Implementation of written consent for newborn screening in Victoria, Australia

Journal of Paediatrics and Child Health

Volumn 50, Issue 5, 2014, Pages 399-404

  Charles, Taryn ^a   Pitt, James ^a,b   Halliday, Jane ^a,b   Amor, David J ^a,b  

^a ROYAL CHILDREN'S HOSPITAL   (Australia)

^b UNIVERSITY OF MELBOURNE   (Australia)

Author keywords

Guthrie card; newborn screening; storage; written consent

Indexed keywords

ARTICLE; AUSTRALIA; CONTINUING EDUCATION; HEALTH CARE PLANNING; HEALTH PROGRAM; HUMAN; INFORMED CONSENT; MEDICAL RESEARCH; NEWBORN SCREENING; PARENT; PARENTAL CONSENT; PRIORITY JOURNAL; STAFF TRAINING; TOTAL QUALITY MANAGEMENT; WRITTEN CONSENT; EVALUATION STUDY; NEWBORN; PRACTICE GUIDELINE; STANDARDS; STATISTICS AND NUMERICAL DATA; UTILIZATION; WRITING;

GUIDELINE ADHERENCE; HUMANS; INFANT, NEWBORN; NEONATAL SCREENING; PARENTAL CONSENT; PRACTICE GUIDELINES AS TOPIC; QUALITY IMPROVEMENT; VICTORIA; WRITING;

EID: 84899124265     PISSN: 10344810     EISSN: 14401754     Source Type: Journal    
DOI: 10.1111/jpc.12484     Document Type: Article

References (42)

