American Journal of Law & Medicine

Missing the "Target": Preventing the Unjust Inclusion of Vulnerable Children for Medical Research Studies


Nearly everyone has experienced a burn and the resulting pain. Now imagine that you suffer a third-degree radiation burn that injures all the layers of your skin as well as the tissue, causing you extreme pain.. The burn turns your skin white, cherry red, or black and may produce blisters that are dry, hard, and leathery-looking. The burn can also be seen on the surface of your lungs and gastrointestinal tract. If the burn is big enough you will need skin grafts and surgery to replace the skin and tissue that will never grow back, as well as treatment to prevent infection. Assumedly, no human being would intentionally cause another human being to experience this type of pain and suffering. However, U.S. researchers did. Researchers at the Medical College of Virginia conducted radiation tests on healthy African American children, as young as 6 months old, deliberately causing third-degree burns to their skin. (1) The tests not only damaged the skin of these children, causing them extreme pain, but it also required surgery and skin grafts. (2)

Although the central purpose of medical research on children is to "generate new knowledge" that can improve children's health, research "can never take precedence over the rights and interests of children serving as research subjects. (3) Unfortunately, medical research has too often taken precedence over the rights and interests of children, which is why many researchers and bioethicists have characterized the history of medical research on children as a history of child abuse. (4) Usually, the debate regarding the use of children in medical research studies has centered on questions regarding the ethical principles of autonomy (informed consent) (5) and beneficence (the best interest of the child based on a benefit risk analysis). (6) The debate has rarely focused on the justice principle. (7)

My article begins to fill this void by critically analyzing medical research studies conducted on children by discussing the requirements of the justice principle. The justice principle, used to determine who will serve as a research subject, (8) is the most significant ethical principle governing medical research studies because the first thing that researchers must consider when designing their study is subject selection. Once it is decided who will serve as a research subject, the researcher can determine whether the study complies with the requirements of autonomy and beneficence.

When selecting research subjects, the justice principle prohibits targeting. Targeting is the systematic selection of research subjects who are from vulnerable populations, such as racial minorities, children, and the economically disadvantaged, "because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied." (9) Additionally, even if the research is directly related to a condition suffered by the vulnerable population, researchers should not use these populations as research subjects if they are already overburdened due to lack of access to essential goods, such as food and housing. Consequently, research subjects should be chosen according to an order of preference of subjects for research: the economically advantaged before the economically disadvantaged, the majority before minorities, and adults before children.

Notwithstanding the Justice Principle, researchers continue to target children for medical research studies. Since the late 1700s, children have repeatedly been targeted for participation in medical research studies because they were readily accessible and easy to manipulate. (10) Using economically disadvantaged minority children as an example of the harm all children suffer when targeted for medical research studies, I argue that the justice principle must be redefined and new safeguards must be implemented to protect all child participants. Specifically, Section II provides a descriptive overview of the purpose and structure of medical research studies, as well as a brief history of medical research studies that targeted economically disadvantaged minority children. Section III examines the parameters of the justice principle and further defines what constitutes targeting. Section IV discusses the problems with the enforcement of the justice principle and provides examples of medical research studies that targeted and harmed economically disadvantaged minority children in the United States and abroad as a result of these problems.

In Section V, I propose several ways to end targeting in the United States and abroad. First, the justice principle must be redefined to mean equity in participation. Equity in participation would require researchers to use non-disadvantaged children as research subjects unless the study is a priority to and does not overburden economically disadvantaged minority children. To measure whether equity in participation is met, researchers should be required to use the proposed Vulnerability and Equity Impact Assessment (VEIA) tool," to determine whether the selection of children from particular groups as research subjects violates the redefined justice principle. Finally, I suggest the creation of a Board of Children to review all medical research studies regulated by the United States that use children as research subjects. If all of these recommendations are implemented, it will prevent economically disadvantaged minority children from being targeted in medical research studies for the benefit of an unworthy society.


There are two types of medical research studies involving human subjects: Non-therapeutic and Therapeutic. (12) Regardless of the type of medical research study, all studies using children entail risk of psychological and physical harm, as well as the possibility of stigma. In fact, countless children have suffered harm as a result of study participation, often without any benefit in return. (13) Economically disadvantaged (14) minority children have been and continue to be overrepresented in medical research studies. (15)


A non-therapeutic medical research study is conducted to obtain generalizable scientific knowledge. (16) This research is done to learn more "about the subjects' disorder or condition which is of vital importance for the understanding or amelioration of the subjects' disorder or condition." (17) An example of non-therapeutic research is a study to ascertain the effects of household pesticide use on children's health. (18)

A therapeutic medical research study tests a vaccine, drug, or medical device for the treatment of a disease. (19) An example of a therapeutic medical research study is the testing of HIV/AIDS drugs. There are five Phases of therapeutic medical research studies: Phase 0, I, II, III, and IV. (20) Using drug medical research studies as an example, each Phase is discussed below.

