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Summaries of Closed Inquiries and Investigations Not Resulting in Findings of Research Misconduct - 1998

. Handling Misconduct
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. Introduction

. Technical Assistance
. Complainant
. Respondents
. Allegations
. Preliminary Assessment
. Inquiries
. Investigations
. Institutional Decision
. ORI Oversight Review
. PHS/HHS Decision
. Hearings
. Administrative Actions
. Case Summaries
. Legal Concerns

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Fabrication: The respondent, who was a clinical research assistant, allegedly fabricated responses on questionnaires received from eight study participants. The institution conducted an investigation and determined that the respondent had furnished three responses that were missing on a questionnaire received from one subject without first obtaining the responses from the subject. However, the institution found that the respondent had done this in an attempt to ensure that the subject would be given a clinical assessment due to the respondent's concerns about the subject's health, with the intent of subsequently obtaining the missing responses from the subject before entering them into the study database. Therefore, the institution concluded that there had been no intent to enter the false answers into data on the part of the respondent. The institution also concluded that there was insufficient evidence that the respondent had fabricated responses on the questionnaires from the other seven subjects. ORI accepted the institution's conclusions and did not make a finding of research misconduct.

Fabrication: The respondent, a post-doctoral research fellow, allegedly fabricated data on contraction and relaxation responses to vasoactive compounds of biopsies containing human blood vessels. The institution conducted an investigation into the matter and determined that the evidence supported an alternative explanation for how the questioned data were generated. ORI accepted the conclusion of the institution's investigation that there was insufficient evidence to make a finding of research misconduct.

Fabrication: The respondent, a research scientist, allegedly fabricated data on interview forms and failed to follow the research protocol in a study involving prevention of seizures. The study was supported by a National Institutes of Health grant. The institution conducted an investigation into the matter and determined that the respondent had failed to follow the study protocol in recording the results of interviews, constituting a serious deviation in research. However, ORI does not consider such protocol violations to fall under the PHS definition of research misconduct. The institution determined that there was insufficient evidence to support a finding that the respondent had fabricated interview data because of the time lag between patient interviews and the investigation of misconduct and the possibility that interviewer notes had been lost. ORI accepted this conclusion and did not make a finding of research misconduct in the case.

Falsification: The respondent, a post-doctoral fellow, allegedly falsified data in continuing research supported by PHS funds involving demyelinating diseases. ORI conducted an investigation into the matter. ORI found that there was insufficient evidence to prove that the respondent had committed research misconduct. ORI also concluded that proving that the respondent intended to commit research misconduct would be made more difficult because in some instances any apparent acts of falsification appeared trivial and their totality did not constitute a convincing pattern that favored the hypothesis. Further, the respondent did not publish any of the questioned data. The alleged falsifications were limited to laboratory notebooks and to an abstract that was not submitted and a draft manuscript. Thus, ORI concluded that further action was not warranted in this matter.

Falsification: The respondent, an associate professor, allegedly altered experimental data for collaborative experiments involving kidney tissue research. The institution conducted an investigation into the matter. The institution determined that there was a history of difficulties in the relationship between the respondent and the complainant and that in part the allegations involved an authorship dispute. The institution also concluded that the respondent's conduct during the collaborative research did not reflect high standards of professional behavior but that the evidence did not support a finding of research misconduct. ORI accepted the institution's finding and concluded that there was insufficient evidence to warrant a finding of research misconduct.

Falsification: The respondent, the principal investigator (PI) at one site of a multicenter clinical trial, allegedly falsified monthly screening logs for that trial on seven occasions and submitted the altered forms to the trial's coordinating center. The institution conducted an investigation into the matter. The institution found that monthly screening logs had been falsified on seven occasions and that several research approval forms also had been altered. The institution determined that the study coordinator at the questioned site had been responsible for the records. The institution concluded that the respondent had neglected some of his responsibility as PI by not responding to and correcting recurring problems regarding data that had been submitted to the coordinating center. However, the institution found that this neglect on the part of the respondent did not constitute research misconduct. ORI accepted the institution's conclusion and did not make a finding of research misconduct on the part of the PI.

