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Pediatric Assent: Subject Protection Issues among Adolescent Females Enrolled in Research

Published online by Cambridge University Press:  01 January 2021

Theresa O'Lonergan  and
John J. Zodrow
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Extract

Randomized Clinical Trials (RCTs) in the medical community are generally lasting longer due to a number of factors, including an increase in the total volume of biomedical research, expanded federal regulatory requirements, and a rise in patient interest in participating as research subjects. Leading national and international initiatives promote clinical research in children. The primary impetus for these initiatives is the need for adequate data for clinical application of new products and treatment approaches in the pediatric population. Clinical investigations must maintain ethical conduct as an essential component of pediatric research.

Ethical issues associated with clinical research in general have received prominent public and scientific attention. Of particular interest is informed consent, or assent, as applied to pediatrics. There is little practical guidance concerning pediatric assent from legal and ethical disciplines; the law has played only a small role in few cases.

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Independent
Information
Journal of Law, Medicine & Ethics , Volume 34 , Issue 2 , Summer 2006 , pp. 451 - 459
Copyright
Copyright © American Society of Law, Medicine and Ethics 2006

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References

Noah, L., “Informed Consent and the Elusive Dichotomy Between Standard and Experimental Therapy,” American Journal of Law & Medicine 28 (2002): 361–2CrossRefGoogle Scholar
Id.Google Scholar
Erb, T., Schulman, S., and Sugarman, J., “Permission and Assent for Clinical Research in Pediatric Anesthesia,” Anesthesia and Analgesia 94, no. 5 (2002): 1155–60.CrossRefGoogle Scholar
Best Pharmaceuticals for Children Act of 2002, Pub. L. No. 107-109, 115 Stat. 1408 (codified as amended in scattered sections of 21 U.S.C. and 42 U.S.C) (increasing clinical testing on pediatric populations); Pediatric Research Equity Act of 2003, Pub. L No. 108-155, 117 Stat. 1936; (requiring research into pediatric uses for new drugs and biological products); Achenbach, T. M., Howell, C. T., Quay, H. C., and Conners, K. C., “National Survey of Problems and Competencies Among Four to Sixteen-Year-Olds: Parents' Reports for Normative and Clinical Samples,” Monographs of the Society for Research in Child Development 56, no. 3 (1991): 1–131; The Food and Drug Administration Modernization Act of 1997 (FDAMA), Pub. L. No. 105-115, §111, 111 Stat. 2296, 2305-2309, which amended the Federal Food, Drug, and Cosmetic Act of 1938 (FFDCA), as amended, 21 U.S.C. 301, et seq. (2004) (The FDAMA codifies FDA's regulations to increase patient access to experimental drugs and medical devices, accelerate review of important new medications, and promote pediatric clinical testing); Alderman, E. M., Rieder, J., and Cohen, M. I., “A History of Pediatric Specialties: The History of Adolescent Medicine,” Pediatric Research 54, no. 1 (2003): 137–147; Breitmayer, B. J., Gallo, A. M., Knafl, K. A., and Zoeller, L. H., “Social Competence of School-Aged Children With Chronic Illnesses,” Journal of Pediatric Nursing 7, no. 3 (1992): 181–188; Dorn, L. D., Susman, E. J., and Fletcher, J. C., “Informed Consent in Children and Adolescents: Age, Maturation and Psychological State,” Journal of Adolescent Health 16 (1995): 185–190; English, A., “Treating Adolescents: Legal and