Hostname: page-component-586b7cd67f-t7fkt Total loading time: 0 Render date: 2024-11-20T11:37:29.089Z Has data issue: false hasContentIssue false
  • English
  • Français

Raising Genomic Citizens: Adolescents and the Return of Secondary Genomic Findings

Published online by Cambridge University Press:  01 January 2021

Maya Sabatello  and
Paul S. Appelbaum
Get access Rights & Permissions [Opens in a new window]

Abstract

Whole genome and exome sequencing (WGS/WES) techniques raise hope for a new scale of diagnosis, prevention, and prediction of genetic conditions, and improved care for children. For these hopes to materialize, extensive genomic research with children will be needed. However, the use of WGS/WES in pediatric research settings raises considerable challenges for families, researchers, and policy development. In particular, the possibility that these techniques will generate genetic findings unrelated to the primary goal of sequencing has stirred intense debate about whether, which, how, and when these secondary or incidental findings (SFs) should be returned to parents and minors. The debate is even more pronounced when the subjects are adolescents, for whom decisions about return of SFs may have particular implications. In this paper, we consider the rise of “genomic citizenship” and the main challenges that arise for these stakeholders: adolescents' involvement in decisions relating to return of genomic SFs, the types of SFs that should be offered, privacy protections, and communication between researchers and adolescents about SFs. We argue that adolescents' involvement in genomic SF-related decisions acknowledges their status as valuable stakeholders without detracting from broader familial interests, and promotes more informed genomic citizens.

Type
Independent Articles
Information
Journal of Law, Medicine & Ethics , Volume 44 , Issue 2: Ethical and Legal Issues in Pediatrics , Summer 2016 , pp. 292 - 308
Copyright
Copyright © American Society of Law, Medicine and Ethics 2016

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

Abdul-Karim, R., et al., “Disclosure of Incidental Findings from Next-Generation Sequencing in Pediatric Genomic Research,” Pediatrics 131, no. 3 (2013): 564-71; Hens, K., Levesque, E., and Dierickx, K., “Children and Biobanks: A Review of the Ethical and Legal Discussion,” Human Genetics 130, no. 3 (2011): 403-13; Hens, K., et al., “Genetic Research on Stored Tissue Samples from Minors: A Systematic Review of the Ethical Literature,” American Journal of Medical Genetics A 149a, no. 10 (2009): 2346-58.CrossRefGoogle Scholar
Goodwin, M. and Duke, N., “Capacity and Autonomy: A Thought Experiment on Minors' Access to Assisted Reproductive Technology,” Harvard Journal of Law and Gender 34, no. 2 (2011): 503-52 at 534.Google Scholar
Wilfond, B. S. and Carpenter, K. J., “Incidental Findings in Pediatric Research,” Journal of Law, Medicine and Ethics 36, no. 2 (2008): 332-40, 213 at 334.CrossRefGoogle Scholar
Heath, D., Rapp, R., and Taussig, K.S., “Genetic Citizenship,” in Nugent, D. and Vincent, L., eds., Companion to the Anthropology of Politics (MA, USA: Wiley-Blackwell 2008): 152-67.Google Scholar
The White House, “Fact Sheet: President Obama's Precision Medicine Initiative,” January 30, 2015, available at <https://www.whitehouse.gov/the-press-office/2015/01/30/fact-sheet-president-obama-s-precision-medicine-initiative> (last accesed April 30, 2016); The Precision Medicine Initiative Working Group, “The Precision Medicine Initiative Cohort Program – Building a Research Foundation for the 21st Century Medicine,” Sep. 17, 2015, pg 1-5, available at <http://www.himss.org/News/NewsDetail.aspx?ItemNumber=44601> (last accessed April 30, 2016). (last accesed April 30, 2016); The Precision Medicine Initiative Working Group, “The Precision Medicine Initiative Cohort Program – Building a Research Foundation for the 21st Century Medicine,” Sep. 17, 2015, pg 1-5, available at (last accessed April 30, 2016).' href=https://scholar.google.com/scholar?q=The+White+House,+“Fact+Sheet:+President+Obama's+Precision+Medicine+Initiative,”+January+30,+2015,+available+at++(last+accesed+April+30,+2016);+The+Precision+Medicine+Initiative+Working+Group,+“The+Precision+Medicine+Initiative+Cohort+Program+–+Building+a+Research+Foundation+for+the+21st+Century+Medicine,”+Sep.+17,+2015,+pg+1-5,+available+at++(last+accessed+April+30,+2016).>Google Scholar
Spinner, J., The Boundaries of Citizenship: Race, Ethnicity, and Nationality in the Liberal State (Baltimore & London: John Hopkins University Press, 1994): 46-47.Google Scholar
