Elizabeth McEvoy presents “Beyond the Ori Process: False Claims Act Liability and the Evolving Landscape of Government Scrutiny Over Academic Research Integrity” at the MeRTEC Three I's Biosecurity and Research Integrity conference, which runs from April 27 to 30.
The federal government's use of the False Claims Act (FCA) as a tool to address research misconduct at academic and medical research institutions has shifted dramatically over the past decade, culminating in a wave of high-profile settlements that signal an enforcement environment well beyond the scope of the Office of Research Integrity (ORI) process prescribed under the Public Health Service (PHS) Act and its implementing regulations. The December 2025 settlement between Dana-Farber Cancer Institute (DFCI) and the Department of Justice (DOJ) — in which DFCI agreed to pay $15 million to resolve allegations that researchers submitted materially false statements and certifications in connection with NIH grant applications and published scientific articles containing duplicated and manipulated images — represents the latest, and perhaps most instructive, milestone in this trend. Notably, the case was initiated not through an institutional research misconduct complaint or ORI referral, but through a qui tam action filed by self-described internet sleuth-turned-FCA whistleblower.
This presentation examines a series of significant FCA settlements involving academic research institutions and identifies emerging...
Although on appeal the court distinguished that there was new information in the claim, the court ultimately found the new information was not material, nor was it plead with particularity. The U....