natgillin/translations-raw huggingface dataset:
Where the law allows research on persons deprived of liberty, such persons may participate in a research project in which the results do not have the potential to produce direct benefit to their health only if the following additional conditions are met:
Kadar zakon dovoljuje raziskave na osebah, ki jim je odvzeta prostost, smejo take osebe sodelovati pri raziskovalnem projektu, pri katerem od izsledkov ni mogoče pričakovati neposredne koristi za njihovo zdravje le, če so izpolnjeni ti dodatni pogoji:
i research of comparable effectiveness cannot be carried out without the participation of persons deprived of liberty;
i. primerljivo uspešne raziskave ni mogoče opraviti brez sodelovanja oseb, ki jim je odvzeta prostost;
ii the research has the aim of contributing to the ultimate attainment of results capable of conferring benefit to persons deprived of liberty;
ii. cilj raziskave je prispevati h končnim izsledkom, ki bodo lahko koristili osebam, ki jim je odvzeta prostost;
Safety and supervision
Varnost in nadzor
Minimisation of risk and burden
Zmanjševanje tveganj in obremenitev
1 All reasonable measures shall be taken to ensure safety and to minimise risk and burden for the research participants.
Sprejmejo se vsi primerni ukrepi za zagotavljanje varnosti in zmanjševanje tveganj ter obremenitev za udeležence raziskave.
Assessment of health status
Ocena zdravstvenega stanja
1 The researcher shall take all necessary steps to assess the state of health of human beings prior to their inclusion in research, to ensure that those at increased risk in relation to participation in a specific project be excluded.
Raziskovalec stori vse potrebno, da oceni zdravstveno stanje človeških bitij pred njihovo vključitvijo v raziskavo, s čimer zagotovi, da se iz raziskave izključijo tisti, ki bi bili zaradi sodelovanja pri posameznem projektu izpostavljeni večjemu tveganju.
2 Where research is undertaken on persons in the reproductive stage of their lives, particular consideration shall be given to the possible adverse impact on a current or future pregnancy and the health of an embryo, foetus or child.
Kadar se raziskava opravlja na osebah, ki so v reproduktivnem obdobju svojega življenja, se posebna pozornost nameni mogočim škodljivim vplivom na trenutno ali prihodnjo nosečnost in zdravje zarodka, plodu ali otroka.
Non-interference with necessary clinical interventions
Nevmešavanje v potrebne klinične posege
1 Research shall not delay nor deprive participants of medically necessary preventive, diagnostic or therapeutic procedures.
Zdravstveno potrebni preventivni, diagnostični ali terapevtski postopki za udeležence v raziskavi ne smejo biti odloženi ali preprečeni zaradi nje.
2 In research associated with prevention, diagnosis or treatment, participants assigned to control groups shall be assured of proven methods of prevention, diagnosis or treatment.
Pri raziskavah, povezanih s preprečevanjem, diagnosticiranjem ali zdravljenjem, se udeležencem, razporejenim v kontrolne skupine, zagotovijo preskušene metode preprečevanja, diagnosticiranja ali zdravljenja.
3 The use of placebo is permissible where there are no methods of proven effectiveness, or where withdrawal or withholding of such methods does not present an unacceptable risk or burden.
Uporaba placeba je dovoljena, kadar ni dokazano učinkovitih metod ali kadar njihova prekinitev ali zavrnitev ne pomeni nesprejemljivega tveganja ali obremenitve.
New developments
Novi dosežki
1 Parties to this Protocol shall take measures to ensure that the research project is re-examined if this is justified in the light of scientific developments or events arising in the course of the research.
Pogodbenice tega protokola sprejmejo ukrepe, da zagotovijo ponovno proučitev raziskovalnega projekta, če je to upravičeno zaradi znanstvenih dosežkov ali dogodkov, ki nastanejo med raziskavo.
2 The purpose of the re-examination is to establish whether:
Namen ponovne proučitve je ugotoviti, ali:
i the research needs to be discontinued or if changes to the research project are necessary for the research to continue;
i. je treba raziskavo prekiniti oziroma ali je treba za nadaljevanje raziskave spremeniti raziskovalni projekt;
ii research participants, or if applicable their representatives, need to be informed of the developments or events;
ii. je treba udeležence raziskave, ali če je primerno, njihove zastopnike obvestiti o dosežkih ali dogodkih;
iii additional consent or authorisation for participation is required.
iii. je potrebna dodatna privolitev ali dovoljenje za sodelovanje.
3 Any new information relevant to their participation shall be conveyed to the research participants, or, if applicable, to their representatives, in a timely manner.
