Guthrie Cards in Scotland: Ethical, Legal and Social Issues

FOOTNOTES

1. Professor of Medical Jurisprudence and Founding Director of the JK Mason Institute for Medicine, Life Science and the Law, School of Law, University of Edinburgh. Research for the report began while Laurie was Director of AHRC/SCRIPT, a law and technology research centre based in Edinburgh Law School and sponsored by the Arts and Humanities Research Council (2002-2012).

2. Dr Hunter was Research Manager for AHRC/SCRIPT at the time research for this report began and subsequently held the post of Senior Lecturer in Law at Northumbria University.

3. Professor of Medical and Family Sociology, Head of School of Molecular, Genetic and Population Health Sciences, University of Edinburgh.

4. The EC Privileged Project examines privacy in law, ethics and genetic data. See: http://www.privileged.group.shef.ac.uk/

5. Genewatch, 'Keeping blood spots from newborn babies', January 2006, available at: http://www.genewatch.org/pub-507666

6. http://www.healthcareimprovementscotland.org/ (established 1 April 2011).

7. http://nrs.mtcserver8.com/ (last visited 8 April 2013). For the strategy see: "Investing in Research|Improving Health: The Research Strategy for Health and Healthcare" (2009), available at - http://www.nhsresearchscotland.org.uk/cms/documents/CSO%20Investinng%20in%20Research%20-%20Improving%20Health.pdf

8. For details of the Accreditation Scheme (2011), see http://www.sehd.scot.nhs.uk/cmo/CMO(2011)07.pdf. Note, Para 4 of the Scheme makes it explicit that it extends to the Guthrie card collection.

9. NSS is a non-departmental public body. As such, it is subject to Freedom of Information requests and applications for judicial review of its policies and decisions.

10. http://www.screening.nhs.uk/about

11. http://newbornbloodspot.screening.nhs.uk/programmecentre

12. http://www.screening.nhs.uk/policyreview

13. This was initiated because Scotland started screening for Cystic Fibrosis at that time. The CF test is done in two stages; the second stage involves DNA analysis, which was a departure from the kinds of tests that were done previously. Due to sensitivity around DNA testing, explicit consent was introduced for newborn blood spot screening.

14. "Your Guide to Newborn Screening Tests" (2012): http://www.healthscotland.com/documents/4258.aspx

15. Newborn blood spot screening in the UK - Policies and Standards, April 2005. ISBN 0955013801, available at: http://newbornbloodspot.screening.nhs.uk/cms.php?folder=2547. This document remains current and embodies as Code of Practice on how the retained Guthrie cards will be used, see: http://newbornbloodspot.screening.nhs.uk/public#13

16. Your Guide to Newborn Screening Tests, p20, n14 above.

17. Procedures exist to record parental wishes about use/non-use and parents who express a wish that retention does not continue after 12-months are re-contacted to confirm this.

18. Pers. comm.

19. Available on request from Chief Scientist Office.

20. http://www.nhsggc.org.uk/content/default.asp?page=s1685.

21. UK Newborn Screening Programme Centre, Standards and Guidelines for Newborn Blood Spot Screening, August 2008.

22. UK Newborn Screening Programme Centre, Consultation on the newborn blood spot screening standards mapped to the generic standards framework: 20th December 2012 - 4th February 2013 - Consultation report, March 2013: http://newbornbloodspot.screening.nhs.uk/standards-consultation-2012-13.

23. In March 2004, a public consultation on "Telling parents about the heel-prick test" was undertaken by Stewart, Hargreaves and Oliver, report available at: http://newbornbloodspot.screening.nhs.uk/cms.php?folder=2488; another consultation was held in 2005 on the "Storage and use of newborn babies blood spot cards: a public consultation" (Oliver, S, Stewart, R, Hargreaves, K and Dezateux, C. London: Social Science Research Unit, Institute of Education, University of London); however, the report of this consultation is not yet available.

24. Freedom of Information (Scotland) Act 2002. In the rest of the UK the law is contained in the Freedom of information Act 2000.

