,Chapter 01: Drug Development and Ethical Considerations
McCuistion: Pharmacology: A Patient-Centered Nursing Process Approach, 9th Edition
MULTIPLE CHOICE
1. 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.”
ANS: B
All participants have the right to autonomy, which is the right to self-determination. Patients
have the right to refuse to participate or to withdraw from a study at any time without
penalty. Patients generally are not allowed to choose participation in either the treatment or
the control group.
DIF: Cognitive Level: Understanding (Comprehension) REF: p. 3
TOP: Nursing Process: Nursing Intervention
MSC: NCLEX: Management of Client Care
2. 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.
ANS: A
All participants have the right to autonomy, which is the right to self-determination. Patients
have the right to refuse to participate or to withdraw from a study at any time without
penalty even if the health care provider disagrees with that choice.
DIF: Cognitive Level: Understanding (Comprehension) REF: p. 3
TOP: Nursing Process: N/A MSC: NCLEX: Management of Client Care
3. 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
, ANS: A
Beneficence is the duty to do good and to not harm others. Once a serious adverse effect is
noted in a majority of subjects, researchers have an ethical obligation to stop the study.
DIF: Cognitive Level: Understanding (Comprehension) REF: p. 4
TOP: Nursing Process: N/A MSC: NCLEX: Management of Client Care
4. 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
ANS: B
The principle of justice requires that all people be treated fairly, including equal access to
health care for all. Once a benefit is demonstrated, it should be available to all participants.
DIF: Cognitive Level: Understanding (Comprehension) REF: p. 4
TOP: Nursing Process: N/A MSC: NCLEX: Management of Client Care
5. 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.
ANS: D
In a double-blind experimental study, subjects in the experimental group receive the
treatment or drug under study. They are randomly assigned and not selected. They should
have similar baseline characteristics to those in the control group. They do not receive a
placebo.
DIF: Cognitive Level: Understanding (Comprehension) REF: p. 6
TOP: Nursing Process: Nursing Intervention: Patient Teaching
MSC: NCLEX: Management of Client Care
6. 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.
ANS: C
, If a nurse suspects that a patient is being coerced to participate in the study, the nurse should
report this to the party named on the informed consent. When a patient verbalizes
participation based on a financial reward, there is an element of coercion.
DIF: Cognitive Level: Applying (Application) REF: p. 3
TOP: Nursing Process: Nursing Intervention
MSC: NCLEX: Management of Client Care
7. 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
ANS: A
Preclinical in vivo testing is performed in animals or other living organisms. In vitro studies
occur in test tubes. Safe therapeutic dose studies are part of clinical research. Prior to
clinical trials, an assessment is made of the disease and its seriousness.
DIF: Cognitive Level: Understanding (Comprehension) REF: p. 4
TOP: Nursing Process: N/A MSC: NCLEX: Management of Client Care
8. 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.
ANS: C
Drug research was historically done only with Caucasian males, causing uncertainty as to
the validity of the research results.
DIF: Cognitive Level: Understanding (Comprehension) REF: p. 4
TOP: Nursing Process: N/A MSC: NCLEX: Management of Client Care
9. 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
ANS: A
Phase I drug trials are performed to assess safety and to identify the pharmacokinetics, such
as metabolism and elimination, of drugs in healthy subjects.
DIF: Cognitive Level: Understanding (Comprehension) REF: p. 4
TOP: Nursing Process: N/A MSC: NCLEX: Management of Client Care
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