Uredba o ratifikaciji Dodatnega protokola h Konvenciji o človekovih pravicah v zvezi z biomedicino glede biomedicinskih raziskav

Ratificira se Dodatni protokol h Konvenciji o človekovih pravicah v zvezi z biomedicino glede biomedicinskih raziskav, sestavljen v Strasbourgu 25. januarja 2005.

Besedilo protokola se v izvirniku v angleškem jeziku ter v prevodu v slovenskem jeziku glasi: The member States of the Council of Europe, the other States and the European Community signatories to this Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (hereinafter referred to as “the Convention”), Considering that the aim of the Council of Europe is the achievement of greater unity between its members and that one of the methods by which this aim is pursued is the maintenance and further realisation of human rights and fundamental freedoms; Considering that the aim of the Convention, as defined in Article 1, is to 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 the application of biology and medicine; Considering that progress in medical and biological sciences, in particular advances obtained through biomedical research, contributes to saving lives and improving quality of life; Conscious of the fact that the advancement of biomedical science and practice is dependent on knowledge and discovery which necessitates research on human beings; Stressing that such research is often transdisciplinary and international; Taking into account national and international professional standards in the field of biomedical research and the previous work of the Committee of Ministers and the Parliamentary Assembly of the Council of Europe in this field; Convinced that biomedical research that is contrary to human dignity and human rights should never be carried out; Stressing the paramount concern to be the protection of the human being participating in research; Affirming that particular protection shall be given to human beings who may be vulnerable in the context of research; Recognising that every person has a right to accept or refuse to undergo biomedical research and that no one should be forced to undergo such research; Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and freedoms of the individual with regard to biomedical research, Have agreed as follows: 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. text="  1 This Protocol covers the full range of research activities in the health field involving interventions on human beings. 2 This Protocol does not apply to research on embryos in vitro. It does apply to research on foetuses and embryos 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." The interests and welfare of the human being participating in research shall prevail over the sole interest of society or science. 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. Research on human beings may only be undertaken if there is no alternative of comparable effectiveness. 1 Research shall not involve risks and burdens to the human being disproportionate to its potential benefits. 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. 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. 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. 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. 1 Every research project shall be submitted for independent examination of its ethical acceptability to an ethics committee. Such projects shall be submitted to independent examination in each State in which any research activity is to take place. 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. The assessment of the ethical acceptability shall draw on an appropriate range of expertise and experience adequately reflecting professional and lay views. 3 The ethics committee shall produce an opinion containing reasons for its conclusion. 1 Parties to this Protocol shall take measures to assure the independence of the ethics committee. That body shall not be subject to undue external influences. 2 Members of the ethics committee shall declare all circumstances that might lead to a conflict of interest. Should such conflicts arise, those involved shall not participate in that review. 1 All information which is necessary for the ethical assessment of the research project shall be given in written form to the ethics committee. 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. 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. 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. In this respect, particular attention must be given to vulnerable or dependent persons. text="  1 The persons being asked to participate in a research project shall be given adequate information in a comprehensible form. This information shall be documented. 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. 