Ethical Considerations,” Adolescent Medicine 74, no. 5 (1990): 1097–1112; Gaylin, W., “The ‘Competence’ of Children No Longer All or None,” Journal of the American Academy of Child Psychiatry 21 (1982): 153–162; Grisso, T., Appelbaum, T., and Appelbaum, P. S., Assessing Competence to Consent to Treatment: A Guide for Physicians and Other Health Professionals (New York: Oxford University Press, 1998): 17–34; Hurley, J. C. and Underwood, M. K., “Children's Understanding of their Research Rights before and after Debriefing: Informed Assent, Confidentiality, and Stopping Participation,” Child Development 73, no. 1 (2002): 132–143; King, N. P., and Cross, A. W., “Children as Decision Makers: Guidelines for Pediatricians,” The Journal of Pediatrics 115, no. 1 (1989): 10–16; Koocher, G. P., and DeMaso, D. R., “Children's Competence to Consent to Medical Procedures,” Pediatrician 17 (1990): 68–73; Koren, G., Carmeli, D. B., Carmeli, Y. S., and Haslam, R., “Maturity of Children to Consent to Medical Research: The Babysitter Test,” Journal of Medical Ethics 19 (1993): 142–147; Larcher, V., “ABC of Adolescent Consent, Competence and Confidentiality,” British Medical Journal 330, no. 7487 (2005): 353–356; Lewis, C. C., “How Adolescents Approach Decisions: Changes over Grades Seven to Twelve and Policy Implications,” Child Development 52 (1981): 538–544; Lewis, M. A. and Lewis, C. E., “Consequences of Empowering Children to Care for themselves,” Pediatrician 17 (1990): 63–67; Morrissey, J. M., Hofmann, A. D., and Thrope, J. C., Consent and Confidentiality in the Health Care of Children and Adolescents: A Legal Guide (New York: Free Press, 1986): 87–93; Olechnowicz, J. Q., Eder, M., Simon, C., Zyzanski, S., and Kodish, E., “Assent Observed: Children's Involvement in Leukemia Treatment and Research Discussions,” Pediatrics 109, no. 5 (2002): 806–14; Ondrusek, N., Abramovitch, R., Pencharz, P., Koren, G., “Empirical Examination of the Ability of Children to Consent to Clinical Research,” Journal of Medical Ethics 24 (1998): 158–165; Peterson, A. C., and Leffert, N., “Developmental Issues Influencing Guidelines for Adolescent Health Research: A Review,” Journal of Adolescent Health 17, no. 5 (1995): 298–305; Roth, L. H., Meisel, A., and Lidz, C. W., “Tests of Competency to Consent to Treatment,” American Journal of Psychiatry 134, no. 3 (1977): 279–84; Sigman, G. S. and O'Connor, C., “Exploration for Physicians of the Mature Minor Doctrine,” The Journal of Pediatrics 119, no. 4 (1991): 520–25; Tsai, A. K., Schafermeyer, R. W., Kalifon, D., Barkin, R. B., Lumpkin, J. R., Smith, E. E. III, “Evaluation and Treatment of Minors: Reference on Consent,” Annals of Emergency Medicine 22, no. 7 (1993): 1211–1217; Walker, L. J., “Cognitive and Perspective-taking Prerequisites for Moral Development,” Child Development 51 (1980): 131–39; Weithorn, L. A., “Children's Capacities to Decide about Participation in Research,” IRB 5, no. 2 (1983): 1–5; Weithorn, L. A. and Campbell, S. B., “The Competency of Children and Adolescents to Make Informed Treatment Decisions,” Child Development 53 (1982): 1589–1598; Zinner, S. E., “The Elusive Goal of Informed Consent by Adolescents,” Theoretical Medicine 16 (1995): 323–31.CrossRefGoogle Scholar
