Advertisement

Ethics in Research and Publication

  • Stephen H. JacksonEmail author
  • Gail A. Van Norman
Chapter
  • 647 Downloads

Abstract

Medical research and publication serve to promote the scientific integrity and efficacy of the medical profession. The ethical principles of beneficence and nonmaleficence demand that physicians strive to advance medical knowledge so as to improve patient’s lives and avoid harmful or ineffective patient care. The objective of medical research is to seek scientific truths and support these ethical principles. The integrity of clinical investigation involves the just and honest conduct of experimentation, the honest analysis and reporting of data, and then, the fair peer review and publication of these investigations. Research and the publication of research executed dishonestly divert the search for factuality and defile the medical literature. Within the last two decades, several clinical researchers from various specialties whose publications profoundly influenced the practice of anesthesiology were guilty of extensive research fraud and misconduct, and therein, adversely affected the safe practice of anesthesiology.

Keywords

Research and Publication Fraud Research Misconduct Fabrication and Falsification of Data Plagiarism Ghost and Honorary Authorship Redundant Publication Ethical Peer Review Ethical Journal Editorship Perioperative Beta-Blockade Quality Performance Measures 

References

  1. 1.
    Mangano DT, Layug EL, Wallace A, Tateo I. Effect of atenolol on mortality and cardiovascular morbidity after noncardiac surgery. Multicenter Study of Perioperative Ischemia Research Group. NEJM. 1996;335:1713–20.CrossRefPubMedGoogle Scholar
  2. 2.
    Poldermans D, Boersma E, Bax JJ, Thomson IR, van de Ven LL, Blankensteijn JD, et al. The effect of bisoprolol on perioperative mortality and myocardial infarction in high-risk patients undergoing vascular surgery. Dutch Echocardiograph Cardiac Risk Evaluation Applying Stress Echocardiography Study Group. NEJM. 1999;341:1789–94.CrossRefPubMedGoogle Scholar
  3. 3.
    Jackson S, Van Norman G. Anesthesia, anesthesiologists and modern medical ethics. In: Eger II E, Saidman L, Westhorpe R, editors. The wondrous story of anesthesia. New York: Springer; 2014. p. 205–18.CrossRefGoogle Scholar
  4. 4.
    Pelligrino E. Beneficence, scientific autonomy, and self-interest. Camb Q Healthc Ethics. 1992;4:361–9.CrossRefGoogle Scholar
  5. 5.
    Van Norman G, Jackson S. Publication ethics: obligations of authors, peer reviewers, and editors. In: Van Norman G, Jackson S, Rosenbaum S, Palmer S, editors. Clinical ethics in anesthesiology. Cambridge: Cambridge University Press; 2011. p. 209–25.Google Scholar
  6. 6.
    Jackson S, Van Norman G. Ethical issues in the publication of medical research. ASA Newsl. 2011;75:14–6.Google Scholar
  7. 7.
    Alberts B. Promoting scientific standards. (Editorial). Science. 2010;327:12–3.CrossRefPubMedGoogle Scholar
  8. 8.
    Fanelli D. How many scientists fabricate and falsify research? A systematic review and metaanalysis of survey data. PLoS One. 2009;4:e5748.CrossRefGoogle Scholar
  9. 9.
    Gardner W, Lidz C, Hartwig K. Authors’ reports about research integrity problems in clinical trials. Contemp Clin Trials. 2005;26:244–51.CrossRefPubMedGoogle Scholar
  10. 10.
    Wakefield AJ, Murch SH, Anthony A, Linnell J, Casson DM, Malik M, et al. Ileal lymphoid nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children [RETRACTED]. Lancet. 1998;351:637–41.CrossRefPubMedGoogle Scholar
  11. 11.
    Godlee F, Smith J, Marcovitch H. Wakefield’s article linking MMR vaccine and autism was fraudulent. BMJ. 2011;342:c7452.CrossRefPubMedGoogle Scholar
  12. 12.
    Borell B. A medical Madoff: anesthesiologist faked data in 21 studies. Scientific American. 2009. http://www.scientificamerican.com/article.cfm?id=a-medical-madoff-anesthesiologist-faked-data. Accessed 5 July 2015.
  13. 13.
    White P, Carl R, Shafer S. The Scott Reuben saga: one last retraction. Anesth Analg. 2011;112:512–5.CrossRefPubMedGoogle Scholar
  14. 14.
  15. 15.
    Yentis S. Lies, damn lies, and statistics. Anaesthesia. 2012;67:455–6.CrossRefPubMedGoogle Scholar
  16. 16.
    Wagner E. Who is responsible for investigating suspected research misconduct? Anaesthesia. 2012;67:462–6.CrossRefGoogle Scholar
