natgillin/translations-raw huggingface dataset:
That: a. in the context of healthcare, genetic testing be accompanied by theprovision of key information and, where appropriate, by the offer ofindividualised counselling and medical advice (in the case of highly predictivegenetic tests for serious disorders, the offer of specific counselling shouldbe mandatory, and patients should be strongly encouraged to takeadvantage of it); b. specific educational programmes on counselling and exchange of experiencein the field be organised at the European level;c. specific qualifications and quality standards for those engaged in theprovision of specific genetic counselling, whether clinicians or non-clinicians,be established and made mandatory; d. appropriate financial means for such training and the subsequentaccreditation be made available;e. Europe-wide general standards for fundamental principles of geneticcounselling be developed by relevant medical professional groups, with dueconsideration given to patients’ views.
Da naj: a. v sklopu zdravstvene oskrbe gensko testiranje spremlja posredovanje kljuãnihpodatkov in po potrebi ponudba svetovanja in zdravstvenih nasvetov, prilagojenaposamezniku (v primeru visoko napovednih genskih testov za resne motnje naj boponudba specifiãnega svetovanja obvezna, bolnikom pa jo je treba priporoãiti); b. se na evropski ravni organizirajo specifiãni izobraÏevalni programi o svetovanju inizmenjava izku‰enj na tem podroãju;c. se doloãi obvezne specifiãne usposobljenosti in standarde kakovosti za tiste, ki se ukvarjajo z genskim svetovanjem, pa naj bodo to kliniãni zdravniki ali drugi; d. se zagotovijo ustrezna denarna sredstva za tako usposabljanje in poslediãneakreditacije;e. ustrezne zdravstvene strokovne skupine razvijejo evropske splo‰ne standardetemeljnih naãel genskega svetovanja z upo‰tevanjem bolnikovega mnenja.
Public concern regarding genetic testing is grounded to some extent in the fear of misuse ofgenetic data and of inappropriate access to such data by third parties.
Javna skrb glede genskega testiranja do neke mere temelji na strahu pred zlorabo genskihpodatkov in neustreznim dostopom do takih podatkov s strani tretjih oseb.
Confidentiality and privacywith regard to all personal medical data, including those derived from genetic testing, are basicrights and must be respected.
Zaupnost in zasebnostglede vseh osebnih zdravstvenih podatkov, vkljuãno s podatki, ki izvirajo iz genskega testiranja,sta osnovni pravici in ju moramo upo‰tevati.
An individual’s right to determine the extent of privacy andconfidentiality that he or she will be afforded encompasses both access to personal informationand data and to tissue samples as carriers of information.
Pravica posameznika, da doloãi obseg zasebnosti inzaupnosti, ki ju bo uÏival, obsega dostop tako do osebnih podatkov kot tudi do tkivnih vzorcev kotnosilcev informacije.
The individual has both the right toknow and not to know.
Posameznik ima pravico vedeti in tudi pravico ne vedeti.
Affording legal protection in this field is of paramount importance andthe existing EU Data Protection Directive2provides an appropriate framework for the need to protect personal data.
Zagotavljanjepravne za‰ãite na tem podroãju je prvenstvenega pomena in obstojeãa Smernica o varovanjupodatkov EU (EU Data Protection Directive)2daje ustrezno ogrodje tej potrebi po varstvu osebnih podatkov.
See report, chapters 3.2, 4.1 and 7.2.2.
Glej poroãilo, poglavja 3.2, 4.1 in 7.2.2.
Recommendation 10
Priporoãilo 10
That: a. genetic data of importance in a clinical and/or family context should receivethe same level of protection as other comparably sensitive medical data;b. the relevance for other family members has to be addressed;c. the importance of a patient’s right to know or not to know be recognisedand mechanisms incorporated into professional practice that respect this.In the context of genetic testing, encompassing information provision,counselling, informed consent procedures, and communication of testresults, practices should be established to meet this need;d. these issues are of particular relevance to vulnerable populations, whetherin the EU or elsewhere in the world.
