The Committee of Ministers of the Council of Europe adopts Recommendation CM/Rec(2016)6 of the Committee of Ministers to member States on research on biological materials of human origin
This Recommendation is a revision of Recommendation (2006)4 and takes into account new developments in the field of biobanking, such as the increasingly diverse origin of biological materials stored in collections, the difficulty to guarantee non-identifiability of such samples, the increasing amount of research involving materials coming from different collections, and the importance of research on biomaterials removed from persons not able to consent.
The Council of Europe's Recommendation (2006)4 on research on biological materials of human origin aims to safeguard the fundamental rights of individuals whose biological materials could be included in a research project after having been collected and stored.
The purpose of this new Recommendation is to spell out and safeguard fundamental rights of the persons whose biological materials are intended for biomedical research. Their dignity, integrity and privacy must be guaranteed, while at the same time the researchers should benefit from the access to biological materials.
The new legal instrument sets out the conditions for obtaining and storing materials for future research as well as for using them in specific research projects, in particular regarding appropriate information and consent of the persons concerned.
Legal instruments and related documents
- Convention on Human Rights and Biomedicine (Oviedo Convention)
- Recommendation CM/Rec(2016)6 on research on biological materials of human origin
- Explanatory memorandum
- Report of the European Commission Expert Group on biobanks
- Press release - Research on biological materials of human origin: new recommendations to member States
- Draft Recommendation on research on biological materials of human origin (2015)