False Claims Act: A Primer and Guide for Research Organizations

This module introduces the False Claims Act (FCA), including the scope of FCA liability, the role of “whistleblower” or “qui tam relator,” and penalties available under the act. Learners will also review civil monetary penalty (CMP) liability and the penalties available under the Civil Monetary Penalties Law (CMPL). The module concludes with a discussion on the applicability of both FCA and CMPL to federally funded research.

Recommended Use: Required
ID (Language): 20026 (English)
Author(s): Keri Godin, MS - Brown University; Valerie H. Bonham, Esq. - Ropes and Gray, LLP; S. Susan Zhu, Esq - Ropes and Gray, LLP

The threat of False Claims Act (FCA) liability or costs to defend FCA claims has compelled some academic and clinical research organizations to develop more robust internal controls and dedicate resources to building effective compliance and research integrity programs. This module explores risk indicators for potential FCA and civil monetary penalty vulnerabilities, including areas of potential risk for research organizations accepting federal funds. The module concludes with practical ways to mitigate risk.

Recommended Use: Required
ID (Language): 20027 (English)
Author(s): Keri Godin, MS - Brown University; Valerie H. Bonham, Esq - Ropes and Gray, LLP; S. Susan Zhu, Esq - Ropes and Gray, LLP

Even organizations that have implemented appropriate safeguards are not immune to the emerging risk of False Claims Act (FCA) liability and civil monetary penalty (CMP) vulnerabilities. They must establish and, if warranted, implement a plan for self-reporting when confronted with activities involving federal research dollars that may constitute fraud. Organizations must be prepared to respond when an FCA or CMP allegation is brought to light, either through self-discovery or an externally-initiated investigation. This module discusses potential benefits and drawbacks of self-disclosure, practical considerations for responding to government requests, and the role of counsel in helping organizations navigate FCA and CMP actions.

Recommended Use: Required
ID (Language): 20028 (English)
Author(s): Keri Godin, MS - Brown University; Valerie H. Bonham, Esq - Ropes and Gray, LLP; S. Susan Zhu, Esq - Ropes and Gray, LLP