Jans, M., “Children as Citizens: Towards a Contemporary Notion of Child Participation,” Childhood 11, no. 1 (2004): 27-44 at 30-31.CrossRefGoogle Scholar
See Jans, supra note 7, at 38-9; Kayess, R. and French, P., “Out of Darkness into Light? Introducing the Convention on the Rights of Persons with Disabilities,” Human Rights Law Review 8 no. 1 (2008): 1-34 at 11-2, 16.Google Scholar
See Heath, Rapp, and Taussig, supra note 4, at 153.Google Scholar
See Jans, supra note 7, at 38-9.Google Scholar
See Heath, Rapp, and Taussig, supra note 4, at 152.Google Scholar
Sabatello, M., Children's Bioethics: The International Biopolitical Discourse on Harmful Traditional Practices and the Right of the Child to Cultural Identity (Leiden; Boston: Martinus Nijhoff Publishers, 2009): 215-220.Google Scholar
See Heath, Rapp, and Taussig, supra note 4, at 154-5; Landy, D. C., et al., “How Disease Advocacy Organizations Participate in Clinical Research: A Survey of Genetic Organizations,” Genetics in Medicine 14, no. 2 (2012): 223-8 at 226-7.CrossRefGoogle Scholar
Wehling, P., “The “Technoscientization” of Medicine and Its Limits: Technoscientific Identities, Biosocialities, and Rare Disease Patient Organizations,” Poiesis Prax 8, no. 2-3 (Dec 2011): 67-82 at 72-74.CrossRefGoogle Scholar
Kerr, A., “Genetics and Citizenship,” Society 40, no. 6 (2003): 44-50, at 45-46.CrossRefGoogle Scholar
Saunders, C. J., et al., “Rapid Whole-Genome Sequencing for Genetic Disease Diagnosis in Neonatal Intensive Care Units,” Science Translational Medicine 4, no. 154 (2012): 154ra35; Lazaro-Munoz, G., et al., “Looking for Trouble: Preventive Genomic Sequencing in the General Population and the Role of Patient Choice,” American Journal of Bioethics 15, no. 7 (2015): 3-14, at 3-5.CrossRefGoogle Scholar
See Wehling, supra note 14, at 72-75.Google Scholar
Lemke, A. A. and Harris-Wai, J. N., “Stakeholder Engagement in Policy Development: Challenges and Opportunities for Human Genomics,” Genetics in Medicine 17, no. 3 (2015): at 1-2.Google Scholar
Timmermans, S. and Buchbinder, M., “Patients-in-Waiting: Living between Sickness and Health in the Genomics Era,” Journal of Health and Socical Behavior 51, no. 4 (2010): 408-23.CrossRefGoogle Scholar
23andMe, “The 23andme Research Portal,” available at <https://www.23andme.com/23andMeResearchPortal/> (last accessed April 30, 2016).+(last+accessed+April+30,+2016).>Google Scholar
Gene by Gene, “We Are Genetics – Research,” available at <https://www.genebygene.com> (last accessed on April 30, 2016).+(last+accessed+on+April+30,+2016).>Google Scholar
See Lemke and Harris-Wai, supra note 18, at 1-2.Google Scholar
Henderson, G. E., et al., “Characterizing Biobank Organizations in the U.S.: Results from a National Survey,” Genome Medicine 5, no. 1 (2013): 1-12 at 9.CrossRefGoogle Scholar
Brothers, K. B., et al., “Practical Guidance on Informed Consent for Pediatric Participants in a Biorepository,” Mayo Clinic Proceedings 89, no. 11 (2014): 1471-80 at 1471.Google Scholar
Hawkins, A. K., “Biobanks: Importance, Implications and Opportunities for Genetic Counselors,” Journal of Genetic Counseling 19, no. 5 (2010): 423-9 at 428; Ridgeway, J. L., et al., “Potential Bias in the Bank: What Distinguishes Refusers, Nonresponders and Participants in a Clinic-Based Biobank?” Public Health Genomics 16, no. 3 (2013): 118-26 at 124-5.CrossRefGoogle Scholar
Michie, M., et al., “”If I Could in a Small Way Help”: Motivations for and Beliefs About Sample Donation for Genetic Research,” Journal of Empirical Research on Human Research Ethics 6, no. 2 (2011): 57-70 at 65-7.CrossRefGoogle Scholar
See The White House, “Fact Sheet,” supra note 5.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Convention on the Rights of the Child, G.A. Res. 44/25, annex, 44th Sess., 61st plenary meeting. U.N. GAOR Supp. (No. 49) at 167, U.N. Doc. A/44/49 (1989), entered into force Sept. 2, 1990, reprinted in 28 I.LAWM. 1448 (1989); Society for Adolescent Medicine, “Access to health care for adolescents and young adults,” Journal of Adolescent Health 35 (2004): 342-344.CrossRefGoogle Scholar
Partridge, B. C., “The Decisional Capacity of the Adolescent: An Introduction to a Critical Reconsideration of the Doctrine of the Mature Minor,” Journal of Medicine and Philosophy 38, no. 3 (2013): 249-55; Boddington, P. and Gregory, M., “Adolescent Carrier Testing in Practice: The Impact of Legal Rulings and Problems with “Gillick Competence”,” Journal of Genetic Counseling 17, no. 6 (2008): 509-21, at 517-18.CrossRefGoogle Scholar
Fortin, J., Children's Rights and the Developing Law (UK & NY: Cambridge University Press, 2009): 84; Partridge, B. C., “Adolescent Psychological Development, Parenting Styles, and Pediatric Decision Making,” Journal of Medical Philosophy 35, no. 5 (2010): 518-25 at 522-23.CrossRefGoogle Scholar
