• Policy Statements Regarding the Department's Research Testing

    1. After a Principal Investigator (PI) has submitted a Request for Research Testing (RRT) form to the Pathology Research Coordinator, the RRT form is submitted to the clinical laboratories involved and the Vice Chair of Research for approval. After the proposed project is approved, an approval packet is issued to the Principal Investigator. A copy of the approved RRT is also forwarded to appropriate laboratory staff and the Special Programs office of the hospital billing office when applicable.

    2. The method of reporting will be dependent on which of the following Reporting Options is chosen.

    (A.) Research result data will be available via INFORMM terminals (IPR) retrieved under the patient medical record number and the research result data will be incorporated into the University of Iowa Hospitals and Clinics (UIHC) patient medical record.

    If this option is chosen the Principal Investigator must contact Lori Lawton, Joint Office of Patient Financial Services, 2100 UCC, Phone 319-384-2456. Special Programs will take research tests from the patient’s bill and bill Principal Investigator’s account. However, if the study utilizes the ICTS Clinical Research Unit, Contact Mary McDermott at 319-384-8319 or 157 MRF.

    B.) Research result data will be available via a Pathology hard copy chart printed by Research Project Code # or Unique Patient Identifier.

    Option 'B' may not be appropriate for projects which:

    1. require test results appear on the INFORMM computer system
    2. require test result appear in the patient’s chart
    3. require a turnaround time for specimen results less than 48 hours

    (C.) Research result data is NOT required by this study but Pathology services are requested (e.g. phlebotomy, slide staining, etc.)

    3. If you have chosen reporting Option 'B' or 'C', use of a University of Iowa Health Care medical record number on the requisition may result in patient billing unless the appropriate research study-specific requisition is submitted. If a patient is inadvertently charged instead of the research account, a Request for Research Crediting form must be completed by the principal investigator and hand delivered to the supervisor of Specimen Control to remove the charge from the patient’s account. Although a medical record number is an acceptable subject identification when used in conjunction with the research project number, a subject’s specimen can alternatively be identified by the subject’s name, social security number, or other unique identification assigned by the researcher. Non-human specimens should be identified as such on the requisition.

    4. Pathology Billed Research Clients - Pathology will automatically deduct funds via Credit Voucher from the research Master File Key (MFK) provided at the time the Pathology Request for Research Testing form was completed. Researchers receive a statement of services performed for their records. Credits, adjustments, or other questions regarding the billing statement should be addressed to the Pathology billing office at 319-356-2991.

    5. Pathology will provide research testing for the ICTS Clinical Research Unit . Test results will be provided through the hospital information system under the patient’s medical record number. ICTS Clinical Research Unit will use patient’s medical record number and charges will initially be posted to the patient’s bill. The Program Assistant in ICTS Clinical Research Unit will review the charges posted to ICTS Clinical Research Unit patients and will notify the UIHC Business Office of the necessary patient bill adjustments.

    6. Reference ranges will be reported by age and sex of the patient only if that information is recorded on the requisition. Default reference ranges will be used for non-human subjects or when date-of-birth (DOB) and sex are not on the requisition.

    7. Laboratories will retain specimens, worksheets, and other data related to research testing for the same period of time as they would for patient specimens of the same type. If additional specimen storage, return specimens, or special processing is required, it must be noted on the RRT.

    8. Only laboratory tests listed on Page 2 of the Request for Research Testing form (RRT) have been formally approved for research testing. Additional tests may be added to the original RRT by contacting the Pathology Research Coordinator, 319-356-4149. Multi-year studies – please allow for moderate annual price increase (approx. 5-10%).

    9. Laboratory requires advance notice if research specimens are in batches of 35 or greater.

    10. Any changes in the information supplied on the RRT (i.e. P.I., contact person, MFK to bill, report mailing address) should be communicated to the Pathology Research Coordinator, Pathology, 6233 Roy Carver Pavilion, or by phone 319-356-4149.

    If you need assistance with any of these decisions please contact Julie Happel, Pathology Research Coordinator at 319-356-4149.