The Nuremberg Code

Question 1

What is the Nuremberg Code?

Answer 1

It is a set of ten ethical principles for human experimentation developed in 1947. Result of trials held in Nuremberg, Germany at the end of WWII which involved medical professionals accused of murder and torture in the conduct of medical experiments on prisoners of concentration camps.

Question 2

Ethical Principle 1: _______ is absolutely essential.

Answer 2

Voluntary consent

Question 3

Ethical Principle #2: The experiment should yield fruitful results for the good of society, _______ and not ________

Answer 3

unprocurable by other methods or means of study

not random and unnecessary in nature.

Question 4

Ethical Principle #3: The experiment design should be based on the results of _______ and ________ or ______. Anticipated results will justify the performance of the experiment.

Answer 4

animal experimentation

a knowledge of the natural history of the disease

other problems under study

Question 5

Ethical Principle #4: Experiments should be conducted to void all _______ and _____ and ____

Answer 5

unnecessary physical
mental suffering
injury.

Question 6

Ethical Principle #5: No experiment should be conducted where there is a reason to believe that death or disabling injury will occur; EXCEPT _____

Answer 6

in experiments where the experimental physicians also serve as subjects.

Question 7

Ethical Principle #6: __________ never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.

Answer 7

the degree of risk

Question 8

Ethical Principle #7: Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of ____, ____, or ____.

Answer 8

injury, disability, or death.

Question 9

Ethical Principle #8: The experiment should be conducted only by _______

Answer 9

scientifically qualified persons.

Question 10

Ethical Principle #9: During the course of the experiment the human subject should be at liberty to bring the experiment to an end if it has reached the ______ or _____ where continuation of the experiment seems to him to be impossible.

Answer 10

physical
mental state

Question 11

Ethical Principle #10: During the course of the experiment the scientists in charge must be prepared to _______, if he has probable cause to believe in the exercise of the good faith, superior skill and careful judgement required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

Answer 11

terminate the experiment at any stage

Question 12

What year was the Nuremberg code written?

Answer 12

1947

Question 13

What are two publicized examples of ethical abuses in research?

Answer 13

Willowbrook studies (1956-1970) & Jewish Chronic Disease Hospital Study (1963).

Question 14

What was the atrocity of the Willowbrook Studies?

Answer 14

Children with intellectual disabilities were deliberately infected with the hepatitis virus.

Question 15

What was the atrocity of the Jewish Chronic Disease Hospital Study?

Answer 15

live cancer cells were injected into 22 cognitively impaired patients.

Question 16

When was the Tuskegee Syphillis Study?

Answer 16

1932-1972

Question 17

What was the problem with the Tuskegee Syphillis Study?

Answer 17

Black American men were unknowing subjects in the study; they were not told that they had syphillis, nor were they offered effective treatment when it became available in the late 1940s (penicillin)

Question 18

In response to the public concern about the ethics of the Tuskegee Syphillis Study, prisoner research, Willowbrook, and other abuses hearings on “Quality of health Care– Human Experimentation” were held before the Subcommittee on health of the US Senate Committee on Labor and Public Welfare (commonly referred to as the “Kennedy Hearings”) in 1973. What act was passed because of these hearings?

Answer 18

The 1974 National Research Act.

Question 19

What are the two major provisions of the National Research Act relevant to human subjects research?

Answer 19

1) It esablished the “National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research” to identify the basic ethical principles underlying human subjects research and develop guidelines for ensuring that human subjects research is conducted according to those guidelines.
2) It required the establishment of IRBs at organizations receiving Public Health Services support for human subjects research.

Question 20

The National Commission met from 1975-1978 and issued a series of reports on vulnerable populations, psychosurgery, IRBs, and other topics that included recommendations for regulating human subjects research. A final report was published in 1979 and is commonly referred to as?

Answer 20

The Belmont Report

Question 21

What are the 10 principles established with the Nuremberg Code?

Answer 21

Voluntary consent
Yield results for the good of society
Design based on animal experiments
Avoid unnecessary suffering and injury
No experiment conducted if death/disabling injury will occur
Benefits outweigh risks
Proper facilities / preparation of site
Qualified persons performing study
Subject can withdraw at any time
Investigator can terminate study at any time