natgillin/translations-raw huggingface dataset:
Parties to this Protocol shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to any research involving interventions on human beings in the field of biomedicine.
Pogodbenice tega protokola varujejo dostojanstvo in identiteto vseh človeških bitij ter vsakomur brez razlikovanja jamčijo spoštovanje njegove duševne in telesne nedotakljivosti ter drugih pravic in temeljnih svoboščin v zvezi z vsemi biomedicinskimi raziskavami, ki vključujejo posege na človeških bitjih.
1 This Protocol covers the full range of research activities in the health field involving interventions on human beings.
Ta protokol ureja vse raziskovalne dejavnosti na področju varovanja zdravja, ki vključujejo posege na človeških bitjih.
2 This Protocol does not apply to research on embryos in vitro.
Ta protokol se ne uporablja za raziskave na zarodkih in vitro.
It does apply to research on foetuses and embryos in vivo.
Uporablja se za raziskave na plodu in zarodku in vivo.
3 For the purposes of this Protocol, the term “intervention” includes: i a physical intervention, and ii any other intervention in so far as it involves a risk to the psychological health of the person concerned.
V tem protokolu izraz »poseg« pomeni: i. fizični poseg in ii. kateri koli drug poseg, če vključuje tveganje za psihično zdravje osebe.
The interests and welfare of the human being participating in research shall prevail over the sole interest of society or science.
Koristi in skrb za človeško bitje, ki sodeluje pri raziskavi, prevladajo nad izključno koristjo družbe ali znanosti.
Research shall be carried out freely, subject to the provisions of this Protocol and the other legal provisions ensuring the protection of the human being.
Raziskovanje je svobodno ob upoštevanju določb tega protokola in drugih pravnih določb, ki zagotavljajo varstvo človeškega bitja.
Absence of alternatives
Odsotnost drugih možnosti
Research on human beings may only be undertaken if there is no alternative of comparable effectiveness.
Raziskave na človeških bitjih se smejo opravljati le, če takih raziskav ni mogoče nadomestiti z drugimi, podobno uspešnimi raziskavami.
Risks and benefits
Tveganja in koristi
1 Research shall not involve risks and burdens to the human being disproportionate to its potential benefits.
Raziskava ne sme vključevati tveganj in obremenitev za človeško bitje, ki so v nesorazmerju z mogočimi koristmi.
2 In addition, where the research does not have the potential to produce results of direct benefit to the health of the research participant, such research may only be undertaken if the research entails no more than acceptable risk and acceptable burden for the research participant.
Kadar od izsledkov raziskave poleg tega ni mogoče pričakovati neposredne koristi za zdravje udeleženca raziskave, se sme raziskava opraviti le, če ne povzroči tveganja in obremenitve, ki sta večja od sprejemljivih za udeleženca raziskave.
This shall be without prejudice to the provision contained in Article 15 paragraph 2, sub-paragraph ii for the protection of persons not able to consent to research.
To ne posega v določbo iz točke ii drugega odstavka 15. člena o varstvu oseb, ki niso sposobne dati soglasja za raziskavo.
Research may only be undertaken if the research project has been approved by the competent body after independent examination of its scientific merit, including assessment of the importance of the aim of research, and multidisciplinary review of its ethical acceptability.
Raziskava se sme opraviti le, če je raziskovalni projekt odobril pristojni organ, potem ko je neodvisno proučil njegovo znanstveno vrednost vključno z ovrednotenjem pomembnosti cilja raziskave in njene etične sprejemljivosti z vidika različnih strok.
Scientific quality
Znanstvena kakovost
Any research must be scientifically justified, meet generally accepted criteria of scientific quality and be carried out in accordance with relevant professional obligations and standards under the supervision of an appropriately qualified researcher.
Vsaka raziskava mora biti znanstveno utemeljena, izpolnjevati mora splošno sprejeta merila znanstvene kakovosti in se mora opraviti v skladu z ustreznimi strokovnimi nalogami in standardi pod nadzorom primerno usposobljenega raziskovalca.
Ethics committee
Odbor za etiko
Independent examination by an ethics committee
Neodvisna presoja odbora za etiko
1 Every research project shall be submitted for independent examination of its ethical acceptability to an ethics committee.
Vsak raziskovalni projekt se predloži v neodvisno presojo svoje etične sprejemljivosti odboru za etiko.
Such projects shall be submitted to independent examination in each State in which any research activity is to take place.
Taki projekti se predložijo v neodvisno presojo v vsaki državi, v kateri naj bi potekala katera koli raziskovalna dejavnost.
