Minimizing risks: The ethics of predictive diabetes mellitus screening research in newborns

Archives of Pediatrics and Adolescent Medicine

Volumn 157, Issue 1, 2003, Pages 89-95

  Ross, Lainie F ^a,b  

^a UNIVERSITY OF CHICAGO   (United States)

^b UNIVERSITY OF CHICAGO   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA 1 ANTITRYPSIN DEFICIENCY; ARTICLE; CHILD DEVELOPMENT; DISEASE COURSE; DISEASE PREDISPOSITION; ETHICS; FOLLOW UP; GENETIC PREDISPOSITION; GENETIC RISK; GENOTYPE; HUMAN; INCIDENCE; INSULIN DEPENDENT DIABETES MELLITUS; MEDICAL RESEARCH; MENTAL STRESS; NEWBORN SCREENING; NONHUMAN; PREDICTION; PRIORITY JOURNAL; RELATIVE; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; SOCIAL PSYCHOLOGY;

EID: 0037235021     PISSN: 10724710     EISSN: None     Source Type: Journal    
DOI: 10.1001/archpedi.157.1.89     Document Type: Article

References (98)

1. Prevention of Type 1 Diabetes Mellitus (Conference Summary from American Diabetes Association). Available at: Diabetes Forum. http://www.diabetesforum.net/cgi-bin/display_engine.pl?category_id=15 &content_id=230. Accessed June 18, 2002.
2. Heine RJ. Diabetes in the next century: challenges and opportunities. Neth J Med. 1999;55:265-270.
3. Infant diabetes test is good start [editorial]. St Petersburg Times. January 8, 2002:8A.
4. Ziegler A-G, Hummel M, Schenker M, Bonifacio E. Autoantibody appearance and risk for development of childhood diabetes in offspring of parents with type 1 diabetes: the 2-year analysis of the German BABYDIAB Study. Diabetes. 1999;48:460-468.
5. Hummel M, Fuchtenbusch M, Schenker M, Ziegler A-G. No major association of breast-feeding, vaccinations, and childhood viral diseases with early islet autoimmunity in the German BABYDIAB Study. Diabetes Care. 2000;23:969-974.
6. Roll U, Christie MR, Fuchtenbusch M, Payton MA, Hawkes CJ, Ziegler A-G. Perinatal autoimmunity in offspring of diabetic parents: the German Multicenter BABY-DIAB Study: detection of humoral immune responses to islet antigens in early childhood. Diabetes. 1996;45:967-973.
7. Colman PG, Steele C, Couper JJ, et al. Islet autoimmunity in infants with a type 1 diabetic relative is common but is frequently restricted to one autoantibody. Diabetologia. 2000;43:203-209.
8. Couper JJ. Annotation: environmental triggers of type 1 diabetes. J Paediatr Child Health. 2001;37:218-220.
9. Buzzetti R, Quattrocchi CC, Nistico L. Dissecting the genetics of type 1 diabetes: relevance for familial clustering and differences in incidence. Diabetes Metab Rev. 1998;14:111-128.
10. Flanders G, Graves P, Rewers M. Review: prevention oftype 1 diabetes from laboratory to public health. Autoimmunity. 1999;29:235-246.
11. Dahlquist GG. Primary and secondary prevention strategies of pre-type 1 diabetes: potentials and pitfalls. Diabetes Care. 1999;22(2S, suppl):4B-6B.
12. Kimpimaki T, Kupila A, Hamalainen A-M, et al. The first signs of B-cell autoimmunity appear in infancy in genetically susceptible children from the general population: the Finnish Type I Diabetes Prediction and Prevention Study. J Clin Endocrinol Metab. 2001;86:4782-4786.
13. Ronningen KS. Genetics in the prediction of insulin-dependent diabetes mellitus: from theory to practice. Ann Med. 1997;29:387-392.
14. Greener M. PANDA identifies babies at risk of developing type 1 diabetes. Mol Med Today. 2000;6:3.
15. Paronen J, Knip M, Savilahti E, et al. Effect of cow's milk exposure and maternal type 1 diabetes on cellular and humoral immunization to dietary insulin in infants at genetic risk for type 1 diabetes. Diabetes. 2000;49:1657-1665.
16. Karges W, Hammond-McKibben D, Cheung RK, et al. Immunological aspects of nutritional diabetes prevention in NOD mice: a pilot study for the cow's milkbased IDDM Prevent Trial. Diabetes. 1997;46:557-564.
17. Norris JM, Beaty B, Klingensmith G, et al. Lack of association between early exposure to cow's milk protein and β-cell autoimmunity: Diabetes Autoimmunity Study in the Young (DAISY). JAMA. 1996;276:609-614.
18. Couper JJ, Steele C, Beresford SD, et al. Lack of association between duration of breast feeding or introduction of cow's milk and development of islet autoimmunity. Diabetes. 1999;48:2145-2149.
19. Institute of Medicine. Assessing Genetic Risks: Implications for Health and Social Policy. Washington, DC: National Academy Press; 1994.
20. Working Party of the Clinical Genetics Society (UK). The genetic testing of children. J Med Genet. 1994;31:785-797.
