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| § |
Obtain
and maintain up-to-date IRB approval
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| § |
Keep
adequate records of IRB related activities
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including
correspondence with the IRB
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Keep
adequate records on study and research
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activities,
including field staff, data managers,
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data analysts
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| § |
Record
keeping on study and research activities
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is
less burdensome, but not less important for
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minimal
risk protocols
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| § |
Absence
of a local IRB does not absolve
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investigators
of responsibility of obtaining
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outside
approval of their research
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