1 National Institute of Allergy and Infectious Diseases, Backgrounder—Pediatric AIDS 1 (June 1993) [hereinafter NIAID] (citing estimates of the World Health Organization).

2 Id.

3 Id. at 2.

4 New York City Dep't of Health, Aids Surveillance Update 10 (July 1993). A discrepancy between the estimated number of HIV-infected children and the number reported to the CDC may exist because some HIV-infected children may be asymptomatic, improperly diagnosed as having another disease, or not reported to the CDC. See Id.

5 Id.

6 NIAID, supra note 1, at 3.

7 See infra text accompanying notes 18-20.

8 See infra part II.

9 Am. Found, for Aids Research, AIDS/HIV Treatment Directory 188 (1993) [hereinafter AMFAR].

10 Telephone Interview with National AIDS Information Clearinghouse (September 22, 1993).

11 See Martin, Judith M. & Sacks, Henry S., Do HIV-infected Children in Foster Care Have Access to Clinical Trials of New Treatments?, 5 AIDS & PUB. POL'YJ. 3 (1990)Google Scholar; Deborah, Weimer, Beyond Parens Patriae: Assuring Timely, Informed, Compassionate Decisionmaking for HIV-Positive Children in Foster Care, 46 U. MIAMI L. REV. 379, 380 (1991)Google Scholar.

12 Martin & Sacks, supra note 11, at 3. In the survey, state child protection agencies reported 785 HIV-infected children out of 331,000 foster children. Only 15 out of 785 HIV-infected foster children participated in clinical trials. Id. A corresponding survey of selected researchers conducting pediatric trials reported that 432 children were enrolled in clinical trials. The researchers reported that 69 out of the 432 children were in foster care. Id. at 4.

13 The Food and Drug Administration recognizes three phases of drug studies. Clinical trials occur in the third phase and involve subjects for whom the investigational drug is intended. Clinical trials occur after investigators have tested the drug on healthy subjects in Phase I studies and conducted controlled studies on a limited number of subjects in Phase II studies. Robert J. Levine, Ethics and Regulation of Clinical Research 4-5 (1981). Protocols may occur simultaneously with clinical trials and provide investigational treatment to patients outside of the research context. See infra text accompanying notes 76-79.

14 Interview with Maria Favuzzi, Director of the Pediatric AIDS Unit of the New York City Child Welfare Administration, in New York, N.Y. (October 5, 1993). The figure of 618 HIV-infected foster children represents the total number of HIV-infected foster children as of June 30, 1993. The actual number of HIV-infected foster children participating in clinical trials and protocols may be fewer than 124 because some children may have participated in more than one study. The total number of HIV-infected foster children also may be fewer than 618. Some of the children initially included in that figure may have tested negative for HIV antibodies, been adopted, returned to their biological parents or died. Id.

15 Martin & Sacks, supra note 11, at 3.

16 Besharov, Douglas J., Crack Children in Foster Care: Reexamining the Balance Between Children's Rights and Parent's Rights, 19 Children Today 21, at 22 (July-Aug. 1990)Google Scholar.

17 NIAID, supra note 1, at 1. The NIAID, a division of the National Institutes of Health, has sponsored most pediatric AIDS trials in the United States. Currently, the NIAID supports twentyeight AIDS Clinical Trial Units for pediatric research. Id.

18 Id. at 4.

19 Id. at 5; AMFAR, supra note 9, at 9. See Wolters, P. et al., The Effects of Dideoxyinosine (ddI) on the Cognitive Functioning of Children with HIV Infection After 6 and 10 Months of Treatment, 2 VII Intl. Conf. AIDS 194 (1991)Google Scholar (finding no overall change in IQ, but reporting individual IQ improvements in 21% of the children, IQ stabilization in 70%, and IQ decline in 9%).

20 AMFAR, supra note 9, at 67-68. The study conducted by the National Institute of Child Health and Development reported that only 7% of the children receiving IVIG experienced serious bacterial infection while 15% of the children receiving die placebo suffered from bacterial infection. Significant results occurred only in children with CD4 cell counts below.

21 Id. at 68.

22 Kathleen, Nolan, AIDS and Pediatric Research, 14 Evaluation Rev. 477 (1990)Google Scholar (citing U.S. Dep't Health & Human Servs., The Secretary's Work Group on Pediatric HIV Infection and Disease: Final Report (1988)).

23 Id.

24 Id.

25 Interview with Dr. William Borkowsky, Director of Division of Infectious Diseases & Immunology, Department of Pediatrics, New York University Medical Center, in New York, N.Y. (November 18, 1993).

26 The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Report and Recommendations: Research Involving Children 21, 23 (1977).