Udeležencem raziskave, ali če je primerno, njihovim zastopnikom se pravočasno priskrbijo vse nove informacije, pomembne za njihovo sodelovanje pri raziskavi.
4 The competent body shall be informed of the reasons for any premature termination of a research project.
Pristojni organ je obveščen o razlogih za vsako predčasno prenehanje raziskovalnega projekta.
Confidentiality and right to information
Zaupnost in pravica do obveščenosti
1 Any information of a personal nature collected during biomedical research shall be considered as confidential and treated according to the rules relating to the protection of private life.
Vsi osebni podatki, zbrani med biomedicinsko raziskavo, so zaupni in se obravnavajo skladno s pravili o varovanju zasebnosti.
2 The law shall protect against inappropriate disclosure of any other information related to a research project that has been submitted to an ethics committee in compliance with this Protocol.
Zakon varuje pred neprimernim razkritjem katerih koli drugih podatkov, povezanih z raziskovalnim projektom, ki so bili predloženi odboru za etiko v skladu s tem protokolom.
1 Research participants shall be entitled to know any information collected on their health in conformity with the provisions of Article 10 of the Convention.
Udeleženci raziskave imajo pravico izvedeti za vsak podatek, pridobljen o njihovem zdravju, v skladu z določbami 10. člena konvencije.
2 Other personal information collected for a research project will be accessible to them in conformity with the law on the protection of individuals with regard to processing of personal data.
Drugi osebni podatki, pridobljeni za raziskovalni projekt, so jim dostopni v skladu z zakonom o varstvu posameznikov pri obdelavi osebnih podatkov.
Duty of care
Obveznost varstva
If research gives rise to information of relevance to the current or future health or quality of life of research participants, this information must be offered to them.
Če raziskava privede do podatkov, pomembnih za trenutno ali prihodnje zdravje ali kakovost življenja udeležencev raziskave, jim je treba te podatke dati.
That shall be done within a framework of health care or counselling.
To poteka v okviru zdravstvenega varstva ali svetovanja.
In communication of such information, due care must be taken in order to protect confidentiality and to respect any wish of a participant not to receive such information.
Pri sporočanju takih podatkov je treba ravnati skrbno, da se varuje zaupnost in upošteva morebitna želja udeleženca, da se mu ti podatki ne povedo.
Availability of results
Razpoložljivost izsledkov
1 On completion of the research, a report or summary shall be submitted to the ethics committee or the competent body.
Po opravljeni raziskavi se odboru za etiko ali pristojnemu organu predloži poročilo ali povzetek.
2 The conclusions of the research shall be made available to participants in reasonable time, on request.
Izsledki raziskave se dajo udeležencem na razpolago v primernem času, če to zahtevajo.
3 The researcher shall take appropriate measures to make public the results of research in reasonable time.
Raziskovalec ustrezno poskrbi za pravočasno javno objavo izsledkov raziskave.
Research in States not parties to this Protocol
Raziskave v državah, ki niso pogodbenice protokola
Sponsors or researchers within the jurisdiction of a Party to this Protocol that plan to undertake or direct a research project in a State not party to this Protocol shall ensure that, without prejudice to the provisions applicable in that State, the research project complies with the principles on which the provisions of this Protocol are based.
Sponzorji ali raziskovalci pod jurisdikcijo pogodbenice protokola, ki nameravajo opravljati ali voditi raziskovalni projekt v državi, ki ni pogodbenica protokola, zagotovijo, da je raziskovalni projekt skladen z načeli, na katerih temeljijo določbe protokola, brez poseganja v določbe, ki se uporabljajo v tej državi.
Where necessary, the Party shall take appropriate measures to that end.
Če je potrebno, pogodbenica v ta namen sprejme ustrezne ukrepe.
Infringement of the provisions of the Protocol
Kršitev določb protokola
Infringement of the rights or principles
Kršitev pravic ali načel
The Parties shall provide appropriate judicial protection to prevent or to put a stop to an unlawful infringement of the rights or principles set forth in this Protocol at short notice.
Pogodbenice zagotavljajo primerno sodno varstvo za takojšnjo preprečitev ali ustavitev nezakonitega poseganja v pravice ali načela, opredeljena v tem protokolu.
The person who has suffered damage as a result of participation in research shall be entitled to fair compensation according to the conditions and procedures prescribed by law.
Oseba, ki je zaradi sodelovanja pri raziskavi utrpela škodo, ima v skladu s pogoji in postopki, ki jih predpisuje zakon, pravico do pravičnega nadomestila.
As between the Parties, the provisions of Articles 1 to 32 of this Protocol shall be regarded as additional articles to the Convention, and all the provisions of the Convention shall apply accordingly.
