Bioethics
Biobanks

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 (1) for a previous specific research project, (2) for future unspecified research or (3) as residual material originally removed for clinical or forensic purposes or for a previous specific research project. As was envisaged in the Recommendation, a careful re-examination is now called for, both in the light of the experience acquired in the first five years of its implementation and in the light of recent developments. The evolution of the origin of the samples stored in biobanks and its consequences with regard to consent; the identifiability of samples and accompanying data which may have repercussions on protection of privacy and confidentiality; technological evolutions providing easier access to genome wide sequencing and analysis which may raise issues of risk and benefit, consent, and privacy; the increasing amount of multicentre research using large quantities of samples and data coming from different biobanks, and the related problems of transborder flow of materials and associated personal data; rapidly evolving technological advances coupled with the increasing volume of data readily available which may allow identification of an individual from data that is currently considered non-identifiable; those are some of the developments in the light of which the provisions of Rec(2006)4 may need to be re-examined.

Public consultation

Cover letter
Working document

This consultation is opened until 15 August 2015. It takes place within the context of the re-examination of Recommendation (2006)4 of the Committee of Ministers on research on biological materials of human origin. The working document was prepared on the basis of Recommendation (2006) 4, taking into account the outcome of the Symposium on Biobanks and Biomedical Collections, held on 19-20 June 2012 in Strasbourg (France) and the comments made by the delegations to the DH-BIO. The aim of this work carried out by the intergovernmental Committee on Bioethics (DH-BIO) is to address the challenges raised by new developments in the field of biobanking and use of stored and residual biological materials for research purposes since 2006. The main issues taken into consideration include:

1. The need to more specifically address the diverse origins and different levels of identification of biological materials stored for future research;
2. The particular situation of the removal, storage and use of materials from persons not able to consent;
3. The increasing importance of the governance of collections in the light of the interests concerned.

The purpose of this consultation is to elicit comments, in particular from the sectors directly concerned (such as researchers, relevant bodies or institutions, patient organisations and biobank managers). These comments will be taken into consideration in finalising the revision process of the Recommendation.

The DH-BIO would be particularly interested in receiving comments on the following issues:

1. Storage for future research of residual biological materials
Article 13 covers storage for future research of residual biological materials, including materials initially removed within a clinical context or for a specific research project. Article 13 covers both identifiable residual biological materials and already anonymised residual biological materials. In the latter case, as it is not possible to contact the person concerned, storage may require a process of authorisation.

2. Removal, storage and use of biological materials from persons not able to consent
Article 12 gives specific consideration to the removal of biological materials from persons not able to consent, for storage for future research. Paragraph 3 sets conditions for such removal, based on the principles set out in Article 17 of the Convention on Human Rights and Biomedicine, available at http://conventions.coe.int/Treaty/EN/Treaties/Html/164.htm. The same considerations apply to Article 14, covering the storage for future research of residual biological materials from persons not able to consent and Article 17, paragraph 4, addressing the use in research projects of biological materials from persons not able to consent.

3. Governance
A separate chapter on governance was introduced, including in Article 20 general provisions which are applicable to all collections. More specific provisions have been introduced on individual feedback (Article 21), access (Article 22) and transborder flows (Article 23) which will only be relevant for collections engaging in the activities covered in those articles. The provisions on oversight (Article 24) apply proportionate to the risks involved for the persons whose biological materials are stored in the collection.

In addition to the priority issues highlighted above, you are also invited to comment on the other provisions contained in this document.

The consultation process launched today will close on 15 August 2014. You are invited to submit comments in English or French, by 15 August 2014 via email to the following address: dgI.consultation@coe.int

We thank you in advance for your contribution to this consultation.

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.

Any questions you may have about this Symposium should be addressed by e-mail to: bioethics.biobanks@coe.int

Recommendation (2006)4
Explanatory memorandum
Report of the European Commission Expert Group on biobanks
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
Photos of the Symposium
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[1] The interpretation of the seminars, conferences and other events serves to facilitate communication and does not constitute an authentic record of the proceedings. Only the original speech is authentic. No liability shall be incurred by the interpreter in the exercise of his/her function