Policies & Procedures - Emory IRB - Emory University

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Emory University IRB P&Ps Revised 1/18/2013 time to time, the IRB Director in consultation with the IRB Chair may create and recruit personnel for additional positions to assist the Emory IRB in carrying out its responsibilities. Selection, Supervision and Evaluation of Staff: Staff are supervised and evaluated by the Director or designated supervisory staff. Evaluation of staff occurs on an annual basis at the end of the fiscal year using the Emory University Human Resources Policies and Procedures. Applicable Regulations: 45 CFR § 46.103; Emory FWA. 38 CFR §46.103. Page 26 of 370
Emory University IRB P&Ps Revised 1/18/2013 POLICY: 10 EMORY IRB P&PS The Emory IRB shall draft and maintain written Policies and Procedures (P&Ps, formerly known as SOPs) for the operation of the Emory HRPP including, policies and procedures for all required items set forth in the HHS, VA FDA Regulations, and DOD Regulations/Requirements . These P&Ps are an integral component of the University’s HRPP. This document contains and sets forth those P&Ps. They shall be reviewed at least annually, including review for conformance with current law. The IRB staff shall draft and maintain written administrative standard operating procedures (Administrative SOPs) providing detailed guidance on the daily functions of the IRB administration. These shall be stored as a separate collection or document from the P&Ps. PROCEDURES: P&P Requirements: Per HHS, FDA, VA Regulations, and DOD Regulations/Requirements, the Emory IRB’s written P&Ps must address the following items: Review: Conduct of initial and continuing review of Research protocols. Reporting Findings: Reporting of findings and actions to Investigators and to Emory University. Review Frequency: Determination as to which Research protocols require review every twelve (12) months, and which require more frequent review. Verification: Determination as to which Research protocols undergoing Continuing Review require verification from sources other than the PI that no material changes occurred within the Research protocol since the last IRB review. Reporting Changes in Research Protocols: Prompt reporting of proposed changes in approved Research protocols and ensuring that changes are not initiated without prior Emory IRB review and approval, except as necessary to eliminate immediate hazards to Human Subjects. Reporting to Emory IRB and Appropriate Officials: Prompt reporting to the Emory IRB and to appropriate Research Sponsors; Emory University officials; and/or HHS/FDA/VA/DOD officials of the following: Unanticipated Problems Involving Risks to Participants or Others; Any Serious or Continuing Non-Compliance with HHS, FDA, DOD and/or VA Regulations or the requirements or determinations of the Emory IRB; Any Suspension or Termination of Emory IRB approval of a Research protocol. Page 27 of 370
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Policies & Procedures - Emory IRB - Emory University

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