25. See, for example, J. Kaye, 'From single biobanks to international networks: Developing e-governance' (2011) 130(3) Human Genetics 377-382.

26. J. Couzin-Frankel, 'Newborn blood collections. Science gold mine, ethical minefield' (2009) 324 (5924) Science 166-8 and J. Wilkinson, 'Analysis of Guthrie cards could provide insight into epigenome at birth' (2012) 4(5) Epigenomics 480-1.

27. See, M. Carmichael, 'Newborn screening: a spot of trouble' (2011) 475 Nature 156-158, doi:10.1038/475156a, and M.H. Lewis, A. Goldenberg, R. Anderson, E. Rothwell and J. Botkin, 'Blood samples: State laws regarding the retention and use of residual newborn screening blood samples' (2011) 127 Paediatrics 703-712.

28. Beleno v Tex. Dept. of State Health Services, (2009); For commentary, see K. Drabiak-Syed, 'Legal regulation of banking newborn blood spots for research: How Bearder and Beleno resolved the question of consent' (2011) 11 Houston Journal of Health Law and Policy 1-46.

29. For selected docket material from the case and reference to the settlement agreement, see here: http://iucb.wordpress.com/2010/02/26/newborn-blood-spots-biobanks-the-law-research-ethics-in-the-news/

30. For an account of the circumstances, see: http://www.genomicslawreport.com/index.php/2010/03/16/the-texas-newborn-bloodspot-saga-has-reached-a-sad-and-preventable-conclusion/

31. S. Hu, 'Minnesota Supreme Court hears whether the Genetic Privacy Act protects newborn blood spot samples obtained under the state's newborn screening statutes--Bearder v. State of Minnesota.' (2012) 38(1) Am J Law Med 225-7.

32. See L.D. (Guardian ad litem of) v. Provincial Health Services Authority (2011) BCSC 628.

33. M.H. Lewis, A. Goldenberg, R. Anderson, E. Rothwell and J. Botkin, 'State laws regarding the retention and use of residual newborn screening blood samples' (2011) 127 Paediatrics 703-712. For an argument for harmonisation of guidance, see: B.L. Jr Therrell, W.H. Hannon, D.B. Jr Bailey, E.B. Goldman, J. Monaco, B. Norgaard-Pedersen, S.F. Terry, A. Johnson, and R.R. Howell, 'Committee report: Considerations and recommendations for national guidance regarding the retention and use of residual dried blood spot specimens after newborn screening' (2011) 13(7) Genetic Medicine 621-4.

34. Note 32, at paras 51-55.

35. Id., at para 58.

36. See, R. McGreevey, "Calls for 'priceless resource' of heel prick test results to be saved", The Irish Times, 5 February 2013, available at: http://www.irishtimes.com/news/health/calls-for-priceless-resource-of-heel-prick-test-results-to-be-saved-1.1254279

37. See, M. Houston, "Reilly does U-turn ordering HSE not to destroy newborn blood samples - Heel prick cards to be retained until expert group reports", The Irish Times, 26 March 2013, available at: http://www.irishtimes.com/news/health/reilly-does-u-turn-ordering-hse-not-to-destroy-newborn-blood-samples-1.1338666.

38. See Health and Disability Commissioner (Code of Health and Disability Services Consumers' Rights) Regulations 1996 (SR 1996/78), Right 7(10), and for a lay explanation The NZ National Screening Unit: http://www.nsu.govt.nz/current-nsu-programmes/2917.aspx.

39. Australian Law Reform Commission, Essentially Yours: The Protection of Human Genetic Information in Australia (2003), chapter 19.

40. Victorian Newborn Screening Review Committee, Final Report for the Minister for Health (2006), available at: https://www.privacy.vic.gov.au/privacy/web2.nsf/files/victorian-newborn-screening-review-committee-final-report/$file/report_08_06.pdf

41. See D.M. Bowman and D.M. Studdert, 'Newborn screening cards: a legal quagmire' (2011) 194(6) Medical Journal of Australia 319-322, at 319 quoting Office of the Victorian Privacy Commissioner, Submission to the Forensic Procedures Review Committee on its review of Part ID of the Crimes Act 1914 (Cth). (2002) Melbourne: Privacy Victoria.

