natgillin/translations-raw huggingface dataset:
the subject's rights and guarantees regarding his or her protection, in particular his or her right to refuse to participate in and the right to withdraw from the performance study at any time without any resulting detriment and without having to provide any justification;
morebitna alternativna zdravljenja, vključno z ukrepi za nadaljnje spremljanje, če udeleženec ne sodeluje več v študiji učinkovitosti;
the conditions under which the performance study is to be conducted, including the expected duration of the subject's participation in the performance study; and
so izčrpne, kratke, jasne, ustrezne in razumljive udeležencu ali njegovemu zakonito imenovanemu zastopniku;
the possible treatment alternatives, including the follow-up measures if the participation of the subject in the performance study is discontinued;
se zagotovijo v predhodnem razgovoru s članom raziskovalne skupine, ki je ustrezno usposobljen v skladu z nacionalnim pravom ter
be kept comprehensive, concise, clear, relevant, and understandable to the subject or his or her legally designated representative;
vključujejo informacije o veljavnem sistemu odškodnin za škodo iz člena 65;
be provided in a prior interview with a member of the investigating team who is appropriately qualified under national law; and
vključujejo enotno identifikacijsko številko zadevne študije učinkovitosti, navedeno v členu 66(1), ki je edinstvena za celotno Unijo, in informacije o razpoložljivosti rezultatov študije učinkovitosti v skladu z odstavkom 6 tega člena.
include information about the applicable damage compensation system referred to in Article 65;
Informacije iz odstavka 2 se pripravijo v pisni obliki in so na voljo udeležencu ali njegovemu zakonito imenovanemu zastopniku, kadar udeleženec ne more podati privolitve po seznanitvi.
include the Union-wide unique single identification number for the performance study referred to in Article 66(1) and information about the availability of the performance study results in accordance with paragraph 6 of this Article.
Med razgovorom iz točke (c) odstavka 2 se posebna pozornost nameni potrebam posebnih skupin pacientov in posameznih udeležencev po informacijah ter metodam za dajanje informacij.
The information referred to in paragraph 2 shall be prepared in writing and be available to the subject or, where the subject is not able to give informed consent, his or her legally designated representative.
Med razgovorom iz točke (c) odstavka 2 se preveri, ali je udeleženec informacije razumel.
In the interview referred to in point (c) of paragraph 2, special attention shall be paid to the information needs of specific patient populations and of individual subjects, as well as to the methods used to give the information.
Udeleženca je treba obvestiti, da bosta ne glede na izid študije učinkovitosti poročilo o študiji učinkovitosti in povzetek, pripravljen na predvidenemu uporabniku razumljiv način, na podlagi člena 73(5) na voljo v elektronskem sistemu za študije učinkovitosti iz člena 69, in če je mogoče, bo obveščen, čim se bo to zgodilo.
In the interview referred to in point (c) of paragraph 2, it shall be verified that the subject has understood the information.
Ta uredba ne posega v nacionalno pravo, ki zahteva, da mladoletnik, ki je sposoben oblikovati mnenje in oceniti prejeto informacijo, poleg privolitve po seznanitvi, ki jo predloži njegov zakonito imenovani zastopnik, še sam pristane, da se bo udeležil študije učinkovitosti.
The subject shall be informed that a report of the performance study and a summary presented in terms understandable to the intended user will be made available pursuant to Article 73(5) in the electronic system on performance studies referred to in Article 69, irrespective of the outcome of the performance study, and shall be informed, to the extent possible, when they have become available.
Člen 60
This Regulation is without prejudice to national law requiring that, in addition to the informed consent given by the legally designated representative, a minor who is capable of forming an opinion and assessing the information given to him or her, shall also assent in order to participate in a performance study.
