Rare disease research: Breaking the privacy barrier

Applied and Translational Genomics

Volumn 3, Issue 2, 2014, Pages 23-29

  Mascalzoni, Deborah ^a   Paradiso, Angelo ^b,c   Hansson, Matts ^a  

^a UPPSALA UNIVERSITY   (Sweden)

^b Scientifico Istituto Oncologico Bari   (Italy)

^c Laboratorio Oncologia Sperimentale Clinica Istituto Oncologico Bari   (Italy)

Author keywords

Informed consent; Privacy; Private sphere; Research barriers

Indexed keywords

ACCESS TO INFORMATION; ARTICLE; CLINICAL DATA REPOSITORY; COMPUTER SECURITY; GENETIC PRIVACY; GENOMICS; HEALTH CARE QUALITY; HUMAN; HUMAN GENOME; INFORMATION DISSEMINATION; INFORMED CONSENT; PATIENT AUTONOMY; PATIENT INFORMATION; PATIENT PARTICIPATION; PRIORITY JOURNAL; RARE DISEASE; VULNERABLE POPULATION;

EID: 84902293753     PISSN: 22120661     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.atg.2014.04.003     Document Type: Article

References (30)

1. Bledsoe M.J., Clayton E.W., McGuire A.L., Grizzle W.E., O'Rourke P.P., Zeps N. Return of research results from genomic biobanks: a call for data. Genet. Med. 2013, 15(2):159-160.
2. Center for Disease Control and Prevention (Webpage accessed on September 10th 2013). http://www.cdc.gov/genomics/public/.
3. Cohen J.E. Examined lives: informational privacy and the subject as object. Stanf. Law Rev. 2000, 52(5):1373-1438.
4. Council of Europe The Convention for the Protection of Human Right and Dignity of the Human Being With Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (Oviedo Convention) 1997.
5. Council of Europe Committee of Ministers, CE Recommendation No. R (97) 5 on the Protection of Medical Data 1997.
6. Council of Europe Committee of Ministers, CE Recommendation Rec (2006) 4 of the Committee of Ministers to Member States on Research on Biological Materials of Human Origin 2006.
7. COUNCIL RECOMMENDATION COUNCIL RECOMMENDATION. of 8 June 2009 on an action in the field of rare diseases 2009, (2009/C 151/02).
8. Francis L.P., Francis J.G. Data citizenship and informed consent. Am. J. Bioeth. 2013, 13(4):38-39.
9. Genetic Alliance (Webpage accessed on 11 Sept. 2013). http://www.geneticalliance.org/reg4all.
10. Giesbertz N.A., Bredenoord A.L., Van Delden J.J. A thick opt-out is often sufficient. Am. J. Bioeth. 2013, 13(4):44-46.
11. Hansson M. The Private Sphere Dordrecht 2008, springer.
12. Hansson M. Where should we draw the line between quality of care and other ethical concerns related to medical registries and biobanks?. Theor. Med. Bioeth. 2012, 33(4):313-323.
13. Hansson M.G., Van Ommen G.J., Chadwick R., Dillner J. Patients would benefit from simplified ethical review and consent procedure. Lancet Oncol 2013, 14(6):451-453.
14. Howie B., Fuchsberger C., Stephens M., Marchini J., Abecasis G.R. Fast and accurate genotype imputation in genome-wide association studies through pre-phasing. Nat. Genet. 2012, 44(8):955-959.
15. Johnsson L., Hansson M.G., Eriksson S., Helgesson G. Patients' refusal to consent to storage and use of samples in Swedish biobanks: cross sectional study. BMJ 2008, 337:a345.
16. Kaye J. The tension between data sharing and the protection of privacy in genomics research. Annu. Rev. Genomics Hum. Genet. 2012, 13:415-431.
17. Kaye J., Curren L., Anderson N., Edwards K., Fullerton S.M., Kanellopoulou N., Lund D., MacArthur D.G., Mascalzoni D., Shepherd J., Taylor P.L., Terry S.F., Winter S.F. From patients to partners: participant-centric initiatives in biomedical research. Nat. Rev. Genet. 2012, 13(5):371-376.
18. Mascalzoni D., Hicks A., Pramstaller P., Wjst M. Informed consent in the genomics era. PLoS Med. 2008, 5(9):e192.
19. Mascalzoni D., Knoppers B.M., Ayme S., Macilotti M., Dawkins H., Woods S., Hansson M.G. Rare disease and now rare data?. Nat. Rev. Genet. 2013, 14(6):372.
20. McGuire A.L., Gibbs R.A. No longer de-identified. Science 2006, 312(5772):370-371.
21. Mello M.M., Wolf L.E. The Havasupai Indian tribe case - lessons for research involving stored biologic samples. N. Engl. J. Med. 2010, 363(3):204-207.
22. Oliver J.M., Slashinski M.J., Wang T., Kelly P.A., Hilsenbeck S.G., McGuire A.L. Balancing the risks and benefits of genomic data sharing: genome research participants' perspectives. Pub. Health Gen. 2012, 15(2):106-114.
23. NIH Office of rare diseases research, http://rarediseases.info.nih.gov/research/pages/43/global-rare-disease-patient-registry-and-data-repository. accessed 02.05.2014.
24. Orphanet (Webpage accessed on September 11th 2013). http://www.orpha.net/consor/cgi-bin/Education_AboutRareDisease.php.
25. Rothstein M.A., Shoben A.B. Does consent bias research?. Am. J. Bioeth. 2013, 13(4):27-37.
26. Rothstein M.A., Shoben A.B. An unbiased response to the open peer commentaries on "does consent bias research?". Am. J. Bioeth. 2013, 13(4):W1-W4.
27. Tabor H.K., Berkman B.E., Hull S.C., Bamshad M.J. Genomics really gets personal: how exome and whole genome sequencing challenge the ethical framework of human genetics research. Am. J. Med. Genet. A 2011, 155(12):2916-2924.
28. Tallacchini M. Il corpo anonimo. retorica dell'appropriazione dei materiali biologici umani KOS 2005.
29. Thomson J.J. The realm of rights. Philosophical Dimension of Privacy: An Anthology 1990, 285-288.
30. Williams J. The rhetoric of property. Iowa L. Rev. 1998, 83:277.