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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