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: i of the nature, extent and duration of the procedures involved, in particular, details of any burden imposed by the research project; ii of available preventive, diagnostic and therapeutic procedures; iii of the arrangements for responding to adverse events or the concerns of research participants; iv of arrangements to ensure respect for private life and ensure the confidentiality of personal data; v of arrangements for access to information relevant to the participant arising from the research and to its overall results; vi of the arrangements for fair compensation in the case of damage; vii of any foreseen potential further uses, including commercial uses, of the research results, data or biological materials; viii of the source of funding of the research project. 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." 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. Such consent may be freely withdrawn by the person at any phase of the research. 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. 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. text="  1 Research on a person without the capacity to consent to research may be undertaken only if all the following specific conditions are met: i the results of the research have the potential to produce real and direct benefit to his or her health; ii research of comparable effectiveness cannot be carried out on individuals capable of giving consent; 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; 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’s previously expressed wishes or objections. An adult not able to consent shall as far as possible take part in the authorisation procedure. The opinion of a minor shall be taken into consideration as an increasingly determining factor in proportion to age and degree of maturity; v the person concerned does not object. 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: i the research has the aim of contributing, through significant improvement in the scientific understanding of the individual'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; 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. 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." 1 Those being asked to authorise participation of a person in a research project shall be given adequate information in a comprehensible form. This information shall be documented. 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. 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. They shall be specifically informed according to the nature and purpose of the research of the items of information listed in Article 13. 3 The information shall also be provided to the individual concerned, unless this person is not in a state to receive the information. 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. 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. In assessing the burden for an individual, a person enjoying the special confidence of the person concerned shall assess the burden where appropriate. text="  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: 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; ii research of comparable effectiveness cannot be carried out on women who are not pregnant; iii the research entails only minimal risk and minimal burden. 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." text="  1 The law shall determine whether, and under which protective additional conditions, research in emergency situations may take place when: i a person is not in a state to give consent, and 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. 2 The law shall include the following specific conditions: i research of comparable effectiveness cannot be carried out on persons in non-emergency situations; ii the research project may only be undertaken if it has been approved specifically for emergency situations by the competent body; iii any relevant previously expressed objections of the person known to the researcher shall be respected; 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'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. 3 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. Consent or authorisation for continued participation shall be requested as soon as reasonably possible." text="  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: i research of comparable effectiveness cannot be carried out without the participation of persons deprived of liberty; ii the research has the aim of contributing to the ultimate attainment of results capable of conferring benefit to persons deprived of liberty; iii the research entails only minimal risk and minimal burden." 1 All reasonable measures shall be taken to ensure safety and to minimise risk and burden for the research participants. 2 Research may only be carried out under the supervision of a clinical professional who possesses the necessary qualifications and experience. 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. 