Research with Children

Leonard H. Glantz^ INTRODUCTION In the United States we have very mixed feelings about research with human subjects.1 The Nuremberg Code (the Code), which provides a foundation for the protection of human subjects, was written by American judges in the context of trying Nazi doctors who committed atrocious acts of human experimentation on concentration camp inmates.2 The Code provides ten common-sense guidelines controlling research.3 For example, a researcher may not conduct research on human subjects without that subject's informed consent,4 or if there is an a priori reason to believe that the research will cause death or disabling injury to the subject.5 What is remarkable about the creation of the Code is that it was thought to be necessary to document and impose the most fundamental moral principles on researchers.6 The Code demonstrates a remarkable suspicion of research with human subjects and those who perform such research.7 Of course, given the context in which the Code was written, these suspicions were more than justified.8 But since the Code was written, other abuses of human subjects have come to light.9 The most notorious is the Tuskegee syphilis research in which black men were not treated for their disease so the researchers could follow the natural course of syphilis in black males. io Not only was their informed consent not acquired, they were lied to about the reasons for procedures that were conducted on them for research purposes and they suffered numerous other indignities and injuries at the hands of the researchers.II Recent disclosures demonstrate that post-1945 radiation research was conducted on nonconsenting human subjects in the United States.lt This history causes suspicion of research with human subjects.13 On the other hand, research with human subjects has also led to remarkable health benefits.34 The advent of new treatment modalities is largely dependent on the use of human subjects to determine their safety and effectiveness. The creation of antibiotics, vaccines, medical devices and other beneficial modalities all result from research with human subjects.is The mixed feelings we have about research with human subjects are described in the title of a 1975 National Academy of Sciences report entitled Experiments and Research with Humans: Values in Conflict.16 This conflict in values is even more pronounced when the research subjects are children.17 Children have been particularly subjected to abuses by researchersl8 and "those who do research with children today have inherited the legacy of researchers who have come before them."19 Recognizing this history provides a context for understanding the current rules that govern research with children. Susan Lederer and Michael Grodin have well documented many of the abuses of research with children.20 Most of the following historical information comes from their work. The first tests of immunization were performed on slaves and children.2 Edward Jenner vaccinated his one-year-old son with cowpox to see if it offered immunity to smallpox.22 His next subject was an eight-year-old child who was challenged with an inoculation of smallpox material in order to determine if the inoculation was effective.23 In 1802, Jenner's vaccine was tested on forty-eight children living in an almshouse.24 All the children were challenged with smallpox to see if they were effectively immunized.25 Following the exploitation of children as laborers in the Industrial Revolution, the 1900s saw an increased interest in child welfare along with an increased desire to learn more about children's health problems.26 In the first decade of the 1900s, Alfred Hess, a respected pediatrician, became the medical director of the Hebrew Infant Asylum in New York.27 He noted that conducting research in an asylum was ideal because it approximated those "conditions which are insisted on in considering the course of experimental infection among laboratory animals, but which can rarely be controlled in a study of infection in man. …