1 Harriet Washington, Medical Apartheid 236-37 (2007) (discussing a Medical College of Virginia experiment to determine “whether radiation inflicted different degrees of damage on the skins of black people than on that of whites”).

2 See id.

3 Declaration of Helsinki, World Med. Ass'n (2016), http://www.wma.net/en/30publications/10policies/b3/ [http://perma.cc/HNL2-JSZ9] (last amended in October 2013).

4 Susan E. Lederer & Michael A. Grodin, Historical Overview: Pediatric Experimentation, in Children as Research Subjects: Science, Ethics, and Law 18-19 (Michael A. Grodin & Leonard H. Glantz eds., 1994).

5 45 C.F.R. § 46.408 (2015). For a detailed discussion regarding the balance between the need for medical research studies on children and the need for informed consent, see Additional Protections for Children Involved as Subjects in Research, 48 Fed. Reg. 9814 (Mar. 8, 1983); Fed. Reg. 31,786 (July 21, 1978); National Institutes of Health, NIH Policy And Guidelines On The Inclusion Of Children As Participants In Research Involving Human Subjects (Mar. 6, 1998), http://grants.nih.gov/grants/guide/notice-files/not98-024.html [https://perma.cc/53WP-LVQZ]; Nat'l Comm'n for the Protection of Human Subjects of Biomedical & Behav. Res., Publ'n No. (OS) 77-0004, Report and Recommendations: Research Involving Children, passim (1977). Paul Ramsey and Richard McCormick provided the most influential discussion regarding 2 (arguing that “any non-therapeutic research on children was absolutely unethical—even with parental approval”); Richard, A. McCormick, Experimentation in Children: Sharing in Sociality, 6 Hasting Ctr. Rep. 41, 42 (1976)Google Scholar (arguing that children may participate in medical research studies with parental consent if it would benefit the child and is a “reasonable presumption of the child's wishes”).

6 45 C.F.R. §§ 46.404-46.407 (2010); Nat'l Insts. of Health, supra note 5; Nat'l Comm'n for the Protection of Human Subjects of Biomedical & Behav. Res., supra note 5. See also, Loretta, Kopelman, Children as Research Subjects: Moral Disputes, Regulatory Guidance, and Recent Court Decisions, 73 Mount Sinai J. Med. 596 (2006)Google Scholar; Michelle, Oberman & Joel, Frader, Dying Children and Medical Research: Access to Clinical Trials as Benefit and Burden, 29 Am. J.L. & Med. 301 (2003)Google Scholar.

7 45 C.F.R. § 46.111(a)(3) (2015) (prohibiting targeting children for use in medical research studies).

8 The Belmont Report, 76 Fed. Reg. 23,192, 23,194 (Apr. 18, 1979).

9 Id. The justice principle also requires that if vulnerable populations are used in medical research studies then the benefits of the research must be distributed to those vulnerable populations. See id. I discuss the justice principle's requirement that the populations that participate in medical research studies must be the populations that benefit from the research in my forthcoming article entitled, Exploitation in Medical Research Forty Years After the Tuskegee Syphilis Study, 67 Case W. Res. Univ. L. Rev. (2017) (forthcoming).

10 Leonard, Glantz, Research with Children, 24 Am. J.L. & Med 213, 215-18 (1998)Google Scholar; Lederer & Grodin, supra note 4, at 12, 19. Children have also been exploited in medical research studies for conditions that were not limited to children. Id. Moreover, many medical research studies conducted on children produce minimal scientific benefits in comparison to their costs and are stigmatizing. See, e.g., Solomon, R. Benatar, Global Health and Justice: Re-Examining Our Values, 27 Bioethics 297, 301-02 (2013)Google Scholar; Iain, Chalmers & Paul, Glasziou, Avoidable Waste in the Production and Reporting of Research Evidence, 374 Lancet 86 (2009)Google Scholar; Washington, supra note 1, at 271-96; Lainie Ross, Children in Medical Research: Access versus Protection 48-56 (2006).

11 The Vulnerability and Equity Impact Assessment tool is based on the Health Equity Impact Assessment tool. For a description and evaluation of the Health Equity Impact Assessment tool see Rebecca Haber, Health Equity Impact Assessment: A Primer (Wellesley Institute 2010) and Rainer, Fehr, Environmental Health Impact Assessment, Evaluation of a Ten-Step Model, 10 Epidemiology 618 (1999)Google Scholar (analyzing various ways to assess health impacts).

12 Declaration of Helsinki (1964), 313 Brit. Med. J. 1448, 1448 (1996) (distinguishing between research “in which the aim is essentially diagnostic or therapeutic for a patient” and that which “is purely scientific and without implying direct diagnostic or therapeutic value to the person subjected”).

13 Glantz, supra note 10, at 215-18. See also Lederer & Grodin, supra note 4, at 12, 19.

14 Throughout the article, I use the term “economically disadvantaged” to discuss children who lack access to essential goods such as food, housing, and health care. Although the term can be over inclusive, for clarity, I have used the word accepted in the medical research community. For more discussion, see Carol Levine, Changing Views of Justice after Belmont: AIDS and the Inclusion of “Vulnerable” Subjects, in The Ethics of Research Involving Human Subjects: Facing the 21^st Century 105-24 (1996).

15 See, e.g., Washington, supra note 1, at 271-96, Ross, supra note 10, at 48; Vernellia, Randall, Slavery, Segregation and Racism: Trusting the Health Care System Ain't Always Easy! An African American Perspective on Bioethics, 15 St. Louis U. Pub. L. Rev. 191, 199 (1996)Google Scholar.