42. The UK Newborn Screening Programme Centre's website sets out the various uses of the stored blood spots: 1. To monitor and improve the newborn screening programme; 2. To directly benefit individuals and their families; 3. To monitor the health of the general population; 4. To answer questions about specific health problems; 5. To develop new equipment and tests; 6. For police forensic work. See: http://newbornbloodspot.screening.nhs.uk/FAQs.

43. G. Haddow, G. Laurie, S. Cunningham-Burley and K.G. Hunter, 'Tackling community concerns about commercialisation and genetic research: A modest interdisciplinary proposal' (2007) 64 Soc Sci & Med 272-282.

44. See Article 8(1) and 8(2) of the European Convention on Human Rights as incorporated in the Human Rights Act 1998.

45. See further: http://newbornbloodspot.screening.nhs.uk

46. http://newbornbloodspot.screening.nhs.uk/standards#fileid10827

47. Available at: http://newbornbloodspot.screening.nhs.uk/standards-consultation-2012-13

48. Available at: http://www.healthcareimprovementscotland.org/previous_resources/standards/pregnancy_and_newborn_screen.aspx

49. See the leaflet on newborn blood spot screening at: http://newbornbloodspot.screening.nhs.uk/languages; and NHS Scotland, Your Guide to Newborn Screening Tests, available at: http://www.healthscotland.com/uploads/documents/20214-YourGuidetoNewbornScreeningTests.pdf

50. http://newbornbloodspot.screening.nhs.uk/health-professional-handbook

51. For comment on this fragmented approach to legal regulation of tissue and data, see G. Laurie and S.H.E. Harmon, 'Through the thicket and across the divide: Successfully navigating the regulatory landscape in life sciences research' in M Pickersgill and E Cloatre (eds), Knowledge, Technology and Society: Interrogating the Nexus, (2013), Routledge.

52. The HTA 2004 applies primarily in England, Wales and Northern Ireland (except certain sections including section 45, which also applies to Scotland, see further below).

53. 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, OJ L 281, Nov. 23, 1995.

54. The Article 29 Data Protection Working Party is a group experts established by the European Commission to advise member states on the implementation and interpretation of the Data Directive which is the basis of the UK's Data Protection Act 1998. See, Opinion 4/2007 on the concept of personal data, 20^th June 2007, (01248/07/EN WP 136). On "separate sets of rules" the Working Party recommends considering the Council of Europe Recommendation No. Rec (2006) 4 of the Committee of Ministers to Member States on research on biological materials of human origin, 15 March 2006.

55. S and Marper v United Kingdom (2009) 48 EHRR 50, para 68.

56. The Scottish Government, A guide to the required standards of practice in the management of records for those who work within or under contract to NHS organisations in Scotland, [NHS Code of Practice: v2.1.] (2012) p.66. Available at: http://www.scotland.gov.uk/Resource/Doc/366562/0124804.pdf

57. Ibid.

58. Scottish Government, Records Management: Code of Practice (Scotland) Version 1.0, Annex D 'The Management, Retention and Disposal of Personal Health Records', July 2008, p.88.

59. 'Category E' data are those held by public authorities in non-electronic or un-filed records.

60. Information Commissioner's Office, Use and Disclosure of Health Data (2002), chapter 3.

61. Ibid.

62. CSAGC, Protecting Patient Confidentiality - Final Report (2002), paras 6.5-6.8, available at: http://www.sehd.scot.nhs.uk/publications/ppcr/ppcr.pdf

63. As the Guide points out, "NHS organisations need robust records management procedures to meet the requirements set out under the Data Protection Act 1998, the Freedom of Information (Scotland) Act 2002 and the Environmental Information (Scotland) Regulations 2004. In addition they will be required to produce and implement a records management plan under the terms of the Public Records (Scotland) Act 2011." (para 17).

