79C3C34C52B45572883A05D425EB0F82
Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research
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This file was generated: 2020-12-01 09:22:35
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Illegal Activity
Searching for indicator unlawful:
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p.000007:
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000008:
p.000008:
p.000008: Article 28 – Availability of results
p.000008:
p.000008: 1 On completion of the research, a report or summary shall be submitted to the ethics committee or
p.000008: the competent body.
p.000008:
p.000008: 2 The conclusions of the research shall be made available to participants in reasonable time, on request.
p.000008:
p.000008: 3 The researcher shall take appropriate measures to make public the results of research in
p.000008: reasonable time.
p.000008:
p.000008: CHAPTER IX – Research in States not parties to this Protocol Article 29 – Research in States not parties to this
p.000008: Protocol
p.000008: Sponsors or researchers within the jurisdiction of a Party to this Protocol that plan to undertake or
p.000008: direct a research project in a State not party to this Protocol shall ensure that, without prejudice to the provisions
p.000008: applicable in that State, the research project complies with the principles on which the provisions of this Protocol
p.000008: are based. Where necessary, the Party shall take appropriate measures to that end.
p.000008:
p.000008: CHAPTER X – Infringement of the provisions of the Protocol Article 30 – Infringement of the rights or principles
p.000008: The Parties shall provide appropriate judicial protection to prevent or to put a stop to an unlawful
p.000008: infringement of the rights or principles set forth in this Protocol at short notice.
p.000008:
p.000008: Article 31 – Compensation for damage
p.000008:
p.000008: The person who has suffered damage as a result of participation in research shall be entitled to fair compensation
p.000008: according to the conditions and procedures prescribed by law.
p.000008:
p.000008: Article 32 – Sanctions
p.000008:
p.000008: Parties shall provide for appropriate sanctions to be applied in the event of infringement of the provisions contained
p.000008: in this Protocol.
p.000008:
p.000008: CHAPTER XI – Relation between this Protocol and other provisions and re-examination of the Protocol
p.000008:
p.000008: Article 33 – Relation between this Protocol and the Convention
p.000008:
p.000008: As between the Parties, the provisions of Articles 1 to 32 of this Protocol shall be regarded as additional articles
p.000008: to the Convention, and all the provisions of the Convention shall apply accordingly.
p.000008:
p.000008: Article 34 – Wider protection
p.000008:
p.000008: None of the provisions of this Protocol shall be interpreted as limiting or otherwise affecting the possibility for a
p.000008: Party to grant research participants a wider measure of protection than is stipulated in this Protocol.
p.000008:
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p.000008:
p.000009: 9
p.000009:
p.000009: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000009:
p.000009:
p.000009: Article 35 – Re-examination of the Protocol
p.000009:
p.000009: In order to monitor scientific developments, the present Protocol shall be examined within the Committee referred to in
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Political / political affiliation
Searching for indicator party:
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p.000007:
p.000007: 2 Other personal information collected for a research project will be accessible to them in
p.000007: conformity with the law on the protection of individuals with regard to processing of personal data.
p.000007:
p.000007: Article 27 – Duty of care
p.000007:
p.000007: If research gives rise to information of relevance to the current or future health or quality of life of research
p.000007: participants, this information must be offered to them. That shall be done within a framework of health care or
p.000007: counselling. In communication of such information, due care must be taken in order to protect confidentiality
p.000007: and to respect any wish of a participant not to receive such information.
p.000007:
p.000007:
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p.000007:
p.000008: 8
p.000008:
p.000008: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000008:
p.000008:
p.000008: Article 28 – Availability of results
p.000008:
p.000008: 1 On completion of the research, a report or summary shall be submitted to the ethics committee or
p.000008: the competent body.
p.000008:
p.000008: 2 The conclusions of the research shall be made available to participants in reasonable time, on request.
p.000008:
p.000008: 3 The researcher shall take appropriate measures to make public the results of research in
p.000008: reasonable time.
p.000008:
p.000008: CHAPTER IX – Research in States not parties to this Protocol Article 29 – Research in States not parties to this
p.000008: Protocol
p.000008: Sponsors or researchers within the jurisdiction of a Party to this Protocol that plan to undertake or
p.000008: direct a research project in a State not party to this Protocol shall ensure that, without prejudice to the provisions
p.000008: applicable in that State, the research project complies with the principles on which the provisions of this Protocol
p.000008: are based. Where necessary, the Party shall take appropriate measures to that end.
p.000008:
p.000008: CHAPTER X – Infringement of the provisions of the Protocol Article 30 – Infringement of the rights or principles
p.000008: The Parties shall provide appropriate judicial protection to prevent or to put a stop to an unlawful
p.000008: infringement of the rights or principles set forth in this Protocol at short notice.
p.000008:
p.000008: Article 31 – Compensation for damage
p.000008:
p.000008: The person who has suffered damage as a result of participation in research shall be entitled to fair compensation
p.000008: according to the conditions and procedures prescribed by law.
p.000008:
p.000008: Article 32 – Sanctions
p.000008:
p.000008: Parties shall provide for appropriate sanctions to be applied in the event of infringement of the provisions contained
p.000008: in this Protocol.
p.000008:
p.000008: CHAPTER XI – Relation between this Protocol and other provisions and re-examination of the Protocol
p.000008:
p.000008: Article 33 – Relation between this Protocol and the Convention
p.000008:
p.000008: As between the Parties, the provisions of Articles 1 to 32 of this Protocol shall be regarded as additional articles
p.000008: to the Convention, and all the provisions of the Convention shall apply accordingly.
p.000008:
p.000008: Article 34 – Wider protection
p.000008:
p.000008: None of the provisions of this Protocol shall be interpreted as limiting or otherwise affecting the possibility for a
p.000008: Party to grant research participants a wider measure of protection than is stipulated in this Protocol.
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000009:
p.000009:
p.000009: Article 35 – Re-examination of the Protocol
p.000009:
p.000009: In order to monitor scientific developments, the present Protocol shall be examined within the Committee referred to in
p.000009: Article 32 of the Convention no later than five years from the entry into force of this Protocol and thereafter at such
p.000009: intervals as the Committee may determine.
p.000009:
p.000009: CHAPTER XII – Final clauses
p.000009:
p.000009: Article 36 – Signature and ratification
p.000009:
p.000009: This Protocol shall be open for signature by Signatories to the Convention. It is subject to ratification,
p.000009: acceptance or approval. A Signatory may not ratify, accept or approve this Protocol unless it has
p.000009: previously or simultaneously ratified, accepted or approved the Convention. Instruments of ratification,
p.000009: acceptance or approval shall be deposited with the Secretary General of the Council of Europe.
p.000009:
p.000009: Article 37 – Entry into force
p.000009:
p.000009: 1 This Protocol shall enter into force on the first day of the month following the expiration of a period of
p.000009: three months after the date on which five States, including at least four member States of the Council of
p.000009: Europe, have expressed their consent to be bound by the Protocol in accordance with the provisions of Article 36.
p.000009:
p.000009: 2 In respect of any Signatory which subsequently expresses its consent to be bound by it, the Protocol shall
p.000009: enter into force on the first day of the month following the expiration of a period of three months after the date of
p.000009: the deposit of the instrument of ratification, acceptance or approval.
p.000009:
p.000009: Article 38 – Accession
p.000009:
p.000009: 1 After the entry into force of this Protocol, any State which has acceded to the Convention may also accede to
p.000009: this Protocol.
p.000009:
p.000009: 2 Accession shall be effected by the deposit with the Secretary General of the Council of Europe
p.000009: of an instrument of accession which shall take effect on the first day of the month following the
p.000009: expiration of a period of three months after the date of its deposit.
p.000009:
p.000009: Article 39 – Denunciation
p.000009:
p.000009: 1 Any Party may at any time denounce this Protocol by means of a notification addressed to the Secretary General
p.000009: of the Council of Europe.
p.000009:
p.000009: 2 Such denunciation shall become effective on the first day of the month following the expiration of a period
p.000009: of three months after the date of receipt of such notification by the Secretary General.
p.000009:
p.000009: Article 40 – Notifications
p.000009:
p.000009: The Secretary General of the Council of Europe shall notify the member States of the Council of Europe, the European
p.000009: Community, any Signatory, any Party and any other State which has been invited to accede to the Protocol of:
p.000009:
p.000009: a any signature;
p.000009:
p.000009: b the deposit of any instrument of ratification, acceptance, approval or accession;
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000010:
p.000010:
p.000010: c any date of entry into force of this Protocol in accordance with Articles 37 and 38;
p.000010:
p.000010: d any other act, notification or communication relating to this Protocol.
p.000010:
p.000010:
p.000010:
p.000010: In witness whereof the undersigned, being duly authorised thereto, have signed this Protocol.
p.000010:
p.000010: Done at Strasbourg, this 25th day of January 2005, in English and in French, both texts being equally authentic, in a
p.000010: single copy which shall be deposited in the archives of the Council of Europe. The Secretary General of the Council of
p.000010: Europe shall transmit certified copies to each member State of the Council of Europe, to the non-member States which
p.000010: have participated in the elaboration of this Protocol, to any State invited to accede to the Convention and to the
p.000010: European Community.
p.000010:
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Political / vulnerable
Searching for indicator vulnerable:
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p.000002: of the methods by which this aim is pursued is the maintenance and further realisation of human rights and fundamental
p.000002: freedoms;
p.000002:
p.000002: Considering that the aim of the Convention, as defined in Article 1, is to protect the dignity and identity of all
p.000002: human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and
p.000002: fundamental freedoms with regard to the application of biology and medicine;
p.000002:
p.000002: Considering that progress in medical and biological sciences, in particular advances obtained through biomedical
p.000002: research, contributes to saving lives and improving quality of life;
p.000002:
p.000002: Conscious of the fact that the advancement of biomedical science and practice is dependent on knowledge and discovery
p.000002: which necessitates research on human beings;
p.000002:
p.000002: Stressing that such research is often transdisciplinary and international;
p.000002:
p.000002: Taking into account national and international professional standards in the field of biomedical research and the
p.000002: previous work of the Committee of Ministers and the Parliamentary Assembly of the Council of Europe in this
p.000002: field;
p.000002:
p.000002: Convinced that biomedical research that is contrary to human dignity and human rights should never be carried out;
p.000002:
p.000002: Stressing the paramount concern to be the protection of the human being participating in research;
p.000002:
p.000002: Affirming that particular protection shall be given to human beings who may be vulnerable in the context of research;
p.000002:
p.000002:
p.000002:
p.000002: (*) The Treaty of Lisbon amending the Treaty on European Union and the Treaty establishing the European Community
p.000002: entered into force on 1 December 2009. As a consequence, as from that date, any reference to the European
p.000002: Economic Community shall be read as the European Union.
p.000002:
p.000002: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000002:
p.000002:
p.000002: Recognising that every person has a right to accept or refuse to undergo biomedical research and that no one should be
p.000002: forced to undergo such research;
p.000002:
p.000002: Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and
p.000002: freedoms of the individual with regard to biomedical research,
p.000002:
p.000002: Have agreed as follows:
p.000002:
p.000002: CHAPTER I – Object and scope Article 1 – Object and purpose
p.000002: Parties to this Protocol shall protect the dignity and identity of all human beings and guarantee everyone, without
p.000002: discrimination, respect for their integrity and other rights and fundamental freedoms with regard to any research
p.000002: involving interventions on human beings in the field of biomedicine.
p.000002:
p.000002: Article 2 – Scope
p.000002:
p.000002: 1 This Protocol covers the full range of research activities in the health field involving
p.000002: interventions on human beings.
p.000002:
p.000002: 2 This Protocol does not apply to research on embryos in vitro. It does apply to research on foetuses and
p.000002: embryos in vivo.