16 Declaration of Helsinki (1964), supra note 12. Children are allowed to participate in these studies where they present more than minimal risk to the subjects only if “[t]he risk represents a minor increase over minimal risk” and “[t]he intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations.” 45 C.F.R. § 46.406 (2015).

17 45 C.F.R. § 46.406.

18 For an example of one such study, see Jack, K. Leiss & David, A. Savitz, Home Pesticide Use and Childhood Cancer: A Case-Control Study, 85 Am. J. Pub. Health 249 (1995)Google Scholar.

19 Declaration of Helsinki (1964), supra note 12.

20 Nat'l Insts. of Health, Glossary of Common Site Terms, ClinicalTrials.gov, http://clinicaltrials.gov/ct2/info/glossary#Phasel (Feb. 2016) [https://perma.cc/V82C-BULR] (describing the five phases under the definition of “Phase”).

21 Patient and Caregiver Resources: Phases of Clinical Trials, Nat'l Comprehensive Cancer Network (2016), https://www.nccn.org/patients/resources/clinical_trials/phases.aspx [https://perma.cc/WE4Q-WRP5].

22 Id.

23 Phases of Clinical Trials, Cancer Research U.K., (Oct. 21, 2015), http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/what-clinical-trials-are/phases-of-clinical-trials [https://perma.cc/46RB-MAVZ].

24 Step 3: Clinical Research, U.S. Food & Drug Admin., http://www.fda.gov/ForPatients/ Approvals/Drugs/ucm405622.htm (May 19, 2016) [https://perma.cc/N7PJ-VDAK].

25 Id.

26 Nat'l Insts. of Health, supra note 20.

27 U.S. Food & Drug Admin., supra note 24.

28 See id.

29 Id.

30 21 C.F.R. § 312.85 (2016). See also Leslie, Pickering Francis, Legitimate Expectations, Unreasonable Beliefs, and Legally Mandated Coverage of Experimental Therapy, 1 Ind. Health L. Rev. 215, 228 (2004)Google Scholar (“Phase IV trials undertake continued collection of data after a new drug is given marketing approval based on data from earlier trials. The goal of Phase IV is to collect data on an ongoing basis as an approved therapy becomes employed in the general population of patients in need of treatment. Distribution of a therapy into the general population of patients, outside the research context, may reveal quite different aspects of the therapy's risks and benefits.”).

31 See Francis, supra note 30, at 228.

32 Oberman & Frader, supra note 6, at 308-10.

33 Francis, supra note 30, at 228-29.

34 Oberman & Frader, supra note 6, at 308-10.

35 Washington, supra note 1, at 271-96; Rupali, Ghandhi, Research Involving Children: Regulations, Review Boards and Reform, 8 J. Health Care L. & Pol'y 264, 264-65 (2005)Google Scholar; Oberman & Frader, supra note 6, at 308-10; Glantz supra note 10, at 215-17; Randall, supra note 15, at 199; Lederer & Grodin, supra note 4, at 19.

36 Washington, supra note 1, at 284.

37 Id.

38 Id.

39 Id. at 236-37. This is the example referenced in the Introduction of this article.

40 Id. at 294.

41 Globe Reports Research Team Deprived Infants of Essential Nutrient, Lewiston Evening Journal (Mar. 29, 1973), https://news.google.com/newspapers?id=oJggAAAAIBAJ&sjid=mmgFAAAAIBAJ&pg=1205%2C3872215 [https://perma.cc/UQ6T-LNYB].

42 Washington, supra note 1, at 294

43 Id. at 238-39.

44 Id. at 233.

45 Id.

46 Randall, Clark, Speed, Safety, and Dignity: Pediatric Pharmaceutical Development in an Age of Optimism, 9 U. Chi. L. Sch. Roundtable 1, 44 (2002)Google Scholar, reprinted in The Ethics and Regulations of Research with Human Subjects 529 (2005).

47 See Belmont Report, supra note 8, at 23,194.

48 Lederer & Grodin, supra note 4, at 3, 18-19. The precursor to international protections of human subjects participating in medical research studies was the Nuremberg Code in 1947, which was developed in response to the Trials of War Criminals before the Nuremberg Military Tribunals. See Nuremberg Code (1947), 313 Brit. Med. J. 1448 (1996).

49 Belmont Report, supra note 8, at 23,194. In fact, the justice principle was found only in the Belmont Report until 2000, when the World Medical Association added the principle to the Declaration of Helsinki, a renowned document of bioethics for medical research. See Robert V. Carlson, Kenneth M. Boyd & David J. Webb, The Revision and the Declaration of Helsinki: Past, Present, and Future, 57 British J. Clinical Pharmacology 695, 699-704 (outlining the 2000 revisions to the Decaration of Helsinki). For a discussion regarding the ethical documents that discuss the use of children in research trials, see Duane Alexander, Regulation of Research with Children: The Evolution from Exclusion to Inclusion, 6 J. Health Care L. & Pol'y 1, 1-3 (2002).

50 Belmont Report, supra note 8, at 23,196-97.

51 45 C.F.R. § 46.111(a)(3) (2015); Proposed Model Federal Policy for the Protection of Human Subjects, 51 Fed. Reg. 20,204 (June 3, 1986) (providing the opportunity for the public comment that provided the basis for the Common Rule); 53 Fed. Reg. 45,660 (Nov. 10, 1988) (recognizing that the response to public comment on 51 Fed. Reg. 20,204 led to the development of the Common Rule).

52 International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use, Guideline for Good Clinical Practice 1 (1996) (providing “an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects”).

