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Research Integrity

  • David B. Resnik
Chapter
Part of the International Library of Ethics, Law, and the New Medicine book series (LIME, volume 74)

Abstract

In Chaps.  5,  6,  7,  8, and  9 I have focused on specific issues related to research with human subjects, such as informed consent, confidentiality, risks, benefits, and vulnerability. In this chapter, I will shift gears and examine a topic that indirectly impacts human subjects but which is nevertheless very important: research integrity. Research integrity (or responsible conduct of research, RCR) has to do with following ethical and legal standards in the conduct of research (Shamoo and Resnik 2015). These include rules pertaining to research with human and animals subjects as well as those concerning the conduct of science itself, such as norms for recording, reporting, analyzing, sharing, publishing and interpreting data; assigning authorship; disclosing and handling conflicts of interest; working with collaborators, students, and trainees; reviewing manuscripts and grants; managing financial and other resources; and investigating allegations of misconduct (Shamoo and Resnik 2015). This chapter will consider some RCR issues which have an important bearing on research with human subjects. But first, I will explain why investigator integrity is essential to research with human subjects.

References

  1. Ancker, J.S., and A. Flanagin. 2007. A comparison of conflict of interest policies at peer-reviewed journals in different scientific disciplines. Science and Engineering Ethics 13 (2): 147–157.CrossRefGoogle Scholar
  2. ———. 2008. Industry-sponsored clinical research: A broken system. Journal of the American Medical Association 300 (9): 1069–1071.CrossRefGoogle Scholar
  3. Association for the Accreditation of Human Research Protection Programs. 2012a. Considering accreditation. Available at: http://www.aahrpp.org/learn/considering-accreditation. Accessed 26 July 2017.
  4. ———. 2012b. The value of accreditation. Available: http://www.aahrpp.org/learn/considering-accreditation/value-of-accreditation. Accessed 26 July 2017.
  5. Bekelman, J.E., Y. Li, and C.P. Gross. 2003. Scope and impact of financial conflicts of interest in biomedical research: A systematic review. Journal of the American Medical Association 289 (4): 454–465.CrossRefGoogle Scholar
  6. Brown, J.R. 2000. Essays on science and society: Privatizing the university—The new tragedy of the commons. Science 290 (5497): 1701–1702.CrossRefGoogle Scholar
  7. ———. 2002. Funding, objectivity and the socialization of medical research. Science and Engineering Ethics 8 (3): 295–308.CrossRefGoogle Scholar
  8. Cho, M.K., and L.A. Bero. 1996. The quality of drug studies published in symposium proceedings. Annals of Internal Medicine 124 (5): 485–489.CrossRefGoogle Scholar
  9. ———. 2017. FDAAA 801 requirements. Available at: https://clinicaltrials.gov/ct2/manage-recs/fdaaa. Accessed 17 Aug 2017.
  10. Committee on Publication Ethics. 2012. Cooperation between research institutions and journals on research integrity cases: Guidance from the Committee on Publication Ethics (COPE). Available at: http://publicationethics.org/files/Research_institutions_guidelines_final_0_0.pdf. Accessed 17 Aug 2017.
  11. Coombes, K.R., J. Wang, and K.A. Baggerly. 2007. Microarrays: Retracing steps. Nature Medicine 13 (11): 1276–12777.CrossRefGoogle Scholar
  12. Cooper, R.J., M. Gupta, M.S. Wilkes, and J.R. Hoffman. 2006. Conflict of interest disclosure policies and practices in peer-reviewed biomedical journals. Journal of General Internal Medicine 21 (12): 1248–1252.CrossRefGoogle Scholar
  13. Coors, M.E., K.M. Raymond, S.K. McWilliams, C.J. Hopfer, and S.K. Mikulich-Gilbertson. 2015. What adolescents enrolled in genomic addiction research want to know about conflicts of interest. Drug and Alcohol Dependence 147: 272–275.CrossRefGoogle Scholar
  14. Davis, M. 1982. Conflict of interest. Business and Professional Ethics Journal 1 (4): 17–27.CrossRefGoogle Scholar
  15. DeAngelis, C.D. 2000. Conflict of interest and the public trust. Journal of the American Medical Association 284 (17): 2237–2238.CrossRefGoogle Scholar
  16. DeAngelis, C.D., and P.B. Fontanarosa. 2008. Impugning the integrity of medical science: The adverse effects of industry influence. Journal of the American Medical Association 299 (15): 1833–1835.CrossRefGoogle Scholar
  17. ———. 2011. Responsibility of applicants for promoting objectivity in research for which Public Health Service funding is sought and responsible prospective contractors; final rule. Federal Register 76 (165): 53256–53293.Google Scholar
  18. Dickersin, K., and D. Rennie. 2003. Registering clinical trials. Journal of the American Medical Association 290 (4): 516–523.CrossRefGoogle Scholar
  19. ———. 2012. The evolution of trial registries and their use to assess the clinical trial enterprise. Journal of the American Medical Association 307 (17): 1861–1864.CrossRefGoogle Scholar
  20. Dubois, J.M., J.T. Chibnall, R. Tait, and Wal J. Vander. 2016. Lessons from researcher rehab. Nature 534 (7605): 173–175.CrossRefGoogle Scholar
  21. Elliott, K.C. 2008. Scientific judgment and the limits of conflict-of-interest policies. Accountability in Research 15 (1): 1–29.CrossRefGoogle Scholar
