2006. évi LXXXI. törvény

az Európa Tanácsnak az emberi lény emberi jogainak és méltóságának a biológia és az orvostudomány alkalmazására tekintettel történő védelméről szóló, Oviedóban, 1997. április 4-én kelt Egyezményéhez kapcsolódó, az orvosbiológiai kutatásokról szóló, Genfben, 2005. szeptember 28-án aláírt Kiegészítő Jegyzőkönyv kihirdetéséről1

1. § Az Országgyűlés e törvénnyel felhatalmazást ad az Európa Tanácsnak az emberi lény emberi jogainak és méltóságának a biológia és az orvostudomány alkalmazására tekintettel történő védelméről szóló, Oviedóban, 1997. április 4-én kelt Egyezményéhez kapcsolódó, az orvosbiológiai kutatásokról szóló, Genfben, 2005. szeptember 28-án aláírt Kiegészítő Jegyzőkönyv kötelező hatályának elismerésére.

2. § Az Országgyűlés a Kiegészítő Jegyzőkönyvet e törvénnyel kihirdeti.

3. § A Kiegészítő Jegyzőkönyv hiteles angol nyelvű szövege és annak hivatalos magyar nyelvű fordítása a következő:

Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research)~Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research

Preamble

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:

Chapter I

OBJECT AND SCOPE

Article 1

Object and purpose

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.

Article 2

Scope

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.

Chapter II

GENERAL PROVISIONS

Article 3

Primacy of the human being

The interests and welfare of the human being participating in research shall prevail over the sole interest of society or science.

Article 4

General rule

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.

Article 5

Absence of alternatives

Research on human beings may only be undertaken if there is no alternative of comparable effectiveness.

Article 6

Risks and benefits

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.

Article 7

Approval

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.

Article 8

Scientific quality

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.

Chapter III

ETHICS COMMITTEE

Article 9

Independent examination by an ethics committee

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.

Article 10

Independence of the ethics committee

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.

Article 11

Information for the ethics committee

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.

Article 12

Undue influence

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.

Chapter IV

INFORMATION AND CONSENT

Article 13

Information for research participants

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.

Article 14

Consent

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.

Chapter V

PROTECTION OF PERSONS NOT ABLE TO CONSENT TO RESEARCH

Article 15

Protection of persons not able to consent to research

1. Research on a person without the capacity to consent to research may be undertaken only if all the following specific conditions are met:

1. 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.

Article 16

Information prior to authorisation

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.

Article 17

Research with minimal risk and minimal burden

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.