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Department heads, faculty members, and supervisors are also directly responsible for maintaining an atmosphere that promotes full compliance with University safety policies and procedures in all facets of University operations, including human research. This mandate places equal responsibility on investigators and administration to handle biohazardous agents and radiation-producing devices safely, following established policies, procedures, and regulations, and in accordance with research reviews conducted by the IBC and the RSC.

A1.1300 OFFICE OF SPONSORED PROJECTS ADMINISTRATION A1.1350 Procurement, Review, Approval, and Submission of Sponsored Projects

The Office of Sponsored Projects Administration, a unit within the Office of the VPR, serves both UK and the University of Kentucky Research Foundation (UKRF) in the review, approval, and submission of proposals. The University Administrative Regulation, AR 7:3 (Sponsored Projects Grants and Contracts) formalizes unit responsibilities for ensuring compliance with the terms and conditions of grants and contracts and for providing general grant, contract, and agreement administration with project sponsors. In addition, OSPA is responsible for the following HRPP functions: monitoring funding agency assurance/certification requirements and ensuring compliance; posting federal and state regulatory guidelines relevant to sponsored research; coordinating with the IRB to ensure accuracy of completed assurances and certifications; maintaining agency-required documentation; and maintaining a working knowledge of the types of projects needing IRB review.

OSPA administers the Internal Approval Form, which ensures that the proposed project has been reviewed across institutional levels for scientific and sound scholarly design. Department chairs, directors and deans receive a summary of pertinent details of proposed sponsored research projects on the IAF, including the use of human subjects, hazardous materials, or radioactive materials. The IAF contains investigator certifications that he/she will adhere to University policies on conflict of interest, ethical standards in the conduct of research, intellectual properties, and the use of human subjects in research and that he/she has completed and submitted a Research Financial Interest Disclosure Statement and submitted it to the appropriate dean or director. Signatures of chairs, deans and directors certify both that the proposed research is consistent with the educational and research objectives of the unit and that a Research Financial Interest Disclosure Statement has been completed.

Every sponsored project must include a written agreement between the sponsor and the institution. OSPA negotiates the terms of the agreements to ensure compliance with federal and state law, University policy, and good business practice. A Guide for Industry: Research Agreements with the University of Kentucky, available from OSPA, clearly articulates UK policy with regard to agreements with industry. The Clinical Trial Agreements Information Sheet posted on the OSPA website outlines administrative and contractual issues applicable to clinical trial agreements. Sample agreements for industry and clinical studies, which include provisions addressing freedom to publish research results, coverage of subject injury expense, and adherence to human subject protection regulations, are available from OSPA.

OSPA is responsible for negotiating the terms of all sponsored agreements, including clinical study agreements on behalf of UKRF. OSPA also prepares subagreements with collaborators, which include provisions for adherence to human research protections, the research protocol, and applicable federal and state regulations. Internal OSPA policy requires IRB approval prior to

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