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The CCTS will advance new research paradigms, both within the institution and across a network of external constituents. In doing so, it will engage diverse basic science, clinical, community, industry partners and will involve increasingly diverse and expanded numbers of research participants. This transformation carries with it distinct regulatory, organizational, and cultural challenges. Thus, UK’s initiative to advance clinical research methods and approaches and to engage new partners mandates an integrated regulatory support and research integrity infrastructure that will enable this ongoing research transformation while ensuring the protection of research participants. We propose to enhance research ethics across the spectrum of regulatory processes in an integrative fashion in such areas as human research protections, responsible conduct of research, regulatory and fiscal compliance, and research misconduct. Implicit in this restructuring is the promotion of an ethical culture within the university that will be critical to the success of UK’s initiative. |
UK already operates individually effective but operationally disparate units and programs which provide regulatory support, research integrity services through training, institutional review, good clinical practice (GCP), compliance monitoring, & quality assurance initiatives. In fact, UK has achieved national prominence for its engagement in research integrity outreach and leadership and has implemented an innovative, dynamic program in bioethics in recent years. These strengths and a comprehensive institution-wide human research protection program (HRPP), a series of formal courses and periodic seminars for investigators and trainees in the responsible conduct of research (see KF-9 Research Education, Training and Career Development), and existing quality assurance/improvement instruments form the basis for regulatory support to the CCTS. However, currently, bioethics, regulatory, & research integrity services are not well integrated, & there is no focused approach to meeting specific needs of clinical research enterprise. |
Thus, for clinical investigator, navigating the complex of research integrity services can be challenging & time-consuming. The emphasis on community outreach, a hallmark of UK’s CCTS, will result in significant growth in the number of community practitioners, scientists, and research staff actively engaged in clinical and translational research. Since many Kentuckians reside in predominantly rural, geographically isolated communities, the broader engagement of community practitioners in translating research from bench to bedside and back will result in recruitment of larger numbers of research participants from severely disadvantaged populations. |
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