“Failure to Investigate” Project

For the past two years, Amerandus Research, with the assistance of fraud investigators at INA, have been collecting information about the cases of, and in several instances contacting, biomedical researchers who believe that allegations and evidence of falsification, fabrication, or plagiarism (including intellectual property theft) they have made were not adequately investigated by their responsible academic institutions or by the federal Office of Research Integrity (ORI), which is supposed to oversee the handling of allegations of biomedical research misconduct at academic entities external to the National Institutes of Health in the United States.
In some of these alleged scientific misconduct cases, pressure was eventually brought to bear by press exposure and even by the intervention of members of the U.S. Congress, but in none was the original process felt by those making the claims to be in accordance with institutional and agency responsibilities. Other cases to be presented in these posts were made in qui tam (U.S. False Claims Act) lawsuits, usually after requests for institutional investigation. In the qui tam cases, which were intended to take a route independent of the institution and ORI, ORI nevertheless often acted as an investigator for the Department of Justice.
We classify these cases under the general rubric of “failure to investigate” (“FTI”), though in some instances an institutional inquiry or investigation may have been made. Therefore, a more accurate term might be “failure to adequately investigate”. What we mean by “adequately”, i.e. by what standards performance should be audited, is presented in a manuscript just completed by our firm. The article we have written, titled, “The Essential Need for Research Misconduct Allegation Audits”, can be obtained in pre-print form from PeerJ while the peer review process is underway. The article is an assessment of U.S. federal law with respect to the handling of allegations of research misconduct in the U.S. A major flaw in extant legal requirements for performance audit is presented in that work. The “allegation audit” manuscript will be also presented in the “News and Analysis” series of posts for convenience.
Selected cases
The intention in this series of posts is to begin to present some alleged research misconduct cases which serve to illustrate the more abstract, law-based arguments made in the article cited above. One goal in particular for subsequent posts within this section of the blog (“Project Data”), will be to present primary documentation that we have found or obtained from the various researchers who have worked with us.
Table 1 attempts to set out a preliminary overview of some of the cases of current interest from the perspective of the performance of the ORI. The responses of the academic institutions are also mentioned, as these are integral to what ORI must oversee in the present research misconduct investigative process.
Nomenclature
We first note that the use of such “case names” in the table or elsewhere in this series of posts does not necessarily imply any findings of liability or guilt. If anyone so named has an objection or wishes to comment in any way, please contact us through the secure forms on this site. We have no interest in engaging in any defamatory activity, and should we learn of any error or other statement made on this site that should be corrected, we will strive to do so in an expeditious manner. We have in several cases in part relied upon documents presented to us by various “whistleblowers”, i.e. researchers and others who have acted as correspondents, plaintiffs, relators, or all of those. Almost always, institutions, agencies, and respondents/defendants have not been responsive. In some cases, even minimal responses from the latter have been of interest and will be presented here as well. We have a relatively deep base of legal support, at least with respect to U.S. law. At this point, we do not address any cases or law external to the United States, although we believe that principles which arise here may be of general relevance elsewhere.
Illustrative cases are identified here using one or more names of respondents, defendants, or other individuals whose behavior or performance may have been in question. The institution is named if there was any claim, including generally a failure to investigate adequately or act ethically, against it by any complainant. If the latter was not the case (to our current knowledge), the institution name, or the claimant’s name, is presented in parentheses to allow simplified reference.
"PI" ("principal investigator") is defined here as the person or persons we believe were most responsible for obtaining and revealing key evidence at issue. "PI" may include laboratory "insiders", external researchers, journalists, government personnel, complainants, plaintiffs, relators, and "whistleblowers".
Finally, we note here that the senior author, Dr. Bauchwitz, remains involved with various aspects of one of these research misconduct cases. We do not see this as any conflict of interest, but rather as an obvious motivation and source of experience to conduct such work. Whether the general analysis is useful can speak for itself; the preprint manuscript submitted to PeerJ on December 3, 2015 referenced above, assessing the need for performance audit in the handling of biomedical research misconduct allegations, does not reference any of these cases.
Table 1. ORI Investigative Oversight Issues

case

name

type

summary

ORI issues claimed

1

Han,
(Iowa State University)
Academic data falsification and grant fraud.
Spiking of research samples related to HIV research. Institutional investigation was initiated based on concerns expressed by external researchers.
Failure to impose strong penalties, retract affected literature, or make self-initiated effort to recover funds prior to press and Congressional attention.
Also, questions arose as to why focusing action against one underling without any consequences for or audit of the head of laboratory’s practices was appropriate.

