International norms pertaining to biomedical research in general

• Council of Europe (CoE)
  Additional Protocol to the Convention on Human Rights and Biomedicine Concerning Biomedical Research, Strasbourg, June 30, 2004, opened for signature January 25, 2005.
  
  Convention on Human Rights and Biomedicine adopted in 1997 and its Explanatory Report.

• World Medical Association (WMA)
  Declaration of Helsinki, 1964, last version as amended in Seoul in 2008, and including clarification notes of 2002 and 2004.

• Council for International Organizations of Medical Sciences (CIOMS)
  International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva, November 1, 2002.

International norms specific to biobanks of human biological materials and/or (associated) data and corresponding genetic testing

• Organisation for Economic Cooperation and Development (OECD)
  Council Recommandation on Human Biobanks and Genetic Research Databases of 22 October 2009
  
  OECD Global Forum on Knowledge Economy: Biotechnology; Guidance for the operation of Biological Research Centres (BRCs): General Requirements for all BRCs, adopted in 2004.
  
  Guidelines on the Protection of Privacy and Transborder Flows of Personal Data, adopted in 2001 and including the "Declaration on Transborder Data Flows" and the "Ministerial Declaration on the Protection of Privacy on Global Networks".

• International Society for Biological and Environmental Repositories (ISBER)
  Best Practices for repositories: Collection, Storage, Retrieval and Distribution of Biological Materials for research, adopted in 2008.

• Council of Europe (CoE)
  Protocol on genetic testing for health purposes, adopted by the Committee of Ministers on May 7, 2008. It will be opened for signature at a date to be fixed around mid-november at the handover from the Swedish Chair to the Spanish Chair.
  
  Recommendation (Rec 2006/4) of the Committee of Ministers to Member States on research on biological material of human origin, adopted on March 15, 2006.

• European Nutrigenomics Organisation (NuGO)
  Bioethics Guidelines on Human Studies, officially released September 17th, 2007 in Oslo

• European Union (EU)
  Directive 2006/86/EC of 24 October 2006 implementing Directive2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (Text with EEA relevance), Official Journal L 294, 25/10/2006, p. 32- 50.
  
  Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells, Official Journal L 38, 09/02/2006, p. 40-52.
  
  Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, Official Journal L 102, 07/04/2004 p. 48- 58.
  
  N.B.: Though the scope of these directives is limited to therapeutic applications, the principles it lays down have implications for research.
  
  Directive 95/46 of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, Official Journal L 281.
  
  European Commission, Directorate-General for Research, Directorate L - Science and Society, 25 Recommendations on the ethical, legal and social implications of genetic testing, May 2004.
  
  N.B. These recommendations were prepared by a multidisciplinary expert group consulted by the European Commission. Though this document focuses on genetic testing, several recommendations address human biological material collections and associated data specifically (see e.g. Recommendations 19, 20 and 21). Their base is detailed in a report, from the same group including a chapter on biobanks and were discussed at a Conference in May 2004.

See the Report on ethical, legal ans social aspects of genetic testing and the Conference proceedings

The European Charter of Fundamental Rights of the European Union, included in the Treaty of Lisbon, 2010 version, also available in French; this text does not concern directly biobanks nor genetic testing but it is one of the paramount texts within the EU.

European Commission's Decisions concerning standard contractual clauses for personal data protection in transfers for processing outside the European Union Member States and the European Economic Area (EEA) 

The following European Commission’s decisions have been adopted under the European Data Protection Directive 95/46/EC for setting standard contractual clauses ensuring data protection in personal data transfers from EU member States to countries outside the EU and EEA.

Concerning personal data transfer from data controllers to data controllers:

Decision 2004/915/EC amending the European Commission decision 2001/497/ECas regards the introduction of an alternative set of standard contractual clauses for the transfer of personal data to third countries, C(2004) 5271 (available in all official EU languages)

Concerning personal data transfer from data contollers to data processors (until 15^th of May 2010):

Decision 2002/16/EC on standard contractual clauses for the transfer of personal data to processors established in third countries, under Directive 95/46/EC, C(2001) 4540 (available in all official EU languages)

N.B. From the 15^th of May 2010 the Decision 2010/87/UE repeals the Decision 2002/16/EC.

Concerning personal data transfer from data controllers to data processors AND from data processors to sub-data processors:

Decision 2010/87/EU on standard contractual clauses for the transfer of personal data to processors established in third countries under Directive 95/46/EC of the European Parliament and of the Council, C(2010) 593 (available in all official EU languages)

European Commission's decisions on the adequacy of personal data protection in third countries are available on the website of the Commision.

• World Health Organization (OMS)- European Partnership on Patients’ Rights and Citizens’ Empowerment
  Genetic Databases – Assessing the Benefits and the Impact on Human and Patient Rights, 2003

• United Nations Educational, Scientific and Cultural Organization (UNESCO)
  International Declaration on Human Genetic Data, Paris, October 16, 2003.

• Human Genome Organisation (HUGO)
  Statement on Human Genomic Databases, London, December 2002.

• World Medical Association (WMA)
  The World Medical Association Declaration on Ethical Considerations Regarding Health Databases, Washington, October 6, 2002.

• European Society of Human Genetics (ESHG)
  Data Storage and DNA Banking for Biomedical Research: Technical, Ethical and Social Issues, 2003.