1. Wilcken B,. Newborn screening: how are we travelling, and where should we be going? J. Inherit. Metab. Dis. 2011; 34: 569-574.
2. Couzin-Frankel J,. Newborn blood collections. Science gold mine, ethical minefield. Science 2009; 324: 166-168.
3. Norgaard-Pedersen B, Simonsen H,. Biological specimen banks in neonatal screening. Acta Paediatr. Suppl. 1999; 88: 106-109.
4. Institute of Medicine (US) Roundtable on Translating Genomic-Based Research for Health: Challenges and Opportunities in Using Residual Newborn Screening Samples for Translational Research. Washington 2010. Available from: http://www.ncbi.nlm.nih.gov/books/NBK52737/. [accessed September 2013].
5. Laberge C, Kharaboyan L, Avard D,. Newbron Screening, Banking and Consent. GenEdit. 2004; 2: 1-15.
6. Carmichael M,. Newborn screening: a spot of trouble. Nature 2011; 475: 156-158.
7. Carnahan SJ,. Biobanking Newborn Bloodspots for Genetic Research without Consent. ExpressO. 2010. Available from: http://works.bepress.com/sandra- carnahan/1 [accessed December 2013]
8. Noble T,. How your DNA is falling into private hands. The Age 2004. Available from: http://www.theage.com.au/articles/2004/07/04/1088879374782.html [accessed July 2004].
9. Newborn screening: A blueprint for the future executive summary: newborn screening task force report. Pediatrics 2000; 106 (2 Pt 2): 386-388.
10. Clayton EW,. Talking with parents before newborn screening. J. Pediatr. 2005; 147 (3 Suppl.): S26-29.
11. Kerruish NJ, Webster D, Dickson N,. Information and consent for newborn screening: practices and attitudes of service providers. J. Med. Ethics 2008; 34: 648-652.
12. National Statement on Ethical Conduct in Human Research. Commonwealth of Australia, Canberra: The National Health and Medical Research Council, the Australian Research Council and the Australian Vice-Chancellors' Committee. 2007 (Updated May 2013).
13. Ross LF,. Mandatory versus voluntary consent for newborn screening? Kennedy Inst. Ethics J. 2010; 20: 299-328.
14. Barr G,. Staking the Public Trust on Newborn Dried Blood Spot Retention. Health Law Rev. 2010; 18: 30-38.
15. Cohen E, The government has your baby's DNA. CNN 2010. Available from: http://edition.cnn.com/2010/HEALTH/02/04/baby.dna.government/. [accessed September 2013].
16. Tarini BA,. Storage and use of residual newborn screening blood spots: a public policy emergency. Genet. Med. 2011; 13: 619-620.
17. Bowman DM, Studdert DM,. Newborn screening cards: a legal quagmire. Med. J. Aust. 2011; 194: 319-322.
18. Lawson C,. Newborn screening in Victoria: a case study of tissue banking regulation. J. Law Med. 2008; 16: 523-544.
19. Lewis MH, Goldenberg A, Anderson R, Rothwell E, Botkin J,. State laws regarding the retention and use of residual newborn screening blood samples. Pediatrics 2011; 127: 703-712.
20. Therrell BL Jr, Hannon WH, Bailey DB Jr, et?al. Committee report: Considerations and recommendations for national guidance regarding the retention and use of residual dried blood spot specimens after newborn screening. Genet. Med. 2011; 13: 621-624.
21. Kharaboyan L, Avard D, Knoppers BM,. Storing newborn blood spots: modern controversies. J. Law Med. Ethics 2004; 32: 741-748.
22. Suriadi C, Jovanovska M, Quinlivan JA,. Factors affecting mothers' knowledge of genetic screening. Aust. N. Z. J. Obstet. Gynaecol. 2004; 44: 30-34.
23. Davey A, French D, Dawkins H, O'Leary P,. New mothers' awareness of newborn screening, and their attitudes to the retention and use of screening samples for research purposes. Genomics, Soc. Policy 2005; 1: 41-51.
24. Muchamore I, Morphett L, Barlow-Stewart K,. Exploring existing and deliberated community perspectives of newborn screening: informing the development of state and national policy standards in newborn screening and the use of dried blood spots. Aust. New Zealand Health Policy 2006; 3: 14.
25. Hider K, Naksook C,. Identifying fundamental problems with the Victorian newborn screening program. Health Issues 2007; 90: 36-39.
26. Hider K, McBride TH, Naksook C, Informed Consent for Newborn Screening in Victoria. Melbourne: Health Issues Centre, Latrobe University; 2005. Available from: http://www.healthissuescentre.org.au/documents/items/2008/04/204840- upload-00001.pdf. [accessed September 2013].
27. Essentially Yours: The Protection of Human Genetic Information in Australia. Canberra: Australian Law Reform Commission and Australian Health Ethics Committee; 2003.
28. Delatycki MB,. The ethics of screening for disease. Pathology 2012; 44: 63-68.
29. Dhondt JL,. Implementation of informed consent for a cystic fibrosis newborn screening program in France: low refusal rates for optional testing. J. Pediatr. 2005; 147 (3 Suppl.): S106-108.
30. Faden R, Chwalow AJ, Holtzman NA, Horn SD,. A survey to evaluate parental consent as public policy for neonatal screening. Am. J. Public Health 1982; 72: 1347-1352.
31. Liebl B, Nennstiel-Ratzel U, von Kries R, et?al. Very high compliance in an expanded MS-MS-based newborn screening program despite written parental consent. Prev. Med. 2002; 34: 127-131.
32. Johnstone MJ,. Nursing ethics and informed consent. Aust. Nurs. J. 2011; 19: 29.
33. Victorian Newborn Screening Review Committee Final Report for the Minister for Health. Melbourne: Department of Human Services, Victoria; 2006. Available from: https://www.privacy.vic.gov.au/privacy/web2.nsf/files/victorian- newborn-screening-review-committee-final-report. [accessed September 2013].
34. Nijsinghe N,. Informed consent and the expansion of newborn screening. In:, Dawson AV, Verweij M, eds. Ethics, Prevention and Public Health. Oxford: Clarendon Press, 2007; 199-212.
35. Newborn screening e-learning tool. 2012. Available from: http://www.vcgs.org.au/pathology/nbs/etool/Default.aspx. [accessed 6 June 2013].
36. Newborn Screening. 2012. Available from: http://www.vcgs.org.au/ pathology/sections/NewbornScreening/?docid=aa3a4d81-d44b-42ff-8340-99360112c7a7. [accessed 12 September 2013].
37. Newson AJ,. Should parental refusals of newborn screening be respected. Camb. Q. Healthc. Ethics 2006; 15: 135-146.
38. Jaques AM, Collins VR, Pitt J, Halliday JL,. Coverage of the Victorian newborn screening programme in 2003: a retrospective population study. J. Paediatr. Child Health 2008; 44: 498-503.
39. Miller FA, Hayeems RZ, Carroll JC, et?al. Consent for newborn screening: the attitudes of health care providers. Public Health Genomics. 2010; 13: 181-190.
40. Duquette D, Rafferty AP, Fussman C, Gehring J, Meyer S, Bach J,. Public support for the use of newborn screening dried blood spots in health research. Public Health Genomics. 2011; 14: 143-152.
41. Tarini BA, Goldenberg A, Singer D, Clark SJ, Butchart A, Davis MM,. Not without my permission: parents' willingness to permit use of newborn screening samples for research. Public Health Genomics 2010; 13: 125-130.
42. Holtzman NA, Faden R, Chwalow AJ, Horn SD,. Effect of informed parental consent on mothers' knowledge of newborn screening. Pediatrics 1983; 72: 807-812.