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. 1 Research shall not delay nor deprive participants of medically necessary preventive, diagnostic or therapeutic procedures. 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. 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. text="  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. 2 The purpose of the re-examination is to establish whether: i the research needs to be discontinued or if changes to the research project are necessary for the research to continue; ii research participants, or if applicable their representatives, need to be informed of the developments or events; iii additional consent or authorisation for participation is required. 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. 4 The competent body shall be informed of the reasons for any premature termination of a research project." 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. 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. 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. 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. 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. That shall be done within a framework of health care or counselling. 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. 1 On completion of the research, a report or summary shall be submitted to the ethics committee or the competent body. 2 The conclusions of the research shall be made available to participants in reasonable time, on request. 3 The researcher shall take appropriate measures to make public the results of research in reasonable time. 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. Where necessary, the Party shall take appropriate measures to that end. 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. 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. Parties shall provide for appropriate sanctions to be applied in the event of infringement of the provisions contained in this Protocol. 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. 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. 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. This Protocol shall be open for signature by Signatories to the Convention. It is subject to ratification, acceptance or approval. A Signatory may not ratify, accept or approve this Protocol unless it has previously or simultaneously ratified, accepted or approved the Convention. Instruments of ratification, acceptance or approval shall be deposited with the Secretary General of the Council of Europe. 1 This Protocol shall enter into force on the first day of the month following the expiration of a period of three months after the date on which five States, including at least four member States of the Council of Europe, have expressed their consent to be bound by the Protocol in accordance with the provisions of Article 36. 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. 1 After the entry into force of this Protocol, any State which has acceded to the Convention may also accede to this Protocol. 2 Accession shall be effected by the deposit with the Secretary General of the Council of Europe of an instrument of accession which shall take effect on the first day of the month following the expiration of a period of three months after the date of its deposit. 1 Any Party may at any time denounce this Protocol by means of a notification addressed to the Secretary General of the Council of Europe. 2 Such denunciation shall become effective on the first day of the month following the expiration of a period of three months after the date of receipt of such notification by the Secretary General. text="  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: a any signature; b the deposit of any instrument of ratification, acceptance, approval or accession; c any date of entry into force of this Protocol in accordance with Articles 37 and 38; d any other act, notification or communication relating to this Protocol." In witness whereof the undersigned, being duly authorised thereto, have signed this Protocol. Done at Strasbourg, this 25th day of January 2005, in English and in French, both texts being equally authentic, in a single copy which shall be deposited in the archives of the Council of Europe. The Secretary General of the Council of Europe shall transmit certified copies to each member State of the Council of Europe, to the non-member States which have participated in the elaboration of this Protocol, to any State invited to accede to the Convention and to the European Community. Information to be given to the ethics committee Information on the following items shall be provided to the ethics committee, in so far as it is relevant for the research project: Description of the project i the name of the principal researcher, qualifications and experience of researchers and, where appropriate, the clinically responsible person, and funding arrangements; ii