Structuring a Compensation Framework for Clinical Research

Funding and budgeting for clinical research may implicate a number of state and Federal laws. Given recent changes to the enforcement environment, counsel involved with clinical research operations should have an understanding of and framework for evaluating the implications of financing and compensation decisions for research. Various providers and research sponsors, including hospitals, academic medical centers, physicians and pharmaceutical and medical device companies, have had to pay a steep price to resolve issues and allegations related to improper payments in the context of clinical research.

Listen as our authoritative panel of healthcare attorneys examines the healthcare providers’ role in clinical research and recent trends in compensation and enforcement. The panel will discuss what puts providers at risk and will offer guidance on creating a framework for compensation that complies with federal laws.

1. Physicians and clinical research activity
2. Areas of risk
   1. Stark Law
   2. AKS
   3. Inducements
3. Best practices for creating a framework for compensation
   1. Factors to consider
      1. Sponsor needs and goals
      2. Investigator needs and goals
      3. Regulatory enforcement environment
   2. Role of fair market value in clinical research budgeting

Discussion topics will include specific legal risks and strategies for mitigating those risks, including:

• How the flow of clinical research dollars from sponsors to providers may or may not implicate Federal and state laws, such as anti-kickback laws, self-referral laws, tax exemption requirements for not-for-profit entities, and the Foreign Corrupt Practices Act for parties engaged in international research activities.
• Lessons learned from recent enforcement actions, including the importance of (and factors that determine) reasonable, fair market value research compensation.
• Real world examples, tips and strategies for creating a long term and sustainable regulatory compliance and risk mitigation framework for clients involved in clinical research.