Da: a. naj bodo pomembni genski podatki v kliniãnem in/ali druÏinskem okolju enakoza‰ãiteni kot drugi primerljivo obãutljivi zdravstveni podatki;b. je treba obravnavati pomen za druge osebe v druÏini; c. naj se prizna pomembnost bolnikove pravice vedeti ali ne vedeti in naj se vstrokovno prakso vgradijo mehanizmi, ki to upo‰tevajo. V sklopu genskegatestiranja je treba vzpostaviti postopke, ki bodo zadostili potrebam po dajanjupodatkov, svetovanju, postopkih obve‰ãenega soglasja ter sporoãanju izsledkovtestov;d. so ta vpra‰anja posebno pomembna za ranljive populacije v EU in drugod posvetu.
Irrespective of confidentiality issues, personal medical data including genetic data must not beused to discriminate unfairly against individuals.
Ne glede na vpra‰anja zaupnosti se osebnih zdravstvenih podatkov, vkljuãno z genskimi podatki,ne sme uporabljati za nepraviãno diskriminacijo posameznikov.
The Group acknowledges the risk of discriminationas a result of genetic testing but notes that the field of discrimination extends far beyond genetics.Such discrimination may affect individuals, families or larger groups.
Skupina se zaveda tveganjadiskriminacije kot posledice genskega testiranja, a tudi priznava, da se podroãje diskriminacijerazteza daleã prek genetike. Taka diskriminacija lahko prizadene posameznike, druÏine ali veãjeskupine.
Recommendation 11
Priporoãilo 11
That: a. data derived from genetic sources should not be used in ways thatdisadvantage or discriminate unfairly against individuals, families or groupsin either clinical or non-clinical contexts, including employment, insurance,access to social integration, and opportunities for general well-being; b. EU-level regulations addressing these issues should be promoted; c. timely access to genetic testing should be based on need and appropriatelyresourced with no discrimination based on gender, ethnic origin, social oreconomic status.
Da naj: a. se podatkov, pridobljenih iz genskih virov, ne uporablja na naãine, ki bi onemogoãali ali nepraviãno diskriminirali posameznike, druÏine ali skupine v kliniãnem ali nekliniãnem okolju, vkljuãujoã zaposlitev, zavarovanje, dostop do druÏbene vkljuãenosti in priloÏnosti za splo‰no dobrobit; b. se podpira predpise na ravni EU, ki se nana‰ajo na ta vpra‰anja; c. ãimprej‰nji dostop do genskega testiranja temelji na potrebi in naj bo ustreznopridobljen brez diskriminacije na podlagi spola, etniãnega porekla, druÏbenega ali ekonomskega poloÏaja.
There may be differentiation of patient populations, based on ethnic groupings, with respectto genetic testing.
Glede na gensko testiranje lahko obstaja razloãevanje populacij bolnikov na podlagi etniãnegarazvr‰ãanja v skupine.
Some genetic variants are more common in certain populations or groupsin the EU and elsewhere.
Nekatere genske razliãice so bolj pogoste v doloãenih populacijah aliskupinah, v EU in drugod.
Specific attention should be paid to such groups in the context of testdevelopment and in the conditions set up for the use of these tests, both to ensure fair accessand to avoid stigmatisation or stereotyping.
Takim skupinam je treba posvetiti posebno pozornost v smislu razvojatestov in pri postavljenih pogojih za uporabo teh testov, oboje za zagotavljanje praviãnegadostopa ter v izogib stigmatizaciji ali stereotipiziranju.
Specifically, genetic tests are inappropriate todetermine ethnicity and must never be used for this purpose.
Zlasti pa so genski testi neustrezni zadoloãanje sestava po narodnosti in se jih v ta namen ne sme nikoli uporabiti.
See report, chapter 3.3.2.
Glej poroãilo,poglavje 3.3.2.
Recommendation 12
Priporoãilo 12
That: a. genetic tests be clinically evaluated in the populations in which they are tobe used;b. those who are involved in genetic research, the provision of genetic testingand healthcare policy-making be sensitive to the risks of stereotyping andstigmatisation based on ethnic origin, and recognise and respect ethnic andcultural sensitivities;c.minority ethnic groups should not be excluded from access to those genetictests appropriate for them.
