Ethics

Question 1

What is the role of the Institutional Review Board (IRB)?

Answer 1

Committee whose purpose is to review research proposals with an eye to scientific validity and subject protections

Question 2

What is the name of the document used to safeguard human research issued by the National Committee for the Protection of Human Subjects in 1978?

Answer 2

Belmont report

Question 3

Which of the following is NOT addressed in the Declaration of Helsinki?

a. Right to self determination
b. Respect for the individual
c. Right to make informed decisions (informed consent)
d. The experiment be based on previous knowledge justifying the experiment

Answer 3

d. The experiment be based on previous knowledge justifying the experiment

Question 4

What do phase I trials aim to define or determine?

Answer 4

Safety, toxic dose, absorption of drug

Question 5

The recruitment goal for a phase II trial is approximately how many participants?

Answer 5

30-120

Question 6

Randomized control trials are part of this trial phase.

Answer 6

Phase III

Question 7

(T or F) Generally, both parents need to give consent for a child to participate in a clinical trial for cancer research.

Answer 7

True