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Minority Children in Pediatric Research

Published online by Cambridge University Press:  06 January 2021

Lainie Friedman Ross  and
Catherine Walsh
Lainie Friedman Ross
Affiliation:
Princeton University, University of Pennsylvania School of Medicine, Yale University
Catherine Walsh
Affiliation:
Davidson College, University of Chicago Pritzker School of Medicine
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Extract

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.

Type
Research Article
Information
American Journal of Law & Medicine , Volume 29 , Issue 2-3 , June 2003 , pp. 319 - 336
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2003

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Footnotes

†

Dr. Ross' research is funded by an NIH Grant (NLM 1 G13 LM0742-01).

References

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.

8 See, e.g., Gifford, Allen L. et al., Participation in Research and Access to Experimental Treatments by HIV-infected Patients, 346 NEW ENG. J. MED. 1373 (2002)Google Scholar; Harris, David J. & Douglas, Pamela S., Enrollment of Women in Cardiovascular Clinical Trials Funded by the National Heart, Lung and Blood Institute, 343 NEW ENG. J. MED. 475 (2000)Google Scholar; Heiat, Asefeh et al., Representation of the Elderly, Women and Minorities in Heart Failure Clinical Trials, 162 ARCHIVES INTERNAL MED. 1682 (2002)Google Scholar; INSTITUTE OF MEDICINE (IOM), THE UNEQUAL BURDEN OF CANCER: AN ASSESSMENT OF NIH RESEARCH AND PROGRAMS FOR ETHNIC MINORITIES AND THE MEDICALLY UNDERSERVED (M. Alfred Haynes & Brian D. Smedley eds., 1999); Vidaver, Regina M. et al., Women Subjects in NIH-Funded Clinical Research Literature: Lack of Progress in Both Representation and Analysis by Sex, 9 J. WOMEN's HEALTH GENDER BASED MED. 495 (2000)Google Scholar.

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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).

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13 Id. at 2.

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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).

21 Id.

22 Food and Drug Administration Modernization Act (FDAMA) of 1997, Pub. L. No. 105-115, 111 Stat. 2296.

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24 Best Pharmaceuticals for Children Act, Pub. L. No. 107-109, 115 Stat. 1408 (2002).

25 NIH, supra note 5.

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27 Children's Health Act of 2000, Pub. L. 106-310 (2000).

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32 Ass’n of Am. Physicians & Surgeons, Inc., 226 F.Supp.2d at 222.

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47 Id. at 2.

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49 Id. at 265.

50 Editorial, Genes, Drugs and Race, 29 NATURE GENETICS 239, 239-240 (2001).

51 Risch et al., supra note 46, at 6.

52 Exner et al., supra note 36.

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67 The 2000 census sought to collect both racial and ethnic data. For the census, one could choose between: (1) American Indian or Alaska Native, (2) Asian Indian, (3) Black or African American, (4) Native Hawaiian or Other Pacific Islander and (5) White. Respondents were able to select one or more of these racial categories. The minimum categories for ethnicity will be Spanish/Hispanic/Latino or Non-Spanish/Hispanic/Latino. U.S. DEP't OF COMMERCE, BUREAU OF THE CENSUS, U.S. Census 2000, available at http://www.census.gov/dmd/www/pdf/d20bp0.pdf (last visited Mar. 2, 2003).

68 AAP, Committee on Pediatric Research, Race/Ethnicity, Gender, Socioeconomic Status— Research Exploring Their Effects on Child Health: A Subject Review, 105 PEDIATRICS 1349, 1350 (2000)Google Scholar.

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72 See sources cited supra note 8.

73 These issues are addressed more fully in two manuscripts: Catherine Walsh & Lainie Friedman Ross, Are Minority Children Under or Overrepresented in Pediatric Research?, PEDIATRICS (forthcoming) [hereinafter Minority Children in Research]; Catherine Walsh & Lainie Friedman Ross, Whether and Why Pediatric Researchers Report Race and Ethnicity. ARCHIVES OF PED. ADOL. MED. (forthcoming)[hereinafter Whether and Why].

74 Id.

75 See sources cited supra notes 4-5.

76 Walsh & Ross, Minority Children in Research, supra note 73.

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84 Id.

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87 Id. at 426.

88 Id.

89 Office of Management and Budget, Directive No. 15: Race and Ethnic Standards for Federal Statistics and Administrative Reporting (1977), reprinted in Executive Office of the President, Office of Management and Budget, Office of Information and Regulatory Affairs, Recommendations From the Interagency Committee for the Review of the Racial and Ethnic Standards to the Office of Management and Budget Concerning Changes to the Standards for the Classification of Federal Data on Race and Ethnicity, 62 Fed. Reg. app. 1, at 36,874 (1997).

90 Executive Office of the President, Office of Management and Budget, Revisions to the Standards for the Classification of Federal Data on Race and Ethnicity, 62 Fed. Reg. 58,782 (1997).

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96 Corbie-Smith, Giselle et al., Attitudes and Beliefs of African Americans Toward Participation in Medical Research, 14 J. GEN. INTERN. MED. 537 (1999)Google Scholar; Giuliano, Anna R. et al., Participation of Minorities in Cancer Research: The Influence of Structural, Cultural, and Linguistic Factors, 10 ANNALS EPIDEMIOLOGY 22 (Supp. 2000)Google Scholar; IOM, supra note 8; Kressin, Nancy R. et al., Racial Disparities in Participation in Biomedical Research, 92 J. NAT’L MED. ASS’N 62 (2000)Google Scholar; Shavers-Hornaday, Vickie L. et al., Why Are African Americans Under-represented in Medical Research Studies? Impediments to Participation, 2 ETHNICITY & HEALTH 31 (1997)Google Scholar.

97 IOM, supra note 8; Shavers-Hornaday et al., supra note 96.

98 The term “children” in the index of the IOM report has three page references. Under children, the report references “adolescents” and “clinical trials” with six page references each. IOM, supra note 8, at 326.

99 Walsh & Ross, Minority Children in Research, supra note 73.

100 Park, Tricia L. et al., Sociodemographic Factors in Health Psychology Research: 12 Years in Review, 17 HEALTH PSYCHOL. 381 (1998)Google Scholar.

101 CDC, supra note 78, at 9.

102 See sources cited supra note 60.

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.