...
p.000002:
p.000002: Article 10 – Independence of the ethics committee
p.000002:
p.000002: 1 Parties to this Protocol shall take measures to assure the independence of the ethics committee.
p.000002: That body shall not be subject to undue external influences.
p.000002:
p.000002: 2 Members of the ethics committee shall declare all circumstances that might lead to a conflict of interest.
p.000002: Should such conflicts arise, those involved shall not participate in that review.
p.000002:
p.000002: Article 11 – Information for the ethics committee
p.000002:
p.000002: 1 All information which is necessary for the ethical assessment of the research project shall be given in
p.000002: written form to the ethics committee.
p.000002:
p.000002: 2 In particular, information on items contained in the appendix to this Protocol shall be provided, in so far
p.000002: as it is relevant for the research project. The appendix may be amended by the Committee set up by
p.000002: Article 32 of the Convention by a two-thirds majority of the votes cast.
p.000002:
p.000002: Article 12 – UndueXinfluence
p.000002:
p.000002: The ethics committee must be satisfied that no undue influence, including that of a financial nature, will be
p.000002: exerted on persons to participate in research. In this respect, particular attention must be given to
p.000002: vulnerable or dependent persons.
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000003:
p.000003:
p.000003: CHAPTER IV – Information and consent
p.000003:
p.000003: Article 13 – Information for research participants
p.000003:
p.000003: 1 The persons being asked to participate in a research project shall be given adequate information
p.000003: in a comprehensible form. This information shall be documented.
p.000003:
p.000003: 2 The information shall cover the purpose, the overall plan and the possible risks and benefits of the research
p.000003: project, and include the opinion of the ethics committee. Before being asked to consent to participate in a
p.000003: research project, the persons concerned shall be specifically informed, according to the nature and purpose of
p.000003: the research:
p.000003:
p.000003: i of the nature, extent and duration of the procedures involved, in particular, details of any burden imposed
p.000003: by the research project;
p.000003:
p.000003: ii of available preventive, diagnostic and therapeutic procedures;
p.000003:
p.000003: iii of the arrangements for responding to adverse events or the concerns of research participants;
p.000003:
p.000003: iv of arrangements to ensure respect for private life and ensure the confidentiality of personal
p.000003: data;
p.000003:
...
Health / Pregnant
Searching for indicator pregnant:
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p.000004: or to withdraw authorisation at any time, without the person concerned being subject to any form of discrimination, in
p.000004: particular
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000005:
p.000005:
p.000005: regarding the right to medical care. They shall be specifically informed according to the nature and purpose of the
p.000005: research of the items of information listed in Article 13.
p.000005:
p.000005: 3 The information shall also be provided to the individual concerned, unless this person is not in a state to
p.000005: receive the information.
p.000005:
p.000005: Article 17 – Research with minimal risk and minimal burden
p.000005:
p.000005: 1 For the purposes of this Protocol it is deemed that the research bears a minimal risk if, having regard to the
p.000005: nature and scale of the intervention, it is to be expected that it will result, at the most, in a very slight and
p.000005: temporary negative impact on the health of the person concerned.
p.000005:
p.000005: 2 It is deemed that it bears a minimal burden if it is to be expected that the discomfort will be, at the most,
p.000005: temporary and very slight for the person concerned. In assessing the burden for an individual, a person enjoying the
p.000005: special confidence of the person concerned shall assess the burden where appropriate.
p.000005:
p.000005: CHAPTER VI – Specific situations
p.000005:
p.000005: Article 18 – Research during pregnancy or breastfeeding
p.000005:
p.000005: 1 Research on a pregnant woman which does not have the potential to produce results of direct benefit to her
p.000005: health, or to that of her embryo, foetus or child after birth, may only be undertaken if the following
p.000005: additional conditions are met:
p.000005:
p.000005: i the research has the aim of contributing to the ultimate attainment of results capable of conferring benefit
p.000005: to other women in relation to reproduction or to other embryos, foetuses or children;
p.000005:
p.000005: ii research of comparable effectiveness cannot be carried out on women who are not pregnant;
p.000005:
p.000005: iii the research entails only minimal risk and minimal burden.
p.000005:
p.000005: 2 Where research is undertaken on a breastfeeding woman, particular care shall be taken to avoid any adverse
p.000005: impact on the health of the child.
p.000005:
p.000005: Article 19 – Research on persons in emergency clinical situations
p.000005:
p.000005: 1 The law shall determine whether, and under which protective additional conditions, research in emergency
p.000005: situations may take place when:
p.000005:
p.000005: i a person is not in a state to give consent, and
p.000005:
p.000005: ii because of the urgency of the situation, it is impossible to obtain in a sufficiently timely manner,
p.000005: authorisation from his or her representative or an authority or a person or body which would in the absence of
p.000005: an emergency situation be called upon to give authorisation.
p.000005:
p.000005: 2 The law shall include the following specific conditions:
p.000005:
p.000005: i research of comparable effectiveness cannot be carried out on persons in non- emergency
p.000005: situations;
p.000005:
p.000005: ii the research project may only be undertaken if it has been approved specifically for emergency
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Health / breastfeeding
Searching for indicator breastfeeding:
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p.000004: or to withdraw authorisation at any time, without the person concerned being subject to any form of discrimination, in
p.000004: particular
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000005:
p.000005:
p.000005: regarding the right to medical care. They shall be specifically informed according to the nature and purpose of the
p.000005: research of the items of information listed in Article 13.
p.000005:
p.000005: 3 The information shall also be provided to the individual concerned, unless this person is not in a state to
p.000005: receive the information.
p.000005:
p.000005: Article 17 – Research with minimal risk and minimal burden
p.000005:
p.000005: 1 For the purposes of this Protocol it is deemed that the research bears a minimal risk if, having regard to the
p.000005: nature and scale of the intervention, it is to be expected that it will result, at the most, in a very slight and
p.000005: temporary negative impact on the health of the person concerned.
p.000005:
p.000005: 2 It is deemed that it bears a minimal burden if it is to be expected that the discomfort will be, at the most,
p.000005: temporary and very slight for the person concerned. In assessing the burden for an individual, a person enjoying the
p.000005: special confidence of the person concerned shall assess the burden where appropriate.
p.000005:
p.000005: CHAPTER VI – Specific situations
p.000005:
p.000005: Article 18 – Research during pregnancy or breastfeeding
p.000005:
p.000005: 1 Research on a pregnant woman which does not have the potential to produce results of direct benefit to her
p.000005: health, or to that of her embryo, foetus or child after birth, may only be undertaken if the following
p.000005: additional conditions are met:
p.000005:
p.000005: i the research has the aim of contributing to the ultimate attainment of results capable of conferring benefit
p.000005: to other women in relation to reproduction or to other embryos, foetuses or children;
p.000005:
p.000005: ii research of comparable effectiveness cannot be carried out on women who are not pregnant;
p.000005:
p.000005: iii the research entails only minimal risk and minimal burden.
p.000005:
p.000005: 2 Where research is undertaken on a breastfeeding woman, particular care shall be taken to avoid any adverse
p.000005: impact on the health of the child.
p.000005:
p.000005: Article 19 – Research on persons in emergency clinical situations
p.000005:
p.000005: 1 The law shall determine whether, and under which protective additional conditions, research in emergency
p.000005: situations may take place when:
p.000005:
p.000005: i a person is not in a state to give consent, and
p.000005:
p.000005: ii because of the urgency of the situation, it is impossible to obtain in a sufficiently timely manner,
p.000005: authorisation from his or her representative or an authority or a person or body which would in the absence of
p.000005: an emergency situation be called upon to give authorisation.
p.000005:
p.000005: 2 The law shall include the following specific conditions:
p.000005:
p.000005: i research of comparable effectiveness cannot be carried out on persons in non- emergency
p.000005: situations;
p.000005:
p.000005: ii the research project may only be undertaken if it has been approved specifically for emergency
p.000005: situations by the competent body;
p.000005:
p.000006: 6
p.000006:
p.000006: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000006:
p.000006:
p.000006: iii any relevant previously expressed objections of the person known to the researcher shall be respected;
p.000006:
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Social / Access to Social Goods
Searching for indicator access:
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p.000002: vulnerable or dependent persons.
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000003:
p.000003:
p.000003: CHAPTER IV – Information and consent
p.000003:
p.000003: Article 13 – Information for research participants
p.000003:
p.000003: 1 The persons being asked to participate in a research project shall be given adequate information
p.000003: in a comprehensible form. This information shall be documented.
p.000003:
p.000003: 2 The information shall cover the purpose, the overall plan and the possible risks and benefits of the research
p.000003: project, and include the opinion of the ethics committee. Before being asked to consent to participate in a
p.000003: research project, the persons concerned shall be specifically informed, according to the nature and purpose of
p.000003: the research:
p.000003:
p.000003: i of the nature, extent and duration of the procedures involved, in particular, details of any burden imposed
p.000003: by the research project;
p.000003:
p.000003: ii of available preventive, diagnostic and therapeutic procedures;
p.000003:
p.000003: iii of the arrangements for responding to adverse events or the concerns of research participants;
p.000003:
p.000003: iv of arrangements to ensure respect for private life and ensure the confidentiality of personal
p.000003: data;
p.000003:
p.000003: v of arrangements for access to information relevant to the participant arising from the research
p.000003: and to its overall results;
p.000003:
p.000003: vi of the arrangements for fair compensation in the case of damage;
p.000003:
p.000003: vii of any foreseen potential further uses, including commercial uses, of the research results, data or
p.000003: biological materials;
p.000003:
p.000003: viii of the source of funding of the research project.
p.000003:
p.000003: 3 In addition, the persons being asked to participate in a research project shall be informed of the rights and
p.000003: safeguards prescribed by law for their protection, and specifically of their right to refuse consent or to
p.000003: withdraw consent at any time without being subject to any form of discrimination, in particular regarding the
p.000003: right to medical care.
p.000003:
p.000003: Article 14 – Consent
p.000003:
p.000003: 1 No research on a person may be carried out, subject to the provisions of both Chapter V and Article 19,
p.000003: without the informed, free, express, specific and documented consent of the person. Such consent may be
p.000003: freely withdrawn by the person at any phase of the research.
p.000003:
p.000003: 2 Refusal to give consent or the withdrawal of consent to participation in research shall not lead to any form
...