the aim and justification for the research based on the latest state of scientific knowledge; iii methods and procedures envisaged, including statistical and other analytical techniques; iv a comprehensive summary of the research project in lay language; v a statement of previous and concurrent submissions of the research project for assessment or approval and the outcome of those submissions; Participants, consent and information vi justification for involving human beings in the research project; 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; viii reasons for the use or the absence of control groups; ix a description of the nature and degree of foreseeable risks that may be incurred through participating in research; 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; xi arrangements to monitor, evaluate and react to contingencies that may have consequences for the present or future health of research participants; 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; 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; xiv arrangements to ensure respect for the private life of those persons who would participate in research and ensure the confidentiality of personal data; 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; Other information xvi details of all payments and rewards to be made in the context of the research project; xvii details of all circumstances that might lead to conflicts of interest that may affect the independent judgement of the researchers; xviii details of any foreseen potential further uses, including commercial uses, of the research results, data or biological materials; xix details of all other ethical issues, as perceived by the researcher; xx details of any insurance or indemnity to cover damage arising in the context of the research project. The ethics committee may request additional information necessary for evaluation of the research project. Države članice Sveta Evrope, druge države in Evropska skupnost, podpisnice tega dodatnega protokola h Konvenciji o varstvu človekovih pravic in dostojanstva človeškega bitja v zvezi z uporabo biologije in medicine (v nadaljnjem besedilu »konvencija«) so se, ker je cilj Sveta Evrope ustvariti večjo enotnost med njegovimi članicami in ker je eden od načinov za uresničevanje tega cilja ohranjanje in nadaljnje uveljavljanje človekovih pravic in temeljnih svoboščin; ob upoštevanju, da je cilj konvencije, kakor je opredeljen v 1. členu, varovati dostojanstvo in identiteto vseh človeških bitij ter vsakomur brez razlikovanja jamčiti spoštovanje njegove duševne in telesne nedotakljivosti ter drugih pravic in temeljnih svoboščin v zvezi z uporabo biologije in medicine; ker napredek v medicinskih in bioloških znanostih, zlasti napredek, dosežen z biomedicinskimi raziskavami, prispeva k reševanju življenj in izboljšanju kakovosti življenja; ob zavedanju, da je napredek biomedicinske znanosti in prakse odvisen od znanja in odkritij, ki zahtevajo raziskave na človeških bitjih; ob poudarjanju, da so take raziskave pogosto transdisciplinarne in mednarodne; ob upoštevanju državnih in mednarodnih strokovnih standardov na področju biomedicinskih raziskav in preteklega dela Odbora ministrov in Parlamentarne skupščine Sveta Evrope na tem področju; v prepričanju, da se biomedicinske raziskave, ki so v nasprotju s človekovim dostojanstvom in človekovimi pravicami, nikoli ne bi smele izvajati; ob poudarjanju, da je najpomembnejša skrb varstvo človeškega bitja, ki sodeluje pri raziskavi; ob potrditvi, da se posebno varstvo nameni človeškim bitjem, ki bi lahko bila zaradi raziskave ranljiva; v spoznanju, da ima vsaka oseba pravico sprejeti ali zavrniti biomedicinsko raziskavo na sebi in da se ne sme nikogar prisiliti, da sodeluje pri taki raziskavi; odločene, da v zvezi z biomedicinskimi raziskavami sprejmejo ukrepe, potrebne za zaščito človekovega dostojanstva ter temeljnih pravic in svoboščin posameznika, sporazumele o naslednjem: 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. text="  1. Ta protokol ureja vse raziskovalne dejavnosti na področju varovanja zdravja, ki vključujejo posege na človeških bitjih. 2. Ta protokol se ne uporablja za raziskave na zarodkih in vitro. Uporablja se za raziskave na plodu in zarodku in vivo. 3. V tem protokolu izraz »poseg« pomeni: i. fizični poseg in ii. kateri koli drug poseg, če vključuje tveganje za psihično zdravje osebe." Koristi in skrb za človeško bitje, ki sodeluje pri raziskavi, prevladajo nad izključno koristjo družbe ali znanosti. Raziskovanje je svobodno ob upoštevanju določb tega protokola in drugih pravnih določb, ki zagotavljajo varstvo človeškega bitja. Raziskave na človeških bitjih se smejo opravljati le, če takih raziskav ni mogoče nadomestiti z drugimi, podobno uspešnimi raziskavami. 1. Raziskava ne sme vključevati tveganj in obremenitev za človeško bitje, ki so v nesorazmerju z mogočimi koristmi. 2. 