Falsification: The respondents, a graduate student and mentor, allegedly falsified research results in a published paper involving a study of messenger RNA in tumor and normal tissues. The research was supported by two National Institutes of Health grants. The institution conducted an investigation and determined that inappropriate data selection had been performed for the paper. However, the investigation committee found the student to be poorly trained in research methods and the mentor to have poorly supervised the research and data analysis. Based on the available evidence, ORI found insufficient evidence of an intent to deceive on the part of either respondent and found insufficient evidence that the mentor had reviewed the original data and had been aware of the extent of data selection done by the student. Thus, ORI did not make a finding of research misconduct in this case.

Falsification: The respondent, an associate professor, allegedly falsely reported research in a study involving the characterization of glutamate receptors by intentionally mislabeling a slide for a meeting presentation and falsifying experimental conditions described in an abstract. The research was supported by a National Institutes of Health grant. The institution conducted an investigation and determined that the respondent had not knowingly falsified data or reported falsified information related to the study conditions. ORI accepted the institution's investigative report and its conclusion and did not make a finding of research misconduct in this case.

Falsification: The respondent, a staff scientist, allegedly falsified a patient record on a followup report in a clinical trial involving breast cancer research. The institution conducted an investigation into the matter. The institution found that the patient record had been falsified and was not the result of an honest error. An internal audit of all clinical trial records for patients for which the respondent was responsible revealed an additional apparent falsification in a nonPHS-supported study as well as a pattern of errors and incomplete data reporting. Since the respondent's employment already had been terminated, the institution concluded that no further action was warranted. ORI accepted the institution's report. However, because only a single instance of possible data falsification was related to PHS-supported research and numerous errors by the respondent indicated carelessness, ORI did not make a PHS finding of research misconduct or propose further PHS action.

Falsification: The respondent, a post-doctoral fellow, allegedly falsified data in a research experiment on chemically-treated DNA oligonucleotides. The institution conducted an investigation into the matter. The institution determined that there was credible evidence to conclude that tampering with the samples of the questions experiment had occurred. However, the institution did not find any evidence to indicate that the respondent had tampered with the samples. Thus, the institution did not find scientific misconduct on the part of the respondent. ORI accepted the institution's finding and concluded that there was not sufficient evidence to warrant a finding of research misconduct, since it was not possible to determine who was responsible for the apparent falsification of data.

Falsification/Fabrication: The respondent, who was a professor and senior clinical trial investigator, allegedly falsified and/or fabricated research records and data submitted to the coordinating center of a multicenter clinical study involving bladder cancer. The institution conducted an investigation into the matter. The institution determined that some discrepant data were the result of inadvertent errors made by the nurse coordinator, who was under the supervision of the respondent. The institution further concluded that the respondent had failed to provide adequate training and supervision to the nurse coordinator, which led to these errors. However, the institution concluded that the respondent was not the individual responsible for apparently altered data submitted to the coordinating center. ORI accepted the institution's determination that insufficient evidence existed to make a finding of scientific misconduct.

Falsification/Fabrication: The respondent, a staff nurse, allegedly falsified and/or fabricated data in a nutrition research study supported by a National Institutes of Health contract. After conducting an investigation, the institution determined that the respondent had committed research misconduct by fabricating a response on a questionnaire and by deviating from the study protocol by not contacting the subject before adding or filling in certain information. However, ORI did not consider the deviation from the study protocol, on its own, as falling within the PHS definition of scientific misconduct. Also, under the PHS standards, ORI found there was insufficient evidence to prove that the respondent had intended to falsify or fabricate the questionnaire entry. Therefore, although ORI accepted the institution's report, it did not make a finding of research misconduct.



 
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