FAQs for Researchers | Norton Healthcare Louisville, Ky.

FAQs for Researchers

NHC Health Information Management (HIM) will not release medical records for research purposes without proof of IRB approval, documentation of authorization or waiver of authorization per HIPAA, and NHORA approval. The following process must be followed for access to patient PHI through HIM:

  • All approvals are obtained
  • HIM personnel verifies all appropriate approvals are accurate and active, and that all those viewing the PHI have been approved to do so
  • Researcher is responsible for presenting all appropriate approvals and waivers to HIM personnel
  • HIM will pull the requested medical records within their specified time frame, and notify the researcher when the records are ready for review

All personnel accessing electronic medical records for research purposes must do so under an IRB and NHORA approved protocol. All non-Norton research staff requiring electronic access to PHI for research must have the appropriate NHC credentials, be approved research personnel, and have an individual user ID and password.

Non-Norton Healthcare employed research personnel having contact with patients or protected health information (PHI) in any NHC facility are required by the Norton Medical Staff Office to obtain the appropriate privileges to gain access to patients or PHI. All research subjects seen in NHC facilities are considered NHC patients and therefore all NHC policies apply. Research personnel are defined as the PI, co-investigators, sub-investigators, study coordinators and all other personnel including students in contact with patients or PHI. The credentialing process is based upon the researcher’s level of PHI and patient contact. NHORA will verify that all personnel have appropriate credentials before granting study approval.

There are two classes of Level I credentials. Both classes are processed internally through NHORA and do not require dependent allied health privileges (DAHP).

No Patient Contact: Those granted credentials under this classification are limited to PHI access only, such as chart reviews and case studies.

Limited Patient Contact: Those granted credentials under this classification have access to PHI as well as limited patient contact under the supervision of a privileged medical staff member at NHC. This limited contact may include recruiting subjects, performing the informed consent discussion, administering questionnaires and surveys, collecting data, and other research discussions. This also includes non-invasive medical procedures such as taking vital signs. Such non-invasive medical procedures performed by a researcher with Limited Patient Contact privileges are not a substitute for those performed by NHC clinical staff in accordance with applicable assessment/reassessment policies.
For specific requirements for each level of credentialing please contact NHORA.

For studies reviewed by the UofL IRB, individuals on the study are required to have a UofL sponsored account. A sponsored account provides limited access to UofL systems such as BRAAN, Blackboard and sometimes university email. Without a sponsored account the IRB submission software will not allow non-UofL employees to be added in BRAAN.

Contact the NHORA office at nhora@nortonhealthcare.org for a form to request a sponsored account. Complete the form and return the document to NHORA at nhora@nortonhealthcare.org. The form will be submitted on your behalf to the Human Subjects Protection Program for creation of the sponsored account.

Originally the University of Louisville assigned an email account to the individual for whom a sponsored account was requested for correspondence from BRAAN2. This is no longer the case. If you have a UofL sponsored email account you were notified when it was established. To keep the account active you must change your password every six months. If you do not keep the password current, your account may be inactivated permanently. New sponsored accounts are no longer assigned a university email account.

If you are a brand new to BRAAN2, schedule BRAAN2 training with the IRB at http://louisville.edu/research/braan2/registration. This will provide you with an introduction to the BRAAN2 system. If you have had BRAAN2 training, review the BRAAN2 User’s Guide. You may find the solution to your problem there. If not, contact the IRB office at (502) 852-5188.

For specific requirements for each level of credentialing please contact NHORA.

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