To conduct a clinical trial with Norton Healthcare (NHC), researchers must first receive approval from the Norton Healthcare Office of Research Administration (NHORA) and an institutional review board (IRB). Norton Healthcare holds a Federal-Wide Assurance with the Office for Human Research Protections listing the University of Louisville IRB and the Western IRB (WIRB) as IRBs of record.
- Contact the Norton Healthcare Office of Research Administration (NHORA) to set up a meeting to review your research before you submit the application packet for review.
- You may need Research Credentials at NHC: please complete this Level I Access Application, and email it to NHORA@nortonhealthcare.org. The NHORA department will contact you upon receipt of the completed application.
- There is special system access for Researchers at NHC.
- A Financial Disclosure Declaration is required for all personnel directly involved in research conducted within NHC facilities, including chart reviews and registry studies. For NHC employees, this declaration must be completed before your research project can be approved and renewed annually. All questions must be answered based upon the 12 months preceding the disclosure signature date. For non-NHC employees, the UofL annual disclosure or sponsor financial disclosure is accepted. If the cumulative amounts identified on the declaration exceed $5,000, then a conflict of interest review will be required. Status changes to the declaration must be reported to NHORA within 30 days.
- 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 – (502) 629-8547
Audubon – (502) 636-7131
Women’s and Children’s Hospital – (502) 899-6039
- NHC has a process and application for release of specimens for research purposes.
- NHC has a process and image services request form so copies on a disc can be released to a research study sponsor.
- 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. To introduce a new technology for a clinical evaluation or research project, please contact Claire Rupert at (502) 629-8365 for TAC applications and a worksheet. From the time of receipt of the completed forms it may take up to six 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.
- You can submit a data query request to Health Information Management (HIM) in preparation for your research project.
- The University of Louisville Institutional Bio-safety Committee must be notified of any human genetic research reviewed by the UofL IRB.
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