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. The code came about as a 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

Name the 10 ethical principles for human experimentation as outlined in the Nuremberg code.

Answer 2

go!

Question 3

1 Voluntary consent is absolutely essential.

Answer 3

Yup! sign that consent form!

Question 4

2 The experiment should yield fruitful results for the good of society, unprocurable by other methods or means of study and not random and unnecessary in nature.

Answer 4

Study purpose and design is KEY

Question 5

3 The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problems under study that the anticipated results will justify the performance of the experiment.

Answer 5

Do no just to experimentation in humans as your first resource.

Question 6

4 The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.

Answer 6

Do no harm.

Question 7

5 No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; EXCEPT (what??) in experiments where the experimental physicians also serve as subjects.

Answer 7

That is CRAY.

Question 8

6 The degree of risk should never exceed that determined by the humanitarian importance of the problem to be solved by the experiement.

Answer 8

Do not design a study investigating the importance of orange juice in a diet where there’s a for potential amputation. duh.

Question 9

7 Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.

Answer 9

Do no harm (again).

Question 10

8 The experiment should be conducted only be scientifically qualified persons.

Answer 10

Don’t ask Ricky Bobby to design a study investigating the role of Nivolumab in combination with GemCis in MIBC.

Question 11

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 physical or mental state where continuation of the experiment seems to him to be impossible.

Answer 11

Research is completely voluntary.

Question 12

10 During the course of the experiment the scientists in charge must be prepared to terminate the experiment at any stage, if he has probably 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 12

Let’s say Geraldine has stable disease, but she is experiencing life threatening toxicities to the study drug – the scientist/doctor should terminate that subject’s participation in the study.

if this is common across subjects then the scientist/doctor should terminate the study altogether.

Question 13

What year was the Nurember written?

Answer 13

1947

Question 14

What are two other publicized examples of ethical abuses in research?

Answer 14

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

Question 15

What was the atrocity of the Willowbrook Studies?

Answer 15

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

Question 16

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

Answer 16

live cancer cells were injected into 22 cognitively impaired patients.

Question 17

When was the Tuskegee Syphillis Study?

Answer 17

1932-1972

Question 18

What was the problem with the Tuskegee Syphillis Study?

Answer 18

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

Question 19

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 19

The 1974 National Research Act.

Question 20

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

Answer 20

1) It esablished the “National Commission for the Protection of Human Subjects of Biomedical adn 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 establishedment of IRBs at organizations receiving Public Health Services support for human subjects research.

Question 21

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

Answer 21

The Belmont Report