Published online by Cambridge University Press: 06 January 2021
Medical research is heavily funded: the National Institutes of Health had a budget of over $20 billion in 2001, and even more money was spent by the pharmaceutical industry on research. Children's health issues, however, receive only a small fraction of these funds. In 2001, for example, less than $1 billion of NIH funding was allocated to the National Institute of Child Health and Human Development (NICHD). In part, the problem stems from a modern predisposition to protect children from participating in research.
Several federal policies in the 1990s changed the face of the “typical research subject.” Historically, researchers sought “white men,” but the NIH announced in 1994 that all research would need to include women and minorities, and in 1998, the NIH added the requirement of including children. The shift in policies reflects a shift in focus. When the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research addressed fairness in subject selection in the Belmont Report of 1979, the main concern was ensuring fairness in the distribution of risks.
Dr. Ross' research is funded by an NIH Grant (NLM 1 G13 LM0742-01).
1 In 2001, federal spending on biomedical science was slightly more than $20 billion, whereas drug companies spent $22.4 billion in 2000. Robert Lee Hotz, Science File: Scientists Sharing Fewer Discoveries, L.A. TIMES, Feb. 11, 2002, at 12. Biomedical research is also sponsored by not-for-profit philanthropies.
2 Duane Alexander, Fiscal Year 2001 President's Budget Request for the National Institute of Child Health and Human Development, NICHD-FY 2001 Appropriation Hearing, at http://www.nichd.nih.gov/about/dir_statement.htm (last visited Mar. 2, 2003).
3 See infra text accompanying notes 9-14.
4 Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, 59 Fed. Reg. 14,508 (Mar. 28, 1994).
5 National Institutes of Health, Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects, at http://grants2.nih.gov/grants/guide/noticefiles/not98-024.html (last visited Mar. 2, 2003) [hereinafter NIH].
6 NAT’L COMM’N FOR THE PROT. OF HUMAN SUBJECTS OF BIOMEDICAL & BEHAVIORAL RESEARCH, U.S. DEP't OF HEALTH, EDUC. & WELFARE, THE BELMONT REPORT: ETHICAL PRINCIPLES AND GUIDELINES FOR THE PROTECTION OF HUMAN SUBJECTS OF RESEARCH Appendix (1978).
7 See infra text accompanying notes 16-27.
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11 World Medical Association (W.M.A.), Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects, as adopted by the 18th W.M.A., Helsinki, Finland, 1964. The declaration has been amended multiple times at W.M.A. meetings: the 29th W.M.A., Tokyo, Japan, 1975; the 35th W.M.A., Venice, Italy, 1983; the 41st W.M.A., Hong Kong, China, 1989; the 48th W.M.A. Somerset West, Republic of South Africa, 1996; the 52nd W.M.A., Edinburgh, Scotland, 2000. The note of clarification on paragraph 29 was added by the W.M.A. General Assembly, Washington 2002, at http://www.wma.net/e/policy/17cnote.pdf (last visited Mar. 17, 2003).
12 NAT’L COMM’N FOR THE PROTECTION OF HUMAN SUBJECTS OF BIOMEDICAL & BEHAVIORAL RESEARCH, REPORT AND RECOMMENDATIONS: RESEARCH INVOLVING CHILDREN, DHEW PUBLICATION NO. (OS) 77-0004 (1977).
13 Id. at 2.
14 Protection of Human Subjects, 45 C.F.R. § 46 (2001); Additional Protections for Children Involved as Subjects in Research, Id. § 46, Subpart D.
15 Proceedings of Workshop, Inclusion of Children in Clinical Research (Sept. 5, 1996) (unpublished, on file with author, supplied by Mona Rowe, Deputy Director, Office of Science Policy, Analysis and Communication, National Institute of Child Health and Human Development).
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20 Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients, 21 C.F.R. §§ 201, 312, 314, 601 (1998) (63 Fed. Reg. 66,632).
22 Food and Drug Administration Modernization Act (FDAMA) of 1997, Pub. L. No. 105-115, 111 Stat. 2296.
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25 NIH, supra note 5.
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28 Press Release, National Association of Children's Hospitals, Children's Hospitals Herald White House Signing of “Children's Health Act of 2000” (Oct. 18, 2000), available at http://www.childrenshospitals.net/nach/news/pr_healthact2000.asp (last visited Mar. 6, 2003).
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32 Ass’n of Am. Physicians & Surgeons, Inc., 226 F.Supp.2d at 222.
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75 See sources cited supra notes 4-5.
76 Walsh & Ross, Minority Children in Research, supra note 73.
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103 Adapted from Walsh & Ross, Whether and Why, Table 1, see supra note 73.
104 Adapted from Walsh & Ross, Minority Children in Research, Table 3, see supra note 73.
105 Adapted from Walsh & Ross, Minority Children in Research, Table 4, see supra note 73.