Biobanks. Re-examination of Recommendation (2006)4

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.

Below are some of the developments in the light of which the provisions of Rec(2006)4 may need to be re-examined:

  • 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

Public consultation

Cover letter
Working document
Compilaton of replies

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.

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 will be taken into consideration when finalising the revision of the Recommendation.

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:

Recommendation (2006)4
Explanatory memorandum
Report of the European Commission Expert Group on biobanks
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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