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WP. 4. Judit S á ndor 1-2 December, 2006, Leuven

GeneBanC Genetic bio and DataBanking: Confidentiality and Protection of Data: Towards a European harmonization and policy. WP. 4. Judit S á ndor 1-2 December, 2006, Leuven Center f or Ethics and Law in Biomedicine CELAB, Budapest.

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WP. 4. Judit S á ndor 1-2 December, 2006, Leuven

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  1. GeneBanCGenetic bio and DataBanking:Confidentiality and Protection of Data: Towards a European harmonization and policy WP. 4. Judit Sándor 1-2 December, 2006, Leuven Center for Ethics and Law in Biomedicine CELAB, Budapest

  2. WP 4. Comparative research regarding the regulatory framework of biobanks in the EU Member States • Objectives: Presentation by Herman Nys: • Collecting and analyzing legislation and regulation regarding the establishment, management and functioning of classical, population and forensic biobanks across Europe • Describing the similarities and differences in such legislation and regulations • Looking for the best rules by comparing these similarities and differences • Proposal for a harmonized regulatory framework across the EU

  3. Methodology • Three distinct questionnaires will be made up and send to local contact persons, one for each type of bio-bank ( classical; population and forensic). These questionnaires will contain detailed questions regarding the regulatory framework of these bio-banks in their countries.

  4. Division of labor Leuven-CEU

  5. Introduction to the Problem Property law, confidentiality, privacy, data protection,

  6. Relevant legal concepts • Personal rights • Privacy (proprietary privacy) • Confidentality • Informed consent • Access to information • Freedom of research • Property, property-like interest • Transferability

  7. How to protect the information related to stored tissues? • What information is stored with the tissue? • Property? Private information? Personal data? Collective data? • What is the difference between the genome and the DNA? • Should all genetic information be protected as genetic data? • Who should have an access? • Do we need innovation or would a new interpretation of the existing data protection laws suffice? • What are the consequences of anonymity and how to secure confidentiality?

  8. As a starting point:Some international legal sources Oviedo Convention, International Declaration on Human Genetic Data (UNESCO)

  9. Relevant articles from the Oviedo Convention • Article 2. Primacy of the Human Being • Article 5. Informed Consent • Article 10. Private Life • Article 11. Non-Discrimination • Article 21. Prohibition of Financial Gain • Article 22. Disposal of a Removed Part of the Human Body

  10. Article 22 of the Oviedo Convention • Disposal of a Removed Part of the Human Body • When in the course of an intervention any part of a human body is removed, it may be stored and used for a purpose other than that for which it was removed, only if this is done in conformity with appropriate information and consent procedures.

  11. Recommendation on Research on Biological Materials of Human Origin • Drafted by the CDBI ( Steering Committee on Bioethics) • Adopted by the Committee of Ministers 15 March, 2006

  12. Population biobanks(CDBI) • a collection of biological materials that has the following characteristics: • collection has a population basis. • it is established, or has been converted, to supply biological materials or data derived therefrom for multiple future research projects; • it contains biological materials and associated personal data which may include or be linked to genealogical, medical and lifestyle data and which may be regularly updated; • It receives and supplies materials in an organized manner

  13. International Declaration on Human Genetic Data (UNESCO, 2003) • Four main pillars: • Collection, Processing, Use, Storage • Article 4 Human genetic data have a special status • Article 7 Non-discrimination and non-stigmatisation • Article 14 Privacy and confidentiality

  14. Preliminary Questions ... Before the Questionnaires

  15. What are the limits of personal autonomy concerning human tissues? • To what extent are we able to control and to make informed decisions on the extra-corporeal elements of body? • With the possibility of storing tissues and to use them for further studies, such as genetic studies, not only ethical and legal perspectives are affected but individual expectations and even personal(ity) rights may emerge or change.

  16. Shall we use the same ethical and legal standards for all kinds of biobanks? • If not, which specific features require additional ethical and legal guarantees? • The fact that samples are taken from vulnerable groups, such as minors? ( this require special consent rules) • Or what matters more is the frequency of the collection, the size of the biobank, or the type of the actual biologic material that is collected?

  17. Some possible policy consequences • Biobanks are subject of regulation • Data protection rules are developed or/and extended to this field • Biobanks have been considered predominantly as a challenge to data protection laws • Security and legality have also been concerns for legal policy • Commercialization and its consequences, however, are not yet adequately assessed in the context of information • Comparative study on various types of biobanks is still missing

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