Social / Age
Searching for indicator age:
(return to top)
p.000004: consent to research
p.000004: 1 Research on a person without the capacity to consent to research may be undertaken only if all the following
p.000004: specific conditions are met:
p.000004:
p.000004: i the results of the research have the potential to produce real and direct benefit to his or her health;
p.000004:
p.000004: ii research of comparable effectiveness cannot be carried out on individuals capable of giving
p.000004: consent;
p.000004:
p.000004: iii the person undergoing research has been informed of his or her rights and the safeguards
p.000004: prescribed by law for his or her protection, unless this person is not in a state to receive the information;
p.000004:
p.000004: iv the necessary authorisation has been given specifically and in writing by the legal representative
p.000004: or an authority, person or body provided for by law, and after having received the information required
p.000004: by Article 16, taking into account the person’s previously expressed wishes or objections. An adult not able to
p.000004: consent shall as far as possible take part in the authorisation procedure. The opinion of a minor shall be taken into
p.000004: consideration as an increasingly determining factor in proportion to age and degree of maturity;
p.000004:
p.000004: v the person concerned does not object.
p.000004:
p.000004: 2 Exceptionally and under the protective conditions prescribed by law, where the research has not the potential
p.000004: to produce results of direct benefit to the health of the person concerned, such research may be authorised
p.000004: subject to the conditions laid down in paragraph 1, sub- paragraphs ii, iii, iv, and v above, and to the
p.000004: following additional conditions:
p.000004:
p.000004: i the research has the aim of contributing, through significant improvement in the scientific understanding of
p.000004: the individual's condition, disease or disorder, to the ultimate attainment of results capable of conferring benefit to
p.000004: the person concerned or to other persons in the same age category or afflicted with the same disease or
p.000004: disorder or having the same condition;
p.000004:
p.000004: ii the research entails only minimal risk and minimal burden for the individual concerned; and any consideration
p.000004: of additional potential benefits of the research shall not be used to justify an increased level of risk or burden.
p.000004:
p.000004: 3 Objection to participation, refusal to give authorisation or the withdrawal of authorisation to
p.000004: participate in research shall not lead to any form of discrimination against the person concerned, in
p.000004: particular regarding the right to medical care.
p.000004:
p.000004: Article 16 – Information prior to authorisation
p.000004:
p.000004: 1 Those being asked to authorise participation of a person in a research project shall be given adequate
p.000004: information in a comprehensible form. This information shall be documented.
p.000004:
p.000004: 2 The information shall cover the purpose, the overall plan and the possible risks and benefits of the research
p.000004: project, and include the opinion of the ethics committee. They shall further be informed of the rights and safeguards
p.000004: prescribed by law for the protection of those not able to consent to research and specifically of the right to refuse
p.000004: or to withdraw authorisation at any time, without the person concerned being subject to any form of discrimination, in
p.000004: particular
p.000004:
p.000004:
p.000005: 5
p.000005:
...
Social / Child
Searching for indicator child:
(return to top)
p.000005:
p.000005:
p.000005: regarding the right to medical care. They shall be specifically informed according to the nature and purpose of the
p.000005: research of the items of information listed in Article 13.
p.000005:
p.000005: 3 The information shall also be provided to the individual concerned, unless this person is not in a state to
p.000005: receive the information.
p.000005:
p.000005: Article 17 – Research with minimal risk and minimal burden
p.000005:
p.000005: 1 For the purposes of this Protocol it is deemed that the research bears a minimal risk if, having regard to the
p.000005: nature and scale of the intervention, it is to be expected that it will result, at the most, in a very slight and
p.000005: temporary negative impact on the health of the person concerned.
p.000005:
p.000005: 2 It is deemed that it bears a minimal burden if it is to be expected that the discomfort will be, at the most,
p.000005: temporary and very slight for the person concerned. In assessing the burden for an individual, a person enjoying the
p.000005: special confidence of the person concerned shall assess the burden where appropriate.
p.000005:
p.000005: CHAPTER VI – Specific situations
p.000005:
p.000005: Article 18 – Research during pregnancy or breastfeeding
p.000005:
p.000005: 1 Research on a pregnant woman which does not have the potential to produce results of direct benefit to her
p.000005: health, or to that of her embryo, foetus or child after birth, may only be undertaken if the following
p.000005: additional conditions are met:
p.000005:
p.000005: i the research has the aim of contributing to the ultimate attainment of results capable of conferring benefit
p.000005: to other women in relation to reproduction or to other embryos, foetuses or children;
p.000005:
p.000005: ii research of comparable effectiveness cannot be carried out on women who are not pregnant;
p.000005:
p.000005: iii the research entails only minimal risk and minimal burden.
p.000005:
p.000005: 2 Where research is undertaken on a breastfeeding woman, particular care shall be taken to avoid any adverse
p.000005: impact on the health of the child.
p.000005:
p.000005: Article 19 – Research on persons in emergency clinical situations
p.000005:
p.000005: 1 The law shall determine whether, and under which protective additional conditions, research in emergency
p.000005: situations may take place when:
p.000005:
p.000005: i a person is not in a state to give consent, and
p.000005:
p.000005: ii because of the urgency of the situation, it is impossible to obtain in a sufficiently timely manner,
p.000005: authorisation from his or her representative or an authority or a person or body which would in the absence of
p.000005: an emergency situation be called upon to give authorisation.
p.000005:
p.000005: 2 The law shall include the following specific conditions:
p.000005:
p.000005: i research of comparable effectiveness cannot be carried out on persons in non- emergency
p.000005: situations;
p.000005:
p.000005: ii the research project may only be undertaken if it has been approved specifically for emergency
p.000005: situations by the competent body;
p.000005:
p.000006: 6
p.000006:
p.000006: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000006:
p.000006:
p.000006: iii any relevant previously expressed objections of the person known to the researcher shall be respected;
p.000006:
p.000006: iv where the research has not the potential to produce results of direct benefit to the health of the person
...
p.000006: liberty;
p.000006:
p.000006: ii the research has the aim of contributing to the ultimate attainment of results capable of conferring benefit
p.000006: to persons deprived of liberty;
p.000006:
p.000006: iii the research entails only minimal risk and minimal burden.
p.000006:
p.000006: CHAPTER VII – Safety and supervision
p.000006:
p.000006: Article 21 – Minimisation of risk and burden
p.000006:
p.000006: 1 All reasonable measures shall be taken to ensure safety and to minimise risk and burden for the research
p.000006: participants.
p.000006:
p.000006: 2 Research may only be carried out under the supervision of a clinical professional who possesses
p.000006: the necessary qualifications and experience.
p.000006:
p.000006: Article 22 – Assessment of health status
p.000006:
p.000006: 1 The researcher shall take all necessary steps to assess the state of health of human beings prior to their
p.000006: inclusion in research, to ensure that those at increased risk in relation to participation in a specific
p.000006: project be excluded.
p.000006:
p.000006: 2 Where research is undertaken on persons in the reproductive stage of their lives, particular consideration
p.000006: shall be given to the possible adverse impact on a current or future pregnancy and the health of an embryo, foetus or
p.000006: child.
p.000006:
p.000006: Article 23 – Non-interference with necessary clinical interventions
p.000006:
p.000006: 1 Research shall not delay nor deprive participants of medically necessary preventive,
p.000006: diagnostic or therapeutic procedures.
p.000006:
p.000006: 2 In research associated with prevention, diagnosis or treatment, participants assigned to control
p.000006: groups shall be assured of proven methods of prevention, diagnosis or treatment.
p.000006:
p.000007: 7
p.000007:
p.000007: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000007:
p.000007:
p.000007: 3 The use of placebo is permissible where there are no methods of proven effectiveness, or where withdrawal
p.000007: or withholding of such methods does not present an unacceptable risk or burden.
p.000007:
p.000007: Article 24 – New developments
p.000007:
p.000007: 1 Parties to this Protocol shall take measures to ensure that the research project is re-examined if this is
p.000007: justified in the light of scientific developments or events arising in the course of the research.
p.000007:
p.000007: 2 The purpose of the re-examination is to establish whether:
p.000007:
p.000007: i the research needs to be discontinued or if changes to the research project are necessary for
p.000007: the research to continue;
p.000007:
p.000007: ii research participants, or if applicable their representatives, need to be informed of the developments or
p.000007: events;
p.000007:
p.000007: iii additional consent or authorisation for participation is required.
p.000007:
...
Searching for indicator children:
(return to top)
p.000005:
p.000005: 1 For the purposes of this Protocol it is deemed that the research bears a minimal risk if, having regard to the
p.000005: nature and scale of the intervention, it is to be expected that it will result, at the most, in a very slight and
p.000005: temporary negative impact on the health of the person concerned.
p.000005:
p.000005: 2 It is deemed that it bears a minimal burden if it is to be expected that the discomfort will be, at the most,
p.000005: temporary and very slight for the person concerned. In assessing the burden for an individual, a person enjoying the
p.000005: special confidence of the person concerned shall assess the burden where appropriate.
p.000005:
p.000005: CHAPTER VI – Specific situations
p.000005:
p.000005: Article 18 – Research during pregnancy or breastfeeding
p.000005:
p.000005: 1 Research on a pregnant woman which does not have the potential to produce results of direct benefit to her
p.000005: health, or to that of her embryo, foetus or child after birth, may only be undertaken if the following
p.000005: additional conditions are met:
p.000005:
p.000005: i the research has the aim of contributing to the ultimate attainment of results capable of conferring benefit
p.000005: to other women in relation to reproduction or to other embryos, foetuses or children;
p.000005:
p.000005: ii research of comparable effectiveness cannot be carried out on women who are not pregnant;
p.000005:
p.000005: iii the research entails only minimal risk and minimal burden.
p.000005:
p.000005: 2 Where research is undertaken on a breastfeeding woman, particular care shall be taken to avoid any adverse
p.000005: impact on the health of the child.
p.000005:
p.000005: Article 19 – Research on persons in emergency clinical situations
p.000005:
p.000005: 1 The law shall determine whether, and under which protective additional conditions, research in emergency
p.000005: situations may take place when:
p.000005:
p.000005: i a person is not in a state to give consent, and
p.000005:
p.000005: ii because of the urgency of the situation, it is impossible to obtain in a sufficiently timely manner,
p.000005: authorisation from his or her representative or an authority or a person or body which would in the absence of
p.000005: an emergency situation be called upon to give authorisation.
p.000005:
p.000005: 2 The law shall include the following specific conditions:
p.000005:
...
