The Brody School of Medicine is committed to the integrity of its research. The safety and well-being of our study patients is paramount. In addition, the scientific integrity of our study data is integral to the development of innovative medical care and the overall contribution to medical knowledge by our scientists and physician-researchers.
Given the importance of research integrity, the Office of Compliance has developed a Research Monitoring Program to help ensure compliance with the relevant federal and state laws, regulations, and ECU policy that govern our research at the Brody School of Medicine. This Program involves the random review of various clinical studies and follow-up educational sessions with the applicable principal investigator and other study staff as appropriate.
Clinical Trial Billing Compliance
In addition, our Office is committed to help ensure compliance as it relates to billing in clinical research. Clinical research often involves costs that may be reimbursed differently – i.e., some procedures or tests may be paid for by the sponsor of the study and others may be the responsibility of the study patient or the third party payor. It is imperative that items paid for by the sponsor are not billed to the patient or third party payor (including a government payor). Please refer to Clinical Trial Billing Policy.
Medicare now pays for certain services that are routine standard of care (i.e., the service would be provided regardless of whether the patient was participating in a clinical trial) and are provided under a “qualifying clinical trial.” To view the flowsheet for determination of whether the trial is a qualifying clinical trial, click the link below.
Qualifying Clinical Trial Flowsheet
As part of the UMCIRB approval process, a Financial Services Review Form must be completed. In addition, a Clinical Trial Participant List must be completed and updated in a timely manner as new participants are added and sent to Frank Evans, Director, Clinical Financial Services.
We are available to provide education and training as it relates to any aspect of research compliance. This includes information relating to such topics as obtaining proper informed consent, time and effort reporting, conflict of interest issues in research, reporting requirements, and clinical trial billing issues, just to name a few. The UMCIRB offers bimonthly education sessions to clinical trial coordinators. Any BSOM employee who is interested in research, however, is welcome to attend.