natgillin/translations-raw huggingface dataset:
They recognisedthat there is no progress without cost and investment, and that all progress has both positive andnegative implications. The conditions and context of the application of genetic testing thereforeneed assessment on a case-by-case basis to provide maximum benefit and minimum risk.
Zaveda se, da ni razvojabrez stro‰kov in vlaganj in da ima vsak napredek tako pozitivne kot tudi negativne implikacije.Razmere in ozadje uporabe genskega testiranja torej potrebujejo oceno vsakega posameznegaprimera, da bi omogoãili najveãjo korist ob najmanj‰em tveganju. DruÏba mora zagotoviti, da je gensko testiranje stvar svobodne izbire in da ni nikoli vsiljeno.
General framework
Splo‰en okvir
There are various definitions of genetic testing and genetic data.
Obstajajo razliãne definicije genskega testiranja in genskih podatkov.
Clarification of the issues at stakeis an important prerequisite to any debate or official position.
Razjasnitev Ïgoãihvpra‰anj je pomemben pogoj za kakr‰nokoli razpravo ali uradno stali‰ãe.
See report, introduction and Annex2.
Glej poroãilo, uvod in prilogo 2.
Recommendation 1
Priporoãilo 1
That: a. any official statement or position should refer precisely to an explicitdefinition of the terms used or topic addressed;b. a consensus definition of genetic testing should be developed globally byall respective public and private bodies involved (including the World Health Organisation, the Organisation for Economic Co-operation and Development, the European Commission, the International Federation of Genetic Societies, and the International Conference on Harmonisation);c. the European Commission should consider taking the initiative on this topic.
Da naj: a. se kakr‰na koli uradna izjava ali stali‰ãe toãno nana‰a na jasno definicijouporabljenih izrazov ali obravnavanih tem;b. vsi vpleteni javni in zasebni organi (vkljuãujoã Svetovno zdravstveno organizacijo,Organizacijo za ekonomsko sodelovanje in razvoj, Evropsko komisijo, Mednarodnozvezo genskih druÏb in Mednarodno konferenco o harmonizaciji) skupaj razvijejodogovorno definicijo genskega testiranja;c. Evropska komisija razmisli o prevzemu pobude na tem podroãju.
The definitions used by the Group can be found in Annex 2 of the report.
Definicije, ki jih uporablja skupina, lahko najdete v poroãilu, priloga 2.
A broad definitionwas used for genetic testing, i.e. “any test that yields genetic data”.
Za gensko testiranje je bila uporabljena ‰iroka definicija, t. j. "katerikoli test, ki da genske podatke".
Genetic data or informationrelate to inherited or acquired properties that are transmitted during cell division and that affectsubsequent generations of offspring (“germinal genetic data”) or cells and tissues (“somatic geneticdata”).
Genski podatki aliinformacije so povezani s podedovanimi ali pridobljenimi znaãilnostmi, ki se med delitvijo celicprena‰ajo in vplivajo na naslednje generacije potomstva ("zarodni genski podatki") ali na celice in tkiva ("somatski genski podatki").
The Group focused mainly on genetic data transmissible at the germinal level, pertainingto heritable diseases or traits, and not on somatic genetic data which are subject to increasinginterest as tools for identification of disease mechanisms and pathways, disease classificationand identification of targets for new medicines.
Skupina se je posvetila predvsem genskim podatkom, ki seprena‰ajo na zarodni ravni in se nana‰ajo na dedne bolezni ali lastnosti, in ne toliko somatskimgenskim podatkom, ki so predmet poveãanega zanimanja kot orodja za identifikacijo bolezenskihmehanizmov in poti, razvr‰ãanje bolezni in identifikacijo ciljev za nova zdravila.
Further issues are at stake with respect to non-germinal (somatic) testing that require more indepth reflection and investigation.
Glede nezarodnega (somatskega) testiranja ostajajo odprta ‰e mnoga vpra‰anja, ki zahtevajobolj poglobljeno preuãitev in raziskovanje.
See report, chapter 9.1.
Glej poroãilo, poglavje 9.1.