In a Phase 0 drug study, research is conducted using at most ten people and involves the administration of small doses of an experimental drug over a short period of time to determine if there is any pharmacological effect. (21) The purpose of the study is to evaluate whether there is any effect in humans, before undertaking Phase I and II drug studies. (22) Unlike Phase I drug studies, there is no therapeutic intent and little to no toxic effect in a Phase 0 drug study, which is primarily done for cancer drugs and therapies. (23)

In a Phase I drug study, research is conducted using a small number of subjects, less than 100 people, to obtain information regarding the safety and efficacy of the candidate drug on human subjects. (24) Phase II studies obtain information from several hundred subjects regarding the subjects' immune system's response, the efficacy of the drug on different populations, and the effect of different doses on the population. (25)

After preliminary evidence has been obtained suggesting effectiveness of the drug, a Phase III drug study is conducted "to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide an adequate basis for physician labeling." (26) Researchers determine the efficacy of the drug in preventing the disease by following several thousand subjects. (27) This is the last phase before the drug is marketed and distributed. (28) Phase IV is the final step in drug studies. (29) It includes "[p]ost-marketing... studies to delineate additional information about the drug's risks, benefits, and optimal use." (30)

The main difference between each Phase is the purpose of the study and the benefit. In Phase 0, I, and II studies, the goal is primarily the attainment of scientific knowledge, whereas in Phase III and IV studies, the goal is treatment. (31) Many patients, physicians, and scholars often misunderstand the difference between research and therapy. (32) Although there is no potential for a benefit in Phase 0, I, and II medical research studies, many patients, providers, and even researchers believe that enrollment in these studies is beneficial for the patient because the patient will receive treatment. (33) This therapeutic misconception is used to justify the targeting of vulnerable research subjects, such as economically disadvantaged minority children, for participation in medical research studies. (34)


Although the definitions seem clear, ascertaining whether a study is non-therapeutic or therapeutic can be difficult because both studies may potentially benefit society through either generalizable knowledge or direct treatment. Nevertheless, no matter whether the study is non-therapeutic or therapeutic, some researchers have targeted economically disadvantaged minority children for use in medical research studies, causing lifelong disability and/or death. (35)

Between 1936 and 1960, psychiatrists and neurosurgeons conducted lobotomies on healthy African American boys as young as five years old that obliterated their thought ability and personality. (36) The psychiatrists and neurosurgeons used crude tools such as the icepickalon. (37) Inserting the tools into the boys' brains, the researchers "blindly swept [the tools] back and forth... cutting all the connecting nerves," removing any chance for the once healthy boys to lead a normal life. (38) From 1949 to 1960, the Medical College of Virginia conducted radiation tests on healthy African American children, as young as six months old, deliberately causing third-degree burns ' to their skin. (39) In 1956, seventeen healthy African American infants were deprived of an essential nutrient, which researchers knew the body could not survive without. (40) Ten of the seventeen suffered severe complications, in order for scientists to determine if canned milk caused skin rash, diarrhea, or slow weight gain. (41) Notwithstanding the complications, the study was repeated with 428 infants and seven of the infants died. (42)

The U.S. Atomic Energy Commission (AEC) "irradiated 235 African American newborns from 1953 to 1954 in various hospitals across the nation" for no recorded therapeutic purpose since the infants were healthy. (43) Between 1960 and 1970, the AEC sponsored a study in which radioactive material was added to the oatmeal of thirty healthy orphans, some of which were African American. (44) The government obtained the bodies of the research participants who died to measure the levels of radioactivity and biological damage. (45)

These are just a few examples of the targeting of economically disadvantaged minority children in medical research studies for the benefit of society. The children who participated in these studies were chosen because they were readily accessible and in a compromised position, not because they were particularly affected by the condition being studied. These historical abuses were the foundation for the application of social justice to medical research studies and the protection of vulnerable populations, particularly economically disadvantaged minority children, from exploitation. (46)


The concept of social justice has been applied in the allocation of societal benefits and burdens, such as "punishment, taxation and political representation." (47) Before 1979, most scholars, bioethicists, and researchers did not view social justice as relevant to medical research studies. (48) The first discussion concerning the proper allocation of burdens and benefits of medical research studies appeared in the Belmont Report's, discussion of the justice principle. (49) This report, mandated by the United States' Congress, not only defined the term, but also provided the framework for which to apply the principle to medical research studies. (50) Since 1986, when the Common Rule was enacted, the justice principle has been applied to all medical research funded by the federal government. (51) Beginning in 1996, the justice principle was also applied to any medical research studies conducted outside the United States by a company seeking drug approval in the United States. (52)


In the early 1970s, the U.S. Senate Committee on Labor and Human Resources held hearings on some of America's most egregious medical research studies, such as the Willowbrook study (53) and the Tuskegee Syphilis study. (54) As a result of the hearings, Congress created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Commission). (55) In addition, Congress imposed a moratorium on research conducted or supported by the U.S. Department of Health and Human Services (HHS) on a living human fetus (56) until adequate protections for such subjects were developed. (57)