53 For fifteen years (1956-1971) researchers conducted a non-therapeutic medical research studies on children at the Willowbrook State School, an institutional facility for mentally ill children on Staten Island, New York. Carl Coleman, et al, Historical Antecedents: Medical Research in the United States from 1900 to the Early 1970s, in The Ethics and Regulations of Research with Human Subjects 39 (2005). Researchers infected healthy children, thus the study was not to treat a disease from which the children suffered. Early in the study the children were fed “extracts of stools from [Hepatitis-]infected children” and injected with “more purified virus preparations” to determine “the natural history of hepatitis and the effects of gamma globulin in preventing or moderating its effects.” Id. While the study led researchers to develop a hepatitis vaccine and better understand the differences between Hepatitis A and B, healthy children were infected with life-long debilitating diseases. Id. The infected children could never use the new vaccine, and as a result of the studies were subject to costly treatment for the rest of their lives.

The researchers defended their work by noting hepatitis “was prevalent in the institution.” Id. They assumed the children would eventually acquire the disease. Id. Major medical journals (the Journal of the American Medical Association and the New England Journal of Medicine) published the results of the study, commending the researchers for their use of vulnerable children. Id. (noting that Franz Inglefinger argued in the New England Journal of Medicine that “the children benefited from being infected under carefully controlled research conditions and receiving expert attention.”) Furthermore, many scholars argue that parental consent forms were not entirely voluntary as due to overcrowding, the only way to have a child admitted to Willowbrook was through the hepatitis study. Id.

54 See Belmont Report, supra note 8, at 23,194. The Tuskegee Syphilis Study, conducted from 1932 through 1972, denied economically disadvantaged African-American men access to standard treatment. See generally James H. Jones, Bad Blood: The Tuskegee Syphilis Experiment (1981).

55 Belmont Report, supra note 8, at 23,192. The Commission was composed of eleven members appointed by the Secretary of HHS. Protection of Human Subjects of Biomedical and Behavioral Research Act, Pub. L. No. 93-348, § 201, 88 Stat. 348 (1974). The National Research Act advised the Secretary of HHS to choose the members of the Commission from distinguished individuals from the fields of medicine, law, ethics, theology, philosophy, humanities, health administration, government, public affairs, and the biological, physical, behavioral, and social sciences. Id. Five of the members of the Commission had to be individuals engaged in biomedical or behavioral research involving human subjects. Id. Members of the Commission included Dorothy I. Height, President of the National Council of Negro Women, Inc., Dr. Albert R. Jonsen, Associate Professor of Bioethics at the University of California at San Francisco, and Patricia King, Associate Professor of Law at Georgetown University Law Center. Office for Human Research Protections, The Belmont Report, HHS.GOV (March 15, 2016), http://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/ [https://perma.cc/6665-WG3C].

56 Prior to 1980 and the enactment of the National Research Act, the U.S. Department of Health and Human Services was originally named the U.S. Department of Health, Education, and Welfare. See Department of Education Organization Act, Pub. L. No. 96-88, § 509(e), 93 Stat. 695 (1979) (codified at 20 U.S.C. § 3508 (2012). To avoid confusion when discussing events before and after the name change, I refer to the agency only as the U.S. Department of Health and Human Services.

57 Pub. L. No. 93-348, § 213, 88 Stat. at 353.

58 Belmont Report, supra note 8, at 23,192.

59 Id. at 23,194. The two other principles were respect for persons and beneficence. These principles focus on ensuring that the subjects' choices are voluntary (respect for persons) and that subjects are not sacrificed for the benefit of society (beneficence). Id. at 23,193-94.

60 Id. at 23,194.

61 Jones, supra note 54, at 4.

62 Washington, supra note 1, at 164.

63 See id. at 162-63.

64 Belmont Report, supra note 8, at 23,194. See also Deleso, Alford Washington, Examining the “Stick” of Accreditation for Medical Schools Through Reproductive Justice Lens: A Transformative Remedy For Teaching the Tuskegee Syphilis Study, 26 J. of Civ. Rights & Econ. Dev. 153, 177, 193 (2011)Google Scholar.

65 See Washington, supra note 64, at 179-80.

66 After a lawsuit was filed on July 23, 1973, the government settled the case for approximately $10 million dollars ($37,500 to research participants with syphilis who were alive as of July 23, 1973, $15,000 to the heirs of research participants with syphilis, $16,000 to research participants without syphilis who were alive as of July 23, 1973, and $5,000 to the heirs of research participant without syphilis). Jones, supra note 54, at 217-19. Researchers directly involved the study never apologized. Id.

