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regularly scheduled meetings; maintain pertinent records and documentation of protocol review and IRB decisions for mandated periods; complete federally and UK-mandated reports; receive and respond to complaints and allegations of noncompliance; assist in developing HRPP policies and procedures; and manage staff and infrastructure to assist the IRB in completing their responsibilities. ORI administrators also assist in the development of education materials, provide and oversee mandated education on the ethical conduct of research, coordinate institutional/IRB/investigator responsibilities, conduct quality improvement and assurance reviews, assist with IRB review of HIPAA waivers and authorizations, and coordinate “off-site” administrative agreements.

A1.0700 Community Outreach

UK is committed to a policy of providing the community and all persons participating or considering participation in human research information on the rights of research subjects. The ORI maintains a comprehensive set of online outreach materials for human subjects through the department website. These resources familiarize the broader community and potential human subjects with information on human research in general and institutional policies and regulatory guidance governing the conduct of human research. Web pages also offer specific information on clinical trials, including An Introduction to Clinical Trials and a Glossary of Clinical Trials Terms, Advice to Legally Authorized Representatives of Adult Participants as well as linking directly to the UK Clinical Research Development and Operations Center (CR-DOC), the UK clinical research volunteer website, and pertinent external sites relating to human research protections. The CR-DOC also delivers patient/subject education through posters, dedicated research wall mounts, and traveling exhibits at outreach events. The website and approved informed consent and assent forms provide a means for human subjects to contact the ORI directly in the event that they have questions, problems, or concerns about their rights as subjects and to do so in a confidential manner. Contact information is prominently posted both on the ORI website, the clinical research volunteer website and promotional materials, and in the informed consent forms. In addition, the ORI maintains a toll-free phone number to ensure human subject access to ORI personnel, particularly the Research Compliance Officer (RCO).

A1.0750 Handling Allegations of Regulatory Noncompliance and/or Research Misconduct

The UK Administrative Regulation, AR 7:1 (Research Misconduct) defines and provides direction on the handling of research misconduct. The IRB/ORI has a standard operating procedure (SOP) for handling allegations of IRB noncompliance. The Research Compliance Officer (RCO), a staff member in the ORI, provides critical leadership in handling allegations of IRB noncompliance and any research misconduct which may also have IRB implications. In these cases, the RCO is responsible for identifying the specific allegation of noncompliance or misconduct to ensure coordination among the various components of the HRPP and implementation of the institutional policy. Key areas of responsibility include developing and implementing policies and procedures for issues related to research misconduct and noncompliance; serving as a liaison with all agencies, organizations, complainants, witnesses, and other personnel impacted by allegations of noncompliance; coordinating IRB investigations of allegations; advising senior administration on federal and institutional requirements, proposed changes, or actions related to noncompliance; preparing federally mandated reports and correspondence; and assisting in developing and directing the institutional education program and tools to educate the University community on research misconduct and noncompliance. The

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