2

Birge, Kiel, Washington University of St. Louis
Business lawsuit led to request for ORI investigation.
Important evidence was obtained during the discovery phase of a lawsuit. ORI refused to act, but another U.S. federal agency (OHRP) did investigate because of the potential immediate impact on patient health.
ORI failed to ensure adequate investigation of potential NIH grant misconduct or to
ensure correction of the scientific literature. OHRP did investigate and substantiate
plaintiff's concerns.

3

Potti, Nevins, Duke University
Statistical forensic evidence was specifically withheld by
the responsible investigating institution from external review
. No significant action taken until falsehoods in a respondent’s cv were exposed by a journalist/blogger.
Potentially serious risk to patients in cancer diagnosis.
A case for which a completely institution-independent investigation would have been very beneficial in overcoming institutional conflicts of interest.
ORI failure to adequately oversee institutional investigation.

4

Bishayee, Howell, Rutgers University

Data fabrication and falsification qui tam (U.S. False Claims Act) lawsuit.
The case relied on eyewitness testimony, forensic statistics, and new discovery evidence.
ORI failed to ensure adequate investigation or correction of the literature, despite support for the claims from its own statistician.

5

Holloman, Kmiec, Weill Cornell, Thomas Jefferson University

 

Data fabrication and falsification qui tam (U.S. False Claims Act) lawsuit.
Multi-decade, multi-phase grant and publishing research misconduct and grant frauds alleged. The responsible institution testified that it had never investigated any allegation made against the defendants prior to the lawsuit, nor would it do so using new evidence acquired during the legal case. 
Although ORI claimed to have been already investigating one of the defendants, and agreed to participate in a qui tam suit, it failed to adequately investigate both:
1) prior to the suit, ORI apparently did not contact a third party provider for evidence; wrongly claimed no new evidence was likely
to be obtained; and failed to correct erroneous claims of law and science made by its DIO scientists (start point of eucaryotic transcription; FCA scienter);
2) after the suit, ORI did not investigate based on new evidence acquired during the suit upon which there had been no judgment
(evidence which the responsible institution claimed to have brought to its attention); nor did ORI correct fictitious claims of law by the responsible institution (res judicata and use of evidence).
The responsible institution, journal, and ORI have failed to take action to
correct the affected literature despite clear evidence and expert reports indicating data fabrication and falsification, and despite claims that relevant COPE guidelines were to be adhered to by the journal and its
editors.
ORI failed to adequately audit the handling of allegations by responsible institutions; in this case one institution (Weill Cornell) claimed that no allegation against its defendant PI had ever gone before its faculty (as an inquiry or investigation).

6

(Rider), unnamed professor, Boston University
Theft of intellectual property during grant review; subsequent plagiarism likely in
NIH grants.
There was some institutional investigation and support for the allegations. The “respondent” had to withdraw a patent and was required to cite the plaintiff’s research. However, no findings of research misconduct were made.
ORI failed to investigate. An appeal of the alleged failures of ORI to an HHS
administrative judge was rejected on the basis that such reviews were not possible under current regulations.

7

(Taylor) University of Wisconsin
Data falsification and whistleblower retaliation.
The claimant felt pressured by his superior who needed publication for a tenure review to publish data which he believed was not adequately established as sound. Departmental chairman agreed that there appeared to have been questionable practices by the laboratory head (according to transcripts), but the university legal counsel recommended termination of the claimant if he did not acquiesce or resign.
When claimant tried to obtain unemployment payments, the university rejected payment, claiming he had resigned "voluntarily", despite only doing so 30 minutes before he would have been fired. An appeals court ruled in the claimant's favor that he had not voluntarily resigned, thereby forcing the university to pay for his unemployment.
Further legal action obtained some relevant research data (now presented on the PubPeer website). A related article not involving this complainant was retracted.
Alleged failure to ensure that whistleblower retaliation claims were adequately handled. ORI claimed that the allegations did not involve falsification or fabrication, which is disputed by the complainant as to falsification.

 

[end Table 1 part 1]

 

 

 

 

 

 

 

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