Študije učinkovitosti na udeležencih, ki niso sposobni odločati o sebi
Article 60
V primeru, da udeleženec, ki ni sposoben odločati o sebi, ni dal privolitve po seznanitvi ali je ni zavrnil, dokler je bil še sposoben odločati o sebi, se lahko študija učinkovitosti izvede samo, če so poleg pogojev iz člena 58(5) izpolnjeni vsi naslednji pogoji:
Performance studies on incapacitated subjects
pridobljena je bila privolitev po seznanitvi, ki jo je dal njihov zakonito imenovani zastopnik;
In the case of incapacitated subjects who have not given, or have not refused to give, informed consent before the onset of their incapacity, a performance study may be conducted only where, in addition to the conditions set out in Article 58(5), all of the following conditions are met:
udeleženci, ki niso sposobni odločati o sebi, so informacije iz člena 59(2) prejeli na način, ki je glede na njihove sposobnosti razumevanja ustrezen;
the informed consent of their legally designated representative has been obtained;
udeleženec, ki ni sposoben odločati o sebi, lahko pa oblikuje lastno mnenje in oceni informacije iz člena 59(2), izrecno želi zavrniti sodelovanje v študiji učinkovitosti ali se iz nje kadar koli umakniti, raziskovalec to njegovo željo spoštuje;
the incapacitated subjects have received the information referred to in Article 59(2) in a way that is adequate in view of their capacity to understand it;
udeleženci ali njihovi zakonito imenovani zastopniki niso deležni spodbud ali finančne podpore razen nadomestila za stroške in izgubljene prihodke, ki so neposredna posledica sodelovanja v študiji učinkovitosti;
the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing the information referred to in Article 59(2) to refuse participation in, or to withdraw from, the performance study at any time, is respected by the investigator;
študija učinkovitosti je bistvena za ovrednotenje podatkov o udeležencih, ki niso sposobni odločati o sebi, in podatki primerljive veljavnosti se ne morejo pridobiti v študijah učinkovitosti na osebah, ki so sposobne dati privolitev po seznanitvi, ali z drugimi raziskovalnimi metodami;
no incentives or financial inducements are given to subjects or their legally designated representatives, except for compensation for expenses and loss of earnings directly related to the participation in the performance study;
študija učinkovitosti se neposredno nanaša na zdravstveno stanje udeleženca;
the performance study is essential with respect to incapacitated subjects and data of comparable validity cannot be obtained in performance studies on persons able to give informed consent, or by other research methods;
obstajajo znanstveni razlogi za pričakovanje, da bo sodelovanje v študiji učinkovitosti prineslo:
the performance study relates directly to a medical condition from which the subject suffers;
neposredno korist za udeleženca, ki ni sposoben odločati o sebi, ki bo odtehtala tveganja in bremena, ali
there are scientific grounds for expecting that participation in the performance study will produce:
nekaj koristi za prebivalstvo, ki ga predstavlja zadevni udeleženec, ki ni sposoben odločati o sebi, če bo taka študija učinkovitosti pomenila minimalno nevarnost in breme za zadevnega udeleženca, ki ni sposoben odločati o sebi, v primerjavi z običajnim zdravljenjem njegovega zdravstvenega stanja.
a direct benefit to the incapacitated subject outweighing the risks and burdens involved; or
Udeleženec v čim večji meri sodeluje pri postopku privolitve po seznanitvi.
some benefit for the population represented by the incapacitated subject concerned when the performance study will pose only minimal risk to, and will impose minimal burden on, the incapacitated subject concerned in comparison with the standard treatment of the incapacitated subject's condition.
Točka (g)(ii) odstavka 1 ne posega v strožja nacionalna pravila, ki prepovedujejo izvajanje teh študij učinkovitosti na udeležencih, ki niso sposobni odločati o sebi, če ni znanstveno utemeljeno pričakovati, da bo sodelovanje v študiji učinkovitosti prineslo neposredno korist, ki bo odtehtala tveganja in bremena.
The subject shall as far as possible take part in the informed consent procedure.
Člen 61
Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the conduct of those performance studies on incapacitated subjects, where there are no scientific grounds to expect that participation in the performance study will produce a direct benefit to the subject outweighing the risks and burdens involved.