Steinberg, L., “Does Recent Research on Adolescent Brain Development Inform the Mature Minor Doctrine?” Journal of Medical Philosophy 38, no. 3 (2013): 256-67, at 264; Santelli, J. S., et al., “Guidelines for Adolescent Health Research. A Position Paper of the Society for Adolescent Medicine,” Journal of Adolescent Health 33, no. 5 (2003): 396-409; Weithorn, L. A. and Campbell, S. B., “The Competency of Children and Adolescents to Make Informed Treatment Decisions,” Child Development 53, no. 6 (1982): 1589-98, at 1595.Google Scholar
Rew, L., Mackert, M., and Bonevac, D., “Cool, but Is It Credible? Adolescents' and Parents' Approaches to Genetic Testing,” Western Journal of Nursing Research 32, no. 5 (2010): 610-27 at 621.CrossRefGoogle Scholar
McQueen, J., Wright, J. J., and Fox, J. A., “Design and Implementation of a Genomics Field Trip Program Aimed at Secondary School Students,” PLoS Computational Biololgy 8, no. 8 (2012): e1002636.Google Scholar
Lenhart, A., et al., “Teens, Social Media & Technology Overview 2015,” available at <http://www.pewinternet.org/files/2015/04/PI_TeensandTech_Update2015_0409151.pdf> (last accessed on April 30, 2016).+(last+accessed+on+April+30,+2016).>Google Scholar
Borzekowski, D. G. and Rickert, V. I., “Adolescent Cybersurfing for Health Information: A New Resource That Crosses Barriers,” Archives of Pediatrics & Adolescent Medicine 155, no. 7 (2001): 813-17 at 816-7; Jones, S. and Fox, S., “Generations Online in 2009,” available at <http://www.pewinternet.org/2009/01/28/generations-online-in-2009/> (last accessed April 30, 2016).Google Scholar
See Lenhart, et al., supra note 37, at 8-9.Google Scholar
Illumina Inc., “Illumina Launches Mygenome(R) App for Ipad(R)First Tool of Its Kind for Visualizing the Human,” available at <Genomehttp://investor.illumina.com/phoenix.zhtml?c=121127&p=irol-newsArticle&ID=1686310> (last accessed April 30, 2016); Illumina Inc., “Mygenome,” available at <https://itunes.apple.com/us/app/mygenome/id516405838?mt=8> (last accessed April 30, 2016).+(last+accessed+April+30,+2016);+Illumina+Inc.,+“Mygenome,”+available+at++(last+accessed+April+30,+2016).>Google Scholar
Scott, H., “23 a Go-Go,” available at <http://blog.23andme.com/news/23-a-go-go/> (last accessed on April 30, 2016).+(last+accessed+on+April+30,+2016).>Google Scholar
Duncan, R. E., et al., “An International Survey of Predictive Genetic Testing in Children for Adult Onset Conditions,” Genetics in Medicine 7, no. 6 (2005): 390-6, at 394-395.Google Scholar
Wehbe, R. M., et al., “When to Tell and Test for Genetic Carrier Status: Perspectives of Adolescents and Young Adults from Fragile X Families,” American Journal of Medical Genetics A 149a, no. 6 (2009): 1190-9, at 1197-8; Mand, C., et al., “”It Was the Missing Piece”: Adolescent Experiences of Predictive Genetic Testing for Adult-Onset Conditions,” Genetics in Medicine 15, no. 8 (2013): 643-9 at 647; Tercyak, K. P., et al., “Interest of Adolescents in Genetic Testing for Nicotine Addiction Susceptibility,” Preventive Medicine 42, no. 1 (2006): 60-5 at 62; Bradbury, A. R., et al., “Learning of Your Parent's BRCA Mutation During Adolescence or Early Adulthood: A Study of Offspring Experiences,” Psychooncology 18, no. 2 (2009): 200- 208, at 205.Google Scholar
Levenseller, B. L., et al., “Stakeholders' Opinions on the Implementation of Pediatric Whole Exome Sequencing: Implications for Informed Consent,” Journal of Genetic Counseling 23, no. 4 (2014): 552-65; Hens, K. at al., “The Storage and Use of Biological Tissue Samples from Minors for Research: A Focus Group Study,” Public Health Genomics 14, no. 2 (2011): 68-76; Tomlinson, A. N., et al., ““I Want to Know, but I Don't”: Adolescent Involvement in Sequencing Incidental Finding Decisions,” abstract from presentation at Society of Behavioral Medicine, Texas, April 22–25, 2015.Google Scholar
McGuire, A. L. et al., “Social Networkers' Attitudes toward Direct-to-Consumer Personal Genome Testing,” American Journal of Bioethics 9, no. 6-7 (2009): 3-10 at 9.CrossRefGoogle Scholar
Borry, P., et al., “Health-Realted Direct-to-Consumer Genetic Testing: A Reivew of Companies' Policies with Regard to Genetic Testing in Minors,” Familial Cancer 9 (2010): 51-59, at 52, 54, 56-8.CrossRefGoogle Scholar
23andMe Inc., “Full Privacy Statement,” available at <https://www.23andme.com/about/privacy/> (last visited on April 30, 2016); Scott, H., “23 A Go-Go,” available at <http://blog.23andme.com/news/23-a-go-go/> (last visited May 9, 2016).+(last+visited+on+April+30,+2016);+Scott,+H.,+“23+A+Go-Go,”+available+at++(last+visited+May+9,+2016).>Google Scholar
