Chapter 01: Drug Development and Ethical Considerations

Chapter 01: Drug Development and Ethical Considerations

 

Complete Chapter Questions With Answers

 

Sample Questions Are Posted Below

 

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