Examination: the Willowbrook Study

Examination: the Willowbrook Study

A look at a longterm, unacknowledged breach in ethical conduct

Bethany Wynia

Background Information on this Experiment

THE WILLOWBROOK STUDY

• Conducted from 1963-1966 (some reports claim it went on for 15 years)

• Willowbrook State School in Stanten Island, New York

• A total of over 700 participants were involved - all were mentally disabled children who resided at the school

• Intention and purpose: to develop protection or immunization against Hepatitis

National Institutes of Health, 2009.

Experimentation was led by Dr. Saul Krugman

Krugman was an award winning pediatrician who was working to develop a vaccine that could protect children from Hepatitis

Krugman worked alongside Dr. Joan Giles and a team of over 1000 medical and school staff to complete this research

Why was Hepatitis so common at Willowbrook?

National Institutes of Health. (2009).

• Hepatitis is a disease that can easily be passed from one person to the next through contact with bodily fluids, especially blood transfer

• The cramped space and poor sanitation were most likely the biggest factors!

• High prevelence of hepatitis here made it a prime location for Krugman to set up his research

Robinson & Unruh, n.d.

References

The IRB

National Institutes of Health. (2009). Willowbrook Hepatitis Experiments. U.S. Department of Health and Human Services, Education Development Center, Inc. Exploring Bioethics. Retrieved from https://science.education.nih.gov/supplements/nih9/bioethics/guide/pdf/master_5-4.pdf

Robinson, W. M., & Unruh, B. T. (n.d.). The Hepatitis Experiments at the Willowbrook State School. A Selected History of Research with Humans. Retrieved from http://science.jburroughs.org/mbahe/BioEthics/Articles/WilliowbrookRobinson2008.pdf

Pecorino, P. A., (2002). Case: Willowbrook Experiments. Retrieved from http://www.qcc.cuny.edu/SocialSciences/ppecorino/MEDICAL_ETHICS_TEXT/Chapter_7_Human_Experimentation/Case_Study_Willowbrook_Experiments.htm

The Willowbrook Letters, (1971). The Lanclet. Retrieved from https://philosophy.tamucc.edu/readings/ethics/willowbrook-letters?destination=node%2F583

Fouka, G., & Mantzorou, M. (2001). What are the Major Ethical Issues in Conducting Research? Is there a Conflict between the Research Ethics and the Nature of Nursing? Health Science Journal. Vol. 5, Issue 1. Retrieved from http://www.hsj.gr/medicine/what-are-the-major-ethical-issues-in-conducting-research-is-there-a-conflict-between-the-research-ethics-and-the-nature-of-nursing.pdf

Bernstein, M. (n.d.) Human Subjects in Research (IRB: A Brief History). Written for Brandeis University, Retreived from http://www.brandeis.edu/ora/compliance/irb/101/history.html

Institutional Review Board

1974: National Research Act authored regulatory measures for all human experimentation, which gave rise to IRB development

Ethical Issues in Research Conduct

As in the Willowbrook Study, ethical issues can easily arise in research

The role of the IRB:

- regulate human experimental studies, protecting rights and welfare of the subjects involved.

- ensures that researchers do not step out of line, & provides an objective view to maintain order in the medical research field.

Bernstein, n.d.

Major ethical issues in medical research:

- True Informed Consent

- Beneficence (to promote the welfare of another)

- Confidentiality

- Vulnerable people groups

Rights and Welfare of the Children

Benefits of IRB to research today

The Willowbrook Experiments violated almost all of these. Because of this and many other unethical experiments, research has since developed a system of accountability.

*allows for great, safe strides in medical research.

*Researchers have the freedom to work within their parameters with *accountability and input

People can participate without the fear of being taken advantage of .

Were the Children's Rights Protected?

(Fouka & Mantzorou, 2001)

These children were used as guinea pigs for a disease experiment

There were claims that it was okay because they would've gotten the illness anyway - shouldn't they have been taken care of enough in the first place not to have had that risk? Why didn't the researchers see the problem of unsanitary conditions and try to help change it? Instead, they took advantage.

The children's basic human rights were not protected

The Willowbrook Letters, 1971.

These children were vulnerable. Their families were vulnerable.

There was no benefit that the research could have given to the children overall.

Using mentally disabled children for research is dehumanizing and is not in their best interests.

This research did not protect the wellbeing of the subjects - doing that would have involved creating better conditions for them to grow and thrive in without the threat of disease.

Willowbrook Study Risks and Informed Consent

Families were not told the whole truth regarding intentional injection for study, not just for immunization.

The school soon closed admissions to anyone not willing to have their child participate in the research. This left poorer families who couldn't afford better care with no options, and researchers knew it.

Even though the parents signed consent, the children were not aware of what was happening to them due to their conditions.

Informed Consent

• Parents were asked for permission
• Oral and written descriptions of the research was given to them
• The researchers collected signed consent statements from each family
• This all is moral, legal, and legitimate but.....

Risks

National Institutes of Health, 2009.

Hepatitis causes high fever, diarrhea, nausea, vomiting, abdominal pain, yellowing of the eyes and skin, and liver damage.

At the time of the study, this disease was still under research.

Because the risk of Hepatitis was so incredibly high at the school already, researchers did not consider the intentional distribution of the disease a risk.

Pecorino, 2002.

Robinson & Unruh, n.d.