64. http://www.knowledge.scot.nhs.uk/ig.aspx

65. Dame Fiona Caldicott, Information: To share or not to share? The Information Governance Review, March 2013, available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/192572/2900774_InfoGovernance_accv2.pdf. Note that this report is directed only at England but the comment is made that: "…there is much in our report which should prove useful in all the jurisdictions of the United Kingdom.", p.7.

66. For example, the NHS Scotland Code of Practice on Protecting Patient Confidentiality sets expectations against relying on exemptions in the Data Protection Act 1998, s.33 with respect to research.

67. This position has been laid down by the UK Information Commissioner, and upheld by the Information Tribunal in Bluck and The Information Commissioner and Epsom & St Helier University NHS Trust, 17 September 2007, EA/2006/0090.

68. The House of Lords has confirmed that the common law of confidentiality must been read in terms of the Human Rights Act 1998, see Campbell v Mirror Group Newspapers Ltd. [2004] 2 AC 457, [2004] 2 All ER 995.

69. The Human Tissue (Scotland) Act 2006 regulates only the use of human organs, tissue and samples from the deceased, which are removed post mortem, and subsequently used for research purposes. It does not regulate the use of human tissue from the living for research.

70. MRC Regulatory Support Centre, Research and Human Tissue Legislation Series, "Research and the Human Tissue Act 2004 -DNA Analysis", October 2007. Updates available here: http://www.mrc.ac.uk/Ourresearch/Ethicsresearchguidance/Useofhumantissue/index.htm

71. MRC Guide, Clarification p.4.

72. http://www.hta.gov.uk/aboutus.cfm. A review of fundamental functions of the HTA will be conducted in 2013, to report to government in April of that year.

73. HTA Code of Practice 1: Consent, September 2009, para 114 . Available at: http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice/code1consent.cfm

74. HTA Code of Practice 9: Research, September 2009, para 26, available at: http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice/code9research.cfm?faArea1=customwidgets.content_view_1&cit_id=757

75. As McLean et al have commented, "when the retention of tissue from the living [is] considered the law [becomes] unclear", see S McLean et al, 'Human tissue legislation: A benefit or a burden?" (2006) 8(1) Medical Law International 1-21 at 11.

76. For an in-depth discussion of the position in Scots law see N Whitty 'Rights of Personality, Property Rights and the Human Body in Scots Law' (2005) 9 Edin LR 194 and more recently Stevens v Yorkhill NHS Trust and another 2006 SLT 889; 2007 SCLR 606; (2007) 95 BMLR.

77. R v Rothery [1976] RTR 550, (1976) 63 Cr App R 231 and R v Welsh [1974] RTR 478.

78. For English authority on this point see R v Kelly [1998] 3 All ER 741.

79. Yearworth v North Bristol NHS Trust [2009] EWCA Civ 37; [2009] 2 All ER 986; [2009] 3 WLR 118; (2009) 107 BMLR 47. For commentary on this ruling and its likely implications, see S.H.E. Harmon and G.T. Laurie, 'Yearworth v. North Bristol NHS Trust: Property, principles, precedents and paradigms' (2010) 69 Cambridge Law Journal 476-93.

80. For discussion of possible ramifications and the on-going uncertain legal nature of any consent that is provided, see G. Laurie and E. Postan, 'Rhetoric or Reality: What is the Legal Status of the Consent Form in Health-related Research?' (2012) Medical Law Review 44pp, doi: 10.1093/medlaw/fws031

81. See Human Tissue Authority, Code of Practice 1: Consent, 2009. paras 152-156.

82. Pursuant to section 45(3), a person found guilty of an offence under this section is liable on summary conviction to a fine, or on indictment to imprisonment for a term not exceeding 3 years, or a fine, or both.

83. "Bodily material" is defined in section 45(5) as "material which has come from the human body [living or deceased] and consists of or includes human cells". This definition covers human blood, as it 'consists of or includes human cells'; it does not, however, cover extracted DNA or RNA where no whole cells remain. This definition, thus, covers newborn blood spot screening cards.