Med pogodbenicami veljajo določbe od 1. do 32. člena protokola kot dodatni členi konvencije, vse določbe konvencije pa se uporabljajo skladno s tem.
None of the provisions of this Protocol shall be interpreted as limiting or otherwise affecting the possibility for a Party to grant research participants a wider measure of protection than is stipulated in this Protocol.
Nobena določba tega protokola se ne razlaga, kot da omejuje ali drugače vpliva na možnost pogodbenice, da udeležencem raziskave zagotovi večje varstvo, kot je določeno v tem protokolu.
In order to monitor scientific developments, the present Protocol shall be examined within the Committee referred to in Article 32 of the Convention no later than five years from the entry into force of this Protocol and thereafter at such intervals as the Committee may determine.
Da bi sledili razvoju znanosti, bo odbor, naveden v 32. členu konvencije, ponovno pregledal protokol najpozneje pet let po začetku njegove veljavnosti, nato pa v presledkih, ki jih določi odbor.
2 In respect of any State which subsequently expresses its consent to be bound by it, the Protocol shall enter into force on the first day of the month following the expiration of a period of three months after the date of the deposit of the instrument of ratification, acceptance or approval.
Za vsako državo, ki pozneje izrazi soglasje, da jo protokol zavezuje, začne protokol veljati prvi dan meseca po poteku treh mesecev po datumu deponiranja listine o ratifikaciji, sprejetju ali odobritvi.
The Secretary General of the Council of Europe shall notify the member States of the Council of Europe, the European Community, any Signatory, any Party and any other State which has been invited to accede to the Protocol of:
Generalni sekretar Sveta Evrope uradno obvesti države članice Sveta Evrope, Evropsko skupnost, vsako podpisnico, vsako pogodbenico in vsako drugo državo, ki je bila povabljena, da pristopi k protokolu, o:
Appendix to the Additional Protocol on Biomedical Research
Dodatek k Dodatnemu protokolu o biomedicinskih raziskavah
Information to be given to the ethics committee
Informacije, ki se zagotovijo odboru za etiko
Information on the following items shall be provided to the ethics committee, in so far as it is relevant for the research project:
Odboru za etiko se dajo informacije po naslednjih točkah, če so pomembne za raziskovalni projekt:
i the name of the principal researcher, qualifications and experience of researchers and, where appropriate, the clinically responsible person, and funding arrangements;
i. ime glavnega raziskovalca, izobrazba in usposobljenost ter izkušnje raziskovalcev in po potrebi osebe, odgovorne za klinični del, ter ureditev financiranja;
ii the aim and justification for the research based on the latest state of scientific knowledge;
ii. cilj in utemeljitev raziskave na podlagi najnovejših znanstvenih spoznanj;
iii methods and procedures envisaged, including statistical and other analytical techniques;
iii. predvidene metode in postopki, vključno s statističnimi in drugimi analitičnimi tehnikami;
iv a comprehensive summary of the research project in lay language;
iv. izčrpen povzetek raziskovalnega projekta v poljudnem jeziku;
v a statement of previous and concurrent submissions of the research project for assessment or approval and the outcome of those submissions;
v. izjava o prejšnjih in tekočih vlogah za ovrednotenje ali odobritev raziskovalnega projekta ter o izidih obravnave teh vlog;
Participants, consent and information
Udeleženci, privolitev in informacije
vi justification for involving human beings in the research project;
vi. utemeljitev vključitve človeških bitij v raziskovalni projekt;
vii the criteria for inclusion or exclusion of the categories of persons for participation in the research project and how those persons are to be selected and recruited;
vii. merila za vključitev posameznih kategorij oseb v raziskovalni projekt ali izključitev iz njega ter načini izbiranja in pridobivanja teh oseb;
viii reasons for the use or the absence of control groups;
viii. razlogi za uporabo ali odsotnost kontrolnih skupin;
ix a description of the nature and degree of foreseeable risks that may be incurred through participating in research;
ix. opis narave in stopnje predvidljivih tveganj, ki jih lahko prinaša sodelovanje pri raziskavi;
x the nature, extent and duration of the interventions to be carried out on the research participants, and details of any burden imposed by the research project;
x. narava, obseg in trajanje posegov, ki se opravijo na udeležencih raziskave, ter podatki o vseh obremenitvah, ki jih prinaša raziskovalni projekt;
xi arrangements to monitor, evaluate and react to contingencies that may have consequences for the present or future health of research participants;