Recommendation 2
Priporoãilo 2
That: a. a specific working group be set up to discuss further issues relevant to genetictesting for acquired genetic properties.
Da naj: a. se ustanovi posebna delovna skupina za razpravo o nadaljnjih vpra‰anjih v zvezi z genskim testiranjem za pridobljene genske lastnosti.
GENERAL FRAMEWORK exceptionalism”) is inappropriate.
Obãutek, da se genski podatki razlikujejo od drugih zdravstvenih podatkov (izjemnost genskihpodatkov), je neprimeren.
Genetic information is part of the entire spectrum of all healthinformation and does not represent a separate category as such.
Genski podatki so del popolnega spektra vseh zdravstvenih podatkovin kot taki ne pomenijo posebne kategorije.
All medical data, including geneticdata, must be afforded equally high standards of quality and confidentiality at all times.
Vsi zdravstveni podatki, vkljuãujoã genske podatke,morajo ves ãas imeti enako visoke standarde kakovosti in zaupnosti.
However, the current public perception that genetic information is somehow different isacknowledged by the Group.
Seveda pa skupina priznava trenuten vtis v javnosti, da so genski podatki nekako drugaãni.
This perception is due to a number of factors.
Takozaznavanje je posledica veã dejavnikov.
These include historicalreasons (eugenics), the current predominance of predictive genetic tests for rare monogenicdiseases which may give rise to particularly sensitive information affecting patients’ relatives,the fact that no treatment is available yet for most monogenic diseases, potential loss ofcontrol over samples, plus a number of other reasons.
Ti vkljuãujejo zgodovinske razloge (evgenika), trenutnoprevladovanje napovednih genskih testov za redke monogenske bolezni, ki lahko dajo ‰eposebej obãutljive podatke, ki vplivajo na bolnikove sorodnike, dejstvo, da za veãinomonogenskih bolezni ‰e ni zdravljenja, moÏno izgubo nadzora nad vzorci in ‰tevilne drugerazloge.
Current efforts to establish guidelines, recommendations, rules, regulatory texts and laws that applyspecifically to genetic testing and data handling should be viewed as an understandable responseto specific public concerns.
Trenutno prizadevanje za vzpostavljanje smernic, priporoãil, pravil, pravilnikov in zakonov, ki se nana‰ajo posebej na gensko testiranje in ravnanje s podatki, je treba sprejeti kot razumljivodziv na doloãene skrbi javnosti.
They are, however, only acceptable as a stepping stone to more consideredand inclusive legal and regulatory frameworks that encompass allmedical data and testing, andwhich reflect advancements made in healthcare provision.
Seveda je to sprejemljivo samo kot vmesni korak na poti k boljpreuãenim in doreãenim pravnim in regulatornim okvirom, ki bodo zajemali vsezdravstvenepodatke in testiranja ter bodo odraÏali napredek v ponudbi zdravstvene oskrbe.
See report, chapter 3.2.
Glej poroãilo,poglavje 3.2.
Recommendation 3
Priporoãilo 3
That: a. “genetic exceptionalism” should be avoided, internationally, in the contextof the EU and at the level of its Member States.
Da: a. se izogibajmo »izjemnosti« genskih podatkov, mednarodno, v sklopu EU in naravni njenih drÏav ãlanic.
However, the publicperception that genetic testing is different needs to be acknowledged andaddressed; b. all medical data, including genetic data, must satisfy equally high standardsof quality and confidentiality;c. in order to track the evolution of public perception of genetic testing andto identify issues for future debate:• further research on ethical and social perceptions of genetic testing isnecessary and should be promoted by the European Commission andnational bodies; and •questions relevant to genetic testing should be included in pan-Europeansurveys such as the Eurobarometer.
Seveda pa je treba priznati in obravnavati vtis javnosti, da je gensko testiranje drugaãno; b. morajo vsi zdravstveni podatki, vkljuãno z genskimi podatki, zado‰ãati enakovisokim standardom kakovosti in zaupnosti;c. je za sledenje razvoja vtisa javnosti o genskem testiranju in za ugotavljanjevpra‰anj za prihodnjo razpravo:• nujno nadaljnje raziskovanje etiãnega in druÏbenega zaznavanja genskegatestiranja in da ga spodbujajo Evropska komisija in nacionalni organi; in • da je treba v panevropske raziskave, kot je Eurobarometer, vkljuãiti vpra‰anja v zvezi z genskim testiranjem.
