Archive for Biomedical Research Ethics

Findings of Research Misconduct

Times two …

Notice is hereby given that ORI has taken final action in the following case:

Based on the reports of two investigations conducted by The Ohio State University and additional analysis conducted by ORI in its oversight review, ORI found that Terry S. Elton, PhD, Professor, College of Pharmacy and Davis Heart and Lung Research Institute, engaged in research misconduct in research supported by grants R01 HL048848, R01 HL084498, P01 HL70294, R21 HD058997, R01 AG021912, R01 AI39963, and R01 ES012241.

ORI found that the Respondent engaged in research misconduct by falsifying and/or fabricating data that were included in 1 R21 HD058997-01, 1 R21 HD058997-01A1, 1 R21 HD058997-01A2, 1 RC1 HL100298-01, and in:

1. Kuhn, D.E., Nuovo, G.J., Terry, A.V. Jr., Martin, M.M., Malana, G.E., Sansom, SE., Pleister, A.P., Beck, W.D., Head, E., Feldman, D.S., & Elton, T.S. “Chromosome 21-derived microRNAs provide an etiological basis for aberrant protein expression in human Down syndrome brains.’ J Biol Chem 285(2):1529-43, 2010 Jan 8.

2. Kuhn, D.E., Nuovo, G.J., Martin, M.M., Malana, G.E., Pleister, A.P., Jiang, J., Schmittgen, T.D., Terry, A.V. Jr., Gardiner, K., Head, E., Feldman, D.S., & Elton, T.S. “Human chromosome 21-derived miRNAs are overexpressed in Down syndrome brains and hearts.’ Biochem Biophys Res Commun 370(3):473-7, 2008 Jun 6.

3. Martin, M.M., Buckenberger, J.A., Jiang, J., Malana, G.E., Knoell, D.L., Feldman, D.S., & Elton, T.S. ” TGFß1 stimulates human AT1 receptor expression in lung fibroblasts by cross talk between the Smad, p38 MAPK, JNK, and PI3K signaling pathways.’ Am. J. Physiol. Lung Cell. Mol. Physiol. 293(3):L790-9, 2007 Sept. (Retracted: Am. J. Physiol. Lung Cell. Mol. Physiol. 302(7):L719, 2012 Apr.)

4. Martin, M.M., Buckenberger, J.A., Jiang, J., Malana, G.E., Nuovo, G.J., Chotani, M., Feldman, D.S., Schmittgen, T.D., & Elton, T.S. “The human angiotensin II type 1 receptor +1166 A/C polymorphism attenuates microRNA-155 binding.’ J Biol Chem 282(33):24262-9, 2007, Aug 17.

5. Martin, M.M., Buckenberger, J.A., Knoell, D.L., Strauch, A.R., & Elton, T.S. “TGF-beta(1) regulation of human AT1 receptor mRNA splice variants harboring exon 2.’ Mol Cell Endocrinol 249(1-2):21-31, 2006 Apr 25.

6. Duffy, A.A., Martin, M.M., & Elton, T.S. “Transcriptional regulation of the AT1 receptor gene in immortalized human trophoblast cells.’ Biochim. Biophys. Acta. 1680(3):158-70, 2004 Nov 5.

As a result of its investigation, OSU has recommended that all of the above publications be retracted.

Specifically, ORI found that the Respondent:

  • Falsified and/or fabricated Western blots in an NIH grant application in three submissions of the same grant application:
    • Figures 4, 7, 11C: 1 R21 HD058997-01
    • Figures 7B, 7E, 8B: 1 R21 HD058997-01A1
    • Figures 3C, 3F, 6C: 1 R21 HD058997-01A2 and false Western blots were also included in Figure 6 in grant application 1 RC1 HL100298-01.
  • Falsified and/or fabricated Western blots in eighteen (18) figures and in six (6) published papers. Specifically false and/or fabricated images were included in:
    • Figures 2C, 2D, 2F, 3C, 3E, 4G, 5C, 5F: J Biol Chem 285(2):1529-43, 2010 Jan 8
    • Figures 3B, 3C, 3F, 3H, 3I, 3J: Biochem Biophys Res Commun 370(3):473-7, 2008 Jun 6
    • Figures 2, 3, 4B, 5B, 6, 7B, 8A, 9B: Am. J. Physiol. Lung Cell. Mol. Physiol. 293(3):L790-9, 2007 Sept
    • Figure 6: J Biol Chem 282(33):24262-9, 2007 Aug 17
    • Figure 6: Mol Cell Endocrinol 249(1-2):21-31, 2006 Apr 25
    • Figures 5, 6B, 7B, 9B: Biochim. Biophys. Acta 1680(3):158-70, 2004 Nov 5.

