Individual | Institutional
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Promoting Integrity in Research
Individual | Institutional |
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Summaries of Closed Inquiries and Investigations Not Resulting in Findings of Research Misconduct - 1995David Plotkin, M.D., Memorial Cancer Research Foundation of Southern California (MCRF), Los Angeles: ORI investigated allegations that clinical trial data forms submitted from the MCRF contained falsified and fabricated information. The data forms were submitted to the Statistical Office of the National Surgical Adjuvant Breast and Bowel Project (NSABP) located at the University of Pittsburgh. The NSABP project at MCRF received funding from the National Cancer Institute (NCI), with Dr. Plotkin as principal investigator. In mid April 1994, the Chicago Tribune obtained a copy of an April 1990 NSABP Audit Report that indicated there was a "serious problem . . . with respect to the accuracy of the data reported to the NSABP" from the MCRF. A Chicago Tribune reporter reviewed records on some subjects entered on NSABP trials at MCRF and found apparent discrepancies between reported data and medical records. Much of the questioned data was related to the B-06 clinical trial which compared lumpectomy (with or without radiation therapy) to total mastectomy for the treatment of breast cancer. ORI reviewed records and data on 59 patients reported to NSABP between 1973 and 1994 and did not find falsification, fabrication, or deliberate misrepresentation on the part of Dr. Plotkin or his staff. ORI found that many of the discrepancies originally identified by the NSABP and the Chicago Tribune were the result of a review of incomplete records, honest error on the part of one or more of the participating parties, or differences in interpretations or judgments of the facts. Fabrication: A former postdoctoral fellow alleged that the respondent fabricated data in three papers and a grant application so that the data purportedly misrepresented the number of experiments performed and the averaged values in figures and tables. The institutional investigation committee did find evidence of fabricated data in one publication. However, the committee concluded there was no credible evidence that the respondent had participated in the misconduct. Instead, the committee believed the testimony of the respondent who reported that he relied on the complainant to draft the questioned publication and to prepare the data summaries. The committee concluded that the evidence indicates the complainant was responsible for the fabricated data. ORI accepted the institutional finding. Falsification: The respondent was charged with falsifying data by inappropriately editing points on standard curves for hormone assays and publishing falsified data in one figure in each of two articles. The institutional investigation committee found research misconduct on both counts. During its oversight review, ORI found that the respondent had learned the inappropriate editing practice from her postdoctoral mentor and had not been told by her supervisors to stop the practice which the respondent made no attempt to hide in her annotated notebooks. ORI also found that the respondent lacked the skill and understanding to properly use experimental methods and to analyze data. ORI concluded that there was insufficient evidence to support a finding of intentional falsification on either charge. Falsification: A technician alleged that the laboratory chief falsely claimed in a grant application that his laboratory had identified three crucial reagents needed for a technique that would allow the laboratory to distinguish between the bacterium that caused a specific disease and other closely related bacteria that do not. The technician alleged that there was no authentic experimental basis for these claims of specificity for these reagents. An institutional inquiry which found no reason to conduct an investigation was considered inadequate by the former Office of Scientific Integrity (OSI) because the inquiry failed to examine notebook data and interview the complainant. OSI conducted its own inquiry and investigation. After reviewing the OSI investigation and conducting further analysis, ORI verified the OSI conclusion that there was insufficient scientific support to claim the reported specificity for the reagents. However, ORI did not find research misconduct because there was insufficient evidence to demonstrate a deliberate misrepresentation. ORI concluded that reasonable scientists could differ on whether the preliminary results showed sufficient promise of success to justify their presentation as initial observations, plans, and suggestive results in an application. In addition, no falsified or fabricated research data were presented in the application. Falsification: A co-investigator alleged that inconsistencies in the methodology and data reported by her colleague in several publications that were based on the same study indicated that they were falsified. An institutional inquiry concluded that there were problematic aspects of data management and reporting, but no evidence of deliberate deception or research misconduct. The complainant questioned the conclusions of the inquiry and the institution agreed to conduct an investigation. Four members of the investigation committee found that the conclusions in the questioned publications would not be weakened if all errors and other irregularities in data management were removed and they concluded there was no intent to deceive and no misconduct. One committee member dissented, holding that the irregularities were serious enough to constitute misconduct and, if there was no intent to deceive, that the respondent was incompetent to conduct independent research. During its review, ORI conducted further analysis to determine whether a pattern of inconsistencies could be identified. ORI's analysis demonstrated that there was no example of a repeated inconsistency associated with any variable examined. ORI concluded that, if any misrepresentation had occurred, it was likely due to honest