Chapter 03: Legal and Ethical Considerations
MULTIPLE CHOICE
1. In the development of a new drug by a pharmaceutical company, the researcher must ensure that
the participants in experimental drug studies do not have unrealistic expectations of the new drug’s
usefulness. What will the researcher include in the design of the study to prevent bias that may occur?
a. A placebo
b. Health Canada approval
c. Informed consent
d. Efficacy information
ANS: A
To prevent bias that may occur as a result of unrealistic expectations of an investigational new drug, a
placebo will be incorporated into the study. Health Canada approval, if given, does not be obtained until
after phase III of the study. Informed consent is required in all drug studies. Efficacy information is not
determined until the study is under way.
DIF: Cognitive Level: Comprehension
2. A member of an investigational drug study team is working with healthy volunteers whose
participation will help determine the optimal dosage range and pharmacokinetics of the drug. In what
type of study is the team member participating?
a. Phase I
b. Phase II c. Phase III d. Phase IV
ANS: A
Phase I studies involve small numbers of healthy volunteers to determine the optimal dosage range and
the pharmacokinetics of the drug. Phases II, III, and IV involve progressively larger numbers of
volunteers who have the disease or ailment that the drug is designed to diagnose or treat.
DIF: Cognitive Level: Application
3. A patient has a prescription for a drug classified as Schedule F. What important information should
the nurse give this patient about obtaining refills for this medication?
, a. No prescription refills are permitted.
b. Refills may be obtained via telephone order.
c. Refills are indicated by the prescriber.
d. The patient may have no more than six refills in a 12-month period.
ANS: C
Schedule F contains a list of drugs that can be sold and refilled only on prescription; prescriptions can be
refilled as often as indicated by the prescriber.
DIF: Cognitive Level: Analysis
4. A patient has been chosen to be a recipient of an investigational drug for heart failure and has given
informed consent. Which is indicated by the patient’s informed consent?
a. The patient has been informed of the possible benefits of the new therapy.
b. The patient will be informed of the details of the study as the research continues.
c. The patient will not be assured of receiving the actual drug during the experiment.
d. The patient has received an explanation of the study’s purpose, procedures, and the benefits
and risks involved.
ANS: D
Informed consent involves the careful explanation of the purpose of the study, procedures to be used,
and the possible benefits and risks involved. Being informed of the possible benefits of the new therapy,
being informed of the study details as research continues, and being assured of receiving the actual drug
during the experiment do not describe informed consent.
DIF: Cognitive Level: Comprehension
5. Which is the most significant part of legislation in regard to professional nursing practice?
a. Canada Health Act
b. Nursing Practice Act
c. Controlled Drugs and Substances Act
d. Personal Information Protection and Electronic Documents Act
ANS: B
Nurse practice acts (NPAs) are regulatory laws that are instrumental in defining the scope of nursing
practice and that protect public health, safety, and welfare. Nursing practice in Canada is regulated by
separate acts in each of the 10 provinces and 3 territories. These acts grant self-governance to the
nursing profession, direct entry into nursing practice, define the scopes of practice, and identify
disciplinary actions. NPAs are the most significant part of legislation in regard to professional nursing
practice.
DIF: Cognitive Level: Comprehension
MULTIPLE CHOICE
1. In the development of a new drug by a pharmaceutical company, the researcher must ensure that
the participants in experimental drug studies do not have unrealistic expectations of the new drug’s
usefulness. What will the researcher include in the design of the study to prevent bias that may occur?
a. A placebo
b. Health Canada approval
c. Informed consent
d. Efficacy information
ANS: A
To prevent bias that may occur as a result of unrealistic expectations of an investigational new drug, a
placebo will be incorporated into the study. Health Canada approval, if given, does not be obtained until
after phase III of the study. Informed consent is required in all drug studies. Efficacy information is not
determined until the study is under way.
DIF: Cognitive Level: Comprehension
2. A member of an investigational drug study team is working with healthy volunteers whose
participation will help determine the optimal dosage range and pharmacokinetics of the drug. In what
type of study is the team member participating?
a. Phase I
b. Phase II c. Phase III d. Phase IV
ANS: A
Phase I studies involve small numbers of healthy volunteers to determine the optimal dosage range and
the pharmacokinetics of the drug. Phases II, III, and IV involve progressively larger numbers of
volunteers who have the disease or ailment that the drug is designed to diagnose or treat.
DIF: Cognitive Level: Application
3. A patient has a prescription for a drug classified as Schedule F. What important information should
the nurse give this patient about obtaining refills for this medication?
, a. No prescription refills are permitted.
b. Refills may be obtained via telephone order.
c. Refills are indicated by the prescriber.
d. The patient may have no more than six refills in a 12-month period.
ANS: C
Schedule F contains a list of drugs that can be sold and refilled only on prescription; prescriptions can be
refilled as often as indicated by the prescriber.
DIF: Cognitive Level: Analysis
4. A patient has been chosen to be a recipient of an investigational drug for heart failure and has given
informed consent. Which is indicated by the patient’s informed consent?
a. The patient has been informed of the possible benefits of the new therapy.
b. The patient will be informed of the details of the study as the research continues.
c. The patient will not be assured of receiving the actual drug during the experiment.
d. The patient has received an explanation of the study’s purpose, procedures, and the benefits
and risks involved.
ANS: D
Informed consent involves the careful explanation of the purpose of the study, procedures to be used,
and the possible benefits and risks involved. Being informed of the possible benefits of the new therapy,
being informed of the study details as research continues, and being assured of receiving the actual drug
during the experiment do not describe informed consent.
DIF: Cognitive Level: Comprehension
5. Which is the most significant part of legislation in regard to professional nursing practice?
a. Canada Health Act
b. Nursing Practice Act
c. Controlled Drugs and Substances Act
d. Personal Information Protection and Electronic Documents Act
ANS: B
Nurse practice acts (NPAs) are regulatory laws that are instrumental in defining the scope of nursing
practice and that protect public health, safety, and welfare. Nursing practice in Canada is regulated by
separate acts in each of the 10 provinces and 3 territories. These acts grant self-governance to the
nursing profession, direct entry into nursing practice, define the scopes of practice, and identify
disciplinary actions. NPAs are the most significant part of legislation in regard to professional nursing
practice.
DIF: Cognitive Level: Comprehension
