The Committee of Ministers, under the terms of article 15.b
of the Statute of the Council of Europe. Consider that the aim of
the Council for Europe is to achieve a greater unity between its
members, in particular by the adoption of minimum common rules on
matters of common interest.
Having regard for the Convention for the Protection of Human
Rights and Fundamental Freedoms, in particular its Articles 2.1,3 and
8; to Article 7 of the United Nations International Covenant on Civil
and Political Rights; to Recommendations 874 (1979) of the
Parliamentary Assembly of the Council of Europe on a European Charter
on the Rights of the Child;
to Recommendation No R (83) 2 of the Committee of Ministers
concerning the legal protection of persons suffering from mental
disorder placed as involuntary patients, and to the Declaration of
Helsinki, adopted at the 18th World Medical Assembly (1964) and
amended by the 29th Assembly in Tokyo (1975), the 35th Assembly in
Venice (1983) and the 41st Assembly in Hong Kong (1989), concerning
recommendations guiding physicians in biomedical research involving
human subjects;
Being aware of the fact that the advancement of medical
science and practice is dependant on knowledge and discovery
which necessitate, as a last resort, experimentation on human
beings;
Being convinced that medical research should never be
carried out contrary to human dignity;
1. When this recommendation was adopted, The Representative of
the Federal Republic of Germany, in application of Article 10.2c of
the Rules of Procedure for the meetings of the Ministers'
Deputies, reserved the right of his Government to comply with it or
not.
Considering the paramount concern to be the protection of
the person undergoing medical research;
Considering that particular protection should be given to
certain groups of persons;
Considering that every person has a right to accept or to
refuse to undergo medical research and that no one should be
subject be forced to undergo it;
Considering that medical research on human beings should
take into account ethical principles, and should also be subject to
legal provisions;
Realising that in member states existing legal provisions
are either divergent or insufficient in this field; Noting the wish
and the need to harmonise legislation, Recommends the governments of
member states;
a. to adopt legislation in conformity with the principles
appended to this recommendation, or to take any other measures in
order to ensure their implementation;
b. to ensure that the provision so adopted are brought to
the knowledge of all persons concerned.
Principles concerning medical research on human beings
Scope and definition
For the purpose of application of these principles, medical
research means any trial and experimentation carried out on human
beings, the purpose of which or one of the purposes of which is to
increase medical knowledge.
Principle 1
Any medical research must be carried out within the
framework of a scientific plan and in accordance with the
following principles.
Principle 2
- In medical research the interests and well being
of the person undergoing medical research must always prevail over
the interests of science and society.
- The risk incurred by a person undergoing medical research
must be kept to a minimum. The risks should not be
disproportionate to the benefits to that person or the importance of
the aims pursued by the research.
Principle 3
- No medical research may be carried out without the informed,
free, express and specific consent of the person undergoing it.
Such consent may be withdrawn at any phase of the research and the
person undergoing the research should be informed, before being
included in it, of his right to withdraw his consent.
- The person who is to undergo medical research should be
given information on the purpose of the research and the
methodology of the experimentation. He should also be informed of
the foreseeable risks and inconveniences to him of the proposed
research. This information should be sufficiently clear and
suitably adapted to enable consent to be given or refused in full
knowledge of the relevant facts.
- The provisions of this principle should apply also to a
legal representative and to a legally incapacitated person having the
capacity of understanding, in the situations described in
Principles 4 and 5.
Principle 4
A legally incapacitated person may only undergo medical
research where authorised by Principle 5 and if his legal
representative, or an authority or an individual authorised or
designated under his national law, consents. If the legally
incapacitated person is capable of understanding, his consent is
also required and no medical research may be undertaken if he
does not give his consent.
Principle 5
- A legally incapacitated person may not undergo medical
research unless it is expected to produce a direct and
significant benefit to his health.
- However, by way of exception, national law may authorise
research involving a legally incapacitated person which is not of
direct benefit to his health when that person offers no
objection, provided that the research is to the benefit of
persons in the same category and that the same scientific results
cannot be obtained by research on persons who do not belong in
this category.
Principle 6
Pregnant or nursing women may not undergo medical research
where their health and /or that of the child would not benefit
directly unless this research is aimed at benefiting other women and
children who are in the same position and the same scientific results
cannot be obtained by research on who are not pregnant or nursing.
Principle 7
Persons deprived of liberty may not undergo medical research
unless it is expected to produce a direct and significant benefit to
their health.
Principal 8
In an emergency situation, notwithstanding Principle 3,
where a patient is unable to give a prior consent, medical
research can be carried out only when the following conditions are
fulfilled;
the research must have been planned to be carried out
in the emergency in question;
the systematic research plan must have been approved by an
ethics committee;
the research must be intended for the direct health benefit of
the patient.
Principle 9
Any information of a personal nature obtained during medical
research should be treated as confidential.
Principle 10
Medical research may not be carried out unless satisfactory
evidence as to its safety for the person undergoing research is
furnished.
Principle 11
Medical research that is not in accordance with scientific
criteria in its design and cannot answer the questions posed is
unacceptable even if the way it is to be carried out poses no
risk to the person undergoing research.
Principle 12
- Medical research must be carried out under the
responsibility of a doctor or a person who exercises full
clinical responsibility and who possesses appropriate knowledge and
qualifications to meet any clinical contingency.
- The responsible doctor or other person referred to in the
preceding paragraph should enjoy full professional independence and
should have the power to stop the research at any time.
Principle 13
- Potential subjects of medical research should not be offered any
inducement which compromises free consent. Persons undergoing medical
research should not gain any financial benefit. However, expenses
and any financial loss may be refunded and in appropriate
cases a modest allowance may be given for any inconvenience
inherent in the medical research.
- If the person undergoing research is legally incapacitated,
his legal representatives should not receive any form of
remuneration, except for the refund of their expenses.
Principle 14
- Persons undergoing medical research and/or their dependants
should be compensated for injury and loss caused by medical
research.
- Where there is no existing system providing compensation for
the person concerned, states should ensure that sufficient
guarantees for such compensation are provided.
- Terms and conditions which exclude or limit, in advance,
compensation to the victim should be considered to be null and
void.
Principle 15
All proposed medical research plans should be the subject of
an ethical examination by an independent and multi disciplinary
committee.
Principle 16
Any medical research which is:
unplanned, or
contrary to any of the preceding principles, or
in any other way contrary to ethics or law, or
not in accordance with scientific methods in its design and
cannot answer the questions posed should be prohibited or, if the
research has already begun, stopped or revised, even if it poses no
risk to the person(s) undergoing research.
Dated 16/9/2000
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