Policies & Procedures - Emory IRB - Emory University

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Emory University IRB P&Ps Revised 1/18/2013 21 CFR Parts 50 and 56, including 21 CFR §§ 56.109 & 56.112. 38 CFR Part 16, including 38 CFR §§ 16.103(b)(1) – (2); 16.109; 16.111; & 16.112 32 CFR Part 219; DOD Addendum. Page 34 of 370
Emory University IRB P&Ps Revised 1/18/2013 POLICY: 12 JURISDICTION OF THE EMORY IRB With the exception of non-Human Subjects Research and non-Clinical Investigations, the Emory IRB has jurisdiction over all Human Subjects Research (whether funded or not funded), that is conducted at Emory University; that is conducted at locations other than Emory University by Emory University faculty, staff and students, or that it assumes jurisdiction over per written agreement; or that uses any non-public Individually Identifiable Private Information or Protected Health Information (PHI) maintained by Emory University, or any of the components covered under the Emory FWA, to identify or contact Human Subjects. Within its jurisdiction the Emory IRB is responsible for initial and continuing review and oversight of any Human Subjects Research, Clinical Investigations. For Research subject to a DOD Addendum, its jurisdiction includes Research Involving a Human Being as an Experimental Subject. PROCEDURES: Scope of Emory IRB Jurisdiction: With the exception of non-Human Subjects Research and non- Clinical Investigations, the Emory IRB has jurisdiction over all Human Subjects Research (whether funded or not funded), that is conducted at Emory University; that is conducted at locations other than Emory University by Emory University faculty, staff and students, or that it assumes jurisdiction over per written agreement; or that uses any non-public Individually Identifiable Private Information or Protected Health Information (PHI) maintained by Emory University, or any of the components covered under the Emory FWA, to identify or contact Human Subjects. The Emory IRB’s jurisdiction also extends to other entities or individuals who enter into agreements with the Emory IRB per which these entities or individuals subject their Research to Emory IRB review. Accordingly, Emory IRB review is required when: The Human Subjects Research is conducted by Emory University or any of the components covered by the Emory FWA. The Human Subjects Research is conducted by or under the direction or supervision of Emory University or of any employee, faculty member, staff member, student or agent of Emory University, or of any of the components covered under the Emory FWA, in connection with that person’s institutional responsibilities or program of education; The Human Subjects Research is conducted by or under the direction or supervision of any employee, faculty member, staff member, student or agent of Emory University, or of any of the components covered under the Emory FWA, using Emory University property, facilities or resources; Page 35 of 370
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Policies & Procedures - Emory IRB - Emory University

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