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Nov 30
2009
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Research Ethics:
Is misleading data "fraud"?
Reader Question: As PIs, we understand of course that research fraud is intolerable. However, at times misleading data could be reported to a journal or sponsor merely because of a serious, though fully accidental, mistake in recordkeeping, faulty statistical calculations etc. Does such a mixup constitute "fraud"? What is the difference in the eyes of granting agencies and legal doctrine? When and how does "accident" cross over to PI "crime"?
Expert Comments:
The U.S. Public Health Service Policies on Research Misconduct, 42 CFR Part 93, state that research misconduct does not include honest error or differences of opinion (§ 93.103(d)). The misconduct must be a significant departure from accepted practices, and it must be committed intentionally, knowingly or recklessly (§ 93.104).
However, the respondent, i.e., the person accused of the misconduct, has the burden of proving "affirmative defenses" (§ 93.516) to the conduct alleged. In other words, the respondent has to prove that, even if the factual allegations are admitted or proven, there is some other justification or excuse for the action that would limit or eliminate his or her culpability. For example, he or she made an honest and reasonable error or mistake.
The level of intent needed for culpability under these regulations gives guidance as to whether accidents, mistakes, faulty calculations, or other “mixups” should constitute research misconduct. Intentional acts are those where the person has a conscious objective to engage in the conduct that caused the offensive result. Knowing acts are acts in which the alleged offender is aware of the nature of the conduct and the fact that it will almost certainly cause the offensive result. Reckless acts are those in which the person acts with a conscious disregard of a substantial and unjustifiable risk that the offense will result from the conduct. Reckless acts exhibit a gross disregard for the standard of conduct that a reasonable person would observe.
From the preceeding common interpretations, it could certainly be argued that a mere act of negligence or inadvertent mistake, without circumstances that would point to a significant departure from and disregard of accepted practices in the profession, should not constitute the level of intent needed to prove research misconduct under the PHS regulations..
Comments by Kendra Dimond, JD and Leslie Platt, JD. Ms Dimond is a Director at Daylight Forensic and Advisory LLC, Washington, DC. Mr. Platt is a Managing Director at the firm, and leader of its Healthcare Practice. Ms. Dimond is a former Counsel to the NIH Office of Scientific Integrity, and former Acting Director of NIH's Office of Legislative Policy and Analysis. Mr. Platt is a former Deputy General Counsel-Legal Counsel in HHS and former Executive Assistant to the Director and Chief of Operations, Office of the Director, NIH.
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That aside, if erroneous data or interpretation and conclusions get published, an honest scientist must somehow make it known, and if the conclusions are of some consequence, the retraction must be as conspicuous as the original. So, perhaps another paper in which the purpose of the experiment is summarized, the error (made by the computer, of course) is explained, and the correct interpretation provided. Additional data confirming the correct interpretation would be helpful.
Of course, if the data were fabricated and the originator doesn't own up to it, it is up to someone more senior than the authors (the department chair, the Dean, the editor, ...) to point out the fradulent nature of the published article. Subsequent manuscripts by that author will be suspect and probably never published. Such is the just reward for intentional fraud by a non-repentant scientist. Unfortunately, sometimes the institution wants to be rid of the discovered fraudulent scientist and provides a high recommendation to another institution, andnever reveals the fraud. There is double shame.