Da naj: a. se genski testi kliniãno vrednotijo v populacijah, v katerih se bodo uporabljali;b. bodo tisti, ki se ukvarjajo z genskimi raziskavami, zagotavljanjem genskegatestiranja in oblikovanjem politike zdravstvene oskrbe pozorni na nevarnostistereotipiziranja in stigmatizacije na podlagi etniãnega porekla ter priznavajo in upo‰tevajo etniãne in kulturne obãutljivosti;c. se manj‰inske etniãne skupine ne izloãijo iz dostopa do zanje ustreznih genskihtestov.
There are well-established differences between men and women regarding the risk of certaindisorders, including genetic diseases.
Glede tveganja za doloãene motnje, vkljuãno z genskimi boleznimi, so jasno ugotovljene razlikemed mo‰kimi in Ïenskami.
The Group considers that specific gender issues mayarise in the context of genetic testing.
Skupina meni, da se lahko v sklopu genskega testiranja pojavijoposebna vpra‰anja, povezana s spolom.
However, little evidence for this exists so far.
Vendar pa do sedaj o tem ni veliko podatkov.
See report,chapter 3.3.1.
Glej poroãilo, poglavje 3.3.1.
Recommendation 13
Priporoãilo 13
That: a. further studies at EU level address the impact of genetic testing, in particularin societies where women and men are given different rights or privileges;b. governments and society be aware of the possible consequences of theapplication of genetic testing to aid reproductive choice for prospective sexselection;c. criteria be established at EU level to ensure that no gender discriminationoccurs in the course of, or as a result of, EU-funded research projects.
Da naj: a. nadaljnje ‰tudije na ravni EU obravnavajo vpliv genskega testiranja, zlasti v druÏbah, kjer uÏivajo Ïenske in mo‰ki razliãne pravice ali ugodnosti;b. se vlade in druÏba zavedajo moÏnih posledic uporabe genskega testiranja za pomoã pri reproduktivnem odloãanju o vnaprej‰nji izbiri spola;c. se na ravni EU vzpostavijo merila, ki bodo zagotovila, da v poteku raziskovalnihprojektov, ki jih podpira EU, ne bo diskriminacije med spoloma, niti takadiskriminacija ne bo posledica teh projektov.
Relatively little information is presently available at EU level on the impact of genetic testing onhealth systems and on health economics.
Na ravni EU je trenutno na voljo le malo podatkov o vplivu genskega testiranja na zdravstvenesisteme in zdravstveno ekonomijo.
See report, chapters 8.3 and 8.5.
Glej poroãilo, poglavja 8.3 in 8.5.
Recommendation 14
Priporoãilo 14
That: a. the European Commission funds more research relating to the impact ofgenetic testing on the social, cultural and economic aspects of healthcareprovision.
Da naj: a. Evropska komisija podpre veã raziskovanja o vplivu genskega testiranja na druÏbene, kulturne in ekonomske vidike zagotavljanja zdravstvene oskrbe.
The responsibilities of primary and specialised care providers will expand as genetic testing, includingpharmacogenetics, evolves.
Odgovornosti primarnih in specializiranih ponudnikov zdravstvene oskrbe se bodo raz‰irile zrazvojem genskega testiranja, vkljuãno s farmakogenetiko.
This will require appropriate changes in medical school curricula.
To bo zahtevalo ustrezne spremembev programih medicinskih ‰ol.
Otherhealthcare professionals will also require enhanced initial professional education and continuingprofessional development in the area of genetics.
Drugi zdravstveni delavci bodo prav tako potrebovali raz‰irjenozaãetno strokovno izobraÏevanje in nadaljnji strokovni razvoj na podroãju genetike.
See report, chapters 7.1.3 and 8.1.
Glej poroãilo,poglavja 7.1.3 in 8.1.
Recommendation 15
Priporoãilo 15
That: a. initial educational and professional requirements be coordinated in allcountries of the European Union;b. continued professional training be offered for healthcare professionals.
Da naj: a. se zaãetne izobraÏevalne in strokovne potrebe uskladijo po vseh drÏavah Evropske unije;b. se zdravstvenim strokovnjakom ponudi nadaljnje strokovno usposabljanje.
