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Biomedical Research

The Additional Protocol to the Convention on Human Rights and Biomedicine on Biomedical Research 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 Ethical review of Biomedical Research Activity (DEBRA). DEBRA consists of multilateral and bilateral meetings, study visits and informative materials on best practice in Europe.

Progress of work

The Working Party on Biomedical Research, responsible for preparing the draft Additional Protocol, was appointed in November 1991, but as the CDBI focused its efforts on the preparation of the Convention itself, work on the Protocol was suspended until April 1997. The working parties responsible for drafting the Additional Protocols are made up of high-level experts nominated by Council of Europe Member States with the assistance of the Secretariat of the Council of Europe. The high level experts take into account the views of non-governmental and professional organisations active, in this case, in areas related to biomedical research. Altogether, the Working Party has held twelve meetings.

The draft Additional Protocol was declassified for the purpose of consultation by the CDBI during its 20th meeting (5-8 June 2001). CDBI delegations carried out consultations on the national level and submitted comments to the CDBI. The Council of Europe Secretariat carried out consultation with Pan-European non-governmental organisations. The consultation period extended to March 2002. The CDBI reviewed the Protocol in June 2003 with a view to approval. The CDBI agreed to approve the draft Protocol and it was submitted to the Parliamentary Assembly for consultation by the Committee of Ministers prior to final adoption by the Committee of Ministers.

The Committee of Ministers adopted the Protocol on 30 June 2004. Opened for signature on 25 January 2005. Entered into force on 1 September 2007.

An International Conference on "Ethics Review of Clinical Research in Pharmaceuticals" organised by the Council of Europe and the Ministry of Health and Social Development of the Russian Federation took place in Moscow on 28-29 November 2011. The Guide for Research Ethics Committee members was presented on this occasion.