Abstract
Following its determination of a finding of scientific misconduct the Office of Research Integrity (ORI) will seek redress for any injury sustained. Several remedies both administrative and statutory may be available depending on the strength of the evidentiary findings of the misconduct investigation. Pursuant to federal regulations administrative remedies are primarily remedial in nature and designed to protect the integrity of the affected research program, whereas statutory remedies including civil fines and criminal penalties are designed to deter and punish wrongdoers. This commentary discusses the available administrative and statutory remedies in the context of a specific case, that of former University of Vermont nutrition researcher Eric Poehlman, and supplies a possible rationale for the legal result.
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Notes
The term “institution” includes any individual or person that applies for or receives PHS support (70 FR 28387). Prior to June 16, 2005 “institution” was defined as the public or private entity or organization (including federal, state, and other agencies) that is applying for financial assistance from PHS (42 CFR §50.102).
Effective July 16, 2005 ORI revised and updated its regulation pertaining to scientific misconduct. The regulation “Public Health Service Policies on Research Misconduct” is codified at 42 CFR Part 93. Prior to this time and during the Poehlman case the antecedent regulation, “Responsibility of PHS Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science” codified at 42 CFR Part 50 Subpart A, was in effect. The basic institutional approach for responding to allegations of misconduct is essentially the same in both regulations.
A thorough discussion of research fraud in health care may be found in Fabrikant et al. (1996), Chapter 2 Section 4 which is titled “Research Fraud”.
For example the government charged Eric Poehlman under U.S. Code Title 18, entitled Crimes and Criminal Procedure, which in relevant part states: “§1001 Statements or entries generally”. []… whoever, in any matter within the jurisdiction of the executive, legislative, or judicial branch of the Government of the United States, knowingly and willfully
(1) falsifies, conceals, or covers up by any trick, scheme, or device a material fact;
(2) makes any materially false, fictitious, or fraudulent statement or representation; or
(3) makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry;
shall be fined under this title, imprisoned not more than 5 years, … or both.
See e.g. 18 USC §287 (false, fictitious or fraudulent claims), 18 USC §1341 (mail fraud), 18 USC §1343 (wire fraud), 18 USC §1347 (health care fraud).
See 31 USC §3729 (false claims); 31 USC §3730 (civil actions for false claims). A “qui tam” lawsuit joined by the federal government was brought against Eric Poehlman under these statutes.
U.S. attorneys as part of the U.S. Department of Justice prosecute crimes committed against federal agencies.
References
Code of Federal Regulations (CFR). (2004). Title 42, Part 50, Subpart A, Section (§)102.
Code of Federal Regulations (CFR). (2009). Title 42, Part 93, Sections (§§) 307–317, 400–408.
Dahlberg, J. E., & Davidian, N. M. (2010). Scientific forensics: How the office of research integrity can assist institutional investigations of research misconduct during oversight review. Science and Engineering Ethics. doi:10.1007/s11948-010-9208-4.
Fabrikant, R., Kalb, P. E., Hopson, M. D., & Bucy, P. H. (1996). Health care fraud enforcement and compliance. New York, NY: Law Journal Press.
Federal Register (FR). (2005). Vol. 70, pp. 28387 (17 May).
Poehlman v. University of Vermont, et al. (2001). No. 2:01-CV-120, Paper 1, Complaint, pp. 1 and 6 (D. Vt. 16 Apr).
Poehlman v. University of Vermont, et al. (2005a). No. 2:01-CV-120, Paper 34, reply memorandum of United States, Exhibit 1 (Transcript) pp. 47 (D. Vt. 23 Nov).
Poehlman v. University of Vermont, et al. (2005b). No. 2:01-CV-120, Paper 34, reply memorandum of United States, Exhibit 1 (Transcript) pp. 54 (D. Vt. 23 Nov).
United States Code (USC). (2009). Title18, Sections (§§) 287, 1001, 1341, 1343, 1347, 3729, 3730.
United States v. Poehlman. (2005). No. 2:05-CV-66, Paper 2, settlement agreement and stipulation and order for entry of judgment (D. Vt. 21 Mar).
United States v. Poehlman. (2006a). No. 2:05-CR-38-01, Paper 26, judgment in a criminal case (D. Vt. 30 June).
United States v. Poehlman. (2006b). No. 2:05-CR-38-01, Paper 20, sentencing memorandum by Eric T. Poehlman, pp. 17–19 (D. Vt. 21 June).
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Tilden, S.J. Incarceration, Restitution, and Lifetime Debarment: Legal Consequences of Scientific Misconduct in the Eric Poehlman Case. Sci Eng Ethics 16, 737–741 (2010). https://doi.org/10.1007/s11948-010-9228-0
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DOI: https://doi.org/10.1007/s11948-010-9228-0