Dr. Elton has entered into a Voluntary Exclusion Agreement and has voluntarily agreed:

(1) To exclude himself from any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government referred to as “covered transactions’ pursuant to HHS’ Implementation (2 CFR part 376 et seq.) of OMB Guidelines to Agencies on Government wide Debarment and Suspension, 2 CFR part 180 (collectively the “Debarment Regulations’) for a period of 3 years, beginning on November 26, 2012;

(2) To exclude himself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant for a period of 3 years, beginning on November 26, 2012; and

(3) To request that the following publications be retracted:

  • J Biol Chem 285(2):1529-43, 2010 Jan 8
  • Biochem Biophys Res Commun 370(3):473-7, 2008 Jun 6
  • J Biol Chem 282(33):24262-9, 2007, Aug 17
  • Mol Cell Endocrinol 249(1-2):21-31, 2006 Apr 25
  • Biochim. Biophys. Acta. 1680(3):158-70, 2004 Nov 5

 

Notice is hereby given that ORI has taken final action in the following case:

Based on the report of an investigation conducted by the Texas Tech University Health Sciences Center and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Shuang-Qing Zhang, former Postdoctoral Researcher, Department of Pharmaceutical Sciences, engaged in research misconduct in research supported by grant R01 GM069869.

ORI found that Respondent engaged in research misconduct by the falsification and fabrication of plagiarized data that were included in the publication: Zhang, S.Q. & Mehavr, R. “Determination of dextra-methylprednisolone conjugate with glycine linker in rat plasma and liver by high-performance liquid chromatography and its application in pharmacokinetics.’ Biomed. Chromatogr. 24(4):351-357, 2010.

Specifically, ORI found that the Respondent:

  • Falsified Figures 2(c) and 3(c) of the BC 2010 article by misrepresenting HPLC data that he had plagiarized, originally generated prior to the Respondent’s arrival in the laboratory by a former postdoctoral researcher; in Figure 2(c), the Respondent claimed that the HPLC chromatogram was of a “plasma sample obtained 12 h after intravenous injection of DMP to rats at a single dose of 5 mg/kg,’ while the actual chromatogram was of a calibration test of 1 [mu]g/ml of DMP added to rat plasma, and similarly in Figure 3(c), the Respondent claimed that the HPLC chromatogram was of a ” liver homogenate obtained 3 h after intravenous dose of DMP at a dose of 5 mg/kg,’ while the actual chromatogram was of a calibration test of 2 [mu]g/ml DMP added to rat liver homogenate.
  • Falsified and fabricated Figure 4 of the BC 2010 article; in the top panel, the Respondent reported the measurement of DMP concentrations in plasma samples of three rats after a single injection of 5 mg/kg DMP while the actual data that he had plagiarized, originally generated prior to the Respondent’s arrival in the laboratory by a former postdoctoral researcher, was from a single rat. In the bottom panel, the Respondent reported the measurement of DMP concentrations in liver samples obtained from three rats at 1, 30, 90, 180, 300, and 720 minutes after a single injection of 5 mg/kg DMP, requiring a total of 18 rats, while the actual data that he had plagiarized, originally generated prior to the Respondent’s arrival in the laboratory by a former postdoctoral researcher, was from plasma samples from a single rat, and the error bars for both panels were fabricated.

Dr. Zhang has entered into a Voluntary Settlement Agreement and has voluntarily agreed:

(1) To have his research supervised for a period of 3 years; Respondent voluntarily agrees that within 60 days of the effective date of the Agreement, any institution that submits an application for PHS support for a research project on which the Respondent’s participation is proposed or that uses the Respondent in any capacity on PHS supported research, or that submits a report of PHS-funded research in which the Respondent is involved, must concurrently submit a plan for supervision of the Respondent’s research to ORI for approval; Respondent agrees that he will not participate in any PHS-supported research after 60 days from the effective date of the Agreement until an appropriate supervision plan is submitted to ORI; the supervision plan must be designed to ensure the scientific integrity of the Respondent’s research contribution; and

(2) To exclude himself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant for a period of 3 years, beginning on December 4, 2012.