Oesterheld, J. M., Fogas, B. P., and Rutten, S. M., “Ethical Standards for Research on Children,” Journal of the American Academy of Child and Adolescent Psychiatry 37, no. 7 (1998): 684–685; Porter, J., “Regulatory Considerations when Children are Involved as Subjects in Research,” Journal of School Health 55 (1985): 175–178; Ramsey, P., “Ethical Dimensions of Experimental Research on Children,” in van Eys, J., ed., Research on Children: Medical Imperatives, Ethical Quandaries, and Legal Constraints (Baltimore: University Press, 1978): 57–68; Redmon, R., “How Children Can be Respected as ‘Ends’ Yet Still be Used as Subjects in Non-Therapeutic Research,” Journal of Medical Ethics 12 (1986) 77–82; Rogers, A. S., and the Committee on Research Ethics, “The Society for Adolescent Medicine's Code of Research Ethics – Commentary,” Journal of Adolescent Health 24 (1999): 283; Santelli, J., “Human Subjects Protection and Parental Permission in Adolescent Health Research,” Journal of Adolescent Health 21, no. 6 (1997): 384–87; Silber, T. J., “Justified Paternalism in Adolescent Health Care: Cases of Anorexia Nervosa and Substance Abuse,” Journal of Adolescent Health Care 10, no. 6 (1989): 449–53; Steinbrook, R., “Testing Medications in Children,” N. Engl. J. Med. 347, no. 18 (2002): 1462–70; Strasburger, V. C., “Parental Permission in Adolescent Health Research,” Journal of Adolescent Health 22 (1998): 322; Tarnowski, K. J., Allen, D. M., Mayhall, C., and Kelly, P. A., “Readability of Pediatric Biomedical Research Informed Consent Forms,” Pediatrics 85, no. 1 (1990): 58–62; The American Society of Human Genetics Board of Directors and The American College of Medical Genetics Board of Directors, “ASHG/ACMG REPORT Points to Consider: Ethical, Legal, and Psychosocial Implications of Genetic Testing in Children and Adolescents,” American Journal of Human Genetics 57 (1995): 1233–41; Thompson, P., “Protection of the Rights of Children as Subjects for Research,” Journal of Pediatric Nursing 2, no. 6 (1987): 392–99; Thurber, F. W., Deatrick, J. A., and Grey, M., “Children's Participation in Research: Their Right to Consent,” Journal of Pediatric Nursing 7, no. 3 (1992): 165–170; Vaux, K., “Lazarus Revisited: Moral and Spiritual Aspects of Experimental Therapeutics with Children,” in van Eys, J. ed., Research on Children: Medical Imperatives, Ethical Quandaries, and Legal Constraints (Baltimore: University Press, 1978): 77–84; Wendler, D., and Shaah, S., “Should Children Decide whether they Are Enrolled in Non-Beneficial Research?” The American Journal of Bioethics 2, no. 4 (2003): 1–7; Wertz, D. J., Fanos, J. H., and Reilly, P. R., “Genetic Testing for Children and Adolescents,” JAMA 272, no. 11 (1994): 875–81; Zipursky, A., “Ethics and Responsibilities in Pediatric Research: Editor's Commentary,” Pediatric Research 46, no. 4 (1999): 357; Protection of Human Subjects in Research; Uniform National Applicability of Common Rule and Provisions Protecting Vulnerable Populations, in Code 42, Section 491, H. R. 4697, May 9, 2002; Protection of Human Subjects: Policies and Procedures, Part II, in Code 38, Section 221. November 16, 1973; The Public Health And Welfare Chapter 6A – Public Health Service Subchapter II – General Powers and Duties Part A – Research and Investigations, in Code 42, Section 241, January 5, 1995; 45 C.F.R. § 46.109 (2003); 21 C.F.R. Parts 50 and 56: 66 (2004); Annas, G. J., The Rights of Patients: The Basic ACLU Guide to Patient Rights, second ed. (Totowa: Humana Press 1992): 83–100; Annas, G. J., Glantz, L. H., and Katz, B. F., Informed Consent to Human Experimentation: The Subject's Dilemma (Cambridge: Ballinger Publishing Company, 1977): 62–96; Berg, J., Appelbaum, P., Lidz, C., and Parker, L., Informed Consent: Legal Theory and Clinical Practice, Second Ed. (New York: Oxford University Press, 2001): 249–279; Bernat, J., “Informed Consent,” Muscle and Nerve (2001): 614–620; National Bioethics Advisory Commission, Ethical and Policy Issues in Research Involving Human Participants, 