Hostname: page-component-8448b6f56d-t5pn6 Total loading time: 0 Render date: 2024-04-23T16:32:59.862Z Has data issue: false hasContentIssue false
  • English
  • Français

Storing Newborn Blood Spots: Modern Controversies

Published online by Cambridge University Press:  01 January 2021

Linda Kharaboyan ,
Denise Avard  and
Bartha Maria Knoppers
Get access Rights & Permissions [Opens in a new window]

Extract

Though in existence for over thirty-five years, due to the increasing panoply of possible tests. Newborn screening programs are drawing public attention. Many jurisdictions have mandatory newborn screening programs for treatable disorders. Disorders are detected through tests on blood spots drawn from a newborn’s heel soon after birth and verified through a diagnostic test with follow-up. Unbeknownst to most parents, these blood spot cards are also stored thereafter. Indeed, while dried blood spots (DBSs) are primarily used for screening for health problems, experience demonstrates that they can be made useful in various contexts unrelated to screening.

Newborn dried blood spots have taken on a new life as a result of developments in genetics and the increasing ability of bioinformatics to link DNA information with clinical data. Additionally, storage and secondary uses have been documented to occur without parental consent.

Type
Independent
Information
Journal of Law, Medicine & Ethics , Volume 32 , Issue 4 , Winter 2004 , pp. 741 - 748
Copyright
Copyright © American Society of Law, Medicine and Ethics 2004

