Complete the post-test online at www.cmeuniversity.com. On the navigation menu, click on "Find Post-tests by Course" and search by project ID 4962. Upon registering and successfully completing the post-test with a score of 70% or better and the evaluation, your certificate will be made available immediately. At this time, you will also have the opportunity to download a pdf of the post-test answer rationales.
Quiz
Once the clinical trial is underway, as PI, what should be your most important ethical concern?
a) Maximizing the trial’s benefit to society
b) Honoring your commitment to the sponsor and IRB/REC by seeing the trial through to completion
c) Monitoring the efficacy of the investigational therapy
d) Protecting the research participants

You have delegated recruitment and enrollment for an upcoming clinical trial to your clinical trial coordinator. You should instruct her or him to do all but which of the following in reference to recruiting and enrolling potential participants?
a) Ensure that potential participants have an adequate understanding of the nature of the trial as well as clinical trials in general
b) Ensure that enrollment of potential participants is determined independently of whether the number of currently enrolled subjects is “behind” the enrollment target
c) Ensure that potential participants have heard of the pharmaceutical company that is sponsoring the trial
d) Ensure that the recruitment advertising is clear, truthful, and does not mislead or play too strongly upon potential participants’ hopes and fears

You are pondering acting as PI for a new study. When reviewing the study protocol, the principle of justice should lead you to consider all but which of the following:
a) Will the participants be compensated for research-related injuries?
b) Will the participants potentially benefit from their participation in the trial?
c) Will this research be valuable to society?
d) Will the participants’ care be as good as the care that you would expect for them to receive if they had chosen not to participate in the trial?

You decided to withdraw a participant from a clinical trial. Which of the following could have served as the basis for taking that action?
a) Respect for persons or non-malfeasance
b) Clinical equipoise or non-malfeasance
c) Compassionate use or non-malfeasance
d) Clinical equipoise or compassionate use

JoJune Pharmaceuticals has asked you to serve as PI for their study of a new oral calcium channel blocker. Which of the following should you be least concerned with?
a) None of your staff has ever been educated in the protection of research subjects or conducted a clinical trial
b) All of your staff is salaried
c) The protocol indicates that research participants will be paid an extra $1000 for completing the trial
d) The protocol indicates that there is a pretrial washout period of 6 months