xi. načini spremljanja in vrednotenja nepredvidljivih primerov, ki bi lahko imeli posledice za sedanje ali prihodnje zdravje udeležencev raziskave, ter načini odzivanja na take primere;
xii the timing and details of information for those persons who would participate in the research project and the means proposed for provision of this information;
xii. časovna razporeditev in podrobne informacije za osebe, ki bi sodelovale pri raziskovalnem projektu, ter predlagani načini zagotavljanja teh informacij;
xiii documentation intended to be used to seek consent or, in the case of persons not able to consent, authorisation for participation in the research project;
xiii. dokumentacija, namenjena za pridobivanje privolitve, ali pri osebah, ki niso sposobne privoliti v raziskavo, dovoljenja za sodelovanje pri raziskovalnem projektu;
xiv arrangements to ensure respect for the private life of those persons who would participate in research and ensure the confidentiality of personal data;
xiv. ukrepi za zagotavljanje spoštovanja zasebnosti oseb, ki bi sodelovale pri raziskavi, ter zagotavljanje zaupnosti osebnih podatkov;
xv arrangements foreseen for information which may be generated and be relevant to the present or future health of those persons who would participate in research and their family members;
xv. predvideni ukrepi glede informacij, ki se lahko pridobijo in so pomembne za sedanje ali prihodnje zdravje oseb, ki bi sodelovale pri raziskavi, in njihovih družinskih članov;
xvi details of all payments and rewards to be made in the context of the research project;
xvi. podrobnosti o vseh plačilih in nagradah, ki se izplačajo v okviru raziskovalnega projekta;
xvii details of all circumstances that might lead to conflicts of interest that may affect the independent judgement of the researchers;
xvii. podrobnosti o vseh okoliščinah, ki bi lahko privedle do nasprotja interesov, kar bi lahko vplivalo na neodvisno presojo raziskovalcev;
xviii details of any foreseen potential further uses, including commercial uses, of the research results, data or biological materials;
xviii. podrobnosti o vseh predvidenih mogočih nadaljnjih uporabah izsledkov raziskave, podatkov ali biološkega materiala, vključno s komercialno uporabo;
xix details of all other ethical issues, as perceived by the researcher;
xix. podrobnosti o vseh drugih etičnih vprašanjih, kot jih dojema raziskovalec;
xx details of any insurance or indemnity to cover damage arising in the context of the research project.
xx. podrobnosti o vseh zavarovanjih ali odškodninah za kritje škode, ki nastane pri raziskovalnem projektu.
The ethics committee may request additional information necessary for evaluation of the research project.
Odbor za etiko lahko zahteva dodatne informacije, ki so potrebne za ovrednotenje raziskovalnega projekta.
Convention setting up a European University Institute
Konvencija o ustanovitvi Evropskega univerzitetnega inštituta
RESOLVED to foster the advancement of learning in fields which are of particular interest for the development of Europe, especially its culture, history, law, economics and institutions,
ODLOČENI podpirati napredek znanja na področjih, ki so posebnega pomena za razvoj Evrope, zlasti njeno kulturo, zgodovino, pravo, ekonomijo in ustanove;
DESIRING to promote cooperation in these fields and to stimulate joint research,
V ŽELJI spodbujati sodelovanje na teh področjih in skupne raziskave;
HAVING DECIDED to realize the intentions expressed on the subject in the Declarations made by the Heads of State or of Government meeting at Bonn on 18 July 1961 and at The Hague on 1 and 2 December 1969,
S SKLEPOM, da uresničijo namere, izražene v zvezi s tem v izjavah, ki so jih dali voditelji držav ali vlad na zasedanju v Bonnu 18. julija 1961 in v Haagu 1. in 2. decembra 1969;
CONSIDERING that a further contribution should be made to the intellectual life of Europe and that in this spirit a European Institute should be set up at the highest university level,
UPOŠTEVAJOČ, da je potreben nadaljnji prispevek k intelektualnemu življenju Evrope in da je v tem duhu treba ustanoviti Evropski inštitut na najvišji univerzitetni ravni;
HAVE DECIDED to revise certain provisions of the Convention setting up a European University Institute, and to this end have designated as their Plenipotentiaries:
SKLENILI ustanoviti Evropski univerzitetni inštitut in določiti razmere za njegovo delovanje, zato so v ta namen imenovali svoje pooblaščence:
PRINCIPLES GOVERNING THE SETTING UP OF THE INSTITUTE
NAČELA O USTANOVITVI INŠTITUTA
By this Convention, the Member States of the European Communities (hereinafter called the &quot;Contracting States&quot;) jointly set up the European University Institute (hereinafter called the &quot;Institute&quot;).
