Pharmacology Chapter 13

Front 1

Active Control

Back 1

A control group receiving a different drug.

Front 2

Autonomy

Back 2

The right of self-determination

Front 3

Beneficence

Back 3

The duty to not harm others, to maximize possible benefits, and to minimize possible harm that might occur in research.

Front 4

Control Group

Back 4

Participants who do not receive the experimental intervention or treatment and provide a baseline against which to measure the effects of the treatment.

Front 5

Declaration of Helsinki

Back 5

Determines ethical principles for medical research involving human subjects.

Front 6

Double-blind

Back 6

Technique wherein neither the health care provider nor the subject knows whether the subject is receiving the experimental or control form of therapy.

Front 7

Experimental Group

Back 7

Participants who receive the experimental intervention or treatment.

Front 8

FDA Modernization Act of 1997

Back 8

Increases the minimum age for subjects of human clinical experimentations.

Front 9

Good Clinical Practice (GCP)

Back 9

Consolidated Guideline: An international, ethical, and scientific standard for design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials; is the foundation of clinical trials.

Front 10

Informed Consent

Back 10

Designed to protect the individual client’s choice, promote individual autonomy, protect clients and subjects from harm, avoid fraud and duress in health care, encourage professionals to be thorough and clear in communicating information, promote educated decision-making among clients, and promote self-determination of the client.

Front 11

Open-Label Study

Back 11

All parties - data collectors, prescribing health care provider, and subject – know the treatment group assignment

Front 12

Placebo

Back 12

A pharmacologically inert substance.

Front 13

Prescription Drug User Fee Act

Back 13

An act that provided the Food and Drug administration with funds to expedite the drug review process, decreasing the average drug approval time from 30-12 months.

Front 14

Single-blind

Back 14

Only the subject is unaware of the group to which he or she is assigned.

Front 15

Triple-blind

Back 15

A researcher other than the prescribing health care provider collects data and is unaware of the subject’s treatment group.