Read about the Willowbrook Hepatitis Study and then answer the questions.  

The Willowbrook Hepatitis Study

found at: https://willowbrookhs.wikispaces.com/

The Willowbrook State School in Staten Island, NY was a state institute that was home to mentally disabled children. Beginning in the mid 1950s, studies were conducted in an attempt to understand the transmission and manifestation of the hepatitis virus. Under the supervision of Dr. Saul Krugman from the New York University School of Medicine, researchers and the staff at Willowbrook intentionally infected children at the institution with hepatitis in an attempt to determine if gamma globulin antibodies were an effective means of immunity to the virus ("Willowbrook hepatitis experiments," 2009).

DESCRIPTION OF THE STUDY

Dr. Saul Krugman a physician at the New York University School of Medicine and his coworkers began conducting hepatitis studies in the mid 1950's at Willowbrook State School in Staten Island, NY. The study conducted by Krugman and his staff continued for more than 15 years. Hepatitis was a great problem at Willowbrook for patients and staff. Krugman believed that most newly admitted children became infected with hepatitis within the first year of residence in the institution. Estimates put the risk of a child contracting hepatitis at Willowbrook at 30 to 50 percent. Krugman was interested in using antibodies taken from the blood of hepatitis patients as a way to create immunity in others. Krugman believed if a child was infected with hepatitis after he or she had been injected with the protective antibodies, a mild case of hepatitis would result. Krugman believed the child would have long-lasting protection against future, potentially more serious, infections. The quantitative research was conducted on more than 700 children at the Willowbrook facility. The children involved in the studies fell into two categories. Krugman first used children who were already at Willow-brook. Researchers injected some with protective antibodies (the experimental group) and did not inject others (the control group). Krugman observed the children’s degree of immunity to hepatitis. Krugman also gave newly admitted children protective antibodies. A subset of these children was then deliberately infected with hepatitis virus taken from sick children. The children who received protective antibodies but were not deliberately infected served as the controls. It established that two types of hepatitis (A and B) occurred at Willowbrook and that injections of gamma globulin can have a protective effect against infection by hepatitis A virus. The research conducted by Krugman resulted in a reduced the amount of hepatitis among patients and employees by 80 to 85 percent. However, some of the children benefited just from better health care and living conditions in the special part of the facility ("Willowbrook hepatitis experiments," 2009).

ETHICAL PROBLEMS IN THE STUDY

Ethical standards and guidelines are vitally important when conducting a research study.

Ethical guidelines are in place to ensure research studies are conducted morally and ethically correct.

Researchers must follow ethical guideline to ensure the protection of the research participants.

The ethical issues surrounding the Willowbrook Hepatitis study involved the fundamental rights of children.

Ethical Principles

Protecting participants from Harm – Researchers must ensure the participants are protected from psychological harm, physical harm and danger at all times (Fraenkel & Wallen, 2009, pp. 53-63).

The researchers involved in the Willowbrook hepatitis study failed to protect the participants from harm. Children involved in the study were deliberately infected with the hepatitis virus. The children were initially fed extracts of feces from infected individuals and later children received injections of a more purified hepatitis virus.

Deception - Researchers should not provide false, incomplete, or misleading information to research participants for purpose of research gain (Fraenkel & Wallen, 2009, pp.53-63).

The researchers involved in the Willowbrook hepatitis study lead the parents to believe the children would be participating in a study that would benefit them. The parents were led to believe their children would receive preventive care; Instead, the children were intentionally infected with the hepatitis virus.

Ensuring Confidentiality – Researchers should ensure the participant’s name and personal information is kept private. The research participant’s information should only be available to the researcher and perhaps the research assistant (Fraenkel & Wallen, 2009,pp.53-63).

Research data did not indicate whether the names and personal information of the Willowbrook participants was disclosed or not.

Informed Consent - The informed consent of parents or legal guardians should be obtained on behalf of children. The parents or guardians should be informed of all the characteristics of the research. The parent or guardian should be informed that they may refuse to participate without incurring any penalty to them or to the child (Fraenkel & Wallen, 2009, 53-63).

The researchers involved in the Willowbrook hepatitis study obtained consent from the children’s parents. However, the consent form was misleading and deceptive. 

Immediate admission was given to children whose parents signed the consent letter. Parents who did not provide consent were not assured of immediate admission to the facility.

Researchers are responsible for ensuring the study is done morally and ethically correct.