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Findings of Research Misconduct

Notice is hereby given that ORI has taken final action in the following case:

Based on the report of an investigation conducted by The J. David Gladstone Institutes and additional analysis conducted by ORI in its oversight review, ORI found that Paul J. Muchowski, PhD, former Senior Investigator, Gladstone Institute of Neurological Disease, engaged in research misconduct in research supported by grant R01 NS054753-06A1.

ORI found that the Respondent engaged in research misconduct by falsifying and fabricating data that was included in 1 funded NIH grant R01 NS054753-06A1 and 2 submitted NIH grant applications, R01 NS054753-06 and R01 NS047237-06.

Specifically, ORI finds that the Respondent knowingly and intentionally:

  • Falsely reported research experiments when the results did not exist at the time the grant applications were submitted.  Specifically in:
    • Figures 19-21 and related text of grant application R01 NS047237-06, the Respondent claimed he had successfully transduced human neuroblastoma SH-SY5Y cells expressing a-synuclein (a Syn) with lentiviruses containing small hairpin RNAs (shRNAs) that targeted Cog6, Stx7, Vps52, or Vps33a. The Respondent reported lentiviral expressed Cog6 significantly exacerbated a-Syn toxicity in SH-SY5Y cells, when only plasmid shRNAs were generated and utilized at the time the grant application was submitted.
    • Figure 5 and the accompanying text of grant R01 NS054753-06A1, the Respondent described the insertion of toxic and inert mutant huntingtin (htt) fragments into maltose binding protein-Htt-Cerulean constructs with a nonpathogenic (25Q) or pathogenic (46Q) polyQ repeat, with and without Cerulean. The modified proteins were claimed to have been purified, when the constructs had not been made at the time the grant was submitted.
    • Figures 5 and 6 and the accompanying text of grant R01 NS054753-06A1, the Respondent claimed to have cloned toxic and inert mutant htt fragments into lentiviral constructs and generated lentiviruses, when the constructs were not made.
    • Figure 6 and related text in grant R01 NS054753-06A1, the Respondent claimed to have tested immunoblots of lysates from primary neurons with an antibody against mutant htt, which demonstrated that levels of htt expression in transduced cells were roughly equivalent to levels in normal neurons, when the experiment was not conducted.
  • Falsified Figure 3 of grant application R01 NS054753-06 by labeling the Western blot images for the expression of mutant htt in lentiviral-transduced primary neurons as `Cortex’ (left panel) and `Striatum’ (right panel), when the results were actually from the microglial cell lines N9 and BV2, respectively.

Dr. Muchowski has entered into a Voluntary Settlement Agreement and has voluntarily agreed for a period of 2 years, beginning on December 10, 2012:

(1) To have his research supervised; Respondent agreed that prior to the submission of an application for PHS support for a research project on which his participation is proposed and prior to his participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of his duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of his research contribution; he agreed that he shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agreed to maintain responsibility for compliance with the agreed upon supervision plan; and

(2) To exclude himself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.

Muchowski, who resigned from Gladstone (as noted earlier here by Spiny Norman), submitted a signed, written apology to the scientific community (via Retraction Watch) in which, in addition to expressing his sincere remorse and apology for “serious errors in judgment”, he reassures his peers that his “research findings have never been in question” and that “there was no impact on the proposed or reported research record, research subjects, other researchers, institutions, or the public health or welfare as a result of my inappropriate actions.” There will be no retractions, and Muchowski hopes to “continue to work and collaborate with others around the world, focusing on the future.”

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Findings of Research Misconduct

Notice that ORI has taken final action in the following case:

Based on the report of an investigation conducted by the University of Kentucky and ORI, ORI found that Eric J. Smart, PhD, former Professor of Pediatrics and Physiology, Department of Pediatrics and Physiology, University of Kentucky, engaged in research misconduct in research supported by grants R01HL062844, R01HL058475, R01HL064056, R01HL068059, R0 HL073693, R56DK063025, and P20RR105592.

