Available July 11, 2011
Human Subject Research billing is one of the "hot topics" nationally and is being given more and more attention by the U.S. Attorney's Office. A number of high-profile cases have resulted in multi-milliondollar settlements. Research administrators, who are often involved in negotiating agreements or managing post-award activities related to these human research studies, need to understand the issues involved and be prepared to develop procedures to ensure institutional compliance with applicable laws. This session will provide an overview of laws, regulations, and recent enforcement activity related to billing, discuss recent examples of non-compliance (including settlements), and discuss best practices to ensure compliance. Acceptable agreement language related to this type of billing will also be covered.
Program Level: Intermediate
Target Audience: Departmental, Billing and Research Compliance, Pre-Award, Post-Award Financial Administrators
Learning Objectives
Participants will develop a better understanding of, and a resource toolkit for addressing, the following aspects of contract negotiation:
- An understanding of the laws related to billing, as well as familiarity with recent examples of non-compliance and resulting settlements;
- An understanding of the critical role of budget development and fiscal compliance;
- An understanding of institutional policies and procedures that should be in place to ensure compliance;
- An understanding of agreement language related to billing compliance.
Moderator: Jamie Caldwell, Director, Office of Research Services for the Health Sciences, Loyola Medicine, Loyola University Chicago
Panel: Barbara Cole, Associate Vice President for Research Administration, University of Miami; Matthew Staman, Managing Director, Huron Consulting Group; Angela Wishon, Vice President for Research Administration, University of Texas Southwestern Medical Center