27 Id. at 21-22.

28 Id. at 24. After physicians had treated newborns with the antibiotic chloramphenicol for years, research revealed that many newborns suffered from “gray-baby syndrome” and died because their enzyme systems could not properly metabolize accumulations of the drug. Similarly, research conducted after physicians began administering the antibacterial drug sulfisoxazole to newborns indicated that the drug caused neural injury and cerebral palsy in infants. Id.

29 LEVINE, supra note 13, at 159 (citing Shirkey, H.C., Therapeutic Orphans, 72 J. Pediatrics 199-20 (1968))CrossRefGoogle Scholar. As one study revealed, over 80% of the drugs used to treat children in 1975 carried the FDA-required warning that they were “not to be used in children.” Id.

30 AMFAR, supra note 9, at 20.

31 Id. at 31.

32 Id. at 99; NIAID, supra note 1, at 5. See Centers for Disease Control, Recommendations for Prophylaxis Against Pneumocystis carinii pneumonia for Adults and Adolescents Infected with Human Immunodeficiency Virus, 41 Morbidity & Mortality Weekly Report, March 15, 1991, at 1, 1-11.

33 AMFAR, supra note 9, at 99.

34 NIAID, supra note 1, at 4-5.

55 Id. at 6.

36 Id. at 3.

37 Id.

38 See supra text accompanying notes 18-20.

39 NIAID, supra note 1, at 3.

40 Id. Only 30% of infants born of HIV-infected mothers will develop HIV infection. Field, Martha A., Pregnancy and AIDS, 52 Md. L. Rev. 402 (1993)Google Scholar. However, many newborns will falsely test positive for HIV infection during the first eighteen months. As Field explains:

Id. at 424.

41 NIAID, supra note 1, at 3.

42 Nolan, supra note 21, at 466.

43 Id.; NIAID, supra note 1, at 3.

44 See supra text accompanying notes 18-20.

45 Josephine, Gittler & Merle, McPherson, Symposium: HIV Infection Among Women of Reproductive Age, Children, and Adolescents, 22 Iowa L. Rev. 1283 (1992)Google Scholar.

46 Anthony, Japour, Report from the Ninth International Conference on AIDS, in AIDS/HIV Treatment Directory 11 (July 29, 1993)Google Scholar.

47 Id. at 11.

48 Weimer, supra note 11, at 380. The survey included only HIV-infected children living in Los Angeles, San Francisco, Massachusetts, New York, Washington, D.C., and Texas. Id. at 380 n.l.

49 Center for Health Pol'y Studies, Pediatric HIV Continuum of Care Study: Final Report 3-19 (July 10, 1992). The residential placement of HIV-infected children in New York City occurred in the following pattern: 42.9% with parents; 9% with relatives; 10% with related foster parents; 31.3% with unrelated foster parents; and 6.8% in other settings. Id.

50 NIAID, supra note 1, at 2. Between 1981 and 1992, 86% of HIV-infected children contracted HIV from perinatal transmission. Gittler & McPherson, supra note 44, at 1287 (citing CDC, U.S. Dep't Health & Human Servs., HIV/AIDS Surveillance, Feb. 1993, at 9). The rate of perinatal transmission from HIV-infected women to their children ranges from 12% to 35%. NIAID, supra note 1, at 2.

51 Gittler & McPherson, supra note 44, at 1288. By late 1992, the CDC reported that fifty percent of adult and adolescent females with HIV infection had contracted the infection from IV drug use. Id. (citing CDC, U.S. Dep't Health & Human Servs., HIV/AIDS Surveillance, Feb. 1993, at 11). Thirty-six percent of HIV-infected women contracted the infection from heterosexual contact. Id.

52 New York City Dep't of Health, supra note 4, at 11. Fifty-eight percent of HIV-infected children acquired the disease from IV drug using mothers. Twenty percent of the children with HIV infection contracted the disease from mothers with sexual partners who used IV drugs. Id.

53 Diana, Roberts, Child Welfare Services for Drug-Exposed and HIV-Affected Newborns and Their Families, in Families Living with Drugs AND HIV: Intervention and Treatment Strategies 254 (Richard P. Barth et al. eds., 1993)Google Scholar.

54 AMFAR, supra note 9, at 109-39. Some of the trials may no longer have open slots for participants. As of July 1993, the starting date of one vaccine study was pending. Id. at 124.

55 Id. at 109-39. Investigators may have filled many of the slots in some trials.

56 Id. at 145, 147, 170, 171.

57 For example, the pediatric trial involving Alpha Interferon and AZT sets forth inclusion criteria regarding the measurement of children's white blood cells, hemoglobin, bilirubin, creatinine, and neutrophils. In addition, child participants must have received stable AZT therapy for six weeks prior to enrollment and must currently receive PCP prophylaxis. Id. at 109.