Študije učinkovitosti na mladoletnih osebah
Article 61
Študija učinkovitosti na mladoletnih osebah se lahko izvaja le, kadar so poleg pogojev iz člena 58(5) izpolnjeni vsi naslednji pogoji:
Performance studies on minors
mladoletna oseba je od raziskovalcev ali članov raziskovalne skupine, ki so usposobljeni za delo z otroki ali imajo izkušnje na tem področju, informacije iz člena 59(2) dobila tako, kot je ustrezno za njeno starost in duševno zrelost;
A performance study on minors may be conducted only where, in addition to the conditions set out in Article 58(5), all of the following conditions are met:
raziskovalec spoštuje izrecno željo mladoletne osebe, ki je sposobna oblikovati mnenje in oceniti informacije iz člena 59(2), da zavrne sodelovanje v študiji učinkovitosti ali da se iz nje kadar koli umakne;
the minors have received the information referred to in Article 59(2) in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children;
namen študije učinkovitosti je raziskati načine zdravljenja zdravstvenega stanja, ki se pojavlja samo pri mladoletnikih, ali pa je študija učinkovitosti bistvena v povezavi z mladoletniki za potrditev podatkov, pridobljenih v študijah učinkovitosti na udeležencih, ki so sposobni dati privolitev po seznanitvi, ali z drugimi raziskovalnimi metodami;
the explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 59(2) to refuse participation in, or to withdraw from, the performance study at any time, is respected by the investigator;
študija učinkovitosti se neposredno nanaša na zdravstveno stanje zadevne mladoletne osebe ali je take narave, da jo je mogoče izvajati samo na mladoletnih osebah;
the performance study is intended to investigate treatments for a medical condition that only occurs in minors or the performance study is essential with respect to minors to validate data obtained in performance studies on persons able to give informed consent or by other research methods;
neposredno korist za mladoletno osebo, ki bo odtehtala tveganja in bremena, ali
the performance study either relates directly to a medical condition from which the minor concerned suffers or is of such a nature that it can only be carried out on minors;
nekaj koristi za populacijo, ki jo predstavlja zadevni mladoletnik, če bo taka študija učinkovitosti pomenila minimalno nevarnost in breme za zadevnega mladoletnika v primerjavi z običajnim zdravljenjem njegovega zdravstvenega stanja;
a direct benefit to the minor subject outweighing the risks and burdens involved; or
mladoletna oseba je v postopek privolitve po seznanitvi vključena tako, kot je ustrezno za njeno starost in duševno zrelost;
some benefit for the population represented by the minor concerned when the performance study will pose only minimal risk to, and will impose minimal burden on, the minor concerned in comparison with the standard treatment of the minor's condition;
če postane mladoletna oseba med študijo učinkovitosti polnoletna, tj. lahko da privolitev po seznanitvi, kot je opredeljeno v nacionalnem pravu, je treba pridobiti njeno izrecno privolitev po seznanitvi, sicer ne more več sodelovati v študiji učinkovitosti.
the minor shall take part in the informed consent procedure in a way adapted to his or her age and mental maturity;
Točka (g)(ii) odstavka 1 ne posega v strožja nacionalna pravila, ki prepovedujejo izvajanje teh študij učinkovitosti na mladoletnih osebah, če ni znanstveno utemeljeno pričakovati, da bo sodelovanje v študiji učinkovitosti prineslo neposredno korist, ki bo odtehtala tveganja in bremena.
if during a performance study the minor reaches the age of legal competence to give informed consent as defined in the national law, his or her express informed consent shall be obtained before that subject can continue to participate in the performance study.
Člen 62
Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the conduct of those performance studies on minors, where there are no scientific grounds to expect that participation in the performance study will produce a direct benefit to the subject outweighing the risks and burdens involved.
Študije učinkovitosti na nosečnicah ali doječih materah
Article 62
Študija učinkovitosti na nosečnicah ali doječih materah se lahko izvaja samo, kadar so poleg pogojev iz člena 58(5) izpolnjeni vsi naslednji pogoji:
Performance studies on pregnant or breastfeeding women
študija učinkovitosti bi lahko prinesla neposredno korist za zadevno nosečnico ali doječo mater ali njen zarodek, plod ali novorojenca, ki bi odtehtala z udeležbo v študiji povezana tveganja in invazivnost;
A performance study on pregnant or breastfeeding women may be conducted only where, in addition to the conditions set out in Article 58(5), all of the following conditions are met:
če taka študija učinkovitosti nima neposrednih koristi za zadevno nosečnico ali doječo mater ali njen zarodek, plod ali novorojenca, se lahko izvaja samo, če:
the performance study has the potential to produce a direct benefit for the pregnant or breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved;
se študija učinkovitosti primerljive učinkovitosti ne more izvajati na ženskah, ki niso noseče oziroma ne dojijo;
if such a performance study has no direct benefit for the pregnant or breastfeeding woman concerned, or her embryo, foetus or child after birth, it can be conducted only if:
študija učinkovitosti prispeva k doseganju rezultatov, ki bi lahko koristili nosečnicam ali doječim materam ali drugim ženskam v zvezi z oploditvijo ali drugim zarodkom, plodom ali otrokom, ter
a performance study of comparable effectiveness cannot be carried out on women who are not pregnant or breastfeeding;
študija učinkovitosti prinaša minimalno tveganje in minimalno breme za zadevno nosečnico ali doječo mater, njen zarodek, plod ali novorojenca;
the performance study contributes to the attainment of results capable of benefitting pregnant or breastfeeding women or other women in relation to reproduction or other embryos, foetuses or children; and
kadar se raziskava izvaja na doječih materah, je zlasti treba paziti, da se preprečijo vsakršni negativni vplivi na otrokovo zdravje,
the performance study poses a minimal risk to, and imposes a minimal burden on, the pregnant or breastfeeding woman concerned, her embryo, foetus or child after birth;
udeleženci niso deležni nobene spodbude ali finančne podpore, razen nadomestila za stroške in izgubljene prihodke, ki so neposredna posledica sodelovanja v študiji učinkovitosti.
