Transcript Consent Letter

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?