Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research

The Additional Protocol to the Convention on Human Rights and Biomedicine on Biomedical Research (ETS 195) is intended to build on the principles embodied in the Convention, with a view to protecting human rights and dignity in the specific field of biomedical research. Its purpose is to define and safeguard fundamental rights in biomedical research, in particular of those participating in research.

The Protocol is to cover the full range of biomedical research activities involving interventions on human beings. It is important to note that pharmaceutical research is not the only field of biomedical research to be addressed by the Protocol. New methods of treatment, diagnosis, and prevention may also require research on human beings. Research on embryos and foetuses in vivo, and pregnant women is to be covered by the Protocol.

The fundamental principle for research involving human beings, as in the Convention itself, is the free, informed, express, specific, and documented consent of the person(s) participating. It is foreseen that the Protocol will address issues such as risks and benefits of research, consent, protection of persons not able to consent to research, scientific quality, independent examination of research by an ethics committee, information to be submitted to the ethics committee, information for research participants, confidentiality and the right to information, dependent persons, undue influence, safety, duty of care, and research in States not Party to the Protocol.

Particular attention is being paid at the Council of Europe to the fulfilment of the requirement of independent and multidisciplinary review of the ethical acceptability of biomedical research. First of all, this is being done through a more detailed examination of the subject of ethical review and ethics committees in the Additional Protocol. This will serve to harmonise the principles of ethical review of research involving human beings in Europe. Additionally, the Council of Europe is undertaking a programme of cooperation during 1997-2004 with its Member States in central and eastern Europe and elsewhere called the Demo droit Ethical review of Biomedical Research Activity (DEBRA). DEBRA consists of multilateral and bilateral meetings, study visits and informative materials on best practice in Europe.

See also related url for ETS 203: Biological and medical research has led to remarkable progress in the field of human health. The rapid developments in this sphere have prompted the Council of Europe to consider the ethical and legal aspects of applications of genetics, particularly genetic testing, and to draw up legal rules to protect fundamental human rights with regard to these applications.

The new Protocol sets down principles relating inter alia to the quality of genetic services, prior information and consent and genetic counselling. It lays down general rules on the conduct of genetic tests, and, for the first time at international level, deals with the directly accessible genetic tests for which a commercial offer could develop in future. It specifies the conditions in which tests may be carried out on persons not able to consent. Also covered are the protection of private life and the right to information collected through genetic testing. Finally, the Protocol touches on genetic screening.

Council of Europe: European Treaty Series, No.203, (2008): Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes http://conventions.coe.int/Treaty/Commun/QueVoulezVous.asp?NT=203&CM=8&DF=2/23/2009&CL=ENG

Council of Europe: European Treaty Series, No.164 (1997): Convention for the protection of Human Rights and dignity of the human being with regard to the application of biology and medicine: Convention on Human Rights and Biomedicine http://conventions.coe.int/Treaty/Commun/QueVoulezVous.asp?NT=164&CM=8&DF=2/23/2009&CL=ENG

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