The Belmont Report was an outgrowth of the Commission's deliberations regarding ethical protections and a 1976 conference at the Smithsonian Institute's Belmont Conference Center. (58) In the Belmont Report, the Commission selected justice as one of the three fundamental ethical principles to protect vulnerable groups from exploitation in medical research studies. (59) The Commission noted that in the United States the burden of participating in medical research studies was borne principally by the economically disadvantaged while the rich enjoyed the benefits, as evidenced by the Tuskegee Syphilis Study. (60)

From 1932 until 1972, researchers enrolled economically disadvantaged black men in a study to document the course of syphilis, even though the course of the disease was already known. (61) In exchange for free meals, medical exams and burial insurance, the researchers promised the men that they would provide treatment for their 'bad blood," which could include "anemic blood to muscle aches, general malaise, disorders such as parasitic infections, gonorrhea, syphilis, and other venereal disease." (62) The researchers never informed the men that they were participating in a medical research study, and therefore, never told them about the purpose of the study. (63) Researchers also intentionally deprived these men of "demonstrably effective treatment in order not to interrupt the project, long after such treatment became generally available," causing the unnecessary disability and death of the men, their wives, and their children. (64) The study was not a therapeutic study because it was not testing a possible treatment of syphilis and blocked any access to treatment. (65) Additionally, the study was not a non-therapeutic study to attain generalizable knowledge because the medical community had already documented the disease process of syphilis. (66) Thus, there was nothing gained from the study other than exploiting the economically disadvantaged and minorities.

To put an end to the exploitation of the economically disadvantaged and minorities, the Commission incorporated social justice into the ethical principles governing medical research studies using human subjects. (67) Specifically, the Commission created the justice principle to determine "Who ought to receive the benefits of research and bear its burdens?" (68) To answer this question and establish the contours of the justice principle, the Commission defined what is just and what is unjust in the selection of research subjects. (69)

In selecting research subjects, the justice principle requires that researchers ensure disadvantaged groups such as minorities, women, children, the institutionalized mentally infirm, prisoners, and the economically disadvantaged (70) are not "being systematically selected simply because of their easy availability, their compromised position, or manipulability, rather than for reasons directly related to the problem being studied." (71) The Commission reasoned that:

whenever research supported by public funds leads to the development
of therapeutic devices and procedures, justice demands both that these
not provide advantages only to those who can afford them and that such
research should not unduly involve persons from groups unlikely to be
among the beneficiaries of subsequent applications of the research.

According to the Commission, "the principle of justice gives rise to moral requirements that there be fair procedures and outcomes in the selection of research subjects" on two levels: Individual and Social. (73) On the Individual level, researchers should include the disadvantaged in potentially beneficial research that is usually reserved for the rich, instead of using them for non-therapeutic and dangerous medical research studies. (74) On the Social level, researchers must draw a distinction "between classes of subjects that ought, and ought not, to participate in any particular kind of research, based on the ability of members of that class to bear burdens and on the appropriateness of placing further burdens on [an already burdened group]." (75) The Belmont Report noted that it was not fair for the economically disadvantaged, who rely on public funds for health care, to be considered as preferred research subjects for publicly funded research because of their need to access health care. (76) Thus, there is an order of preference in the selection of research subjects, such that researchers should use the rich before the economically disadvantaged, the majority before minorities, and adults before children.

On an Individual level, the justice principle requires inclusion of vulnerable groups for potentially beneficial research, while on a Social level this inclusion must be limited to protect vulnerable groups from being overburdened. (77) Nevertheless, even after researchers balance the Individual and Social level requirements of the justice principle, the use of certain classes of people for research may be unjust because of "social, racial, sexual, and cultural biases institutionalized in society" that place a class of people in a vulnerable and compromised position, easily manipulated into participating in medical research studies. (78)

For example, over three decades of empirical research studies show that racial bias institutionalized in society prevents many African Americans from receiving quality education, obtaining jobs, and accessing housing in safe, diverse, and environmentally-friendly neighborhoods. (79) Studies show that African Americans seeking employment have a harder time obtaining employment because non-African American managers tend to hire more Caucasians. (80) Also, African Americans with non-Caucasian names receive fifty percent less callbacks than African Americans with Caucasian sounding names. (81) As a result, many African Americans are more likely to be unemployed or employed with no health insurance. (82) Lacking health insurance or money to pay for health care, African Americans are left in a compromised position and easily manipulated into participating in medical research studies to obtain access to health care. Consequently, even if researchers fairly select African Americans as research subjects, without bad intent, these institutional racial biases, which place African Americans in a vulnerable and compromised position, easily manipulated into participating in medical research studies, make their use as research subjects a violation of the justice principle. (83) To counteract these unjust social patterns the Belmont Report requires researchers to consider distributive justice in selecting research subjects and follow the order of preference, using the rich before the economically disadvantaged, the majority before minorities, and adults before children. (84)


In 1986, the Belmont Report in its entirety, was adopted by sixteen federal agencies and departments, including HHS, and codified in 45 C. …

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