Patient/family views on data sharing in rare diseases: Study in the European LeukoTreat project

European Journal of Human Genetics

Volumn 24, Issue 3, 2016, Pages 338-343

  Darquy, Sylviane ^a   Moutel, Grégoire ^b,e   Lapointe, Anne Sophie ^a   D'Audiffret, Diane ^a   Champagnat, Julie ^a   Guerroui, Samia ^c   Vendeville, Marie Louise ^d   Boespflug Tanguy, Odile ^a,d   Duchange, Nathalie ^a  

^a UNIVERSITÉ PARIS DESCARTES   (France)

^b Paris Descartes University   (France)

^c UNIVERSITÉ CLERMONT AUVERGNE   (France)

^d HÔPITAL ROBERT DEBRÉ   (France)

^e Grégoire Moutel EA7348 Equipe Management des Organisations de Santé MOS   (France)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DATA BASE; ETHICS; EUROPEAN; FAMILY ATTITUDE; HUMAN; LEUKODYSTROPHY; MEDICAL SOCIETY; PATIENT ATTITUDE; PATIENT PARTICIPATION; PRIORITY JOURNAL; QUALITATIVE ANALYSIS; QUANTITATIVE ANALYSIS; QUESTIONNAIRE; RARE DISEASE; ADULT; CLINICAL TRIAL (TOPIC); EUROPE; FACTUAL DATABASE; FAMILY; HEALTH CARE PERSONNEL; INFORMATION DISSEMINATION; LEUKOENCEPHALOPATHIES; MEDICAL RESEARCH; MIDDLE AGED; PERSONNEL; RARE DISEASES;

ADULT; BIOMEDICAL RESEARCH; CLINICAL TRIALS AS TOPIC; DATABASES, FACTUAL; EUROPE; FAMILY; HEALTH PERSONNEL; HUMANS; INFORMATION DISSEMINATION; LEUKOENCEPHALOPATHIES; MIDDLE AGED; RARE DISEASES; RESEARCH PERSONNEL;

EID: 84958114289     PISSN: 10184813     EISSN: 14765438     Source Type: Journal    
DOI: 10.1038/ejhg.2015.115     Document Type: Article

References (37)

