Willowbrook Hepatitis Studies Hany Sleem, MD Henry Silverman, MD

Willowbrook Studies From 1966 to 1969, hepatitis studies were carried out at the Willowbrook State School, a NY 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 from stools of infected individuals, and later subjects received injections of more purified virus preparations.

Willowbrook Studies Investigators defended the deliberate injections 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 get infected under carefully controlled research conditions. The investigators also defended the study by stating that: –They obtained parental consent –The children would receive a subclinical infection followed by immunity to the particular hepatitis virus. –The study had extreme value in understanding an important disease that would lead to a vaccine.

Willowbrook Studies During the course of these studies, Willowbrook closed its doors to new patients, but because the research program had its own space, it was able to admit new patients. Subsequently, parents were able to gain admission for their children only if they agreed to have their children enrolled in the study.

Consent Letter Dear_______________: We are studying the possibility of preventing epidemics of hepatitis on a new principle. Virus is introduced and gamma globulin given later to some, so that either no attack or only a mild attack of hepatitis is expected to follow. This may give the children immunity against this disease for life. We should like to give your child this new form of prevention with the hope that it will afford protection. Permission form is enclosed for your consideration. If you wish to have your child given the benefit of this new preventative, will you so signify by signing the form. Sincerely, H. H. Berman, MD

Questions Of the several justifications given for the study, which one(s) would a research ethics committee would want to investigate to determine its truthfulness? Comment on the proposed benefits of the study to the children? Comment on the letter given to parents for them to sign? – Does the letter adequately express the nature, risks, and benefits of the study? Comment on the recruitment methods, especially the choice given to parents about whether or not to participate in research. Even if the risks were adequately disclosed, are the researchers justified in deliberately exposing children to hepatitis infection?