Findings of Scientific Misconduct

Notice is hereby given that the Office of Research Integrity and the Acting Assistant Secretary for Health have taken final action in the following case:

Based on the findings of an investigation conducted by Huntington Memorial Hospital and information obtained by ORI during its oversight review, the U.S. PHS found that Scott E. Monte, LVN engaged in scientific misconduct by knowingly and intentionally falsifying and fabricating clinical research records in cancer prevention and treatment protocols supported by awards U10CA69651, U10CA12027, U10CA32012, and U10CA86004.

Specifically, Mr. Monte knowingly and intentionally: (1) Entered falsified and fabricated laboratory data or physical examination results on five research protocol case report forms; (2) Falsified a gynecological examination report in a physician’s progress note and entered the falsified document in the patient’s research chart; and (3) Fabricated progress notes for four patients and a case report form for one of these patients.

6 Comments »

  1. bikemonkey said

    Aaaaand another low level grunt gets nailed. I really want to know how these “falsified clinical subjects” things go down. I mean, if it is caught before it goes into a publication or grant application, this is just a fire/reprimand situation, depending on how bad it is, right? Rising to ORI level means there was some high level use, meaning a publication or something. But then how did it get picked up? Must have been such an egregious effect on the data that it was noticeable somewhere, right? and the PI didn’t pick it up him/herself?

    Color me suspicious but this stuff never adds up to a satisfactory explanation to me…

    No need for coloring, BM. I hear you. How or why, out of tens of thousands of clinical coordinators working on thousands of clinical trials on any given day, this specific guy gets nailed for fudging 5 (FIVE!) CRFs from 4 different multisite cooperative trials is beyond me. I cannot believe these few data points would jump out in the ocean of data that must have been involved, so I suspect someone blew him in related to some petty squabble. (I see at least PHS promoted him to “Dr.”) Once an accusation is formerly lodged, it must proceed forward though, all the way to ORI as needed for legal coverage apparently. But more broadly, considering how valuable/expensive these data are, I would put responsibility for quality assurance at the level of the site and/or study PI (who accepted responsibility upon accepting the award and who remains unnamed in this case), including paying the misconduct piper for not closely monitoring data collection & input by the clinical coordinator(s) and other RAs. – writedit

  2. […] Integrity has issued a notice on a finding of research misconduct. As usual, Agent writedit is all over it at Medical Writing, Editing & Grantsmanship, category click for prior findings and discussions. […]

  3. Annie said

    His credential, LVN, I take to be a licensed vocational nurse. Is the appropriate state board of nursing involved? Has his license been suspended or revoked? The nursing profession doesn’t have much to say anymore about professional practice, and the class of minimally trained vocational or practical nurses often operates on the fringes of the regulated healthcare industry. Time to shine a bright light on them because more often than not, they practice in poorly regulated areas such as schools, medical offices, research labs, nursing homes, group homes and home care.

  4. […] under Biomedical Research Ethics 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 […]

  5. Scott Monte LVN said

    I never knowingling falsified anything. I had over 250 subjects on 16 different trials at the time of these alleged accusations. This has ruined my career as a research coordinator and basically ruined my professional life as a health care provider. HMH and ORI made me to be a scapegoat for the principal investigators who are truely resposible for these accusations. I’m just an LVN, we cant have a physician responsible for this kind of misconduct. But I was told by PI’s to sign names, falsify data and “not make waves” so that the funding would continue. But no one cares about some LVN or how my life was ruined.

    • Kevin (student) said

      I believe you; but why didn’t you do more than just email them with a short explanation? I would have exposed the truth (if possible) about the PI’s that let you take all the blame. I have to ask though, why did the dates say Saturday and Sunday? Was that something the PI’s filled out and made you sign, or were you just careless when completing the CRF’s?

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