Start a New Clinical Trial at Norton Healthcare

Research Policies and Forms

In order to conduct a clinical trial with Norton Healthcare (NHC), you must first receive approval from the Norton Healthcare Research Office (NHRO) 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 allowed IRBs of record. 

University of Louisville/BRAAN Submissions

For research involving University of Louisville (U of L) employees or facilities, the UofL IRB must be used as the IRB of record.  All applications to the UofL IRB are required to be submitted electronically through the BRAAN system.  Instructions for using BRAAN may be found on the IRB's website, http://research.louisville.edu/UHSC   .  If a Norton facility is selected as a research site on the BRAAN application, the NHRO will have access to all documents in BRAAN associated with the research study.  If you are a Norton employee and do not have access to BRAAN, please contact the NHRO at 629-3905. 

For those studies with patient billing, the NHRO will create a “billing compliance table” (BCT) to be used as a tool to guide the hospital and physician’s claims processing for the study.  The Principal Investigator (PI) must designate each procedure on the protocol “schedule of events” as either “S” for standard-of-care, or “R” for research billing.  An item classified as standard-of-care would be performed for that patient population at the protocol-required time point outside of clinical trial participation. The PI must then sign and date the schedule, and send to the NHRO.  Please refer to the billing compliance policy for process details.The NHRO will also need a copy of the contract and budget for sponsored studies. 

Once the contract/budget information has been received and the BRAAN materials are available, the NHRO will assign an internal tracking number to the application, and email a confirmation receipt to the researcher. 

  • The NHRO will conduct an internal review of the submission, and forward any questions or comments to the researcher.
  • Once all questions and comments have been addressed, the UofL IRB approval has been granted, and the contract is finalized, the NHRO will email an approval letter to the researcher.   
  • The final BCT will be issued to the researcher, if applicable.  
Non-University of Louisville/WIRB Submissions

For research at Norton not affiliated with UofL, researchers may use Western Institutional Review Board (WIRB) as the IRB of record.  The WIRB submission forms may be found here.  Please note that not every form found in this listing is required.  The Multi-Institutional Research Application (MIRA)is required to be submitted along with the WIRB application, study protocol, draft contract and budget, informed consent, any applicable HIPAA documents, and any other materials the subject will receive. 

For those studies with patient billing, the NHRO will create a “billing compliance table” (BCT) to be used as a tool to guide the hospital and physician’s claims processing for the study.  The Principal Investigator (PI) must designate each procedure on the protocol “schedule of events” as either “S” for standard-of-care, or “R” for research billing.  An item classified as standard of care would be performed for that patient population at the protocol-required time point outside of clinical trial participation. The PI must then sign and date the schedule, and send to the NHRO.  Please refer to the billing compliance policy for process details.The NHRO will also need a copy of the contract and budget for sponsored studies. 

Once the MIRA, contract/budget information, and the WIRB application materials are received, the NHRO will assign an internal tracking number to the application, and email a confirmation receipt to the researcher. 

  1. The NHRO will conduct an internal review of the WIRB submission, and forward any questions or comments to the researcher.
  2. Once all questions and comments have been addressed and all necessary documents have been supplied to the NHRO, the NHRO will submit the study to WIRB. 
  3. Upon WIRB approval and completion of the final contract, the NHRO will generate an approval letter and send it to the researcher via email. 
  4. The final BCT will be issued to the researcher, if applicable. 
Ancillary Services

If you are not conducting your research primarily in a Norton facility, but would like to use Norton for a procedure required by your protocol, you may qualify for an Ancillary Services in Research  application . If your research does qualify, you must still obtain an IRB approval, but are not required to use those listed in Norton’s FWA (UofL IRB or WIRB).