Deck 14: The Role of the Nurse in Drug Research

Question 1

A powerful tool in which neither subject or healthcare provider knows to which group the individual is assigned is known as a(n) _____ study.

A) double-blind
B) open-label
C) crossover
D) single-blind

Answer 1

double-blind

Question 2

The nurse is assisting with a research project and is told that only the research subjects themselves are unaware of the groups to which they are assigned. The nurse recognizes that this study will be designed as a(n) _____ study.

A) open-label
B) triple-blind
C) single-blind
D) double-blind

Answer 2

single-blind

Question 3

A nurse researcher is designing an experiment. The nurse is aware that participants in the experimental group serve what function?

A) They receive a placebo.
B) They receive the treatment.
C) They provide a baseline for data measurement.
D) None of the above are true.

Answer 3

They receive the treatment.

Question 4

A nurse is assisting in drug trials that have reached the stage in which potential new indications for approved drugs are investigated. The nurse is aware that this phase is known as phase:

A) I.
B) II.
C) III.
D) IV.

Question 5

The role of the nurse in clinical drug trials is best described as:

A) obtaining informed consent from subjects.
B) explaining all aspects of the study to subjects.
C) ensuring the protection of the subjects' rights.
D) answering all client questions related to the study.

Question 6

Which characteristic of a research study represents a threat to veracity?

A) Deceiving a client as to the nature of the study
B) Providing a treatment to one client that is not provided to another
C) Not allowing the client to receive informed consent to a study
D) Allowing a client to participate in a study without knowledge of the risks

Question 7

According to the FDA Modernization Act of 1997, which statement is true regarding drug experimentation with children?

A) Medications tested on adults are safe for children.
B) Medications should not be tested on children.
C) Medications intended for children require research with children as subjects.
D) Children cannot be participants in drug evaluation studies.

Question 8

Clinical experimentation occurs in four stages. The determination of the human dosage range based on responses in healthy subjects is a goal of phase _____ of human clinical experimentation.

A) I
B) II
C) III
D) IV

Question 9

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 10

The nurse who is assisting with a research project is told that each research subject will be used in several different situations. This indicates to the nurse that the research design that is most likely to be used is a _____ design.

A) matched pair
B) crossover
C) double-blind
D) quasi-experimental

Question 11

A study design in which it is difficult to control variables that may influence results is called a(n) _____ design.

A) descriptive
B) quasi-experimental
C) experimental
D) retrospective

Question 12

A nurse designs a study that investigates the effectiveness of a medication in treating menstrual cramps. Which would best represent the inclusion criteria for this study?

A) Adolescent females
B) Women of childbearing age
C) Women of African-American race
D) Women of any age

Question 13

To generalize results from drug studies to a larger population, the nurse researcher employs which strategy?

A) Pure experimentation
B) Placebo treatment
C) Open-label study
D) Probability sampling

Question 14

A client tells a nurse that she wishes to withdraw from a research study. The nurse will:

A) allow the client to withdraw.
B) encourage the client to stay in the study.
C) inform the client that withdrawing is discouraged.
D) reinforce to the client that alternative treatments are substandard.

Question 15

A nurse is asked to provide a placebo to a client who is in pain. Which nursing action is appropriate?

A) Administer the medication, not disclosing its nature.
B) Administer the medication, disclosing to the client that the drug is a placebo.
C) Administer the placebo with another analgesic.
D) Refuse to administer the placebo.

Question 16

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.

Question 17

The following steps represent the basic sequence of new drug development. Place the steps in correct chronological order.
1. Preclinical testing
2. Phase III and phase IV human clinical experiments
3. Phase II human clinical experiments
4. Study design of human clinical experiments
5. Phase I human clinical experiments
6. Identify potential chemical for medication