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Research Misconduct Litigation

An Overview

Every year the federal government gives away hundreds of millions of dollars in grant money to fund medical research at healthcare institutions across the country. The majority of these grants are issued through the National Institute of Health, a division of the Department of Health and Human Services (“HHS”), which, like most branches of the federal government, is very protective of its assets and goes to great lengths to ensure they are utilized properly by the grantee. This includes ensuring that individuals working on federally-funded research do not fabricate, falsify, or plagiarize their results, all of which fall within the federally-defined offense of research misconduct (also known as scientific misconduct). The federal government has an office within HHS—the Office of Research Integrity (“ORI”)—dedicated to ferreting out and punishing individuals who commit research misconduct.

Representative Matter: DBS attorneys on a landmark federal lawsuit against the U.S. Government to overturn a debarment order based on findings of research misconduct and remand the case for the first administrative hearing on research misconduct charges since 2005

It is a common misconception among researchers that research misconduct proceedings are not a serious matter. In reality, the exact opposite is true. A researcher who is found to have committed research misconduct will usually be debarred by HHS from participating in any federally-funded research for several years, if not permanently. Given the high percentage of research that is funded at least in part by federal funds, debarments have effectively ended researchers’ careers by making them, for all intents and purposes, unemployable. And this is even before anyone considers the stigma within the scientific community that accompanies a finding of research misconduct. Given these serious consequences, researchers who are accused of research misconduct should retain legal counsel to defend them against those allegations at the very outset of the process.

Because the federal government requires institutions who host federally-funded research to effectively screen research misconduct allegations by conducting an “inquiry” process, all research misconduct proceedings will begin at the institutional level. The institutional inquiry process will determine whether the allegations of research misconduct are credible. If so, the institution must proceed to a full-scale investigation, the result of which will be a written report that concludes whether any research misconduct occurred. Even though these inquiry and investigation processes are entirely internal, i.e. they take place completely within the institution, they are very serious matters and should be treated as such by accused researchers because the trigger mandatory reporting requirements to the federal government which can result in debarments. Although the federal government (i.e., ORI) has the authority to conduct its own investigation and/or review the institutional findings, in virtually every instance in which an institution finds a researcher guilty of research misconduct ORI will choose to adopt those findings and levy punishment accordingly. Thus, researchers defending themselves against research misconduct allegations to avoid potentially career-threatening punishments must do so at the institutional level. By the time the federal government gets involved it is often too late.

Representative Matter: DBS attorneys represented a university scientist who was ultimately vindicated after being wrongly accused of falsifying data by a colleague, the Secret Service, and a U.S. Congressional Committee.

For most researchers the two most important things are their reputation and their ability to obtain federal grants and work on federally-funded research projects. Research misconduct allegations imperil both of these things. Although the early stages of research misconduct investigations (which take place within an institution rather than a court) may appear informal or trivial, especially when compared to other federal fraud investigations, the determinations that are made in those early, institutional stages are often almost impossible to overturn and, therefore, usually stay with the case through its conclusion. In this sense, research misconduct proceedings have a tendency to snowball, making it absolutely critical for accused researchers to engage counsel who has experience litigating research misconduct cases at both the institutional setting and before ORI.

Kelly McGee and Callan Stein prepared this overview.

Health Law

Health Law




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