Institutional Officials and HRPP Leadership Track
Breakout Session Series E
E09 - Ethical and Operational Issues Related to Clinical Trial Billing: What HRPPs and IRBs Should Consider
Keren Dunn, CIP
Associate Director, Research Compliance & Quality Improvement
Cedars-Sinai Medical Center
F. Lisa Murtha, Esq., CHC, CHRC
Senior Managing Director and Practice Leader
FTI Consulting
Ann Rodavitch, MA
Director Protocol Activation, Review and Human Research Protection Program
Memorial Sloan Kettering Cancer Center
Speaker(s)
In an increasingly complex clinical research environment, HRPPs must recognize the importance of accurate and appropriate clinical trial billing both in the context of minimizing financial harm to human subjects involved in research, as well as promoting and maintaining institutional regulatory compliance. During this session, speakers and attendees will:
Learning Objectives:
- Provide a brief overview of the Centers for Medicare and Medicaid Services clinical trial billing requirements
- Examine the implications of the Centers for Medicare and Medicaid Services requirements as they apply to the ethical review of research, particularly the review of revised informed consent requirements
- Illustrate best practice to integrate Medicare Coverage Analysis with IRB review of research