2001; Committee on Assessing the System for Protecting Human Research Participants, Institute of Medicine, Federman, D. D., Hanna, K. E., and Rodriguez, L. L., eds., Responsible Research: A Systems Approach to Protecting Research Participants (Washington, DC: National Academy of Sciences, 2002); Weisstub, D. N., Verdun-Jones, S. N., and Walker, J., “Biomedical Experimentation with Children: Balancing the Need for Protective Measures with the Need to Respect Children's Developing Ability to Make Significant Life Decisions for themselves,” in Weisstub, D. N., Research on Human Subjects: Ethics, Law and Social Policy (Oxford: Elsevier Science Ltd., 1998): 405–432; Earley, C. L., Strong, L. C., “Certificates of Confidentiality: A Valuable Tool for Protecting Genetic Data,” American Journal of Human Genetics 57 (1995): 727–731; Elger, B. S., “Beneficence Today, or Autonomy (Maybe) Tomorrow?” Hastings Center Report 30, no. 1 (2000): 18–19; Emanuel, E. J., Wendler, D., and Grady, C., “What Makes Clinical Research Ethical?” JAMA 283, no. 20 (2000): 2701–2711; Faden, R. R., Beauchamp, T. L., and King, N. M., A History and Theory of Informed Consent (New York: Oxford University Press, 1986): 151–186; Flory, J. and Emanuel, E., “Interventions to Improve Research Participants' Understanding in Informed Consent for Research: A Systematic Review,” JAMA 292, no. 13 (2004): 1593–1618; Hiller, E. H., Landenburger, G., and Natowicz, M. R., “Public Participation in Medical Policy-Making and the Status of Consumer Autonomy: The Example of Newborn-Screening Programs in the United States,” American Journal of Public Health 87, no. 8 (1997): 1280–1288; Hope, T., “Compensating Subjects of Medical Research,” Journal of Medical Ethics 23 (1997): 131–132; Nelson, R. M., “Children as Research Subjects,” in Kahn, J. P., Mastroianni, A. C., and Sugarman, J., Beyond Consent: Seeking Justice in Research (Oxford: Oxford University Press, 1998): 47–66; Levine, R. J., Ethics and Regulation of Clinical Research, Second Ed. (Baltimore: Urban and Schwarzenberg, 1986): 19–35, 235–256; Munson, R., Intervention and Reflection: Basic Issues in Medical Ethics, sixth ed. (Belmont: Wadsworth/Thomson Learning, 2000): 476–480; National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, United States Department of Health, Education and Welfare, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Pub. No (OS) 78–0012, 1978.CrossRefGoogle Scholar
Broome, M. E. and Stieglitz, K. A., “The Consent Process and Children,” Research in Nursing and Health 15 (1992): 147–152; Brock, D. W., “Ethical Issues in Exposing Children to Risks in Research,” in Grodin, M. A., and Glantz, L. H., eds., Children as Research Subjects: Science, Ethics and Law (New York: Oxford University Press, 1994): 81–101; Glantz, L. H., “The Law of Human Experimentation with Children,” in Grodin, M. A. and Glantz, L. H., eds., Children as Research Subjects: Science, Ethics and Law (New York: Oxford University Press, 1994): 103–130.CrossRefGoogle Scholar
Id.; Alderson, P., “In the Genes or in the Stars? Children's Competence to Consent,” Journal of Medical Ethics 18 (1992): 119–124.CrossRefGoogle Scholar
