Regulatory Knowledge and Support

CCTS Regulatory Knolwedge and Support Core integrates faculty, staff, and community expertise in bioethics, regulatory knowledge, and research integrity to provide investigators, community practitioners, trainees, and research participants with a single point of access to the spectrum of ethical and regulatory committees and support services applicable to clinical and translational research.

Regulatory Support and Research Ethics seeks to establish an interdisciplinary bioethics and research integrity culture within the CCTS and to ensure that CCTS investigators and community partners maintain high levels of regulatory knowledge and accord appropriate priority to research protections.

  • Regulatory Support Unit that provides study initiation support and development, reporting, maintenance and archiving of IRB and other compliance documents.
  • Research Participant Advocate to provide support to research participants and to oversee quality improvement on CCTS clinical and translational studies.
  • Quality Improvement Program focused on supporting investigators and study coordinators at the outset of clinical studies and throughout the continuum of clinical and translational research.
  • IRB Consortium initiative to reduce barriers to research engaging practice-based research networks and community partners.
  • Research Compliance Roundtables to share identified regulatory and compliance needs among appropriate university research support units.
  • Development of courses on responsible conduct of research and research ethics within CCTS curricula.

The CCTS Regulatory Support Unit comprises highly trained regulatory specialists who can provide support to investigators that is tailored to their specific needs.

The following are the categories of services provided by the regulatory support unit. Click on an item to view the list of services associated with that category.

Start-up support
Long-term regulatory maintenance
Archiving assistance
CSC Service Request Form

For a comprehensive guide to institutional authorizations, ethical principles, policies and procedures, and unit and personnel responsibilities for human research protections, please review the document below.

University of Kentucky Human Research Protection Program Comprehensive Plan

The University of Kentucky is fully accredited for human research protections through the Association for the Accreditation of Human Research Protection Program, Inc.

   UK Regulatory Policies and Processes
   Non-Indemnification Clinical Trials Process
   Off-Site Research Process
   Research Compliance Policies, Guidance & Contacts
   UK HealthCare Corporate Compliance Program

 

Other Regulatory Research Policies

NIH Guidance on New Law (Public Law 110-85) Enacted to Expand the Scope of ClinicalTrials.gov: Registration
This outlines application, scope and responsibility of trial registration under the FDAAA.

Food and Drug Administration Amendments Act of 2007 (FDAAA)
This law ensures that FDA staff have the resources needed to conduct the complex and comprehensive reviews necessary to new drugs and devices. Among the many components of the law, the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA) have been reauthorized and expanded.

ClinicalTrials.gov
A international registry of federally and privately supported clinical trials, it provides information about a trial's purpose, who may participate, locations, and phone numbers for more details. Use the Contact Information to obtain an access code to the UK Organizational Account on ClinicalTrials.gov.

Physician Data Query Cancer Clinical Trials Registry
To help ensure the comprehensiveness of the registry, PDQ© and NIH's ClinicalTrials.gov database regularly exchange clinical trial information. Cancer trials registered in PDQ© will automatically be registered in ClinicalTrials.gov and vice versa.

World Health Organization International Clinical Trials Registry Platform
Its mission is to ensure that a complete view of research is accessible to all those involved in health care decision making.