Which of the following is a component of the communications strategy message to
stakeholder
- CORRECT ANSWER: Current research at your HCMO
Minors may be enrolled as experimental subjects when which of the following conditions is
met
- CORRECT ANSWER: A legally authorized representative has authorized, in advance,
for the minor to participate
As the principal investigator, you are in charge of selecting and appointing a medical
monitor for the clinical investigation program. Of the following, who would be the best
person for the job
- CORRECT ANSWER: A nurse who has experience in areas of patient management and
safety
Which of the following is a guideline in human subject research
- CORRECT ANSWER: Preparations must be made for possible adverse events
Who is responsible for writing the clinical investigation research protocol
- CORRECT ANSWER: Principal investigator
The appropriate name of the oversight committee concerned with clinical investigations in
the Air Force
- CORRECT ANSWER: IRB
Adverse event should be reported to the IRB, IRO, or HUC within
- CORRECT ANSWER: 72 hours
Which of the following is a recommended component of a clinical investigation protocol
- CORRECT ANSWER: Investigators
Informed consent is rooted in which one of the following ethical principles
- CORRECT ANSWER: Respect for autonomy
Maxim, primum non nocere, is most closely associated with which ethical principle
- CORRECT ANSWER: Non-maleficence
What is the most critical aspect of carrying out a CI
- CORRECT ANSWER: Informed consent