58 See supra note 4 and accompanying text.

59 See supra text accompanying notes 21-24.

60 45 C.F.R. § 46.101 (a) (1992) (any research funded or sponsored by the DHHS must comply with its regulations); 21 C.F.R. §§ 56.101(a), 56.103(a) (1993) (the FDA's regulations control investigatory research on products which must have FDA approval before they go on the public market).

61 See infra text accompanying notes 80-85.

62 45 C.F.R. §§ 46.404 to 46.408.

63 45 C.F.R. §§ 46.404 - 46.407, 46.408(b),(d)-(e).

64 Assent is defined as “a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.” 45 C.F.R. § 46.402(b).

In determining whether children in a study have capacity to assent, an IRB “shall take into account the ages, maturity, and psychological state of the children involved.” 45 C.F.R. § 46.408(a). An IRB may make determinations of capacity to assent on an individual or group basis. Id. Where an IRB finds that the proposed research offers “a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research,” the research may proceed without the children's assent. Id.

65 45 C.F.R. § 46.408(b).

66 45 C.F.R. § 46.403.

67 45 C.F.R. § 46.404.

68 45 C.F.R. § 46.102(i).

69 45 C.F.R. § 46.405. For research posing more than minimal risk but offering a prospect of direct benefit to the subject, IRBs may determine that the consent of only one parent is necessary. 45 C.F.R. § 46.408(b).

70 45 C.F.R. § 46.406. IRBs may require that both parents provide consent before a child may participate in research of this kind. If IRBs require the consent of both parents, both parents must give their consent “unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.” 45 C.F.R. § 46.408(b).

71 45 C.F.R. § 46.407. IRBs may require that both parents provide consent before a child may participate in research offering only an opportunity for increased knowledge. 45 C.F.R. § 46.408(b).

72 21 C.F.R. §§ 56.111(a)(3), 56.111(b) (1993).

73 21 C.F.R. § 56.111(a)(3).

74 21 C.F.R. § 56.111(b).

75 21 C.F.R. § 56.111(a)(4).

76 21 C.F.R. §56.111(a)(l)-(3),(6),(7).

77 An “immediately life-threatening” disease refers to “a stage of a disease in which there is a reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment.” 21 C.F.R. § 312.34(b)(3)(ii) (1993).

78 21 C.F.R. § 312.34(a). In effect, the FDA has exempted certain drugs from the normally required three rigorous phases of testing. Early in the developmental phase, sponsors of drugs intended to treat HIV- and AIDS-related illnesses may initiate discussions with the FDA to design appropriate first and second stages of clinical trials. 21 C.F.R. § 312.82. If a sponsor can address concerns of the FDA through the early collaborative process, the FDA may grant marketability approval for the drug after only two phases of testing. 21 C.F.R. § 312.82(b).

79 21 C.F.R. § 312.35(a)(l)(i)-(v). A licensed practitioner who acts as an investigator usually receives the drug under investigation through a sponsor's treatment protocol. 21 C.F.R. § 312.35(a)(3). If a sponsor refuses to establish a treatment protocol for an investigational drug, a licensed practitioner can submit a treatment IND which contains a treatment protocol, the practitioner's qualifications, and information regarding the drug's makeup and clinical testing history. 21 C.F.R. § 312.35(b)(1).

80 21 C.F.R. §312.34(b)(l)(i)-(iv).

81 45 C.F.R. § 46.408(c) (1992).

82 Id.

83 45 C.F.R. § 46.409(a) (l)-(2).

84 Id.

85 45 C.F.R. § 46.409(b). An IRB may appoint an advocate to act on behalf of more than one child. Id.

86 Id.

87 See, Note, Constitutional Limitations on the Scope of State Child Neglect Statutes, 79 Colum. L. Rev. 719 (1979); Katz, Howe, & McGrath, , Child Neglect Laws in America, 9 FAM. L. Q. 1 (1975)Google Scholar.

88 Weimer, supra note 11, at 389 n.54.

89 Id. at 383 n.17. In some cities, foster care agencies greatly improved medical care provisions for foster children. In New York City, for example, 95% of the foster care agencies with HIV-infected foster children that responded to a survey by the Child Welfare Administration reported that HIV-infected children in their care received medical care at hospitals or clinics specializing in pediatric AIDS on the following basis: at least monthly until 6 months old; at least every 2 months from 6 months until 1 year; at least every 3 months from 1 to 2 years; at least every 6 months from 2 to 5 years old; and at least yearly after 5 years. New York City Child Welfare Administration, Report of Survey Results: Provision of Services to HIV-Positive Children in Foster Care 7 (February 11, 1993).

