Conducting Research at Norton Healthcare
Documents Required for Research Office Review
The Norton Healthcare Research Office will begin processing a study once all the relevant documents are available. Typically, the documents required for review include:
- New Study Notification Form
- Clinical Trials Agreement
- Informed consent document.
For investigators who are not Norton Healthcare employees, the Norton Healthcare Research Office also will need:
- Sponsor Indemnification Agreement or Facility Use Agreement
- Data Use or Data Sharing Agreements (if required by the sponsor, study type or how data is transferred.)
Norton Healthcare holds a Federalwide Assurance (FWA No. FWA00002217) with the Office for Human Research Protections listing the University of Louisville Institutional Review Board (IRB) and the Western IRB (WIRB) as IRBs of record.
If you are not credentialed through the Norton Healthcare medical staffing office, you will need to review and complete the Research Credentialing Form. Provide the supporting documentation referenced for the type of access requested. If you require electronic access to Norton Healthcare systems for patient data, complete the System Security Request and Network Request forms.
Your request will be considered and documentation of credentialing approval provided once reviewed.
An annual Norton Healthcare Financial Disclosure Form is required for all personnel directly involved in research conducted within Norton Healthcare facilities, including chart reviews and registry studies. For Norton Healthcare employees, this declaration must be completed before your research project can be approved, and it must be renewed annually. All questions are answered based upon the 12 months preceding the disclosure signature date.
For University of Louisville employees, the UofL annual disclosure is accepted. If the cumulative amount identified for a particular vendor on the declaration exceeds $5,000, then a conflict of interest review will be required and may result in a plan to manage the financial conflict of interest. Status changes to the declaration must be reported to the Norton Healthcare Research Office within 30 days. Additional information is found on the form.
Obtaining Clinical Research Data
The Norton Healthcare Research Office reviews all research requests for clinical data to ensure that it is obtained in compliance with privacy and human subject protection regulations.
Norton Healthcare employees complete the Clinical Research Data Request Form found on Nsite on the Applications tab.
If you are not a Norton Healthcare employee, please email email@example.com to discuss your clinical research data request needs and receive guidance on the most appropriate way to submit your request for data.
Obtaining Biomedical Specimens
Should your research study require biomedical specimens from Norton Healthcare, contact the Norton Healthcare Research Office at firstname.lastname@example.org for information on obtaining the specimens.
Biomedical Engineering Review
Biomedical review is required for all electronic equipment used on Norton Healthcare patients. The biomedical engineering department 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 you would like to bring into the Norton Healthcare system.
- Norton Audubon Hospital — (502) 636-7131
- Norton Brownsboro Hospital — (502) 394-6459
- Norton Hospital/Norton Children’s Hospital — (502) 629-8547
- Norton Women’s & Children’s Hospital — (502) 899-6039
Sponsored Account for University of Louisville IRB
In order for Norton Healthcare researchers to use the University of Louisville IRB, a sponsored account form must be completed. The Norton Healthcare Research Office will forward your sponsored account form to the UofL IRB for processing. It may take the UofL IRB up to four weeks to establish the account.
Once the sponsored account is set up, UofL will send an email with your user ID and password to log into the UofL IRB’s protocol submission system. You will need this sponsored account for any role on the study that provides significant contribution to the work and is considered key personnel in the conduct of the project.
Learn more about clinical trials at Norton Healthcare
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