Oversight and Education for Clinical Research
The Research Compliance Program provides oversight, education, and ongoing support to all areas of UC Davis Health related to clinical research billing, research privacy, and other research regulatory matters to ensure compliance with applicable federal and state laws, regulations and policies.
The two major components of the program are focused on clinical research billing compliance and supporting the proper use of protected health information (PHI) related to clinical research. General information about these programs is located below. More information for UCD Health employees and providers is available via the Employee links.
Clinical research billing is a critical compliance concern for any academic medical center or research organization, and a key component of the Research Compliance program at UCD Health. To ensure compliance with clinical research billing regulations, a patient billing review system was developed and implemented in 2016. This system ("Patient Zero Billing Review") assists researchers in differentiating research-related costs that can be billed to a third party payer or Medicare from those that cannot, particularly when such billing would result in double billing or “double dipping.” For example, if a claim is submitted and paid by a third party payer or Medicare and the study sponsor reimburses for all or some of the same service, this is considered double dipping and may constitute fraud.
More information about the UCD Health Clinical Research Billing Compliance program relevant to employees and providers can be found here.
The Health Insurance Portability and Accountability Act (HIPAA) specifically addresses how protected health information (PHI) can be utilized for research purposes. HIPAA provides that PHI may be used for research as follows:
- With a HIPAA authorization signed by the participant or his/her legal representative;
- With a waiver of authorization from the IRB or the UC Davis Health Privacy Board;
- With a limited data set and a data use agreement;
- If the data is fully de-identified;
- For preparatory to research purposes; or
- For research on decedent data.