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Nearly ninety percent 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 describe the laws that empower federal agencies which can oversee investigations of biomedical research misconduct: the Office of Research Integrity (ORI) and Office of the Inspector General (OIG), both located within the Department of Health and Human Services (HHS). Research misconduct pertaining to U.S. physical sciences funded through the National Science Foundation (NSF) is overseen by the NSF's OIG. While OIGs may provide some improvement over 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 as to the effectiveness by which allegations of research misconduct are handled in the United States. Federal audit standards (GAGAS/Yellow Book), if applied to the handling of research misconduct, would allow a determination as to whether the handling of allegations of biomedical research misconduct actually functions adequately, and if not, how it might be improved. Specifically, 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.
Minor modifications were made to the introduction after discussion with Ivan Oransky of Retraction Watch. No changes to the original legal and audit related text was made after reviews by two experts with significant U.S. government performance audit experience. One summarized the analysis as "sound" and the other wrote that the manuscript contained "strong and important information. The bottom line is current controls over scientific research need strengthening to ensure the integrity of data and program results. Once identified or alleged the process for review for research misconduct needs to be strengthened.” Results from the first journal review have not yet been received (submission date December 10, 2015).