Social / Fetus/Neonate
Searching for indicator foetus:
(return to top)
p.000004:
p.000005: 5
p.000005:
p.000005: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000005:
p.000005:
p.000005: regarding the right to medical care. They shall be specifically informed according to the nature and purpose of the
p.000005: research of the items of information listed in Article 13.
p.000005:
p.000005: 3 The information shall also be provided to the individual concerned, unless this person is not in a state to
p.000005: receive the information.
p.000005:
p.000005: Article 17 – Research with minimal risk and minimal burden
p.000005:
p.000005: 1 For the purposes of this Protocol it is deemed that the research bears a minimal risk if, having regard to the
p.000005: nature and scale of the intervention, it is to be expected that it will result, at the most, in a very slight and
p.000005: temporary negative impact on the health of the person concerned.
p.000005:
p.000005: 2 It is deemed that it bears a minimal burden if it is to be expected that the discomfort will be, at the most,
p.000005: temporary and very slight for the person concerned. In assessing the burden for an individual, a person enjoying the
p.000005: special confidence of the person concerned shall assess the burden where appropriate.
p.000005:
p.000005: CHAPTER VI – Specific situations
p.000005:
p.000005: Article 18 – Research during pregnancy or breastfeeding
p.000005:
p.000005: 1 Research on a pregnant woman which does not have the potential to produce results of direct benefit to her
p.000005: health, or to that of her embryo, foetus or child after birth, may only be undertaken if the following
p.000005: additional conditions are met:
p.000005:
p.000005: i the research has the aim of contributing to the ultimate attainment of results capable of conferring benefit
p.000005: to other women in relation to reproduction or to other embryos, foetuses or children;
p.000005:
p.000005: ii research of comparable effectiveness cannot be carried out on women who are not pregnant;
p.000005:
p.000005: iii the research entails only minimal risk and minimal burden.
p.000005:
p.000005: 2 Where research is undertaken on a breastfeeding woman, particular care shall be taken to avoid any adverse
p.000005: impact on the health of the child.
p.000005:
p.000005: Article 19 – Research on persons in emergency clinical situations
p.000005:
p.000005: 1 The law shall determine whether, and under which protective additional conditions, research in emergency
p.000005: situations may take place when:
p.000005:
p.000005: i a person is not in a state to give consent, and
p.000005:
...
p.000006: liberty;
p.000006:
p.000006: ii the research has the aim of contributing to the ultimate attainment of results capable of conferring benefit
p.000006: to persons deprived of liberty;
p.000006:
p.000006: iii the research entails only minimal risk and minimal burden.
p.000006:
p.000006: CHAPTER VII – Safety and supervision
p.000006:
p.000006: Article 21 – Minimisation of risk and burden
p.000006:
p.000006: 1 All reasonable measures shall be taken to ensure safety and to minimise risk and burden for the research
p.000006: participants.
p.000006:
p.000006: 2 Research may only be carried out under the supervision of a clinical professional who possesses
p.000006: the necessary qualifications and experience.
p.000006:
p.000006: Article 22 – Assessment of health status
p.000006:
p.000006: 1 The researcher shall take all necessary steps to assess the state of health of human beings prior to their
p.000006: inclusion in research, to ensure that those at increased risk in relation to participation in a specific
p.000006: project be excluded.
p.000006:
p.000006: 2 Where research is undertaken on persons in the reproductive stage of their lives, particular consideration
p.000006: shall be given to the possible adverse impact on a current or future pregnancy and the health of an embryo, foetus or
p.000006: child.
p.000006:
p.000006: Article 23 – Non-interference with necessary clinical interventions
p.000006:
p.000006: 1 Research shall not delay nor deprive participants of medically necessary preventive,
p.000006: diagnostic or therapeutic procedures.
p.000006:
p.000006: 2 In research associated with prevention, diagnosis or treatment, participants assigned to control
p.000006: groups shall be assured of proven methods of prevention, diagnosis or treatment.
p.000006:
p.000007: 7
p.000007:
p.000007: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000007:
p.000007:
p.000007: 3 The use of placebo is permissible where there are no methods of proven effectiveness, or where withdrawal
p.000007: or withholding of such methods does not present an unacceptable risk or burden.
p.000007:
p.000007: Article 24 – New developments
p.000007:
p.000007: 1 Parties to this Protocol shall take measures to ensure that the research project is re-examined if this is
p.000007: justified in the light of scientific developments or events arising in the course of the research.
p.000007:
p.000007: 2 The purpose of the re-examination is to establish whether:
p.000007:
p.000007: i the research needs to be discontinued or if changes to the research project are necessary for
p.000007: the research to continue;
p.000007:
p.000007: ii research participants, or if applicable their representatives, need to be informed of the developments or
p.000007: events;
p.000007:
p.000007: iii additional consent or authorisation for participation is required.
p.000007:
...
Searching for indicator foetuses:
(return to top)
p.000002:
p.000002:
p.000002:
p.000002: (*) The Treaty of Lisbon amending the Treaty on European Union and the Treaty establishing the European Community
p.000002: entered into force on 1 December 2009. As a consequence, as from that date, any reference to the European
p.000002: Economic Community shall be read as the European Union.
p.000002:
p.000002: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000002:
p.000002:
p.000002: Recognising that every person has a right to accept or refuse to undergo biomedical research and that no one should be
p.000002: forced to undergo such research;
p.000002:
p.000002: Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and
p.000002: freedoms of the individual with regard to biomedical research,
p.000002:
p.000002: Have agreed as follows:
p.000002:
p.000002: CHAPTER I – Object and scope Article 1 – Object and purpose
p.000002: Parties to this Protocol shall protect the dignity and identity of all human beings and guarantee everyone, without
p.000002: discrimination, respect for their integrity and other rights and fundamental freedoms with regard to any research
p.000002: involving interventions on human beings in the field of biomedicine.
p.000002:
p.000002: Article 2 – Scope
p.000002:
p.000002: 1 This Protocol covers the full range of research activities in the health field involving
p.000002: interventions on human beings.
p.000002:
p.000002: 2 This Protocol does not apply to research on embryos in vitro. It does apply to research on foetuses and
p.000002: embryos in vivo.
p.000002:
p.000002: 3 For the purposes of this Protocol, the term “intervention” includes:
p.000002:
p.000002: i a physical intervention, and
p.000002:
p.000002: ii any other intervention in so far as it involves a risk to the psychological health of the person
p.000002: concerned.
p.000002:
p.000002: CHAPTER II – General provisions
p.000002:
p.000002: Article 3 – Primacy of the human being
p.000002:
p.000002: The interests and welfare of the human being participating in research shall prevail over the sole interest of society
p.000002: or science.
p.000002:
p.000002: Article 4 – General rule
p.000002:
p.000002: Research shall be carried out freely, subject to the provisions of this Protocol and the other legal provisions
p.000002: ensuring the protection of the human being.
p.000002:
p.000002: Article 5 – Absence of alternatives
p.000002:
p.000002: Research on human beings may only be undertaken if there is no alternative of comparable effectiveness.
p.000002:
p.000002: Article 6 – Risks and benefits
p.000002:
p.000002: 1 Research shall not involve risks and burdens to the human being disproportionate to its potential
p.000002: benefits.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 2
p.000002:
p.000002: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000002:
p.000002:
p.000002: 2 In addition, where the research does not have the potential to produce results of direct benefit to the
p.000002: health of the research participant, such research may only be undertaken if the research entails no more
...
p.000005:
p.000005: 1 For the purposes of this Protocol it is deemed that the research bears a minimal risk if, having regard to the
p.000005: nature and scale of the intervention, it is to be expected that it will result, at the most, in a very slight and
p.000005: temporary negative impact on the health of the person concerned.
p.000005:
p.000005: 2 It is deemed that it bears a minimal burden if it is to be expected that the discomfort will be, at the most,
p.000005: temporary and very slight for the person concerned. In assessing the burden for an individual, a person enjoying the
p.000005: special confidence of the person concerned shall assess the burden where appropriate.
p.000005:
p.000005: CHAPTER VI – Specific situations
p.000005:
p.000005: Article 18 – Research during pregnancy or breastfeeding
p.000005:
p.000005: 1 Research on a pregnant woman which does not have the potential to produce results of direct benefit to her
p.000005: health, or to that of her embryo, foetus or child after birth, may only be undertaken if the following
p.000005: additional conditions are met:
p.000005:
p.000005: i the research has the aim of contributing to the ultimate attainment of results capable of conferring benefit
p.000005: to other women in relation to reproduction or to other embryos, foetuses or children;
p.000005:
p.000005: ii research of comparable effectiveness cannot be carried out on women who are not pregnant;
p.000005:
p.000005: iii the research entails only minimal risk and minimal burden.
p.000005:
p.000005: 2 Where research is undertaken on a breastfeeding woman, particular care shall be taken to avoid any adverse
p.000005: impact on the health of the child.
p.000005:
p.000005: Article 19 – Research on persons in emergency clinical situations
p.000005:
p.000005: 1 The law shall determine whether, and under which protective additional conditions, research in emergency
p.000005: situations may take place when:
p.000005:
p.000005: i a person is not in a state to give consent, and
p.000005:
p.000005: ii because of the urgency of the situation, it is impossible to obtain in a sufficiently timely manner,
p.000005: authorisation from his or her representative or an authority or a person or body which would in the absence of
p.000005: an emergency situation be called upon to give authorisation.
p.000005:
p.000005: 2 The law shall include the following specific conditions:
p.000005:
...
Social / Incarcerated
Searching for indicator liberty:
(return to top)
p.000005: situations;
p.000005:
p.000005: ii the research project may only be undertaken if it has been approved specifically for emergency
p.000005: situations by the competent body;
p.000005:
p.000006: 6
p.000006:
p.000006: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000006:
p.000006:
p.000006: iii any relevant previously expressed objections of the person known to the researcher shall be respected;
p.000006:
p.000006: iv where the research has not the potential to produce results of direct benefit to the health of the person
p.000006: concerned, it has the aim of contributing, through significant improvement in the scientific understanding of the
p.000006: individual's condition, disease or disorder, to the ultimate attainment of results capable of conferring benefit
p.000006: to the person concerned or to other persons in the same category or afflicted with the same disease or
p.000006: disorder or having the same condition, and entails only minimal risk and minimal burden.
p.000006:
p.000006: 3 Persons participating in the emergency research project or, if applicable, their representatives shall be
p.000006: provided with all the relevant information concerning their participation in the research project as soon as
p.000006: possible. Consent or authorisation for continued participation shall be requested as soon as reasonably
p.000006: possible.
p.000006:
p.000006: Article 20 – Research on persons deprived of liberty
p.000006:
p.000006: Where the law allows research on persons deprived of liberty, such persons may participate in a research project in
p.000006: which the results do not have the potential to produce direct benefit to their health only if the following additional
p.000006: conditions are met:
p.000006:
p.000006: i research of comparable effectiveness cannot be carried out without the participation of persons deprived of
p.000006: liberty;
p.000006:
p.000006: ii the research has the aim of contributing to the ultimate attainment of results capable of conferring benefit
p.000006: to persons deprived of liberty;
p.000006:
p.000006: iii the research entails only minimal risk and minimal burden.
p.000006:
p.000006: CHAPTER VII – Safety and supervision
p.000006:
p.000006: Article 21 – Minimisation of risk and burden
p.000006:
p.000006: 1 All reasonable measures shall be taken to ensure safety and to minimise risk and burden for the research
p.000006: participants.
p.000006:
p.000006: 2 Research may only be carried out under the supervision of a clinical professional who possesses
p.000006: the necessary qualifications and experience.
p.000006:
p.000006: Article 22 – Assessment of health status
p.000006:
p.000006: 1 The researcher shall take all necessary steps to assess the state of health of human beings prior to their
p.000006: inclusion in research, to ensure that those at increased risk in relation to participation in a specific
p.000006: project be excluded.
p.000006:
p.000006: 2 Where research is undertaken on persons in the reproductive stage of their lives, particular consideration
p.000006: shall be given to the possible adverse impact on a current or future pregnancy and the health of an embryo, foetus or
p.000006: child.
p.000006:
p.000006: Article 23 – Non-interference with necessary clinical interventions
p.000006:
p.000006: 1 Research shall not delay nor deprive participants of medically necessary preventive,
p.000006: diagnostic or therapeutic procedures.
p.000006:
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.000009: expiration of a period of three months after the date of its deposit.
p.000009:
p.000009: Article 39 – Denunciation
p.000009:
p.000009: 1 Any Party may at any time denounce this Protocol by means of a notification addressed to the Secretary General
p.000009: of the Council of Europe.
p.000009:
p.000009: 2 Such denunciation shall become effective on the first day of the month following the expiration of a period
p.000009: of three months after the date of receipt of such notification by the Secretary General.
p.000009:
p.000009: Article 40 – Notifications
p.000009:
p.000009: The Secretary General of the Council of Europe shall notify the member States of the Council of Europe, the European
p.000009: Community, any Signatory, any Party and any other State which has been invited to accede to the Protocol of:
p.000009:
p.000009: a any signature;
p.000009:
p.000009: b the deposit of any instrument of ratification, acceptance, approval or accession;
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000010:
p.000010:
p.000010: c any date of entry into force of this Protocol in accordance with Articles 37 and 38;
p.000010:
p.000010: d any other act, notification or communication relating to this Protocol.
p.000010:
p.000010:
p.000010:
p.000010: In witness whereof the undersigned, being duly authorised thereto, have signed this Protocol.
p.000010:
p.000010: Done at Strasbourg, this 25th day of January 2005, in English and in French, both texts being equally authentic, in a
p.000010: single copy which shall be deposited in the archives of the Council of Europe. The Secretary General of the Council of
p.000010: Europe shall transmit certified copies to each member State of the Council of Europe, to the non-member States which
p.000010: have participated in the elaboration of this Protocol, to any State invited to accede to the Convention and to the
p.000010: European Community.
