research cross the line from sloppy or even
deliberately false, to a potential FCA violation? And how early must administrators and
lawyers intervene to prevent the former from
becoming the latter?
Under the traditional ORI process, investigations are delegated to the institution itself,
which relies on “fact finders” — typically
scientific experts — to determine whether misconduct has occurred. The primary goal is to
remove bad science from the published literature. Helping the government recover federal
grant money is secondary.
Because the ORI process can take several
years or more, it can expose an institution to
hefty FCA fines if misconduct is proven at the
end. Every dollar the institution accepts after
the initial referral to ORI could be subject to
treble damages unless the institution halts federal funding immediately. And while the ORI
process is predominately a scientific inquiry,
an FCA investigation is primarily a legal one,
with an emphasis on non-scientific concerns
such as the preservation of evidence and due
process. So at the initiation of an FCA investigation, administrators may face the terrible
Hobson’s choice of either giving researchers
the benefit of the doubt through a confidential and scientifically-driven investigation, or
cutting off funding immediately, potentially
spelling the end of a lab and its workers.
Unfortunately, there are no firm rules to
distinguish scientific misconduct from deliberate fraud, but experience suggests some basic
principles. The National Institutes of Health
defines research misconduct4 as:
· Fabrication — Making up data or results
and reporting them.
· Falsification — Manipulating research
materials, equipment, or processes, or
omitting data so that the research isn’t
accurately represented in the record.
· Plagiarism — Appropriating another person’s ideas, processes, results, or words
without appropriate credit.
Importantly, research misconduct does not
include honest error or differences of opinion.
Experts involved in ORI investigations must
perform meticulous analyses of the research,
first to determine whether it includes false
data and then whether that data was falsified
deliberately or through carelessness, sloppy
technique, or merely the inevitable errors
that occur when scientists are operating at
the cutting edge. Plagiarism is always a serious violation that requires immediate action,
although it may not have any implications
under the FCA.
How does the FCA define a violation? In
theory, any incorrect statement made to the
government when requesting payment for
goods or services can give rise to an FCA penalty, but the U.S. Supreme Court has narrowed
that to statements that are material to obtaining
payment. In Universal Health Services v. U.S. ex
rel. Escobar, the high court stated the FCA is
not “an all-purpose antifraud statute” and isn’t
intended to punish “garden-variety breaches
of contract or regulatory violations.” 5
In the context of medical research, that
means errors and even negligence probably
don’t rise to the level of an FCA violation.
Some labs are incredibly sloppy, and that’s
inexcusable on a professional level. But,
the FCA comes to bear only if the institution knowingly allows false information to
be included in a federal grant proposal or
some other request for payment. A postdoc
who runs off the rails and plagiarizes or
Photoshops microscope images to get the
results she wants may not implicate FCA if
her misconduct was discovered and wasn’t
incorporated in grant proposals. A principal