ORI found that the Respondent engaged in research misconduct by falsifying and/or fabricating data that were included in 10 published papers, 1 submitted manuscript, 7 grant applications, and 3 progress reports over a period of 10 years. Respondent reported experimental data for knockout mice that did not exist in 5 grant applications and 3 progress reports and also falsified and/or fabricated images in 45 figures.

Specifically, ORI finds that Respondent:

  • Falsely reported in Figure 14 and associated text in NIH grant applications R01HL07897601 and -01A1 that experiments were performed to determine if endothelial-specific caveolin-1 null mice were protected from saturated fatty acid-induced atherosclerosis, when these mutant mice did not exist in the laboratory at the time; Dr. Smart also falsely reported the use of these mice in related progress reports R01HL078976-02, -03, and -04 and in 3 additional NIH grant applications: Figure 11 in R01HL088150-01, Figure 11 in U54CA116853, and Figure 9 in R56DK063025-01A2
  • Falsified and/or fabricated images in NIH grant application R01HL078976-01A1 by duplicating and altering bands in 14 Western blot images and 1 RT-PCR image included in Figures 3, 6, 11, 12, 13, 14, and 15; false Western blots were also included in the earlier version of the grant application R01HL078976-01, Figures 3, 6, 11, 13, and 14
  • Falsified and/or fabricated Western blots and 1 RNase protection assay by duplicating and altering bands in 33 figures included in 10 published papers, 1 submitted manuscript, and 2 NIH grant applications. Specifically, false or fabricated images were included in:
    • Figures 5 and 7, J. Biol. Chem. 277(7):4925-31, 2002
    • Figure 4B, Am J. Physiol. Cell Physiol. 291(6):C1271-8, 2006
    • Figures 2A, 3A, 6A, and 7A, Am J. Physiol. Cell Physiol. 294(1):C295-305, 2008
    • Figures 3, 5, and 6, J. Lipid Res. 45:1444-1449, 2001
    • Figure 2A, J. Biol. Chem. 275(33):25595-99, 2000
    • Figures 2A/B/C and 4A/B, J. Biol. Chem. 277(26):23525-33, 2002
    • Figures 2B/D and 4, Proc. Natl. Acad. Sci. USA 101(10):3450-5, 2004
    • Figures 1A and 5B, J. Biol. Chem. 280(33):29543-50, 2005
    • Figures 1A, 2A/B, and 4A, J. Biol. Chem. 273:6525-6532, 1998
    • Figure 1B, Am J. Physiol. Cell Physiol. 282:C935-46, 2002
    • Figures 2A, 4, 6B, 7, and 8 in a submitted manuscript
    • Figures 7A, 8A, 9A, and 10B in grant application HL093155-01
    • Figures 4, 7, and 13 in grant application HL068509-01A1.

Dr. Smart has entered into a Voluntary Exclusion Agreement and has voluntarily agreed for a period of 7 years, beginning on October 23, 2012:

(1) To exclude himself from any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government referred to as “covered transactions” pursuant to HHS’ Implementation (2 CFR part 376 et seq.) of OMB Guidelines to Agencies on Goverment-wide Debarment and Suspension, 2 CFR part 180 (collectively the “Debarment Regulations”);
(2) To exclude himself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant; and
(3) To request that the following publications be retracted or corrected: J. Biol. Chem. 277(7):4925-31, 2002; Am J. Physiol. Cell Physiol. 291(6):C1271-8, 2006; Am J. Physiol. Cell Physiol. 294(1):C295-305, 2008; J. Lipid Res. 42:1444-1449, 2001; J. Biol. Chem. 275:25595, 2000; J. Biol. Chem. 277(26):23525-33, 2002; Proc. Natl. Acad. Sci. USA 101(10):3450-5, 2004; J. Biol. Chem. 280(33):29543-50, 2005; J. Biol. Chem. 273:6525-6532, 1998; Am J. Physiol. Cell Physiol. 282:C935-46, 2002.

