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Director reports directly to the VPR. He/she is the designated official responsible for administrative oversight and coordination, implementation, and review of all HRPP policies, procedures, and functions. This UK official plays a critical leadership role in institutional efforts to remain abreast of current knowledge in the field, including regulatory and other relevant issues. Further, the Director serves as a liaison with federal and other agencies in implementing the UK HRPP and oversees institutional communication and education to ensure that the UK community as a whole and the units specifically responsible for protection of human subjects are informed of all relevant issues in human research. To maintain a high degree of cross-unit communication, collaboration, and interaction, the Director serves as an ex officio member on the Medical and Nonmedical IRBs and on other committees outlined below with significant roles in protecting human subjects.

A1.0550 Program Assessment

The ORI Director, with assistance from the Quality Improvement Program (QIP) Coordinator, the Associate Director, the ORI Compliance Officer, Research Education Specialist, and the IRB, is responsible for annual and other periodic reports which contain assessments of the scope, volume, and nature of human research conducted at UK. These documents serve as the basis for program modifications and are one mechanism for determining the appropriate number of IRBs and for meeting administrative personnel requirements to conduct institutional HRPP functions. The ORI Director makes recommendations to the VPR for additional resources or changes in the program.

A1.0600 Human Research Education and Communication

The VPR and the ORI have primary responsibility for establishing and communicating mandatory human research education requirements to all investigators/study personnel, maintaining current education materials, and documenting completion of required investigator/study personnel training. The ORI maintains up-to-date knowledge of federal regulations and issues affecting human research. ORI staff complete mandatory training in human research protections. The ORI also guides the University and the IRB in developing and implementing policies and procedures which ensure compliance with federal requirements for the ethical conduct of research. Responsibilities include facilitating cross-institutional communication and collaboration among the various units and personnel sharing HRPP functions. In addition to providing leadership and assistance to the HRPP, the ORI also assists with the animal care and use program (i.e., Institutional Animal Care and Use Committee), research misconduct policy, data ownership policy, and other ethical and regulatory issues related to the conduct of research, as appropriate.

A1.0650 Support Services

ORI administrators support the mission of each IRB and the Radioactive Drug Research Committee (RDRC) and serve as liaisons with institutional HRPP leadership, the IRB, RDRC, Office of Sponsored Projects Administration (OSPA), and other administrative units with responsibilities for human research protection. Key responsibilities are to advise investigators and their staffs, the RDRC, IRB and committee chairs/vice chairs, upper-level administration, and other institutional administrative units on the review of research protocols and state and federal regulatory requirements; disseminate IRB applications; manage protocol review at

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