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April 29, 2014

Research Misconduct Penalties and How to Avoid Them

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I previously addressed some of the basics concerning what research misconduct is and who investigates it. The following FAQs address the potential penalties that can be imposed on individuals found to have committed research misconduct, and offer suggestions on how researchers can avoid them.

Realistically, what punishments can ORI impose if it finds I committed research misconduct?

The Office of Research Integrity ("ORI") is empowered to impose a wide spectrum of penalties which include issuing a letter of reprimand, suspending or terminating a researcher’s federal grants, restricting a researcher’s activities on federally-funded research projects, and imposing supervision requirements. But by far the most severe penalty ORI can impose is its ability to exclude, or “debar,” a researcher from participating in any way on any federally-funded research for some period of time.

What does a federal “debarment” entail?

Under federal regulations, a “debarred” individual cannot work on federally-funded research nor can he/she receive any assistance from federal grants. This means that a “debarred” individual is not only prohibited from receiving compensation from federal grant money, but he/she also cannot use equipment, laboratory space, office personnel, or any other resources that are paid for in whole or in part with federal funds. All “debarments” are also publicized by the federal government by listing the “debarred” individual on the Excluded Parties List System and summarizing his/her offending conduct in the Federal Register.

“Debarments” sound like they are potentially career-threatening; ORI must only impose them on the worst offenders, right?

The worst research misconduct offenders can certainly expect ORI to pursue a lengthy, possibly even permanent, “debarment” against them. But the federal government is, appropriately, very protective of its grant money, so shorter “debarments” are a fairly common punishment for anyone ORI finds has committed research misconduct, even those who do not believe their conduct was particularly egregious. Federal regulations do provide ORI with the discretion, though, to lengthen or shorten any “debarment” depending on the seriousness of the conduct and the existence or absence of mitigating or aggravating factors.

Can I appeal ORI’s findings and punishment to a judge?

Federal regulations allow an individual to contest research misconduct findings by requesting a hearing before a Department of Health and Human Services ("HHS") Administrative Law Judge ("ALJ") if he/she can demonstrate that there is a genuine dispute over facts that are material to ORI’s findings, but in practice this has proven to be a very high threshold to satisfy. Since the adoption of the current regulations in 2005, HHS ALJs have consistently denied requests for a hearing to contest ORI research misconduct findings. By way of illustration, in 2012 a researcher whose request for a hearing was denied had to file and win a landmark lawsuit against HHS in Federal Court to overturn that denial and be granted a hearing request.

Given the severity of the potential punishments and the difficulty in obtaining a hearing, what can I do to help myself if I am accused?

There is no question that accused researchers face severe, potentially career-threatening consequences if ORI determines they committed research misconduct. And there is also no question that defending yourself against research misconduct allegations gets progressively harder as your institution and then the federal government make findings against you. In this sense, research misconduct proceedings have a tendency to snowball, which makes it imperative for accused researchers to retain counsel who has experience defending research misconduct allegations at both the institutional level and federal administrative level as early in the process as possible, and certainly well before ORI begins investigating and making findings.

How soon is too soon to get an attorney involved?

As a general rule, it is never too soon to get counsel involved. But at the very latest, an accused researcher should consult an attorney as soon as he/she becomes aware that institutional proceedings are underway. Institutional proceedings present the first opportunity for the researcher to offer his/her version of events, and once he/she does so that explanation becomes etched in stone for the remainder of the case. Accused researchers put themselves at a serious disadvantage when they commit themselves to facts without consulting with counsel and understanding the ramifications of those admissions and denials. Even when an accused researcher hires an attorney later in the process, as is often the case, the damage can already be done if admissions in that initial statement hinder or preclude the later-hired attorney’s ability to advocate for dismissal of the charges or for a more lenient punishment.

What can I do to protect myself from research misconduct allegations when I am actually performing the research?

Simply put, when conducting research you should do everything in your power to maximize accuracy and thoroughness. Not only will this reduce your chances of making a mistake, but it will provide a solid foundation for defending yourself on “honest error” grounds (as discussed in What Is Research Misconduct and Why Should I Care?) if you do make one. More practically speaking, if you are ever accused of research misconduct there are two things you will most wish you had done: document everything thoroughly, and check your work.

Why is thorough documentation so critical to defending research misconduct allegations?

Research misconduct cases often turn on small details, and being able to trace those details may well be the key to disproving allegations that an error was intentional or the product of reckless conduct. It is difficult enough for a researcher to keep track of research details at the time the research is being conducted, much less months or possibly even years later when research misconduct proceedings often arise. Without thorough documentation an accused researcher may not be able to explain his/her conduct which—in the context of a research misconduct investigation—may be viewed as an admission of wrongdoing.

How can checking my work help me defend myself against research misconduct allegations if those checks failed to uncover the error?

As an initial matter, the more carefully you check your work the less likely you are to make a reckless error that can lead to research misconduct findings. But more importantly, by carefully checking your work and painstakingly documenting those checks you can build a strong foundation for establishing the “honest error” defense if a mistake does slip through. Just as doctors are urged to practice “defensive medicine” in order to protect themselves against lawsuits, scientists should practice “defensive research” by taking all steps to document and double-check their work in case it is called into question later.

About the Author

Callan Stein

Callan Stein is an associate in Donoghue Barrett & Singal’s Boston office. He regularly represents small and large businesses in litigation and general corporate matters. You can follow him on Twitter at @CallanSteinEsq

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