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How Much Control Do Children and Adolescents Have over Genomic Testing, Parental Access to Their Results, and Parental Communication of Those Results to Others?

Published online by Cambridge University Press:  01 January 2021

Ellen Wright Clayton
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Extract

Both researchers and clinicians are increasingly offering genomic testing for children and adolescents, a practice which parents have generally endorsed in numerous studies. By contrast, much less effort has been devoted to understanding what minors think about genetic and genomic testing. While a small number of investigators have shown that minors with or at risk for cancer generally concur with their parents and favor testing, other studies reveal that minors are less willing to participate in genomics research. Regardless, genetic and genomic testing of minors raises of host of potential legal questions. Key issues are: (1) To what extent can minors obtain genomic tests without involvement of parents or guardians? (2) To what extent can minors refuse genomic testing? and (3) To what extent can minors obtain their own results, keep their parents from getting access to them, and limit what their parents do with their genomic test results? While a number of authors have written about legal issues in genetic testing of minors, remarkably little has been written about the legal protections of minors’ choices about genomic analysis and return of results.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 43 , Issue 3 , Autumn 2015 , pp. 538 - 544
Copyright
Copyright © American Society of Law, Medicine and Ethics 2015

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References

Hamann, H. A. et al. , “Attitudes toward the Genetic Testing of Children Among Adults in a Utah-Based Kindred Tested For a BRCA1 Mutation,” American Journal of Medical Genetics 92, no. 1 (2000): 25–32; Segal, M. E. et al. , “Adults' Values and Attitudes about Genetic Testing for Obesity Risk in Children,” International Journal of Pediatric Obesity 2, no. 1 (2007): 11–21; Peshkin, B. N. et al. , “Brief Assessment of Parents' Attitudes Toward Testing Minor Children For Hereditary Breast/Ovarian Cancer Genes: Development and Validation of the Pediatric BRCA1/2 Testing Attitudes Scale (P-TAS),” Journal of Pediatric Psychology 34, no. 6 (2009): 627–638; Levine, F. R. et al. , “Parental Attitudes, Beliefs, and Perceptions about Genetic Testing for FAP and Colorectal Cancer Surveillance in Minors,” Journal of Genetic Counseling 19, no. 3 (2010): 269–279; Tercyak, K. P. et al. , “Parents' Attitudes toward Pediatric Genetic Testing for Common Disease Risk,” Pediatrics 127, no. 5 (2011): E1288–e1295; Harris, E. D. et al. , “The Beliefs, Motivations, and Expectations of Parents Who Have Enrolled Their Children in a Genetic Biorepository,” Genetics in Medicine 14, no. 3 (2012): 330–337; Lakes, K. D. et al. , “Maternal Perspectives on the Return of Genetic Results: Context Matters,” American Journal of Medical Genetics Part A 161A, no. 1 (2013): 38–47.3.0.CO;2-Y>CrossRefGoogle Scholar
Geller, G. et al. , “Mothers and Daughters From Breast Cancer Families: A Qualitative Study of Their Perceptions of Risks and Benefits Associated with Minor's Participation in Genetic Susceptibility Research,” Journal of the American Medical Women's Association 55, no. 5 (2000): 280–284; Fernandez, C. V. et al. , “Providing Research Results to Participants: Attitudes and Needs of Adolescents and Parents of Children with Cancer,” Journal of Clinical Oncology 27, no. 6 (2009): 878–883.Google Scholar
Read, K. et al. , “Decision-Making by Adolescents and Parents of Children with Cancer Regarding Health Research Participation,” Pediatrics 124, no. 3 (2009): 959–965.Google Scholar
Clayton, E. W., “Removing the Shadow of the Law from the Debate about Genetic Testing of Children,” American Journal of Medical Genetics 57, no. 4 (1995): 630–634; Hoffman, D. E. Wulfsberg, E. A., “Testing Children for Genetic Predispositions: Is It in Their Best Interest?” Journal of Law, Medicine & Ethics 23, no. 4 (1995): 331–344; Clayton, E. W., “Genetic Testing in Children,” Journal of Medicine and Philosophy 22, no. 3 (1997): 233–251; Pelias, M. Z., “Genetic Testing: Who Decides, Who Informs?” Children's Legal Rights Journal 18, no. 2 (1998): 43–46; Pelias, M. K., “Genetic Testing of Children for Adult-Onset Diseases: Is Testing in the Child's Best Interests?” Mt. Sinai Journal of Medicine 73, no. 3 (2006): 605–608; McGuire, A. L. et al. , “Can I Be Sued for That? Liability Risk and the Disclosure of Clinically Significant Genetic Research Findings,” Genome Research 24, no. 5 (2014): 719–723.CrossRefGoogle Scholar
