CH 4: Cultural, Legal, and Ethical Considerations

Question 1

Any systemic erro in measurement process

Answer 1

Bias

Question 2

A type of warning that appears in a drugs prescribing information and is required by the FDA to alert prescribers of serious adverse events that have occurred with the given drug

Answer 2

Black box warning

Question 3

A research design in which the subjects are purposely unaware of whether the substance they are administered is the drug under study or a placebo. This method serves to minimize bias on the part of research subjects in reporting their body’s responses to investigational drugs

Answer 3

Blinded investigational drug study

Question 4

Any drugs listed on one of the “schedules” of the Controlled Substance Acts (scheduled drugs)

Answer 4

Controlled substances

Question 5

The customary beliefs, social forms, and material traits of a racial, religious, or social group

Answer 5

Culture

Question 6

A research design in which both the investigator(s) and the subjects are purposely unaware of whether the substance administered to a given subject is the drug under study or a placebo. This method minimizes bias on the part of both the investigator and the subject

Answer 6

Double-blind investigational drug study

Question 7

Variation in response to a drug because of patient’s age, gender, size, and/or body composition

Answer 7

Drug polymorphism

Question 8

The rules of conduct recognized in respect to a particular class or group of human actions

Answer 8

Ethics

Question 9

Relating to or characteristic of human group having racial, religion, language, and other traits in common

Answer 9

Ethnicity

Question 10

The study of the effect of ethnicity on drug responses, specifically drug absorption, metabolism, distribution, and excretion as well as the study of genetic variations to drugs (i.e., pharmacogenetics)

Answer 10

Ethnopharmacology

Question 11

Acceleration of the usual investigational new drug approval process by the FDA, usually for drugs used to treat life-threatening diseases

Answer 11

Expedited drug approval

Question 12

An act that protects health insurance coverage for workers and their families when they change jobs. It also protects patient information. If confidentiality of a patient is breathe, sever fines may be imposed

Answer 12

Health Insurance Portability and Accountability Act (HIPPA)

Question 13

Written permission obtained form a patient consenting to a specific procedure

Answer 13

Informed consent

Question 14

A drug not yet approved for marketing by the FDA but available for use in experiments to determine its safety and efficacy

Answer 14

Investigational new drug (IND)

Question 15

An application that must be submitted to the FDA before a drug an be studied in humans

Answer 15

Investigational new drug application

Question 16

Another name for prescription drugs

Answer 16

Legend drugs

Question 17

A special type of negligence or the failure of a professional and/or individual with specialized education and training to act in a reasonable and prudent way

Answer 17

Malpractice

Question 18

A legal term established under the Harrison Narcotic Act of 1914. The term is currently used in clinical setting to refer to any medically administered controlled substance and in legal settings to refer to any illicit or “street” drug: also referred to as opioid

Answer 18

Narcotic

Question 19

The failure to act in a reasonable and prudent manner or failure of the nurse to give the care that a reasonably prudent (cautious) nurse would render to use under similar circumstances

Answer 19

Negligence

Question 20

A special category of drugs that have been identified to help treat patients with rare diseases

Answer 20

Orphan drugs

Question 21

Drugs available to consumers without prescription

Answer 21

Over-the-counter drugs

Question 22

An inactive (inert) substance (i.e., saline, distilled water, starch, sugar) that is not a drug but is formulated resemble a drug for research

Answer 22

Placebo

Question 23

Descendants of a common ancestor; a tribe, family, or people believed to belong to the same linage

Answer 23

Race