  17. 17.
    Normile D. A new record for retractions? Science Insider (American Association for the Advancement of Science). 2 July 2012.Google Scholar
  18. 18.
    Kranke P, Apfel C, Roewer N. Reported data on granisetron and postoperative nausea and vomiting by Fujii et al. are incredibly nice! Anesth Analg. 2000;90:1004–7.CrossRefPubMedGoogle Scholar
  19. 19.
    Moore R, Derry S, McQuay H. Fraud or flawed: adverse impact of fabricated or poor quality research. Anesthesia. 2010;65:327–30.CrossRefGoogle Scholar
  20. 20.
    Shafer S. Anesthesia and Analgesia policy on institutional review board approval and informed consent for research. Anesth Analg. 2011;112:494–5.CrossRefPubMedGoogle Scholar
  21. 21.
    Yentis S. Research, audit, and journal policies. Anes Analg. 2011;112:496–7.CrossRefGoogle Scholar
  22. 22.
    Shafer S. Personal communication to Stephen Jackson. 1 Nov 2012.Google Scholar
  23. 23.
    Shafer S. You will be caught. Anesth Analg. 2011;112:491–3.CrossRefPubMedGoogle Scholar
  24. 24.
    Carlisle J. The analysis of randomised controlled trials to test data integrity. Anaesthesia. 2012;67:521–37.CrossRefPubMedGoogle Scholar
  25. 25.
    Pandit J. On statistical methods to test if sampling in trials is genuinely random. Anaesthesia. 2012;67:456–62.CrossRefPubMedGoogle Scholar
  26. 26.
    Wilcox L. Authorship. The coin of the realm, the source of complaints. JAMA. 1998;280:216–7.CrossRefPubMedGoogle Scholar
  27. 27.
    Fuller W. Who said ‘helix’? Nature. 2003;424:876–8.CrossRefPubMedGoogle Scholar
  28. 28.
    Zallen D. Despite Franklin’s work. Wilkins earned his Nobel. Nature. 2003;425:15.CrossRefPubMedGoogle Scholar
  29. 29.
    Bouville M. Plagiarism: words and ideas. Sci Eng Ethics. 2008;14:311–33.CrossRefPubMedGoogle Scholar
  30. 30.
    Flanagin A, Carey LA, Fontanarosa PB, Phillips SG, Pace BP, Lundberg GD, et al. Prevalence of articles with honorary authors and ghost authors in peer-reviewed medical journals. JAMA. 1998;280:222–4.CrossRefPubMedGoogle Scholar
  31. 31.
    Gotzsche PC, Hrobjartsson A, Johansen HK, Haahr MT, Altman DG, Chan A-W. Ghost authorship in industry-initiated randomized trials. PLoS Med. 2007;4:e19.CrossRefPubMedPubMedCentralGoogle Scholar
  32. 32.
    Khanyile TD, Duma S, Fakude LP, Mbombo N, Daniels F, Sabone MS. Research integrity and misconduct: a clarification of the concepts. Curationis. 2006;29:40–5.CrossRefPubMedGoogle Scholar
  33. 33.
    Resnick D, Gutierrez-Ford C, Peddada S. Perceptions of ethical problems with scientific journal peer review: an exploratory study. Sci Eng Ethics. 2008;14:305–10.CrossRefGoogle Scholar
  34. 34.
    Beecher H. Ethics and clinical research. NEJM. 1966;274:1354–60.CrossRefPubMedGoogle Scholar
  35. 35.
    Freidenfelds L. Recruiting allies for reform: Henry Knowles Beecher’s “Ethics and Clinical Research”. Int Anes Clinic. 2007;45:79–103.CrossRefGoogle Scholar
  36. 36.
    Shojania KG, Duncan BW, McDonald KM, Wachter RM. Making health care safer: a critical analysis of patient safety practices (Evidence Report/Technology Assessment, No. 43). Rockville: U.S. Agency for Healthcare Quality and Research; 2001. p. 1–8.Google Scholar
  37. 37.
    Eagle KA, Berger PB, Calkins H, Chaitman BR, Ewy GA, Fleischmann KE, et al. ACC/AHA guideline update for perioperative cardiovascular evaluation for noncardiac surgery – executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1996 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery). J Am Coll Cardiol. 2002;39:542–53.CrossRefPubMedGoogle Scholar
  38. 38.
    Brady AR, Gibbs JS, Greenhalgh RM, Powell JT, Sydes MR. Preioperative beta-blockade (POBBLE) for patients undergoing infrarenal vascular surgery: results of a randomized double-blind controlled trial. J Vasc Surg. 2005;41:602–9.CrossRefPubMedGoogle Scholar
  39. 39.
    Yang H, Raymer K, Butler R, Parlow J, Roberts R. The effects of perioperative beta-blockade: results of the Metoprolol after Vascular Surgery (MaVS) study, a randomized controlled trial. Am Heart J. 2006;152(5):983–90.CrossRefPubMedGoogle Scholar
  40. 40.