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Opaque Retraction Notices Hiding Growing Culture of Misconduct Incentivized by Academic Career Pressures? (kudos to PNAS paper & Retraction Watch)

Given recent discussions with authors being asked to sign opaque retraction notices (and no explanation even to them as to why the paper must be retracted – and no negotiation on rewording the notice to clear uninvolved/uninformed authors of guilt by association), this PNAS paper by Fang, Steen and Casadevall could not be more timely … and this research could not be more important to the scientific community as a whole:

A detailed review of all 2,047 biomedical and life-science research articles indexed by PubMed as retracted on May 3, 2012 revealed that only 21.3%of retractionswere attributable to error. In contrast, 67.4% of retractions were attributable to misconduct, including fraud or suspected fraud (43.4%), duplicate publication (14.2%), and plagiarism (9.8%). Incomplete, uninformative or misleading retraction announcements have led to a previous underestimation of the role of fraud in the ongoing retraction epidemic. The percentage of scientic articles retracted because of fraud has increased since 1975. Retractions exhibit distinctive temporal and geographic patterns that may reveal underlying causes.

Not surprisingly, Adam Marcus and Ivan Oransky – on whom the PNAS authors rely heavily – run with this theme at Retraction Watch:

It’s now clear that the reason misconduct seemed to play a smaller role in retractions, according to previous studies, is that so many notices said nothing about why a paper was retracted. If scientific journals are as interested in correcting the literature as they’d like us to think they are, and want us to believe they’re transparent, the ones that fail to include that information need to take a lesson from those that do.

… The question, of course, is, how common is scientific misconduct? The simple but unsatisfying answer is that we don’t know, certainly not based on this study, because it’s only of retractions. Some of the best data we have comes from a 2009 paper in PLoS ONE by Daniele Fanelli. In it, Fanelli does his own survey, and combines findings from other surveys.

In other words, 2% of scientists admit to having committed misconduct, but almost three-quarters say their colleagues have been involved in “questionable research practices.” But those may be low figures.

As the authors of the new PNAS study point out, all we can say for sure, based on their findings, is that misconduct plays more of a role in retractions than we thought it did. But we think they make a good argument for why retractions may be the canary in a coal mine when it comes to fraud …

Nature concludes with a discussion of another Retraction Watch theme, a transparency index for journals:

Ivan Oransky, a New York-based journalist and co-founder of Retraction Watch, suggests setting up a ‘transparency index’ for journals, to rank them on criteria such as the clarity of their retraction notices. The idea, which he says he would be keen to work on, could provide a much-needed incentive for journals to improve their performance in this area. Data from the current study could also serve as a basis for a retractions database to help scientists avoid wasting time trying to replicate or build on retracted work, he adds.

“I’m not necessarily opposed to the idea, but I have concerns about how such a database could be properly maintained and updated,” says Fang. “Our study is merely a snapshot. Creating an accurate, centralized database that could be used as an ongoing resource would be a considerable undertaking.”

Science starts off featuring the number of months between publication and retraction by cause but does not duck its role in the top ten retractors list:

Science has the dubious distinction of being ranked first for the number of articles retracted, 70, just edging out PNAS, which comes second with 69. Thirty-two of Science‘s retractions were due to fraud or suspected fraud, and 37 to error. These days, “the value of the work is determined by where it is published,” Casadevall says. Last year, he and Fang devised a “retraction index” to show that journals with relatively high impact factors, such as Science, Nature, and Cell, had a higher rate of retractions.

Apart from the question of how pervasive is misconduct in science today, The Chronicle of Higher Education highlights the implications in terms of pressures to publish for academic promotion and grant funding:

“Right now we’re incentivizing a lot of behavior that’s not actually constructive to science,” Dr. Fang said.

… For Dr. Fang, the amount of misconduct in high-profile journals is a clear sign that researchers are facing far too much pressure from statistical measures such as publication rates and impact factors when seeking job promotions and grant money.

Hopefully coverage in the New York Times and other media outlets will not disillusion the public nor lessen the enthusiasm of Congress to support scientific research …

Dr. Casadevall disagreed. “It convinces me more that we have a problem in science,” he said.

While the fraudulent papers may be relatively few, he went on, their rapid increase is a sign of a winner-take-all culture in which getting a paper published in a major journal can be the difference between heading a lab and facing unemployment. “Some fraction of people are starting to cheat,” he said.