The Group considers that all stakeholders, including governmental authorities, scientists,healthcare providers, industry and patient organisations should work together in a partnershipapproach to optimise future advances in healthcare that may become possible as a result of genetictesting, such as new treatment options and disease prevention.
Skupina meni, da naj vsi zainteresirani udeleÏenci, vkljuãujoã drÏavne organe, znanstvenike,ponudnike zdravstvene oskrbe, organizacije dejavnosti in bolnikov, delujejo skupaj v partnerstvu,da bi optimizirali prihodnji napredek zdravstvene oskrbe, ki ga bo morda omogoãilo genskotestiranje, npr. nove moÏnosti zdravljenja in prepreãevanja bolezni.
For effective development ofnew genetic tests and diagnostics, a productive interchange between academic scientists andthose working in the healthcare industry will continue to be essential.
Za uãinkovit razvoj novihgenskih testov in diagnostike ostaja nujna plodna izmenjava med akademskimi znanstveniki inzdravstvenimi delavci.
See report, chapter 2.2.
Glej poroãilo, poglavje 2.2.
Recommendation 16
Priporoãilo 16
That: a. the European Union stimulates and supports partnerships betweenstakeholders; b. a framework for transparent collaboration between industry and academicscientists be established.
Da naj: a. Evropska unija spodbuja in podpira partnerstvo med zainteresiranimi; b. se vzpostavi ogrodje za transparentno sodelovanje med industrijo in akademskimiznanstveniki.
See report, chapter 6.2.2.
Glej poroãilo, poglavje 6.2.2.
Recommendation 17
Priporoãilo 17
See report, chapters 1.4 and 6.2.3.
Glej poroãilo, poglavja 1.4 in 6.2.3.
Recommendation 18
Priporoãilo 18
That: a. an EU-wide network for diagnostic testing of rare genetic diseases becreated and financially supported as a matter of urgency;b. an EU-level incentive system for the systematic development of genetic testsfor rare diseases be created and financially supported;c. for rare but serious diseases for which treatment is available, Member Statesintroduce universal neonatal screening as a priority.
Da naj: a. se nujno ustanovi in denarno podpre omreÏje EU za diagnostiãno testiranje redkihgenskih bolezni;b. se ustanovi in denarno podpre spodbujevalni sistem za sistematiãno razvijanjegenskih testov za redke bolezni na ravni EU;c. za redke, a hude bolezni, ki jih je mogoãe zdraviti, drÏave ãlanice prednostnouvedejo univerzalno presejalni test novorojenãkov.
The term ‘pharmacogenetics’ describes the study of differences between individuals in drugresponse (efficacy or adverse reactions) which result directly from variations in DNA sequencesand in differences in protein sequence, structure, or gene expression that are the directconsequence of such DNA variations.
Izraz "farmakogenetika" opisuje preuãevanje razlik med posamezniki pri odzivu na zdravila(uãinkovitost ali neÏelene reakcije), ki so neposredna posledica razlik v zaporedjih DNK razlik v beljakovinskih zaporedjih, zgradbi ali izraÏanju genov, ki neposredno izhajajo iz takih razlik v DNK.
The main aim of pharmacogenetics is to help delivermedicines to patients who are most likely to benefit and least likely to experience adverse reactions.Although pharmacogenetics is currently still in a mainly exploratory phase, an increase in itsapplication in healthcare is expected and appropriate measures should be prepared in time forthis evolution.
Glavni namen farmakogenetike je pomoã pri predpisovanju zdravil bolnikom, ki jim bodonajbolj koristila in je zanje najmanj verjetno, da bodo doÏiveli neÏelene reakcije. âeprav jefarmakogenetika trenutno ‰e v predvsem raziskovalni fazi, priãakujemo njeno poveãano uporabov zdravstveni oskrbi in je zato treba dovolj zgodaj pripraviti ustrezne ukrepe za ta razvoj.
See report, chapter 5.
Glej poroãilo, poglavje 5.
