Summaries of Closed Inquiries and Investigations - 1994

Fabrication: A co-author alleged that her colleague had fabricated a figure in a manuscript submitted for publication. An investigation conducted by the institution determined that the disputed figure was not a true representation of the experimental data. The respondent explained that the figure was a montage containing twelve lanes, four lanes for each of three proteins. The respondent said final workprints for six lanes were initially provided to the artist for mounting while a second set of experiments were conducted to obtain satisfactory workprints for the other six lanes. The artist testified that while he was waiting for the second set of workprints he completed the figure by using interim workprints in a paste-up. He said he intended to replace the interim workprints with the final workprints which he never received. The second set of experiments was conducted by a fellow in the laboratory and the results were presented to the photographer who apparently did not provide the artist with final workprints. The respondent did identify original autoradiograms and workprints for 11 of the 12 lanes. Other figures in the original manuscript confirmed results illustrated in three of the lanes. The data in the disputed figure were also confirmed in a replication of the original experiments by another co-author of the paper. The investigating committee concluded that the respondent failed to exercise proper oversight in coordinating activities related to data presentation in the manuscript, but did not fabricate the data in the figure. ORI concurred with the institution's finding of no research misconduct.

Fabrication: A technician in a clinical trial was charged with fabricating data on a subject form. Subject forms could not be completed unless the subject visited the medical center because the study protocol required specialized procedures to be followed in obtaining repeated measurements. The respondent completed the form with single measures of blood pressure and weight obtained from the subject during a phone conversation. She said she was advised by the study coordinator to complete the form in this manner. An institutional investigation concluded that the respondent had made a serious misjudgment in failing to follow the protocol methodology. The committee found no attempt to deceive because the respondent indicated on the form that the data were obtained by phone. She also volunteered this information in a phone conversation with the data coordinating center. The data were withdrawn from the study database. The committee concluded that the technician was inadequately supervised. A data audit conducted by the data coordinating center found additional errors and concluded that the medical center staff was careless in data collection and correction. ORI concurred with the institution's finding of no research misconduct.

Falsification: A laboratory chief alleged that a postdoctoral fellow falsified data in several figures contained in a manuscript prepared for publication and an abstract submitted to a scientific meeting. The complainant filed the allegation after the respondent, who had returned to his native country, had failed to adequately answer questions raised by the complainant. An institutional investigation found that in one figure the dot blot was presented upside down and backwards, the concentrations cited in the legend were incorrect, and the normalization probe was misidentified. In another figure, the dot blot was cut to eliminate a lane that did not support the hypothesis, but the cut was so obvious that it would not deceive others. In a third figure data were attributed to the wrong experiment. The respondent claimed he made the errors because he did not adequately understand the studies he was conducting and he was under great pressure to complete the manuscript before returning home. The investigation committee concluded that the problematic figures represented extremely sloppy preparation of the manuscript and abstract rather than deliberate attempts to deceive. The manuscript was not submitted for publication and the abstract was withdrawn. ORI concurred with the institution's finding of no research misconduct.

Falsification: A research assistant professor was charged with falsifying his credentials in grant applications to NIH for 11 years by claiming he had a bona fide Ph.D. from Northwestern University in Illinois. An institutional inquiry concluded the respondent misrepresented his credentials because the respondent held a mail-order doctorate from Northwestern College of Allied Sciences in Tulsa, Oklahoma which was never licensed or accredited by the Regents of Higher Education of the State of Oklahoma. However, the institution considered this misrepresentation to be academic misconduct and not research misconduct. ORI determined that the misrepresentation fell under the PHS definition of research misconduct and initiated an investigation. ORI concluded that it could not be determined by a preponderance of the evidence that the respondent was responsible for the submission of the false credentials in the NIH grant applications. The respondent provided the institution with a transcript and certificate from Northwestern College showing the awarding of the Ph.D. in 1976. Subsequently, material submitted with grant applications listed the respondent as having a Ph.D. from Northwestern University in Illinois. The respondent said he did not prepare nor did he see the materials submitted with the applications. ORI concluded that it was credible that the persons responsible for the administration of the grant applications had completed these forms for the respondent without his review or approval. The excess personnel costs charged to grants for the respondent's services were part of a $219,686 repayment the institution made to NIH.