Perbal, B., “Communication Is the Key. Part 2: Direct to Consumer Genetics in Our Future Daily Life?” Journal of Cell Communication and Signaling 8, no. 4 (2014): 275-87 at 275.Google Scholar
Clayton, E. Wright, “How Much Control Do Children and Adolescents Have over Genomic Testing, Parental Access to Their Results, and Parental Communication of Those Results to Others?” Journal of Law, Medicine and Ethics 43, no. 3 (2015): 538-544.CrossRefGoogle Scholar
BusinessWire, “23andme, Inc. Provides Update on FDA Regulatory Review,” available at <http://www.businesswire.com/news/home/20131205006550/en/23andMe-Update-FDA-Regulatory-Review-.Vao7dqYmanc> (last accessed on April 30, 2016)+(last+accessed+on+April+30,+2016)>Google Scholar
Smetana, J. G., Campione-Barr, N., and Metzger, A., “Adolescent Development in Interpersonal and Societal Contexts,” Annual Review of Psychollogy 57 (2006): 255-84.Google Scholar
See Fortin, supra note 33, at 90.Google Scholar
Tabor, H. K. and Kelley, M., “Challenges in the Use of Direct-to-Consumer Personal Genome Testing in Children,” American Journal of Bioethics 9, no. 6-7 (2009): 32-4, at 33.Google Scholar
See Henderson, et al., supra note 23, at 6.Google Scholar
See Borry, et al., supra note 46, at 54-55.Google Scholar
Regeneron Pharmaceuticals, Inc., “Regeneron Genetics Center,” available at <http://www.regeneron.com/Regeneron-Genetics-Center> (last accessed April 30, 2016).+(last+accessed+April+30,+2016).>Google Scholar
See Saunders, et al., supra note 16.Google Scholar
Downing, J. R., et al., “The Pediatric Cancer Genome Project,” Nature Genetics 44, no. 6 (2012): 619-622.Google Scholar
Duncan, R. E. and Young, M.-A., “Tricky Teens: Are They Really Tricky or Do Genetic Health Professionals Simply Require More Training in Adolescent Health?” Personalized Medicine 10, no. 6 (2013): 589-600 at 592-594.Google Scholar
See Wright Clayton, supra note 49.Google Scholar
See Goodwin and Duke, supra note 2, at 532.Google Scholar
Duncan, R. E., et al., “”Holding Your Breath”: Interviews with Young People Who Have Undergone Predictive Genetic Testing for Huntington Disease,” American Journal of Medical Genetics A 143a, no. 17 (2007): 1984-9 at 1986-7.Google Scholar
McGuire, A. L., et al., “Confidentiality, Privacy, and Security of Genetic and Genomic Test Information in Electronic Health Records: Points to Consider,” Genetics in Medicine 10, no. 7 (2008): 495-9 at 497.Google Scholar
See Levenseller, et al., supra note 44, at 557, 560; Appelbaum, P. S., et al., “Informed Consent for Return of Incidental Findings in Genomic Research,” Genetics in Medicine 16, no. 5 (2014): 367-373, at 371; Strong, K. A., et al., “Views of Primary Care Providers Regarding the Return of Genome Sequencing Incidental Findings,” Clinical Genetics 86, no. 5 (2014): 461-468, at 463-465; Kaufman, D., et al., “Ethical Implications of Including Children in a Large Biobank for Genetic-Epidemiologic Research: A Qualitative Study of Public Opinion,” American Journal of Medical Genetics C 148c, no. 1 (2008): 31-39, at 36; Townsend, A., et al., “”I Want to Know What's in Pandora's Box”: Comparing Stakeholder Perspectives on Incidental Findings in Clinical Whole Genomic Sequencing,” American Journal of Medical Genetics A 158a, no. 10 (2012): 2519-2525, at 2522-3; Kleiderman, E., et al., “Returning Incidental Findings from Genetic Research to Children: Views of Parents of Children Affected by Rare Diseases,” Journal of Medical Ethics 40, no. 10 (2014): 691-696, at 693; Sapp, J. C., et al., “Parental Attitudes, Values, and Beliefs toward the Return of Results from Exome Sequencing in Children,” Clinical Genetics 85, no. 2 (2014): 120-126, at 125; Fernandez, C. V., et al., “Attitudes of Parents toward the Return of Targeted and Incidental Genomic Research Findings in Children,” Genetics in Medicine 16, no. 8 (2014): 633-640, at 635.CrossRefGoogle Scholar
Grady, C., et al., “Assent in Research: The Voices of Adolescents,” Journal of Adolescent Health 54, no. 5 (2014): 515-20 at 561; Waligora, M., Dranseika, V., and Piasecki, J., “Child's Assent in Research: Age Threshold or Personalisation?” BMC Medical Ethics 15 no. 44 (2014): 1-7, at 1-2.CrossRefGoogle Scholar
Wilfond, B. S. and Diekema, D. S., “Engaging Children in Genomics Research: Decoding the Meaning of Assent in Research,” Genetics in Medicine 14, no. 4 (2012): 437-43 at 439-440.CrossRefGoogle Scholar
Borry, P., et al., “Genetic Testing in Asymptomatic Minors: Background Considerations Towards Eshg Recommendations,” European Journal of Human Genetics 17, no. 6 (2009): 711-719, at 712.CrossRefGoogle Scholar