2 The purpose of the multidisciplinary examination of the ethical acceptability of the research project shall be to protect the dignity, rights, safety and well-being of research participants.
Namen multidisciplinarne presoje etične sprejemljivosti raziskovalnega projekta je varovati dostojanstvo, pravice, varnost in dobro počutje udeležencev raziskave.
The assessment of the ethical acceptability shall draw on an appropriate range of expertise and experience adequately reflecting professional and lay views.
Ovrednotenje etične sprejemljivosti temelji na ustreznem strokovnem znanju in izkušnjah ter primerno izraža strokovne in laične poglede.
3 The ethics committee shall produce an opinion containing reasons for its conclusion.
Odbor za etiko pripravi mnenje, v katerem navede razloge za sprejetje svojega sklepa.
Independence of the ethics committee
Neodvisnost odbora za etiko
1 Parties to this Protocol shall take measures to assure the independence of the ethics committee.
Pogodbenice tega protokola sprejmejo ukrepe, s katerimi zagotovijo neodvisnost odbora za etiko.
That body shall not be subject to undue external influences.
Na ta organ ne smejo vplivati neupravičene zunanje okoliščine.
2 Members of the ethics committee shall declare all circumstances that might lead to a conflict of interest.
Člani odbora za etiko navedejo vse okoliščine, ki bi lahko privedle do neskladja interesov.
Should such conflicts arise, those involved shall not participate in that review.
Če pride do njih, vpleteni ne smejo sodelovati pri tej presoji.
Information for the ethics committee
Informacije za odbor za etiko
1 All information which is necessary for the ethical assessment of the research project shall be given in written form to the ethics committee.
Vse informacije, ki so potrebne za ovrednotenje etične sprejemljivosti raziskovalnega projekta, se v pisni obliki predložijo odboru za etiko.
2 In particular, information on items contained in the appendix to this Protocol shall be provided, in so far as it is relevant for the research project.
Še posebej se navedejo podatki po točkah iz dodatka k temu protokolu, če so pomembni za raziskovalni projekt.
The appendix may be amended by the Committee set up by Article 32 of the Convention by a two-thirds majority of the votes cast.
Dodatek lahko z dvetretjinsko večino oddanih glasov spremeni odbor, ustanovljen z 32. členom konvencije.
Undue influence
Neprimeren vpliv
The ethics committee must be satisfied that no undue influence, including that of a financial nature, will be exerted on persons to participate in research.
Odbor za etiko mora biti prepričan, da se na osebe, ki sodelujejo pri raziskavi, ne bo neprimerno vplivalo, vključno s finančnimi spodbudami.
In this respect, particular attention must be given to vulnerable or dependent persons.
V zvezi s tem se mora posebna pozornost nameniti ranljivim ali odvisnim osebam.
Information and consent
Informacije in privolitev
Information for research participants
Informacije za udeležence raziskave
1 The persons being asked to participate in a research project shall be given adequate information in a comprehensible form.
Osebam, zaprošenim za sodelovanje pri raziskovalnem projektu, se dajo ustrezne informacije v razumljivi obliki.
This information shall be documented.
Te informacije morajo biti dokumentirane.
2 The information shall cover the purpose, the overall plan and the possible risks and benefits of the research project, and include the opinion of the ethics committee.
Informacije vključujejo namen, celovit načrt, mogoča tveganja in koristi raziskovalnega projekta ter mnenje odbora za etiko.
Before being asked to consent to participate in a research project, the persons concerned shall be specifically informed, according to the nature and purpose of the research:
Preden so osebe zaprošene, da privolijo v sodelovanje pri raziskovalnem projektu, so glede na naravo in namen raziskave obveščene predvsem o:
i of the nature, extent and duration of the procedures involved, in particular, details of any burden imposed by the research project;
i. naravi, obsegu in trajanju postopkov, zlasti o podrobnostih glede morebitnih obremenitev, ki jih povzroča raziskovalni projekt;
ii of available preventive, diagnostic and therapeutic procedures;
ii. razpoložljivih preventivnih, diagnostičnih in terapevtskih postopkih;
iii of the arrangements for responding to adverse events or the concerns of research participants;
iii. ukrepih za odzivanje na neželene dogodke ali zaskrbljenost udeležencev raziskave;
iv of arrangements to ensure respect for private life and ensure the confidentiality of personal data;
iv. ukrepih za zagotavljanje spoštovanja zasebnosti in zaupnosti osebnih podatkov;
v of arrangements for access to information relevant to the participant arising from the research and to its overall results;
v. ureditvah glede dostopa do informacij, ki izhajajo iz raziskave in so pomembne za udeleženca, ter do celovitih izsledkov raziskave;
vi of the arrangements for fair compensation in the case of damage;
vi. možnostih za pravično nadomestilo ob škodi;
vii of any foreseen potential further uses, including commercial uses, of the research results, data or biological materials;
vii. vseh predvidenih mogočih nadaljnjih uporabah izsledkov raziskave, podatkov ali biološkega materiala, vključno s komercialno uporabo;
viii of the source of funding of the research project.
viii. virih financiranja raziskovalnega projekta.