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...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
p.000002: human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and
p.000002: fundamental freedoms with regard to the application of biology and medicine;
p.000002:
p.000002: Considering that progress in medical and biological sciences, in particular advances obtained through biomedical
p.000002: research, contributes to saving lives and improving quality of life;
p.000002:
p.000002: Conscious of the fact that the advancement of biomedical science and practice is dependent on knowledge and discovery
p.000002: which necessitates research on human beings;
p.000002:
p.000002: Stressing that such research is often transdisciplinary and international;
p.000002:
p.000002: Taking into account national and international professional standards in the field of biomedical research and the
p.000002: previous work of the Committee of Ministers and the Parliamentary Assembly of the Council of Europe in this
p.000002: field;
p.000002:
p.000002: Convinced that biomedical research that is contrary to human dignity and human rights should never be carried out;
p.000002:
p.000002: Stressing the paramount concern to be the protection of the human being participating in research;
p.000002:
p.000002: Affirming that particular protection shall be given to human beings who may be vulnerable in the context of research;
p.000002:
p.000002:
p.000002:
p.000002: (*) The Treaty of Lisbon amending the Treaty on European Union and the Treaty establishing the European Community
p.000002: entered into force on 1 December 2009. As a consequence, as from that date, any reference to the European
p.000002: Economic Community shall be read as the European Union.
p.000002:
p.000002: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000002:
p.000002:
p.000002: Recognising that every person has a right to accept or refuse to undergo biomedical research and that no one should be
p.000002: forced to undergo such research;
p.000002:
p.000002: Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and
p.000002: freedoms of the individual with regard to biomedical research,
p.000002:
p.000002: Have agreed as follows:
p.000002:
p.000002: CHAPTER I – Object and scope Article 1 – Object and purpose
p.000002: Parties to this Protocol shall protect the dignity and identity of all human beings and guarantee everyone, without
p.000002: discrimination, respect for their integrity and other rights and fundamental freedoms with regard to any research
p.000002: involving interventions on human beings in the field of biomedicine.
p.000002:
p.000002: Article 2 – Scope
p.000002:
p.000002: 1 This Protocol covers the full range of research activities in the health field involving
p.000002: interventions on human beings.
p.000002:
p.000002: 2 This Protocol does not apply to research on embryos in vitro. It does apply to research on foetuses and
p.000002: embryos in vivo.
p.000002:
p.000002: 3 For the purposes of this Protocol, the term “intervention” includes:
p.000002:
p.000002: i a physical intervention, and
p.000002:
p.000002: ii any other intervention in so far as it involves a risk to the psychological health of the person
p.000002: concerned.
p.000002:
p.000002: CHAPTER II – General provisions
p.000002:
p.000002: Article 3 – Primacy of the human being
...
Social / Women
Searching for indicator women:
(return to top)
p.000005: receive the information.
p.000005:
p.000005: Article 17 – Research with minimal risk and minimal burden
p.000005:
p.000005: 1 For the purposes of this Protocol it is deemed that the research bears a minimal risk if, having regard to the
p.000005: nature and scale of the intervention, it is to be expected that it will result, at the most, in a very slight and
p.000005: temporary negative impact on the health of the person concerned.
p.000005:
p.000005: 2 It is deemed that it bears a minimal burden if it is to be expected that the discomfort will be, at the most,
p.000005: temporary and very slight for the person concerned. In assessing the burden for an individual, a person enjoying the
p.000005: special confidence of the person concerned shall assess the burden where appropriate.
p.000005:
p.000005: CHAPTER VI – Specific situations
p.000005:
p.000005: Article 18 – Research during pregnancy or breastfeeding
p.000005:
p.000005: 1 Research on a pregnant woman which does not have the potential to produce results of direct benefit to her
p.000005: health, or to that of her embryo, foetus or child after birth, may only be undertaken if the following
p.000005: additional conditions are met:
p.000005:
p.000005: i the research has the aim of contributing to the ultimate attainment of results capable of conferring benefit
p.000005: to other women in relation to reproduction or to other embryos, foetuses or children;
p.000005:
p.000005: ii research of comparable effectiveness cannot be carried out on women who are not pregnant;
p.000005:
p.000005: iii the research entails only minimal risk and minimal burden.
p.000005:
p.000005: 2 Where research is undertaken on a breastfeeding woman, particular care shall be taken to avoid any adverse
p.000005: impact on the health of the child.
p.000005:
p.000005: Article 19 – Research on persons in emergency clinical situations
p.000005:
p.000005: 1 The law shall determine whether, and under which protective additional conditions, research in emergency
p.000005: situations may take place when:
p.000005:
p.000005: i a person is not in a state to give consent, and
p.000005:
p.000005: ii because of the urgency of the situation, it is impossible to obtain in a sufficiently timely manner,
p.000005: authorisation from his or her representative or an authority or a person or body which would in the absence of
p.000005: an emergency situation be called upon to give authorisation.
p.000005:
p.000005: 2 The law shall include the following specific conditions:
p.000005:
p.000005: i research of comparable effectiveness cannot be carried out on persons in non- emergency
p.000005: situations;
p.000005:
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000004: consent to research
p.000004: 1 Research on a person without the capacity to consent to research may be undertaken only if all the following
p.000004: specific conditions are met:
p.000004:
p.000004: i the results of the research have the potential to produce real and direct benefit to his or her health;
p.000004:
p.000004: ii research of comparable effectiveness cannot be carried out on individuals capable of giving
p.000004: consent;
p.000004:
p.000004: iii the person undergoing research has been informed of his or her rights and the safeguards
p.000004: prescribed by law for his or her protection, unless this person is not in a state to receive the information;
p.000004:
p.000004: iv the necessary authorisation has been given specifically and in writing by the legal representative
p.000004: or an authority, person or body provided for by law, and after having received the information required
p.000004: by Article 16, taking into account the person’s previously expressed wishes or objections. An adult not able to
p.000004: consent shall as far as possible take part in the authorisation procedure. The opinion of a minor shall be taken into
p.000004: consideration as an increasingly determining factor in proportion to age and degree of maturity;
p.000004:
p.000004: v the person concerned does not object.
p.000004:
p.000004: 2 Exceptionally and under the protective conditions prescribed by law, where the research has not the potential
p.000004: to produce results of direct benefit to the health of the person concerned, such research may be authorised
p.000004: subject to the conditions laid down in paragraph 1, sub- paragraphs ii, iii, iv, and v above, and to the
p.000004: following additional conditions:
p.000004:
p.000004: i the research has the aim of contributing, through significant improvement in the scientific understanding of
p.000004: the individual's condition, disease or disorder, to the ultimate attainment of results capable of conferring benefit to
p.000004: the person concerned or to other persons in the same age category or afflicted with the same disease or
p.000004: disorder or having the same condition;
p.000004:
p.000004: ii the research entails only minimal risk and minimal burden for the individual concerned; and any consideration
p.000004: of additional potential benefits of the research shall not be used to justify an increased level of risk or burden.
p.000004:
p.000004: 3 Objection to participation, refusal to give authorisation or the withdrawal of authorisation to
p.000004: participate in research shall not lead to any form of discrimination against the person concerned, in
p.000004: particular regarding the right to medical care.
p.000004:
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.000004: particular
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000005:
p.000005:
p.000005: regarding the right to medical care. They shall be specifically informed according to the nature and purpose of the
p.000005: research of the items of information listed in Article 13.
p.000005:
p.000005: 3 The information shall also be provided to the individual concerned, unless this person is not in a state to
p.000005: receive the information.
p.000005:
p.000005: Article 17 – Research with minimal risk and minimal burden
p.000005:
p.000005: 1 For the purposes of this Protocol it is deemed that the research bears a minimal risk if, having regard to the
p.000005: nature and scale of the intervention, it is to be expected that it will result, at the most, in a very slight and
p.000005: temporary negative impact on the health of the person concerned.
p.000005:
p.000005: 2 It is deemed that it bears a minimal burden if it is to be expected that the discomfort will be, at the most,
p.000005: temporary and very slight for the person concerned. In assessing the burden for an individual, a person enjoying the
p.000005: special confidence of the person concerned shall assess the burden where appropriate.
p.000005:
p.000005: CHAPTER VI – Specific situations
p.000005:
p.000005: Article 18 – Research during pregnancy or breastfeeding
p.000005:
p.000005: 1 Research on a pregnant woman which does not have the potential to produce results of direct benefit to her
p.000005: health, or to that of her embryo, foetus or child after birth, may only be undertaken if the following
p.000005: additional conditions are met:
p.000005:
p.000005: i the research has the aim of contributing to the ultimate attainment of results capable of conferring benefit
p.000005: to other women in relation to reproduction or to other embryos, foetuses or children;
p.000005:
p.000005: ii research of comparable effectiveness cannot be carried out on women who are not pregnant;
p.000005:
p.000005: iii the research entails only minimal risk and minimal burden.
p.000005:
p.000005: 2 Where research is undertaken on a breastfeeding woman, particular care shall be taken to avoid any adverse
p.000005: impact on the health of the child.
p.000005:
p.000005: Article 19 – Research on persons in emergency clinical situations
p.000005:
p.000005: 1 The law shall determine whether, and under which protective additional conditions, research in emergency
p.000005: situations may take place when:
p.000005:
p.000005: i a person is not in a state to give consent, and
p.000005:
...
p.000006: conditions are met:
p.000006:
p.000006: i research of comparable effectiveness cannot be carried out without the participation of persons deprived of
p.000006: liberty;
p.000006:
p.000006: ii the research has the aim of contributing to the ultimate attainment of results capable of conferring benefit
p.000006: to persons deprived of liberty;
p.000006:
p.000006: iii the research entails only minimal risk and minimal burden.
p.000006:
p.000006: CHAPTER VII – Safety and supervision
p.000006:
p.000006: Article 21 – Minimisation of risk and burden
p.000006:
p.000006: 1 All reasonable measures shall be taken to ensure safety and to minimise risk and burden for the research
p.000006: participants.
p.000006:
p.000006: 2 Research may only be carried out under the supervision of a clinical professional who possesses
p.000006: the necessary qualifications and experience.
p.000006:
p.000006: Article 22 – Assessment of health status
p.000006:
p.000006: 1 The researcher shall take all necessary steps to assess the state of health of human beings prior to their
p.000006: inclusion in research, to ensure that those at increased risk in relation to participation in a specific
p.000006: project be excluded.