21. American Society of Human Genetics/American College of Medical Genetics. Points to consider: ethical, legal, and psychosocial implications of genetic testing in children and adolescents. Am J Hum Genet. 1995;57:1233-1241.
22. American Academy of Pediatrics, Committee on Bioethics. Ethical issues with genetic testing in pediatrics. Pediatrics. 2001;107:1451-1455.
23. Kodish E. Testing children for cancer genes: the rule of earliest onset. J Pediatr. 1999;135:390-395.
24. Siegler M, Amiel S, Lantos J. Scientific and ethical consequences of disease prediction. Diabetologia. 1992;35(suppl 2):S60-S68.
25. Nordenfelt L. Prevention and ethics in medicine: the case of diabetes prevention. J Pediatr Endocrinol Metab. 1996;9:381-386.
26. Michie S. Predictive genetic testing in children: paternalism or empiricism. In: Marteau T, Richards M, eds. The Troubled Helix: Social and Psychological Implications of the New Genetics. Cambridge, England: Cambridge University Press; 1996:177-183.
27. Broadstock M, Michie S, Marteau TM. The psychological consequences of predictive genetic testing: a systematic review. Eur J Hum Genet. 2000;8:731-738.
28. Yu MS, Norris JM, Mitchell CM, et al. Impact on maternal parenting stress of receipt of genetic information regarding risk of diabetes in newborn infants. Am J Med Genet. 1999;86:219-226.
29. Johnson SB, Riley WJ, Hansen CA, Nurick MA. Psychological impact of islet cellantibody screening: preliminary results. Diabetes Care. 1990;13:93-97.
30. Johnson SB, Tercyak KP. Psychological impact of islet cell-antibody screening for IDDM on children, adults and their family members. Diabetes Care. 1995;18: 1370-1372.
31. Carmichael SL, Johnson SB, Weiss A, Fuller KG, She JX, Schatz DA. Psychological impact of screening programs in mothers of children at-risk for type 1 diabetes [abstract]. Diabetes. 2000;49(suppl 1):A317.
32. Johnson SB. Screening programs to identify children at risk for diabetes mellitus: psychological impact on children and parents. J Pediatr Endocrinol Metab. 2001;14:653-659.
33. Weber B, Roth R. Psychological aspects in diabetes prevention trials. Ann Med. 1997;29:461-467.
34. 1-antitrypsin deficiency: parental reactions to the first news of their infants' deficiency. Acta Paediatr Scand. 1985;74:787-793.
35. Heyerdahl S. Psychological problems in relation to neonatal screening programmes. Acta Paediatr Scand. 1988;77:239-241.
36. 1-antitrypsin deficiency. Acta Psychiatr Scand. 1985;72:323-330.
37. 1-antitrypsin deficiency: parental attitudes toward "ATD-check-ups" and parental recommendations regarding future screening. Acta Paediatr Scand. 1985;74:841-847.
38. 1-antitrypsin deficiency. Acta Paediatr Scand. 1985;74:427-432.
39. Thelin T, McNeil TF, Aspegren-Jansson E, Sveger T. Identifying children at high somatic risk: possible long-term effects on the parents' view of their own health and current life situation. Acta Psychiatr Scand. 1985;71:644-653.
40. McNeil TF, Thelin T, Aspegren-Jansson E, Sveger T. Identifying children at high somatic risk: possible effects on the parents' views of the child's health and parents' relationship to the pediatric health services. Acta Psychiatr Scand. 1985; 72:491-497.
41. McNeil TF, Harty B, Thelin T, Aspegren-Jansson E, Sveger T. Identifying children at high somatic risk: long-term effects on mother-child interaction. Acta Psychiatr Scand. 1986;74:555-562.
42. 1-antitrypsin screening: parents' views and reactions 20 years after the identification of the deficiency state. Acta Paediatr. 1999;88:315-318.
43. 1-antitrypsin deficiency identified neonatally: their health, knowledge about and adaptation to the high-risk condition. Acta Paediatr. 1997;86:37-40.
44. 1-Antitrypsin deficiency: memorandum from a WHO meeting. Bull World Health Organ. 1997;75:397-415.
45. 1-antitrypsin screening? Acta Paediatr. 2000;89:628-631.
46. 1antitrypsin deficiency. J Pediatr. 1978;92:1006-1010.
47. Wall M, Moe E, Eisenberg J, Powers M, Buist N, Buist AS. Long-term follow-up of a cohort of children with alpha-1-antitrypsin deficiency. J Pediatr. 1990;116: 248-251.
48. Wertz D. Testing children and adolescents. In: Burley J, Harris J, eds. A Companion to Genetics. Oxford, England: Blackwell Publishers; 2002:92-113.
49. Senior V, Marteau TM, Peters TJ. Will genetic testing for predisposition for disease result in fatalism? a qualitative study of parents responses to neonatal screening for familial hypercholesterolaemia. Soc Sci Med. 1999;48:1857-1860.
