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23 Cards in this Set
- Front
- Back
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A control group receiving a different drug
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Active control
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The right of self-determination. The client’s right to make his or her own health care decisions
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Autonomy
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In research, the duty not to harm others, to maximize possible benefits, and to minimize harm that might occur
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Beneficence
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Do not receive the experimental intervention or treatment and provide a baseline against which to measure the effects of the treatment
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control group
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– Ethical principles for medical research involving human subjects created by the World Medical Association
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Declaration of Helsinki
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neither the health care provider nor the subject knows whether the subject is receiving the experimental or control form of therapy
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double blind
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group that receives the experimental treatments
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experimental group
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increased the minimum age for subjects of human clinical experimentation
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FDA Modernization Act of 1997
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– an international ethical and scientific standard for design, conduct, performance, monitoring, auditing, recording analysis, and reporting clinical trials
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Good Clinical Practice (GCP): Consolidated Guideline
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has dimensions beyond protection of the individual client’s choice and includes:
1.Promotion of individual autonomy 2.Protection of clients and subjects from harm 3.Avoidance of fraud and duress in health care 4.Encouragement for professionals to be thorough and clear in communicating information 5.Promotion of educated decision making among clients 6.Promotion of self - determination of the client |
informed consent
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– Indicates that all parties-data collectors, prescribing health care provider, and subject – know the treatment group assignment
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open label study
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pharmacologically inert substance
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placebo
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Passed by Congress in 1992 to expedite the FDA review process by providing funds
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Prescription Drug User Fee Act
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Only the subjects are unaware of which group to which they are assigned
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single blind
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A researcher other than the health care provider collects data and is also unaware of the subject’s treatment group
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triple blind
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Truly Voluntary
Vaild Risks Justified Disability will be avoided Professional Conduct Subject may terminate at any time |
Nuremberg Code
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Phase 1 Small Number of Health Volunteers
Phase II - Clinical Trials Phase III Several sites with large number of clients |
Phases of drug development
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no risk in first trimester
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Category A Drugs
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animal studies indicate no risk
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Category B Drugs
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Animal studies indicate adverse effects
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Category C Drugs
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Positive human fetal risk
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Category D Drugs
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Fetal abnormalities reported
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Category X Drugs
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is an agent which can cause a birth defect
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teratogen
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