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ORI website lists the RCO as the designated contact person in the event of allegations of noncompliance and provides a toll-free phone number. The RCO handles questions about the human subjects outreach process but refers concerns with administrative processes to the ORI Director.

A1.0800 INSTITUTIONAL REVIEW BOARD A1.0850 Institutional Authority and Independence of the IRB

All activity meeting the regulatory definitions outlined above of research involving human subjects or clinical investigations involving human subjects is subject to institutional review through the appropriate UK Medical or Nonmedical IRB committee. The Medical IRB typically reviews research emanating from the Colleges of Dentistry, Health Sciences, Medicine, Nursing, Pharmacy, and Public Health. Also, through memorandum of understanding, the Medical IRB reviews research involving the VAMC. The Nonmedical IRB generally reviews research originating from the Colleges of Agriculture, Arts and Sciences, Business and Economics, Communications and Information Studies, Design, Education, Engineering, Fine Arts, Law, and Social Work.

UK, through the VPR, grants the Medical and Nonmedical IRB committees the authority to act independently to bind all activities falling under their purview to their decisions. No institutional official or committee may approve human research that was disapproved by the IRB.

Specific authority granted to the IRB includes: approval, required modifications, or disapproval of all human research activities overseen and conducted by the investigators/research team; monitoring the consent process and the conduct of the research; and suspension or termination of approval of research that is not conducted in accordance with regulatory or institutional requirements or that has resulted or may result in unexpected serious harm to human subjects, even if previously approved. The IRB investigates allegations of noncompliance with human subjects regulations and reports of unanticipated problems and, in cases where corrective action is needed, issues appropriate sanctions, including, but not limited to, requesting changes, determining data collected cannot be used for publication, suspending or terminating approval, recommending additional education in the protection of human subjects in research, disqualifying investigators from conducting research involving human subjects at the University, and recommending to the University administration that further administrative action be taken.

With applicable approvals and written agreements, the University may also use the IRB of another organization to ensure effective and timely research review.

All UK/VAMC personnel who become aware of attempts to inappropriately influence the IRB are to report such incidents to the ORI RCO, who notifies the VPR and the ORI Director of all allegations. The VPR, in consultation with the ORI Director, investigates and determines the appropriate response to attempts to unduly influence or undermine the mission of the IRB. Types of responses may include but are not limited to educational intervention, or disqualification of the investigator, and further administrative action.

A1.0900 Institutional Review Board Responsibilities

The primary responsibility of the UK IRB is to ensure that the rights and welfare of research subjects at UK are protected. Similarly, the UK Medical IRB serves as the designated IRB for

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