Deck 10: The Role of the Nurse in Drug Research

Question 1

The nurse is participating in a clinical drug trial comparing two drugs for migraine headaches.Each group is randomly assigned to either drug A or drug B and then switched to the other drug group before being asked to compare the effects.This is an example of which type of study?

A)Crossover design
B)Double-blind experimental design
C)Matched pair design
D)Quasi-experimental design

Answer 1

Crossover design

Question 2

In a 5-year experimental clinical trial to investigate a new cancer treatment,researchers in the second year note overwhelming improvement in almost all of the subjects in the treatment group.The lead researcher elects to continue the study.Which ethical principle is being violated?

A)Beneficence
B)Justice
C)Respect for persons
D)Veracity

Answer 2

Justice

Question 3

A clinical drug trial is concluding a study of pharmacokinetics and safety of a drug in healthy individuals.The nurse will assist enrollment of participants into the next phase of the study and will include which subjects?

A)Healthy subjects
B)Healthy and ill subjects
C)Subjects with the disease the drug will treat
D)Subjects with other diseases

Answer 3

Subjects with the disease the drug will treat

Question 4

The nurse is obtaining signatures on consent forms for participation in a clinical drug trial.One patient says,"I'm not sure I want to do this,but I need the cash." The nurse will take which action?

A)Ask the patient to clarify concerns.
B)Reinforce that cash is given to all subjects equally.
C)Report this statement to the party named on the consent.
D)Review the elements of the study and obtain consent.

Question 5

Which statement about the safety and efficacy of medications in children is accurate?

A)Children cannot give consent,so clinical drug trials are not performed on children.
B)Children can only be subjects in quasi-experimental clinical studies.
C)Data from adult clinical drug trials can be extrapolated to children.
D)Federal law requires that drugs for children be tested on children.

Question 6

The nurse is assisting with a clinical drug trial to test the safe dose of an analgesic medication and learns that subjects have been told that the study is about measuring the analgesic effects.Which ethical principle has been violated?

A)Beneficence
B)Justice
C)Respect for persons
D)Veracity

Question 7

The nurse is participating in a clinical study of the effects of teaching on drug compliance.The subjects are randomly assigned to either an experimental group or a control group.Health professionals deliver one of two teaching modules to each patient.This is an example of which kind of study?

A)Double-blind
B)Open-label
C)Single-blind
D)Triple-blind

Question 8

Before marketing a new drug that has been approved for use based on clinical effectiveness and safety,the manufacturer wishes to study the potential new uses for the drug.This is an example of which phase of study?

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

Question 9

The nurse is assisting with a clinical drug trial in which the side effects of two effective drugs are being compared.A patient who would benefit from either drug has elected to withdraw from the study,and the nurse assists with the paperwork to facilitate this.This is an example of

A)autonomy.
B)beneficence.
C)justice.
D)veracity.

Question 10

The nurse is obtaining consent from a subject newly recruited for a clinical drug trial that will last for 6 months.All subjects will be given gift certificates for participating.One subject says,"Well,I guess if the drug doesn't work,I'll just have to put up with the symptoms for 6 months." What will the nurse tell the subject?

A)"Participation for the duration of the study is required."
B)"Participation may end at any time without penalty."
C)"Withdrawal from the study may end at any time,but the gift certificate will not be given."
D)"You can request placement in the treatment group."

Question 11

Which is characteristic of preclinical in vivo testing?

A)A comparison of experimental and control data in animals
B)A study conducted in a test tube in a laboratory
C)A study that determines the parameters of safe therapeutic doses
D)A study to assess the seriousness of the disease to be treated

Question 12

The nurse is enrolling subjects for a double-blind experimental study.One patient asks the nurse to explain the role of the experimental group.The nurse will explain that subjects in the experimental group in this type of study

A)are selected for participation in that group.
B)have unique baseline characteristics.
C)receive a placebo.
D)receive the treatment being evaluated.

Question 13

During a clinical drug trial for a new medication,researchers note a previously unknown serious adverse effect occurring in more than 50% of subjects.The study is discontinued.Which ethical principle is being exercised?

A)Beneficence
B)Justice
C)Respect for persons
D)Veracity

Question 14

Many drugs marketed in the 1980s may not be effective in a majority of the population.The nurse understands that this is because these drugs

A)did not pass through the appropriate phases of clinical trials.
B)did not require human subject protections and are invalid.
C)were not tested on women,minorities,or children.
D)were tested on healthy subjects only.

Question 15

The nurse is enrolling subjects for a clinical drug trial in which subjects will be randomly assigned to either a treatment or a placebo group.The pills in both groups will be in identical packaging with identical appearance.This is an example of which type of study?

A)Crossover
B)Double-blind
C)Open-label
D)Single-blind

Question 16

The nurse is assisting with data collection in a study of drug effects in healthy subjects.The nurse assists with blood and urine collection to determine serum drug levels and the presence of metabolites in the urine.Which phase of a drug study does this represent?

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