Fallat, M. E. et al. , “Ethical and Policy Issues in Genetic Testing and Screening of Children,” Pediatrics 131, no. 3 (2013): 620–622; Ross, L. F. Saal, H. M. David, K. L. Anderson, R. R., American Academy of Pediatrics, American College of Medical Genetics and Genomics “Technical Report: Ethical and Policy Issues in Genetic Testing and Screening of Children,” Genetics in Medicine 15, no. 3 (2013): 234–245.Google Scholar
Botkin, J. R. et al. , “Points to Consider: Ethical, Legal, and Psychosocial Implications of Genetic Testing in Children and Adolescents,” American Journal of Human Genetics 97, no. 1 (2015): 6–21.CrossRefGoogle Scholar
Green, R. C. et al. , “ACMG Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing,” Genetics in Medicine 7, no. 15 (2013): 565–574; American College of Genetics and Genomics, “Incidental Findings in Clinical Genomics: A Clarification,” Genetics in Medicine 15, no. 8 (2013): 664–666.CrossRefGoogle Scholar
Clayton, E. W. et al. , “Addressing the Ethical Challenges in Genetic Testing and Sequencing of Children,” American Journal of Bioethics 14, no. 3 (2014): 3–9.CrossRefGoogle Scholar
ACMG Board of Directors, “ACMG Policy Statement: Updated Recommendations Regarding Analysis and Reporting of Secondary Findings in Clinical Genome-Scale Sequencing,” Genetics in Medicine 17, no. 1 (2014): 68–69.Google Scholar
See, e.g., Ross, L. F., Children, Families, and Health Care Decision Making (New York: Oxford University Press, 2002).Google Scholar
Common conditions for emancipation include formal court order, marriage, and enlistment in the military, although these vary from state to state.Google Scholar
Carey v. Population Services Int'l., 431 U.S. 678 (1977).Google Scholar
See, e.g., Bellotti v. Baird, 428 U.S. 132 (1976) & 433 U.S. 622 (1979).Google Scholar
American Academy of Pediatrics v. Lungren, 940 P.2d 797 (Cal. 1997) (upholding adolescents' right of privacy under the California constitution).Google Scholar
Compare Alfonso v. Fernandez, 606 N.Y.S.2d 259 (App. Div. 1993) (finding that parental rights supersede) and Decker v. Carroll Academy, 1999 WL 332705 (Tenn. Ct. App. 1999) with Curtis v. School Committee of Falmouth, 652 N.E.2d 580 (Mass. 1995) (holding that parental rights are not implicated by providing condoms in school).Google Scholar
Title X of the Public Health Service Act, 42 U.S.C. 300 et seq. (2013); 42 C.F.R. part 59, subpart A (2013); Committee on a Comprehensive Review of the HHS Office of Family Planning Title X Program, A Review of the HHS Family Planning Program: Mission, Management, and Measurement of Results (Washington, D.C.: National Academies Press, 2009).Google Scholar
42 C.F.R. § 59.11 (2013).CrossRefGoogle Scholar
Omnibus Budget Reconciliation Act of 1981, Pub. L. No. 97–35, § 931(b)(1), 95 Stat. 570 (1981) (codified at 42 U.S.C. § 300(a) (1991)).Google Scholar
See generally, English, A. et al. , State Minor Consent Laws: A Summary, 3rd ed. (Chapel Hill: Center for Adolescent Health and the Law, 2010).Google Scholar
Coleman, D. L. Rosoff, P. M., “The Legal Authority of Mature Minors to Consent to General Medical Treatment,” Pediatrics 131, no. 4 (2013): 786–793; cf., Slonina, M. I., “State v. Physicians et al.: Legal Standards Guiding the Mature Minor Doctrine and the Bioethical Judgment of Pediatricians in Life-Sustaining Medical Treatment,” Health Matrix 17, no. 1 (2007): 181–214.CrossRefGoogle Scholar
Scott, E. S. Huntington, C., “Children's Health in a Legal Framework,” The Future of Children 25, no. 1 (2015): 177–197.Google Scholar
Ark. Code Ann. § 20-9-602(7)(2013); see also Ala. Code § 22-8-4, Alaska § 25.20.025(a)(2) (2013) (if parents unavailable); Kan. Stat. Ann. § 38–123b(2013) (16 years old if parent not readily available); La. Rev. Stat. Ann. § 40:1095 (2013) (limited to a minor “who is or believes himself to be afflicted with an illness or disease”); Ore. Rev. Stat. § 109.640 (2013) (15 years old); 35 Pa. Cons. Stat. Ann. § 10101 (2013) (18 or over and high school graduate); S.C. Code Ann. § 63-5-340 (2013) (16 years old, but surgery “only if such is essential to the health or life of such child in the opinion of the performing physician and a consultant physician if one is available”).Google Scholar
Borry, P. et al. , “Health-Related Direct-To-Consumer Genetic Testing: A Review of Companies' Policies with Regard to Genetic Testing in Minors,” Familial Cancer 9, no. 1 (2010): 51–59.Google Scholar
Ariz, R.S. §§ 1–602.A.5 & 8 & 12–2803 (2014); Okla. Stat. Ann. tit. 25, § 2002 (2014); see also 16 Del. Code § 1226 (2014).Google Scholar
