Clinical Trials

Did you know …

  • 1. You can contact the Norton Healthcare Research Office (NHRO) to set up a meeting to review your research before you submit the application packet for review. 
  • 2. You may need Research Credentials at NHC – Are you at Level I or Level II?
  • 3. There is special system access for Researchers at NHC – Who needs it?
  • 4. A Financial Disclosure Declaration is required for all key personnel listed on ALL studies conducted within NHC, including chart reviews and registry studies.  For NHC employees, this annual declaration must be submitted to the NHRO by January 31 each year. For non-NHC employees, the UofL annual disclosure or sponsor financial disclosure is accepted. A conflict management plan is required for all conflicts in excess of $10,000. Status changes must be reported to the NHRO within 30 days.
  • 5. Biomedical Review is required for all electronic equipment used on NHC patients. Biomedical Engineering may need to review the device or equipment that is to be used for your study.    Please contact the appropriate department below to provide the detailed information relating to the equipment being brought into the NHC system.
    Downtown – 629-8547
    Audubon – 636-7131
    Suburban – 899-6039
  • 6. NHC has a process and application for release of specimens for research purposes. 
  • 7. NHC has a process and form for the request of image copies on a disc to be released to a research study sponsor.
  • 8. The NHC Technology Assessment Committee (TAC) must review all new device technologies that are not supplied by the study sponsor. The TAC is chaired by Dr. Steve Hester, VP Medical Affairs and comprised of 10 physicians appointees from various specialties and NHC leaders from finance, operations and supply chain. It meets monthly on the fourth Wednesday of the month in the Gray Street building 9th floor conference room from 5:30-7pm. To introduce a new technology for a clinical evaluation or research project, please contact Claire Rupert at 629-8365 for TAC applications and a worksheet. From the time of receipt of the completed forms it may take up to 6 weeks to schedule the review on the committee agenda, and the applicant will be asked to attend the meeting for a brief presentation on the requested technology.
  • 9. You can submit a data query request to Health Information Management (HIM) in preparation for your research project. 
  • 10. The University of Louisville Institutional Bio-safety Committee must be notified of any human genetic research reviewed by the UofL IRB. 
  • 11. NHC will waive submission of the full Multi-institutional Research Application (MIRA) and the standard review process and accept the ancillary service application for cases in which NHC determines that only an ancillary service is being performed in a NHC facility and in no way is the research associated with NHC. This determination is made at the discretion of NHC.