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Fraud and abuse risks associated with research misconduct

Laura J. Campbell (ljcampbell@houstonmethodist.org) is Senior Business Practices Analyst and R. Patrick Weitzel (rweitzel@houstonmethodist.org) is Program Director, Office of Research Integrity, at Houston Methodist Research Institute in Houston, TX.

Research misconduct proceedings focus primarily on fabrication, falsification, and plagiarism in scientific and medical research; research practices that seriously deviate from commonly accepted methods within the relevant scientific community may also yield research misconduct concerns. (Honest errors or differences in interpreting data do not constitute research misconduct. Research is not limited to published data; it also includes proposing, conducting, and recording research.)

The institution receiving a federal research grant is the grantee of those public health service grant funds and has legal and financial accountability for those awards.[1] Grantee institutions are obliged to assure that their researchers produce accurate supporting data for funded programs and grant applications.[2] In addition to the U.S. Department of Health & Human Services, other federal agencies may distribute research grants; for these grants, grantee obligations are substantially identical.

Grantee institutions are required to have policies in compliance with federal guidelines as a condition of applying for and accepting any award.[3] Research misconduct inquiries and investigations are usually conducted using institutional procedures. If public health service funds are involved, institutional findings will be forwarded to the Office of Research Integrity (ORI) for evaluation and possible imposition of additional sanctions. (Public Health Service grant misconduct is overseen by the ORI; misconduct associated with the National Science Foundation-funded research is the responsibility of the National Science Foundation Office of Inspector General.) Upon determination that research misconduct has occurred, ORI typically issues administrative sanctions, such as debarment from federally funded research, supervision requirements, and/or retractions of compromised data and publications.

Where there is evidence of civil or criminal fraud, ORI must promptly relay those allegations to the U.S. Department of Justice, the Office of Inspector General, or other investigative bodies. A few recent cases have demonstrated that research misconduct may implicate potential violations of fraud, waste, and abuse laws and regulations.

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