Research on biological materials of human origin

Recommendation CM/Rec(2016)6 is the outcome of a re-examination of Recommendation Rec(2006)4 on research on biological materials of human origin undertaken by the Council of Europe in 2012. It takes into account new developments in the field, such as the increasingly diverse origin of biological materials stored in collections, the difficulty to guarantee the non- identifiability of such samples, the increasing amount of research involving materials from different collections, and the importance of protecting the rights of persons not able to consent.

It is widely acknowledged that the acquisition of knowledge from research on biological materials utilising systematic methodologies in the field of biomedicine can benefit human health. However, this kind of research also raises human rights concerns, in particular with regard to the right to respect for private life.

The purpose of this recommendation, adopted by the Committee of Ministers of the Council of Europe on 11 May 2016, is to set out and safeguard the fundamental rights of individuals whose biological materials are intended for biomedical research. Their dignity, integrity and privacy must be guaranteed, while the continued benefits of research should be ensured by providing researchers with appropriate access to biological materials.

The Council of Europe is the continent's leading human rights organisation. It comprises 47 member states, 28 of which are members of the European Union. All Council of Europe member states have signed up to the European Convention on Human Rights, a treaty designed to protect human rights, democracy and the rule of law. The European Court of Human Rights oversees the implementation of the Convention in the member states.