Protection of Human Subjects

Historical Perspective on the Abuse of Human Subjects in Research

One of the earliest examples of the abuse of human subjects was the infamous Tuskegee Syphilis Study that was conducted from 1932 to 1972 in Macon County, Alabama. The purpose of the study was to observe the progression of untreated syphilis in black men. A total of 399 black men with syphilis and 201 black men without it were recruited. The men were told that they were receiving treatment when in fact they were not. In addition, the physicians in the county were told not to treat these men since it would interfere with the study. When penicillin became the established treatment for syphilis in 1947, the treatment was withheld from the men in the study known to have syphilis. The men and the course of their illnesses were documented and observed until they died. Their spouses caught the disease from them and children were born infected with it. Yet their diagnosis and treatment was withheld. Finally, a front-page article in The New York Times exposed what was going on, and the public became outraged. Consequently, a panel was appointed [Page 631]by the Department of Health and Scientific Affairs to review the study. Although the men had freely consented to participate, the panel discovered that they were never told of the considerable risks to their health and to the health of their families. In October 1972, the panel advised that the study be discontinued because the men had not been told about the risk of physical harm, which was necessary for the men to have given informed consent. One month later, the Assistant Secretary of Health and Scientific Affairs announced that the study was ended. The termination of the study was followed by a lawsuit brought by the National Association for the Advancement of Colored People (NAACP), which resulted in an award of $9 million to the participants as well as free medical care and burials for those who were still living.

A second example of the abuse of human research participants was the Willowbrook Hepatitis Study that was carried out from 1963 through 1966 at the Willowbrook State School of New York. Here, mentally disabled individuals were intentionally infected with hepatitis in order to study the disease and a possible treatment, gamma globulin. These individuals were all children who by reason of their mental status could not legally give consent themselves. Parents who wished to have their children admitted to the institution were told that there was no room for their child unless they agreed to have the child participate in the hepatitis studies. The investigators claimed that most of the children at Willowbrook would eventually become infected with hepatitis anyway. The public became outraged that the parents and their children were forced to enter the hepatitis research program or else admission to the institution would be denied.

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