For years, misconduct in scientific research was policed primarily by the Office of Research Integrity (ORI) at
the U.S. Department of Health and Human
Services.1 After a lengthy and confidential
review, an institution suspected of producing
false or fraudulent research was either cleared
of the charges or required to issue retractions
and pay back any federal grants that had been
tainted by misconduct.
In recent years, two new players have
entered the field: The Department of Justice
(DOJ) and private whistleblowers. Driven
partly by a University of Iowa scandal that
caught the attention of Sen. Charles Grassley,
the DOJ has become more aggressive in pur-
suing False Claims Act (FCA) cases against
research institutions where researchers have
been accused of misconduct.2 Private whistle-
blowers, sometimes financed by law firms
specializing in such qui tam litigation,
are also bringing suits, galvanized
by the treble damages offered under
the FCA and bounties of up to 30% of
anything the government recovers.
Duke University currently is
facing more than $600 million in
potential damages in an FCA suit
brought by a former lab technician
who alleges another researcher’s
false experimental data was incorporated into grant requests and
progress reports involved in more
than $200 million in grants. 3 A federal
judge in North Carolina allowed the
case to proceed to discovery in April
2017, despite Duke’s arguments the
plaintiff, known as a relator, failed to identify
any grant applications or other claims containing falsified data. Because it failed to “foster
an environment conducive to responsible
research,” the plaintiff argues, Duke is liable.
These new threats force research institutions to confront vexing questions: When does
by Michael Tuteur and Torrey Young
Scientific research misconduct
vs. fraud: How to tell
» The Office of Research Integrity (ORI) has a regulatory framework for research misconduct matters.
» Following ORI regulatory requirements does not shield research institutions from False Claims Act (FCA) liability.
» Understanding when research misconduct creates FCA liability is the first step in protecting a research institution.
» Research misconduct can create FCA liability if the misconduct results in false information submitted in an application that was
material to the government’s decision to fund the research.
» Research institutions may need to conduct parallel investigations to comply with ORI requirements and to mitigate potential
Michael J. Tuteur ( email@example.com) is a Partner and Torrey K. Young
( firstname.lastname@example.org) is a Senior Counsel in the Boston office of Foley &