1. Council recommendation COM (2009/C 151/02): Council ecommendation on an action in the field of rare diseases. http://ec.europa.eu/health/rare-diseases/key-documents/index-en.htm?Page=2
2. Aymé S, Rodwell C: The European Union Committee of Experts on Rare Diseases: three productive years at the service of the rare disease community. Orphanet J Rare Dis 2014; 9: 30
3. Boespflug-Tanguy O, Labauge P, Fogli A., et al. Genes involved in leukodystrophies: a glance at glial functions. Curr Neurol Neurosci Rep 2008; 8: 217-229
4. Kohlschütter A, Eichler F: Childhood leukodystrophies: a clinical perspective. Expert Rev Neurother 2011; 11: 1485-1496
5. Godard B, Schmidtke J, Cassiman JJ., et al. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A professional perspective. Eur J Hum Genet 2003; 11: S88-122
6. Directive 95/46/EC 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. 1995; 31-55
7. European Commission: Regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation) 2012. http://ec. europa.eu/justice/dataprotection/document/review2012/com-2012-11-en.pdf
8. Mascalzoni D, Dove ES, Rubinstein Y., et al. International charter of principles for sharing bio-specimens and data. Eur J Hum Genet 2014; 23: 721-728
9. OECD: Principles and guidelines for access to research data from public funding 2007, http://www.oecd.org/dataoecd/9/61/38500813.pdf
10. Strobl J, Cave E, Walley T: Data protection legislation: interpretation and barriers to research. BMJ 2000; 321: 890-892
11. Vandenbroucke JP. Maintaining privacy and the health of the public should not be seen as in opposition. BMJ 1998; 316: 1331-1332
12. Duchange N, Darquy S, d?Audiffret D., et al. Ethical management in the constitution of a European database for leukodystrophies rare diseases. Eur J Paediatr Neurol 2014; 18: 97-603
13. Farmer A, Aymé S, De Heredia ML., et al. EURO-WABB: an EU rare diseases registry for Wolfram syndrome, Alström syndrome and Bardet-Biedl syndrome. BMC Pediatr 2013; 13: 130
14. Eurordis policy fact sheet. Rare disease patient registries. 2013. www.eurordis.org/sites/default/files/publications/Factsheet-registries.pdf
15. Moutel G, Duchange N, Raffi F., et al. Communication of pharmacogenetic research results to HIV-infected treated patients: standpoints of professionals and patients. Eur J Hum Genet 2005; 13: 1055-1062
16. Griggs RC, Batshaw M, Dunkle M., et al. Clinical research for rare disease: opportunities, challenges, and solutions. Mol Genet Metab 2009; 96: 20-26
17. Thornton H: The UK Biobank project: trust and altruism are alive and well: a model for achieving public support for research using personal data. Int J Surg 2009; 7: 501-502
18. Almeida AM. Optimizing treatments in rare diseases: will our evidence come from registry data?. Leuk Res 2014; 38: 421-422
19. Bladen CL, Rafferty K, Straub V., et al. The TREAT-NMD Duchene muscular dystrophy registries: conception, design, and utilization by industry and academia. Hum Mutat 2013; 34: 1449-1457
20. Luchenski SA, Reed JE, Marston C., et al. Patient and public views on electronic health records and their uses in the United Kingdom: cross-sectional survey. J Med Internet Res 2013; 15: e160
21. Hansson MG. The need to downregulate: a minimal ethical framework for biobank research. Methods Mol Biol 2010; 675: 39-59
22. Wendler D: One-time general consent for research on biological samples: is it compatible with the health insurance portability and accountability act?. Arch Intern Med 2006; 166: 1449-1452
23. Trinidad SB, Fullerton SM, Bares JM., et al. Informed consent in genome-scale research: what do prospective participants think?. AJOB Prim Res 2012; 3: 3-11
24. Hansson MG. Ethics and biobanks. Br J Cancer 2008; 100: 8-12
25. Gaskell G, Gottweis H, Starkbaum J., et al. Publics and biobanks: Pan-European diversity and the challenge of responsible innovation. Eur J Hum Genet 2013; 21: 14-20
26. McCormack P, Woods S, Aartsma-Rus A., et al. Guidance in social and ethical issues related to clinical, diagnostic care and novel therapies for hereditary neuromuscular rare diseases: ?translating? the translational. PLoS Curr 2013; 10: 5
27. European Commission: 25 recommendations on the ethical, legal and social implications of genetic testing. Guidelines 2004 http://ec.europa.eu/research/ conferences/2004/genetic/pdf/report-en.pdf
28. Grady C, Rubinstein YR, Groft SC. Informed consent and patient registry for the rare disease community: Editorial. Contemp Clin Trials 2011; 33: 3-4
29. Gliklich RE, Dreyer NA, Leavy MB (eds): Registries for Evaluating Patient Outcomes, 3rd edn. Agency for Healthcare Research and Quality: Rockville, MD, USA, 2014.http://www.ncbi.nlm.nih.gov/books /NBK208616/.
30. Curran WJ. Public health and the law. Informed consent and blanket consent forms. Am J Public Health 1971; 61: 1245-1246
31. Caulfield T: Gene banks and blanket consent. Nat Rev Genet 2002; 3: 577
32. Peppercorn J, Shapira I, Deshields T., et al. Ethical aspects of participation in the Database of Genotypes and Phenotypes of the National Center for Biotechnology Information. Cancer 2012; 118: 5060-5068
33. Hansson MG. Building on relationships of trust in biobank research. J Med Ethics 2005; 31: 415-418
34. Master Z, Nelson E, Murdoch B., et al. Biobanks, consent and claims of consensus. Nat Methods 2012; 9: 885-888
35. Steinsbekk KS, Kåre Myskja B, Solberg B: Broad consent versus dynamic consent in biobank research: Is passive participation an ethical problem?. Eur J Hum Genet 2013; 21: 897-902
36. Kaye J, Whitley EA, Lund D., et al. Dynamic consent: a patient interface for twenty-first century research networks. Eur J Hum Genet 2014; 23: 1-6
37. Mascalzoni D, Hicks A, Pramstaller P., et al. Informed consent in the genomics area. PLoS Med 2008; 5: e192