara elsevierViewall">The Spanish legal framework encompassing genetic testing in regard to both research and assistance&#44; has been established by Law 14&#47;2007 of June 13 on Biomedical Research&#46; Articles 46&#8211;57 of Chapter II&#44; genetic analysis and treatment of genetic data of a personal nature&#44; consider the points summarised in <a class="elsevierStyleCrossRef" href="#tbl0015">Table 3</a>&#46;</p><elsevierMultimedia ident="tbl0015"></elsevierMultimedia><p id="par0145" class="elsevierStylePara elsevierViewall">The transposition of directive 98&#47;79&#47;EC could also be considered through Royal Decree 1662&#47;2000 of September 29&#44; on medical devices for <span class="elsevierStyleItalic">in vitro</span> diagnosis and its modification through a final provision of Royal Decree 1591&#47;2009 of 16 October&#44; which adds to article 13 section 8 &#8220;for reasons of public health&#44; products for genetic diagnosis will not be made available to the public&#8221; and article 25&#44; section 8 &#8220;advertising of products for genetic diagnosis directed to the public is prohibited&#8221;&#46;</p><p id="par0150" class="elsevierStylePara elsevierViewall">Royal Decree 1907&#47;1996 of August 2&#44; on advertising and commercial promotion of products&#44; activities or services with a purported health purpose&#44; requires that the competent bodies manage said publicity in order to ensure they comply with criteria of transparency&#44; accuracy and veracity&#46;</p><p id="par0155" class="elsevierStylePara elsevierViewall">For an analysis regarding DTC advertising within the Spanish legal system see references&#46;<a class="elsevierStyleCrossRefs" href="#bib0180"><span class="elsevierStyleSup">6&#44;27</span></a> The final reflections of reference<a class="elsevierStyleCrossRef" href="#bib0285"><span class="elsevierStyleSup">27</span></a> notes that offering genetic analysis to the general population outside the health-system context is prohibited in the Spanish legal system&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">European regulation of Direct to Consumer Genetic Testing</span><p id="par0160" class="elsevierStylePara elsevierViewall">There is no European or national legislative instrument specifically regulating DTC-GT&#44; but there are aspects of genetic testing that are regulated&#44; such as national services that are subject to protective laws&#46; Ref&#46; <a class="elsevierStyleCrossRef" href="#bib0290">28</a> reviews the legislation of 26 European countries&#44; which could potentially have an impact on the regulation of DTCs&#46; The emphasis focuses on provisions related to medical supervision&#44; genetic counselling and informed consent&#46; Although the laws of specific cases such as France&#44; Spain and Germany do not refer explicitly to the commercial context&#44; offering DTC-GT is clearly restricted&#46;</p><p id="par0165" class="elsevierStylePara elsevierViewall">It is worth noting that these laws in general are designed to apply to genetic testing within the health system&#59; applying these same laws to the commercial sector outside a clinical or hospital setting is complicated&#46; Furthermore genetic tests are also considered medical devices for <span class="elsevierStyleItalic">in vitro</span> diagnostics and in this sense their introduction to the market and their marketing are subject to consumer protection laws in regard to safety and efficiency as a product&#44; which is why many expectations were raised when the European Parliament and the Council of the Union European Commission announced the amendment of Directive 98&#47;79&#47;EC on medical devices for <span class="elsevierStyleItalic">in vitro</span> diagnostics&#46;</p><p id="par0170" class="elsevierStylePara elsevierViewall">The final text approving EU Regulation 2017&#47;746 of the European Parliament and Council of 5 April 2017&#44; on medical devices for <span class="elsevierStyleItalic">in vitro</span> diagnosis&#44; does not contemplate that genetic tests are classified only as medical prescription&#44; but includes in article 4&#46;1 on &#8220;Genetic information&#44; counselling and informed consent&#8221; that when the genetic test is used in a healthcare context and for the medical purposes of diagnosis&#44; treatment improvement&#44; predictive or prenatal tests&#44; the person who takes the test must receive relevant information regarding the nature&#44; importance and consequences of the genetic testing&#46; Article 4&#46;2 also requires access to advice in the case they use genetic tests that provide information on their genetic predisposition to certain disorders or untreatable diseases according to the state of science and technology&#46; Article 4&#46;4 also states that Member States may adopt or maintain more protective national measures regarding informed consent and genetic counselling&#44; and that national laws classifying specific <span class="elsevierStyleItalic">in vitro</span> diagnostic products that require medical prescription will not be affected&#46; This means that the provisions of the Biomedical Research Law regarding medical supervision&#44; genetic counselling and informed consent are applicable in Spain for the commercialisation of health products for <span class="elsevierStyleItalic">in vitro</span> genetic diagnosis&#44; beyond what is stated in EU Regulation 2017&#47;746&#46;<a class="elsevierStyleCrossRef" href="#bib0295"><span class="elsevierStyleSup">29</span></a></p><p id="par0175" class="elsevierStylePara elsevierViewall">In DTC-GT the line between medical devices and consumer products is sometimes blurred&#44; and it is not always clear whether the kind of service they provide constitutes &#8216;medical