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 patterns in DOJ and HHS Office of Inspector General (OIG) enforcement priorities. Specifically, the presentation analyzes how FCA liability theories, specifically those applied recently to FCA matters arising in the research misconduct context, have placed new burdens on institutions to consider parallel tracts of investigation and addressing concerns in federally funded research projects.
The presentation will also explore the structural gap between the ORI misconduct process and FCA enforcement. While the PHS Final Rule (42 C.F.R. Part 93), as recently updated by ORI's 2024 Final Rule, governs institutional inquiry, investigation, and reporting of research misconduct involving PHS-funded research, FCA investigations operate under an entirely separate legal framework — one driven by civil fraud liability, DOJ prosecutorial discretion, and an expanding community of external whistleblowers and online research integrity platforms. The DFCI settlement illustrates how an institution can simultaneously comply with the pertinent ORI reporting obligations while remaining fully exposed to FCA liability arising from the same underlying conduct.
The presentation will offer concrete guidance on how institutions can best restructure their research integrity oversight infrastructure to address these parallel enforcement priorities in a manner that minimizes institutional exposure for false claims while still meeting their due process and regulatory obligations to named respondents.
For more information, visit the conference website.
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