Abstract
Nearly 90 % of allegations of biomedical research misconduct in the United States are dismissed by responsible institutions without any faculty assessment or auditable record. Recently, members of the U.S. Congress have complained that the penalties for those against whom findings of research misconduct are made are too light and that too few grant funds associated with research misconduct have been recovered for use by other researchers and taxpayers. Here we discuss the laws that empower federal agencies that can oversee investigations of biomedical research misconduct: the Office of Research Integrity (ORI) and the Office of the Inspector General (OIG), both located within the Department of Health and Human Services (HHS). Research misconduct investigations pertaining to U.S. physical sciences funded through the National Science Foundation (NSF) are overseen by the NSF’s OIG. While OIGs may provide some improvement over the ORI in the handling of research misconduct, we have found that a much more serious flaw exists which undermines an ability to conduct performance audits of the effectiveness by which allegations of research misconduct are handled in the United States. Specifically, sufficient data do not need to be retained by U.S. research institutions funded by HHS or NSF to allow effective audit of why allegations of research misconduct are dismissed before being seen by faculty inquiry or investigative committees. U.S. federal Generally Accepted Government Auditing Standards (GAGAS/Yellow Book), if applied to the research misconduct oversight process, would allow a determination of whether the handling of allegations of biomedical research misconduct actually functions adequately, and if not, how it might be improved. In particular, we propose that independent, external peer review under GAGAS audit standards should be instituted without delay in assessing the performance of ORI, or any other similarly tasked federal agency, in handling allegations of research misconduct.Electronic supplementary materialThe online version of this article (doi:10.1007/s11948-016-9798-6) contains supplementary material, which is available to authorized users.
Highlights
A recent article in the New York Times by two science journalists described the case of a researcher at Iowa State University who was arrested in June of 2014 and charged with four felony counts of making false statements (Marcus and Oransky 2014)
We discuss the laws that empower federal agencies that can oversee investigations of biomedical research misconduct: the Office of Research Integrity (ORI) and the Office of the Inspector General (OIG), both located within the Department of Health and Human Services (HHS)
While OIGs may provide some improvement over the ORI in the handling of research misconduct, we have found that a much more serious flaw exists which undermines an ability to conduct performance audits of the effectiveness by which allegations of research misconduct are handled in the United States
Summary
A recent article in the New York Times by two science journalists described the case of a researcher at Iowa State University who was arrested in June of 2014 and charged with four felony counts of making false statements (Marcus and Oransky 2014). The authors, who are the co-founders of Retraction Watch, noted that, ‘‘Even though research misconduct is far from rare’’, such stringent outcomes are quite unusual for researchers in the U.S.: ‘‘most investigators who engage in wrongdoing, even serious wrongdoing, continue to conduct research at their institutions.’’ It was attention from the press and the U.S senators from Iowa that probably led to the unlikely outcome for this researcher. Nor does ORI lack the means to obtain information from institutions, including those institutions that are non-compliant or not forthcoming Rather, it is more likely the orientation of the ORI towards remediation of scientists found to have engaged in misconduct, and perhaps most importantly, ORI’s conflicted role in support and education of the very institutions it is supposed to regulate with respect to handling misconduct cases, that may have led to the unreasonably lax penalties like the one of which the senator recently complained. We discuss how existing federal government audit standards might be applied to greatly improve the handling of allegations of research misconduct in the U.S In particular, we note that for the over 87 % of biomedical research misconduct allegations which are dismissed without ever progressing to faculty inquiry or investigation, no auditable evidence needs to be retained by responsible institutions or reported to the government
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