67 See Belmont Report, note 8, at 23,196.

68 Id. at 23,194.

69 See id.

70 Id. at 23,193-34 and 23,196-97.

71 Id. at 23,194.

72 Id.

73 Id. at 23,192.

74 Id. at 23,196.

75 Id.

76 Id.

77 See id. at 23,196.

78 Id.

79 See Martha, E. Lang & Chloe, E. Bird, Understanding and Addressing the Common Roots of Racial Health Disparities: The Case of Cardiovascular Disease and HIV/AIDS in African Americans, 25 Health Matrix 109, 121-24 (2015)Google Scholar; Ruqaiijah, Yearby, Sick and Tired of Being Sick and Tired: Putting an End to Separate and Unequal Health Care in the United States 50 Years After the Civil Rights Act of 1964, 25 Health Matrix 1 (2015)Google Scholar; Richard, Delgado, Two Ways to Think About Race: Reflections on the Id, the Ego, and Other Reformist Theories of Equal Protection, 89 Georgetown L.J. 2279 (2001)Google Scholar; Andrew, Grant-Thomas & John, A. Powell, Toward a Structural Racism Framework, 15 Poverty & Race 3 (2006)Google Scholar; Ian, F. Haney López, The Social Construction of Race: Some Observations on Illusion, Fabrication, and Choice, 29 Harv. C.R.-C.L. L. Rev. 1, 6–7, 11–17 (1994)Google Scholar; Charles, R. Lawrence III, The Id, the Ego, and Equal Protection: Reckoning with Unconscious Racism, 39 Stanford L. Rev. 317 (1989)Google Scholar; Kimberle, Crenshaw, Demarginalizing the Intersection of Race and Sex: A Black Feminist Critique of Antidiscrimination Doctrine, Feminist Theory and Antiracist Politics, U. Chi. L. Forum 139, 139-140 (1989)Google Scholar. These disadvantages affect the health of those that are disadvantaged. See Paula A. Braveman, Catherine Cubbin, Susan Egerter, David. R. Williams & Elsie Pamuk, Socioeconomic Disparities in Health in the United States: What the Patterns Tell Us, 100 Am. J. Pub. Health S186, S186-89 (2010); Leith Mullings & Amy J. Schulz, Intersectionality and Health: An Introduction, in Gender, Race, Class, and Health 3, 12 (Leith Mullings & Amy J. Schulz eds., 2006) (examining the different forms of isms that affect individuals health status); Pamela Braboy Jackson & David R. Williams, The Intersection of Race, Gender, and SES: Health Paradoxes, in Gender, Race, Class, and Health 131 (Leith Mullings & Amy J. Schulz eds., 2006) (examining the affects of different statuses on health disparities); Ruth E. Zambrana & Bonnie Thornton Dill, Disparities in Latina Health: An Intersectional Analysis, in Gender, Race, Class, and Health 192 (Leith Mullings & Amy J. Schulz eds., 2006) (examining the affects of different statuses on health disparities); Peter, Franks, Peter, Muennig, Erica, Lubetkin & Haomiao, Jia, The Burden of Disease Associated With Being African-American in the United States and the Contribution of Socio-Economic Status, 62 Soc. Sci. & Med. 2469 (2006)Google Scholar.

80 Laura Giuliano, David I. Levine & Jonathan Leonard, Manager Race and the Race of New Hires, 27 J. Lab. Econ. 589, 589-91, 598-603 (2009).

81 Michael Luo, In Job Hunt, College Degree Can't Close Racial Gap, N.Y. Times (Nov. 30, 2009), http://www.nytimes.com/2009/12/01/us/01race.html?_r=0; see also Marianne, Bertrand & Sendhil, Mullainathan, Are Emily and Greg More Employable Than Lakisha and Jamal? A Field Experiment on Labor Market Discrimination, 94 Am. Econ. Rev. 991 (2004)Google Scholar.

82 Liz Hamel, Jamie Firth, and Mollyann Brodie, Kaiser Family Foundation/New York Times/CBS News Non-Employed Poll, Kaiser Family Found. (Dec. 11, 2014), http://kff.org/other/poll-finding/kaiser-family-foundationnew-york-timescbs-news-non-employed-poll/ [https://perma.cc/B5R5-5CFA].

83 See Belmont Report, supra note 8, at 23,196.

84 Id.

85 For list of agencies, see ROSS, supra note 10, at 23 n.101.

86 45 C.F.R. § 46.111 (2015).

87 Id.; see also Chapter 6 of Institutional Review Board Guidebook, Dep't of Health and Human Servs., Office for Human Research Prot., http://archive.hhs.gov/ohrp/irb/irb_preface.htm [https://perma.cc/AYG9-6E3Q] [hereinafter OHRP Guidebook] (adding minorities to the list of vulnerable populations. See OHRP, Institutional Review Guidebook (1993) (on the file with the author) and available at http://www.hhs.gov/ohrp/compliance/index.html (last visited Feb. 5, 2016).

88 Carl H. Coleman, Jerry A. Menikoff, Jesse A. Goldner & Nancy Neveloff Dubler, The Federal and State Regulatory Structure, in The Ethics and Regulations of Research with Human Subjects 107 (2005).

89 See generally id. at 137 (discussing different types of assurances).

90 Id.

91 Coleman et al., supra note 88, at 136-37; see also Memorandum from Director to OHRP Staff (Dec. 4, 2000), in The Ethics and Regulations of Research with Human Subjects 138, 139 (2005) [hereinafter OHRP Memorandum]. For government funded medical research studies in which there has been an allegation of noncompliance, Office of Human Rights Protections' (OHRP) initiates an investigation. Id. at 138-41. For a detailed sequence of events in compliance investigations, see id. at 140-41.

92 Coleman et al., supra note 88, at 136-37.

93 See OHRP Memorandum, supra note 91, at 139.

94 Id.

95 Id.

96 Id. at 140. Many, including the former Secretary of HHS, have argued that regulatory agencies have failed to issue meaningful sanctions. See L., Song Richardson, When Human Experimentation Is Criminal, 99 J. Crim. L. and Criminology 89, 126 (2008)Google Scholar; Donna, Shalala, Protecting Research Subjects – What Must Be Done, 343 New Eng. J. Med. 808 (2000)Google Scholar. Usually, the only sanctions that OHRP imposes is posting a letter of violation on its website. See generally OHRP Determination Letters, Dep't of Health and Human Servs., Office for Human Research Prot., http://www.hhs.gov/ohrp/compliance-and-reporting/determination-letters/index.html [https://perma.cc/9C4X-KR8V]. However, in the past when the public pressure has become too much, some institution have voluntarily stopped the research studies, while others have continued the reseach studies. See generally David B. Resnik, Research Ethics Timeline, Nat'l Insts. Of Health, http://www.niehs.nih.gov/research/resources/bioethics/timeline/ [https://perma.cc/LX68-JKNP]. Yet, this is an erratic outcome that simply depends on how much media attention the study received. Id.

