Research on biological materials of human origin:
new recommendations to member States
A new set of recommendations to the Council of Europe member states on the removal, storage and use of biological materials for research purposes was adopted by the Committee of Ministers on May 11.
It 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.
Biomedical research on materials of human origin is a powerful tool to improve human health and healthcare systems, the new legal instrument acknowledges, and the development of collections and cross-border flow of such research materials is increasing. However, this raises questions of the risk for private life of the persons concerned, as well as of the autonomy that these individuals have over their biological materials once they have been removed.
The purpose of these new recommendations 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.
The governance of collections is an important theme covered by the document. Taking into account the trend of developing collections of biological materials of human origin at national level, the Recommendation stresses in particular that their governance should be guided by the principles of transparency and accountability. Information about the management of collections should be publicly available, and clear procedures for storing, accessing, using and, where appropriate, transferring the collection materials should be put in place. Each collection should be subject to independent oversight.
The Committee of Ministers recommends to member States adapting their laws and practices and promoting the establishment of codes of good practice to ensure compliance with these recommendations. The current Recommendation succeeds the Recommendation Rec(2006)4; it was developed following a public consultation process involving all the stakeholders, in particular medical associations, scientists, ethics bodies, and patient organisations.