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Until the middle of this century, concerns about the ethics of the practice of m

ID: 3521945 • Letter: U

Question

Until the middle of this century, concerns about the ethics of the practice of medicine centered on therapeutic medicine, not research medicine. National and international efforts to protect the rights and welfare of human subjects of research have occurred often in response to ethical violations -- situations in which researchers were found to have ignored the fundamental rights of human subjects. The Nazi Party in Germany committed egregious acts in the name of science that shocked the world community (Institutional Review Board (IRB) Training for Research Involving Human Subjects). As a result of this and other unethical studies, the Belmont Report, The Nuremberg Code and the Declaration of Helsinki were written and enacted to protect the rights of human subjects in scientific research. Furthermore, the federal government established ethical guidelines to be followed when conducting research. These guidelines have been adopted and expanded by the American Sociological Association.

You may select one of the studies listed below or identify a study which violated ethical guidelines and provide information on the study, the ethical violations the study committed and the impact of the study on the scientific community’s integrity with the public.

The Willowbrook Study

The Tuskegee Syphilis Study

The Nazi Medical Experiments

Jewish Chronic Diseases Hospital Study

Radiation Tests on Mentally Impaired Boys (Harvard University and MIT)

In this assignment, you are looking at the ramifications of unethical research involving human subjects by answering the following questions as they relate to your selected study.

Specifically, what was the study about? (Who, what, when and where)

What right did the researcher(s) have/ use to expose subjects to such stress?

Why was this group considered to be vulnerable and in need of protection?

Which ethical guideline do you believe was violated?

Despite the controversy, did the search for knowledge justify such "costs" to subjects?

Explanation / Answer

Willowbrook Study:

What was the study about?

In this study, mentally retarted children of Willowbrook State School in Staten Island, New York city were infected with Hepatitis to understand the development of the viral infection. The experimentation took place in 1956-1970 for 14 years. Usage of gamma globulin injections and their effectiveness against the hepatitis infection was also studied during this study.

What right did the researchers used to expose subjects to such stress?

The researchers carried down the experimentation in a pretext that if there high risk of infection in the institution it is obvious that the children will be infected and the purpose of the study was to eradicate such a future situation (even though there is no indication of infection in the children).

Why was this group considered to be vulnerable and in need of protection?

This group of children as they are mentally retarded and housed at a school were the disease spread was high, the researchers considered that they are more vulnerable group. Other reasons the researchers claimed were they do not interfere with the informed consent and the non therapeutic nature of their experiment made them select this group of children. Since, the children were incapable of meeting their personal needs, chances of malnutrition and improper care are high in this group made the researchers think that this group is more vulnerable and need more protection.

Following Ethical guidelines are violated:

i. Crossing moral principles and performing an experiment on mentally retarded children which is not having any benefit to the child near or future health

ii. Using institutionalized children for experimentation purpose.

iii. Instead of improving the condition of the instituition, taking the failure of the institution for the experimental advantage is a moral violation as it is the violation of principles of duty.

iv. Eventhough there is a informed consent, the experimentation violated the legal principles as it should not be done unless it has some benefit for the child.

v. Manipulating and forcing the parents to have admission into institution only through hepatitis unit channel is another potential violation.

vi. Violation of patient's rights which will supercede any other consideration like benefit to humanity is also unethical.

Justification despite the controversy:

Active immunization of the children is the only benefit to justify the 'costs' to the subjects eventhough it is not the intention of the experiment and is merely an expected consequence.

The defense of the researchers is that the subjects are anyways exposed to same strains of hepatitis even if it is not infected, and they are better handled with lower complications, benefit from immunization and little danger of exposure to other diseases. All of this does not justify the moral purpose of the experiment and the experimentation remained as a violation of the medical ethics.

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