Our manuscript on the importance of employing professional audit principles in the oversight of the U.S. research misconduct investigations, which we originally published in PeerJ Preprints in December 2015, has now been published by Science and Engineering Ethics (“SEE”), a Springer journal.
The core of the article remained unchanged from the preprint. At the request of reviewers, discussion was expanded on some topics, including conflicts of interest and the federal False Claims Act as they related to handling of fraud and research misconduct in the U.S. An expanded Conclusion section summarizes more of the points raised in the paper. For convenience, it is reprinted here:
“There have been recent calls from Congress for the Department of Health and Human Services to recover more funds and provide stronger penalties in biomedical research misconduct cases. Others have suggested that HHS’s Office of Research Integrity be given additional powers in order to accomplish such objectives. As reviewed here, ORI is limited by law in its ability to directly investigate misconduct cases. We also note that ORI could be at risk from a SOX-type conflict of interest between its educational-consulting-support and investigative oversight operations; this too could further limit its willingness to pursue cases. It has been proposed by a U.S. Senator who was involved with the 1986 revitalization of the federal False Claims Act that the HHS’ Office of Inspector General become more involved in biomedical research misconduct cases since it already has law enforcement powers of the type proposed for the ORI.
We believe that one means to resolve several of these concerns would be to move the ORI’s Division of Investigative Oversight into the HHS’s OIG. In this way, federal biomedical research misconduct investigators/overseers would be required to follow federal IG and audit standards, have enhanced law enforcement powers, have a reduced potential conflict of interest with ORI’s educational division, and also have access to Congress, all as now exist for the National Science Foundation’s OIG in its oversight of research misconduct in the physical sciences.
In general, we believe that the GAGAS standards on threats to independence mark a significant step forward in addressing conflicts of interest involving governmental agencies and the entities they oversee. Such standards should be codified into federal research misconduct (and other relevant) laws, and not be limited to professional audit entities which follow GAGAS. One consequence of doing so might be to move away from institutional research misconduct self-investigations.
Importantly, regardless of whether HHS’s OIG is used or ORI’s DIO is retained, performance audits, including by independent third parties, would be of critical value in determining whether an oversight system is actually functioning adequately. At present, however, sufficient data do not appear to be retained to allow effective audit of the handling of most allegations of research misconduct in the U.S. As noted in GAGAS, auditors, like scientists, “must obtain sufficient, appropriate evidence”. Consequently, we believe that there is a pressing need – including in the physical sciences – to retain all evidence related to allegations made of research misconduct and how those allegations were handled prior to a decision to dismiss or pass them on to faculty inquiry. With such evidence, we believe that U.S. federal audit standards exist which would permit appropriate assessment of the handling of research misconduct investigations.”
After the article was accepted for publication in May 2016, the Springer publishing team introduced several errors into the text. In particular, they removed parts of a sentence from the abstract (now restored), and perhaps of greater concern, they appear to have removed most of the quotation marks from indented block text. (No plagiarism calls, please!) We can only hope, in the spirit of the audit principles we espouse in the article, that the Springer publishing company has its own oversight process with internal controls. Such controls would be expected to uncover and correct flawed processes that hinder the company from efficiently and effectively achieving its corporate goals, e.g. presumably the accurate and timely publication of research articles. (However, as to efficiency, it has now been more than two months since the initial errors …).
Springer Update: August 18, 2016:
We are happy to report that shortly after the preceding commentary published above, Springer notified us of a new and much speedier publishing protocol they intended to follow:
“Title: The Essential Need for Research Misconduct Allegation Audits
Please find attached corrected proof of the article for your reference. Hope corrections done are all up to your satisfaction. Kindly check and send us your approval/corrections as soon as possible.
Please send your answers within 48 hours by return e-mail. Speed of response is important to everyone involved in publishing (the author, editor, and publisher), and we are utilizing all the electronic means available to achieve rapid turnaround and publication of material. The two-day deadline for answering questions is important in order to help us guarantee regular and timely publication.
Many thanks in advance for your faster response.
Springer did indeed repeatedly adhere to this enhanced 48-hour turn-around timetable. We also note that they also exhibited flexibility with respect to how notice of corrections were specified to an apparently inadvertent publication of the article without various changes approved by the editor and authors. In brief, they early on agreed, at the request of our editors, and a former editor, that the article not be labeled as a “retraction”, “erratum”, “correction”, or some other such term.
We believe that if a flexible and very timely post-acceptance publishing process can be maintained and generalized for others, we would recommend that authors try Springer as a publisher. Please feel free to reference this page in your own dealings with this publisher. (Of course, bear in mind that, as with almost all scientific publishing, it is most important to obtain good editors and reviewers. We believe we had this with original editor-in-chief of Science and Engineering Ethics, Ray Spier, as well as at least one unnamed reviewer. Dr. Spier’s wife, Merilyn, a former editor, was instrumental in getting the publishing issues noted above resolved.)
A final pdf version
The article is available to the public without further cost though an Open Access program. We provide here a link to the most recent pdf version, which contains all the original edits approved by the editor and authors.
And now for something completely different
In addition to the preceding changes, we had a digression during peer review into an area of grammar that is probably arcane to anyone not employed by the U.S. government. It was an interesting enough investigation in its own right – for those who have a strong drive to use proper grammar, as one of the editors of the paper did – that it was suggested by that editor that we publish our research on the grammatical issues after the article was published. We told the editor we would do so, since at the very least it might save others writing on similar topics from having to perform the same research de novo. So for those with an interest in the grammar of initialisms, the link to why we wrote our article the way we did can be found here.
Robert Bauchwitz is a biomedical research scientist and certified fraud examiner. His research expertise is in behavioral neuroscience and molecular genetics. He was the relator (plaintiff acting on behalf of the government) in a U.S. federal False Claims Act qui tam case involving scientific research fraud. He has obtained additional fraud investigation training from the John Jay College of Criminal Justice and operational audit training from the Institute of Internal Auditors. He also has certifications in litigation support from the Widener University Law School's Legal Education Institute and in network security from CompTIA.