Findings of Scientific Misconduct

Been slow at ORI, but today’s a two-fer, including another clinical trial nurse

Notice is hereby given that ORI and the Assistant Secretary for Health have taken final action in the following case:

Based on the report of an investigation conducted by St. Luke’s Hospital in Chesterfield, MO, and additional analysis conducted by ORI during its oversight review, the US PHS found that J. Keith Hampton, MSN, APRN, former Clinical Research Associate, engaged in scientific misconduct in research supported by awards U10 CA69651, U10 CA12027, and U10 CA33601 by falsifying and fabricating data that were reported to the National Surgical Adjuvant Breast & Bowel Project and Cancer and Leukemia Group B cooperative research groups.

Specifically, PHS found [abridged version here] that Mr. Hampton on various protocols falsified a patient’s CT scan reports and registration forms; falsified a patient’s performance status records and registration forms; falsified eligibility data related to hematology and chemistry assays; falsified pelvic exam eligibility; falsified a patient’s multigated acquisition test (MUGA, a test of heart function) records, cardiac function, and registration forms; falsified hematology, chemistry, and MUGA eligibility; falsified urine protein/creatinine ratio eligibility; falsified claims of the urine protein/creatinine ratio and PT(INR) eligibility; and falsified a patient’s colonoscopy report and eligibility [forms related to these falsifications, sometimes for more than one patient enrolled in the same protocol, were reported to the NCI Cancer Trial Support Unit].

and separately

Notice is hereby given that ORI and the Assistant Secretary for Health have taken final action in the following case:

Based on reports submitted by Carnegie Mellon University’s inquiry and investigation committees, the Respondent’s own admission in sworn testimony, and additional analysis conducted by ORI during its oversight review, the US PHS found that Roxana Gonzalez, graduate student, Department of Social and Decision Sciences and Psychology, engaged in scientific misconduct in research supported by grants R01 MH56880, R03 MH62376, and R24 MH67346.

Specifically, PHS found [abridged version here] that Ms. Gonzalez altered the main dependent variable in the electronic file and the manipulation check variables for ease-of-thought generation so that the reported study results are largely unsupported in two publications and one manuscript; falsified cortisol values, and possibly cardiovascular measures and optimistic appraisals, so that a large portion of the mediation analyses of Table 3 does not reflect the data actually collected and analyzed for the study reported in a publication and presented at the May 2005 Annual Meeting of the American Psychological Society (collaborator did not know at the time that the results were tainted); falsified the analyses based on participants’ responses to the manipulation check items in a study reported in a publication; and falsified the main dependent variable in the electronic file for 48 of the 175 subjects participating in a study reported in a 2005 manuscript (a collaborator included a qualitative description of the results in an NIH grant application, although the collaborator did not know at the time that the results were tainted). ORI acknowledges Ms. Gonzalez’ extensive cooperation with CMU’s research misconduct proceedings.

2 Comments »

  1. microfool said

    Just noticed that the first two U10s (U10CA69651, U10CA12027) are the same ones for the previous case, even though the clinical trial assistants were based at different hospitals.

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