error. Falsification: Two colleagues alleged that three researchers had falsely reported the methodology and results of a clinical trial in a published article. An institutional investigation committee found numerous discrepancies between the protocol, the manner in which the study was conducted, and what was reported in the article. Besides containing numerous factual errors, the committee concluded that the article "described a careful prospective clinical study which was not carried out." However, the committee did not find misconduct because it found no intention to deceive. Instead, the committee attributed the respondent's actions to undertaking "a complex task of conducting a clinical investigation while lacking the knowledge and experience necessary to accomplish that task. The respondents' failure to understand the requirements of clinical research was underscored by the lack of any systematic data management or record keeping, essential elements of clinical investigation. Similarly, the respondents failed to understand that subjective clinical judgments, regardless of the clinical expertise of the investigators, do not substitute for more objective means of assessment when a protocol proposes and a paper reports that the more objective means were used . . ." A letter of correction submitted by the respondents was published by the journal. The institution established a committee of experienced clinical investigators to supervise the respondents' continuing clinical research and review their manuscripts prior to submission for publication. ORI accepted the disposition of the case by the institution. Falsification: A researcher alleged that his colleague falsified results of a study by mislabeling blood samples. An investigative committee at the institution concluded that the wrongly-labeled samples seriously distorted the study results. However, the committee could not determine whether the mislabeling was performed intentionally or erroneously. Nor could it determine when, where or by whom the mislabeling was performed. The samples were collected and labeled in another country. Manipulation of the labels at the institutions in this country would have required an elaborate series of actions for which there was no evidence. The institution concluded there was insufficient evidence for a finding of research misconduct. ORI accepted that conclusion because of the low likelihood that credible evidence could be obtained to answer the remaining questions. Plagiarism: Two colleagues accused the respondent who was a junior faculty member of plagiarizing their published article. All three researchers were part of the same department, but the complainants and the respondent had published separate articles on their separate projects. The project director told the three researchers to prepare an article for a special journal issue combining their previously published works and he assigned the respondent as first author. The respondent incorporated verbatim nearly the entire text of the article written by the complainants and their collaborators, who included the project director. Two citations to the complainants' workshop presentation were made, but the verbatim material was not enclosed in quotation marks. The complainants objected to the designation of the respondent as first author and withdrew as co-authors. The article was published with no changes except that the respondent was the sole author. The institutional investigation committee found the respondent "guilty of publishing without adequate attribution verbatim material that had been previously published by other members of the . . . project." However, the committee also concluded that the respondent was guilty of a form of misconduct that does not amount to research misconduct under the PHS regulations. ORI accepted the institutional decision because of the special supervisory circumstances involved in the case. Other Practices: In another aspect of the above case, the two colleagues also alleged that their project director engaged in a serious deviation from commonly accepted practices when, as their supervisor and the editor of a special journal issue, he accepted an article from a member of the department that plagiarized their work. An institutional investigation found that the respondent had instructed the complainants and another project member to prepare an article for a special journal issue he was editing, to combine articles published separately by the complainants and the other project member, and he assigned the latter as lead author for the new article. After reviewing the draft document, the complainants informed the project director that they objected to the text and the order of authorship and withdrew as coauthors. However, nearly the entire text of their article was incorporated verbatim into the combined article with two citations to a workshop presentation but no quotes. The article was published in the special issue with the other project member as sole author. The respondent claimed he did not review the manuscript before including it in the special issue. The institutional investigation committee found the respondent had failed to fulfill the responsibilities of a guest editor and had violated the faculty code of conduct by his uncollegial and unethical behavior toward his junior collaborators but that his actions did not constitute research misconduct under the PHS regulation. ORI accepted the institutional decision. Fabrication/Falsification: A researcher alleged that a colleague used fabricated data in two tables intended for use in a poster presentation. While looking into this allegation, the inquiry committee found sufficient evidence to begin an investigation into whether the respondent falsely described the data collection technique in an abstract. The number of charges was increased during the investigation to include false reporting of data in two publications. The investigation committee did not find misconduct for the following reasons: (1) the poster was neither finalized nor presented in public; (2) the misrepresentation of the data collection technique in the abstract was considered an