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

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Id.; Alderson P. , “In the Genes or in the Stars? Children's Competence to Consent,” Journal of Medical Ethics 18 (1992): 119–124.

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.

Some studies in Type 1 Diabetes Mellitus, polycystic kidney disease and some genetic hematological disorders span not just years, but generations.

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.

Akers , “Should Children be Used as Research Subjects?” Nursing Forum 3 (1994): 28–22.

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).

45 C.F.R. 46 Subpart A (2003).

Coleman , “Rationalizing Risk Assessment in Human Subject Research,” Arizona Law Review 46, no. 1 (2004): 63–134.

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.

United States Congress, Children's Health Act 2000, Pub. L 106–310 (106th Congress. 2d Session).

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.

See Noah , supra note 1.

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.

Committee on Bioethics, American Academy of Bioethics, “Informed Consent, Parental Permission, and Assent in Pediatric Practice,” Pediatrics 95, no. 2 (1995): 314–317.

Id.

See Larcher , supra note 4.

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.

Akers J. , and Bell S. , “Should Children be Used as Research Subjects,” Nursing Forum 29, no. 3 (1994): 28–33.

See Committee on Bioethics, supra note 20.

See King , supra note 4.

See Committee on Bioethics, supra note 20.

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.

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.

A PubMed search on March 24, 2005 for the terms “informed consent” and “pediatric assent” yielded 28,743 and 37 references, respectively.

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.

45 C.F.R.46 Subpart D (2004).

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.

See Wendler , supra note 5.

45 C.F.R. 46.116 (2004).

See Broome , supra note 6.

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.

See Erb , supra note 3; Committee on Bioethics, supra note 20; see Campis Lovejoy , supra note 30.

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).

See Gaylin Weithorn , supra note 4.

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.

See Members of Yale Faculty, supra note 19.

See Society of Adolescent Medicine, supra note 31.

Planned Parenthood of Central Missouri v. Danforth, in 428 US 52, 96 S Ct. 2831, 49 L Ed. 2d 788. 1976.

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.

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.

See Society of Adolescent Medicine, supra note 31.