See Fortin, supra note 33 at 147; Santelli, et al., supra note 34, at 400; Alderson, P., “Competent Children? Minors' Consent to Health Care Treatment and Research,” Social Science & Medicine 65, no. 11 (2007): 2272-2283, at 2276-2277.Google Scholar
See Alderson, id., at 2273, 2277.Google Scholar
See Rew, Mackert, and Bonevac, supra note 35, at 618-19.Google Scholar
See Wehbe, et al., supra note 43, at 1197-8.Google Scholar
Goodenough, T., Williamson, E., and Aschroft, R., “Ethical Protection in Research: Including Children in the Debate,” in Smyth, M. and Bond, C., eds., Researchers and Their ‘Subjects’: Ethics, Power, Knowledge and Consent (Policy Press, 2004): 55-70, at 67; Williamson, E., et al., “Children's Participation in Genetic Epidemiology: Consent and Control,” in Corrigan, O. and Tutton, R., eds., Genetic Databses: Socio-Ethical Issues in the Collection and Use of DNA (NY & Canada: Routledge, 2004): 139- 60 at 157.Google Scholar
See Grady, et al., supra note 65, at 519.Google Scholar
See Hens et al., supra note 44, at 72, 73.Google Scholar
See Levenseller et al., supra note 44, at 557, 561.Google Scholar
See Hens et al., supra note 44, at 75.Google Scholar
Id., at 74-75.Google Scholar
Id., at 75; Tomlinson, A., et al., “Informed Consent for Pediatric Full Genome Sequencing Research: Challenges for Adolescents and Opportunities for Social Work,” abstract from presentation at Society for Social Work and Research, January 14-18, 2015, available at <https://sswr.confex.com/sswr/2015/webprogram/Paper23372.html> (last visited May 6, 2016).+(last+visited+May+6,+2016).>Google Scholar
Drake, R. E., Cimpean, D., and Torrey, W. C., “Shared Decision Making in Mental Health: Prospects for Personalized Medicine,” Dialogues in Clinical Neurosciences 11, no. 4 (2009): 455-463, at 460.Google Scholar
Smets, E. M., et al., “Health-Related Quality of Life of Children with a Positive Carrier Status for Inherited Cardiovascular Diseases,” American Journal of Medical Genetics A 146a, no. 6 (2008): 700-7 at 701.Google Scholar
See Kleiderman et al., supra note 64, at 692.Google Scholar
See Levenseller et al., supra note 44, at 560, 563.Google Scholar
See Lazaro-Munoz et al., supra note 16, at 10.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): 547-52 at 551; Bredenoord, A. L., de Vries, M. C., and van Delden, J. J., “Next-Generation Sequencing: Does the Next Generation Still Have a Right to an Open Future?” Nature Review Genetics 14, no. 5 (2013): 306; Hens, K., et al., “Developing a Policy for Paediatric Biobanks: Principles for Good Practice,” European Journal of Human Genetics 21, no. 1 (2013): 2-7 at 6.Google Scholar
Knoppers, B. M., et al., “Return of Whole-Genome Sequencing Results in Paediatric Research: A Statement of the P3G International Paediatrics Platform,” European Journal of Human Genetics 22, no. 1 (2014): 3-5 at 3; Ross, L. F., et al., “Technical Report: Ethical and Policy Issues in Genetic Testing and Screening of Children,” Genetics in Medicine 15, no. 3 (2013): 234-45 at 237; Klitzman, R., Appelbaum, P. S., and Chung, W., “Return of Secondary Genomic Findings vs Patient Autonomy: Implications for Medical Care,” JAMA 310, no. 4 (2013): 369- 70 at 369; Smetana, Campione-Barr and Metzger, supra note 51, at 256.Google Scholar
American College of Medical Genetics and Genomics, “Incidental Findings in Clinical Genomics: A Clarification,” Genetics in Medicine 15, no. 8 (2013): 664-6 at 664.CrossRefGoogle Scholar
See Wright Clayton, supra note 49.Google Scholar
Hens, K. et al., “The Return of Individual Research Findings in Paediatric Genetic Research,” Journal of Medical Ethics 37, no. 3 (2011): 179-83 at 180; Hens et al., supra note 84, at 6.CrossRefGoogle Scholar
See Holm, et al., supra note 84, at 550; Knoppers, et al., supra note 85, at 5; ACMG, supra note 86, at 664-5; Ross et al., supra note 85, at 238.Google Scholar
See Levenseller et al., supra note 44, at 558; Kleiderman et al., supra note 64, at 693.Google Scholar
See Levenseller et al., supra note 44, at 560; Townsend, et al., supra note 64, at 2522-3; Kaufman, et al., supra note 64, at 36; Sapp et al., supra note 64, at 125; Fernandez, et al., supra note 64, at 635.Google Scholar
See Levenseller et al., supra note 44, at 560, 563; Appelbaum et al., supra note 64, at 371; Borry, P., et al., “Minors and Informed Consent in Carrier Testing: A Survey of European Clinical Geneticists,” Journal of Medical Ethics 34, no. 5 (2008): 370-374 at 373-374.CrossRefGoogle Scholar
See McGuire et al., supra note 45, at 4, 5-6.Google Scholar