    Juul AB, Wetterslev J, Gluud C, Kofoed-Enevoldsen A, Jensen G, Callesen T, et al. Effect of perioperative β blockade in patients with diabetes undergoing major non-cardiac surgery: randomised placebo controlled, blinded multicentre trial. BMJ. 2006;332:1482.CrossRefPubMedPubMedCentralGoogle Scholar
  41. 41.
    Devereaux PJ, Yang H, Yusuf S, Guyatt G, Leslie K, Villar JC, et al. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet. 2008;371:1839–47.CrossRefPubMedGoogle Scholar
  42. 42.
    Leung J. Diabetes and not lack of treatment with atenolol predicts decreased survival after noncardiac surgery. Anesthesiology. 1999;90:1226–7.CrossRefPubMedGoogle Scholar
  43. 43.
    Chopra V, Plaisance B, Cavusoglu E, Flanders SA, Eagle KA. Perioperative beta-blockers for major noncardiac surgery: Primum Non Nocere. Am J Med. 2009;122:222–9.CrossRefPubMedGoogle Scholar
  44. 44.
    Erasmus Medical Center fires Dr. Don Plodermans. www.medscape.com/viewarticle/753941. Accessed 17 Apr 2015.
  45. 45.
    Montori VM, Devereaux PJ, Adhikari NK, Burns KE, Eggert CH, Briel M, et al. Randomized trials stopped early for benefit: a systematic review. JAMA. 2005;294:2203–9.CrossRefPubMedGoogle Scholar
  46. 46.
    Bouri S, Shun-shin MJ, Cole GD, Mayet J, Francis DP. Meta-analysis of secure randomised controlled trials of β-blockade to prevent perioperative death in non-cardiac surgery. Heart. 2014;100:456–64.CrossRefPubMedGoogle Scholar
  47. 47.
    Chopra V, Eagle K. Perioperative mischief: the price of academic misconduct. Am J Med. 2102;125:953–5.CrossRefGoogle Scholar
  48. 48.
    Fleisher LA, Beckman JA, Brown KA, Calkins H, Chaikof EL, Fleischmann KE, et al. 2009 ACCF/AHA focused update on perioperative beta blockade incorporated into the ACC/AHA 2007 guidelines on perioperative cardiovascular evaluation and care for non-cardiac surgery. J Am Coll Cardiol. 2009;54:e13–118.CrossRefPubMedGoogle Scholar
  49. 49.
    Shekelle PG, Wachter RM, Pronovost PJ, et al. Making health care safer II: an updated critical analysis of the evidence for patient safety practices. (Evidence report/technology assessment No. 211). Rockville: U.S. Agency for Healthcare Research and Quality; 2013. p. 169–71.Google Scholar
  50. 50.
    Fleisher LA, Fleischmann KE, Auerbach AD, Barnason SA, Beckman JA, Bozkurt B, Davila-Roman VG, et al. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: executive summary. Journal of Nuclear Cardiology. 2015;22(1):162–215.Google Scholar
  51. 51.
    National Quality Forum. http://qualityforum.org.
  52. 52.
    Joint Commission/SCIP – Specification Manual for National Hospital Inpatient Quality Measures. http://jointcommission.org/specificationsmanualfor_national_inpatient_quality_measures.aspx. Accessed 17 Apr 2015.
  53. 53.
    American Society of Anesthesiologists. Statement on the surgical care improvement project (SCIP). 2010. http://www.asahq.org/Search.aspx?q=care+improvement+project+scip. Accessed 17 Apr 2015.
  54. 54.
    Prasad V, Cifu A, Ioannidis JPA. Reversals of established medical practices: evidence to abandon ship. JAMA. 2012;307:37–8.CrossRefPubMedGoogle Scholar
  55. 55.
    Prasad V, Vandross A, Toomey C, Cheung M, Rho J, Quinn S, et al. A decade of reversal: an analysis of 146 contraindicated medical practices. Mayo Clin Proc. 2013;88:790–8.CrossRefPubMedGoogle Scholar
  56. 56.
    Neuman MD, Goldstein JN, Cirullo MA, Schwartz JS. Durability of Class I American College of Cardiology/American Heart Association clinical practice guideline recommendations. JAMA. 2014;311:2092–100.CrossRefPubMedPubMedCentralGoogle Scholar
  57. 57.
    Feuerstein JD, Akbari M, Gifford AE, Hurley CM, Leffler DA, Sheth SG, et al. Systematic analysis underlying the quality of the scientific evidence and conflicts of interest in interventional medicine subspecialty guidelines. Mayo Clin Proc. 2014;89:16–24.CrossRefPubMedGoogle Scholar
  58. 58.
    Neuman MD, Bosk CL, Fleisher LA. Learning from mistakes in clinical practice guidelines: the case of perioperative β-blockade. BMJ Qual Saf. 2014;23:957–64.CrossRefPubMedPubMedCentralGoogle Scholar

Copyright information

© Springer International Publishing Switzerland 2015

Authors and Affiliations

  1. 1.Department of AnesthesiologyGood Samaritan HospitalSan JoseUSA
  2. 2.Department of Anesthesiology and Pain Medicine, Department of Biomedical EthicsUniversity of WashingtonSeattleUSA

Personalised recommendations