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

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.

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 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.

Public consultation

Public consultation on the working document presenting a draft revised Recommendation was launched in March 2014 with the deadline on 15 August 2014 within the context of re-examination of Recommendation (2006) 4 of the Committee of Ministers on research on biological materials of human origin.

Cover letter
Working document
Compilaton of replies

The purpose of this consultation was to elicit comments, in particular from the sectors directly concerned (such as researchers, relevant bodies or institutions, patient organisations and biobank managers).

Following the closure of the public consultation, the replies have been compiled in one document and have been taken into consideration when finalising the revision of the Recommendation.

At it's 8th meeting, following indicative votes on the individual provisions, the DH-BIO approved the revised Draft Recommendation with the unanimity of the votes cast (with 4 abstentions), with a view to its presentation to the Committee of Ministers for adoption. One delegation expressed reservations with regard to three Articles.

Symposium on Biobanks and Biomedical Collections - An ethical framework for future research , organised by the Committee on Bioethics (DH-BIO), was held on 19-20 June 2012 in Strasbourg, France.

The objective of this Symposium was to provide a basis for the re-examination of the Council of Europe Recommendation (2006)4 on research on biological materials of human origin.

To that end, the Symposium examined the developments in biobanking and research on biological materials of human origin, that have taken place since the adoption of the Recommendation and considered their possible evolution, in order to assess the challenges they may raise with respect to the ethical and legal principles enshrined in the Recommendation.

Programme

Chairs and speakers. Biographical notes

The Speakers. Abstracts

Conclusions to the Symposium

Proceedings (abstracts, full texts, biographical notes)

List of participants

Broadcast of the Symposium

Press review

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