See Hens et al., supra note 44; Tomlinson et al., supra note 78; Levenseller et al., supra note 44.Google Scholar
See Levenseller, et al., supra note 44, at 558.Google Scholar
See Tomlinson et al., supra note 78.Google Scholar
See The Precision Medicine Initiative Working Group, supra note 5, at 26-7.Google Scholar
See Knoppers et al., supra note 85,, at 3; Ross et al., supra note 85, at 237.Google Scholar
See Levenseller et al., supra note 44, at 560; Townsend et al., supra note 64, at 2523.Google Scholar
Codori, A. M., et al., “Genetic Testing for Hereditary Colorectal Cancer in Children: Long-Term Psychological Effects,” American Jouranl of Medical Genetics A 116a, no. 2 (2003): 117-28 at 124-7; Michie, S., Bobrow, M., and Marteau, T. M., “Predictive Genetic Testing in Children and Adults: A Study of Emotional Impact,” Journal of Medical Genetics 38, no. 8 (2001): 519-526, at 524-525.CrossRefGoogle Scholar
Duncan, R. E., et al., “”You're One of Us Now”: Young People Describe Their Experiences of Predictive Genetic Testing for Huntington Disease (HD) and Familial Adenomatous Polyposis (FAP),” American Journal of Medical Genetics C 148c, no. 1 (2008): 47-55, at 50-53.Google Scholar
Id.Google Scholar
Harel, A., Abuelo, D., and Kazura, A., “Adolescents and Genetic Testing: What Do They Think About It?” Journal of Adolescent Health 33, no. 6 (2003): 489-494, at 493; Rew, Mackert and Bonevac, supra note 35, at 621; Bradbury et al., supra note 43, at 204-207; Bernhardt, B. A., et al., “Parents' and Children's Attitudes toward the Enrollment of Minors in Genetic Susceptibility Research: Implications for Informed Consent,” American Journal of Medical Genetics A 116a, no. 4 (2003): 315-23 at 319-22.Google Scholar
Webster, T. HG, Beal, S. J., and Brothers, K. B., “Motivation in the Age of Genomics: Why Genetic Findings of Disease Susceptibility Might Not Motivate Behavior Change,” Life Sciences, Society and Policy 9, no. 8 (2013): 1-15 at 3-4.Google Scholar
Vassy, J. L., “Can Genetic Information Change Patient Behavior to Reduce Type 2 Diabetes Risk?” Personlized Medicine 10, no. 1 (2013): 1-4 at 3; Marteau, T., et al., “Effects of Communicating DNA-Based Disease Risk Estimates on Risk-Reducing Behaviours,” Cochrane Database of Systematic Reviews, no. 10 (2010): 1-77 at 19; Chao, S., et al., “Health Behavior Changes after Genetic Risk Assessment for Alzheimer Disease: The Reveal Study,” Alzheimer Disease and Associated Disorders 22, no. 1 (2008): 94-7.Google Scholar
See Duncan et al., supra note 62, at 1985-7. Mand et al., supra note 43, at 664-5.Google Scholar
Lipkus, I. M., “Conveying Genetic Risk to Teenagers,” in Tercyak, K. P., ed., Handbook of Genomics and the Family, Issues in Clinical Child Psychology (NY; Springer, 2010): 191-217 at 208.Google Scholar
See McGuire et al., supra note 63, at 497.Google Scholar
Id.Google Scholar
Sabatello, M., et al., “Genetic Causal Attribution of Epilepsy and Its Implications for Felt Stigma,” Epilepsia 56, no. 10 (2015): 1542–1550 at 1548-9.Google Scholar
Phelan, J. C., “Geneticization of Deviant Behavior and Consequences for Stigma: The Case of Mental Illness,” Journal of Health and Social Behavior 46, no. 4 (2005): 307-22 at 317-8; Koschade, J. and Lynd-Stevenson, R, “The Stigma of Having a Parent with Mental Illness: Genetic Attributions and Associative Stigma,” Australian Journal of Psychology 63 (2011): 93-99 at 93-4.Google Scholar
Ziskind, S., “The Genetic Information Nondiscrmination Act: A New Look at an Old Problem,” Rutgers Computer and Technology Law Journal 25, no. 2 (2008-9): 163-202 at 172, 177-8.Google Scholar
Genetic Information Nondiscrimination Act, Pub.L. 110–233, 122 Stat. 881 (2008).Google Scholar
Evan, J. P. and Burke, W.. “Genetic Exceptionalism: Too Much of a Good Thing?” Genetics in Medicine 10, no. 7 (2008): 500-1.CrossRefGoogle Scholar
Presidential Commission for the Study of Bioethical Issues, “Privacy and Progress in Whole Genome Sequencing,” 23-25, at 2, available at <http://bioethics.gov/sites/default/files/PrivacyProgress508_1.pdf,2012> (last visited May 6, 2016).+(last+visited+May+6,+2016).>Google Scholar
See Levenseller et al., supra note 44, at 558.Google Scholar
Tabor, H. K., et al., “Informed Consent for Whole Genome Sequencing: A Qualitative Analysis of Participant Expectations and Perceptions of Risks, Benefits, and Harms,” American Journal of Medical Genetics A 158a, no. 6 (2012): 1310-9 at 1317.Google Scholar
Gallo, A. M., et al., “Parents' Concerns About Issues Related to Their Children's Genetic Conditions,” Journal of Specialists in Pediatric Nursing 13, no. 1 (2008): 4-14 at 7.Google Scholar
See Bernhardt et al., supra note 103.Google Scholar