3 In addition, the persons being asked to participate in a research project shall be informed of the rights and safeguards prescribed by law for their protection, and specifically of their right to refuse consent or to withdraw consent at any time without being subject to any form of discrimination, in particular regarding the right to medical care.
Poleg tega so osebe, zaprošene za sodelovanje pri raziskovalnem projektu, seznanjene s pravicami in jamstvi, ki jih predpisuje zakon za njihovo varstvo, posebno z njihovo pravico, da lahko zavrnejo privolitev ali jo kadar koli prekličejo, ne da bi bile kakor koli diskriminirane, zlasti glede pravice do zdravstvenega varstva.
Consent
Privolitev
1 No research on a person may be carried out, subject to the provisions of both Chapter V and Article 19, without the informed, free, express, specific and documented consent of the person.
Ob upoštevanju določb V. poglavja in 19. člena se na osebi ne sme opravljati nobena raziskava brez pojasnjene, prostovoljne, izrecne, posebne in dokumentirane privolitve te osebe.
Such consent may be freely withdrawn by the person at any phase of the research.
Tako privolitev lahko oseba prostovoljno prekliče v kateri koli fazi raziskave.
2 Refusal to give consent or the withdrawal of consent to participation in research shall not lead to any form of discrimination against the person concerned, in particular regarding the right to medical care.
Zavrnitev privolitve ali njen preklic za sodelovanje pri raziskavi ne sme povzročiti nobene oblike diskriminacije te osebe, zlasti glede pravice do zdravstvenega varstva.
3 Where the capacity of the person to give informed consent is in doubt, arrangements shall be in place to verify whether or not the person has such capacity.
Ob dvomu o tem, ali je oseba sposobna dati prostovoljno privolitev ali ne, se predvidijo načini preverjanja, ali je oseba za to sposobna ali ne.
Protection of persons not able to consent to research
Varstvo oseb, ki niso sposobne privoliti v raziskavo
1 Research on a person without the capacity to consent to research may be undertaken only if all the following specific conditions are met:
Na osebi, ki ni sposobna privoliti v raziskavo, se sme raziskava opravljati le, če so izpolnjeni vsi posebni pogoji:
i the results of the research have the potential to produce real and direct benefit to his or her health;
i. od izsledkov raziskave je mogoče pričakovati resnično in neposredno korist za zdravje take osebe;
ii research of comparable effectiveness cannot be carried out on individuals capable of giving consent;
ii. primerljivo uspešne raziskave ni mogoče opraviti na osebah, ki so sposobne privoliti vanjo;
iii the person undergoing research has been informed of his or her rights and the safeguards prescribed by law for his or her protection, unless this person is not in a state to receive the information;
iii. oseba, ki sodeluje pri raziskavi, je seznanjena s svojimi pravicami in jamstvi, ki jih predpisuje zakon za njeno varstvo, razen če ni sposobna sprejeti takih informacij;
iv the necessary authorisation has been given specifically and in writing by the legal representative or an authority, person or body provided for by law, and after having received the information required by Article 16, taking into account the person&apos;s previously expressed wishes or objections.
iv. pravni zastopnik ali zavod, oseba ali organ, kakor je določeno z zakonom, je dal potrebno dovoljenje posebej v ta namen in v pisni obliki ter potem ko je prejel informacije na podlagi 16. člena ter ob upoštevanju predhodno izraženih želja ali pripomb osebe.
An adult not able to consent shall as far as possible take part in the authorisation procedure.
Odrasla oseba, ki ni sposobna privoliti v raziskavo čim bolj sodeluje pri postopku pridobitve dovoljenja.
The opinion of a minor shall be taken into consideration as an increasingly determining factor in proportion to age and degree of maturity;
Mnenje mladoletne osebe se upošteva kot odločilni dejavnik sorazmerno z njeno starostjo in stopnjo zrelosti;
v the person concerned does not object.
v. oseba ne nasprotuje.