The new knowledge has to be disseminated quickly.
Novo znanje moramo hitro ‰iriti.
As the scientific background is complexand not always easy to understand, it is imperative that opportunities for education areorganised for both the public and the media.
Ker je znanstveno ozadje zapleteno in ga ni vedno lahkorazumeti, je nujno, da organiziramo priloÏnosti za izobraÏevanje javnosti in obãil.
It is important to increase public awareness, educationand understanding of genetic concepts.
Treba jepoveãati zavedanje javnosti, izobraÏevanje in razumevanje genskih konceptov.
Genetic research and its clinical applications should berepresented in an impartial way, and realistic expectations as to what they can achieve shouldbe set.
Genskoraziskovanje in njegove kliniãne uporabe je treba nepristransko predstaviti ter vzpostavitirealistiãna priãakovanja o tem, kaj lahko z njimi doseÏemo.
See report, chapters 3.1.2 and 7.2.1.
Glej poroãilo, poglavja 3.1.2 in 7.2.1.
Recommendation 4
Priporoãilo 4
That: a. materials and resources be developed and made available at the EU,national, and local level to provide information about genetic testing,genetic screening, and pharmacogenetics through a variety of media; b. science curricula at all levels (from primary to university level and vocationaltraining) include reference to progress and potential in the field of medicalgenetics;c. national education systems ensure an adequate supply of appropriatelytrained scientists and teachers, including technicians and clinicians, toensure that benefits arising from genetic research and genetic testing canbe made real and delivered to all EU citizens;d. concerted efforts to promote dialogue, education, information and debatebe encouraged;e. the ‘Science and Society’ component of the EC research and developmentframework be strengthened further.
Da naj: a. se razvije in da na razpolago na ravni EU, na drÏavni in lokalni ravni prek razliãnihmedijev materiale in vire, ki bodo postregli s podatki o genskem testiranju, genskempresejanju in farmakogenetiki; b. znanstveni uãni naãrti na vseh ravneh (od osnovno‰olske do univerzitetne ravni inpoklicnega usposabljanja) vkljuãujejo snovi o napredku in moÏnostih na podroãjumedicinske genetike;c. nacionalni izobraÏevalni sistemi zagotovijo dovolj ustrezno usposobljenihznanstvenikov in uãiteljev, vkljuãujoã tehnike in klinike, da bodo koristi iz genskihraziskav in testiranj dostopne vsem drÏavljanom EU;d. se spodbujajo skupni napori za spodbujanje dialoga, izobraÏevanja, obve‰ãanja inrazprave;e. se ‰e bolj okrepi veja "Znanost in druÏba" v raziskovalnem in razvojnem okviru Evropske skupnosti.
Dialogue should have a defined scope, be multidisciplinary, organised transparently and carefullydesigned to involve all relevant and interested stakeholders in an egalitarian fashion. Participantsin the dialogue should be encouraged to be open-minded, willing to listen, respectful of localcultural values, and should treat this dialogue as an exchange of opinions rather than as anopportunity for proselytising.
Dialog mora imeti doloãen namen, naj bo multidisciplinaren, transparentno organiziran in skrbnozasnovan, da vkljuãuje vse pomembne in zainteresirane udeleÏence na enakopraven naãin.Sodelujoãe v dialogu je treba spodbujati, da naj bodo odprti, pripravljeni poslu‰ati, spo‰tljivi dolokalnih kulturnih vrednot ter da naj jim ta dialog pomeni bolj izmenjavo mnenj kot pa priloÏnost za spreobrnjenje.
An effective dialogue will require discussion leaders to ensure that all participants in the debateare given equal opportunities to voice their respective positions, and that provision is made forquestions and answers.
Uãinkovit dialog bo zahteval vodje razprave, ki bodo zagotovili, da imajo vsi sodelujoãi v razpravienake priloÏnosti za izraÏanje svojih stali‰ã ter da se omogoãi vpra‰anja in odgovore.