97 See OHRP Determination Letters, supra note 96.

98 45 C.F.R. § 46.103(a).

99 Coleman et al., supra note 88, at 137.

100 45 C.F.R. § 46.101(a)(2).

101 Alison, Wichman, Protecting Vulnerable Research Subjects: Practical Realities of Institutional Review Board Review and Approval, 1 J. Health Care L. and Pol'y 88, 97 (1998)Google Scholar.

102 45 C.F.R. § 46.101(a)(2).

103 45 C.F.R. § 46.103(b)(1).

104 45 C.F.R. § 46.101(a)(2).

105 See id.

106 See 10 C.F.R. § 745.101; 45 C.F.R. § 46.101; 45 C.F.R. § 46.109(a).

107 45 C.F.R. 46.111(a)(1). 45 C.F.R. 46.111(a)(1).

108 45 C.F.R. 46.111(a)(3). 45 C.F.R. 46.111(a)(3).

109 Id.

110 45 C.F.R. § 46.101(a).

111 Value & Benefits, Int'l Council On Harmonisation http://www.ich.org/fileadmin/Public_Web_Site/ABOUT_ICH/Vision/Value_Benefits_for_Industry_2000.pdf.

112 Vision, Int'l Council On Harmonisation http://www.ich.org/about/vision.html [https://perma.cc/STF7-73C6].

113 Good Clinical Practice: Consolidated Guidance, Int'l Council On Harmonisation 1 (1996), http://www.fda.gov/downloads/Drugs/…/Guidances/ucm073122.pdf [hereinafter Good Clinical Practice]

114 Id.

115 Id. at 7. The clinical guidelines came from countries and organizations including countries in the European Union, Japan, United States, Australia, Canada, the Nordic countries and the World Health Organization (WHO). Id. at 1.

116 Id. at 10.

117 Id. at 1.

118 See Declaration of Helsinki, supra note 3.

119 The 2000 revision of the Declaration of Helsinki was the fifth revision to the document. Id. The document was revised in 1975, 1983, 1989, 1996, 2000, 2002, 2004, 2008, and 2013. Id.

120 Carlson, supra note 49, at 699-704.

121 See Declaration of Helsinki, supra note 3. Unlike the Common Rule, the Declaration of Helsinki does not define vulnerable populations using explicit characteristics. See id. Instead it states that “some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm. All vulnerable groups and individuals should receive specifically considered protection.” Id. at Section 19.

122 Id. at Section 20. The Declaration of Helsinki also requires that if vulnerable groups are used in medical research studies, the “group should stand to benefit from the knowledge, practices or interventions that result from the research.” Id. In addition, the Declaration states that “[i]n advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.” Id. at Section 34.

123 See id. at Section 20.

124 Sarah H. Kiskaddon, Balancing Access to Participation in Research and Protection from Risks: Applying the Principles of Justice, J. Nutrition 929, 931 (2005).

125 Id. For more background regarding the conflict, see Michael, Shevell, Ethics of Clinical Research in Children, 9 Seminars in Pediatric Neurology 46 (2002)Google Scholar; Levine, supra note 14, at 116.

126 Harold, Varmus & David, Satcher, Ethical Complexities of Conducting Research in Developing Countries, 337 New Eng. J. Med. 1003, 1003-04 (1997)Google Scholar.

127 The belief that medical research is treatment is called a “therapeutic misconception.” Oberman & Frader, supra note 6, at 308-10.

128 Ross, supra note 10, at 51, 56.

129 Id.

130 Steven Epstein, Inclusion: The Politics of Difference in Medical Research 63 (2007).

131 See id. at 61.

132 Donald Barlett & James Steele, Deadly Medicine, Vanity Fair (Feb. 5, 2016), http://www.vanityfair.com/news/2011/01/deadly-medicine-201101 [http://perma.cc/4S8G-VFYG] (pointing out that independent contractors now run many drug medical research studies and select research subjects). Even though the same laws apply to these independent contractors and researchers from institutions with IRBs, the government does not even regulate these independent contractors. See id. Therefore, not only does the government need to regulate these contractors, but it should also apply the suggestions I have for preventing targeting discussed in Section V.

133 For more discussion regarding the failures of IRBs, see Carl, H. Coleman, Rationalizing Risk Assessment in Human Subject Research, 46 Ariz. L. Rev. 1 (2004)Google Scholar; Hazel, Glenn Beh, The Role of Institutional Review Board in Protecting Human Subjects: Are We Really Ready to Fix a Broken System?, 26 L. & Psychol. Rev. 1, 34-41 (2002)Google Scholar.

134 Beh, supra note 133, at 34-41.

135 Id.

136 See id. at 32-33

137 Robert Cooke, Vulnerable Children, in Children as Research Subjects: Science, Ethics, and Law 193, 208 (Michael A. Grodin & Leonard H. Glantz eds., 1994).

138 Id.

139 Id.

140 Beh, supra note 133, at 34.

141 Barlett & Steele, supra note 132.

142 Harold Y. Vanderpool, Introduction to Part 1, in The Ethics of Research Involving Human Subjects: Facing the 21st Century 33, 39 (1996).