p.000006:
p.000006: 2 Where research is undertaken on persons in the reproductive stage of their lives, particular consideration
p.000006: shall be given to the possible adverse impact on a current or future pregnancy and the health of an embryo, foetus or
p.000006: child.
p.000006:
p.000006: Article 23 – Non-interference with necessary clinical interventions
p.000006:
p.000006: 1 Research shall not delay nor deprive participants of medically necessary preventive,
p.000006: diagnostic or therapeutic procedures.
p.000006:
p.000006: 2 In research associated with prevention, diagnosis or treatment, participants assigned to control
p.000006: groups shall be assured of proven methods of prevention, diagnosis or treatment.
p.000006:
p.000007: 7
p.000007:
p.000007: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000007:
p.000007:
p.000007: 3 The use of placebo is permissible where there are no methods of proven effectiveness, or where withdrawal
p.000007: or withholding of such methods does not present an unacceptable risk or burden.
p.000007:
p.000007: Article 24 – New developments
p.000007:
p.000007: 1 Parties to this Protocol shall take measures to ensure that the research project is re-examined if this is
p.000007: justified in the light of scientific developments or events arising in the course of the research.
p.000007:
p.000007: 2 The purpose of the re-examination is to establish whether:
p.000007:
p.000007: i the research needs to be discontinued or if changes to the research project are necessary for
p.000007: the research to continue;
p.000007:
p.000007: ii research participants, or if applicable their representatives, need to be informed of the developments or
p.000007: events;
p.000007:
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000002: independent examination of its scientific merit, including assessment of the importance of the aim of research, and
p.000002: multidisciplinary review of its ethical acceptability.
p.000002:
p.000002: Article 8 – Scientific quality
p.000002:
p.000002: Any research must be scientifically justified, meet generally accepted criteria of scientific quality and be
p.000002: carried out in accordance with relevant professional obligations and standards under the supervision of an
p.000002: appropriately qualified researcher.
p.000002:
p.000002: CHAPTER III – Ethics committee
p.000002:
p.000002: Article 9 – Independent examination by an ethics committee
p.000002:
p.000002: 1 Every research project shall be submitted for independent examination of its ethical
p.000002: acceptability to an ethics committee. Such projects shall be submitted to independent examination in each
p.000002: State in which any research activity is to take place.
p.000002:
p.000002: 2 The purpose of the multidisciplinary examination of the ethical acceptability of the research project shall
p.000002: be to protect the dignity, rights, safety and well-being of research participants. The assessment of the ethical
p.000002: acceptability shall draw on an appropriate range of expertise and experience adequately reflecting professional and lay
p.000002: views.
p.000002:
p.000002: 3 The ethics committee shall produce an opinion containing reasons for its conclusion.
p.000002:
p.000002: Article 10 – Independence of the ethics committee
p.000002:
p.000002: 1 Parties to this Protocol shall take measures to assure the independence of the ethics committee.
p.000002: That body shall not be subject to undue external influences.
p.000002:
p.000002: 2 Members of the ethics committee shall declare all circumstances that might lead to a conflict of interest.
p.000002: Should such conflicts arise, those involved shall not participate in that review.
p.000002:
p.000002: Article 11 – Information for the ethics committee
p.000002:
p.000002: 1 All information which is necessary for the ethical assessment of the research project shall be given in
p.000002: written form to the ethics committee.
p.000002:
p.000002: 2 In particular, information on items contained in the appendix to this Protocol shall be provided, in so far
p.000002: as it is relevant for the research project. The appendix may be amended by the Committee set up by
p.000002: Article 32 of the Convention by a two-thirds majority of the votes cast.
p.000002:
p.000002: Article 12 – UndueXinfluence
p.000002:
p.000002: The ethics committee must be satisfied that no undue influence, including that of a financial nature, will be
p.000002: exerted on persons to participate in research. In this respect, particular attention must be given to
p.000002: vulnerable or dependent persons.
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000003:
p.000003:
p.000003: CHAPTER IV – Information and consent
p.000003:
p.000003: Article 13 – Information for research participants
p.000003:
p.000003: 1 The persons being asked to participate in a research project shall be given adequate information
p.000003: in a comprehensible form. This information shall be documented.
p.000003:
p.000003: 2 The information shall cover the purpose, the overall plan and the possible risks and benefits of the research
p.000003: project, and include the opinion of the ethics committee. Before being asked to consent to participate in a
p.000003: research project, the persons concerned shall be specifically informed, according to the nature and purpose of
p.000003: the research:
p.000003:
p.000003: i of the nature, extent and duration of the procedures involved, in particular, details of any burden imposed
p.000003: by the research project;
p.000003:
p.000003: ii of available preventive, diagnostic and therapeutic procedures;
p.000003:
p.000003: iii of the arrangements for responding to adverse events or the concerns of research participants;
p.000003:
p.000003: iv of arrangements to ensure respect for private life and ensure the confidentiality of personal
p.000003: data;
p.000003:
p.000003: v of arrangements for access to information relevant to the participant arising from the research
p.000003: and to its overall results;
p.000003:
p.000003: vi of the arrangements for fair compensation in the case of damage;
p.000003:
p.000003: vii of any foreseen potential further uses, including commercial uses, of the research results, data or
p.000003: biological materials;
p.000003:
p.000003: viii of the source of funding of the research project.
p.000003:
p.000003: 3 In addition, the persons being asked to participate in a research project shall be informed of the rights and
p.000003: safeguards prescribed by law for their protection, and specifically of their right to refuse consent or to
...
p.000004: consent to research
p.000004: 1 Research on a person without the capacity to consent to research may be undertaken only if all the following
p.000004: specific conditions are met:
p.000004:
p.000004: i the results of the research have the potential to produce real and direct benefit to his or her health;
p.000004:
p.000004: ii research of comparable effectiveness cannot be carried out on individuals capable of giving
p.000004: consent;
p.000004:
p.000004: iii the person undergoing research has been informed of his or her rights and the safeguards
p.000004: prescribed by law for his or her protection, unless this person is not in a state to receive the information;
p.000004:
p.000004: iv the necessary authorisation has been given specifically and in writing by the legal representative
p.000004: or an authority, person or body provided for by law, and after having received the information required
p.000004: by Article 16, taking into account the person’s previously expressed wishes or objections. An adult not able to
p.000004: consent shall as far as possible take part in the authorisation procedure. The opinion of a minor shall be taken into
p.000004: consideration as an increasingly determining factor in proportion to age and degree of maturity;
p.000004:
p.000004: v the person concerned does not object.
p.000004:
p.000004: 2 Exceptionally and under the protective conditions prescribed by law, where the research has not the potential
p.000004: to produce results of direct benefit to the health of the person concerned, such research may be authorised
p.000004: subject to the conditions laid down in paragraph 1, sub- paragraphs ii, iii, iv, and v above, and to the
p.000004: following additional conditions:
p.000004:
p.000004: i the research has the aim of contributing, through significant improvement in the scientific understanding of
p.000004: the individual's condition, disease or disorder, to the ultimate attainment of results capable of conferring benefit to
p.000004: the person concerned or to other persons in the same age category or afflicted with the same disease or
p.000004: disorder or having the same condition;
p.000004:
p.000004: ii the research entails only minimal risk and minimal burden for the individual concerned; and any consideration
p.000004: of additional potential benefits of the research shall not be used to justify an increased level of risk or burden.
p.000004:
p.000004: 3 Objection to participation, refusal to give authorisation or the withdrawal of authorisation to
p.000004: participate in research shall not lead to any form of discrimination against the person concerned, in
p.000004: particular regarding the right to medical care.
p.000004:
p.000004: Article 16 – Information prior to authorisation
p.000004:
p.000004: 1 Those being asked to authorise participation of a person in a research project shall be given adequate
p.000004: information in a comprehensible form. This information shall be documented.
p.000004:
p.000004: 2 The information shall cover the purpose, the overall plan and the possible risks and benefits of the research
p.000004: project, and include the opinion of the ethics committee. They shall further be informed of the rights and safeguards
p.000004: prescribed by law for the protection of those not able to consent to research and specifically of the right to refuse
p.000004: or to withdraw authorisation at any time, without the person concerned being subject to any form of discrimination, in
p.000004: particular
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000005:
p.000005:
p.000005: regarding the right to medical care. They shall be specifically informed according to the nature and purpose of the
p.000005: research of the items of information listed in Article 13.
p.000005:
p.000005: 3 The information shall also be provided to the individual concerned, unless this person is not in a state to
p.000005: receive the information.
p.000005:
p.000005: Article 17 – Research with minimal risk and minimal burden
p.000005:
p.000005: 1 For the purposes of this Protocol it is deemed that the research bears a minimal risk if, having regard to the
p.000005: nature and scale of the intervention, it is to be expected that it will result, at the most, in a very slight and
p.000005: temporary negative impact on the health of the person concerned.
p.000005:
p.000005: 2 It is deemed that it bears a minimal burden if it is to be expected that the discomfort will be, at the most,
p.000005: temporary and very slight for the person concerned. In assessing the burden for an individual, a person enjoying the
p.000005: special confidence of the person concerned shall assess the burden where appropriate.
...
General/Other / Dependent
Searching for indicator dependent:
(return to top)
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: Council of Europe Treaty Series - No. 195
p.000002:
p.000002: Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research *
p.000002:
p.000002: Strasbourg, 25.I.2005
p.000002:
p.000002:
p.000002:
p.000002: Preamble
p.000002:
p.000002: The member States of the Council of Europe, the other States and the European Community signatories to this Additional
p.000002: Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to
p.000002: the Application of Biology and Medicine (hereinafter referred to as “the Convention”),
p.000002:
p.000002: Considering that the aim of the Council of Europe is the achievement of greater unity between its members and that one
p.000002: of the methods by which this aim is pursued is the maintenance and further realisation of human rights and fundamental
p.000002: freedoms;
p.000002:
p.000002: Considering that the aim of the Convention, as defined in Article 1, is to protect the dignity and identity of all
p.000002: human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and
p.000002: fundamental freedoms with regard to the application of biology and medicine;
p.000002:
p.000002: Considering that progress in medical and biological sciences, in particular advances obtained through biomedical
p.000002: research, contributes to saving lives and improving quality of life;
p.000002:
p.000002: Conscious of the fact that the advancement of biomedical science and practice is dependent on knowledge and discovery
p.000002: which necessitates research on human beings;
p.000002:
p.000002: Stressing that such research is often transdisciplinary and international;
p.000002:
p.000002: Taking into account national and international professional standards in the field of biomedical research and the
p.000002: previous work of the Committee of Ministers and the Parliamentary Assembly of the Council of Europe in this
p.000002: field;
p.000002:
p.000002: Convinced that biomedical research that is contrary to human dignity and human rights should never be carried out;
p.000002:
p.000002: Stressing the paramount concern to be the protection of the human being participating in research;
p.000002:
p.000002: Affirming that particular protection shall be given to human beings who may be vulnerable in the context of research;
p.000002:
p.000002:
p.000002:
p.000002: (*) The Treaty of Lisbon amending the Treaty on European Union and the Treaty establishing the European Community
p.000002: entered into force on 1 December 2009. As a consequence, as from that date, any reference to the European
p.000002: Economic Community shall be read as the European Union.
p.000002:
p.000002: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000002:
p.000002:
p.000002: Recognising that every person has a right to accept or refuse to undergo biomedical research and that no one should be
p.000002: forced to undergo such research;
p.000002:
p.000002: Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and
...
p.000002:
p.000002: 1 Parties to this Protocol shall take measures to assure the independence of the ethics committee.
p.000002: That body shall not be subject to undue external influences.
p.000002:
p.000002: 2 Members of the ethics committee shall declare all circumstances that might lead to a conflict of interest.
p.000002: Should such conflicts arise, those involved shall not participate in that review.
p.000002:
p.000002: Article 11 – Information for the ethics committee
p.000002:
p.000002: 1 All information which is necessary for the ethical assessment of the research project shall be given in
p.000002: written form to the ethics committee.
p.000002:
p.000002: 2 In particular, information on items contained in the appendix to this Protocol shall be provided, in so far
p.000002: as it is relevant for the research project. The appendix may be amended by the Committee set up by
p.000002: Article 32 of the Convention by a two-thirds majority of the votes cast.
p.000002:
p.000002: Article 12 – UndueXinfluence
p.000002:
p.000002: The ethics committee must be satisfied that no undue influence, including that of a financial nature, will be
p.000002: exerted on persons to participate in research. In this respect, particular attention must be given to
p.000002: vulnerable or dependent persons.