Recommendation 19
Priporoãilo 19
That: a. national health authorities play a more active part in encouragingdevelopment of the field of pharmacogenetics: • by providing particular incentives to enable the development ofpharmacogenetic tests and associated therapeutics which are clinicallydesirable but which may not be economically viable; and• by enhancing the possibilities of co-operation between industry, patients,and academia in this field;b. an appropriate harmonised legal, regulatory, and healthcare policyframework for pharmacogenetics be developed at EU level, taking intoaccount research, therapy development, and clinical practice.
Da naj: a. nacionalne zdravstvene oblasti bolj aktivno delujejo pri spodbujanju razvoja napodroãju farmakogenetike: • z zagotavljanjem posebnih spodbud, ki omogoãajo razvoj farmakogenetskihtestov ter povezanih zdravljenj, ki so kliniãno zaÏelena, a ne nujno tudiekonomsko upraviãena; in• s spodbujanjem moÏnosti sodelovanja med industrijo, bolniki in znanstveniki na tem podroãju.b. se na ravni EU razvije ustrezno usklajeno pravno, regulatorno in zdravstvenopolitiko za razvoj farmakogenetike, z upo‰tevanjem raziskovanja, razvojazdravljenja in kliniãne prakse.
Genetic testing as a research tool
Gensko testiranje kotraziskovalna metoda
A large part of research relevant to genetic testing relies on the use and exchange of humantissue samples and associated data because all biological samples contain DNA.
Velik deleÏ raziskovanja, pomembnega za gensko testiranje, temelji na uporabi in izmenjavivzorcev ãlove‰kih tkiv in povezanih podatkov, ker vsi biolo‰ki vzorci vsebujejo DNK.
These may allow,to a variable degree, identification of the individuals who are the source of the samples and data.Genetic studies also rely on genealogical, population, clinical, and personal data.
Ti lahko do razliãnih stopenj omogoãajo identifikacijo posameznikov, ki so vir vzorcev in podatkov.Genske ‰tudije potrebujejo tudi genealo‰ke, populacijske, kliniãne in osebne podatke.
The Group hasconcentrated on research aspects in terms of sample and data resources of human origin asindispensable means for the identification, validation, and development of genetic testing forpotential clinical use, including pharmacogenetics, and on the relevant ethical, legal, andsocietal issues.
Skupinase je osredotoãila na raziskovalne vidike v smislu virov vzorcev in podatkov ãlove‰kega izvorakot nepogre‰ljivih sredstev za identifikacijo, potrditev in razvoj genskega testiranja za potencialnokliniãno uporabo, vkljuãno s farmakogenetiko, in na ustrezna etiãna, pravna in druÏbena vpra‰anja.
The term ‘biobank’ is used variably to designate several types of collections of biologicalsamples.
Izraz "biolo‰ka banka" uporabljamo razliãno za oznaãevanje ‰tevilnih vrst zbirk biolo‰kih vzorcev.
The Group has considered biobank collections to mean the biological samplesthemselves, plus the related databases, allowing a certain level of accessibility, availability andexchange for scientific studies.
Skupina je upo‰tevala, da zbirke biolo‰kih bank pomenijo biolo‰ke vzorce same, skupaj s povezanimi podatkovnimi zbirkami, ki omogoãajo doloãeno raven dostopnosti, razpoloÏljivosti in izmenjave za znanstvene ‰tudije.
Public trust in research surrounding genetic testing is largelydependent on how the use of samples and data in and from such biobanks is undertaken andcommunicated.
Javno zaupanje v raziskave na podroãjugenskega testiranja je v veliki meri odvisno od tega, kako se lotevamo uporabe in posredovanjavzorcev in podatkov v takih biolo‰kih bankah in iz njih.
This applies in particular to the areas of informed consent, storage, dataprotection and the degree of anonymity of samples, the communication of study results and,where appropriate, of individual test results.
To se zlasti nana‰a na podroãjaobve‰ãenega soglasja, shranjevanja, varstva podatkov in stopnje zagotavljanja anonimnostivzorcev, sporoãanje izsledkov ‰tudije in po potrebi posameznikovih rezultatov testiranja.
