Council of Europe: Convention on Human Rights and Biomedicine

 

Article 17 – Protection of persons not able to consent to research

1 Research on a person without the capacity to consent as stipulated in Article
5 may be undertaken only if all the following conditions are met:

i the conditions laid down in Article 16, sub-paragraphs i to iv, are
fulfilled;

ii the results of the research have the potential to produce real and direct
benefit to his or her health;

iii research of comparable effectiveness cannot be carried out on individuals
capable of giving consent;

iv the necessary authorisation provided for under Article 6 has been given
specifically and in writing, and

v the person concerned does not object.

2 Exceptionally and under the protective conditions prescribed by law, where the
research has not the potential to produce results of direct benefit to the
health of the person concerned, such research may be authorised subject to the
conditions laid down in paragraph 1, suparagraphs i, iii, iv and v above, and to
the following additional conditions:

i the research has the aim of contributing, through significant improvement in
the scientific understanding of the individual’s condition, disease or disorder,
to the ultimate attainment of results capable of conferring benefit to the
person concerned or to other persons in the same age category or afflicted with
the same disease or disorder or having the same condition.

ii the research entails only minimal risk and minimal burden for the individual
concerned.

Article 18 – Research on embryos in vitro

1 Where the law allows research on embryos in vitro, it shall ensure adequate
protection of the embryo.

2 The creation of human embryos for research purposes is prohibited.

Chapter VI – Organ and tissue removal from living donors for
transplantation Purposes

Article 19 – General rule

1 Removal of organs or tissue from a living person for transplantation purposes
may be carried out solely for the therapeutic benefit of the recipient and where
there is no suitable organ or tissue available from a deceased person and no
other alternative therapeutic method of comparable effectiveness.

2 The necessary consent as provided for under Article 5 must have been given
expressly and specifically either in written form or before an official body.

Article 20 – Protection of persons not able to consent to organ removal

1 No organ or tissue removal may be carried out on a person who does not have
the capacity to consent under Article 5.

2 Exceptionally and under the protective conditions prescribed by law, the
removal of regenerative tissue from a person who does not have the capacity to
consent may be authorised provided the following conditions are met:

i there is no compatible donor available who has the capacity to consent,

ii the recipient is a brother or sister of the donor,

iii the donation must have the potential to be life-saving for the recipient,

iv the authorisation provided for under paragraphs 2 and 3 of Article 6 has been
given specifically and in writing, in accordance with the law and with the
approval of the competent body,

v the potential donor concerned does not object.

Chapter VII – Prohibition of financial gain and disposal
Of a Part of the Human Body

Article 21 – Prohibition of financial gain

The human body and its parts shall not, as such, give rise to financial gain.

Article 22 – Disposal of a removed part of the human body

When in the course of an intervention any part of a human body is removed, it
may be stored and used for a purpose other than that for which it was removed,
only if this is done in conformity with appropriate information and consent
procedures.

Chapter VIII – Infringements of the provisions of the Convention

Article 23 – Infringement of the rights or principles

The Parties shall provide appropriate judicial protection to prevent or to put a
stop to an unlawful infringement of the rights and principles set forth in this
Convention at short notice.

Article 24 – Compensation for undue damage

The person who has suffered undue damage resulting from an intervention is
entitled to fair compensation according to the conditions and procedures
prescribed by law.

Article 25 – Sanctions

Parties shall provide for appropriate sanctions to be applied in the event of
infringement of the provisions contained in this Convention.

Chapter IX – Relation between this Convention and other
Provisions

Article 26 – Restrictions on the exercise of the rights

1 No restrictions shall be placed on the exercise of the rights and protective
provisions contained in this Convention other than such as are prescribed by law
and are necessary in a democratic society in the interest of public safety, for
the prevention of crime, for the protection of public health or for the
protection of the rights and freedoms of others.

2 The restrictions contemplated in the preceding paragraph may not be placed on
Articles 11, 13, 14, 16, 17, 19, 20 and 21.

Article 27 – Wider protection

None of the provisions of this Convention shall be interpreted as limiting or
otherwise affecting the possibility for a Party to grant a wider measure of
protection with regard to the application of biology and medicine than is
stipulated in this Convention.

Chapter X – Public debate

Article 28 – Public debate

Parties to this Convention shall see to it that the fundamental questions raised
by the developments of biology and medicine are the subject of appropriate
public discussion in the light, in particular, of relevant medical, social,
economic, ethical and legal implications, and that their possible application is
made the subject of appropriate consultation.

Chapter XI – Interpretation and follow-up of the Convention

Article 29 – Interpretation of the Convention

The European Court of Human Rights may give, without direct reference to any
specific proceedings pending in a court, advisory opinions on legal questions
concerning the interpretation of the present Convention at the request of:

– the Government of a Party, after having informed the other Parties,

– the Committee set up by Article 32, with membership restricted to the
Representatives of the Parties to this Convention, by a decision adopted by a
two-third majority of votes cast.

Article 30 (Reports on the application of the Convention)

On receipt of a request from the Secretary General of the Council of Europe any
Party shall furnish an explanation of the manner in which its internal law
ensures the effective implementation of any of the provisions of the Convention.

Chapter XII – Protocols

Article 31 – Protocols

Protocols may be concluded in pursuance of Article 32, with a view to
developing, in specific fields, the principles contained in this Convention.

The Protocols shall be open for signature by Signatories of the Convention. They
shall be subject to ratification, acceptance or approval. A signatory may not
ratify, accept or approve Protocols without previously or simultaneously
ratifying accepting or approving the Convention.

 

Author: international

Mentioned in these Entries

Council of Europe: Convention on Human Rights and Biomedicine.