UAB is committed to proper stewardship and ensuring that charges associated with clinical services are charged to the appropriate party as required by applicable laws, regulations, contractual obligations, and sound clinical research billing practices. This policy, in addition to the responsibilities and processes outlined in Appendix A, establishes uniform requirements for billing clinical services for participants in research studies, in which claims to themselves or third-party payers may be generated for items or services designated as part of a research protocol and billed through the UAB Health System Offices.
This policy applies to all operating units of UAB, including all of its clinical facilities ("UAB Medicine"), and individuals conducting Clinical Research Activities.
Clinical Research Activities are defined as research studies, trials, or projects that enroll and/or treat research participants, which may result in any charges that the facility could apply to a patient, the patient's medical insurer (including but not limited to government programs), and/or other sources. Clinical Research Activities may be sponsored by various entities, including extramural industry, non-profit, or governmental funding, and/or private sources outside the facilities, as well as internal funds.
UAB is committed to submitting charges to appropriate parties for Clinical Research Activities that are in compliance with applicable state and federal laws, regulations, and contractual obligations. Individuals involved in conducting Clinical Research Activities must comply with this policy and the responsibilities and process outlined in Appendix A.
Failure to adhere to this policy or the responsibilities and process outlined in Appendix A may result in corrective and disciplinary action including, but not limited to, suspension of study activities, suspension of billing to participants and third parties and reassignment of claims from billing entities to research accounts. Further, confirmed violations of this policy or failure to adhere to the responsibilities and process outlined in Appendix A by individuals will result in consequences commensurate with the offense, up to and including termination of employment, appointment, student status, or other relationships with UAB.
The Dean for the Heersink School of Medicine is responsible for implementation of this policy as it pertains to the Clinical Trials Administrative Office and investigators. The Vice President for Research is responsible for implementation of this policy as it pertains to UAB central research administration units. The CEO of UAB Medicine is responsible for implementation of this policy as it pertains to UAB Medicine clinical facilities and billing offices.