50. Lefcourt HM. Locus of Control: Current Trends in Theory and Research. 2nd ed. New York, NY: Halstead; 1982.
51. Michie S, Marteau TM. Predictive genetic testing in children: the need for psychological research. In: Clarke AJ, ed. The Genetic Testing of children. Oxford, England: Bios Scientific Publishers; 1998:169-181.
52. Croyle RT, Lerman C. Psychological impact of genetic testing. In: Croyle RT, ed. Psychosocial Effects of Screening for Disease Prevention and Detection. New York, NY: Oxford University Press; 1995:11-38.
53. Headings VE. Counselling in a hospital-based newborn screening service. Patient Counsel Health Ed. 1980;2:80-83.
54. Clayton EW. What should be the role of public health in newborn screening and prenatal diagnosis? Am J Prev Med. 1999;16:111-115.
55. Fyro K. Neonatal screening: life-stress scores in families given a false-positive result. Acta Paediatr Scand. 1988;77:232-238.
56. Tymstra T. False positive results in screening test: experience of parents of children screened for congenital hypothyroidism. Fam Pract. 1986;3:92-96.
57. Davison C, Macintyre S, Smith GD. The potential social impact of predictive genetic testing for susceptibility to common chronic disease: a review and proposed research agenda. Sociol Health Illness. 1994;16:340-371.
58. Meadow CK. The last well person. N Engl J Med. 1994;330:440-441.
59. Reilly PR, Boshar MF, Holtzman SH. Ethical issues in genetic research: disclosure and informed consent. Nat Genet. 1997;15:16-20.
60. Billings PR, Kohn MA, de Cuevas M, Beckwith J, Alper JS, Natowicz MR. Discrimination as a consequence of genetic testing. Am J Hum Genet. 1992;50: 476-482.
61. Geller LN, Alper JS, Billings PR, Barash CI, Beckwith J, Natowicz MR. Individual, family, and societal dimensions of genetic discrimination: a case study analysis. Sci Eng Ethics 1996;2:71-88.
62. Office for Human Research Protections. Institutional Review Board Guidebook, chap 5, part H: Human Genetic Research. Available at: http://ohrp.osophs.dhhs.gov/irb/irb_chapter5ii.htm#h12. Accessed October 16, 2002.
63. Nelkin D, Tancredi L. Dangerous Diagnostics: The Social Power of Biological Information. New York, NY: Basic Books; 1989.
64. Andrykowski MA, Lightner R, Studts JL, Munn RK. Hereditary cancer risk notification and testing: how interested is the general population? J Clin Oncol. 1997; 15:2139-2148.
65. Marteau TM, Croyle RT. The new genetics: psychological responses to genetic testing. BMJ. 1998;316:693-696.
66. Schatz DA, Krischer JP, Syler JS. Therapeutic controversy: now is the time to prevent type 1 diabetes. J Clin Endocrinol Metab. 2000;85:495-498.
67. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; 1979.
68. Nuremberg Code, 1946, Principle 1. Reprinted in: Reich WT, ed. Encyclopedia of Bioethics. New York, NY: Free Press; 1978;4:1764.
69. World Medical Association Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects. Adopted by the 18th World Medical Association (WMA) General Assembly, Helsinki, Finland, June 1964, and amended by the 29th WMA General Assembly, Tokyo, Japan, October 1975; 35th WMA General Assembly, Venice, Italy, October 1983; 41st WMA General Assembly, Hong Kong, September 1989; 48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996; and the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000. Available at: http://www.faseb.org/arvo/helsinki/htm. Accessed October 16, 2002.
70. Medical Research Council of Canada, Natural Science and Engineering Research Council of Canada, Social Science and Humanities Research Council of Canada. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. August 1998. Available at: http://www.nserc.ca/programs/ethics/english/ethics-e.pdf. Accessed June 18, 2002.
71. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Report and Recommendations: Research Involving Children. Washington, DC: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; 1977.
72. Nicholson RH, ed. Medical Research With Children: Ethics, Law and Practice. The Report of an Institute of Medical Ethics Working Group on the Ethics of Clinical Research Investigations on Children. Oxford, England: Oxford University Press; 1986.
73. Department of Health and Human Services (45 CFR 46 Subpart A). Final regulations amending basic HHS policy for the protection of human research subjects. 46 Federal Register 8366 (1981), revised 56 Federal Register 28003 (1991).
