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April 23, 2014

What is Research Misconduct and Why Should I Care?

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What is research misconduct? (It’s more than you think!)

It is a common misconception that one must make up research data or results to commit research misconduct. Such conduct (known as “Fabrication”) is a common form of research misconduct but it is not the only form. One also commits research misconduct by presenting true data/results in a misleading manner. This form of misconduct (known as “Falsification”) does not involve making up data or results and is, instead, often achieved by unduly emphasizing one portion of data over another or omitting data altogether. Research misconduct also encompasses traditional “Plagiarism,” i.e., appropriating another person’s ideas or words without attribution.

What if I publish a paper with an unintentionally-made mistake in it? Have I committed research misconduct?

Probably not. Federal regulations are clear that “honest errors” do not constitute research misconduct. That is because intent is a required element for a finding of research misconduct, and an “honest error” (i.e., one that is both unintentional and reasonable) negates that element. But this exception does not exempt every unintentional error. An error that results from a researcher’s reckless conduct (i.e., conduct that he/she should have known was likely to result in an error) may constitute research misconduct even if it was technically unintentional. Similarly, a researcher who takes affirmative steps to prevent himself/herself from learning of errors in published research (i.e., remaining willfully blind) cannot claim the “honest error” defense even if he/she did not technically know of the errors.

Can a minor error that does not even warrant a retraction still constitute research misconduct?

Yes. Unlike intent, materiality is not a required element for establishing research misconduct. Therefore, whether the error is significant enough to warrant a retraction of the paper/publication is immaterial to the question of whether research misconduct occurred. But the materiality, or lack thereof, of the error may be relevant as either a mitigating or aggravating factor when determining punishment for research misconduct.

Who monitors publications to identify research misconduct?

The short answer is everyone, but individuals and institutions who receive funding from federal grants are particularly attentive. Federal grants are extremely competitive, which creates an environment that incentivizes researchers to carefully monitor each other and report any suspicions of wrongdoing. In addition, because the federal government imposes significant burdens on grant recipients to monitor, investigate, and report potential research misconduct, institutions are known to be meticulous in monitoring publications for potential misconduct.

How do I know if I’ve been accused of research misconduct?

Research misconduct allegations frequently come from individuals, i.e. colleagues, competitors, or sometimes even collaborators of the accused researcher. And more often than not, the accuser does not raise the allegations with the accused before making a report to the relevant institution or publication. As a result, the accused usually will not learn of the allegations until the initial step of the institutional process, called the “Institutional Inquiry,” in which the institution assigns a committee to perform an initial review of the evidence of research misconduct to determine whether it warrants a formal investigation. Federal regulations require the institution to notify the accused of an “Institutional Inquiry” and allow him/her to comment on the allegations.

What if the institution finds the evidence of misconduct credible?

If the institution finds that the allegations have merit, it will elevate the matter to an “Institutional Investigation,” which entails a more thorough and detailed analysis of the evidence and results in institutional findings as to whether the researcher committed research misconduct in the form of an “Investigation Report.” In doing so, the institution must interview the relevant parties, including the accused researcher, and give the accused an opportunity to comment on the “Investigation Report.” This is a critical stage as it represents the accused researcher’s first opportunity to be interviewed and formally tell his/her side of the story.

What is ORI?

ORI (which stands for the Office of Research Integrity) is the federal body within the Department of Health and Human Services ("HHS") that is primarily responsible for investigating allegations of research misconduct involving federal funds and imposing punishments. An institution must alert ORI any time it conducts an “Institutional Investigation,” and must likewise provide ORI with a copy of its “Investigation Report.”

What authority does ORI have to investigate research misconduct allegations?

ORI’s authority to investigate allegations of research misconduct and make findings is virtually unfettered. Once ORI learns of allegations (usually by virtue of the institution’s “Investigation Report”) it can, among other things: consider or ignore any evidence it wants; obtain additional evidence or information; conduct independent analyses; develop new theories; and, make its own findings. And ORI is authorized to do all of this without notifying the accused researcher or providing him/her with an opportunity to rebut its evidence and findings. In fact, ORI is not required to notify the accused until after it has made its findings in a document called a “Charge Letter.” But by that time ORI has already made up its mind that research misconduct occurred.

My salary is not paid by federal grant money so I am beyond ORI’s jurisdiction, right?

Not necessarily. Although ORI’s primary jurisdictional hook is whether the research in question is federally funded, ORI and federal administrative law judges interpret ORI’s jurisdiction very broadly to include, among other things, all research conducted in a laboratory that receives federal funding, regardless of a specific research project’s funding source. Therefore, even an individual whose specific research (and salary) is exclusively privately funded would still be subject to ORI jurisdiction if he/she conducts that research in a federally-funded laboratory.

For further reading on this subject, please see: Research Misconduct Penalties and How to Avoid Them

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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