90 Weimer, supra note 11, at 383.

91 “[G]rossly inadequate” resources and “long waiting lists” for substance abuse programs enrolling women further undermine opportunities for foster children's reunification with their biological parents. Roberts, supra note 52, at 254.

92 Under the common law, parents have traditionally held the right to make medical decisions for their children. Ann MacLean, Massie, Withdrawal of Treatment for Minors in a Persistent Vegetative State: Parents Should Decide, 35 Ariz. L. Rev. 173 (Spring 1993)Google Scholar. Only Maryland allows foster parents to provide consent to foster children's medical treatment. Martin & Sacks, supra note 11, at 3.

93 Martin & Sacks, supra note 11, at 6. “The regulations were set up with the intention of protecting foster children from the types of inappropriate medical intervention perpetrated against other classes of individuals (e.g., medical experiments on prisoners and cases of involuntary sterilization).” Id.

94 N.Y. Soc. Servs. Law § 383-b (McKinney 1992).

95 Joseph R. Carrieri, Practice Commentaries, N.Y. Soc. Servs. Law § 383-b (McKinney 1992).

96 See, e.g.. Conn. Gen. Stat. Ann. § 17a-10(c) (West 1992) (“When deemed in the best interests of a child in the custody of the commissioner, the commissioner, his designee, a superintendent or assistant superintendent or, when the child is in transit between department facilities, a designee of the commissioner, may authorize, on the advice of a physician licensed to practice in the state, medical treatment, including surgery, to insure the continued good health or life of the child.“); Ill. Ann. Stat. ch. 705, para. 405/2-11 (Smith-Hurd 1992) (“At all times during temporary custody or shelter care, the court may authorize a physician, a hospital or any other appropriate health care provider to provide medical, dental or surgical procedures if such procedures are necessary to safeguard the minor's life or health.“).

97 Martin & Sacks, supra note 11, at 3.

98 Id. The seven states include Connecticut, Georgia, Illinois, Massachusetts, New Jersey, Texas and Wyoming.

99 Id.

100 Id.

101 The Commissioner heads the Child Welfare Administration (CWA), New York City's child protection agency.

102 New York City Child Welfare Administration, HIV/AIDS Related Activities ¶ 5 (March 31, 1993) [hereinafter HIV/AIDS Related Activities]. The Commissioner has the authority to consent to the enrollment of children committed to the Commissioner's custody and guardianship and children committed to the Commissioner's care and custody. New York City Child Welfare Administration, Cover Letter to Sample Letter of Agreement 1 (March 30, 1993) (on file with author).

103 HIV/AIDS Related Activities, supra note 102, at ¶ 5.

104 Id. New York State laws protecting human subjects do not overlap federal regulations. Section 2445 states that the “provisions of this article shall not apply to the conduct of human research which is subject to, and which is in compliance with, policies and regulations promulgated by any agency of the federal government for the protection of human subjects.” N.Y. Pub. Health Law § 2445 (McKinney 1993).

105 HIV/AIDS Related Activities, supra note 102, at ¶ 5.

106 Cover Letter to Sample Letter of Agreement, supra note 101, at ¶ 2. The Pediatric AIDS Unit processes letters of agreement between the Commissioner and the principal investigator of an approved clinical trial.

107 New York City Child Welfare Administration, Sample Letter of Agreement ¶ 4 (March 30, 1993).

108 Id. at ¶ 5.

109 Id. at ¶ 6.

110 Id. at ¶ 7. The hospital and its staff must comply with N.Y. Social Servs. Law §§ 372, 422 and N.Y. Pub. Health Law §§ 2780-87 (McKinney 1993).

111 New York City Child Welfare Administration, Sample Letter of Agreement ¶ ¶ 8-10 (March 30, 1993)(on file with author).

112 Id. at ¶ d.

113 Id. at ¶ ¶ a-c.

114 Id. at ¶ ¶ b-c.

115 See supra text accompanying note 14.

116 Borkowsky, supra note 24.

117 Weimer, supra note 11, at 384 n.18.

118 Id.

119 Martin & Sacks, supra note 11, at 4; Weimer, supra note 11, at 384 n. 18. Connecticut also has considered adopting a policy requiring protocol reviews and individual determination as to each child's eligibility for enrollment. Martin & Sacks, supra note 11, at 4.

120 Martin & Sacks, supra note 11, at 4, 6.

121 Id. at 3, 6.

122 Id. at 3, 6. California has considered adopting a similar policy. Id.

123 Weimer, supra note 11, at 289.

124 Id.

125 Martin & Sacks, supra note 11, at 6.

126 Id.

127 Id.

128 Id. at 6.

l29 Weimer, supra note 11, at 390.

130 Id.