2 Exceptionally and under the protective conditions prescribed by law, where the research has not the potential to produce results of direct benefit to the health of the person concerned, such research may be authorised subject to the conditions laid down in paragraph 1, sub paragraphs ii, iii, iv, and v above, and to the following additional conditions:
Izjemoma in pod varovalnimi pogoji, ki jih predpisuje zakon, se lahko dovoli raziskava, od izsledkov katere ni mogoče pričakovati neposredne koristi za zdravje osebe, če so izpolnjeni pogoji, navedeni v točki ii, iii, iv in v prvega odstavka tega člena, in ti dodatni pogoji:
i the research has the aim of contributing, through significant improvement in the scientific understanding of the individual&apos;s condition, disease or disorder, to the ultimate attainment of results capable of conferring benefit to the person concerned or to other persons in the same age category or afflicted with the same disease or disorder or having the same condition;
i. cilj raziskave je s precej boljšim znanstvenim razumevanjem stanja, bolezni ali motnje posameznika prispevati h končnim izsledkom, ki bodo lahko koristili osebi ali drugim osebam enake starostne skupine ali osebam, ki imajo enako bolezen ali motnjo ali so v enakem stanju;
ii the research entails only minimal risk and minimal burden for the individual concerned; and any consideration of additional potential benefits of the research shall not be used to justify an increased level of risk or burden.
ii. raziskava pomeni le najmanjše tveganje in najmanjšo obremenitev za osebo, pri čemer se morebitne dodatne koristi raziskave ne smejo uporabiti kot opravičilo za večjo stopnjo tveganja ali obremenitve.
3 Objection to participation, refusal to give authorisation or the withdrawal of authorisation to participate in research shall not lead to any form of discrimination against the person concerned, in particular regarding the right to medical care.
Nasprotovanje sodelovanju, zavrnitev izdaje dovoljenja ali preklic dovoljenja za sodelovanje pri raziskavi ne sme povzročiti nobene oblike diskriminacije osebe, zlasti glede pravice do zdravstvenega varstva.
Information prior to authorisation
Informacije pred odobritvijo dovoljenja
1 Those being asked to authorise participation of a person in a research project shall be given adequate information in a comprehensible form.
Tistim, ki so zaprošeni, da dovolijo sodelovanje osebe pri raziskovalnem projektu, se dajo ustrezne informacije v razumljivi obliki.
They shall further be informed of the rights and safeguards prescribed by law for the protection of those not able to consent to research and specifically of the right to refuse or to withdraw authorisation at any time, without the person concerned being subject to any form of discrimination, in particular regarding the right to medical care.
Prav tako so seznanjeni s pravicami in jamstvi, ki jih predpisuje zakon za varstvo oseb, ki niso sposobne privoliti v raziskavo, in še posebno s svojo pravico, da lahko kadar koli zavrnejo ali prekličejo dovoljenje, ne da bi bila oseba kakor koli diskriminirana, zlasti glede pravice do zdravstvenega varstva.
They shall be specifically informed according to the nature and purpose of the research of the items of information listed in Article 13.
Glede na naravo in namen raziskave so še posebej seznanjeni z informacijami iz 13. člena.
3 The information shall also be provided to the individual concerned, unless this person is not in a state to receive the information.
Informacije se dajo tudi osebi, razen če jih ni sposobna sprejeti.
Research with minimal risk and minimal burden
Raziskave z najmanjšim tveganjem in najmanjšo obremenitvijo
1 For the purposes of this Protocol it is deemed that the research bears a minimal risk if, having regard to the nature and scale of the intervention, it is to be expected that it will result, at the most, in a very slight and temporary negative impact on the health of the person concerned.
Za namene tega protokola se šteje, da raziskava prinaša najmanjše tveganje, če se ob upoštevanju narave in obsega posega od nje lahko pričakuje, da bo imela za posledico majhen in začasen negativen vpliv na zdravje osebe.
2 It is deemed that it bears a minimal burden if it is to be expected that the discomfort will be, at the most, temporary and very slight for the person concerned.
Šteje se, da raziskava prinaša najmanjšo obremenitev, če se lahko pričakuje, da bo neugodje za osebo začasno in majhno.
In assessing the burden for an individual, a person enjoying the special confidence of the person concerned shall assess the burden where appropriate.
Kadar je to primerno, obremenitev za osebo ovrednoti nekdo, ki uživa posebno zaupanje te osebe.
