The danish newborn screening biobank in practice and research: Revised biobank regulations

Genomics and public health: Legal and socio-ethical perspectives

Volumn , Issue , 2006, Pages 97-110

  Norgaard Pedersen, Bent ^a   Hougaard, David ^a  

^a STATENS SERUM INSTITUT   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84882434210     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1163/ej.9789004155596.i-329     Document Type: Chapter

References (38)

1. B. Nørgaard-Pedersen, Use of Stored Samples from the Danish PKU Register in, 303 Human DNA: Law and Policy (B. M. Knoppers & C. M. Laberge eds., 1997); B. Nørgaard-Pedersen, The Danish PKU Register and Biobank, in 59 Proceedings from the Workshop on Human Biobanks: Ethical and Social Issues (vol. 9, Nord Biotechnol. Series) (1997); B. Nørgaard-Pedersen & H. Simonsen, Biological Specimen Banks in Neonatal Screening, 432 ACTA PÆDIATR. (supplement) 106 (1999).
2. H. Simonsen et al., Neonatal Screening i Danmark. Status og Fremtidsperspektiver, 160 UGESKR. LAEG. 5777 (1998).
3. Statens Serum Institut, http://www.ssi.dk(gravide/nyfødte).
4. Sundhedsstyrelsen, http://www.Sundhedsstyrelsen.dk/vaev.
5. G. Almind et al., Health Science Information Banks: Biobanks (1996).
6. Public Register Act, available in An Account on Biobanks (Summary in English), 1414 (2002).
7. Regulations for the PKU Registry, Ministry of Health Executive Order, Jan. 14, 1993, Copenhagen.
8. Statens Serum Institut, 2004: 1-3.
9. Council Directive 95/46, 1995 O. J. (L 281) 31.
10. An Account on Biobanks (Summary in English), 1414 (2002), at 245.
11. Act on Processing of Personal Data, No. 429, May 31, 2000 (Dan.).
12. Act on the Legal Status of Patients, No. 482, July 1, 1998 (Dan.).
13. Act on a Scientific Ethical Committee System and the Handling of Biomedical Research Projects, No. 402, May 28, 2003 (Dan.).
14. No. 141, March 5, 2001 (Dan.).
15. Anonymous, Guidelines about Notification etc. of a Biomedical Research Project to the Committee System on Biomedical Research Ethics (2004), http://www.cvk.im.dk/visArtikel.asp?artikelID=1642.
16. Vejledning om biobanker inden for sundhedsområdet: Patientrettigheder og mundighedskrav [Guidelines for Biobanks in the Health Care Area: Patient Rights and Authority Claims], 1 SK. T., J. NR. (2004)1660-24.
17. Act on Patients' Rights, available in An Account on Biobanks (Summary in English), 1414 (2002).
18. Act on Scientific Committee, available in An Account on Biobanks (Summary in English), 1414 (2002).
19. Act on Health, available in An Account on Biobanks (Summary in English), 1414 (2002).
20. M. B. Petersen et al., Early Manifestations of the Carbohydrate-Deficient Glycoprotein Syndrome, 122 J. PEDIATR 66 (1993).
21. C. Jacobs et al., Diagnosis of Zellweger Syndrome by Analysis of Very Long-Chain Fatty Acids in Stored Blood Spots Collected at Neonatal Screening, 16 J. INHERIT.METAB. DIS. 63 (1993).
22. L. A. Larsen et al., Recessive Romano-Ward Syndrome Associated with Compound Heterozygosity for Two Mutations in the KVLQT1 Gene, 7 EUR. J. HUM. GENET. 724 (4); M. Christiansen et al., Mutations in the HERG K+-ion Channel: A Novel Link Between Long QT Syndrome and Sudden Infant Death Syndrome, 95 AM. J.CARDIOL. 433 (2005).
23. K. Christensen et al., Oral Clefts, Transforming Growth Factor Alpha Gene Variants, and Maternal Smoking: A Population-Based Case-Control Study in Denmark, 1991-1994, 149 AM. J. EPIDEMIOL. 248 (4).
24. B. Nørgaard-Pedersen et al., Immunoreactive Trypsin and a Comparison of Two ▲F508 Mutation Analyses in Newborn Screening for Cystic Fibrosis: An Anonymous Pilot Study in Denmark 2 SCREENING 1 (4).
25. M. Lebech et al., Feasibility of Neonatal Screening for Toxoplasma Infection in the Absence of Prenatal Treatment, 353 LANCET 1834 (1999).
26. P. J. Meikle et al., Newborn Screening for Lysosomal Storage Disorders, MOL. GEN.METAB. (forthcoming 2006).
27. J. B. Lundemose et al., The Frequency of a Disease-Causing Point-Mutation in the Gene Coding for Medium-Chain Acyl-CoA Dehydrogenase (MCAD) in Sudden Infant Death Syndrome (SIDS), 82 ACTA PAEDIATR. 544 (1993).
28. P. S. Hansen et al., Incidence of the Apolipoprotein B-3500 Mutation in Denmark, 230 CLIN. CHIM. ACTA 101 (1994).
29. T. B. Larsen et al., The Arg506Gln Mutation (FV Leiden) among a Cohort of 4188 Unselected Danish Newborns, 89 THROMB. RES. 211 (1998).
30. A. T. Merryweather-Clarke et al., A Retrospective Anonymous Pilot Study in Screening Newborns for HFE Mutations in Scandinavian Populations, 13 HUM. MUTAT. 154 (1999).
31. C. Nilsson et al., Determination of a Common Genetic Variant of Luteinizing Hormone Using DNA Hybridization and Immunoassays, 49 CLIN. ENDOCRINOL. (OXF.) 369 (1998).
32. M. Jiang et al., The Frequency of an Inactivating Point Mutation (566C→T) of the Human Follicle-Stimulating Hormone Receptor Gene in Four Populations Using Allele-Specific Hybridization and Time-Resolved Fluorometry, 83 J. CLIN. ENDOCRINOL. METAB. 4338 (1998).
33. H. Eiberg et al., Cholestasis Familiaris Groenlandica/ Byler-Like Disease in Greanland - A Population Study, Proceedings of the 12th International Congress on Circumpolar Health, 63 INT. J. CIRCUMPOLAR HEALTH (supplement 2) 189 (2004).
34. A. K. Valeur-Jensen et al., Risk Factors for Parvovirus B19 Infection in Pregnancy, 281 J. A. M. A. 1099 (1999).
35. M. Lebech & E. Petersen, Neonatal Screening for Congenital Toxoplasmosis in Denmark: Presentation of the Design of a Prospective Study, 84 SCAND. J. INFECT. DIS. (supplement) 75 (1992).
36. J. Olsen et al., The Danish National Birth Cohort - Its Background, Structure and Aim, 29 SCAND. J.PUBLIC HEALTH 300 (2001).
37. M. Hartlev & U. Lind, Use of Blood Samples from the Danish PKU-Biobank - A Study of the Conceptualization of Research in Law and in Action, Eureca Workshop, Tenerife 2005 (forthcoming 2006).
38. Statens Serum Institut, http://www.ssi.dk.