1115 wed katrine wager

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  • Gross manipulation of blots. (A) Example of a band deleted from the original data (lane 3). (B) Example of a band added to the original data (lane 3).
  • Gross manipulation of blots. (A) Example of a band deleted from the original data (lane 3). (B) Example of a band added to the original data (lane 3).
  • This shows a timeline leading up to the current position 1980s – concern about publication bias started to come from people compiling systematic reviews (eg the Cochrane collaboration) 1986 – the first major paper calling for trial registration was by John Simes in the Journal of Clinical Oncology 1990 – a more influential paper was published in JAMA by Iain Chalmers (one of the founders of the Cochrane collaboration) In the same year (1990), Kay Dickersin published an important paper about risk factors for publication bias The study from Tramer et al in 1997 provided clear evidence that covert duplicate publication (in this case about GW's anti-emetic ondansetron) could bias the results of meta-analyses FDAMA (the FDA Modernization Act) came into force in late 1997 and clinicaltrials.gov was set up to register trials ( these will be covered in more detail in later slides) Glaxo Wellcome was one of the first drug companies to establish its own trial register (in 1999) – it was retrospective (i.e. included studies only after a product was licensed) and didn't survive the GSK merger The UK industry association (ABPI) created a register but it was largely ignored
  • In late 2004, the editors of several major journals announced that trial registration would be compulsory, and that trials had to be registered by Sept 15 th 2005 This graph clearly shows the effects of that deadline It's interesting to note that it's not only commercial but also academic studies being registered (The graph shows the number of NEW registrations per week at clinicaltrials.gov)
  • 1115 wed katrine wager

