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A1.0100 OVERVIEW OF UK RESEARCH ENVIRONMENT - page 1 / 23

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A1.0050

UNIVERSITY OF KENTUCKY HUMAN RESEARCH PROTECTION PROGRAM COMPREHENSIVE PLAN

A1.0100 OVERVIEW OF UK RESEARCH ENVIRONMENT

The University of Kentucky (UK), the Commonwealth of Kentucky’s flagship institution of higher education, is a public, research-extensive, land grant University dedicated to enriching people’s lives through excellence in teaching, research, and service. The role of the UK research enterprise in developing new knowledge for transfer through teaching and service is critical to the broader institutional mission. Research is conducted in 16 colleges (Agriculture, Arts and Sciences, Business and Economics, Communications and Information Studies, Dentistry, Design, Education, Engineering, Fine Arts, Health Sciences, Law, Medicine, Nursing, Pharmacy, Public Health, and Social Work) as well as the Graduate School. Six graduate research centers have both faculty within the Centers and associated faculty whose primary appointments are in other units. In addition, UK’s multidisciplinary research focus extends to more than 20 multidisciplinary research centers, institutes, and core research facilities. Significant human research at UK is conducted in many of these units and in major research centers.

As a major postsecondary institution with extensive human research activity, UK recognizes its institutional obligation to provide research subjects the highest standards in research protection. The human research protection program (HRPP) at UK is a multi-faceted enterprise designed to protect human subjects across broad-ranging research activities through established institution- wide policies and procedures. The institution’s comprehensive plan for human research protection provides a guide to institutional authorizations, ethical principles, accreditation standards, standard operating procedures, responsible units and personnel, and the supporting documents that lay the foundation for the protections provided to research subjects. Essential components of the HRPP include policy, education, procedures, protocol review, conduct of study, study monitoring, and program assessment. All HRPP regulations, policies, and operating procedures relevant to these components are incorporated into the comprehensive plan.

A1.0150 MISSION STATEMENT

UK is committed to the highest ethical standards in the conduct of research and to ensuring the protection of human subjects involved in research. This commitment governs the structure of the institutional HRPP and forms the basis for the following institutional Administrative Regulations: AR 7.1 (Research Misconduct), AR 7:4 (Human Research Subject Protection and Institutional Review Boards), and AR 7:2 (Research Conflict of Interest and Financial Disclosure Policy).

A1.0200 ETHICAL PRINCIPLES AND FEDERAL/STATE REGULATORY GUIDANCE

The conduct of all UK research, as well as that of the Lexington Veterans Affairs Medical Center (VAMC), involving human subjects shall be in accordance with the ethical principles outlined in the Belmont Report, and specifically in accordance with three key concepts: respect for persons (consent, privacy, and confidentiality, with additional safeguards for special populations), beneficence (minimize risks and maximize benefits), and justice (fair sharing of benefits and burdens of research). All human research conducted by UK/VAMC personnel at institutional or

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