S to konvencijo države članice Evropskih skupnosti (v nadaljevanju »države pogodbenice«) skupaj ustanavljajo Evropski univerzitetni inštitut (v nadaljevanju »inštitut«).
It shall have legal personality. The seat of the Institute shall be in Florence.
Inštitut je pravna oseba. Sedež inštituta je v Firencah.
The aim of the Institute shall be to contribute, by its activities in the fields of higher education and research, to the development of the cultural and scientific heritage of Europe, as a whole and in its constituent parts.
Cilj inštituta je z dejavnostmi na področjih visokega šolstva in raziskovanja prispevati k razvoju kulturne in znanstvene dediščine Evrope kot celote in vseh njenih sestavnih delov.
Its work shall also be concerned with the great movements and institutions which characterize the history and development of Europe.
Njegovo delo zajema tudi velika gibanja in ustanove, ki zaznamujejo zgodovino in razvoj Evrope.
It shall take into account Europe&apos;s cultural and linguistic pluralism and relations with cultures outside Europe.
Upošteva evropsko kulturno in jezikovno mnogovrstnost ter odnose s kulturami zunaj Evrope.
This aim shall be pursued through teaching and research at the highest university level.
Za ta cilj si prizadeva s poučevanjem in raziskovanjem na najvišji univerzitetni ravni.
As part of the general programme of its scientific activities, the Institute shall develop interdisciplinary research programmes on the major issues confronting contemporary European society, including matters relating to the construction of Europe.
Inštitut kot del splošnega programa svoje znanstvene dejavnosti razvija interdisciplinarne raziskovalne programe o poglavitnih problemih, s katerimi se srečuje sodobna evropska družba, vključno z zadevami, povezanimi z graditvijo Evrope.
The Institute should also be a forum for the exchange and discussion of ideas and experience in subjects falling within the areas of study and research with which it is concerned.
Inštitut naj bi obenem deloval kot forum za izmenjavo in obravnavanje idej in izkušenj, povezanih z zadevami, ki spadajo na področja njegovega preučevanja in raziskovanja.
The Contracting States shall take all the measures necessary to facilitate the pursuit of the aim of the Institute while observing freedom of research and teaching.
Države pogodbenice sprejmejo vse potrebne ukrepe, da olajšajo uresničevanje cilja inštituta, pri tem pa spoštujejo svobodo raziskovanja in poučevanja.
The Contracting States shall encourage the spread of the Institute&apos;s influence in the scientific and university world.
Države pogodbenice spodbujajo širjenje vpliva inštituta v znanstvenem in univerzitetnem prostoru.
To this end, they shall assist the Institute to establish appropriate bonds of cooperation with the universities and scientific institutions in their territories and with the European and international bodies concerned with education, culture and research.
V ta namen pomagajo inštitutu vzpostavljati ustrezne vezi sodelovanja z univerzami in znanstvenimi organizacijami na svojih ozemljih ter evropskimi in mednarodnimi organi, ki se ukvarjajo z izobraževanjem, kulturo in raziskovanjem.
Within its terms of reference, the Institute shall cooperate with universities and with any national or international teaching or research body wishing to cooperate.
Inštitut v okviru svojih pristojnosti sodeluje z univerzami in katero koli nacionalno in mednarodno izobraževalno ali raziskovalno organizacijo, ki želi z njim sodelovati.
It may conclude agreements with States and international bodies.
Z državami in mednarodnimi organizacijami lahko sklepa sporazume.
The Institute and its staff shall enjoy such privileges and immunities as are necessary for the performance of their tasks, under the conditions laid down in the Protocol annexed to this Convention, which forms an integral part thereof.
Inštitut in njegovo osebje uživata privilegije in imunitete, ki jih potrebujeta za opravljanje svojih nalog, pod pogoji, določenimi v protokolu, ki je priložen konvenciji in je njen sestavni del.
The Institute shall conclude a headquarters agreement with the Italian Government, to be approved unanimously by the High Council.
Inštitut z italijansko vlado sklene sporazum o sedežu, ki ga soglasno odobri visoki svet.
The authorities of the Institute shall be: a) the High Council, b) the Principal of the Institute, c) the Academic Council.
Organi inštituta so: a) visoki svet, b) predstojnik inštituta, c) akademski svet.
The High Council shall be composed of representatives of the Governments of the Contracting States; each Government shall have one vote in the Council and shall delegate to it two representatives.
Visoki svet sestavljajo predstavniki vlad držav pogodbenic; vsaka vlada ima v svetu en glas in imenuje dva predstavnika.
The High Council shall meet at least once a year in Florence.
Visoki svet se sestane vsaj enkrat letno v Firencah.