Falsification: An anonymous letter charged a professor with falsifying data in several publications. In the first allegation, the respondent was charged with using the same figure to represent the outcome of different experiments in two publications. An institutional investigation examined the original data and found unequivocal differences in the two experiments. However, when the graphs were photographically reduced, the figures appeared quite similar, but not identical. The second allegation claimed the respondent falsified the recovery of H3-labeled norepinephrine because he claimed the same recovery for different experiments published in different journals. The investigation found that a standard recovery rate was determined for each batch of H3-norepinephrine and that rate was cited for every experiment using material from that batch. The third allegation claimed the respondent cited the same recovery rate for experiments using 10 and 20 nanograms of material. The investigation concluded that citing these amounts was an error because 20 micrograms of material was consistently used for standardization. ORI concurred with the institution's finding of no research misconduct.

Falsification:

A reviewer noticed that a grant application submitted by the respondent in 1992 had a figure depicting the effects of one compound on platelet aggregation that was very similar to a figure in an application the respondent submitted in 1991 that showed the effect of another compound on platelet aggregation. ORI asked the institution to look into the matter. During an enFalsification: Asuing investigation, the respondent said that he had given an unlabeled figure which he thought represented the effects of the compound that was reported in the 1992 application to an artist for labeling. However, the figure actually represented the effects of the compound reported in the 1991 application. The original recordings for both compounds were obtained by the investigation committee and the experiments were independently replicated. The investigation committee concluded that the falsified figure was the result of an error. The committee also concluded that the failure of the respondent to adequately check the figures when they were initially called into question by the reviewers represented professional negligence and constituted research misconduct under the institution's standards. ORI concurred with the institution's finding of no research misconduct under the PHS definition.

Falsification:

Senior collaborators alleged that the respondent had falsely claimed success with a technique in a grant application despite the absence of data to support his conclusions. In the application, the respondent reported success in an important pilot experiment using the technique and cited the data shown in an accompanying figure. However, the figure was not included in the application. The institutional investigation committee found that the respondent had been asked by NIH to provide the missing figure. The respondent told NIH that he had removed the figure because the experiment he conducted at another institution was flawed but he had forgotten to remove the text referring to the figure. Instead of the requested figure, the respondent furnished NIH with data from a different but closely related experiment conducted by a prospective collaborator. The respondent told the investigation committee that the text citation of the figure was simply a "placeholder" for results of planned experiments. The investigation committee found the respondent's practice of using "placeholder text" to be highly inadvisable and concluded that the respondent had been extremely negligent in allowing the "false text" to be submitted to NIH. ORI concurred with the institution's finding of no research misconduct.

Falsification:

Two researchers alleged that the respondent had falsified research affecting a significant public health issue through biased selection of control variables and subjects and falsification of methodology and results. An institutional investigation concluded that the respondent had not biased the research results. However, the investigation committee recommended that the respondent correct the description of the study procedures that had been published and make the complete data set available to any interested scholar. In reviewing the case, ORI found that the study procedures were inaccurately reported and that three points were misplotted on a graph supporting the hypothesis. ORI concluded that this evidence was insufficient for a finding of research misconduct, so it accepted the institutional determination and supported the committee recommendations.

Falsification:

A research nurse alleged that a researcher used inappropriate criteria for randomization and exclusion of patients in a clinical trial. An institutional inquiry concluded that the methods used by the researcher in conducting the trial were inadequate but did not constitute research misconduct. The inquiry committee noted that problems of bias are often encountered when a clinical study is conducted by a single investigator, especially when randomized patients are disqualified retrospectively and the eligibility criteria of the study are changed as the trial progresses. The study was underway for seven years when the allegations were made. The inquiry committee concluded that the study did not reflect the research standards of the institution. It recommended that a manuscript be revised to include all patients registered in the study with detailed explanations of why some cases were excluded and that the work of the researcher be monitored for a minimum of three years. OSI opened an investigation because it found that available evidence indicated that further investigation was warranted. After a panel of experts reviewed the case, ORI concluded the researcher had little or no training in clinical trial design or methodology, nor understanding of the profound effect that retrospective exclusion could have in biasing the results of a small study. ORI accepted the finding of the institutional inquiry and closed its investigation.

Falsification:

A postdoctoral fellow alleged that a Ph.D. candidate had changed data in a laboratory notebook more than two years after the original entries were made without any postdating or other explanation for the changes. These data were included in a manuscript submitted for publication and in two reports to NIH. The respondent admitted altering the data but claimed he was correcting an error in his notebook, not falsifying data. He acknowledged that he should have followed laboratory procedures and annotated the entries to indicate they were being made to reflect other records and his recollections of the earlier results. The institutional investigating committee concluded that research misconduct had occurred because the respondent could not provide direct evidence to support the changed data. The committee concluded that the alteration in the data was necessary to make the presentations and publications by the respondent credible. After reviewing the institutional report, the ORI concluded that the respondent's explanation that he was retroactively correcting an error that he had made in recording the original data was credible. Although unable to provide exact documentation for the altered data, the ORI noted the respondent was able to provide other records that made his explanation plausible. The ORI further noted that the respondent used a different color ink (blue over black) for the changes, thereby, making it readily recognizable that the data had been changed after the postdoctoral fellow had seen the original data in the notebook. Consequently, ORI found that a preponderance of evidence did not support a finding of misconduct.