practice&#8217; or not&#44; since companies sometimes minimise their service&#39;s health implications and instead emphasise the product&#39;s &#8216;educational&#8217;&#44; &#8216;informative&#8217; and even &#8216;fun&#8217; aspects&#46; Additionally&#44; as there is no uniform definition in Europe of what constitutes the &#8216;practice of medicine&#8217;&#44; the imposition of strictly uniform standards on medical supervision&#44; genetic counselling and informed consent through Regulation is considered to be impracticable and restrictive&#44; an interference in European Union clinical practice&#44; and beyond its legislative powers&#46; On this basis&#44; an Internet-based industry operating globally cannot be forced to comply with laws or regulations on a per country basis&#46;<a class="elsevierStyleCrossRef" href="#bib0290"><span class="elsevierStyleSup">28</span></a></p><p id="par0180" class="elsevierStylePara elsevierViewall">However&#44; the same level of protection of patients&#8217; rights can be guaranteed throughout Europe&#44; by applying the Council of Europe Oviedo Convention Additional Protocol for genetic testing for health purposes and ensuring compliance with relevant international and European guidelines&#46;<a class="elsevierStyleCrossRef" href="#bib0290"><span class="elsevierStyleSup">28</span></a></p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">US regulations of Direct to Consumer Genetic Testing</span><p id="par0185" class="elsevierStylePara elsevierViewall">The public health implications of DTC-GT are mainly the validity&#44; safety and effectiveness of the tests&#44; which federal regulatory agencies in the US have given special attention to&#46; The <span class="elsevierStyleItalic">Food and Drug Administration</span> that regulates the validity of medical devices and the strict procedures to follow to ensure their accuracy and safety&#44; consider DCT-GT to be health devices and even sent warning letters to various companies for violations of the Food&#44; Drug and Cosmetic Act&#46; As a consequence&#44; in 2013 the company 23andMe&#44; ceased to offer its joint tests for ancestor and health-related genetic information&#44; and now only supplies results as uninterpreted raw genetic sequence&#46; However&#44; there are websites that offer consumers alternative means to obtain information about their health from this data&#44; although interpretation by third parties also raises questions about accuracy&#44; quality and privacy&#44; adding a new ethical dimension to the debate&#46;<a class="elsevierStyleCrossRef" href="#bib0300"><span class="elsevierStyleSup">30</span></a></p><p id="par0190" class="elsevierStylePara elsevierViewall">Despite this&#44; in 2015 the <span class="elsevierStyleItalic">Food and Drug Administration</span> classified 40 tests for the detection of carriers and five tests for the detection of risk for specific diseases as Class II&#44; <span class="elsevierStyleItalic">i&#46;e&#46;</span> medium risk devices rather than Class III or high risk devices&#44; granting this approval based on the aforementioned 23andMe company&#39;s ability to demonstrate the tests&#8217; clinical validity and consumers&#8217; understanding of the results&#46; The company also has permission to sell tests in the UK because the kit for the test has the CE conformity marking&#44; and while this only means that the kit is considered safe for the purpose of collecting the saliva sample&#44; and does not include the reliability or security of the sequencing service&#44;<a class="elsevierStyleCrossRef" href="#bib0165"><span class="elsevierStyleSup">3</span></a> in this case the laboratory is certified by the Clinical Laboratory Improvement Amendments&#46;</p><p id="par0195" class="elsevierStylePara elsevierViewall">DTC-GT companies bring together three areas surrounding its regulatory debate&#58; technological innovation&#44; new diagnostic modalities and changes in the provision of tests model&#44; such that certain authors point to regulations beyond medical devices to focus on a more generic protection of consumers&#46;<a class="elsevierStyleCrossRefs" href="#bib0160"><span class="elsevierStyleSup">2&#44;3</span></a></p></span></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Conclusions</span><p id="par0200" class="elsevierStylePara elsevierViewall">Carrying out genetic tests for health purposes is part of a complex process that has the potential to positively and negatively impact individuals&#8217; health and well-being&#46;</p><p id="par0205" class="elsevierStylePara elsevierViewall">The offer and propaganda of genetic tests for health purposes without medical supervision&#44; informed consent and adequate independent genetic counselling&#44; compromise the basic ethical principles of medicine and go against all deontological standards that are the foundations of scientific and professional associations&#46;</p><p id="par0210" class="elsevierStylePara elsevierViewall">The freedom of people to manage their life and health must be respected&#44; but this value must be reconciled with protecting people&#39;s fundamental rights corresponding to genetic tests and the genetic information that is obtained from them&#46;</p><p id="par0215" class="elsevierStylePara elsevierViewall">Although the Spanish legal framework does not specifically mention them&#44; it places clear limits on DTC-GT and as such the competent bodies must ensure compliance with existing provisions on genetic analysis by Spanish or foreign companies based in Spain&#46; Section &#8220;Spanish legal framework for genetic testing&#8221; and <a class="elsevierStyleCrossRef" href="#tbl0015">Table 3</a>&#46;</p><p id="par0220" class="elsevierStylePara elsevierViewall">For greater