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

McEwen, J.E. and Reilly, P.R., “Stored Guthrie Cards as DNA ‘Banks’” American Journal of Human Genetics 55 (1994): 196–200.Google Scholar
Therrell, B.L., Hannon, W.H., Pass, K.A., et al., “Guidelines for the Retention, Storage, and Use of Residual Dried Blood Spot Samples after Newborn Screening Analysis: Statement of the Council of Regional Networks for Genetic Services,” Biochemical and Molecular Medicine 57 (1996): 116–24.CrossRefGoogle Scholar
Hannon, W.H. Henderson, L.O., and Bell, C.J., “Newborn Screening Quality Assurance” in Khoury, M.J., Burke, W., and Thomson, E.J., eds., Genetics and Public Health in the 21st Century (New York: Oxford University Press, 2000): 243–60.CrossRefGoogle Scholar
Human Genetics Society of Australasia (HGSA), Policy Statement on the Retention, Storage and Use of Sample Cards from Newborn Screening Programs, Australia, (1999).Google Scholar
American Academy of Pediatrics (AAP), “Serving the Family from Birth to the Medical Home. Newborn Screening: A Blueprint for the Future,” Pediatrics 106, no. 2, suppl. (2000): 389–422.Google Scholar
See Therrell, , supra note 2.Google Scholar
See AAP, supra note 5.Google Scholar
Elkin, K., “Guthrie Cards: Legal and Ethical Issues” New Zealand Bioethics Journal 1 (2000): 22–26.Google Scholar
See Therrell, , supra note 2; See HGSA, supra note 4; Association française pour le dépistage et la prévention des handicaps de l’enfant (AFDPHE), “Les Prélèvements de Sang sur Papier pour le Dépistage Néonatal. Recommandations pour leur Collecte, leur Traitement et leur Conservation,” Archives de Pédiatrie 2 (1995): 3–7.CrossRefGoogle Scholar
Personal communication with Dr. Claude Laberge from the Centre Hospitalier de l’Université Laval in November 2002.Google Scholar
See AFDPHE, supra note 9.Google Scholar
France – National Consultative Bioethics Committee (CCNE), Opinion and Recommendations on “Genetics and Medicine: From Prediction to Prevention,” Report, No. 46 (October 30, 1995).Google Scholar
Australia – National Pathology Accreditation Advisory Council, Retention of Laboratory Records and Diagnostic Material (2002).Google Scholar
Australia – National Pathology Accreditation Advisory Council, Retention of Laboratory Records and Diagnostic Material (1998).Google Scholar
United Kingdom – Working Party of the Royal College of Pathologists and the Institute of Biomedical Science, The Retention and Storage of Pathological Records and Archives, Report of the Working Party of Biomedical Science, 2d. edition (1999).Google Scholar
Norgaard-Pederson, B., “Use of Stored Samples from the Danish PKU Register” in Knoppers, B.M., ed., Human DNA: Law and Policy, International and Comparative Perspectives (Amsterdam: Kluwer Law International, 1997): 303–11.Google Scholar
Danish Medical Research Council, Health Science Information Banks – Biobanks, Report, (January 1996), available at <http://www.forsk.dk/eng/ssvf/publ/biobanker-uk/>..>Google Scholar
See Therrell, , supra note 2Google Scholar
See Avard, D., Kharaboyan, L., and Knoppers, B.M., “Using ‘Spots’ in Research: Moving Beyond Screening and Treatment” in Association of Public Health Laboratories, 2002 Newborn Screening and Genetic Testing Symposium Proceedings (Phoenix, November 4–7 2002): 319–21.Google Scholar
See Norgaard-Pederson, , supra note 16.Google Scholar
See Danish Medical Research Council, supra note 17.Google Scholar
See AAP, supra note 5.Google Scholar
Andrews, L. B., Fullarton, J.E., Holtzman, N.A., et al., eds., Assessing Genetic Risks: Implications for Health and Social Policy (Washington, D.C.: National Academy Press, 1993): at 277; The New York State Task Force on Life and the Law, Genetic Testing and Screening in the Age of Genomic Medicine, Report (2000), available at <http://www.health.state.ny.us/nysdoh/taskfce/screening.htm>; American Society of Human Genetics, “Statement on Informed Consent for Genetic Research,” American Journal of Human Genetics 59 (1996): 471–74; Tomoeda, K. and Matsuda, I., “Biomedical Ethics and Mass Screening of the Newborn in Japan,” Eubios Journal of Asian and International Bioethics 8 (1998): 75–76.Google Scholar
The Nuffield Trust, Learning from Experience: Privacy and the Secondary Use of Data, Report (2002); Royal College of Physicians Committee on Ethical Issues in Medicine, “Research Based on Archived Information and Samples,” Journal of the Royal College of Physicians of London 33 (1999): 264–66.Google Scholar
Clayton, E., Steinberg, K., Khoury, M.J., et al., “Informed Consent for Genetic Research on Stored Tissue Samples,” JAMA 274 (1995): 1786–92.CrossRefGoogle Scholar
National Bioethics Advisory Commission (NBAC), Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, Report (1999).Google Scholar
See New York State Task Force, supra note 23.Google Scholar
Wald, N.J. and Law, M., “The Threat to the Use of Records and Stored Blood Samples in Medical Screening Research,”, Journal of Medical Screening 8 (2001): 58–59.CrossRefGoogle Scholar
See NBAC, supra note 26.Google Scholar
See Therrell, , supra note 2.Google Scholar
Mills, D., “Alternative Uses of Guthrie Spots from Newborn Screening Programs. Increased Demand for DNA Specimens,” Genetic Drift Newsletter 15 (1998), available at <http://www.mostgene.org/gd/gdvol15b.htm> (last visited October 3, 2003).Google Scholar
Annas, G.J., “Privacy Rules for DNA Databanks. Protecting Coded ‘Future Diaries’,” JAMA 270 (1993): 2346–2350.CrossRefGoogle Scholar
Personal communication with Dr. Gerard Loeber from the RIVM in November 2002.Google Scholar
Loeber, J.G. and Elvers, B., “(Il)legality of Long Term Storage of Newborn Filter Paper Cards,” Proceedings of the Newborn Screening and Genetics Symposium (Washington: Association of Public Health Laboratories, 2001).Google Scholar
H v G. [M/1868/98]. 1999. Upheld in H v G (2000) 18 FRNZ 572.Google Scholar
New Zealand – Health and Disability Commissioner, Auckland Healthcare – Report on Opinion, Case 99HDC09011 (2000).Google Scholar
See H v G, supra note 34.Google Scholar
See Elkin, , supra note 8.Google Scholar
Id.Google Scholar
Abramson, D., “Passing the Test: New York’s Newborn HIV Testing Policy, 1987–1997,” in Stoto, M.A., Almario, D.A., and McCormick, M.C., eds., Reducing the Odds – Preventing Perinatal Transmission of HIV in the United States (Washington: National Academy Press, 1999): 313–40.Google Scholar
Roy, D., “Anonymous HIV Seroprevalence Studies: Ethical Conditions,” in Knoppers, B.M. and Laberge, C.M., eds., Genetic Screening. From Newborn to DNA Typing (Amsterdam: Elsevier Science Publishers, 1990): 95–110.Google Scholar