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." W...
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." - ANSWER "Participation may end at any
time without penalty."
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 - ANSWER autonomy
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 - ANSWER Beneficence
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 Justice
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 - ANSWER Phase I
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. The group that receives the intervention is the
a. control group.
b. experimental group.
c. dependent group.
d. independent group - ANSWER experimental group
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 - ANSWER Veracity
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 Subjects with the disease the drug will treat
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 - ANSWER Phase IV
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. - ANSWER receive the treatment being evaluated
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. - ANSWER Report this statement to the
party named on the consent
Which is the 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 effects of the placebo in human participants
d. A study to assess the seriousness of the disease to be treated - ANSWER A comparison of
experimental and control data in animals
, 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. - ANSWER were not tested on women, minorities, or
children.
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. - ANSWER Federal law requires
that drugs for children be tested on children
The nurse is preparing to administer a schedule II injectable drug and is drawing up half of the
contents of a single-use vial. Which nursing action is correct?
a. Ask another nurse to observe and cosign wasting the remaining drug from the vial.
b. Keep the remaining amount in the patient's drawer to give at the next dose.
c. Record the amount unused in the patient's medication record.
d. Dispose of the vial with the remaining drug into a locked collection box - ANSWER Ask another
nurse to observe and cosign wasting the remaining drug from the vial
A patient is prescribed a medication and asks the nurse if the drug is available in a generic form. The
nurse understands that a generic medication will have a name that
a. is a registered trademark.
b. is always capitalized.
c. is related to the drug's chemical structure.
d. is nonproprietary. - ANSWER is nonproprietary
A patient receives a prescription on which the provider has noted that a generic medication may be
given. The patient asks the nurse what this means. What will the nurse tell the patient about generic
drugs?
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