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. To ne posega v določbo iz točke ii drugega odstavka 15. člena o varstvu oseb, ki niso sposobne dati soglasja za raziskavo. 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. 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. 1. Vsak raziskovalni projekt se predloži v neodvisno presojo svoje etične sprejemljivosti odboru za etiko. Taki projekti se predložijo v neodvisno presojo v vsaki državi, v kateri naj bi potekala katera koli raziskovalna dejavnost. 2. Namen multidisciplinarne presoje etične sprejemljivosti raziskovalnega projekta je varovati dostojanstvo, pravice, varnost in dobro počutje udeležencev raziskave. Ovrednotenje etične sprejemljivosti temelji na ustreznem strokovnem znanju in izkušnjah ter primerno izraža strokovne in laične poglede. 3. Odbor za etiko pripravi mnenje, v katerem navede razloge za sprejetje svojega sklepa. 1. Pogodbenice tega protokola sprejmejo ukrepe, s katerimi zagotovijo neodvisnost odbora za etiko. Na ta organ ne smejo vplivati neupravičene zunanje okoliščine. 2. Člani odbora za etiko navedejo vse okoliščine, ki bi lahko privedle do neskladja interesov. Če pride do njih, vpleteni ne smejo sodelovati pri tej presoji. 1. Vse informacije, ki so potrebne za ovrednotenje etične sprejemljivosti raziskovalnega projekta, se v pisni obliki predložijo odboru za etiko. 2. Še posebej se navedejo podatki po točkah iz dodatka k temu protokolu, če so pomembni za raziskovalni projekt. Dodatek lahko z dvetretjinsko večino oddanih glasov spremeni odbor, ustanovljen z 32. členom konvencije. Odbor za etiko mora biti prepričan, da se na osebe, ki sodelujejo pri raziskavi, ne bo neprimerno vplivalo, vključno s finančnimi spodbudami. V zvezi s tem se mora posebna pozornost nameniti ranljivim ali odvisnim osebam. text="  1. Osebam, zaprošenim za sodelovanje pri raziskovalnem projektu, se dajo ustrezne informacije v razumljivi obliki. Te informacije morajo biti dokumentirane. 2. Informacije vključujejo namen, celovit načrt, mogoča tveganja in koristi raziskovalnega projekta ter mnenje odbora za etiko. Preden so osebe zaprošene, da privolijo v sodelovanje pri raziskovalnem projektu, so glede na naravo in namen raziskave obveščene predvsem o: i. naravi, obsegu in trajanju postopkov, zlasti o podrobnostih glede morebitnih obremenitev, ki jih povzroča raziskovalni projekt; ii. razpoložljivih preventivnih, diagnostičnih in terapevtskih postopkih; iii. ukrepih za odzivanje na neželene dogodke ali zaskrbljenost udeležencev raziskave; iv. ukrepih za zagotavljanje spoštovanja zasebnosti in zaupnosti osebnih podatkov; v. ureditvah glede dostopa do informacij, ki izhajajo iz raziskave in so pomembne za udeleženca, ter do celovitih izsledkov raziskave; vi. možnostih za pravično nadomestilo ob škodi; vii. vseh predvidenih mogočih nadaljnjih uporabah izsledkov raziskave, podatkov ali biološkega materiala, vključno s komercialno uporabo; viii. virih financiranja raziskovalnega projekta. 3. 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." 1. 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. Tako privolitev lahko oseba prostovoljno prekliče v kateri koli fazi raziskave. 2. Zavrnitev privolitve ali njen preklic za sodelovanje pri raziskavi ne sme povzročiti nobene oblike diskriminacije te osebe, zlasti glede pravice do zdravstvenega varstva. 3. 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. text="  1. Na osebi, ki ni sposobna privoliti v raziskavo, se sme raziskava opravljati le, če so izpolnjeni vsi posebni pogoji: i. od izsledkov raziskave je mogoče pričakovati resnično in neposredno korist za zdravje take osebe; ii. primerljivo uspešne raziskave ni mogoče opraviti na osebah, ki so sposobne privoliti vanjo; 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. 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. Odrasla oseba, ki ni sposobna privoliti v raziskavo čim bolj sodeluje pri postopku pridobitve dovoljenja. Mnenje mladoletne osebe se upošteva kot odločilni dejavnik sorazmerno z njeno starostjo in stopnjo zrelosti; v. oseba ne nasprotuje. 2. 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. 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. 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. 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." 1. Tistim, ki so zaprošeni, da dovolijo sodelovanje osebe pri raziskovalnem projektu, se dajo ustrezne informacije v razumljivi obliki. Te informacije morajo biti dokumentirane. 2. Informacije vključujejo namen, celovit načrt, mogoča tveganja in koristi raziskovalnega projekta ter mnenje odbora za etiko. 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. Glede na naravo in namen raziskave so še posebej seznanjeni z informacijami iz 13. člena. 3. Informacije se dajo tudi osebi, razen če jih ni sposobna sprejeti. 1. 