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Policies & Procedures - Emory IRB - Emory University

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<strong>Emory</strong> <strong>University</strong> <strong>IRB</strong> P&Ps Revised 1/18/2013<br />

The Human Subjects Research uses any non-public Individually Identifiable Private<br />

Information or Protected Health Information (PHI) maintained by <strong>Emory</strong> <strong>University</strong>, or<br />

any of the components covered under the <strong>Emory</strong> FWA, to identify or contact Human<br />

Subjects;<br />

The Human Subjects Research is conducted by a person who, or entity that, has entered<br />

into an agreement with <strong>Emory</strong> <strong>University</strong> per which the <strong>Emory</strong> <strong>IRB</strong> is designated under<br />

the <strong>Emory</strong> FWA as the reviewing <strong>IRB</strong> for the Human Subjects Research.<br />

Applicable Regulations:<br />

45 CFR Part 46, including 45 CFR §§ 46.103(b)(1)-(2); 46.109; 46.111; & 46.112.<br />

21 CFR Parts 50 and 56, including 21 CFR §§ 56.109 & 56.112.<br />

38 CFR Part 16, including 38 CFR §§ 16.103(b)(1) – (2); 16.109; 16.111; & 16.112.<br />

Page 36 of 370

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