74. EURODIAB ACE Study Group. Variation and trends in incidence of childhood diabetes in Europe. Lancet. 2000;355:873-876.
75. Feltbower RG, McKinney PA, Bodansky HJ. Rising incidence of childhood diabetes is seen at all ages and in urban and rural settings in Yorkshire, United Kingdom. Diabetologia. 2000;43:682-684.
76. Entwistle V. The potential contribution of decision aids to screening programmes. Health Expectations. 2001;4:109-115.
77. Clarke AJ. Newborn screening. In: Harper PS, Clarke AJ, eds. Genetics, Society and Clinical Practice. Oxford, England: Bios Scientific Publishers; 1997:107-117.
78. Escolar DM, Scacheri CG. Pharmacologic and genetic therapy for childhood muscular dystrophies. Curr Neurol Neurosci Rep. 2001;1:168-174.
79. Diabetes Prevention Trial-Type 1 Diabetes Study Group. Effects of insulin in relatives of patients with type 1 diabetes mellitus. N Engl J Med. 2002;346:1685-1691.
80. Davison C, Macintyre S, Smith GD. The potential social impact of predictive genetic testing for susceptibility to common chronic disease: a review and proposed research agenda. Sociol Health Illness. 1994;16:340-371.
81. Burris S, Gostin LO. Genetic screening from a public health perspective: three "ethical" principles. In: Burley J, Harris J, eds. A Companion to Genetics. Oxford, England: Blackwell Publishers; 2002:455-464.
82. Clarke AJ. The genetic dissection of multifactorial disease: the implications of susceptibility screening. In: Harper PS, Clarke AJ, eds. Genetics, Society and Clinical Practice. Oxford, England: Bios Scientific Publishers; 1997:93-106.
83. Samuelsson U, Sundkvist G, Borg H, Fernlund P, Ludvigsson J. Islet autoantibodies in the prediction of diabetes in school children. Diabetes Res Clin Pract. 2001;51:51-57.
84. Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 4th ed. New York, NY: Oxford University Press; 1994:274.
85. Buchanan AE, Brock DW. Deciding for Others: The Ethics of Surrogate Decision Making. New York, NY: Cambridge University Press; 1989.
86. Ross LF. Children, Families, and Health Care Decision Making. Oxford, England: Oxford University Press; 1998.
87. Rewers M, Bugawan TL, Norris JM, et al. Newborn screening for HLA markers associated with IDDM: Diabetes Autoimmunity Study in the Young (DAISY). Diabetologia. 1996;39:807-812.
88. Buzzetti R, Quattrocchi CC, Nistico L. Dissecting the genetics of type 1 diabetes: relevance for familial clustering and differences in incidence. Diabetes Metab Rev. 1998;14:111-128.
89. Veijola R, Reijonen H, Vahasalo P, et al. HLA-DQB1 - defined genetic susceptibility, beta cell autoimmunity, and metabolic characteristics in familial and nonfamilial insulin-dependent diabetes mellitus. J Clin Invest. 1996;98:2489-2495.
90. Bingley PJ, Bonifacio E, Shattock M, et al. Can islet cell antibodies predict IDDM in the general population? Diabetes Care. 1993;16:45-50.
91. Landin-Olsson M, Palmer JP, Lernmark A, et al. Predictive value of islet cell and insulin autoantibodies for type 1 (insulin-dependent) diabetes mellitus in a population-based study of newly-diagnosed diabetic and matched control children. Diabetologia. 1992;35:1068-1073.
92. Schatz D, Krischer J, Horne G, et al. Islet cell antibodies predict insulin-dependent diabetes in United States school age children as powerfully as in unaffected relatives. J Clin Invest. 1994;93:2403-2407.
93. Marteau TM. Psychology and screening, narrowing the gap between efficacy and effectiveness. Br J Clin Psychol. 1994;33:1-10.
94. Wagner A, Tibben A, Bruining GJ, et al. Preliminary experience with predictive testing for insulin-dependent diabetes mellitus. Lancet. 1995;346:380-381.
95. Lucidarme N, Donmingues-Muriel E, Castro D, Czernichow P, Levy-Marchal C. Appraisal and implications of predictive testing for insulin-dependent diabetes mellitus. Diabetes Metab. 1998;23:550-553.
96. Shepherd M, Hattersley AT, Sparkes AC. Predictive genetic testing in diabetes: a case study of multiple perspectives. Qual Health Res. 2000;10:242-259.
97. Department of Health and Human Services (45 CFR 46 Subpart D). Additional Protections for Children Involved as Subjects in Research, 48 Federal Register 9814-20 (1983); revised 56 Federal Register 28,032 (1991).
98. Roth R. Psychological and ethical aspects of prevention trials. J Pediatr Endocrinol Metab. 2001;14:669-674.