| Real Impact |
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| • | Research
may be done if: |
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| – | No
PHI is needed |
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| – | A
limited data set is used (need data use agreement) |
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| – | Approval
(authorization) from patient to do prospective |
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| research |
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| – | May
do “preparatory research” w/o IRB approval |
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| – | “Waiver
of Consent” is needed in retrospective studies |
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| and
with a Limited Data Set |
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| • | All
patients need to sign additional paper for |
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| approval
of information for prospective research |
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