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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.

9 Lederer, Susan E. & Grodin, Michael A., Historical Overview: Pediatric Experimentation, in CHILDREN AS RESEARCH SUBJECTS: SCIENCE, ETHICS & LAW 19 (Grodin, Michael A. & Glantz, Leonard H. eds., 1994)Google Scholar.

10 For information on medical research performed without consent, see 2 U.S. GOV't PRINTING OFFICE, TRIALS OF WAR CRIMINALS BEFORE THE NUREMBERG MILITARY TRIBUNALS UNDER CONTROL COUNCIL LAW NO. 10 (1948).

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).

16 American Academy of Pediatrics (AAP), Council on Pediatric Research, Meeting the Research Needs of Children and Youth: Research Along the Life Cycle (unpublished, undated manuscript that served as a background piece for the meeting, on file with author).

17 Shirkey, Harry, Editorial Comment; Therapeutic Orphans, 72 J. PEDIATRICS 119 (1968)Google Scholar.

18 Committee on Drugs, AAP, Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations, 95 PEDIATRICS 286, 286 (1995)Google Scholar.

19 Specific Requirements on Content and Format of Labeling for Human Prescription Drugs, Revision of “Pediatric Use” Subsection in the Labeling, 21 C.F.R. § 201.57(f)(9) (1994) (59 Fed. Reg. 64,240).

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.

23 DEP’T. OF HEALTH AND HUMAN SERVICES (HHS) & FDA, THE PEDIATRIC EXCLUSIVITY PROVISION, JANUARY 2001 STATUS REPORT TO CONGRESS, at http://www.fda.gov/cder/pediatric/reportcong01.pdf (last visited Mar. 2, 2003).

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

25 NIH, supra note 5.

26 NAT’L INSTITUTES OF HEALTH, OFFICE OF EXTRAMURAL RESEARCH, QUESTIONS AND ANSWERS ABOUT THE NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS (March 17, 1999), at http://grants.nih.gov/grants/funding/children/pol_children_qa.htm (last visited Mar. 2, 2003).

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

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).

29 Murphy, Dianne, quoted by Steinbrook, Robert, Testing Medications in Children, 347 NEW ENG. J. MED. 1462, 1467 (2002)Google Scholar.

30 Ass’n. of Am. Physicians & Surgeons, Inc. v. FDA, 226 F.Supp.2d 204 (D.D.C. 2002).

31 AP, Reversal On ‘Pediatric Rule’, N.Y. TIMES, Apr. 20, 2002, at A13. Two of the bills introduced by Congress were S.2394, which would amend the Federal Food, Drug and Cosmetic Act to require labeling containing information applicable to pediatric patients, introduced in the Senate Apr. 29, 2002, and H.R. 4730, which would amend the Federal Food, Drug and Cosmetic Act to require labeling containing information applicable to pediatric patients, introduced in the House May 14, 2002.

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

33 Ross, Lainie Friedman & Justin Coffey, M., (Women and) Children First: Applicable to Lifeboats? Applicable to Human Experimentation?, 6 J. HEALTH CARE L. & POL’Y 14 (2002)Google Scholar.

34 Gifford et al., supra note 8.

35 Wong, Mitchell D. et al., Contribution of Major Diseases to Disparities in Mortality, 347 NEW ENG. J. MED. 1585 (2002)Google Scholar.

36 See, e.g., Exner, Derek V. et al., Lesser Response to Angiotensin-Converting Enzyme Inhibitor Therapy in Black as Compared with White Patients with Left Ventricular Dysfunction, 344 NEW ENG. J. MED. 1351 (2001)Google Scholar; Jacobson, Mark A. et al., Zidovudine Side Effects as Reported by Black, Hispanic, and White/Non-Hispanic Patients with Early HIV Disease: Combined Analysis of Two Multicenter Placebo-Controlled Trials, 11 J. ACQUIRED IMMUNE DEFICIENCY SYNDROMES & HUM. RETROVIROLOGY 45 (1996)Google Scholar; Johnson, Julie A., Influence of Race or Ethnicity on Pharmacokinetics of Drugs, 86 J. PHARMACEUTICAL SCI. 1328 (1997)Google Scholar.