143 See OHRP Guidebook, supra note 87.

144 Id.

145 Id.

146 Id.

147 Id.

148 T., Howard Stone, The Invisible Vulnerable: The Economically and Educationally Disadvantaged Subjects of Clinical Research, 31 J.L. Med. & Ethics 149, 150 (2003)Google Scholar.

149 Id.

150 See Ross, supra note 10, at 25.

151 See Levine, supra note 14, at 109.

152 Sheryl, L. Buske, Foster Children and Pediatric Clinical Trials: Access Without Protection Is Not Enough, 14 Va. J. Soc. Pol'y & L. 253, 253, 271 (2007)Google Scholar.

153 Epstein, supra note 130, at 63 (emphasis added).

154 Id.

155 Francis, supra note 30, at 228-29; Oberman & Frader, supra note 6, at 308-10.

156 Francis, supra note 30, at 228-29; Oberman & Frader, supra note 6, at 308-10.

157 Francis, supra note 30, at 229-30.

158 Bridget, Pratt, & Bebe, Loff, Linking International Research to Global Health Equity: The Limited Contribution of Bioethics, 27 Bioethics 208, 209-10 (2013)Google Scholar; Bridget, Pratt, Deborah, Zion & Bebe, Loff, Evaluating the Capacity of Theories of Justice to Serve as a Justice Framework for International Clinical Research, 12 Am J. Bioethics 30, 32 (2012)Google Scholar; Varmus & Satcher, supra note 126, at 1003. There is a moral conflict between pursuing medical discoveries through medical research to find cures that will benefit society and protecting subjects from exploitation. The theory that medical research is conducted for the common good becomes corrupted when pursuing medical discoveries is suffused with a profit motive. Therefore, before medical research is conducted the social and economic needs of the society must be considered. Daniel Callahan, What Price Better Health?: Hazards of the Research Imperative 57, 62 (2003).

159 Washington, supra note 1, at 295.

160 Grimes v. Kennedy Krieger Institute, Inc., 782 A.2d 807, 811-17 (Md. 2001).

161 Id. Washington, supra note 1, at 292.

162 Grimes, 782 A.2d at 811-17; Washington, supra note 1, at 292.

163 Grimes, 782 A.2d at 824; Washington, supra note 1, at 292.

164 Grimes, 782 A.2d at 823-33.

165 Lead Exposure in Children Affects Brain and Behavior, 15 Am. Acad. Child & Adolescent Psychiatry 1 (2012).

166 Washington, supra note 1, at 272.

167 Id. at 274-78.

168 Id. at 278-79.

169 Id. at 275-76.

170 Id.

171 Ross, supra note 10, at 48-50.

172 Epstein, supra note 130, at 61.

173 See id. at 63-64.

174 See id.

175 John Solomon, Government Tested AIDS Drugs on Foster Kids, NBC News (May 4, 2005, 5:30 PM), http://www.nbcnews.com/id/7736157/ns/health-aids/t/government-tested-aids-drugs-foster-kids/#.V-V6r5MrJE4 [https://perma.cc/LH66-YQVZ]. For a discussion about the conduct of HIV transmission clinical trials on economically disadvantaged populations abroad, see George, Annas & Michael, Grodin, Human Rights and Maternal-Fetal HIV Transmission Prevention Trials in Africa, 88 Am. J. Pub. Health 560, 560-61 (1998)Google Scholar and Ronald, Bayer, The Debate over Maternal-Fetal HIV Transmission Prevention Trials in Africa, Asia, and the Caribbean: Racist Exploitation or Exploitation of Racism?, 88 Am. J. Pub. Health 567, 567-68 (1998)Google Scholar.

176 See Solomon, supra note 175.

177 Am. Acad. of Pediatrics, Increasing Antiretroviral Drug Access for Children with HIV Infection, 119 Pediatrics 838-845, 838 (2007); Sarah Childress, Why Some with HIV Still Can't Get Treatment, PBS Frontline (July 11, 2012), http://www.pbs.org/wgbh/pages/frontline/social-issues/endgame-aids-in-black-america/why-some-with-hiv-still-cant-get-treatment/ [https://perma.cc/PNP9-4LFZ].

178 Kelly Hearn, The Rise of Unregulated Drug Trails in South America, Nation (Sept. 21, 2011), http://www.thenation.com/article/rise-unregulated-drug-trials-south-america/ [https://perma.cc/K5623QU2].

179 Id.

180 Gail, Shor-Posner et al., Massage Treatment in HIV-1 Infected Dominican Children: A Preliminary Report on the Efficacy of Massage Therapy to Preserve the Immune System in Children Without Antiretroviral Medication, 10 J. Alternative & Complimentary Med. 1093, 1095 (2004)Google Scholar (reporting that massage therapy as a complementary treatment may “have a positive impact on immune function in HIV+ children not receiving antiretroviral medications”).

181 Id. at 1094.

182 Id. at 1094-95.

183 Id.

184 Epstein, supra note 130, at 61; see also Ross, supra note 10, at 24.

185 Levine, supra note 14, at 110. In response to these campaigns, Congress enacted Section 492B of the 1993 NIH Revitalization Act, mandating the inclusion of some vulnerable populations, including women and minorities, in all research projects funded by the NIH. Id. at 112.