error because the stated technique was used to produce some data in the study; and (3) the publication of the inaccurate and misleading papers was due to egregious and unacceptable data and laboratory management practices. The investigation committee recommended that the abstract and publications be retracted and that appropriate actions be taken against the respondent and his supervisor who reportedly knew of the errors in the publications but failed to correct them. The reviewing faculty committee concluded that the respondent's conduct fell under the "other practices clause" of the PHS definition of research misconduct and recommended that his appointment not be renewed and that the supervisor be evaluated to determine whether she should continue as laboratory director. ORI determined that the abstract and one publication fell under PHS jurisdiction. ORI determined that insufficient evidence existed to find misconduct. Fabrication/Falsification: A senior research associate accused two researchers of fabricating or falsifying experimental results reported in figures and tables in a grant application. The complainant claimed the data did not reflect the results he had obtained in a set of experiments. He further stated that he was the only person in the laboratory conducting those particular experiments because he was the only person permitted to handle radioactive isotopes. The investigation committee determined that where experimental records were available they were consistent with the data presented in the grant application. However, because much data had not been retained, it was not possible to determine whether the reported results were completely accurate. In addition, the committee found that other laboratory members also performed the questioned experiments even though they were not authorized to handle radioactive isotopes. The committee suggested that the complainant may not have known that particular experiments were being conducted by others because of his frequent and lengthy absences from the laboratory. The committee concluded there was insufficient evidence to find research misconduct, but recommended actions to be taken to improve record keeping and the handling and retention of data in the laboratory. The respondents appealed the recommended actions within the institution asserting that the record keeping and data handling and retention problems were limited to the experiments conducted by the complainant. A separate review of the laboratory concluded that record keeping was generally acceptable, but improvements could be made in some areas. The recommended actions were significantly reduced. ORI accepted the disposition of the case by the institution. Fabrication/Falsification: A former postdoctoral fellow in the PHS intramural program alleged that her ideas and data had been plagiarized by four colleagues who failed to include her as a co-author on a submitted manuscript. An agency inquiry also raised the possibility of data fabrication and falsification in the submitted manuscript and concluded that an investigation was warranted. ORI determined that the alleged theft of ideas and failure to include the complainant as an author constituted an authorship dispute between collaborators and ORI referred it to the agency for resolution. ORI conducted an investigation into the alleged data fabrication and falsification by one of the co-authors. ORI found that purchase and mortality records for mice, laboratory notebooks, handwritten tables, computer files, and testimony of witnesses demonstrated that the research had been conducted and accurately reported. ORI concluded that research misconduct did not occur. Fabrication/Falsification/Plagiarism: Three colleagues accused the respondent of falsification, fabrication, and plagiarism in research publications, manuscripts, and grant applications. The institutional investigation committee found "substantial evidence" to support the allegations. During its oversight review, ORI found PHS funding was involved in only two of the allegations. ORI found insufficient evidence to conclude that the respondent had deliberately fabricated or falsified citations to published articles in a grant application. ORI also concluded that the subsequent use by the respondent of text from an article he coauthored did not constitute plagiarism. Falsification/Plagiarism: An author charged that a colleague in the department had plagiarized from his book in writing journal articles. During the inquiry, the committee found that the respondent may have falsified his credentials in several grant applications, claiming he was an associate professor at a nearby university rather than an adjunct assistant professor. The institutional investigation committee found that the respondent had committed plagiarism because the citation of the book in the introductory section was not sufficient to indicate that the disputed text and table formats were taken from the book, but did not find misconduct because the questioned text was not considered to have materially affected the scientific conclusions of the article. The allegation of false credentials was dismissed because the resume files and biographical sketches were maintained by the editorial staff, so it could not be shown who was responsible for the misrepresentations. ORI considered the questioned text to be material but ORI concluded the presentation of the citation of the book relative to the questioned text demonstrated a lack of intent to deceive. In addition, ORI did not consider the limited use of identical or nearly-identical phrases which describe a commonly-used methodology to warrant finding plagiarism in this case. ORI also agreed with the institutional finding on the credentials allegation because the respondent did not completely control the selection of biographical information for applications and because he had always properly cited his position at his own institution, and indicated that the university positions were not full-time. |
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This page last was updated on March 27, 2007
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