security&#44; a future regulatory development of certain sections of the Law 14&#47;2007 on Biomedical Research related to genetic analysis could include specific mention of DTC-GT and the processing and use of the genetic information obtained from them&#46; Spain is the only European country that does not regulate genetics as a health specialty and its development is key to ensuring the quality and safety of genetic services&#44; including diagnostic laboratories&#46; It would also be pertinent if Spain ratified and signed the Oviedo Convention Additional Protocol for genetic testing for health purposes&#46;</p><p id="par0225" class="elsevierStylePara elsevierViewall">The AEGH adheres to DTC-GT requirements outlined by scientific societies and bioethics committees&#8217; position articles cited in the &#8216;Considerations of best professional practices in Direct to Consumer Genetic Testing&#8217; section and outlined in <a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>&#46; For this purpose&#44; AEGH has posted a document on its website &#40;<a href="http://www.aegh.org/">www&#46;AEGH&#46;org</a>&#41; stating its position and which concludes that &#8220;&#8230;based on ethical requirements&#44; best professional practices and Spanish legal regulations&#44; it believes that a company&#47;laboratory should <span class="elsevierStyleItalic">not</span> offer direct to consumer diagnostic genetic tests&#8221;&#46;</p><p id="par0230" class="elsevierStylePara elsevierViewall">The <span class="elsevierStyleItalic">in vitro</span> diagnostic industry is of great importance as an element of research and innovation&#46; The purpose of this article was to identify ethical&#44; best practices and legislative tools that can serve as a guide for the agents involved in its development&#58; consumers&#44; patients&#44; health professionals and companies that offer DTC-GT&#44; in order to ensure they act responsibly&#44; by promoting awareness and adhering to internationally accepted ethical standards and best practices&#44; or at least those that are aspired to&#46;</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conflict of interest</span><p id="par0235" class="elsevierStylePara elsevierViewall">The authors declare no conflict of interest&#46;</p></span></span>"
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          "titulo" => "The technological and social context that has facilitated the emergence of Direct to Consumer Genetic Testing"
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        "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as&#58; P&#224;mpols Ros T&#44; Garc&#237;a Sagredo JM&#44; P&#233;rez Ayt&#233;s A&#44; D&#237;az de Bustamante A&#46; Pruebas gen&#233;ticas de venta directa a los consumidores&#46; Perspectiva de la Comisi&#243;n de &#201;tica de la Asociaci&#243;n Espa&#241;ola de Gen&#233;tica Humana&#46; Med Clin &#40;Barc&#41;&#46; 2019&#59;153&#58;35&#8211;40&#46;</p>"
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                  \t\t\t\t">&#8226; In the area of biomedical sciences&#44; genetics is the field that has grown fastest&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">&#8226; Advances in the discovery of more than 1000 variations in the DNA sequence associated with complex diseases&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">&#8226; The evolution of massive DNA sequencing techniques has dramatically reduced costs&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">&#8226; The Internet&#44; new trends in online medicine&#44; medicine 2&#46;0 and ideas driven by the promise of predictive&#44; preventive&#44; personalised and participatory genomic medicine&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
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                  \t\t\t\t">&#8226; Modern society&#44; which&#44; especially in more developed countries&#44; are characterised by the promotion of consumerism and the encouragement of economic growth&#46; Health is included in this trend and health services are often seen as a consumer good&nbsp;\t\t\t\t\t\t\n
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          "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Main technological and social factors that have led to the emergence of DTC-GT for health purposes&#46;</p>"
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          "leyenda" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall"><span class="elsevierStyleItalic">Source</span>&#58; Refs&#46; <a class="elsevierStyleCrossRefs" href="#bib0170">4&#44;12&#8211;19</a>&#46;</p>"
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                  \t\t\t\t">&#8226; The relationship between genetic marker and disease must have analytical and clinical validity and clinical utility&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">&#8226; Special precautions must be taken with tests for&#58; severe disorders with high penetrance&#59; prenatal diagnosis&#59; detection of heterozygote&#59; risk or predisposition tests and nutrigenomics and pharmacogenetics that may induce inappropriate changes in diet&#44; lifestyle or medication&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">&#8226; The information provided defining the meaning of the health test must be rigorous&#46; Many DTC-GT tests do not give definitive answers&#44; and simply provide risks or probabilities&#46; This information must be transmitted to the consumer in a coherent and understandable way&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">&#8226; Laboratories must meet internationally accepted quality assurance standards&#44; which includes ensuring their professionals have the appropriate qualifications&#59; the results are