37 THE CONCEPT OF RACE 3-4 (A. Montagu ed., 1964). An overview of the history of race in medicine is given in Cooper, Richard & David, Richard, The Biological Concept of Race and its Application to Public Health and Epidemiology, 11 J. HEALTH POL. POL’Y & L. 97 (1986)Google Scholar.

38 GOULD, STEPHEN J., EVER SINCE DARWIN: REFLECTIONS IN NATURAL HISTORY 233 (1979)Google Scholar.

39 Caldwell, Stephen H. & Popenoe, Rebecca, Perceptions and Misperceptions of Skin Color, 122 ANNALS INTERNAL MED. 614 (1995)Google Scholar.

40 Witzig, Ritchie, The Medicalization of Race: Scientific Legitimization of a Flawed Social Construct, 125 ANNALS INTERNAL MED. 675 (1996)Google Scholar.

41 See, e.g., RICHARD C. LEWONTIN ET AL., NOT IN OUR GENES: BIOLOGY, IDEOLOGY AND HUMAN NATURE (1984); Goodman, Alan H., Why Genes Don't Count (for Racial Differences in Health), 90 AM. J. PUB. HEALTH 1699 (2000)Google Scholar; American Anthropological Association Statement on “Race” (May 17, 1998), at http://www.aaanet.org/stmts/racepp.htm (last visited Mar. 6, 2003).

42 Kaufman, Jay S. & Cooper, Richard S., Commentary: Considerations for Use of Racial/Ethnic Classification in Etiologic Research, 154 AM. J. EPIDEMIOLOGY 291 (2001)Google Scholar.

43 See, e.g., Andrews, Roxanne M. & Elixhauser, Anne, Use of Major Therapeutic Procedures: Are Hispanics Treated Differently than Non-Hispanic Whites?, 10 ETHNICITY & DISEASE 384 (2000)Google Scholar; Epstein, Arnold M. & Ayanian, John Z., Racial Disparities in Medical Care, 344 NEW ENG. J. MED. 1471 (2001)Google Scholar; IOM, supra note 8; Kaufman, Jay S. et al., Socioeconomic Status and Health in Blacks and Whites: The Problem of Residual Confounding and the Resiliency of Race, 8 EPIDEMIOLOGY 621 (1997)Google Scholar; Wong et al., supra note 35.

44 See, e.g., Cabana, Michael D. & Flores, Glenn, The Role of Clinical Practice Guidelines in Enhancing Quality and Reducing Racial/Ethnic Disparities in Paediatrics, 3 PAEDIATRIC RESPIRATORY REVIEWS 52 (2002)Google Scholar; Flores, Glenn et al., The Impact of Ethnicity, Family Income, and Parental Education on Children's Health and Use of Health Services, 89 AM. J. PUB. HEALTH 1066 (1999)Google Scholar; Weitzman, Michael et al., Black and White Middle Class Children Who Have Private Health Insurance in the United States, 104 PEDIATRICS 151 (1999)Google Scholar.

45 Kaufman et al., supra note 43; Sondik, Edward J. et al., Race/Ethnicity and the 2000 Census: Implications for Public Health, 90 AM. J. PUB. HEALTH 1709 (2000)Google Scholar; Williams, David R., Race/Ethnicity and Socioeconomic Status: Measurement and Methodological Issues, 26 INT’L J. HEALTH SERVICES 483 (1996)Google Scholar.

46 Neil Risch et al., Categorization of Humans in Biomedical Research: Genes, Race and Disease, 3 GENOME BIOLOGY 2007.1, 1 (2002), available at http://genomebiology.com/2002/3/7/comment/2007 (last visited Mar. 6, 2003).

47 Id. at 2.

48 Wilson, James F. et al., Population Genetic Structure of Variable Drug Response, 29 NATURE GENETICS 265 (2001)Google Scholar.

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.

53 Yancy, Clyde W. et al., Race and the Response to Adrenergic Blockade with Carvedilol in Patients with Chronic Heart Failure, 344 NEW ENG. J. MED. 1358, 1362 (2001)Google Scholar.

54 Schwartz, Robert S., Racial Profiling in Medical Research, 344 NEW ENG. J. MED. 1392, 1392 (2001)Google Scholar.

55 Dries, Daniel L. et al., Efficacy of Angiotensin-Converting Enzyme Inhibition in Reducing Progression from Asymptomatic Left Ventricular Dysfunction to Symptomatic Heart Failure in Black and White Patients, 40 J. AM. C. CARDIOLOGY 311 (2002)Google Scholar, erratum 40 J. AMER. C. CARDIOLOGY 1019 (2002).

