| Purpose and Responsibilities of the IRB |
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| § | Represent
the best interests of the patients or healthy |
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| volunteers
who serve as research subjects |
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| § | The
responsibilities of the IRB include: |
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| · | Review
research and evaluate potential benefits and |
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| risks to
participants |
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| · | Ensure
that the rights and welfare of subjects are |
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| safeguarded,
including the fairness of selection |
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| procedures
and proper management during the |
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| conduct
of the study |
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| · | Ensure
that all appropriate steps needed for true |
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| informed
consent are planned and carried out |
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| Content
modified from the Columbia University GCP Training Course 2001 |