See report, chapters 3.1.2 and 9.1.
Glejporoãilo, poglavja 3.1.2 in 9.1.
Recommendation 5
Priporoãilo 5
That: a. opportunities for public dialogue between different stakeholders beorganised, offering participants equal opportunities for expression;b. different formats of dialogue and debate be organised as no single formatwill fit all purposes and all publics.
Da naj: a. se organizirajo priloÏnosti za javni dialog med razliãnimi vpletenimi, ki bo omogoãilsodelujoãim enake moÏnosti izraÏanja; b. se organizirajo razliãne oblike dialoga in razprave, ker nobena posamezna oblikane bo ustrezala vsem namenom in obãinstvom.
Provision of genetic testing in the context of human healthcare requires appropriate proceduresfor obtaining informed consent, equitable access to testing as well as to appropriate counselling,and protection of confidentiality and privacy.
Omogoãanje genskega svetovanja v sklopu zdravstvene oskrbe ljudi zahteva ustrezne postopkeza pridobivanje obve‰ãenega soglasja, enak dostop do testiranja in ustreznega svetovanja tervarovanje zaupnosti in zasebnosti.
These requirements will ensure that genetictesting offers new possibilities for individual choice rather than generating further constraints.
Te zahteve bodo zagotovile, da bo gensko testiranjeposamezniku prej ponudilo nove moÏnosti izbire kot pa prineslo nove omejitve.
The Group acknowledges the present activity of the Council of Europe1 on such matters.
Skupina izreka priznanje sedanji dejavnosti Sveta Evrope1 na tem podroãju.
Predictive genetic testing has real potential to provide options for personal choice. However, itis imperative to recognise both the right to know and the right not to know as important individualrights.
Napovedno gensko testiranje ima resniãni potencial za podajanje moÏnosti za osebno izbiro.Vendar pa se nujno mora priznati tako pravica vedeti kot tudi pravica ne vedeti kot pomembnapravica posameznika.
Equitable access to information and to quality genetic services must be assured.
Treba je zagotoviti enak dostop do podatkov in kakovostnih genskihstoritev.
Inaddition, measures must be taken to prevent undesirable societal consequences as a result ofgenetic testing.
Poleg tega je treba ukrepati za prepreãevanje neÏelenih druÏbenih posledic izsledkovgenskega testiranja.
The application of genetic testing for non-medical reasons requires carefulconsideration with regard to its potential consequences for society.
Uporaba genskega testiranja za nemedicinske namene zahteva skrbnopreuãitev glede moÏnih posledic za druÏbo.
See report, chapters 1.2, 3.1,7.1.2 and 8.1.
Glej poroãilo, poglavja 1.2, 3.1, 7.1.2 in 8.1.
Recommendation 6
Priporoãilo 6
That: a. medically relevant genetic testing be considered an integral part of healthservice provision;b. medically relevant genetic testing should never be imposed and shouldalways be a matter of free personal choice;c. comprehensive information about the availability of genetic tests be freelyavailable from a range of reputable sources including public authorities,physicians, and patient groups;d. national healthcare systems ensure that genetic testing will be accessibleequitably to all who need it.
Da naj: a. zdravstveno pomembno gensko testiranje velja za integralni del ponudbezdravstvenih storitev;b. ne bo zdravstveno pomembno gensko testiranje nikoli vsiljeno in naj bo vedno stvarsvobodne odloãitve posameznika;c. bodo obseÏni podatki o razpoloÏljivosti genskih testov prosto na razpolago iz vrsteuglednih virov, vkljuãno z javnimi oblastmi, zdravniki in skupinami bolnikov;d. nacionalni sistemi zdravstvene oskrbe zagotovijo, da bo gensko testiranje enakodostopno vsem, ki ga potrebujejo.
Genetic-testing services in Europe, while based on high-quality scientific know-how, tend to sufferfrom an intolerably high level of technical error and poor reporting.
Storitve genskega testiranja v Evropi kljub temu, da temeljijo na visoko kakovostnemznanstvenem znanju, rade vsebujejo nedopustno visoko stopnjo tehniãnih napak in slaboporoãanje.
