Children in HIV/AIDS Clinical Trials: Still Vulnerable after All These Years

Rousseau Jean-Jacques , Confessions (Paris, 1964 [1782]). Quoted in Boswell John , The Kindness of Strangers (New York: Vintage Books, 1990), pp. 1, 20–21 (fn 42).

Geison Gerald L. , “Pasteur's Work on Rabies: Re-examining the Ethical Issues”, Hastings Center Report, April 1978, pp. 26–33.

Katz Jay , Experimentation with Human Subjects (New York: Russell Sage Foundation, 1972), pp. 633, 1010–17).

Department of Health and Human Services Rules and Regulations, 45 CFR 46: Subpart D-Additional Protections for Children Involved as Subjects in Research (March 8, 1983).

Shirkey H. C. , “Therapeutic Orphans”, journal of Pediatrics, Vol. 72 (1968): 119–20.

Public Law No. 97-414, 96 Stat. 2049 (1983).

Levine Robert J. , Ethics and Regulation of Clinical Research, 2nd Edition (New Haven: Yale University Press, 1988), p. 240.

Unicef, “Children and AIDS: An Impending Calamity” (New York: 1990), pp. 4–5.

Centers for Disease Control, “HIV/AIDS Surveillance”, July 1991, p. 5.

Department of Health and Human Services, Secretary's Work Group on Pediatric HIV Infection and Disease, “Final Report” (Washington: 1988), p. 7.

Secretary's Work Group on Pediatric HIV Infection and Disease, pp. 16, 18.

Institute of Medicine, The AIDS Research Program of the National Institutes of Health: Report of a Study (Washington, DC: 1991), p. 12.

Levine Carol Dubler Nancy Neveloff and Levine Robert J. , “Building a New Consensus: Ethical Principles and Policies for Clinical Research on HIV/AIDS”, IRB: A Review of Human Subjects Research, Vol. 13, Nos. 1–2 (January-April 1991), p. 14.

Nolan Kathleen , “AIDS and Pediatric Research”, Evaluation Review, Vol. 14, No. 4 (October 1990), 465.

Quoted in Sari Staver, “Apply Adult HIV Drug Studies to Kids' Care, Experts Urge”, American Medical News, September 22/29, 1989, p. 40.

Levine R.J. , p. 236.

Martin Judith M. and Sacks Henry S. , “Do HIV-Infected Children in Foster Care Have Access to Clinical Trials of New Treatments?” AIDS & Public Policy Journal, Vol. 5, No. 1 (1990), 3–8.

Sabol Barbara J. , letter to Sarmistha Hauger, M.D., Assistant Medical Director, New York State AIDS Institute, May 28, 1991.

See Levine Dubler and Levine , p. 15 for a further discussion of the role of a child advocate.

Secretary's Work Group, p. 21.

Nolan , pp. 471–72.

Ackerman Terrence , “Protectionism and the New Research Imperative in Pediatric AIDS”, IRB: A Review of Human Subjects Research, Vol. 12, No. 5 (September/October 1990), p.2.

Nolan , p. 474, Citing Charles Fried, Medical Experimentation: Personal Integrity and Social Policy (New York: Elsevier, 1974).

Kovacs Andrea Frederick Toni Church Joseph Eller Andrea Oxtoby Margaret and Mascola Laurence , “CD4 T-Lymphocyte Counts and Pneumocystis carinii Pneumonia in Pediatric HIV Infection”, JAMA, Vol. 265, No. 13 (April 3, 1991), 1702.

Levine Dubler and Levine , p. 8.

See, for example, Prentice Ernest D. Antonson Dean L. Jameton Andrew Graver Benjamin and Sears Thomas , “Case Study: Can Children Be Enrolled in a Placebo-Controlled Trial of Synthetic Growth Hormone?” IRB: A Review of Human Subjects Research, Vol. 11, No. 1 (January/February 1989), pp. 6–10.

National Institute of Child Health and Human Development Intravenous Immunoglobulin Study Group, “Intravenous Immune Globulin for the Prevention of Bacterial Infections in Children with Symptomatic Human Immunodeficiency Virus Infection”, New England Journal of Medicine, Vol. 325, No. 2 (July 11, 1991), 73–80.

Freedman Benjamin , “Equipoise and the Ethics of Clinical Research”, New England Journal of Medicine, Vol. 317, No. 3 (1987), 141–45.

Levine Dubler and Levine , p. 6.

Litt Iris , “Adolescent Medicine”, JAMA, Vol. 265, No. 23 (June 19, 1991), 3100.

See, e.g., Melton Gary , “Ethical and Legal Issues in Research and Intervention”, Journal of Adolescent Health Care, Vol. 10 (1989), 36S–44S.

Ad Hoc Committee on Adolescents and HIV, New York State AIDS Advisory Council, “Illusions of Immortality: The Confrontation of Adolescence and AIDS”, New York, n.d. [1991], pp. 29–33.

Levine Dubler and Levine , p. 15.

“Romanian Halts AIDS Drug Test,” New York Times, October 30, 1990.

Office of Protection from Research Risks, Division of Human Subject Protections, “Findings and Required Actions Regarding Investigation of Noncompliance with HHS Regulations for the Protection of Human Subjects Involving the National Institutes of Health Intramural Research Program”, July 3, 1991. The author was a member of a panel of special consultants to OPRR during this investigation; the information presented here is drawn solely from OPRR's “Interim Report.””

Geison , p. 32.