45 C.F.R. § 46.408 (2015).Google Scholar
See, e.g., Wolf, S. M. et al. , “Managing Incidental Findings and Research Results in Genomic Research Involving Biobanks and Archived Data Sets,” Genetics in Medicine 14, no. 4 (2012): 361–384.CrossRefGoogle Scholar
Federal Register 76 (143) (2011): 44512–44531.Google Scholar
27. Porter, E. G., “Tort Liability in the Age of the Helicopter Parent,” Alabama Law Review 64, no. 3 (2013): 533–587. By contrast, there is general but not complete consensus that children can seek damages if their parents' negligence causes injuries, which is not applicable here. Restatement (Second) of Torts § 895G (1965 & 2014). See, e.g., Glaskox v. Glaskox, 614 So.2d 906 (Miss. 1992) (overturning parental tort immunity for negligence, originally articulated in the United States in Hewlett v. George, 9 So. 885 (Miss. 1891)).Google Scholar
Kohrman, A. et al. , “Informed Consent, Parental Permission, and Assent in Pediatric Practice,” Pediatrics 95, no. 2 (1995): 314–317; American Academy of Pediatrics, “AAP Publications Reaffirmed and Retired,” Pediatrics 130, no. 2 (2012): e467–e468.Google Scholar
Lee, K. J. et al. , “Assent for Treatment: Clinician Knowledge, Attitudes, and Practice,” Pediatrics 118, no. 2 (2006): 723–730.CrossRefGoogle Scholar
Numerous commentators, however, debated the potential impact of testing on parental behavior, the risk of false positive results, as well as foreclosing the minor's right to make his or her own decisions about testing upon attaining adulthood. See, e.g., Clayton, et al. , supra note 8; Ross, et al. , supra note 5.Google Scholar
Geller, G. et al. , “Informed Consent for Enrolling Minors in Genetic Susceptibility Research: A Qualitative Study of At-Risk Children's and Parents' Views about Children's Role in Decision-Making,” Journal of Adolescent Health 32, no. 4 (2003): 260–271.CrossRefGoogle Scholar
45 C.F.R. § 408(a) (2015).Google Scholar
Holm, I. A. et al. , “Guidelines for Return of Research Results from Pediatric Genomic Studies: Deliberations of the Boston Children's Hospital Gene Partnership Informed Cohort Oversight Board,” Genetics in Medicine 16, no. 7 (2014): 547–552.CrossRefGoogle Scholar
45 C.F.R. §164.524 (2014).Google Scholar
English, A. Ford, C. A., “The HIPAA Privacy Rule and Adolescents: Legal Questions and Clinical Challenges,” Perspectives on Sexual and Reproductive Health 36, no. 2 (2004): 80–86; Office of Civil Rights, U.S. Department of Health and Human Services, Personal Representatives [45 C.F.R. 164.502(g)] (2013), available at <http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/personalrepresentatives.pdf> (last visited August 10, 2015).Google Scholar
English, et al. , supra note 19.Google Scholar
Borry, et al. , supra note 23.Google Scholar
Compare 42 C.F.R. § 263a (2014) (promulgated under the Clinical Laboratory Improvement Amendments) with 45 C.F.R. § 164.524 (2014) (promulgated under the Health Information Technology for Economic and Clinical Health Act); see Evans, B. J. et al. , “Regulatory Changes Raise Troubling Questions for Genomic Testing,” Genetics in Medicine 16, no. 11 (2014): 799–803; Clayton, E. W. McGuire, A. L., “The Legal Risks of Returning Results of Genomics Research,” Genetics in Medicine 14, no. 4 (2012): 473–477.CrossRefGoogle Scholar
Tabor, H. K. et al. , “Parent Perspectives on Pediatric Genetic Research and Implications for Genotype-Driven Research Recruitment,” Journal of Empirical Research in Human Research Ethics 6, no. 4 (2011): 41–52; Harris, E. D. et al. , “The Beliefs, Motivations, and Expectations of Parents Who Have Enrolled Their Children in a Genetic Biorepository,” Genetics in Medicine 14, no. 3 (2012): 330–337; Halverson, C. M. Ross, L. F., “Attitudes of African-American Parents about Biobank Participation and Return of Results for Themselves and Their Children,” Journal of Medical Ethics 38, no. 9 (2012): 561–566; Ziniel, S. I. et al. , “Parents' Preferences for Return of Results in Pediatric Genomic Research,” Public Health Genomics 17, no. 2 (2014): 105–114.CrossRefGoogle Scholar
45 C.F.R. §164.524 (2014).Google Scholar
Even proposals for reform would require parental involvement. See, e.g., Glover, M., “Rethinking the Testamentary Capacity of Minors,” Missouri Law Review 79, no. 1 (2014): 69–118 (proposing that minors be allowed to execute wills with their parents' consent).Google Scholar
Porter, , supra note 28.Google Scholar
Fallat, et al. , supra note 5; Ross, et al. , supra note 5.Google Scholar
Green, et al. , supra note 7; American College of Genetics & Genomics, supra note 7; ACMG Board of Directors, supra note 9.Google Scholar