Author Question: Which criterion would be most likely to eliminate a client from providing informed consent? a. ... (Read 35 times)

karlynnae · **on:** Jul 23, 2018

Which criterion would be most likely to eliminate a client from providing informed consent?

a. Client cannot state the correct ratio of benefits to risks of the drug.
b. Client states the compensation that will occur if injury results.
c. Client can state the name and only a partial phone number for the contact person.
d. Client writes consent clearly and understands at the eighth-grade reading level.

Question 2

A nurse is participating in clinical trials for a medication. The nurse is told that this study is known as a phase IV trial. A patient asks the nurse what a phase IV trial entails, and the nurse responds that it is testing a medication for:

a. identification of the pharmacokinetics of the drug.
b. safety of the drug for clients who have the disease it treats.
c. human dosage range based on the response from healthy human subjects.
d. safety of the drug for a wide client population.

spencer.martell · **Reply #1 on:** Jul 23, 2018

Answer to Question 1

ANS: D
The client must be able to write consent and understand at the tenth-grade reading level.

Answer to Question 2

ANS: D
The objectives of phases III and IV are to demonstrate the safety and efficacy of the drug for a wide client population and to include long-term data if a chronic regimen is under consideration. Phase IV studies may also examine potential new indications for approved drugs.