Research during pregnancy or breastfeeding
Raziskave med nosečnostjo ali dojenjem
1 Research on a pregnant woman which does not have the potential to produce results of direct benefit to her health, or to that of her embryo, foetus or child after birth, may only be undertaken if the following additional conditions are met:
Raziskava na nosečnici, od izsledkov katere ni mogoče pričakovati neposredne koristi za njeno zdravje ali zdravje njenega zarodka, plodu ali otroka po porodu, se sme opraviti le, če so izpolnjeni ti dodatni pogoji:
i the research has the aim of contributing to the ultimate attainment of results capable of conferring benefit to other women in relation to reproduction or to other embryos, foetuses or children;
i. cilj raziskave je prispevati h končnim izsledkom, ki bodo lahko koristili drugim ženskam v zvezi z reproduktivnim zdravstvenim varstvom ali drugim zarodkom, plodom ali otrokom;
ii research of comparable effectiveness cannot be carried out on women who are not pregnant;
ii. primerljivo uspešne raziskave ni mogoče opraviti na ženskah, ki niso noseče;
iii the research entails only minimal risk and minimal burden.
iii. raziskava pomeni le najmanjše tveganje in najmanjšo obremenitev.
2 Where research is undertaken on a breastfeeding woman, particular care shall be taken to avoid any adverse impact on the health of the child.
Kadar se raziskava opravlja na doječi ženski, se še posebej poskrbi, da nikakor negativno ne vpliva na zdravje otroka.
Research on persons in emergency clinical situations
Raziskave na osebah v nujnih kliničnih primerih
1 The law shall determine whether, and under which protective additional conditions, research in emergency situations may take place when:
Zakon določi, ali in pod katerimi dodatnimi varovalnimi pogoji se lahko opravlja raziskava v nujnih primerih, kadar:
i a person is not in a state to give consent, and
i. oseba ni sposobna dati privolitve in
ii because of the urgency of the situation, it is impossible to obtain in a sufficiently timely manner, authorisation from his or her representative or an authority or a person or body which would in the absence of an emergency situation be called upon to give authorisation.
ii. je zaradi nujnosti primera nemogoče pravočasno dobiti dovoljenje njenega zastopnika ali zavoda ali osebe ali organa, ki bi bil, če ne bi bilo nujnega primera, povabljen, da izda dovoljenje.
2 The law shall include the following specific conditions:
Zakon vključuje te posebne pogoje:
i research of comparable effectiveness cannot be carried out on persons in non-emergency situations;
i. primerljivo uspešne raziskave ni mogoče opraviti na osebah, ki niso nujni primeri;
ii the research project may only be undertaken if it has been approved specifically for emergency situations by the competent body;
ii. raziskovalni projekt se sme izvajati le, če ga je posebej za nujne primere odobril pristojni organ;
iii any relevant previously expressed objections of the person known to the researcher shall be respected;
iii. upoštevajo se vsi pomembni predhodno izraženi ugovori osebe, s katerimi je seznanjen raziskovalec;
iv where the research has not the potential to produce results of direct benefit to the health of the person concerned, it has the aim of contributing, through significant improvement in the scientific understanding of the individual&apos;s condition, disease or disorder, to the ultimate attainment of results capable of conferring benefit to the person concerned or to other persons in the same category or afflicted with the same disease or disorder or having the same condition, and entails only minimal risk and minimal burden.
iv. kadar od raziskave ni mogoče pričakovati izsledkov, ki bi neposredno koristili zdravju osebe, je cilj te raziskave s precej boljšim znanstvenim razumevanjem stanja, bolezni ali motnje posameznika prispevati h končnim izsledkom, ki bodo naposled lahko koristili osebi ali drugim osebam iz iste kategorije ali osebam, ki imajo enako bolezen ali motnjo ali so v enakem stanju, ter pomeni le najmanjše tveganje in najmanjšo obremenitev.
Persons participating in the emergency research project or, if applicable, their representatives shall be provided with all the relevant information concerning their participation in the research project as soon as possible.
Osebam, ki sodelujejo pri raziskovalnih projektih v nujnih primerih, ali če je primerno, njihovim zastopnikom se čim prej dajo vse ustrezne informacije v zvezi z njihovim sodelovanjem pri raziskovalnem projektu.
Consent or authorisation for continued participation shall be requested as soon as reasonably possible.
Takoj ko je mogoče, se zahteva privolitev ali dovoljenje za stalno sodelovanje.
Research on persons deprived of liberty
Raziskave na osebah, ki jim je odvzeta prostost