186 Epstein, supra note 130, at 61.

187 Washington, supra note 1, at 233, 236-37, 284, and 294; Carl Coleman et al., supra note 53, at 39.

188 Food & Drug Administration Modernization Act of 1997, Pub. L. No. 105-115, § 505A, 111 Stat. 2296, 2305 (1997).

189 Id.

190 Ross, supra note 10, at 25.

191 Children's Health Act of 2000, Pub. L. No. 106-310, § 1001, 114 Stat. 1101, 1127 (2000).

192 Ross, supra note 10, at 27.

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

194 Pediatric Research Equity Act of 2003, Pub. L. No. 108-155, 117 Stat. 1936 (2003).

195 Ross, supra note 10, at 26.

196 Id. at 27.

197 Id.

198 Eyal, Cohen & Randi, Zlotnik Shaul, Beyond the Therapeutic Orphan: Children and Clinical Trials, 2 Pediatric Health 151, 156 (2008)Google Scholar.

199 Id.

200 Sensipar: Pediatric Trials of Calcium-Lowering Drug Halted After 14-Year-Old's Death, Huffington Post (Feb. 26, 2013), http://www.huffingtonpost.com/2013/02/26/sensipar-trials-halted-death-calcium-lowering-drug_n_2766721.html [https://perma.cc/C8TZ-5WNC].

201 Id.

202 The medical research tested various drugs including protease inhibitors, Ritonavir therapy, and the live-attenuated Varicella vaccine. See Letter from Karena Cooper, Compliance Oversight Coordinator, Office for Human Res. Protections to Harvey Colten, Vice President & Senior Assoc. Dean for the Faculties of Health Sciences & Med., Columbia Univ. Med. Ctr. and Laura Forese, Vice President & Chief Med. Officer, N.Y. Presbyterian Hosp. (May 23, 2005), http://archive.hhs.gov/ohrp/detrm_letrs/YR05/may05c.pdf [https://perma.cc/H95W-X82K].

203 Solomon, supra note 175. In response to reports of ethical violations, the New York City Administration for Children's Services (ACS) commissioned a study by the Vera Institute of Justice. Khabir Ahmad, Ethics of AIDS Drug Trials on Foster Children Questioned, 5 Lancet Infect. Dis. 333, 333 (newsdesk)(2005). Some questioned the credibility of the investigation since “ACS lied about the number of children involved, stating in April 2004 that only 76 children were involved; later the number increased to 100, and now 465.” Id. The report is at Vera Institute of Justice, The Experiences of New York City Foster Children in HIV/AIDS Clinical Trials 75 (January 2009) (a state-sponsored, independent review of New York City's involvement in the medical research revealed that “sixty-four percent of the children were non-Hispanic blacks, 30 percent were Hispanic of varying races and fewer than 2 percent were non-Hispanic whites.”).

204 Id.

205 Solomon, supra note 175.

206 In addition to this subjection of economically disadvantaged minority children to hazardous drug trials, some researchers failed to obtain proper consent from participate in the trials. There were two common practices that violated the informed consent laws. First, five children participating in the New York drug trials between five and ten years of age were asked to sign consent forms once they were told of the risks and benefits. See Solomon, supra note 175. Second, many of the researchers failed to obtain consent from an authorized person, such as an independent advocate, for each child. Id. The only consent researchers obtained for participating foster children were blanket consents from child welfare agencies. Id. None of the 200 Illinois foster children were appointed independent monitors even though researchers signed a document guaranteeing “the appointment of an advocate for each individual ward participating in the respective medical research.” Id. In New York, monitors were only appointed to less than one-third of the 465 foster children participating in the medical research studies. Id.

207 See Letter from Karena Cooper, supra note 202.

208 Id. at 2.

209 The following institutions received letters determining that they had selected foster children inequitably: Bellevue Hospital Center, Bronx-Lebanon Hospital Center, Children's Hospital of King's Daughters, Children's Hospital Association, Children's Hospital of Philadelphia, Children's Hospital and Research Center at Oakland, Children's Hospital and Regional Medical Center, Cook County Bureau of Health Services, Drexel University College of Medicine, Duke University School of Medicine, Johns Hopkins University/Johns Hopkins Health System, State University of New York-Upstate Medical University, University of Chicago, and University of Miami. See, e.g., Letter from Kristina C. Borror, Dir., Div. of Compliance Oversight, Dept. of Health & Human Servs., to Lynda D. Curtis, Senior Vice President & Exec. Dir., Bellevue Hosp. Ctr. (June 19, 2006), http://www.hhs.gov/ohrp/compliance-and-reporting/determination-letters/index.html; Letter from Julia Gorey, Div. of Compliance Oversight, Dept. of Health & Human Servs., to Steve Anderman, Senior Vice President & Chief Operating Officer, Bronx-Lebanon Hosp. Ctr. (June 19, 2006), http://www.hhs.gov/ohrp/compliance-and-reporting/determination-letters/index.html. Additional letters available at http://www.hhhs.gov/ohrp/compliance-and-reporting/determination-letters/index.html.

210 See OHRP letters, note 209.

211 Id.

212 Belmont Report, supra note 8, at 23,196.

213 See Vera Institute of Justice Report, supra note 203, at 164.

214 Belmont Report, supra note 8, at 23,196.

215 Solomon, supra note 175. There was a question whether those children who participated in the New York studies were infected, but unclear because the identity and number of children in the New York study was unclear. Ahmad, supra note 203, at 333.

216 Solomon, supra note 175.

217 Belmont Report, supra note 8, at 23,194.

218 Solomon, supra note 175.

219 Id.

220 Id.

221 Id.

222 Id. This was not the only clinical trial in which death was a side effect of the drugs. See id. (“In one study, researchers reported a ‘disturbing’ higher death rate among children who took higher doses of a drug.”)

