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16 DE SETEMBRO DE 2016 15

Council of Europe Treaty Series - No. 195

ADDITIONAL PROTOCOL TO THE CONVENTION

ON HUMAN RIGHTS AND BIOMEDICINE, CONCERNING BIOMEDICAL

RESEARCH

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: