title: The Essential Need for Research Misconduct Allegation Audits.
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.
authors.affiliation: Amerandus Research, 1735 Market Street, Suite 3750, Philadelphia, PA, 19103, USA.
authors.forename: Lisa
authors.initials: L
authors.lastname: Loikith
authors.affiliation: Amerandus Research, 1735 Market Street, Suite 3750, Philadelphia, PA, 19103, USA. rbauch@amerares.com.
authors.forename: Robert
authors.initials: R
authors.lastname: Bauchwitz
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D006801:Humans; D012108:Research Personnel / Q000941:ethics*; D015871:Scientific Misconduct / Q000331:legislation & jurisprudence* / Q000639:trends; D014481:United States; D018172:United States Office of Research Integrity
keywords: Audit; Conflicts of interest; GAGAS; HHS; Inspector General; NSF; ORI; Research misconduct; Threats to independence; Yellow Book