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. Šteje se, da raziskava prinaša najmanjšo obremenitev, če se lahko pričakuje, da bo neugodje za osebo začasno in majhno. Kadar je to primerno, obremenitev za osebo ovrednoti nekdo, ki uživa posebno zaupanje te osebe. text="  1. 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. 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. primerljivo uspešne raziskave ni mogoče opraviti na ženskah, ki niso noseče; iii. raziskava pomeni le najmanjše tveganje in najmanjšo obremenitev. 2. Kadar se raziskava opravlja na doječi ženski, se še posebej poskrbi, da nikakor negativno ne vpliva na zdravje otroka." text="  1. Zakon določi, ali in pod katerimi dodatnimi varovalnimi pogoji se lahko opravlja raziskava v nujnih primerih, kadar: i. oseba ni sposobna dati privolitve in 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. Zakon vključuje te posebne pogoje: i. primerljivo uspešne raziskave ni mogoče opraviti na osebah, ki niso nujni primeri; ii. raziskovalni projekt se sme izvajati le, če ga je posebej za nujne primere odobril pristojni organ; iii. upoštevajo se vsi pomembni predhodno izraženi ugovori osebe, s katerimi je seznanjen raziskovalec; 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. 3. 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. Takoj ko je mogoče, se zahteva privolitev ali dovoljenje za stalno sodelovanje." text="  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. primerljivo uspešne raziskave ni mogoče opraviti brez sodelovanja oseb, ki jim je odvzeta prostost; ii. cilj raziskave je prispevati h končnim izsledkom, ki bodo lahko koristili osebam, ki jim je odvzeta prostost; iii. raziskava pomeni le najmanjše tveganje in najmanjšo obremenitev." 1. Sprejmejo se vsi primerni ukrepi za zagotavljanje varnosti in zmanjševanje tveganj ter obremenitev za udeležence raziskave. 2. Raziskava se sme opraviti le pod nadzorom kliničnega strokovnjaka, ki je za to ustrezno usposobljen in ima ustrezne izkušnje. 1. 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. 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. 1. Zdravstveno potrebni preventivni, diagnostični ali terapevtski postopki za udeležence v raziskavi ne smejo biti odloženi ali preprečeni zaradi nje. 2. Pri raziskavah, povezanih s preprečevanjem, diagnosticiranjem ali zdravljenjem, se udeležencem, razporejenim v kontrolne skupine, zagotovijo preskušene metode preprečevanja, diagnosticiranja ali zdravljenja. 3. Uporaba placeba je dovoljena, kadar ni dokazano učinkovitih metod ali kadar njihova prekinitev ali zavrnitev ne pomeni nesprejemljivega tveganja ali obremenitve. text="  1. 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. Namen ponovne proučitve je ugotoviti, ali: i. je treba raziskavo prekiniti oziroma ali je treba za nadaljevanje raziskave spremeniti raziskovalni projekt; ii. je treba udeležence raziskave, ali če je primerno, njihove zastopnike obvestiti o dosežkih ali dogodkih; iii. je potrebna dodatna privolitev ali dovoljenje za sodelovanje. 3. Udeležencem raziskave, ali če je primerno, njihovim zastopnikom se pravočasno priskrbijo vse nove informacije, pomembne za njihovo sodelovanje pri raziskavi. 4. Pristojni organ je obveščen o razlogih za vsako predčasno prenehanje raziskovalnega projekta." 1. Vsi osebni podatki, zbrani med biomedicinsko raziskavo, so zaupni in se obravnavajo skladno s pravili o varovanju zasebnosti. 2. 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. Udeleženci raziskave imajo pravico izvedeti za vsak podatek, pridobljen o njihovem zdravju, v skladu z določbami 10. člena konvencije. 2. Drugi osebni podatki, pridobljeni za raziskovalni projekt, so jim dostopni v skladu z zakonom o varstvu posameznikov pri obdelavi osebnih podatkov. Če raziskava privede do podatkov, pomembnih za trenutno ali prihodnje zdravje ali kakovost življenja udeležencev raziskave, jim je treba te podatke dati. To poteka v okviru zdravstvenega varstva ali svetovanja. Pri sporočanju takih podatkov je treba ravnati skrbno, da se varuje zaupnost in upošteva morebitna želja udeleženca, da se mu ti podatki ne povedo. 1. Po opravljeni raziskavi se odboru za etiko ali pristojnemu organu predloži poročilo ali povzetek. 2. Izsledki raziskave se dajo udeležencem na razpolago v primernem času, če to zahtevajo. 3. Raziskovalec ustrezno poskrbi za pravočasno javno objavo izsledkov raziskave. 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. Če je potrebno, pogodbenica v ta namen sprejme ustrezne ukrepe. Pogodbenice zagotavljajo primerno sodno varstvo za takojšnjo preprečitev ali ustavitev nezakonitega poseganja v pravice ali načela, opredeljena v tem protokolu. Oseba, ki je zaradi sodelovanja pri raziskavi utrpela škodo, ima v skladu s pogoji in postopki, ki jih predpisuje zakon, pravico do pravičnega nadomestila. Pogodbenice predvidijo ustrezne sankcije, ki se uporabijo ob kršitvah določb tega protokola. Med pogodbenicami veljajo določbe od 1. do 32. člena protokola kot dodatni členi konvencije, vse določbe konvencije pa se uporabljajo skladno s tem. 