    1. 1. Publishers’ role in publication ethics: part of the solution or part of the problem? Liz Wager Publications Consultant, Sideview Chair, COPE, 2009-2012 liz@sideview.demon.co.uk©Sideview
    2. 2. Why should publishers be concerned about ethics? Responsible for the integrity of their publications (with editors) As professionals To avoid expensive problems (litigation) Good for business©Sideview
    3. 3. Scholarly publishers have special obligations “Be careful about reading health books. You may die of a misprint.” Mark Twain©Sideview
    4. 4. Not only in medicine …©Sideview
    5. 5. What can go wrong? Misconduct by authors • Plagiarism, fabrication, falsification Misconduct by editors • Abuse of position, unfairness Misconduct by peer reviewers • Theft of ideas/data Misconduct by publishers • Undue commercial influence©Sideview
    6. 6. How common is misconduct? Systematic review (screened 3207 papers) Meta-analysis (18 studies) • surveys of fabrication or falsification • NOT plagiarism 2% admitted misconduct themselves (95% CI 0.9-4.5) 14% aware of misconduct by others (95% CI 9.9-19.7) Fanelli PLoS One 2009;4(5):e5738
    7. 7. How often is misconduct detected?PubMed retractions 0.02%US Office of Research Integrity 0.01-0.001%(ORI) (1 in 10,000 / 100,000 scientists)Image manipulation 1%in J Cell Biology (8/800)FDA audit – investigators guilty 2%of serious sci misconduct
    8. 8. Because major ethical problems are (quite) rare Editors don’t see many cases during their term of office Publishers looking after many journals can provide ‘corporate memory’ AND Editors are largely untrained
    9. 9. Publishers (and editors)Should work to: prevent detect respond appropriatelyto misconduct©Sideview
    10. 10. What should journals & publishers do? Educate  ?screen Raise awareness  ?discipline Have clear policies
    11. 11. Tools for detecting misconduct Anti-plagiarism software (eg eTBLAST, CrossCheck, Turnitin) Screening images (PhotoShop) Chemical structure checks Data review (digit preference)
    12. 12. CrossCheck Based on iParadigms software Compares text against publishers’ d-base D-base run by CrossRef (doi system) D-base currently contains 59,000 titles Shows % concordance + source Can exclude “quotes” and references ?False positives / ‘noise’ level
    13. 13. Image screening Pioneered by J Cell Biology Used in some life sciences journals Important for research where the image = the findings • genetics / cell biology / radiography Found 1% Manual check using PhotoShop unacceptable Requires editor time / expertise manipulation Rossner & Yamada, JCB 2004;166:11-15
    14. 14. Figure 1. Gross manipulation of blots Rossner M., Yamada K. M. J. Cell Biol. 2004:166:11-15© 2004 Rossner et.al.
    15. 15. Figure 1. Gross manipulation of blots Rossner M., Yamada K. M. J. Cell Biol. 2004:166:11-15© 2004 Rossner et.al.
    16. 16. Chemical structure checks Examined structure-factor files Identified >70 bogus organic structures Authors had taken a genuine structure and switched metals (eg Fe / Cu) or chemical groups (CH2 / NH / OH) Editors note: “it is a concern and a disappointment that these [chemically implausible or impossible structures] passed into the literature” >70 articles retracted Acta Crystallographica 2010;E66:e1-2
    17. 17. Frequency Where to screen?high ? yes low no ? Severity low high
    18. 18. Effects of journal policies Educate authors and reviewers Encourage truthful authorship Discourage redundant publication Encourage clinical trial registration©Sideview
    19. 19. Trial registration clinicaltrials.gov start online Concerns re publication ISRCTN ICMJE bias FDAMA launched deadline Chalmers2 ICMJE GW ABPI announcement Simes1 register site Tramèr31980s 1986 1990 1997 1999 2000 2003 2004 2005 1 Publication Underreporting research 2 Impact of covert 3 bias is scientific misconduct duplicate publication JCO 4:1529 JAMA 263:1405 BMJ 315:635
    20. 20. Journal policies are more effective than US laws …©Sideview
    21. 21. New trials registered at clinicaltrials.gov May – Oct 2005
    22. 22. What about misconduct by publishers? … part of the problem?©Sideview
    23. 23. Problems Inappropriate policies Undue commercial interference Breach of editorial independence Undisclosed conflicts of interest©Sideview
    24. 24. ©Sideview
    25. 25. Case study Editor of orthopaedic journal failed to disclose receiving >$20 million in royalties from a device company … What could the publisher have done?©Sideview
    26. 26. Editorial freedom “editorial freedom … cannot be total. I couldn’t turn the BMJ into a soccer magazine because I’d got bored with medicine. Freedom must be accompanied by accountability” Richard Smith (former editor, BMJ)©Sideview
    27. 27. Editorial freedom? “freedom of the press … means freedom to print such of the proprietor’s prejudices as the advertisers don’t object to” Hannen Swaffer©Sideview
    28. 28. Why being ethical makes commercial sense©Sideview
    29. 29. It can avoid expensive litigation • authorship disputes • copyright • patent disputes©Sideview
    30. 30. Academic publishing depends on trust© Sideview
    31. 31. ReviewersEditors Authors Readers © Sideview
    32. 32. und ecla biased reviews r ed C oI low qu ality re view Reviewers poor r eview er c ho iceEditors Readers Authors fla we d pr ble oc es po nsi se irres rting s o r ep © Sideview
    33. 33. If trust Fewer advertisers breaks down sed rea dec nue reve fewer submis sionsDissatisfied Fewerparent society readers Unhappy low qu authors ali decrea submis ty se sions revenu d e © Sideview
    34. 34. Journals are powerful brands© Sideview
    35. 35. Consumers trust brands for: Ingredients Process Quality / consistency© Sideview
    36. 36. Consumers increasingly question Company ethos Fair trade Environmental concerns Labour policies Animal testing© Sideview
    37. 37. Being ethical can be a selling point© Sideview
    38. 38. Reputation arrives on foot, and leaves on horseback “the pragmatic issue of how hard it is to build a journal, and how easy it is to destroy one” Frank Davidoff, former editor, Annals of Internal Medicine©Sideview
    39. 39. Reputation “If readers once hear that important, relevant, and well argued articles are being suppressed or that articles are being published simply to fulfil hidden political agendas, then the credibility of the publication collapses—and everybody loses” Richard Smith©Sideview
    40. 40. A fine balance Publishers want to make money Journals depend on reputation for • Independence • Fairness • Academic merit Part of the solution or part of the problem?©Sideview
    41. 41. Part ofthe problem the solution Weak policies  Sound policies No training in ethics  Staff and editor training No corporate memory  Corporate memory Interference  Editorial independence Few resources  Resources for screening Little support for editors (eg CrossCheck)  Support for editors (eg joining COPE) ©Sideview
    42. 42. The things that will destroy us are: politics without principle pleasure without conscience wealth without work knowledge without character business without morality science without humanity and worship without sacrifice Mahatma Gandhi© Sideview

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