Id., at 320.Google Scholar
See Williamson et al., supra note 72, at 155-6.Google Scholar
See Hens et al., supra note 44, at 72.Google Scholar
Koufi, V., et al., “A Framework for Privacy-Preserving Access to Next-Generation EHRs,” Studies in Health Technology and Informatics 205 (2014): 740-4, at 741.Google Scholar
Hazin, R., et al., “Ethical, Legal, and Social Implications of Incorporating Genomic Information into Electronic Health Records,” Genetics in Medicine 15, no. 10 (2013): 810-16, at 812-13.CrossRefGoogle Scholar
See McGuire et al., supra note 63, at 497;Google Scholar
See Precision Medicine Initiative Working Group, supra note 5, at 28.Google Scholar
See Koufi et al., supra note 123, at 741-44.Google Scholar
See Santelli et al., supra note 34, at 398-9.Google Scholar
Britto, M. T., Tivorsak, T. L., and Slap, G. B., “Adolescents' Needs for Health Care Privacy,” Pediatrics 126, no. 6 (2010): e1469-76 at e1472; McDonagh, J. E. and Bateman, B., “’Nothing About Us without Us’: Considerations for Research Involving Young People,” Archives of Disease in Childhood – Education and Practice 97, no. 2 (2012): 55-60 at 56.Google Scholar
Gymrek, M., et al., “Identifying Personal Genomes by Surnames Inference,” Science 339 no. 6117 (2013): 321-24, at 324; Kolata, G., “Poking Holes in Genetic Privacy,” New York Times, June 16, 2013, available at <http://www.nytimes.com/2013/06/18/science/poking-holes-in-the-privacy-of-dna.html?pagewanted=all&_r=2&> (last visited May 6, 2016)..Google Scholar
Oliver, J. M., et al., “Balancing the Risks and Benefits of Genomic Data Sharing: Genome Research Participants' Perspectives,” Public Health Genomics 15, no. 2 (2012): 106-14 at 112; Neidich, A. B., et al., “Empirical Data About Women's Attitudes Towards a Hypothetical Pediatric Biobank,” American Journal of Medical Genetics A 146a, no. 3 (2008): 297-304 at 301.Google Scholar
Lee, S. Soo-Jin and Crawley, L., “Research 2.0: Social Networking and Direct-to-Consumer (DTC) Genomics,” American Journal of Bioethics 9, no. 6-7 (2009): 35-44 at 38, 39-40.Google Scholar
Id., at 37.Google Scholar
West, T., “23andme: See How This Company Is Making Millions Selling Customers DNA Information to Big Pharma,” available at <http://www.inquisitr.com/1739794/23andme-see-how-this-company-is-making-millions-selling-customer-dna-information-to-big-pharma/> (last visited May 6, 2016).+(last+visited+May+6,+2016).>Google Scholar
Lee, S. Soo-Jin and Borgelt, E., “Protecting Posted Genes: Social Networking and the Limits of GINA,” American Journal of Bioethics 14, no. 11 (2014): 32-44 at 35.Google Scholar
Soo-Jin Lee and Crawley, supra note 132, at 37.Google Scholar
Shapiro, L. A. Spies and Margolin, G., “Growing up Wired: Social Networking Sites and Adolescent Psychosocial Development,” Clinical Child and Family Psychology Review 17, no. 1 (2014): 1-18 at 1.Google Scholar
Madden, M. et al., “Teens, Social Media, and Privacy,” 19-21, available at <http://www.pewinternet.org/2013/05/21/teens-social-media-and-privacy/> (last accessed May 6, 2016); Lehnhart, A., et al., “Teens, Social Media and Technology Overview 2015,” 25, available at <http://www.pewinternet.org/2015/04/09/teens-social-media-technology-2015/> (last accessed May 6, 2016).+(last+accessed+May+6,+2016);+Lehnhart,+A.,+et+al.,+“Teens,+Social+Media+and+Technology+Overview+2015,”+25,+available+at++(last+accessed+May+6,+2016).>Google Scholar
Spies Shapiro and Margolin, supra note 137, at 2.Google Scholar
Williams, A. L. and Merten, M. J., “A Review of Online Social Networking Profiles by Adolescents: Implications for Future Research and Intervention,” Adolescence 43, no. 170 (2008): 253-74 at 254-5, 262-67.Google Scholar
See Soo-Jin Lee and Borgelt, supra note 135, at 34.Google Scholar
See Madden et al., supra note 138, at 30-35; Youn, S., “Teenagers' Perceptions of Online Privacy and Coping Behaviors: A Risk–Benefit Appraisal Approach,” Journal of Broadcasting and Electronic Media 49, no. 1 (2005): 86-110 at 104-5.CrossRefGoogle Scholar
See Tabor and Kelley, supra note 53, at 33; Soo-Jin Lee and Crawlwy, supra note 132, at 38.Google Scholar
See Soo-Jin Lee and Borgelt, supra note 135, at 35-41.Google Scholar
See Alderson, supra note 68, at 2279.Google Scholar
Goldenring, J. and Rosen, D., “Getting into Adolescent Heads: An Essential Update,” Contemporary Pediatrics 21 no. 1 (2004): 64-90 at 64-66.Google Scholar
See Alderson, supra note 68, at 2281-2.Google Scholar
Bradbury, A. R., et al., “How Often Do BRCA Mutation Carriers Tell Their Young Children of the Family's Risk for Cancer? A Study of Parental Disclosure of Brca Mutations to Minors and Young Adults,” Journal of Clinical Oncology 25, no. 24 (2007): 3705-11 at 3707-8.Google Scholar