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. 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. Protokol je na voljo za podpis podpisnicam konvencije. Protokol je treba ratificirati, sprejeti ali odobriti. Podpisnica ga ne sme ratificirati, sprejeti ali odobriti, če ni pred tem ali sočasno ratificirala, sprejela ali odobrila konvencije. Listine o ratifikaciji, sprejetju ali odobritvi se deponirajo pri generalnem sekretarju Sveta Evrope. 1. Protokol začne veljati prvi dan meseca po poteku treh mesecev po datumu, ko je pet držav, od katerih so najmanj štiri države članice Sveta Evrope, v skladu z določbami 36. člena izrazilo soglasje, da jih protokol zavezuje. 2. 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. 1. Po začetku veljavnosti protokola lahko katera koli država, ki je pristopila h konvenciji, pristopi tudi k protokolu. 2. Za pristop se pri generalnem sekretarju Sveta Evrope deponira listina o pristopu, veljati pa začne prvi dan meseca po poteku treh mesecev po datumu njenega deponiranja. 1. Vsaka pogodbenica lahko ta protokol kadar koli odpove z uradnim obvestilom, naslovljenim na generalnega sekretarja Sveta Evrope. 2. Odpoved začne veljati prvi dan meseca po poteku treh mesecev po datumu, ko generalni sekretar prejme obvestilo. text="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: a. vsakem podpisu; b. deponiranju vsake listine o ratifikaciji, sprejetju, odobritvi ali pristopu; c. vsakem datumu začetka veljavnosti tega protokola v skladu s 37. in 38. členom; d. vsakem drugem dejanju, obvestilu ali sporočilu v zvezi s tem protokolom.   V potrditev tega so podpisani, ki so bili za to pravilno pooblaščeni, podpisali protokol.   Sestavljeno v Strasbourgu 25. januarja 2005, v angleškem in francoskem jeziku v enem izvodu, ki se hrani v arhivu Sveta Evrope, pri čemer sta besedili enako verodostojni. Generalni sekretar Sveta Evrope pošlje overjene kopije vsem državam članicam Sveta Evrope, državam nečlanicam, ki so sodelovale pri pripravi protokola, vsaki državi, ki je povabljena, da pristopi h konvenciji, ter Evropski skupnosti." Informacije, ki se zagotovijo odboru za etiko Odboru za etiko se dajo informacije po naslednjih točkah, če so pomembne za raziskovalni projekt: Opis projekta i. ime glavnega raziskovalca, izobrazba in usposobljenost ter izkušnje raziskovalcev in po potrebi osebe, odgovorne za klinični del, ter ureditev financiranja; ii. cilj in utemeljitev raziskave na podlagi najnovejših znanstvenih spoznanj; iii. predvidene metode in postopki, vključno s statističnimi in drugimi analitičnimi tehnikami; iv. izčrpen povzetek raziskovalnega projekta v poljudnem jeziku; v. izjava o prejšnjih in tekočih vlogah za ovrednotenje ali odobritev raziskovalnega projekta ter o izidih obravnave teh vlog; Udeleženci, privolitev in informacije vi. utemeljitev vključitve človeških bitij v raziskovalni projekt; vii. merila za vključitev posameznih kategorij oseb v raziskovalni projekt ali izključitev iz njega ter načini izbiranja in pridobivanja teh oseb; viii. razlogi za uporabo ali odsotnost kontrolnih skupin; ix. opis narave in stopnje predvidljivih tveganj, ki jih lahko prinaša sodelovanje pri raziskavi; x. narava, obseg in trajanje posegov, ki se opravijo na udeležencih raziskave, ter podatki o vseh obremenitvah, ki jih prinaša raziskovalni projekt; 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. časovna razporeditev in podrobne informacije za osebe, ki bi sodelovale pri raziskovalnem projektu, ter predlagani načini zagotavljanja teh informacij; xiii. dokumentacija, namenjena za pridobivanje privolitve, ali pri osebah, ki niso sposobne privoliti v raziskavo, dovoljenja za sodelovanje pri raziskovalnem projektu; xiv. ukrepi za zagotavljanje spoštovanja zasebnosti oseb, ki bi sodelovale pri raziskavi, ter zagotavljanje zaupnosti osebnih podatkov; 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; Druge informacije xvi. podrobnosti o vseh plačilih in nagradah, ki se izplačajo v okviru raziskovalnega projekta; xvii. podrobnosti o vseh okoliščinah, ki bi lahko privedle do nasprotja interesov, kar bi lahko vplivalo na neodvisno presojo raziskovalcev; xviii. podrobnosti o vseh predvidenih mogočih nadaljnjih uporabah izsledkov raziskave, podatkov ali biološkega materiala, vključno s komercialno uporabo; xix. podrobnosti o vseh drugih etičnih vprašanjih, kot jih dojema raziskovalec; xx. podrobnosti o vseh zavarovanjih ali odškodninah za kritje škode, ki nastane pri raziskovalnem projektu. Odbor za etiko lahko zahteva dodatne informacije, ki so potrebne za ovrednotenje raziskovalnega projekta.

Za izvajanje protokola skrbi Ministrstvo za zdravje.

Ta uredba začne veljati petnajsti dan po objavi v Uradnem listu Republike Slovenije – Mednarodne pogodbe. Št. 00724-105/2005/4 Ljubljana, dne 17. novembra 2005 EVA 2005-1811-0033 Janez Janša l.r. Predsednik