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Findings of Research Misconduct

The other shoe drops for Marc Hauser, as noted at Retraction Watch and in many media outlets … Hauser responds via the Boston Globe blog.

Notice is hereby given that ORI has taken final action in the following case:

Based on the report of an investigation conducted by Harvard University and additional analysis conducted by ORI in its oversight review, ORI found that Marc Hauser, PhD, former Professor, Department of Psychology, Harvard, engaged in research misconduct in research supported by grants P51RR00168-37, CM-5-P40RR003640-13, R01DC005863, and F31MH075298.
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Findings of Research Misconduct

Notice is hereby given that based on the report of an investigation conducted by the Joslin Diabetes Center and additional analysis conducted by ORI in its oversight review, ORI found that Shane Mayack, PhD, former postdoctoral fellow, Department of Developmental and Stem Cell Biology, Joslin, engaged in research misconduct in research supported by T32DK07260, P30DK036836, and DP2OD004345. ORI found that Respondent engaged in research misconduct involving 2 published papers:

  • Mayack SR, Shadrach JL, Kim FS, Wagers AJ Systemic signals regulate ageing and rejuventation of blood stem cell niches. Nature 2010; 463:495–500.
  • Mayack SR, Wagers AJ. Osteolineage niche cells initiate hemotopoietic stem cell mobilization. Blood 2008;112:519–531.

As a result of Joslin’s investigation, both the Nature and Blood papers have been retracted by the corresponding author. Specifically, ORI found that:

  • Respondent falsely represented von Kossa-stained bone nodule images in 2 published papers:
    • a. Figure 2B in the Blood paper was copied from an unrelated published experiment in Figure 3, J Orth Surg Res 1:7, 2006, and was used to falsely represent Respondent’s own experiment for bone nodules formed in cultured osteoblastic niche cells.
      b. Figure S2c in the Nature paper was copied from an online image for an unrelated experiment and was used to falsely represent Respondent’s own experiment for bone nodules formed in osteoblastic niche cells from young and aged mice.
  • Respondent falsely represented 8 flow cytometry contour plots as different experimental results by using identical plots but with different labels and different numerical percentages. Specifically, the following contour plots in the Blood paper, the Nature paper, an earlier version of the Nature paper submitted to Science, and a July 2008 PowerPoint presentation were identical but were labeled differently:
    • a. Panels 4 and 2 in Figure 6C, Blood paper, and panels 1 and 2, respectively, in supplementary Figure 3b, Nature paper
      b. Panel 3 in Figure 6C, Blood paper, and panel 1 in Figure 2, July 2008 PowerPoint presentation
      c. Panels 1 and 2, Figure 2b, Science manuscript, and panels 2 and 3, respectively, in Figure 2, July 2008 PowerPoint presentation
      d. Panels 2, 3, and 4, supplemental Figure 4A, Blood paper, and panels 3, 1, and 2, respectively, in Figure 4B, Science manuscript

    Both the Respondent and HHS want to conclude this matter without further expenditure of time or other resources and have entered into a Voluntary Settlement Agreement to resolve this matter. Respondent neither admits nor denies ORI’s finding of research misconduct. This settlement does not constitute an admission of liability on the part of the Respondent. Dr. Mayack has voluntarily agreed:

    (1) If within 3 years from the effective date of the Agreement, Respondent does receive or apply for U.S. PHS support, Respondent agrees to have her research supervised for a period of 3 years beginning on the date of her employment in a research position in which she receives or applies for PHS support and to notify her employer(s)/ institution(s) of the terms of this supervision; Respondent agrees that prior to the submission of an application for PHS support for a research project on which the Respondent’s participation is proposed and prior to Respondent’s participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of Respondent’s duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of Respondent’s research contribution; Respondent agrees that she shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agrees to maintain responsibility for compliance with the agreed upon supervision plan;

    (2) If within 3 years from the effective date of the Agreement, Respondent does receive or apply for PHS support, Respondent agrees that any institution employing her shall submit, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS supported research in which Respondent is involved, a certification to ORI that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract; and

    (3) To exclude herself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant for a period of 3 years, beginning on July 27, 2012.