This is caused by a lack ofboth structuring and complementarity at European level and by the absence of a common European objective to provide quality services to all its citizens now and in the future.
To je posledica pomanjkanja organizacije in komplementarnosti na evropski ravni in zaradi odsotnosti skupnega evropskega cilja, da se vsem evropskim drÏavljanom zagotovijokakovostne storitve sedaj in v prihodnosti.
Diverseand heterogeneous quality schemes, a lack of reference systems, and differing Member Stateregulations, have added to the overall fragmentation of services. Nevertheless, genetic servicesface an ever-increasing number of requests for testing, while widespread susceptibility testingand pharmacogenetic tests are lurking on the horizon.
Razliãni in raznovrstni sistemi kakovosti, pomanjkanjereferenãnih sistemov in razliãni predpisi drÏav ãlanic prispevajo k splo‰ni razdeljenosti storitev.Vseeno pa genske sluÏbe dobivajo ãedalje veã zahtev po testiranju, medtem ko se na obzorjupojavljajo splo‰na testiranja dovzetnosti in farmakogenetiãni testi.
IMPLEMENTATION OF GENETIC TESTING IN HEALTHCARE SYSTEMS
IZVAJANJE GENSKEGA TESTIRANJA V SISTEMIH ZDRAVSTVENE OSKRBE
In the context of human healthcare, a test should only be offered when it has been shown toperform reliably and when there is a sound medical reason to consider it.
V sklopu zdravstvene oskrbe ljudi smemo test ponuditi samo, ko je njegova zanesljiva izvedbadokazana in kjer obstaja razumen zdravstveni razlog za njegovo uporabo.
A system for thevalidation of tests should be established.
Treba je vzpostavitisistem potrjevanja testov.
See report, chapters 1.4, 7.1.2 and 8.2.
Glej poroãilo, poglavja 1.4, 7.1.2 in 8.2.
Recommendation 7
Priporoãilo 7
That: a. the European Union institutes a consistent regulatory framework to assurespecific standards of quality for all genetic-testing services and theirproviders, including a system of accreditation for genetic-testinglaboratories;b. test providers ensure that the information provided is accurate, byconforming with internationally agreed quality standards; c. national healthcare systems establish consistent quality requirements forgenetic testing.
Da naj: a. Evropska unija vzpostavi skladen zakonski okvir za zagotavljanje specifiãnihstandardov kakovosti za vse storitve genskega testiranja in njihove ponudnike,vkljuãujoã sistem akreditacije laboratorijev za gensko testiranje;b.ponudniki testov zagotovijo, da so pridobljeni podatki toãni, s tem da se uskladijo z mednarodno dogovorjenimi standardi kakovosti; c.nacionalni sistemi zdravstvene oskrbe vzpostavijo skladne zahteve kakovosti zagensko testiranje.
Genetic screening for increased disease risk will progressively become possible for common disorders.Offering screening to specific subgroups of the population for certain disorders may be beneficial,but may also carry risks.
Gensko presejalni test za poveãano tveganje za bolezen bo za pogoste bolezni postopomapostal moÏen. Ponudba presejanja doloãenim podskupinam prebivalstva za doloãene motnje jelahko koristna, vendar lahko s seboj prina‰a tudi tveganja.
There must be agreement between medical professionals, patients, andthe community that the benefits outweigh the risks.
Obstajati mora soglasje medzdravstvenimi strokovnjaki, bolniki in skupnostjo, da koristi odtehtajo tveganja.
There is a need for meaningful informationand regulation with respect to the provision of genetic screening on a population-wide level aswell as the testing of certain subgroups within that population.
Potrebno jesmiselno obve‰ãanje in zakonsko urejanje glede omogoãanja genskega presejanja na ravniprebivalstva kot tudi testiranja doloãenih podskupin v okviru te populacije.
See report, chapter 8.4.
Glej poroãilo, poglavje8.4.