Fabrication/Falsification:

An investigation into violations of animal care and housing regulations recommended that the work of the respondent be examined for research misconduct. An institutional investigation found falsification and fabrication of data in laboratory notebooks, clinical laboratory log books, published and submitted papers, case report forms, abstracts, and a grant application. During the institutional investigation, a postdoctoral fellow working for the respondent took sole responsibility for the falsified and fabricated data. However, the investigation committee criticized the respondent for poorly supervising the fellow and the laboratory. The respondent resigned his position at the institution. ORI concurred with the institution's finding of no research misconduct.

Fabrication/Falsification:

An allegation of unauthorized use of radioisotopes was made to the U.S. Nuclear Regulatory Commission against a director of a research institute. During an investigation conducted by the Office of Inspector General (OIG), two institute staff members charged the director with fabricating and falsifying data in two grant applications submitted to NIH. One complainant alleged that the respondent fabricated preliminary experimental data in one application because no research using radioactive chromium was done at the institute. The other complainant alleged that the respondent instructed her to falsify data from spinal cord injury experiments in constructing a graph for the second application. During an institutional inquiry (conducted while the OIG investigation was underway), the respondent produced data for some tables in the applications, but not for others. The institution concluded there was insufficient evidence to proceed to an investigation. The OIG asked OSI for assistance in investigating the alleged research misconduct, and at the request of OSI, issued an administrative subpoena for the respondent's notebooks. Another notebook was presented by a complainant. During the OSI investigation, the respondent produced records showing that he had authorization to use radioactive chromium at another institution and a notebook containing experiments using the isotope. The OSI also determined that the graph depicting results of spinal cord injury experiments was falsified. However, OSI could not prove that the respondent instructed the complainant to do so. ORI found no research misconduct.

Falsification and Plagiarism:

A department chairman alleged that a collaborator had falsely described his methodology in abstracts, violated patient confidentiality, used data from other investigators without their permission, failed to get informed consent, failed to be collegial, and abused co-workers. The respondent provided extensive information which led a university inquiry to conclude that the respondent had used careless research methods but had not committed research misconduct. During its review OSI, the predecessor to ORI, became concerned about the definition of research misconduct and the standard of proof employed by the institution. Upon further review, ORI concluded that only two allegations fell within the PHS definition of research misconduct: falsely describing the methodology used in the study and using data in abstracts and manuscripts without permission from collaborators. ORI determined that the respondent did show collaborators' materials prior to submission of abstracts and manuscripts, but ORI was unable to determine whether permission to use the data was obtained and thus found no research misconduct on this issue. ORI also determined that the methodology issue concerned patient confidentiality rather than falsification of methodology. ORI referred the issues concerning patient confidentiality and informed consent to the Office of Protection from Research Risks (OPRR).

Plagiarism and Other:

A professor accused a graduate student of plagiarism and serious deviation from practices that are commonly accepted within the scientific community for proposing, conducting, or reporting research because she sequestered data from a collaborative project for 15 months and published the data without the consent of her collaborators. Three faculty advisors were also charged with research misconduct because they assisted the respondent to prepare the manuscript for publication. An institutional investigation committee, composed entirely of members from outside the institution, found the graduate student had committed research misconduct by sequestering the data and publishing the data without the consent of her collaborators. The investigation committee recommended that an investigation be conducted into the role the faculty advisors played in the publication of the data. ORI supported the finding of misconduct against the graduate student for sequestering the data. However, ORI concluded that the graduate student and faculty advisors committed an error in judgment rather than research misconduct by publishing the sequestered data without the consent of the collaborators because senior administrators at the institution supported the right of the graduate student to publish the data. The graduate student requested a hearing before the Departmental Appeals Board on the misconduct finding stemming from the sequestration of data. Prior to the hearing, ORI and the institution reached a settlement with the graduate student in which ORI and the institution withdrew their misconduct findings and the graduate student acknowledged that her conduct was improper, that PHS had authority over any PHS-supported research in which she may engage, and that the institution had a right to supervise her research program. She also agreed to follow all institutional and Federal requirements for the retention and provision within the laboratory of data, research materials, and analyses. The latter condition implemented the administrative action which ORI proposed in conjunction with its original finding of misconduct.