See Achenbach, Breitmayer, Dorn, English, Gaylin, Grisso, Koocher, Koren, Larcher, Lewis, Morrissey, Olechnowicz, Ondrusek, Peterson, Roth, Sigman, Tsai, Walker, Weithorn, Zinner, supra note 4; See Alderson, , supra note 7; Damon, W., and Hart, D., “The Development of Self-Understanding from Infancy through Adolescence,” Child Development 53 (1982): 841–864; Dorn, L. D., Susman, E. J., and Fletcher, J. C., “Informed Consent in Children and Adolescents: Age, Maturation and Psychological State,” Journal of Adolescent Health 16 (1995): 185–90; Hazard, S. W., “An Alternative Model Act Providing for Consent of Minors for Health Services,” Pediatrics 52, no. 5 (1973): 750–52; Holder, A. R., “Involuntary Commitment, Incompetency and Consent,” Institutional Review Board 5, no. 2 (1983): 6–8; Holder, A. R., “Minor's Rights to Consent to Medical Care,” JAMA 257, no. 24 (1987): 3400–3401; Morris, W. C., “Waiver of Prospective Consent for Pediatric Resuscitation Research: In Reply,” Pediatrics 115 (2005): 829–830; Newburger, P. E., Elfenbein, D. S., and Boxer, L. A., “Adolescents with Cancer: Access to Clinical Trials and Age-Appropriate Care,” Current Opinion in Pediatrics 14 (2002): 1–4; Nottelmann, E. D., Susman, E. J., Inoff-Germain, G., Cutler, G. B. Jr., Loriaux, D. L., and Chrousos, G. P., “Developmental Processes in Early Adolescence: Relationships Between Adolescent Adjustment Problems and Chronologic Age, Pubertal Stage, and Puberty-Related Serum Hormone Levels,” The Journal of Pediatrics 110 (1987): 473–80; Ritchie, M. A., “Psychosocial Functioning of Adolescents with Cancer: A Developmental Perspective,” Oncology Nursing Forum 19, no. 10 (1992):1497–1501; Steinberg, L., and Silverberg, S., “The Vicissitudes of Autonomy in Early Adolescence,” Child Development 57 (1986): 841–51; Thompson, R. A., “Vulnerability in Research: A Developmental Perspective on Research Risk,” Child Development 61 (1990): 1–16; Weinberger, D. A., Tubin, S. K., Ford, M. E., and Feldman, S. S., “Preadolescents' Social-Emotional Adjustment and Selective Attrition in Family Research,” Child Development 61 (1990): 1374–86.Google Scholar
Some studies in Type 1 Diabetes Mellitus, polycystic kidney disease and some genetic hematological disorders span not just years, but generations.Google Scholar
Swallen, K. C., Reither, E. N., Haas, S. A., and Meier, A. M., “Overweight, Obesity, and Health-Related Quality of Life Among Adolescents: The National Longitudinal Study of Adolescent Health,” Pediatrics 115, no. 2 (2005): 340–347.CrossRefGoogle Scholar
Akers, , “Should Children be Used as Research Subjects?” Nursing Forum 3 (1994): 28–22.Google Scholar
See NBAC and Belmont Report, supra note 5; Shalala, D., “Protecting Research Subjects – What Must Be Done,” Sounding Board, N. Engl. J. Med. 343, no. 11 (2000): 808–810; Goldner, J., “An Overview of Legal Controls on Human Experimentation and the Regulatory Implications of Taking Professor Katz Seriously,” St. Louis University Law Journal 38, no. 1 (1993): 63–134; National Research Act of 1974, Pub. L. No 93–348, § 88 Stat. 342, (1974).Google Scholar
45 C.F.R. 46 Subpart A (2003).Google Scholar
Coleman, , “Rationalizing Risk Assessment in Human Subject Research,” Arizona Law Review 46, no. 1 (2004): 63–134.Google Scholar
45 C.F.R Subpart D (2004); Arnold, E. and Cook, E., “Ethical Issues in Biological Psychiatric Research with Children and Adolescents,” Journal of the American Academy of Child and Adolescent Psychiatry 34, no.7 (1995): 929–39.CrossRefGoogle Scholar
United States Congress, Children's Health Act 2000, Pub. L 106–310 (106th Congress. 2d Session).Google Scholar
Menikoff, J., “Full Disclosure: Telling Patients When Not Being a Research Subject is a Good Choice,” Perspectives in Biology and Medicine 48, no. 1 (2005): S 139.CrossRefGoogle Scholar
See Noah, , supra note 1.Google Scholar
Faculty of Yale University School of Medicine, Zaret, B., Jatlaw, P., and Katz, L., eds., The Patients' Guide to Medical Tests (New York: Houghton Miflin Company, 2002): 9–14.Google Scholar
