Deck 17: Biomedical Research on Humans

Question 1

Which of the following claims about the human subjects of the Tuskegee syphilis study is true? The subjects

A) Were infected with syphilis to test different methods of prophylaxis
B) Had syphilis when enrolled, but were not treated, even after the advent of penicillin
C) Had syphilis when enrolled and were treated when penicillin became available
D) None of the above

Answer 1

B

Question 2

The randomized clinical trial (RCT) dilemma facing biomedical research on human subjects is that

A) As medical professionals, they have duties of beneficence toward the subjects enrolled in an RCT
B) As researchers, they should allocate the RCT subjects at random regardless of possible health benefits for them
C) Both A and B
D) Neither A nor B

Answer 2

C

Question 3

Which of the following best expresses the reason for bringing Nazi doctors to trial in 1946 at the end of World War II? The defendants were accused of

A) Providing treatment only to German soldiers wounded in combat
B) Conspiring to defeat the Allied Powers
C) Performing unethical experiments on civilians and prisoners of war
D) All of the above

Answer 3

C

Question 4

During the so-called Doctors' Trial of 1946 at the end of World War II, it became evident that the prosecuted Nazi doctors have violated

A) The researchers' obligations of nonmaleficence
B) The researchers' obligations of beneficence
C) The researchers' obligation to obtain the subjects' informed consent
D) All of the above

Question 5

The Nuremberg Code regards obtaining the subjects' informed consent for biomedical research as

A) A non-negotiable condition under any circumstances
B) A condition negotiable in some circumstances
C) A condition that can be fulfilled by proxy consent
D) A condition that institutionalized people need not fulfill

Question 6

Which of the following captures a recommendation for researchers made by the Declaration of Helsinki?

A) To seek ethical oversight of biomedical trials on human subjects by institutional review boards
B) To obtain proxy consent for any experimental human subjects who cannot give informed consent
C) Both A and B
D) Neither A nor B

Question 7

Which of the following best captures the category of therapeutic research?

A) Any studies on human subjects that might benefit only individuals other than the research subjects
B) Any studies on human subjects that might benefit the research subjects
C) Any studies that fail to achieve the sought result
D) All of the above

Question 8

The Benefits Argument for biomedical research on human subjects invokes

A) Justice to people with untreatable diseases
B) Respect for the autonomy of research subjects
C) The greater balance of benefits over harm in biomedical research
D) None of the above

Question 9

An upshot of the controversy about the AZT trials in Africa was that investigators conducting a randomized clinical trial in developing countries need to consider which of the following?

A) Developing countries have specific ways to approach issues of individual and public health
B) Developing countries have scarce medical and financial resources
C) The global disease burden falls largely on developing countries
D) All of the above

Question 10

For the purpose of biomedical research, which of the following falls under the category 'vulnerable population'?

A) People who are susceptible to undue influence for enrolling in a biomedical study
B) People of low socioeconomic status and members of a racial or ethnic minority
C) People who are under-aged, mentally impaired, or institutionalized (in prisons, the army, nursing homes, etc.)
D) All of the above

Question 11

The AZT trials in sub-Saharan Africa have been compared morally with the Tuskegee syphilis study in the US. Why might such comparisons seem inevitable? In what ways might these trials seem alike? In what ways different? In the context of the moral controversy about the AZT trials in Sub-Saharan Africa, what did the labels 'ethical imperialism' and 'ethical relativism' mean?

Question 12

How might the Jesse Gelsinger case be brought to bear on the obligations of beneficence and nonmaleficence for medical researchers?

Question 13

Why do small children count as a vulnerable population for the purpose of biomedical research? Should proxy consent be sought in their case? If so, who should give it? If not, why not?

Question 14

According to critics of the researchers' actions in the Henrietta Lacks case, which ethical conditions for biomedical research using human biological materials were flouted? Provide at least one Kantian and one consequentialist condition relevant to the case and evaluate the response by the Benefits Argument.