IRB The IRB Chair is responsible for seeing that the IRB discharges its functions in an appropriate and regulatory-compliant manner. (S)he holds ultimate responsibility for convening the Board and facilitating meetings, providing to the Institutional Official (IO) recommendations for IRB Membership (including recommendations for pairing primary members with alternates on the IRB roster), and ensuring the IRB operations are in compliance with applicable federal and state statute and regulations. (S)he may delegate some responsibilities to the Vice-Chairs or other experienced IRB Members. The IRB Chair determines whether an activity must be approved by the IRB and determines whether an activity requires IRB review and approval, and whether human research may be reviewed via exempt, expedited, or a full board review process. The IRB Chair or designate will make determinations regarding events reported to the IRB, or consult with the IRB, IO, Privacy Officer, Information Security Officer, or General Counsel as needed. IRB The Vice-Chairs assist the IRB Chair in carrying out the responsibilities noted in the IRB Chair section and are primarily responsible for the oversight of their designated Full Board meeting. When a Vice-Chair plans to be absent from a full board meeting, the Vice-Chair or IRB Chair may designate an experienced IRB Member to run the meeting, or the IRB Chair will fulfill this duty. IRB Below is an overview of the IRB review process. The IRB administrative staff performs a preliminary review of all protocol materials for determination of completeness, accuracy, and required initial signatures (Scientific Review Committee, Department Chair, PI, and any required ancillary reviewers). Only complete submissions can be approved. The PI will be informed through an email of any missing materials or requirements and applicable response deadlines. The IRB administrative staff will assign protocols for review, based on the scientific content of the protocol, the potential reviewer’s area of expertise, and ensure, where applicable, that a scientific and non-scientific perspective is represented. The IRB may use a primary and secondary reviewer process (e.g., two reviewers), or assign reviews based on special knowledge and expertise of the members (e.g., clinical expertise, informed consent reviewer, research design, statistics, regulatory and policy, ethics) or a combination thereof. When the IRB is presented with a protocol that may be outside of the
IRB The IRB Chair is responsible for seeing that the IRB discharges its functions in an appropriate and regulatory-compliant manner. (S)he holds ultimate responsibility for convening the Board and facilitating meetings, providing to the Institutional Official (IO) recommendations for IRB Membership (including recommendations for pairing primary members with alternates on the IRB roster), and ensuring the IRB operations are in compliance with applicable federal and state statute and regulations. (S)he may delegate some responsibilities to the Vice-Chairs or other experienced IRB Members. The IRB Chair determines whether an activity must be approved by the IRB and determines whether an activity requires IRB review and approval, and whether human research may be reviewed via exempt, expedited, or a full board review process. The IRB Chair or designate will make determinations regarding events reported to the IRB, or consult with the IRB, IO, Privacy Officer, Information Security Officer, or General Counsel as needed. IRB The Vice-Chairs assist the IRB Chair in carrying out the responsibilities noted in the IRB Chair section and are primarily responsible for the oversight of their designated Full Board meeting. When a Vice-Chair plans to be absent from a full board meeting, the Vice-Chair or IRB Chair may designate an experienced IRB Member to run the meeting, or the IRB Chair will fulfill this duty. IRB Below is an overview of the IRB review process. The IRB administrative staff performs a preliminary review of all protocol materials for determination of completeness, accuracy, and required initial signatures (Scientific Review Committee, Department Chair, PI, and any required ancillary reviewers). Only complete submissions can be approved. The PI will be informed through an email of any missing materials or requirements and applicable response deadlines. The IRB administrative staff will assign protocols for review, based on the scientific content of the protocol, the potential reviewer’s area of expertise, and ensure, where applicable, that a scientific and non-scientific perspective is represented. The IRB may use a primary and secondary reviewer process (e.g., two reviewers), or assign reviews based on special knowledge and expertise of the members (e.g., clinical expertise, informed consent reviewer, research design, statistics, regulatory and policy, ethics) or a combination thereof. When the IRB is presented with a protocol that may be outside of the
IRB-01HumanResearchProtectionsProgramPolicyDRAFT03.08.2017-LOCKED.docx