See Levenseller et al., supra note 44, at 561; Hens et al., supra note 44, at 72.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): 260-71 at 261.CrossRefGoogle Scholar
See Levenseller et al., supra note 44, at 560; Bernhardt et al., supra note 103, at 322.Google Scholar
See Rew, Mackert and Bonevac, supra note 35, at 621; Tercyak, K. P., et al., “Parents' Attitudes toward Pediatric Genetic Testing for Common Disease Risk,” Pediatrics 127, no. 5 (2011): e1288-95 at e1293; Borry et al., supra note 67, at 713.CrossRefGoogle Scholar
See Levenseller et al., supra note 44, at 561-2; Metcalfe, A., et al., “Family Communication between Children and Their Parents About Inherited Genetic Conditions: A Meta-Synthesis of the Research,” European Journal of Human Genetics 16, no. 10 (2008): 1193-200 at 1199.Google Scholar
Wilson, B. and Etchegary, H., “Family Communication of Genomic Information,” in Tercyak, K. P., ed., Handbook of Genomics and the Family - Issues in Clinical Child Psychology (NY: Springer, 2010): 163-89 at 166-177.CrossRefGoogle Scholar
See Duncan and Young, supra note 59, at 595-6.Google Scholar
See Appelbaum et al., supra note 64, at 372; Alderson, supra note 68, at 2281-2.Google Scholar
See Duncan and Young, supra note 59, at 595.Google Scholar
Appelbaum, P. S., et al., “Models of Consent to Return of Incidental Findings in Genomic Research,” Hastings Center Report 44, no. 4 (2014): 22-32 at 25-29.Google Scholar
Haga, S. B., et al., “Developing Patient-Friendly Genetic and Genomic Test Reports: Formats to Promote Patient Engagement and Understanding,” Genome Medicine 6, no. 7 (2014): 58; Yu, J. H., et al., “Self-Guided Management of Exome and Whole-Genome Sequencing Results: Changing the Results Return Model,” Genetics in Medicine 15, no. 9 (2013): 684-90 at 687.Google Scholar
See Townsend et al., supra note 64, at 2522.Google Scholar
Rew, L., Mackert, M., and Bonevac, D., “A Systematic Review of Literature About the Genetic Testing of Adolescents,” Journal for Specialists in Pediatric Nursing 14 (2009): 284-294 at 286-7.Google Scholar
See Hens et al., supra note 44, at 69-70.Google Scholar
See Levenseller et al., supra note 44, at 554; Tomlinson et al., supra note 78.Google Scholar
See Michie et al., supra note 26, at 67; Kaufman, D. J., et al., “Public Opinion About the Importance of Privacy in Biobank Research,” American Journal of Human Genetics 85, no. 5 (2009): 643-654, at 650; Yu, J. H., et al., “Attitudes of African Americans toward Return of Results from Exome and Whole Genome Sequencing,” American Journal of Medical Genetics 161a, no. 5 (2013): 1064-1072, at 1067-1069; Lakes, K. D., et al., “Maternal Perspectives on the Return of Genetic Results: Context Matters,” American Journal of Medical Genetics A 161a, no. 1 (2013): 38-47, at 43-44; Hallowell, N., et al., “Balancing Autonomy and Responsibility: The Ethics of Generating and Disclosing Genetic Information,” Journal of Medical Ethics 29, no. 2 (2003): 74-79, at 66-67; Levinson, W., et al., “Not All Patients Want to Participate in Decision Making. A National Study of Public Preferences,” Journal of General Internal Medicine 20, no. 6 (2005): 531-535.Google Scholar
d'Agincourt-Canning, L. and Baird, P., “Genetic Testing for Hereditary Cancers: The Impact of Gender on Interest, Uptake and Ethical Considerations,” Critical Review in Oncology/Hematology 58, no. 2 (2006): 114-123.Google Scholar
See Harel, supra note 103, at 491-492.Google Scholar
Coors, M., et al., “Directives for Retained DNA: Preferences of Adolescent Patients with Substance and Conduct Problems and Their Siblings,” American Journal of Bioethics 8, no. 10 (2008): 77-79, at 78.Google Scholar
Storr, C. L., et al., “Genetic Research Participation in a Young Adult Community Sample,” Journal of Community Genetics 5, no. 4 (2014): 363-375, at 371.Google Scholar
See Madden, et al., supra note 138, at 31,33; Pujazon-Zazik, M. and Park, M. J., “To Tweet, or Not to Tweet: Gender Differences and Potential Positive and Negative Health Outcomes of Adolescents' Social Internet Use,” American Journal of Mens' Health 4, no. 1 (2010): 77-85, at 78-80; Youn, supra note 142, 105.Google Scholar
See Wilson and Etchegary, supra note 154, at 177; Lipkus, supra note 107, at 208-209.Google Scholar
See Precision Medicine Initiative Working Group, supra note 5, at 1-5, 17-20, 38-40, 81-83, 85-6.Google Scholar
Hull, S. C., et al., “Patients' Views on Identifiability of Samples and Informed Consent for Genetic Research,” American Journal of Bioethics 8, no. 10 (2008): 62-70 at 68-9.Google Scholar
Id.Google Scholar