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000003:
p.000003:
p.000003: CHAPTER IV – Information and consent
p.000003:
p.000003: Article 13 – Information for research participants
p.000003:
p.000003: 1 The persons being asked to participate in a research project shall be given adequate information
p.000003: in a comprehensible form. This information shall be documented.
p.000003:
p.000003: 2 The information shall cover the purpose, the overall plan and the possible risks and benefits of the research
p.000003: project, and include the opinion of the ethics committee. Before being asked to consent to participate in a
p.000003: research project, the persons concerned shall be specifically informed, according to the nature and purpose of
p.000003: the research:
p.000003:
p.000003: i of the nature, extent and duration of the procedures involved, in particular, details of any burden imposed
p.000003: by the research project;
p.000003:
p.000003: ii of available preventive, diagnostic and therapeutic procedures;
p.000003:
p.000003: iii of the arrangements for responding to adverse events or the concerns of research participants;
p.000003:
p.000003: iv of arrangements to ensure respect for private life and ensure the confidentiality of personal
p.000003: data;
p.000003:
p.000003: v of arrangements for access to information relevant to the participant arising from the research
p.000003: and to its overall results;
p.000003:
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000005:
p.000005: CHAPTER VI – Specific situations
p.000005:
p.000005: Article 18 – Research during pregnancy or breastfeeding
p.000005:
p.000005: 1 Research on a pregnant woman which does not have the potential to produce results of direct benefit to her
p.000005: health, or to that of her embryo, foetus or child after birth, may only be undertaken if the following
p.000005: additional conditions are met:
p.000005:
p.000005: i the research has the aim of contributing to the ultimate attainment of results capable of conferring benefit
p.000005: to other women in relation to reproduction or to other embryos, foetuses or children;
p.000005:
p.000005: ii research of comparable effectiveness cannot be carried out on women who are not pregnant;
p.000005:
p.000005: iii the research entails only minimal risk and minimal burden.
p.000005:
p.000005: 2 Where research is undertaken on a breastfeeding woman, particular care shall be taken to avoid any adverse
p.000005: impact on the health of the child.
p.000005:
p.000005: Article 19 – Research on persons in emergency clinical situations
p.000005:
p.000005: 1 The law shall determine whether, and under which protective additional conditions, research in emergency
p.000005: situations may take place when:
p.000005:
p.000005: i a person is not in a state to give consent, and
p.000005:
p.000005: ii because of the urgency of the situation, it is impossible to obtain in a sufficiently timely manner,
p.000005: authorisation from his or her representative or an authority or a person or body which would in the absence of
p.000005: an emergency situation be called upon to give authorisation.
p.000005:
p.000005: 2 The law shall include the following specific conditions:
p.000005:
p.000005: i research of comparable effectiveness cannot be carried out on persons in non- emergency
p.000005: situations;
p.000005:
p.000005: ii the research project may only be undertaken if it has been approved specifically for emergency
p.000005: situations by the competent body;
p.000005:
p.000006: 6
p.000006:
p.000006: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000006:
p.000006:
p.000006: iii any relevant previously expressed objections of the person known to the researcher shall be respected;
p.000006:
p.000006: iv where the research has not the potential to produce results of direct benefit to the health of the person
p.000006: concerned, it has the aim of contributing, through significant improvement in the scientific understanding of the
p.000006: individual's condition, disease or disorder, to the ultimate attainment of results capable of conferring benefit
p.000006: to the person concerned or to other persons in the same category or afflicted with the same disease or
p.000006: disorder or having the same condition, and entails only minimal risk and minimal burden.
p.000006:
p.000006: 3 Persons participating in the emergency research project or, if applicable, their representatives shall be
p.000006: provided with all the relevant information concerning their participation in the research project as soon as
p.000006: possible. Consent or authorisation for continued participation shall be requested as soon as reasonably
p.000006: possible.
p.000006:
p.000006: Article 20 – Research on persons deprived of liberty
p.000006:
p.000006: Where the law allows research on persons deprived of liberty, such persons may participate in a research project in
p.000006: which the results do not have the potential to produce direct benefit to their health only if the following additional
p.000006: conditions are met:
p.000006:
p.000006: i research of comparable effectiveness cannot be carried out without the participation of persons deprived of
p.000006: liberty;
p.000006:
p.000006: ii the research has the aim of contributing to the ultimate attainment of results capable of conferring benefit
p.000006: to persons deprived of liberty;
p.000006:
p.000006: iii the research entails only minimal risk and minimal burden.
p.000006:
p.000006: CHAPTER VII – Safety and supervision
p.000006:
p.000006: Article 21 – Minimisation of risk and burden
p.000006:
p.000006: 1 All reasonable measures shall be taken to ensure safety and to minimise risk and burden for the research
p.000006: participants.
p.000006:
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000003: verify whether or not the person has such capacity.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000004:
p.000004:
p.000004: CHAPTER V – Protection of persons not able to consent to research Article 15 – Protection of persons not able to
p.000004: consent to research
p.000004: 1 Research on a person without the capacity to consent to research may be undertaken only if all the following
p.000004: specific conditions are met:
p.000004:
p.000004: i the results of the research have the potential to produce real and direct benefit to his or her health;
p.000004:
p.000004: ii research of comparable effectiveness cannot be carried out on individuals capable of giving
p.000004: consent;
p.000004:
p.000004: iii the person undergoing research has been informed of his or her rights and the safeguards
p.000004: prescribed by law for his or her protection, unless this person is not in a state to receive the information;
p.000004:
p.000004: iv the necessary authorisation has been given specifically and in writing by the legal representative
p.000004: or an authority, person or body provided for by law, and after having received the information required
p.000004: by Article 16, taking into account the person’s previously expressed wishes or objections. An adult not able to
p.000004: consent shall as far as possible take part in the authorisation procedure. The opinion of a minor shall be taken into
p.000004: consideration as an increasingly determining factor in proportion to age and degree of maturity;
p.000004:
p.000004: v the person concerned does not object.
p.000004:
p.000004: 2 Exceptionally and under the protective conditions prescribed by law, where the research has not the potential
p.000004: to produce results of direct benefit to the health of the person concerned, such research may be authorised
p.000004: subject to the conditions laid down in paragraph 1, sub- paragraphs ii, iii, iv, and v above, and to the
p.000004: following additional conditions:
p.000004:
p.000004: i the research has the aim of contributing, through significant improvement in the scientific understanding of
p.000004: the individual's condition, disease or disorder, to the ultimate attainment of results capable of conferring benefit to
p.000004: the person concerned or to other persons in the same age category or afflicted with the same disease or
p.000004: disorder or having the same condition;
p.000004:
p.000004: ii the research entails only minimal risk and minimal burden for the individual concerned; and any consideration
...
p.000005: additional conditions are met:
p.000005:
p.000005: i the research has the aim of contributing to the ultimate attainment of results capable of conferring benefit
p.000005: to other women in relation to reproduction or to other embryos, foetuses or children;
p.000005:
p.000005: ii research of comparable effectiveness cannot be carried out on women who are not pregnant;
p.000005:
p.000005: iii the research entails only minimal risk and minimal burden.
p.000005:
p.000005: 2 Where research is undertaken on a breastfeeding woman, particular care shall be taken to avoid any adverse
p.000005: impact on the health of the child.
p.000005:
p.000005: Article 19 – Research on persons in emergency clinical situations
p.000005:
p.000005: 1 The law shall determine whether, and under which protective additional conditions, research in emergency
p.000005: situations may take place when:
p.000005:
p.000005: i a person is not in a state to give consent, and
p.000005:
p.000005: ii because of the urgency of the situation, it is impossible to obtain in a sufficiently timely manner,
p.000005: authorisation from his or her representative or an authority or a person or body which would in the absence of
p.000005: an emergency situation be called upon to give authorisation.
p.000005:
p.000005: 2 The law shall include the following specific conditions:
p.000005:
p.000005: i research of comparable effectiveness cannot be carried out on persons in non- emergency
p.000005: situations;
p.000005:
p.000005: ii the research project may only be undertaken if it has been approved specifically for emergency
p.000005: situations by the competent body;
p.000005:
p.000006: 6
p.000006:
p.000006: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000006:
p.000006:
p.000006: iii any relevant previously expressed objections of the person known to the researcher shall be respected;
p.000006:
p.000006: iv where the research has not the potential to produce results of direct benefit to the health of the person
p.000006: concerned, it has the aim of contributing, through significant improvement in the scientific understanding of the
p.000006: individual's condition, disease or disorder, to the ultimate attainment of results capable of conferring benefit
p.000006: to the person concerned or to other persons in the same category or afflicted with the same disease or
p.000006: disorder or having the same condition, and entails only minimal risk and minimal burden.
p.000006:
p.000006: 3 Persons participating in the emergency research project or, if applicable, their representatives shall be
...
General/Other / Undue Influence
Searching for indicator undue influence:
(return to top)
p.000002: acceptability shall draw on an appropriate range of expertise and experience adequately reflecting professional and lay
p.000002: views.
p.000002:
p.000002: 3 The ethics committee shall produce an opinion containing reasons for its conclusion.
p.000002:
p.000002: Article 10 – Independence of the ethics committee
p.000002:
p.000002: 1 Parties to this Protocol shall take measures to assure the independence of the ethics committee.
p.000002: That body shall not be subject to undue external influences.
p.000002:
p.000002: 2 Members of the ethics committee shall declare all circumstances that might lead to a conflict of interest.
p.000002: Should such conflicts arise, those involved shall not participate in that review.
p.000002:
p.000002: Article 11 – Information for the ethics committee
p.000002:
p.000002: 1 All information which is necessary for the ethical assessment of the research project shall be given in
p.000002: written form to the ethics committee.
p.000002:
p.000002: 2 In particular, information on items contained in the appendix to this Protocol shall be provided, in so far
p.000002: as it is relevant for the research project. The appendix may be amended by the Committee set up by
p.000002: Article 32 of the Convention by a two-thirds majority of the votes cast.
p.000002:
p.000002: Article 12 – UndueXinfluence
p.000002:
p.000002: The ethics committee must be satisfied that no undue influence, including that of a financial nature, will be
p.000002: exerted on persons to participate in research. In this respect, particular attention must be given to
p.000002: vulnerable or dependent persons.