56 THE ALLHAT OFFICERS & COORDINATORS FOR THE ALLHAT COLLABORATIVE RESEARCH GROUP, Major Outcomes in High-Risk Hypertensive Patients Randomized to Angiotensin-Converting Enzyme Inhibitor or Calcium Channel Blocker vs. Diuretic: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), 288 JAMA 2981 (2002), erratum 289 JAMA 178 (2003).

57 Cooper, Richard S. et al., Race and Genomics, 348 NEW ENGL. J. MED. 1166 (2003)Google Scholar. A type I error is an error that rejects the null hypothesis (i.e., that there is no racial difference in drug responsiveness) when it is true.

58 Burchard, Esteban Gonzalez et al., The Importance of Race and Ethnic Background in Biomedical Research and Clinical Practice, 348 NEW ENG. J. MED. 1170 (2003)Google Scholar; Risch et al., supra note 46.

59 Bhopal, Raj & Donaldson, Liam, White, European, Western, Caucasian, or What? Inappropriate Labeling in Research on Race, Ethnicity, and Health, 88 AM. J. PUB. HEALTH 1303 (1998)Google Scholar; see Gimenez, Martha E., Latino/“Hispanic”—Who Needs a Name? The Case Against a Standardized Terminology, 19 INT’L. J. HEALTH SERV. 557 (1989)Google Scholar; Gonzales Burchard, supra note 58.

60 Berkman, Lisa F. & Macintyre, Sally, The Measurement of Social Class in Health Studies: Old Measures and New Formulations, 138 IARC SCIENTIFIC PUBLICATIONS 51 (1997)Google Scholar; Smith, George Davey, Learning to Live with Complexity: Ethnicity, Socioeconomic Position, and Health in Britain and the United States, 90 AM. J. PUB. HEALTH 1694, 1695-96 (2000)Google Scholar; Jenkins, Renee R. & Parron, Delores, Guidelines for Adolescent Health Research: Issues of Race and Class, 17 J. ADOLESCENT HEALTH 314, 317 (1995)Google Scholar; Moss, Nancy & Krieger, Nancy, Measuring Social Inequalities in Health; Report on the Conference of the National Institutes of Health, 110 PUB. HEALTH REP. 302, 302-03 (1995)Google Scholar; Williams, supra note 45.

61 American Public Health Association, 00-LB-1: Research and Intervention on Racism as a Fundamental Cause of Ethnic Disparities in Health, 91 AM. J. PUB. HEALTH 515 (2001)Google Scholar [hereinafter APHA].

62 Brawley, Otis W. & Freeman, Harold P., Race and Outcomes: Is This the End of the Beginning for Minority Health Research?, 91 J. NAT’L CANCER INST. 1908, 1908-09 (1999)Google Scholar; see also APHA, supra note 61.

63 Weinick, Robin M. et al., Racial and Ethnic Differences in Access to and Use of Health Care Services, 1977 to 1996, 57 MED. CARE RES. & REV. 36, 43–44 (Supp. 2000)Google Scholar; Weitzman et al., supra note 44.

64 Epstein & Ayanian, supra note 43; Williams, David R. & Jackson, James S., Race/Ethnicity and the 2000 Census: Recommendations for African American and other Black Populations in the United States, 90 AM. J. PUB. HEALTH 1728, 1728 (2000)Google Scholar.

65 APHA, supra note 61.

66 INT’L COMM. OF MEDICAL J. EDITORS, Uniform Requirements for Manuscripts Submitted to Biomedical Journals, 126 ANNALS INTERNAL MED. 36, 39 (1997)Google Scholar.

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.

69 Id. at 1349.

70 Rivara, Frederick P. & Finberg, Laurence, Use of the Terms Race and Ethnicity, 155 ARCHIVES PEDIATRICS & ADOLESCENT MED. 119, 119 (2001)Google Scholar.