84. NHS Scotland, Your Guide to Newborn Screening Tests, (2012), p.20.

85. See the details of the UK Biobank Ethics and Governance Framework here: http://www.ukbiobank.ac.uk/wp-content/uploads/2011/05/EGF20082.pdf

86. M.T. Lysaught et al, 'A Pilot Test of DNA-based analysis using anonymized newborn screening cards in Iowa', in R.F. Weir ed., Stored Tissue Samples: Ethical, Legal and Public Policy Implications (University of Iowa Press, 1998).

87. This is accepted by bodies such as Genewatch. See: 'Keeping blood spots from newborn babies', January 2006, available at: http://www.genewatch.org/pub-507666, p. 3, citing J. Kaye, (2004) Abandoning informed consent: the case of genetic research in population collections; S. Weldon, (2004) 'Public consent' or 'scientific citizenship'? What counts as public participation in population-based DNA collections? Both in: R. Tutton and O. Corrigan (eds) Genetic databases: socio-ethical issues in the collection and use of DNA. London, Routledge.

88. See the Age of Legal Capacity (Scotland) Act 1991, s.2(4) although it is unclear if this extends to refusals.

89. The effect of anonymisation for data protection and human tissue regulation purposes is that those processing anonymised data/tissues do not have to comply with the provisions of the legislation, for example, researchers receiving suitably anonymised samples/information. This, however, clearly does not absolve the custodians of the collection from complying with the relevant laws since they hold both the collection and personal data from which specific individuals can be identified.

90. See further, W. Lowrance, Privacy, Confidentiality and Health Research (2012).

91. W. Lowrance and F.S. Collins, 'Identifiability in Genomic Research' (2007) 317:5838 Science 600-602.

92. For discussion, see J.K. Mason and G.T. Laurie, Law and Medical Ethics, 9^th ed, 2013, chapter 6.

93. This point of law was not ultimately determined by the House of Lords in Common Service Agency v Scottish Information Commissioner [2008] UKHL 47, 2008 SLT 901. For comment see G. Laurie and R. Gertz, 'The worst of all worlds? Common Services Agency v Scottish Information Commissioner' (2009) 13 Edin LR 330.

94. http://www.ico.org.uk/for_organisations/data_protection/topic_guides/privacy_impact_assessment

95. D.R. Karp et al. 'Ethical and practical issues associated with aggregating databases' (2008) 5 PLoS Med. e190.

96. http://www.hra.nhs.uk/

97. National Health Service Act 2006, ss251-252.

98. See: S.M. Wolf, 'The challenge of incidental findings' (2008) 36 J. Law Med. Ethics, and the other articles in this symposium edition. Cf, F.A. Miller, R. Christensen, M. Giacomini and J.S. Robert, 'Duty to disclose what? Querying the putative obligation to return research results to participants' (2008) 34(3) Journal of Medical Ethics 201-13.

99. K.M. Boyd, Institute of Medical Ethics: working party report: 'HIV infection: the ethics of anonymised testing and of testing pregnant women' (1990) 16 J. Med. Ethics 173-178. Cf - A.J. Pinching, 'The ethics of anonymised HIV testing of pregnant women: a reappraisal' (2000) 26 J. Med. Ethics 22-24.

100. M.J. Taylor, Genetic Data and the Law: Critical Perspectives on Privacy Protection (2012).

101. N. Homer et al 'Resolving individuals contributing trace amounts of DNA to highly complex mixtures using high-density SNP genotyping microarrays' (2008) 4 PLoS Genet. e1000167.

102. See: M.T. Lysaught et al, 'A pilot test of DNA-based analysis', p. 23, where the authors comment: "…the trend toward seeing newborn screening labs as DNA databanks which can provide samples for secondary purposes has fundamentally altered the nature or status of the blood-spot filter card. Previously, one could have argued that newborn screening was simply one of a series of diagnostic assays performed under the umbrella of general parental consent to actions promoting neonatal health. But now the blood-spot filter card has become a commodity, an item with "value", to be used for purposes unrelated to the health of the individual newborn. In this new context, it will be increasingly difficult to justify conducting newborn screening in the absence of informed consent."