professionally interpreted and that they have been certified by the authorities and accrediting agencies of the country where the company is based&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">&#8226; Genetic testing should not be offered to people who are not over legal age&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">&#8226; How the confidentiality and security of the data are managed and the end use of the DNA samples once the analyses have been carried out must be made clear&#44; and in the case they are used for future research the consent procedures must be made explicit&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">&#8226; Propaganda aimed at consumers and marketing aimed at professionals must conform to criteria of accuracy and veracity and meet international standards and guidelines for medicines or health products&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">&#8226; Government health services must provide information to the public about the risks and benefits of personal genetic profiles&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">&#8226; The offer of health-related genetic testing services can become a growing burden on public resources through using the public health system&#39;s resources&#44; as a demand for unnecessary tests or requests for advice or interpretation of results from consumers after taking such test may increase&#46; For this reason&#44; health authorities and regulatory agencies should establish corresponding criteria to introduce genetic tests&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">&#8226; We must be cautious and vigilant about this growing and influential market of health services and improve coordination between government agencies in order to guarantee minimum standards of transparency&#44; quality and responsibility&nbsp;\t\t\t\t\t\t\n
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          "en" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">DTC-GT requirements&#44; based on scientific societies and bioethics committees&#8217; position articles&#46;</p>"
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                  \t\t\t\t">&#8226; The relevance of the test&#58; prescribed by a qualified professional and occurring together with genetic counselling&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">&#8226; The quality of the tests and that they are taken in accredited centres&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">&#8226; Permission to access data expressed through informed consent&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">&#8226; Fairness and accessibility to tests&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">&#8226; Protection of people who do not have the capacity to consent&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">&#8226; The right to know the genetic information obtained and also the right not to know&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">&#8226; Confidentiality of information and non-communication to third parties&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">&#8226; The possibility of unexpected or incidental results and deciding whether or not to receive notification of such data&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">&#8226; Implications that the information obtained may have for family members and the convenience of communicating such data when appropriate&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">&#8226; Protection of genetic data and samples&nbsp;\t\t\t\t\t\t\n
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          "en" => "<p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Law 14&#47;2007 of June 13&#44; on Biomedical Research&#46; Articles 46&#8211;57 of Chapter II&#44; Genetic analysis and treatment of genetic data of a personal nature&#44; consider the following points&#46;</p>"
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      "titulo" => "References"
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                      "titulo" => "Your genes for sale&#58; shouldn&#8217;t you get a return&#63;"
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                      "titulo" => "Las pruebas gen&#233;ticas directas al consumidor a debate"
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                      "titulo" => "Health-related direct-to-consumer genetic testing&#58; a review of companies&#8217; policies with regard to genetic testing in minors"
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                        0 => array:2 [
                          "etal" => false
                          "autores" => array:4 [
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        "identificador" => "xack414271"
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        "texto" => "<p id="par0240" class="elsevierStylePara elsevierViewall">The AEGH Ethics Commission has been following the DTC-GT issue for several years and presented its first communication on the subject in the AEGH Congress held in 2011 in Murcia&#46; For this reason&#44; we wish to thank all the reflections contributed since then by the members of the two previous commissions&#58; Joaqu&#237;n Rueda&#44; Jordi Rosell&#44; Miguel Fern&#225;ndez-Burriel&#44; Montserrat Mil&#225;&#44; Diana Valverde&#44; Nicol&#225;s Gar&#237;n and Isabel Vallcorba&#46; We also like to thank the AEGH Board of Directors for its decisive involvement in this issue and for its collaboration in the joint preparation of the Position article on DTC-GT posted on the AEGH website in 2015&#46;<a class="elsevierStyleCrossRef" href="#bib0255"><span class="elsevierStyleSup">21</span></a></p>"
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