71 Claude Bennett, J., Inclusion of Women in Clinical Trials—Policies for Population Subgroups, 329 NEW ENG. J. MED. 288 (1993)Google Scholar; Larson, Elaine, Exclusion of Certain Groups from Clinical Research, 26 IMAGE J. NURSING SCHOLARSHIP 185, 186 (1994)Google Scholar; Nunnelee, Janice D., The Inclusion of Women in Clinical Trials of Antihypertensive Medications: A Review of Twenty-Four Trials in One Pharmacology Journal, 13 J. VASCULAR NURSING 41 (1995)Google Scholar; Zahm, Shelia H. et al., Inclusion of Women and Minorities in Occupational Cancer Epidemiologic Research, 36 J. OCCUPATIONAL MED. 842, 843-44 (1994)Google Scholar.

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.

77 Brawley and Freeman, supra note 62; Freeman, Harold P., The Meaning of Race in Science—Considerations for Cancer Research: Concerns of Special Populations in the National Cancer Program, 82 CANCER 219 (1998)Google Scholar; Passel, Jeffery S., Demographic and Social Trends Affecting the Health of Children in the United States, 2 AMBULATORY PEDIATRICS 169 (2002)Google Scholar; Sondik, Edward J. et al., Race/Ethnicity and the 2000 Census; Implications for Public Health, 90 AM. J. PUB. HEALTH 1709 (2000)Google Scholar.

78 AAP, Committee on Pediatric Research, supra note 68; CTRS. FOR DISEASE CONTROL & PREVENTION (CDC), Use of Race and Ethnicity in Public Health Surveillance: Summary of the CDC/ATSDR Workshop, 42 MORBIDITY & MORTALITY WEEKLY REPORT i (1993); Rivara & Finberg, supra note 70.

79 Weinick et al., supra note 63, at 43-44; Weitzman et al., supra note 44.

80 Moy, Ernest et al., Academic Medical Centers and the Care of Underserved Populations, 71 ACAD. MED. 1370 (1996)Google Scholar.

81 See infra notes 89-90 and accompanying text.

82 U.S. Census Bureau, Population Estimates: Race/Ethnicity, available at http://eire.census.gov/popest/data/race.php (last visited Mar. 6, 2003).

83 Flores, Glenn et al., The Health of Latino Children: Urgent Priorities, Unanswered Questions and a Research Agenda, 288 JAMA 82 (2002)Google Scholar.

84 Id.

85 See Frayne, Susan M. et al., The Exclusion of Non-English-Speaking Persons from Research, 11 J. GEN. INTERNAL MED. 39 (1996)Google Scholar.

86 Archie Bleyer, W. et al., Equal Participation of Minority Patients in U.S. National Pediatric Cancer Clinical Trials, 19 J. PEDIATRIC HEMATOLOGY & ONCOLOGY 423, 424 (1997)Google Scholar.

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).

91 Westermeyer, Joseph, A Problem with Surveillance Methods for Alcoholism: Differences in Coding System Among Federal, State and Private Agencies, 78 AM. J. PUB. HEALTH 130 (1988)Google Scholar.

92 See INT’L COMM. OF MEDICAL J. EDITORS, supra note 66.

93 CDC, Reporting of Race and Ethnicity in the National Notifiable Diseases Surveillance System, 1990, 41 MORBIDITY & MORTALITY WKLY. REP. 653, 654-55 (1992)Google Scholar; CDC, Reporting Race and Ethnicity Data—National Electronic Telecommunications System for Surveillance, 1994-1997, 48 MORBIDITY & MORTALITY WKLY. REP. 305, 305 (1999)Google Scholar; Evelyn, B. et al., Participation of Racial/Ethnic Groups in Clinical Trials and Race-Related Labeling: A Review of New Molecular Entities Approved 1995-1999, 93 J. NAT’L MED. ASSOC. 18 (2001)Google Scholar, available at http://www.fda.gov/cder/reports/race_ethnicity/race_ethnicity_report.htm (last visited Mar. 6, 2003).

94 Gross, Cary P. et al., Reporting the Recruitment Process in Clinical Trials: Who Are These Patients and How Did They Get There?, 137 ANNALS INTERNAL MED. 10 (2002)Google Scholar.

95 Begg, Colin et al., Improving the Quality of Reporting of Randomized Controlled Trials: The CONSORT Statement, 276 JAMA 637 (1996)Google Scholar. This was most recently updated in David Moher et al., The CONSORT Statement: Revised Recommendations for Improving the Quality of Reports of Parallel-Group Randomised Trials, 357 LANCET 1191 (2001).

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.