103. The 2005 Consultation on the 'Storage and use of newborn babies blood spot cards', raised the issue of permanent retention of the cards.

104. NHS Scotland, Your Guide to Newborn Screening Tests, (2012), p20.

105. See Chapter 4 above on human rights requirements.

106. Lysaught et al, 'A pilot test of DNA-based analysis', p.25.

107. See: B. Almond, 'Genetic profiling of newborns: ethical and social issues' (2005) 7 Nature Reviews Genetics 67-71.

108. Genewatch, 'Keeping blood spots from newborn babies'.

109. Lysaught et al, "A pilot test of DNA-based analysis', p.27

110. Ibid.

111. GeneWatch, 'Keeping blood spots from newborn babies'.

112. Ibid., citing A. Harrison and B. New (2002), Public interest, private decisions: health-related research in the UK. London, The King's Fund.

113. M. Dixon-Woods et al, 'Tissue samples an 'gifts' for research: a qualitative study of families and professionals' (2008) 9 Medical Law International 131-150.

114. Haddow et al, 'Tackling community concerns'.

115. S.O. Hansson and B. Björkman, 'Bioethics in Sweden' (2006) 15 Cambridge Quarterly of Healthcare Ethics 285-203 at 287.

116. See: 'Privacy fears over method used to take Vicky's DNA', The Herald, 3 December 2008, p.16.

117. Hansson and Björkman, 'Bioethics in Sweden', p.286.

118. http://www.sehd.scot.nhs.uk/mels/CEL2008_13.pdf

119. The 'Section 29' form refers to section 29 of the Data Protection Act 1998, which provides that information can be disclosed without consent where failure to gain the information would be likely to prejudice: the prevention or detection of crime, the apprehension or prosecution of offenders, or the collection or assessment of any tax or duty.

120. In the October 2007 minutes of the UK Council of Caldicott Guardians meeting, it was noted that, while the police in Scotland have a "standard form when requesting information from health organisations… this [does] not negate the need for [the] final decision to be made by the Caldicott Guardian".

121. See C.N. Stoddart, Criminal Warrants (2^nd edn), (Edinburgh: Butterworths, 1999), p.63.

122. This was the procedure in the Stephen Kelly case (unreported), in which the police seized personal medical information and a blood sample, which had been taken as part of a research project, with a warrant. For information on the case see: C. Dyer, 'Use of confidential HIV data helps convict former prisoner', (2001) BMJ 322:633, and S. Connor, "Police access to medical data 'a threat to research''', The Independent, 16 July 2001.

123. See s.9 (1) of the Police and Criminal Evidence Act 1984 and Schedule 1.

124. See: J. Kaye, 'Police collection and access to DNA samples', (2006) 2:1 Genomics, Society and Policy 16-27.

125. Stoddart, Criminal Warrants, p.63.

126. Ibid., p.133ff.

127. Ibid., p.9. See also R. v. Manchester Stipendiary Magistrate and the Lord Advocate (Appellants) Ex Parte Granada Television Ltd. (Respondent) (On appeal from a Divisional Court of the Queen's Bench Division) 14 December 1999, House of Lords, in which Lord Hope of Craighead stated that: 'When a constable of a Scottish police force wishes to obtain a search warrant he makes a report to the procurator fiscal, who in Scotland is the public prosecutor. This is because in Scotland applications to the courts of summary jurisdiction in criminal matters are made by the procurator fiscal, not by the police'. Available at: http://www.publications.parliament.uk/pa/ld199900/ldjudgmt/jd991214/granad-1.htm

128. Ibid., p.19.

129. Ibid., p.69.

130. At the time of writing this can be obtained on written request from Craig.Gilbert@scotland.gsi.gov.uk

131. As an example from the Scottish Health Informatics Programme, see G. Laurie and N. Sethi, 'Towards principles-based approaches to governance of health-related research using personal data' (2013) 4(1) European Journal of Risk Regulation 43-57.

132. See generally, B. Nørgaard-Pedersen and D.M. Hougaard, "Storage policies and use of the Danish Newborn Screening Biobank", (2007) 30 Journal of Metabolic Disease 530-536.