    Retraction Watch has a bit more on this case.

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    Findings of Research Misconduct

    Notice is hereby given that based on the report of an investigation conducted by the John Wayne Cancer Institute (JWCI) and additional analysis conducted by ORI in its oversight review, ORI found that Mepur H. Ravindranath, PhD former Director of the Laboratory of Glycoimmunotheraphy, JWCI, engaged in research misconduct by falsifying results reported for research supported by R21CA107316 and R03CA107831 in progress reports for those grants and in two publications in scientific journals.

    It is expressly understood that by entering into a Voluntary Settlement Agreement (Agreement), Respondent is not admitting to any of the allegations made against him by JWCI and/or ORI, or any of their respective agents, employees, associates, or related persons, including but not limited to the findings made by ORI listed in the Agreement. Respondent agreed to enter into the Agreement and not to contest the findings contained therein solely because contesting the findings would cause Respondent undue financial hardship and stress, and Respondent wished to seek finality.

    Specifically

      1. Respondent falsified the number of subjects accrued in the double-blind study reported in the paper Ravindranath, M.H., Muthugounder, S., Presser, N., Ye, X., Brosman, S., & Morton, D.L. “Endogenous immune response to gangliosides in patients with confined prostate cancer.’ Int. J. Cancer 166:368-377, 2005 (subsequently referred to as the “IJC paper) and later reviewed in Ravindranath, M.H. Yesowitch, P., Sumobay, C., & Morton, D.L. “Glycoimmunomics of human cancer: Current concepts and future perspectives.’ Future Oncology 3(2):201-214, 2007 (subsequently referred to as the “Future Oncology paper’), by reporting data of 7 of 63 patients with serial bleeds taken at different points in time and reporting that the values from the 7 patients were for different patients. This same reporting data of individual patients with serial bleeds taken at different points in time and reporting that those values were for different patients was presented in the CA107316 and CA107831 final reports.

      2. The methodology used for the Tables of ANOVA results comparing Log Titers of IgM antibodies for the different subject groups in the IJC and Future Oncology papers and the CA107316 and CA107831 final reports is incorrect and false, since the papers and reports fail to state that the results are not for a simple ANOVA but include various degrees of repeated measures on the variables.

      3. In Table 1 of the CA107831 Final Report, Respondent reported mean log titer values for GM1b for healthy, BHP, and T3/4 CaP patients. These values exactly matched with values published for a different ganglioside, GM1, for healthy, BHP, and T3/4 CaP patients, earlier in the IJC (Table II) and Future Oncology publications. The only exception was the log titer value for T1/2 CaP patients for GM1b (n = 20), which matched with the earlier published mean log titer value for GT1b (6.22 1.40; n = 36). ORI finds the pairwise-difference in the log titer values of GM1b between the T1/2 CaP and healthy patients, claimed to be significant (p<0.01), to therefore be incorrect and false. Respondent contends otherwise.

      4. Because Respondent included serial bleed values from individual patients in Table 1 of the IJC paper, the summary data for anti-ganglioside antibody values, and the statistical analyses derived from them in Tables II and III of the IJC paper, Tables 1 and 2 of the Future Oncology paper, published Tables A and B of the CA107316 final report, and Tables 1 and 2B of the CA107831 final report are incorrect and false. The inclusion of serial bleeds from individual patients in Table 1 of the IJC paper and their inappropriate impact on the antibody values reported in Table II of the IJC paper were reported in detail by Respondent to the Managing Editor in IJC in email communications dated September 24 and 29, 2008.

    Dr. Ravindranath has entered into a Voluntary Settlement Agreement and has voluntarily agreed for a period of 3 years, beginning on July 2, 2012:

      (1) To have any PHS-supported research supervised; Respondent agreed that prior to the submission of an application for PHS support for a research project on which the Respondent’s participation is proposed and prior to Respondent’s participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of Respondent’s duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of Respondent’s research contribution; Respondent agreed that he shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agreed to maintain responsibility for compliance with the agreed upon supervision plan;

      (2) That any institution employing him shall submit, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent is involved, a certification to ORI that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived, that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract, and that the text in such submissions is his own or properly cites the source of copied language and ideas; and

      (3) To exclude himself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.

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