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