Recommendation 8
Priporoãilo 8
That: a. measures be put in place to ensure that tests are meaningful: the conditionscreened for must be serious, the test highly predictive, and follow-up actionsmust be available in terms of healthcare interventions (includingreproductive choices); b. the relevance of the genetic condition being screened for be validated andregularly evaluated within the framework of the public health context (thismay differ from country to country in the EU);c. the appropriate medical environment for providing information prior totesting and relevant post-test counselling be in place prior to offering suchscreening;d. pilot programmes be performed prior to general introduction of thescreening; e. the economic dimension of envisaged screening programmes should beconsidered carefully.
Da naj: a. se sprejmejo ukrepi za zagotavljanje smiselnosti testov: stanje, za kateregapresejalno testiramo, mora biti resno, test visoko napoveden in dejavnosti sledenjana razpolago v smislu zdravstvenega posredovanja (vkljuãno z reproduktivnoizbiro); b. pomen genskega stanja, za katerega presejalno testiramo, mora biti potrjen inredno vrednoten v okviru konteksta javnega zdravstva (to se v EU lakko razlikujeod drÏave do drÏave); c. bo pred ponudbo za tak presejalni test vzpostavljeno ustrezno medicinsko okoljeza posredovanje podatkov pred testiranjem in ustrezno svetovanje po testiranju;d. se pred splo‰no uvedbo presejanja izvedejo pilotski programi; e. se skrbno preuãijo ekonomske razseÏnosti zami‰ljenih presejalnih programov.
The provision of specialised genetic counselling is considered an essential requirement forcertain genetic tests, particularly for highly predictive tests for serious disorders.
Omogoãanje specializiranega genskega svetovanja velja za bistveno zahtevo pri doloãenihgenskih testih, zlasti za visoko napovedne teste resnih motenj.
Provision of suchcounselling requires professionals who have received specific training.
Ponudba takega svetovanjazahteva posebej usposobljene strokovnjake.
In other instances, thephysician or other non-specialised members of the healthcare team may provide the patient withthe relevant information.
V drugaãnih okoli‰ãinah lahko pomembne podatkebolniku da zdravnik ali drugi nespecializirani ãlani ekipe zdravstvene oskrbe.
The provision of simple, printed information that can be consulted bythe individual after counselling has been shown to be extremely valuable, so such materials shouldalways be available.
Izkazalo se je, da je sporoãilo preprostih, natisnjenih podatkov, ki jih posameznik lahko uporabi po svetovanju,izjemno koristno, zato naj bodo taka gradiva vedno na razpolago.
Non-directive counselling must be the rule.
Pravilo mora biti neusmerjevalno svetovanje.
The main goal of genetic counselling is to helpindividuals or families understand or cope with genetic disease, not to decrease the incidenceof genetic disease.
Glavni cilj genskega svetovanja je pomagatiposameznikom ali druÏinam razumeti gensko bolezen ali se z njo spopasti, ne pa zmanj‰atipojavnosti genske bolezni.
Appropriate explanations and sufficient time should be allocated to peoplein need of support.
Ljudem, ki potrebujejo podporo, je treba ponuditi ustrezne razlage in zadosti ãasa.
General information about genetic testing and counselling is part of regularmedical practice and relevant education must be provided to physicians.
Splo‰ni podatki o genskem testiranju in svetovanju so del redne zdravstveneprakse, zdravnikom pa je treba omogoãiti ustrezno izobraÏevanje.
Specialised counsellingshould be devoted to individual situations where it is of particular relevance.
Specializirano svetovanje bi morali posvetiti individualnim primerom, kadar je ‰e posebej pomembno.
The Group acknowledges, however, that while there should be a common basis of shared principlesregarding standards of genetic counselling, practices will vary depending on cultural settingsand values and therefore a certain heterogeneity of practices will continue to exist throughoutthe EU.
Skupina seveda priznava, da se bodo kljub Ïeleni skupni podlagi deljenih naãel o standardihgenskega svetovanja prakse razlikovale v odvisnosti od kulturnega okolja in vrednot ter bo v EU ‰e naprej obstajala doloãena heterogenost praks.
See report, chapter 7.1.5.
Glej poroãilo, poglavje 7.1.5.
Recommendation 9
Priporoãilo 9