where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse impact on the health of the child;
Člen 63
no incentives or financial inducements are given to subjects, except for compensation for expenses and loss of earnings directly related to the participation in the performance study.
Dodatni nacionalni ukrepi
Article 63
Države članice lahko ohranijo dodatne ukrepe za osebe, ki služijo obvezni vojaški rok, osebe, ki jim je bila odvzeta prostost, osebe, ki se zaradi sodne odločbe ne morejo udeležiti študije učinkovitosti, ali osebe, ki so nastanjene v domovih.
Additional national measures
Člen 64
Member States may maintain additional measures regarding persons performing mandatory military service, persons deprived of liberty, persons who, due to a judicial decision, cannot take part in performance studies, or persons in residential care institutions.
Študije učinkovitosti v nujnih primerih
Article 64
Z odstopanjem od točke (f) člena 58(5), točk (a) in (b) člena 60(1) ter točk (a) in (b) člena 61(1) se lahko privolitev po seznanitvi za sodelovanje v študiji učinkovitosti pridobi, informacije o študiji učinkovitosti pa dajo, potem ko je bila sprejeta odločitev o vključitvi udeleženca v študijo učinkovitosti, pod pogojem, da se ta odločitev sprejme ob prvi intervenciji na udeležencu v skladu z načrtom študije klinične učinkovitosti za to študijo učinkovitosti in da so izpolnjeni vsi naslednji pogoji:
Performance studies in emergency situations
zaradi nujnosti, ki izhaja iz nenadnega življenjsko ogrožujočega ali drugega nenadnega resnega zdravstvenega stanja, udeleženec ne more podati predhodne privolitve po seznanitvi in ne more prejeti predhodnih informacij o študiji učinkovitosti;
By way of derogation from point (f) of Article 58(5), from points (a) and (b) of Article 60(1) and from points (a) and (b) of Article 61(1), informed consent to participate in a performance study may be obtained, and information on the performance studies may be given, after the decision to include the subject in the performance study, provided that that decision is taken at the time of the first intervention on the subject, in accordance with the clinical performance study plan for that performance study and that all of the following conditions are fulfilled:
na podlagi znanstvenih dokazov se upravičeno pričakuje, da bo sodelovanje udeleženca v študiji učinkovitosti prineslo neposredno klinično relevantno korist za udeleženca, ki bi zagotovila merljivo zdravstveno izboljšanje, olajšala trpljenje in/ali izboljšala udeleženčevo zdravje ali diagnozo njegovega stanja;
due to the urgency of the situation, caused by a sudden life-threatening or other sudden serious medical condition, the subject is unable to provide prior informed consent and to receive prior information on the performance study;
v okviru razpoložljivega časa za poseg, ni mogoče dati vseh predhodnih informacij in pridobiti predhodne privolitve po seznanitvi od njegovega zakonito imenovanega zastopnika;
there are scientific grounds to expect that participation of the subject in the performance study will have the potential to produce a direct clinically relevant benefit for the subject resulting in a measurable health-related improvement alleviating the suffering and/or improving the health of the subject, or in the diagnosis of its condition;
raziskovalec uradno potrdi, da ne ve za morebitno že izraženo udeleženčevo nasprotovanje sodelovanju v študiji učinkovitosti, ki bi ga udeleženec izrazil pred tem;
it is not possible within the therapeutic window to supply all prior information to and obtain prior informed consent from his or her legally designated representative;
študija učinkovitosti neposredno zadeva udeleženčevo zdravstveno stanje, zaradi katerega v okviru razpoložljivega časa za poseg od njegovega zakonito imenovanega zastopnika ni mogoče pridobiti predhodne privolitve po seznanitvi in mu zagotoviti predhodnih informacij, študija učinkovitosti pa je takšne vrste, da se lahko izvaja izključno v nujnih primerih;
the investigator certifies that he or she is not aware of any objections to participate in the performance study previously expressed by the subject;
študija učinkovitosti pomeni za udeleženca v primerjavi z običajnim zdravljenjem njegovega stanja minimalno tveganje in minimalno breme.
