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
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