223 Annas & Grodin, supra note 175, at 560-61; Bayer, supra note 175, at 567.

224 Levine, supra note 14, at 117.

225 Solomon, supra note 175; Ahmad, supra note 203, at 333.

226 Oberman & Frader, supra note 6, at 308.

227 See generally Bayer, supra note 175, at 569.

228 Barlett & Steele, supra note 132; Sarah Childress, Why Some with HIV Still Can't Get Treatment, Frontline (July 11, 2012), http://www.pbs.org/wgbh/frontline/article/why-some-with-hiv-still-cant-get-treatment/ [https://perma.cc/ATR9-AWYM].

229 See, e.g., Shor-Posner et al., supra note 180, at 1094.

230 Barlett & Steele, supra note 132.

231 Id.

232 Id.

233 Id.

234 Id.

235 Adriana Petryna, When Experiments Travel: Clinical Trials and the Global Search for Human Subjects 38-39 (2009).

236 Id. at 39.

237 Id.

238 Id.

239 Id.

240 Id. A two-billion-dollar lawsuit was filed in the United States against the U.S. based pharmaceutical company alleging that the low dosing of ceftriaxone caused the children's death. Id. The case has been moved to Nigeria. Id. at 40. In 2006, a panel of judges in Nigeria found that Pfizer's studies violated international law. Joe Stephens, Panel Faults Pfizer in ’96 Clinical Trial in Nigeria, Wash. Post (May 7, 2006), http://www.washingtonpost.com/wp-dyn/content/article/2006/05/06/AR2006050601338.html [https://perma.cc/J6B9-2QF6].

241 Petryna, supra note 235, at 40.

242 See id. at 38-39.

243 See id. at 39.

244 Stephens, supra note 240.

245 Petryna, supra note 235, at 39.

246 Id. at 38.

247 Haber, supra note 11 (explaining the Health Equity Impact Assessment).

248 P., Braveman & S., Gruskin, Defining Equity in Health, 57 J. Epidemiology Cmty. Health 254, 256 (2003)Google Scholar.

249 Susan, Povall et al, Health Equity Impact Assessment, 29 Healthy Promotion Int'l 621, 622 (2013)Google Scholar.

250 Braveman & Gruskin, supra note 248, at 256.

251 Id. at 254.

252 Id.

253 Id.

254 Id. at 255.

255 Id.

256 Ontario Ministry of Health and Long-Term Care, Workbook: Using the Health Equity Impact Assessment Tool 3 (2009).

257 Id.

258 Washington, supra note 1, at 236-37, 284; Ross, supra note 10, at 48.

259 Washington, supra note 1, at 236-37, 284; Ross, supra note 10, at 48.

260 Grimes v. Kennedy Krieger Inst., 782 A.2d 807, 811-17 (Md. 2001).

261 See generally Fehr, supra note 11.

262 National Environmental Policy Act, 42 U.S.C. § 4321 (1970).

263 Fehr, supra note 11, at 618.

264 European Observatory on Health Sys. and Policies, The Effectiveness of Health Impact Assessment: Scope and Limitations of Supporting Decision-Making in Europe, World Health Organization, 1 passim (Mathias Wismar et al. eds., 2007), http://www.euro.who.int/__data/assets/pdf_file/0003/98283/E90794.pdf [https://perma.cc/N52Q-483M].

265 Id. at 3.

266 Id.

267 Povall et al., supra note 249, at 622.

268 Id. at 621-22.

269 Id. at 624 (explaining that one study found that even when equity was a central theme of the HIA, the impact analysis did not go beyond identifying vulnerable populations and the differential effects of the policy on these populations).

270 Id. at 631.

271 Id. at 631-32.

272 Id. at 631.

273 Ontario Ministry of Health, supra note 256, at 3.

274 Id. at 5.

275 Id. at 6-7.

276 Id. at 7.

277 Terry Keleher, An Introduction to Racial Equity Assessment Tools, Race Forward (March 2014), https://racc.org/wp-content/uploads/2015/12/An-Introduction-to-Racial-Equity-Assessment-Tools.pdf [https://perma.cc/V99M-SW9E].

278 Id. at 29.

279 The VEIA can also be used to measure whether researchers are complying with informed consent. Ruqaiijah, Yearby, Involuntary Consent: Conditioning Access to Health Care on Participation in Clinical Trials, 44 J.L. Med. & Ethics 445 (2016)Google Scholar (discussing how certain participants may be unduly influenced into participating in clinical trials).

280 See OHRP Guidebook, supra note 87.

281 Marian Wright Edelman, Children's Defense Fund (2016), http://www.childrensdefense.org/about/leadership/marian-wright-edelman/?referrer.

282 See OHRP Guidebook, supra note 87.

283 Ontario Ministry of Health, supra note 256, at 7.

284 Keleher, supra note 277, at 30.

285 Id.

286 Petryna, supra note 235, at 38-39.

287 Id. at 39.

288 45 C.F.R. §46.407 (2015).

289 In addition, the Board can review issues regarding autonomy and beneficence.

290 The Board would also be responsible for ensuring that the researchers comply with the other requirement of the justice principle, that members of the vulnerable population participating in the study directly benefit from the study.

291 The IBOC would need to ensure that members of the vulnerable population participating in the study will directly benefit from the study.

292 For an example of a study in which researchers would face criminal fines, see Richardson, supra note 96, at 126.

293 See, e.g., 23 U.S.C. § 158 (providing national minimum drinking age) (2012); Mass. Gen. Laws ch. 140, § 131L (2015); 29 U.S.C. § 212 (2012) (setting child labor provisions).

294 See, e.g., 45 C.F.R. § 46.111 (2015).

295 Patricia, A. King, Reflections on Race and Bioethics in the United States, 14 Health Matrix 149, 151 (2004)Google Scholar.