Committee on Bioethics, American Academy of Bioethics, “Informed Consent, Parental Permission, and Assent in Pediatric Practice,” Pediatrics 95, no. 2 (1995): 314–317.Google Scholar
Id.Google Scholar
Id.Google Scholar
See Larcher, , supra note 4.Google Scholar
See Porter, , supra note 5; Broome, M. E., and Stieglitz, K. A., “The Consent Process is Children,” Research in Nursing and Health 15 (1992): 147–52.Google Scholar
Akers, J., and Bell, S., “Should Children be Used as Research Subjects,” Nursing Forum 29, no. 3 (1994): 28–33.CrossRefGoogle Scholar
See Committee on Bioethics, supra note 20.Google Scholar
Id.Google Scholar
See King, , supra note 4.Google Scholar
See Committee on Bioethics, supra note 20.Google Scholar
Campis, L., Lyman, R., and Prentice-Dunn, S., “The Parental Locus of Control Scale: Development and Validation,” Journal of Clinical Child Psychology 15, no. 3 (1986): 260–267; Lovejoy, M., “Convergent and Discriminate Validity of Measures of Parenting Efficacy and Control,” Journal of Clinical Child Psychology 26, no. 4 (1997): 366–76.CrossRefGoogle Scholar
See English, , Dorn, , Gaylin, , Koren, , Larcher, , Morrissey, , Sigman, , Weithorn, , Zinner, , supra note 4; See Rogers, , Santelli, , Strasburger, , ASHG/ACMG, supra note 5; Dorn, , King, , Newburger, , supra note 8; Arnold, , supra note 16; American Society of Human Genetics Board of Directors, and the American College of Medical Genetics Board of Directors, “Points to Consider: Ethical, Legal, and Psychological Implications of Genetic Testing in Children and Adolescents,” American Journal of Human Genetics 57 (1995): 1233–1241; Holder, A. R., Legal Issues in Pediatrics and Adolescent Medicine (New Haven: Yale University Press, 1985): 146–175; Leikin, S. L., “An Ethical Issue in Biomedical Research: The Involvement of Minors in Informed and Third Party Consent,” Clinical Research 294, no. 6575 (1983): Supplement 28–30; Levine, R. J., “Adolescents as Research Subjects Without Permission of Their Parents or Guardians: Ethical Considerations,” Journal of Adolescent Health 17 (1995): 287–97; Society for Adolescent Medicine, “Guidelines for Adolescent Health Research: A Position Paper,” Journal of Adolescent Health 22 (2003): 396–409; Munir, K., and Earls, F., “Ethical Principles Governing Research in Child and Adolescent Psychiatry,” Journal of the American Academy of Child and Adolescent Psychiatry 31, no. 3 (1992): 408–414; Committee on Youth, American Academy of Pediatrics, “The Implications of Minor's Consent Legislation for Adolescent Health Care: A Commentary,” Pediatrics 54, no. 4 (1974): 481–485.Google Scholar
A PubMed search on March 24, 2005 for the terms “informed consent” and “pediatric assent” yielded 28,743 and 37 references, respectively.Google Scholar
A PubMed search run on March 24, 2005 for the terms “research informed consent” and “research pediatric assent” yielded 10,532 and 29 references, respectively.Google Scholar
45 C.F.R.46 Subpart D (2004).Google Scholar
Id.Google Scholar
Nalini, J., Ulrich, C. M., and Ley, C., “Ethical Considerations in the Recruitment of Research Subjects from Hospitalized, Cardiovascular Patient Populations,” Journal of Cardiovascular Nursing 20, no.1 (2005): 56.Google Scholar
See Wendler, , supra note 5.Google Scholar
45 C.F.R. 46.116 (2004).CrossRefGoogle Scholar
See Broome, , supra note 6.Google Scholar
