Council of Europe: Convention on Human Rights and Biomedicine in the United States

Chapter I – General provisions

Article 1 – Purpose and object

Parties to this Convention shall protect the dignity and identity of all human
beings and guarantee everyone, without discrimination, respect for their
integrity and other rights and fundamental freedoms with regard to the

application of biology and medicine.

Each Party shall take in its internal law the necessary measures to give effect
to the provisions of this Convention.

Article 2 – Primacy of the human being

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

Article 3 – Equitable access to health care

Parties, taking into account health needs and available resources, shall take
appropriate measures with a view to providing, within their jurisdiction,
equitable access to health care of appropriate quality.

Article 4 – Professional standards

Any intervention in the health field, including research, must be carried out in
accordance with relevant professional obligations and standards.

Chapter II – Consent

Article 5 – General rule

An intervention in the health field may only be carried out after the person
concerned has given free and informed consent to it.

This person shall beforehand be given appropriate information as to the purpose
and nature of the intervention as well as on its consequences and risks.

The person concerned may freely withdraw consent at any time.

1 Subject to Articles 17 and 20 below, an intervention may only be carried out
on a person who does not have the capacity to consent, for his or her direct
benefit.

2 Where, according to law, a minor does not have the capacity to consent to an
intervention, the intervention may only be carried out with the authorisation of
his or her representative or an authority or a person or body provided for by
law. The opinion of the minor shall be taken into consideration as an increasingly
determining factor in proportion to his or her age and degree of maturity.

3 Where, according to law, an adult does not have the capacity to
consent to an intervention because of a mental disability, a disease or for
similar reasons, the intervention may only be carried out with the authorisation
of his or her representative or an authority or a person or body provided for by
law. The individual concerned shall as far as possible take part in the
authorisation procedure.

4 The representative, the authority, the person or the body mentioned in
paragraphs 2 and 3 above shall be given, under the same conditions, the
information referred to in Article 5.

5 The authorisation referred to in paragraphs 2 and 3 above may be withdrawn at
any time in the best interests of the person concerned.

Article 7 – Protection of persons who have mental disorder

Subject to protective conditions prescribed by law, including supervisory,
control and appeal procedures, a person who has a mental disorder of a serious
nature may be subjected, without his or her consent, to an intervention aimed at
treating his or her mental disorder only where, without such treatment, serious
harm is likely to result to his or her health.

Article 8 – Emergency situation

When because of an emergency situation the appropriate consent cannot be
obtained, any medically necessary intervention may be carried out immediately
for the benefit of the health of the individual concerned.

Article 9 – Previously expressed wishes

The previously expressed wishes relating to a medical intervention by a patient
who is not, at the time of the intervention, in a state to express his or her
wishes shall be taken into account.

Chapter III – Private life and right to information

Article 10 – Private life and right to information

1 Everyone has the right to respect for private life in relation to information
about his or her health.

2 Everyone is entitled to know any information collected about his or her
health. However, the wishes of individuals not to be so informed shall be
observed.

3 In exceptional cases, restrictions may be placed by law on the exercise of the
rights contained in paragraph 2 in the interests of the patient.

Chapter IV – Human genome

Article 11 – Non-discrimination

Any form of discrimination against a person on grounds of his or her genetic
heritage is prohibited.

Article 12 – Predictive genetic tests

Tests which are predictive of genetic diseases or which serve either to identify
the subject as a carrier of a gene responsible for a disease or to detect a
genetic predisposition or susceptibility to a disease may be performed only for
health purposes or for scientific research linked to health purposes, and
subject to appropriate genetic counselling.

Article 13 – Interventions on the human genome

An intervention seeking to modify the human genome may only be undertaken for
preventive, diagnostic or therapeutic purposes and only if its aim is not to
introduce any modification in the genome of any descendants.

Article 14 – Non-selection of sex

The use of techniques of medically assisted procreation shall not be allowed for
the purpose of choosing a future child’s sex, except where serious hereditary
sex-related disease is to be avoided.

Chapter V – Scientific research

Article 15 – General rule

Scientific research in the field of biology and medicine shall be carried out
freely, subject to the provisions of this Convention and the other legal
provisions ensuring the protection of the human being.

Article 16 – Protection of persons undergoing research

Research on a person may only be undertaken if all the following conditions
are met:

i there is no alternative of comparable effectiveness to research on humans,

ii the risks which may be incurred by that person are not disproportionate to
the potential benefits of the research,

iii the research project has been approved by the competent body after
independent examination of its scientific merit, including assessment of the
importance of the aim of the research, and multidisciplinary review of its
ethical acceptability,

iv the persons undergoing research have been informed of their rights and the
safeguards prescribed by law for their protection,

v the necessary consent as provided for under Article 5 has been given
expressly, specifically and is documented. Such consent may be freely withdrawn
at any time.