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A1.0100 OVERVIEW OF UK RESEARCH ENVIRONMENT - page 13 / 23

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A1.0050

establishing an account for a project involving human subjects. In selected circumstances, OSPA may, however, establish accounts under specific written agreements with the investigator prohibiting contact with and enrollment of human subjects prior to obtaining IRB approval.

A1.1400 Research Conflict of Interest Administration

UK’s Research Conflict of Interest and Financial Disclosure Policy (AR 7:2) closely mirrors the federal regulations effective October 1, 1995. The intent of the policy is to ensure the integrity of all research and to avoid any perception that an investigator's financial interests might have either a positive or negative effect on proposed research. Administrative Regulation II-4.0-4 defines investigators as a principal investigator, co-principal investigator or any other person at the University responsible for the "design, conduct or reporting of the research." AR 7:2 provides for review and management of any relevant significant financial interest that could directly affect the design, conduct, or reporting of research activity.

OSPA administers the individual Research Conflict of Interest and Financial Disclosure Policy (AR 7:2), publishing the policy prominently on behalf of the institution and maintaining a website of relevant information. The Conflict of Interest Administrator reports directly to the OSPA Director. OSPA ensures that PIs, co-investigators, and other personnel responsible for the design, conduct, or reporting of sponsored research activities complete Research Financial Interest Disclosure Statements and certify that they have read and understand the Research Conflict of Interest and Financial Disclosure Policy prior to proposal submission to an external funding agency. OSPA is also responsible for coordinating with the ORI on any research project that meets the UK definition of financial conflict of interest and involves human subjects.

A1.1450 RESEARCH CONFLICT OF INTEREST COMMITTEE

The VPR and the University Senate Council are responsible for recommending a committee of at least five members for appointment by the President to a Research Conflict of Interest Committee (RCOIC). A majority of the membership consists of faculty members and the remainder is limited to deans, directors and others employed by the University. In addition, the Directors of OSPA and ORI serve as ex officio members of the Research Conflict of Interest Committee.

Investigators or personnel who have an identified potential conflict of interest propose a plan to eliminate, minimize, or manage the conflict of interest. The authorized University official, i.e., the associate dean for research for the college, will review the plan. The investigator and the authorized University official submit the plan to the RCOIC which may accept the plan as recommended, add to the plan, or formulate a different course of action to manage, reduce, or eliminate the conflict. The RCOIC forwards its recommendations to the VPR for final approval.

The VPR notifies the investigator, dean or director, and the Committee of the final disposition of the issue. No sponsored project award funds may be disbursed until this final disposition. The Director of OSPA sends the final management plan to the ORI/IRB. The IRB withholds approval pending receipt and IRB review of the final management plan. Noncompliance with or violation of the conflict of interest policy is grounds for disciplinary action as specified in AR 7:2.

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