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TermsClinical Trial
FactsResearch Agencies Ethics Ethics
Applied
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IRBInstitutional Review Board
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If participants are unaware of whether they are in
experimental or control arms, then the study is _____
Blinded
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Principle of protecting the identity and medical
information of participants in a clinical trial
Confidentiality
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An inactive pill, powder or liquid that has no treatment value
Placebo
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Method based on chance by which a participant is selected
for one arm of the study or another.
Randomization
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Description of steps to be taken in a
study.
Protocol
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A statement which gives information about the study, its procedures, benefits, and
risks to a prospective subjects so they can make an informed decision about participation.
Consent form
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The factors that are considered to allow someone to
participate in a clinical trial
Inclusion criteria
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The safety factors that disallow someone from
participating in a particular clinical trial
Exclusion criteria
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The standard by which the experimental observations are
evaluated
Control or control group
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This is one of 8 health agencies of the Public Health
Service which is in turn part of the Department of Health and
Human Services and is comprised of 25 separate
Centers of Institutes
NIH
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The federal agency responsible for enforcing drug and food laws enacted by Congress regarding the research, manufacture, and
safety of drugs and foods
Food and Drug Administration (FDA)
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An office within the Department of Health and Human Services
responsible for developing, monitoring, and overseeing
protection of human research subjects
Office of Human Research Protection (OHRP)
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The group responsible for funding a clinical trial
Sponsor
(NIH, private foundations, pharmaceutical companies, etc.)
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A U.S. government agency responsible for protecting the
health of all Americans
Department of Health and Human Services
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A pivotal event in history which drew attention for the need to
have guidelines protecting humans in research.
WWII/ Nazi war crime trials
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You are required to participate in study about teachers in order
to graduate. What principle does this violate?
Autonomy
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This principle requires that research must do no harm while
maximizing benefits and minimizing risks
Beneficence
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The principle of ethics which charges us to treat all
participants fairly and equally is __________
Justice
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When outside interests unduly influence professional judgment
Conflict of interest
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The process in which persons decide to participate in a
research study
Informed consent process
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One of the most important components of making a sound
decision is having enough…
Information
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Every person must have this to ensure they understand what is
being asked of them
Comprehension
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The agreement to participate is valid only if the person feels this
condition is present in the process.
Voluntariness (Autonomy)
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The name of the report outlining these basic principles of the ethical conduct of clinical
research.
The Belmont Report