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
In preparation of conducting your first clinical trial you’ve been doing a lot of reading on the subject of informed consent. What event initiated the modern informed consent process?
a) World War II and the Nuremberg Trials
b) Thalidomide disaster
c) Adoption of the National Research Act
d) Creation of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
You are enrolling a few Spanish-only speaking patients into a clinical trial for an antidiabetes drug. Regarding informed consent, which of the following is the best situation?
a) Do not enroll the Spanish-speaking patients into the trial
b) Give them the informed consent form to take home to someone who understands English
c) Have someone translate the informed consent form into Spanish and send it home with the patients to read over and sign
d) Have someone from the practice who speaks Spanish go over the informed consent form and the study with the patients
You decide to use the short consent form and explain the details of the study in person. You set up a meeting with the first potential subject. He comes to your office where you give him the informed consent form and explain the study. He seems to understand what is involved but you send him home to think about it anyway before he signs the form. What did you do wrong?
a) Nothing
b) You didn’t give him a preaddressed, stamped envelope in which to send the form back
c) You didn’t have a witness present
d) You didn’t give him the journal article about the phase 1 trial of the investigational compound
The informed consent form you were supplied from the study sponsor is 98 pages long. Is this okay?
a) Yes
b) No
You want to make sure that the person you just explained the study to understands what is involved. Which of the following is not a good question to ask?
a) Describe in your own words the purpose of the study?
b) Let me know what you think we are asking you to do?
c) Do you understand the study?
d) Can you describe the potential benefits and risks to you if you decide to participate?