See Dorn, , English, , Gaylin, , King, , Koocher, , Larcher, , Lewis, C., Lewis, M., Morrissey, , Ondrusek, , Peterson, , Roth, , Weithorn, , Zinner, , supra note 4; See Thurber, , Wendler, , supra note 5; See Committee on Bioethics, supra note 21; See Broome, , supra note 27; See Hold, , Committee on Youth, supra note 31; Pediatric Practice Action Group and Task Force on Medical Informatics, American Academy of Pediatrics, “Privacy Protection of Health Information: Patient Rights and Pediatrician Responsibilities” (RE9927) Pediatrics 104, no. 4 (1999): 973–77; Bartholome, W. G., “Informed Consent, Parental Permission, and Assent in Pediatric Practice,” Pediatrics 96, no. 5, part 1 (1995): 981–82; Bartholome, W. G., “Central Themes in the Debate over Involvement of Infants and Children in Biomedical Research: A Critical Examination, in Research on Children,” in van Eys, J., ed., Research on Children: Medical Imperatives, Ethical Quandaries, and Legal Constraints (Baltimore: University Press, 1978): 69–76; Bartholome, W. G., “A New Understanding of Consent in Pediatric Practice: Consent, Parental Permission, and Child Assent,” Pediatric Annals 18, no. 4 (1989): 262–265; Mammel, K. and Kaplan, D., “Research Consent by Adolescent Minors and Institiutional Review Boards,” Journal of Adolescent Health 17 (1995): 323–330; Society of Adolescent Medicine, “Position Paper of the Society for Adolescent Medicine,” Journal of Adolescent Health 24 (1999): 277–282; Midwest Bioethics Center Task Force on Health Care Rights for Minors, “Health Care Treatment Decision-Making Guidelines for Minors,” Bioethics Forum 11, no. 4 (1995): A1–A16; Nelson, R. M., “Children as Research Subjects,” in Kahn, J. P., Mastroianni, A. C., and Sugarman, J., eds., Beyond Consent: Seeking Justice in Research (Oxford: Oxford University Press, 1998): 47–66; Vaughan, V. C. III, and Litt, I. F., Child and Adolescent Development: Clinical Implications (Philadelphia: W. B. Saunders Company, 1990): 255–260, 272–274, 297–306.Google Scholar
See Erb, , supra note 3; Committee on Bioethics, supra note 20; see Campis, , Lovejoy, , supra note 30.Google Scholar
Kuhns v. Bruger, 390 Pa. 331, 401 135 A.2d 395 (1957). Page 401 discusses the concept that minors over the age of fourteen are presumptively capable of negligence and must prove their own incapacity; Dunn v. Teti, 280 Pa. Super. 399, 21 A.2d 782 (1980); 132. United States v. Rosa, 17 F.3d 1531 (2d Cir. 1994), cert. denied, 513 U.S. 879 (1994).Google Scholar
See Gaylin, , Weithorn, , supra note 4.Google Scholar
See Dorn, , English, , Grisso, , King, , Koocher, , Koren, , Larcher, , Lewis, C., Lewis, M., Olechnowicz, , Ondrusek, , Peterson, , Roth, , Weithorn, , Zinner, , supra note 4; see Thurber, , Wendler, , supra note 5; see Committee on Bioethics, supra note 20; see Broome, , supra note 27; see Holder, , Society or Adolescent Medicine, Committee on Youth, supra note 31; see APP Pediatric Practice Action Group, Bartholeme, Mammel, Midwest Bioethics Center, Nelson, , supra note 40.Google Scholar
See Members of Yale Faculty, supra note 19.Google Scholar
See Society of Adolescent Medicine, supra note 31.Google Scholar
Planned Parenthood of Central Missouri v. Danforth, in 428 US 52, 96 S Ct. 2831, 49 L Ed. 2d 788. 1976.Google Scholar
Carey v. Population Services International, 431 U.S. 678, 684, 97 S.Ct. 2010, 2016, 52 L.Ed.2d 675 (1977). These pages discuss that the right to privacy includes an interest in independence in making certain kinds of important decisions including child-bearing decisions.Google Scholar
Belloti v. Baird, 443 U.S. 622, 640, 99 S.Ct. 3035, 3046, 61 L.Ed.2d 797 (1979). These pages reference the premises that the State furthers a constitutionally permissible end by encouraging an unmarried pregnant minor to seek the help and advice of her parents in making the very important decision of whether to have a child.Google Scholar
See Society of Adolescent Medicine, supra note 31.Google Scholar