From 1963 through 1966, studies were carried out at the Willowbrook State School, a New York State institution for “mentally defective persons.”

These studies were designed to gain an understanding of the natural history of infectious hepatitis and subsequently to test the effects of gamma globulin in preventing or ameliorating the disease.

The subjects, all children, were deliberately infected with the hepatitis virus; early subjects were fed extracts of stools from infected individuals and later subjects received injections of more purified virus preparations.

Investigators defended the deliberate injection of these children by pointing out that the vast majority of them acquired the infection anyway while at Willowbrook, and perhaps it would be better for them to be infected under carefully controlled research conditions.

During the course of these studies, Willowbrook closed its doors to new inmates, claiming overcrowded conditions.  However, the hepatitis program, because it occupied its own space at the institution, was able to continue to admit new patients. Thus, in some cases, parents found that they were unable to admit their child to Willowbrook unless they agreed to his or her participation in the studies.

This case caused a public outcry because of the perception that parents and their children were given little choice about whether or not to participate in research.