Research on biological materials of human origin (Recommendation CM/Rec(2016)6 and explanatory memorandum (2016)

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 nonidentifiability 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.