A harmonised approach to these issues at EU levelis considered desirable.
ZaÏelen je usklajen pristop do teh vpra‰anj na ravni EU.
The Group is aware that the Council of Europe is developing an activityregarding storage and research use of biological material and related data.
V Skupini se zavedajo, da Svet Evrope razvija dejavnost v zvezi s shranjevanjem in raziskovalno uporabo biolo‰kih materialov in povezanih podatkov.
Depending on their scope and context, official identification and registration of such biobankingactivities, as well as assurance of their long-term financial sustainability, are desirable and maybe required.
Glede na njihov obseg in ozadje so zaÏeleni in morda potrebni uradna identifikacija in registracijatakih dejavnosti "biolo‰kih bank", pa tudi zagotovilo njihove dolgoroãne finanãne vzdrÏljivosti.
There is a need for education about biobanking and for guidelines to assurequality control of both the collections and the ethical management of such repositories.
Obstaja potreba po izobraÏevanju o biolo‰kih bankah in po smernicah, ki bi zagotovile nadzorkakovosti zbirk in etiãnega upravljanja takih skladi‰ã.
For the study and validation of the association of genes with specific diseases, including thedevelopment of diagnostic products, devices and other tools, access to well-characterisedhuman tissue samples for research and development use is essential.
Za prouãevanje in potrjevanje povezave genov s specifiãnimi boleznimi, vkljuãujoã razvojdiagnostiãnih izdelkov, naprav in drugih orodij, je bistven dostop do dobro oznaãenih ãlove‰kihtkivnih vzorcev za uporabo pri raziskovanju in razvoju.
See report, chapter 4.2.
Glej poroãilo, poglavje 4.2.
Recommendation 20
Priporoãilo 20
That: a. guidelines be developed and coordinated across the EU to ensure that theuse of samples, including those from archival collections, is not undulydelayed or impeded, particularly if proper consideration of their level ofidentification has been taken into account;b. action be taken by Member States to ensure that approval by a competentreview committee is obtained before research is undertaken;c. an inventory of existing biobanks across the EU be created, indicatingstandards and rules of access, to identify which of their contents may or maynot be used for genetic studies;
Da naj: a. se v EU razvije in uskladi smernice za zagotovitev, da se uporaba vzorcev,vkljuãujoã tiste iz arhivskih zbirk, po nepotrebnem ne zavlaãuje ali ovira, zlasti, ãe smo ustrezno upo‰tevali njihovo raven identifikacije;b. drÏave ãlanice sprejmejo ukrepe, da zagotovijo, da se od pristojnih pregledovalnihodborov pridobi odobritev pred zaãetkom raziskovanja;c. se popi‰ejo obstojeãe biolo‰ke banke po EU, z navedbo standardov in pravil o dostopu, da se ugotovi, katere od vsebin smemo in katerih ne smemo uporabljatiza genske ‰tudije; d. se razvije sistem za vrednotenje in spremljanje trenutne uporabe obstojeãihbiolo‰kih bank po EU;
GENETIC TESTING AS A RESEARCH TOOL d. a system be implemented to evaluate and monitor the current usage ofexisting biobanks throughout the EU;e. the task force on ‘biological resource centres’ set up by the OECD befollowed closely by the European Commission regarding development ofstandards;f. the European Commission closely follows this activity.
GENSKO TESTIRANJE KOT RAZISKOVALNA METODA e. glede razvoja standardov Evropska komisija budno spremlja projektno skupino OECD-ja o "sredi‰ãih biolo‰kih virov";f. Evropska komisija skrbno spremlja to dejavnost.
It should be noted that biobanking issues extend far beyond genetic testing.
Treba je omeniti, da vpra‰anja biolo‰kih bank daleã presegajo gensko testiranje.
Few Member Stateshave a well-developed legal framework in this domain.
Le malo drÏav ãlanic ima na tem podroãju dobro razvito pravno podlago.
There is currently no EU directiveregulating the use of tissue and cell conservation for research purposes.
Trenutno ni nobenih direktiv EU gledeuporabe shranjevanja tkiv in celic za raziskovalne namene.
Recommendation 21
Priporoãilo 21