This article describes basic epidemiologic and clinical features of HIV disease in infants,
children, and adolescents and explores controversies about pediatric research in the specific
context of AIDS. Because many potentially therapeutic agents will initially be available only
through clinical trials, it is essential that pediatric populations have access to such trials yet not
be exposed to undue risks. Distinguishing clearly between risks posed by research interventions
versus those associated with attempts to provide treatment may guide the resolution of apparent
ethical dilemmas. Special attention must also be given to concerns raised by trials that involve
placebo administratcon, perinatal interventions, enrollment of foster children, and consent by
adolescents without parental notification .
Get full access to this article
View all access options for this article.
References
1.
Ackerman, T.F.1990. Protectionism and the new research imperative in pediatric AIDS. Paper presented at the Citizens Commission on AIDS, New York, 18 January.
2.
American Psychological Association Task Force On Aids.1989. Pediatric AIDS and human immunodeficiency virus: Infection: psychological issues. American Psychologist February:258-64.
3.
Auger, I., P. Thomas, V. De Gruttola, D. Morse, D. Moore, R. Williams, B. Truman, and C.E. Lawrence.1988. Incubation periods for paediatric AIDS patients. Nature336:575-77.
4.
Bartholome, W.G.1976Parents, children, and the moral benefits of research. Hastings Center Studies4 (6): 44-45.
5.
Bayer, R., C. Levine, and T.H. Murray.1984. Guidelines for confidentiality in research on AIDS. IRB: A Survey of Human Subjects Research6 (6): 7-9.
6.
Capron, A.M.1982. The competence of children as self-deciders in biomedical interventions. In Who speaks for the child: The problems of proxy consent, edited by W. Gaylin and R. Macklin, 57-114. New York: Plenum.
7.
Centers for Disease Control.1990. Estimates of HIV prevalence and projected AIDS cases. Morbidity and Mortality Weekly Report39 (7): 110-19.
8.
Department of Health and Human Services (DHHS).1983. Rules and regulations. Code of Federal Regulations, Title 45, part 46.
9.
—. 1988. Secretary's work group on pediatric HIV infection and disease: Final report. Washington, DC: U.S. Government Printing Office.
10.
Freedman, B.1987. Equipoise and the ethics of clinical research. New England Journal of Medicine317 (3): 141-45.
11.
Fried, C.1974. Medical experimentation: Personal integrity and social policy. New York: Elsevier.
12.
Gaylin, W.1982. Competence: No longer all or none. In Who speaks for the child: The problems ofproxy consent, edited by W. Gaylin and R. Macklin.New York: Plenum.
13.
Goedert, J.J., C.M. Kessler, and L.M. Aledort, et al. 1989. A prospective study of human immunodefiency virus type 1 infection and the development of AIDS in subjects with hemophilia . New England Journal of Medicine321:1141-48.
14.
Gray, J.N.1989. Pediatric AIDS research: Legal, ethical, and policy influences . In Children, Adolescents, & AIDS, edited by J. M. Seibert and R. A. Olson.Lincoln: University of Nebraska Press.
15.
Grodin, M.A., and J.J. Alpert.1988. Children as participants in medical research. Pediatric Clinics of North America35:1389-1401.
16.
Hein, K.1989. AIDS in adolescence: Exploring the challenge. Journal of Adolescent Health Care10 (3, supplement): 10S-35S.
17.
Herceg-Baron, R.1981. Parental consent and family planning research involving minors. IRB: A Review of Human Subjects Research3 (9): 5.
18.
Holder, A.R.1981. Can teenagers participate in research without parental consent? IRB: A Review of Human Subjects Research3 (2): 5.
19.
—. 1985. Legal issues in pediatrics and adolescent medicine. New Haven, CT: Yale University Press.
20.
Katz, B.Z.1989. Natural history and clinical management of the infant born to a mother infected with human immunodeficiency virus. Seminars in Perinatology13 (1): 27-34.
21.
Landesman, S.H.1990. Personal communication.
22.
Levine, C.1981. Teenagers, research, and family involvement. IRB: A Review of Human Subjects Research3 (9): 8.
23.
Levine, R.J.1977. Nondevelopmental research on human subjects: The impact of the recommendations of the National Commission. Federal Proceedings36:2359-64.
24.
—. 1985. The use of placebos in randomized clinical trials. IRB: A Review of Human Subjects Research7 (2): 1-4.
25.
—. 1986. Ethics and regulation of clinical research. Baltimore: Urban & Schwarzenberg.
26.
McCormick, R.A.1976. Experimentation in children: Sharing in sociality. Hastings Center Report6 (6): 41-46.
27.
Melton, G.1989. Ethical and legal issues in research and intervention . Journal of Adolescent Health Care10 (3, supplement), May 1989: 36S-44S.
28.
Mirkin, B.L.1975. Drug therapy and the developing human: Who cares? Clinical Research23:106-13.
29.
Moore, R. S., and A. D. Hoffmann , eds. 1982. American Academy of Pediatrics Conference on Consent and Confidentiality in Adolescent Health Care. Chicago: American Academy of Pediatrics.
30.
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.1977. Report and Recommendations: Research Involving Children. DHEW Publication No. (OS) 77-0004, Washington, DC: Department of Health, Education, and Welfare.
31.
Nicholas, S.W., D.L. Sondeimer, A.D. Willougby, S.J. Yaffe, and S.L. Katz.1989. Human immunodeficiency virus infection in childhood, adolescence, and pregnancy: A status report and national research agenda. Pediatrics83:293-308.
32.
Nolan, K.A.1988. Homosexual adolescents and confidentiality. Pediatrics81:469.
33.
—. 1989a. Ethical issues in caring for pregnant women and newborns at risk for human immunodeficiency virus infection. Seminars in Perinatology13 (1): 55-65.
34.
—. 1989b. The ethics of placebo-controlled trials of therapy for HIV infection. Paper presented at the Fifth International Conference on AIDS, Montreal, Canada, 6 June.
35.
Oleske, J.1987. Natural history of HIV infection II. In Report of the Surgeon General's Workshop on Children with HIV Infection and Their Families. Washington, DC: Department of Health and Human Services.
36.
Quinn, T.C.1987. The global epidemiology of the acquired immunodeficiency syndrome. In Report of the Surgeon General's Workshop on Children with HIV Infection and Their Families. Washington, DC: Department of Health and Human Services.
37.
Ramsey, P.1976. The enforcement of morals: Nontherapeutic research on children. Hastings Center Report6 (4): 21-30.
38.
Rubinstein, A.1987. Supportive care and treatment of pediatric AIDS. In Report of the Surgeon General's Workshop on Children with HIV Infection and Their Families. Washington, DC: Department of Health and Human Services.
39.
Scott, G.B.1987. Natural history of HIV infection in children. In Report of the Surgeon General's Workshop on Children with HIV Infection and Their Families. Washington, DC: Department of Health and Human Services.
40.
Survey assesses AIDS on college campuses. 1989. New York State Journal of Medicine89:438.
41.
Twomey, J.G.1989. The ethics of clinical research with children with HIV infection. Virginia Nurse57 (3): 38-43.
42.
Veatch, R.M.1981. Commentary: Beyond consent to treatment. IRB: A Review of Human Subjects Research3 (2): 7, 8.