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000003:
p.000003:
p.000003: CHAPTER IV – Information and consent
p.000003:
p.000003: Article 13 – Information for research participants
p.000003:
p.000003: 1 The persons being asked to participate in a research project shall be given adequate information
p.000003: in a comprehensible form. This information shall be documented.
p.000003:
p.000003: 2 The information shall cover the purpose, the overall plan and the possible risks and benefits of the research
p.000003: project, and include the opinion of the ethics committee. Before being asked to consent to participate in a
p.000003: research project, the persons concerned shall be specifically informed, according to the nature and purpose of
p.000003: the research:
p.000003:
p.000003: i of the nature, extent and duration of the procedures involved, in particular, details of any burden imposed
p.000003: by the research project;
p.000003:
p.000003: ii of available preventive, diagnostic and therapeutic procedures;
p.000003:
p.000003: iii of the arrangements for responding to adverse events or the concerns of research participants;
p.000003:
...
General/Other / participants in a control group
Searching for indicator placebo:
(return to top)
p.000006: participants.
p.000006:
p.000006: 2 Research may only be carried out under the supervision of a clinical professional who possesses
p.000006: the necessary qualifications and experience.
p.000006:
p.000006: Article 22 – Assessment of health status
p.000006:
p.000006: 1 The researcher shall take all necessary steps to assess the state of health of human beings prior to their
p.000006: inclusion in research, to ensure that those at increased risk in relation to participation in a specific
p.000006: project be excluded.
p.000006:
p.000006: 2 Where research is undertaken on persons in the reproductive stage of their lives, particular consideration
p.000006: shall be given to the possible adverse impact on a current or future pregnancy and the health of an embryo, foetus or
p.000006: child.
p.000006:
p.000006: Article 23 – Non-interference with necessary clinical interventions
p.000006:
p.000006: 1 Research shall not delay nor deprive participants of medically necessary preventive,
p.000006: diagnostic or therapeutic procedures.
p.000006:
p.000006: 2 In research associated with prevention, diagnosis or treatment, participants assigned to control
p.000006: groups shall be assured of proven methods of prevention, diagnosis or treatment.
p.000006:
p.000007: 7
p.000007:
p.000007: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000007:
p.000007:
p.000007: 3 The use of placebo is permissible where there are no methods of proven effectiveness, or where withdrawal
p.000007: or withholding of such methods does not present an unacceptable risk or burden.
p.000007:
p.000007: Article 24 – New developments
p.000007:
p.000007: 1 Parties to this Protocol shall take measures to ensure that the research project is re-examined if this is
p.000007: justified in the light of scientific developments or events arising in the course of the research.
p.000007:
p.000007: 2 The purpose of the re-examination is to establish whether:
p.000007:
p.000007: i the research needs to be discontinued or if changes to the research project are necessary for
p.000007: the research to continue;
p.000007:
p.000007: ii research participants, or if applicable their representatives, need to be informed of the developments or
p.000007: events;
p.000007:
p.000007: iii additional consent or authorisation for participation is required.
p.000007:
p.000007: 3 Any new information relevant to their participation shall be conveyed to the research
p.000007: participants, or, if applicable, to their representatives, in a timely manner.
p.000007:
p.000007: 4 The competent body shall be informed of the reasons for any premature termination of a research
p.000007: project.
p.000007:
p.000007: CHAPTER VIII – Confidentiality and right to information Article 25 – Confidentiality
p.000007: 1 Any information of a personal nature collected during biomedical research shall be considered as confidential
p.000007: and treated according to the rules relating to the protection of private life.
p.000007:
...
Orphaned Trigger Words
p.000002: concerned.
p.000002:
p.000002: CHAPTER II – General provisions
p.000002:
p.000002: Article 3 – Primacy of the human being
p.000002:
p.000002: The interests and welfare of the human being participating in research shall prevail over the sole interest of society
p.000002: or science.
p.000002:
p.000002: Article 4 – General rule
p.000002:
p.000002: Research shall be carried out freely, subject to the provisions of this Protocol and the other legal provisions
p.000002: ensuring the protection of the human being.
p.000002:
p.000002: Article 5 – Absence of alternatives
p.000002:
p.000002: Research on human beings may only be undertaken if there is no alternative of comparable effectiveness.
p.000002:
p.000002: Article 6 – Risks and benefits
p.000002:
p.000002: 1 Research shall not involve risks and burdens to the human being disproportionate to its potential
p.000002: benefits.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: 2
p.000002:
p.000002: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000002:
p.000002:
p.000002: 2 In addition, where the research does not have the potential to produce results of direct benefit to the
p.000002: health of the research participant, such research may only be undertaken if the research entails no more
p.000002: than acceptable risk and acceptable burden for the research participant. This shall be without
p.000002: prejudice to the provision contained in Article 15 paragraph 2, sub-paragraph ii for the protection of
p.000002: persons not able to consent to research.
p.000002:
p.000002: Article 7 – Approval
p.000002:
p.000002: Research may only be undertaken if the research project has been approved by the competent body after
p.000002: independent examination of its scientific merit, including assessment of the importance of the aim of research, and
p.000002: multidisciplinary review of its ethical acceptability.
p.000002:
p.000002: Article 8 – Scientific quality
p.000002:
p.000002: Any research must be scientifically justified, meet generally accepted criteria of scientific quality and be
p.000002: carried out in accordance with relevant professional obligations and standards under the supervision of an
p.000002: appropriately qualified researcher.
p.000002:
p.000002: CHAPTER III – Ethics committee
p.000002:
p.000002: Article 9 – Independent examination by an ethics committee
p.000002:
p.000002: 1 Every research project shall be submitted for independent examination of its ethical
p.000002: acceptability to an ethics committee. Such projects shall be submitted to independent examination in each
p.000002: State in which any research activity is to take place.
p.000002:
p.000002: 2 The purpose of the multidisciplinary examination of the ethical acceptability of the research project shall
p.000002: be to protect the dignity, rights, safety and well-being of research participants. The assessment of the ethical
p.000002: acceptability shall draw on an appropriate range of expertise and experience adequately reflecting professional and lay
p.000002: views.
p.000002:
...
p.000003: and to its overall results;
p.000003:
p.000003: vi of the arrangements for fair compensation in the case of damage;
p.000003:
p.000003: vii of any foreseen potential further uses, including commercial uses, of the research results, data or
p.000003: biological materials;
p.000003:
p.000003: viii of the source of funding of the research project.
p.000003:
p.000003: 3 In addition, the persons being asked to participate in a research project shall be informed of the rights and
p.000003: safeguards prescribed by law for their protection, and specifically of their right to refuse consent or to
p.000003: withdraw consent at any time without being subject to any form of discrimination, in particular regarding the
p.000003: right to medical care.
p.000003:
p.000003: Article 14 – Consent
p.000003:
p.000003: 1 No research on a person may be carried out, subject to the provisions of both Chapter V and Article 19,
p.000003: without the informed, free, express, specific and documented consent of the person. Such consent may be
p.000003: freely withdrawn by the person at any phase of the research.
p.000003:
p.000003: 2 Refusal to give consent or the withdrawal of consent to participation in research shall not lead to any form
p.000003: of discrimination against the person concerned, in particular regarding the right to medical care.
p.000003:
p.000003: 3 Where the capacity of the person to give informed consent is in doubt, arrangements shall be in place to
p.000003: verify whether or not the person has such capacity.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000004:
p.000004:
p.000004: CHAPTER V – Protection of persons not able to consent to research Article 15 – Protection of persons not able to
p.000004: consent to research
p.000004: 1 Research on a person without the capacity to consent to research may be undertaken only if all the following
p.000004: specific conditions are met:
p.000004:
p.000004: i the results of the research have the potential to produce real and direct benefit to his or her health;
p.000004:
p.000004: ii research of comparable effectiveness cannot be carried out on individuals capable of giving
p.000004: consent;
p.000004:
p.000004: iii the person undergoing research has been informed of his or her rights and the safeguards
p.000004: prescribed by law for his or her protection, unless this person is not in a state to receive the information;
p.000004:
p.000004: iv the necessary authorisation has been given specifically and in writing by the legal representative
...
p.000007: or withholding of such methods does not present an unacceptable risk or burden.
p.000007:
p.000007: Article 24 – New developments
p.000007:
p.000007: 1 Parties to this Protocol shall take measures to ensure that the research project is re-examined if this is
p.000007: justified in the light of scientific developments or events arising in the course of the research.
p.000007:
p.000007: 2 The purpose of the re-examination is to establish whether:
p.000007:
p.000007: i the research needs to be discontinued or if changes to the research project are necessary for
p.000007: the research to continue;
p.000007:
p.000007: ii research participants, or if applicable their representatives, need to be informed of the developments or
p.000007: events;
p.000007:
p.000007: iii additional consent or authorisation for participation is required.
p.000007:
p.000007: 3 Any new information relevant to their participation shall be conveyed to the research
p.000007: participants, or, if applicable, to their representatives, in a timely manner.
p.000007:
p.000007: 4 The competent body shall be informed of the reasons for any premature termination of a research
p.000007: project.
p.000007:
p.000007: CHAPTER VIII – Confidentiality and right to information Article 25 – Confidentiality
p.000007: 1 Any information of a personal nature collected during biomedical research shall be considered as confidential
p.000007: and treated according to the rules relating to the protection of private life.
p.000007:
p.000007: 2 The law shall protect against inappropriate disclosure of any other information related to a
p.000007: research project that has been submitted to an ethics committee in compliance with this Protocol.
p.000007:
p.000007: Article 26 – Right to information
p.000007:
p.000007: 1 Research participants shall be entitled to know any information collected on their health in
p.000007: conformity with the provisions of Article 10 of the Convention.
p.000007:
p.000007: 2 Other personal information collected for a research project will be accessible to them in
p.000007: conformity with the law on the protection of individuals with regard to processing of personal data.
p.000007:
p.000007: Article 27 – Duty of care
p.000007:
p.000007: If research gives rise to information of relevance to the current or future health or quality of life of research
p.000007: participants, this information must be offered to them. That shall be done within a framework of health care or
p.000007: counselling. In communication of such information, due care must be taken in order to protect confidentiality
p.000007: and to respect any wish of a participant not to receive such information.
p.000007:
p.000007:
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: CETS 195 – Human Rights and Biomedicine (Protocol), 25.I.2005
p.000008:
p.000008:
p.000008: Article 28 – Availability of results
p.000008:
p.000008: 1 On completion of the research, a report or summary shall be submitted to the ethics committee or
p.000008: the competent body.
p.000008:
p.000008: 2 The conclusions of the research shall be made available to participants in reasonable time, on request.
p.000008:
p.000008: 3 The researcher shall take appropriate measures to make public the results of research in
p.000008: reasonable time.
p.000008:
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| breastfeeding | breastfeeding |
| child | Child |
| children | Child |
| dependent | Dependent |
| embryo | embryo |
| emergency | Public Emergency |
| foetus | Fetus/Neonate |
| foetuses | Fetus/Neonate |
| liberty | Incarcerated |
| minor | Youth/Minors |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| placebo | participants in a control group |
| pregnant | Pregnant |
| single | Marital Status |
| undue influence | Undue Influence |
| union | Trade Union Membership |
| unlawful | Illegal Activity |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| foetus | ['foetuses'] |
| foetuses | ['foetus'] |
Trigger Words
capacity
consent
ethics
protect
protection
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input