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A1.0100 OVERVIEW OF UK RESEARCH ENVIRONMENT - page 14 / 23

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A1.0050

A1.1500 INSTITUTIONAL CONFLICT OF INTEREST

UK Administrative Regulation: AR 7:9 (Institutional Conflicts of Interest Involving Research) identifies areas in which financial dealings of the university could affect research integrity and provides clear guidance on and procedures for the disclosure and management, or elimination, of institutional conflicts of interest, whether real or perceived. The processes cover direct financial holdings of the University or any of its affiliated corporations or personal financial holdings of a University Official who, by virtue of his or her institutional authority, might affect, or reasonably appear to affect, institutional processes for the conduct, review, or oversight of research. The VPR serves as the Institutional Conflict of Interest Official with authority and responsibility for overseeing the implementation of this policy. All identified institutional conflicts of interest shall be disclosed to the UK Institutional Conflict of Interest Committee, which reviews the disclosure and recommends a course of action.

A1.1550 OFFICE OF LEGAL COUNSEL

The Office of Legal Counsel provides legal services through an Associate General Counsel who has primary responsibilities specific to the UK research enterprise to ensure absence of conflicting organizational responsibilities. This position reports to the Office of Legal Counsel, but is funded through the Office of the VPR. Legal counsel serves the IRB and the ORI, advising on such legal issues as consent, state law, and other research-related areas, including handling of differing state and federal laws. In cases where state law is inconsistent with federal, i.e., more stringent, policies are developed and implemented which govern the conduct of the research affected by these laws. Legal counsel serves as an ex officio member of the Medical and Nonmedical IRB committees and works closely with IRB chairs, ORI staff, and the VPR in reviewing legal issues affecting human research, assessing and monitoring UK research practices, and assisting the institution in maintaining compliance with pertinent federal and state legal requirements. Legal counsel maintains external professional affiliations to ensure that the University community is apprised of current legal developments.

A1.1600 COMMITTEE ON SAFETY AND ENVIRONMENTAL HEALTH

The Division of Environmental Health and Safety (EHS) has responsibility for assisting the University in achieving overall safety compliance in all operations, including research. EHS staff members assist investigators in assessing environmental, health and safety needs, and compliance requirements of their proposed research through means of a web-based checklist and use the results of the assessment to direct investigators to the appropriate research review. Two specific subcommittees of the Committee on Safety and Environmental Health, the Institutional Biosafety Committee and the Radiation Safety Committee, play important roles in reviewing research protocols involving human subjects, coordinating approvals with the IRB, and providing ex officio members to serve on the Medical IRBs during research review. These committees coordinate with the IRB and ORI through shared membership. The IRB withholds all approvals pending approval of the IBC and the RSC, when applicable. The ORI Director serves as an ex officio member of the Committee on Safety and Environmental Health.

A1.1650 Institutional Biosafety Committee

This committee is responsible for advising the institution on all matters related to biological safety and for reviewing and approving proposed uses of biohazardous materials in all

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