Information on Protection of Human Subjects in Research Funded or Regulated by U.S. Government

Abstract

Today, a researcher who is compliant with current Federal regulations would not be able to conduct a study, domestically or in another country, with the ethical violations present in the Sexually Transmitted Disease (STD) Inoculation Study. The history of biomedical research in the U.S., 1940-1970’s: There was tremendous growth in research around World War II. Human subjects research entered what some scholars have described as an “unashamedly utilitarian phase.” Subjects were often institutionalized individuals who were not always fully informed of the risks of the study or asked for consent. Infectious disease research, particularly venereal diseases, was a focus of the U.S. government because of the toll diseases like syphilis and gonorrhea were taking on the armed services. One method for studying infectious disease was by intentionally infecting subjects with the disease-causing pathogen. Prisoners were commonly used because they were easily monitored in a highly controlled environment. Dr. Cutler was a researcher on two such studies: infection of prisoners with gonorrhea at the United States Penitentiary at Terre Haute (1943) and with syphilis at Sing Sing Correctional Facility (1953).