the performance study relates directly to the subject's medical condition because of which it is not possible within the therapeutic window to obtain prior informed consent from the subject or from his or her legally designated representative and to supply prior information, and the performance study is of such a nature that it may be conducted exclusively in emergency situations;
Po intervenciji v skladu z odstavkom 1 tega člena se skuša v skladu s členom 59 pridobiti privolitev po seznanitvi, da se nadaljuje udeleženčevo sodelovanje v študiji učinkovitosti, informacije o študiji učinkovitosti pa se dajo v skladu z naslednjimi zahtevami:
the performance study poses a minimal risk to, and imposes a minimal burden on, the subject in comparison with the standard treatment of the subject's condition.
kar zadeva udeležence, ki niso sposobni odločati o sebi, in mladoletne osebe, privolitev po seznanitvi raziskovalec brez odlašanja pridobi od njihovih zakonito imenovanih zastopnikov, informacije iz člena 59(2) pa se čim prej dajo udeležencu in njegovemu zakonito imenovanemu zastopniku;
Following an intervention pursuant to paragraph 1 of this Article, informed consent in accordance with Article 59 shall be sought to continue the participation of the subject in the performance study, and information on the performance study shall be given, in accordance with the following requirements:
kar zadeva druge udeležence, privolitev po seznanitvi raziskovalec brez odlašanja pridobi od udeleženca ali njegovega zakonito imenovanega zastopnika, kar je mogoče prej, informacije iz člena 59(2) pa se, čim je mogoče, dajo udeležencu oziroma njegovem zakonito imenovanemu zastopniku.
regarding incapacitated subjects and minors, the informed consent shall be sought by the investigator from his or her legally designated representative without undue delay and the information referred to in Article 59(2) shall be given as soon as possible to the subject and to his or her legally designated representative;
Kadar je bila privolitev po seznanitvi pridobljena od zakonito imenovanega zastopnika, se za namene točke (b) zaradi nadaljevanja sodelovanja v študiji učinkovitosti privolitev udeleženca po seznanitvi pridobi takoj, ko je udeleženec sposoben dati privolitev po seznanitvi.
regarding other subjects, the informed consent shall be sought by the investigator without undue delay from the subject or his or her legally designated representative, whichever can be done sooner, and the information referred to in Article 59(2) shall be given as soon as possible to the subject or his or her legally designated representative, as applicable.
Če udeleženec ali, kadar je to potrebno, njegov zakonito imenovani zastopnik ne da privolitve, se obvesti o pravici, da nasprotuje uporabi podatkov, pridobljenih v študiji učinkovitosti.
For the purposes of point (b) where informed consent has been obtained from the legally designated representative, informed consent to continue the participation in the performance study shall be obtained from the subject as soon as he or she is capable of giving informed consent.
Člen 65
If the subject or, where applicable, his or her legally designated representative does not give consent, he or she shall be informed of the right to object to the use of data obtained from the performance study.
Odškodnina za škodo
Article 65
Države članice zagotovijo, da so na voljo odškodninski sistemi za morebitno škodo, ki jo utrpi udeleženec zaradi sodelovanja v študiji učinkovitosti, ki se izvaja na ozemlju teh držav, in sicer v obliki zavarovanja, jamstva ali podobne ureditve, ki je enakovredna glede na namen ter ustreza naravi in obsegu tveganja.
Damage compensation
Sponzor in raziskovalec uporabljata sistem iz odstavka 1 v obliki, ki je ustrezna za državo članico, v kateri se izvaja študija učinkovitosti.
Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from participation in a performance study conducted on their territory are in place in the form of insurance, a guarantee, or a similar arrangement that is equivalent as regards its purpose and which is appropriate to the nature and the extent of the risk.
Člen 66
The sponsor and the investigator shall make use of the system referred to in paragraph 1 in the form appropriate for the Member State in which the performance study is conducted.
Vloga za študije učinkovitosti