Issues in protecting privacy in medical research using genetic information and biobanking: The privileged project

Medical Law International

Volumn 10, Issue 4, 2010, Pages 253-268

  Taylor, Mark J ^a   Townend, David ^b  

^a UNIVERSITY OF SHEFFIELD   (United Kingdom)

^b MAASTRICHT UNIVERSITY   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

BIOBANKING; CITIZENSHIP; EUROPE; GENETIC PRIVACY; HEALTH CARE FACILITY; HEALTH CARE POLICY; HUMAN; LAW; LEGAL ASPECT; MEDICAL RESEARCH; PROTECTION; REVIEW;

EID: 79951806670     PISSN: 09685332     EISSN: None     Source Type: Journal    
DOI: 10.1177/096853321001000401     Document Type: Review

References (24)

1. Project number 36775 (Co-ordinating Action under FP6-2005-Science and Society-14): Determining the Ethical and Legal Interests in Privacy and Data Protection for Research Involving the use of Genetic Databases and Bio-banks: PRIVILEGED, http://www.privilegedproject.eu/ (last accessed 23rd September 2010).
2. Beyond the work of PRIVILEGED, see other European funded projects, for example GeneBanC (http://www.genebanc.eu/) and Biobanking and Biomolecular Research Resources infrastructure, BBMRI (http://www.bbmri.eu/).
3. See also, outside European funding, Public Population Project in Genomics, p3g (http:// www.p3g.org/).
4. An interesting recent collection of essays on the subject is Jane Kaye and Mark Stranger (eds.) (2009) Principles and Practice in Biobank Governance. Farnham: Ashgate (http://www.ashgate.com/isbn/9780754678250) (Each site last viewed on 23rd September 2010).
5. Although the definition of 'genetic information' is contested, particularly as to whether it is simply the data derived from a sample, or whether the sample itself is data, we operated in our research with a wide definition. This includes information derived from genotype, phenotype or family information.
6. Greenbaum, D., Du, J., and Gerstein, M. (2008) Genomic Anonymity: Have we already lost it? The American Journal of Bioethics 8: 10, 71, 74;
7. Homer, N., Szelinger, S., Redman, M., Duggan, D., Tembe, W. et al. (2008) Resolving Individuals Contributing Trace Amounts of DNA to Highly Complex Mixtures Using High-Density SNP Genotyping Microarrays. PLoS Genet 4(8): e1000167. doi:10.1371/journal.pgen.1000167
8. Project number 36775 (Co-ordination Action under FP6-2005-Science and Society-14): Determining the Ethical and Legal Interests in Privacy and Data Protection for Research Involving the use of Genetic Databases and Bio-banks: PRIVILEGED. http://www.privilegedproject.eu/ (last accessed 23rd September 2010).
9. A 'Co-ordination Action' is an EC Research Framework instrument designed to bring a consortium of experts in a particular field together to develop their existing ideas. It does not fund new, empirical research, rather it provides a forum for developing new ideas from collective discussion of existing work and perspectives.
10. These countries were included first to address the broad EU and EEA concerns and approaches to the issue, and second, given the international potential for linking biobanks, to examine a small number of countries with different cultures.
11. An account of these findings can be found in Townend, D., Taylor, M.J., Wright, J., and Wickins-Drazilova, D. (2010) Privacy Interests in Biobanking: A Preliminary View on a European Perspective, pp. 137-159 in J. Kaye and M. Stranger Principles and Practice in Biobank Governance. Farnham: Ashgate.
12. A collection of alternative definitions for some of the key terms about 'privacy' and 'biobanking' can be seen at the PRIVILEGED website: http://www. privileged.group.shef.ac.uk/projstages/stage1/ (last viewed 23rd September 2010). We took a similarly inclusive approach to the concept of 'genetic information', recognising that it might be understood to apply to information about genotype, phenotype or family information.
13. For more information about these particular distinctions within genetic information see, for example, Human Genetics Commission report (May 2002) Inside Information page 26 http://www.hgc.gov. uk/UploadDocs/Contents/Documents/ iichapter1.pdf (lasted viewed 15th October 2010).
14. Although it is probably worth noting, they are not entirely fanciful. A report by the Department of Health in 2009 reported attitudes towards using particularly sensitive information (such as that placed within a 'sealed envelope' on an individual's health record) for research purposes. 30% of the general public thought this was acceptable, 43% thought sealed envelope data could be used for research with consent, but 25% thought such sensitive data should never be used for research (even if consented). One of the interesting things about this piece of research, althougth it was not looking at genetic information per se, is that it identified a significant variation between different stakeholder groups: the general public; patients and researchers themselves.
15. See, Department of Health 'Summary of Responses to the Consultation on the Additional Uses of Patient Data' at p6 http://www.dh.gov.uk/prod-consum-dh/ groups/dh-digitalassets/ documents/digitalasset/dh-110715.pdf (Last visited 23rd September 2010).
16. Divergence may also be evident within the spread of attitudes across different stakeholder groups. See fn.2 above.
17. See fn. 7 above.
18. See fn. 2 above.
19. Again, the PRIVILEGED website gives country by country links to available primary and secondary legislation across the countries covered in the study. It also gives comparative analysis about the available laws. See also the PRIVIREAL website (www.privireal.org-last viewed 28 September 2010).
20. PRIVIREAL was an EC FP5 funded project examining, with a similar group of academics, the implementation of the Data Protection Directive (95/46/EC) in relation to medical research, and the operation of Research Ethics Committees in respect of the law (particularly data protection law).
21. For example, in the understanding of 'explicit consent' in Article 8 of the Directive (95/46/EC).
22. This particular question is taken up and discussed in Wright, J., Ploem, C., Sliwka, M., and Gevers, J. 'Regulating Tissue Research: Do We Need Additional Rules to Protect Research Participants?' European Journal of Health Law, Volume 17 (5), 2010, pp. 455-469(15)
23. Article 6(1)(b) and 11(2).
24. Article 13(2).