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$100 $200 $400 $500 $300 $100 $200 $400 $500 $300 $100 $200 $400 $500 $300 $100 $200 $400 $500 $300 $100 $200 $400 $500 $300 Terms Clinical Trial Facts Research Agencies Ethics Ethics Applied

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Page 1: $100 $200 $400 $500 $300 $100 $200 $400 $500 $300 $100 $200 $400 $500 $300 $100 $200 $400 $500 $300 $100 $200 $400 $500 $300 Terms Clinical Trial Facts

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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