133. Nørgaard-Pedersen and Hougaard, "Storage policies and use of the Danish Newborn Screening Biobank", p. 530.

134. Ibid.

135. Ibid.

136. Ibid., p.532

137. Ibid., p.533.

138. Ibid.

139. e.g. SAHSC Bio-repository principles and Bio-repositories - Better Cancer Care.

140. Laurie, the lead author of this report, was Chair of the Ethics and Governance Council (2006-10).

141. UK Biobank Ethics and Governance Council: http://www.egcukbiobank.org.uk/ The Secretariat of the EGC is provided jointly by the Wellcome Trust and the Medical Research Council.

142. Laurie served as a member of the Generation Scotland Advisory Board. The Secretariat for the GSAB was provided by the Chief Scientist Office, Scottish Government.

143. The report on the consultation document has not been made publicly available.

144. http://www.sehd.scot.nhs.uk/publications/ppcr/ppcr.pdf

145. A. Davey, D. French, H. Dawkins and P. O'Leary P, 'New mothers' awareness of newborn screening, and their attitudes to the retention and use of screening for research purposes' (2005) 1(3) Genomics, Society and Policy 41-51.

146. I. Muchamore, L. Morphett and K. Barlow-Stewart, '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' (2006) 3(14) Australia and New Zealand Health Policy: doi: 10.1186/1743-8462-3-14

147. G. Haddow, G. Laurie, S. Cunningham-Burley and K.G. Hunter, 'Tackling community concerns about commercialisation and genetic research: A modest interdisciplinary proposal' (2007) 64 Social Science and Medicine 272-282 and G. Haddow, S. Cunningham-Burley, A. Bruce and S. Parry, 'Generation Scotland: Consulting publics and specialists at an early stage in a genetic database's development' (2008) 18(2) Critical Public Health 139-149.

148. K. Bendikson et al, 'Newborn Blood Spot Cards: Consent, Storage and Use: A public consultation', Research New Zealand, 18 December 2007.

149. D. Avard, H. Vallance, C. Greenberg et al, 'Variability in the storage and use of newborn dried bloodspots in Canada: Is it time for national standards?' (2006) 2(3) Genomics, Society and Policy 80-95.

150. Y. Bombard, F.A. Miller, R. Hayeems et al, 'Citizens' values regarding research with stored samples from newborn screening in Canada' (2012) 129 Pediatrics 239-247.

151. J.R. Botkin, E. Rothwell, R. Anderson et al, 'Public attitudes regarding the use of residual newborn screening specimens for research' (2012) 129 Pediatrics 231-238.

152. E. Rothwell, R. Anderson, A. Goldenberg et al, 'Assessing public attitudes on the retention and use of residual newborn screening blood samples: a focus group study' (2012) 74 Social Science and Medicine 1305-1309.

153. E. Rothwell, R.N. Anderson, J. Botkin, 'Policy issues and stakeholder concerns regarding the storage and use of residual newborn dried blood samples for research' (2010) 11(1) Policy, Politics & Nursing Practice 5-12.

154. D. Duquette, A.P. Rafferty, C. Fussman et al, 'Public support for the use of newborn screening dried blood spots in health research' (2010) 14 Public Health Genomics 143-152.

155. B.A. Tarini, A. Goldenberg, D. Singer et al, 'Not without my permission: Parents' willingness to permit use of newborn screening samples for research' (2010) 13 Public Health Genomics 125-30.

156. A.B. Neidich, W.J. Josh, C. Ober and L.F. Ross, 'Empirical data about women's attitudes towards a hypothetical pediatric biobank' (2010) American Journal of Medical Genetics Part A: 297-304.

157. C. Fujii, Y. Sato, S. Harada et al 'Attitudes to extended use and long-term storage of newborn screening blood spots in Japan' (2010) 52 Pediatrics International 393-397.

158. K. Hargreaves, R.J. Stewart and S.R. Oliver SR, 'Informed choice and public health screening for children: The case of blood spot screening' (2005) 8 Health Expectations 161-171.