Policies & Procedures - Emory IRB - Emory University

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Emory University IRB P&Ps Revised 1/18/2013 POLICY: 8 APPLICABILITY OF STATE LAW The Emory HRPP is subject to the laws of the State of Georgia. The Emory IRB shall consult with appropriate University legal counsel for guidance on the interpretation and application of Georgia State Law. In the event of Human Subjects Research that takes place in jurisdictions other than the State of Georgia, the Emory IRB shall consult with University legal counsel for determination of applicable law and any interpretation thereof. PROCEDURES: Consultation with Emory University’s Office of the General Counsel: The Emory IRB shall consult with attorneys in the University’s Office of the General Counsel when questions arise as to: The application of Georgia state and local laws to Human Subjects Research; and The determination of what other jurisdiction’s laws may apply if the research takes place at a site outside of the Emory University campus. As necessary, the Office of the General Counsel shall consult with other legal experts, including attorneys in other jurisdictions in which a Research project is taking place, for advice regarding the applicability and interpretation of pertinent laws. Applicable Regulations: See specific references as they appear in individual P&Ps. Page 24 of 370
Emory University IRB P&Ps Revised 1/18/2013 POLICY: 9 EMORY UNIVERSITY IRB OFFICE Emory University has established and staffed the Emory University IRB Office, which is responsible for the administration of the Emory University IRB. The Emory IRB Office reports to the Vice President for Research Administration (the IO), who reports to the Executive Vice Presidents, who report to the University President. Mission Statement of IRB Staff: It is the mission of the Emory University IRB staff to protect the rights, privacy, and welfare of participants in Human Subjects Research conducted by or at Emory, primarily through support of the IRB Committees in all of their functions. In fulfilling this objective, the IIRB staff aim to further the University’s research mission by: Protecting each human research subject’s right to privacy and confidentiality Providing reliable analysis in pre-screening Human Subjects Research applications to help IRB members ensure that the Research possesses ethical merit and adheres to applicable laws and federal regulations. Maintaining operational consistency and accountability. Striving for continuous quality improvement and professionalism. Providing education and outreach to investigators. Providing helpful resources to former, current, and prospective Research participants. PROCEDURES: IRB Director: The IRB Office is managed in chief by the IRB Director. The Director reports the IO. The Director has expert knowledge in regulatory issues regarding Human Subjects Research and serves as the chief administrator for the University’s HRPP and the primary contact at Emory University for regulatory agencies on IRB matters. IRB Assistant Director: The IRB Office may have an Assistant Director to assist the Director in carrying out his/her duties and to serve in the place of the Director in the Director’s absence. Alternatively, other supervisory staff may fulfill similar functions as designated by the Director. IRB Director/Assistant Director Responsibilities: The responsibilities of the IRB Director/Assistant Director are detailed in the P&P entitled: Roles and Responsibilities Under The Emory HRPP. Additional IRB Office Staff: The IRB Office also is staffed by persons appropriately chosen and trained (e.g., Education and Quality Assurance Consultant, Team Lead Protocol Analyst. The duties and responsibilities for each of these positions are set forth in their respective job descriptions and their performance is evaluated on at least an annual basis. Additionally, from Page 25 of 370
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Policies & Procedures - Emory IRB - Emory University

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