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Equitable subject selection - PowerPoint PPT Presentation

Getting to Yes* Helping to Get Your Protocol Approved Thomas Diflo, MD, FACS IRB Chairman

NYU School of Medicine HRPP PI Lecture Series. Getting to Yes* Helping to Get Your Protocol Approved Thomas Diflo, MD, FACS IRB Chairman. *With Thanks to Roger Fisher. The Old Days. The Old Days. IRB Chair. PI. Criteria for IRB Approval of Research.

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561 views • 45 slides

Criteria For Approval 45 CFR 46.111 25 CFR 56.111

Criteria For Approval 45 CFR 46.111 25 CFR 56.111. Minimized risks Reasonable risk/benefit ratio Equitable subject selection Informed consent process Informed consent documentation Data monitored for safety Confidentiality/privacy maintained Vulnerable populations protected.

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301 views • 15 slides

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Equitable subject selection - PowerPoint PPT Presentation

Getting to Yes* Helping to Get Your Protocol Approved Thomas Diflo, MD, FACS IRB Chairman

Criteria For Approval 45 CFR 46.111 25 CFR 56.111