  22. Fanelli, D. 2009. How many scientists fabricate and falsify research? A systematic review and meta-analysis of survey data. PLoS One 4 (5): e5738.CrossRefGoogle Scholar
  23. Friedberg, M., B. Saffran, T.J. Stinson, W. Nelson, and C.L. Bennett. 1999. Evaluation of conflict of interest in economic analyses of new drugs used in oncology. Journal of the American Medical Association 282 (15): 1453–1457.CrossRefGoogle Scholar
  24. Friedman, L.S., and M. Friedman. 2016. Financial conflicts of interest and study results in environmental and occupational health research. Journal of Occupational and Environmental Medicine 58 (3): 238–247.CrossRefGoogle Scholar
  25. Friedman, L.S., and E.D. Richter. 2004. Relationship between conflicts of interest and research results. Journal of General Internal Medicine 19 (1): 51–46.CrossRefGoogle Scholar
  26. Gilchrest, B.A. 1988. At last! A medical treatment for skin aging. Journal of the American Medical Association 259 (4): 569–570.CrossRefGoogle Scholar
  27. Goldberg, P. 2015. Duke officials silenced med student who reported trouble in Anil Potti’s lab. The Cancer Letter, 9 January 2015. Available at: http://www.cancerletter.com/articles/20150109_1. Accessed 17 Aug 2017.
  28. Goozner, M. 2004. Unrevealed: Non-disclosure of conflicts of interest in four leading medical and scientific journals. Center for Science and the Public Interest. Available at: https://www.cspinet.org/new/pdf/unrevealed_final.pdf. Accessed 17 Aug 2017.
  29. Grady, C., E. Horstmann, J.S. Sussman, and S.C. Hull. 2006. The limits of disclosure: What research subjects want to know about investigator financial interests. Journal of Law, Medicine & Ethics 34 (3): 592–599.CrossRefGoogle Scholar
  30. Hampson, L.A., J.E. Bekelman, and C.P. Gross. 2008. Empirical data on conflict of interest. In The Oxford handbook of clinical research ethics, ed. E.J. Emanuel, C. Grady, R.A. Crouch, R.K. Lie, F.G. Miller, and D. Wendler, 767–779. New York: Oxford University Press.Google Scholar
  31. Hull, D. 1988. Science as process. Chicago: University of Chicago Press.CrossRefGoogle Scholar
  32. ———. 2002a. Responsible research: A systems approach to protecting research participants. Washington, DC: Institute of Medicine.Google Scholar
  33. ———. 2002b. Integrity in scientific research: Creating and environment the promotes responsible conduct. Washington, DC: National Academy Press.Google Scholar
  34. ———. 2009. Conflict of interest in medical research, education, and practice. Washington, DC: National Academies Press.Google Scholar
  35. Kaiser, J. 2004. Biomedical research. Senators probe alleged financial conflicts at NIH. Science 303 (5658): 603–655.CrossRefGoogle Scholar
  36. Katz, D., A.L. Caplan, and J.F. Merz. 2003. All gifts large and small: Toward an understanding of the ethics of pharmaceutical industry gift-giving. American Journal of Bioethics 3 (3): 39–46.CrossRefGoogle Scholar
  37. Kim, S.Y., R.W. Millard, P. Nisbet, C. Cox, and E.D. Caine. 2004. Potential research participants’ views regarding researcher and institutional financial conflicts of interest. Journal of Medical Ethics 30 (1): 73–79.CrossRefGoogle Scholar
  38. Krimsky, S. 2003. Science in the private interest—Has the lure of profits corrupted biomedical research? Lanham: Rowman and Littlefield.Google Scholar
  39. Laine, C., R. Horton, C.D. DeAngelis, J.M. Drazen, F.A. Frizelle, F. Godlee, C. Haug, P.C. Hébert, S. Kotzin, A. Marusic, P. Sahni, T.V. Schroeder, H.C. Sox, M.B. Van der Weyden, and F.W. Verheugt. 2007. Clinical trial registration—Looking back and moving ahead. New England Journal of Medicine 356 (26): 2734–2746.CrossRefGoogle Scholar
  40. Levinson, W., A. Kao, A.M. Kuby, and R.A. Thisted. 2005. The effect of physician disclosure of financial incentives on trust. Archives of Internal Medicine 165 (6): 625–630.CrossRefGoogle Scholar
  41. Malek, J. 2010. To tell or not to tell? The ethical dilemma of the would-be whistleblower. Accountability in Research 17 (3): 115–129.CrossRefGoogle Scholar
  42. Michaels, D. 2008. Doubt is their product: How industry’s assault on science threatens your health. New York: Oxford University Press.Google Scholar
  43. Miller, A., and M. Davis. 2011. Intellectual property. 4th ed. St. Paul: West Publishing.Google Scholar
  44. Morin, K., H. Rakatansky, F.A. Riddick Jr., L.J. Morse, J.M. O’Bannon 3rd, M.S. Goldrich, P. Ray, M. Weiss, R.M. Sade, and M.A. Spillman. 2002. Managing conflicts of interest in the conduct of clinical trials. Journal of the American Medical Association 287 (1): 78–84.CrossRefGoogle Scholar
  45. Moses, H., 3rd, and J.B. Martin. 2001. Academic relationships with industry: A new model for biomedical research. Journal of the American Medical Association 285 (7): 933–935.CrossRefGoogle Scholar
  46. ———. 2016b. Allegations of noncompliance with requirements of the NIH human research protection program. Available at: http://ohsr.od.nih.gov/ohsr/public/SOP_16A_V3_3-17-16_508.pdf. Accessed 17 Aug 2017.
  47. Office of Research Integrity. 2015. Case summary: Anil Potti. Available at: https://ori.hhs.gov/content/case-summary-potti-anil. Accessed 17 Aug 2017.
  48. Office of Science and Technology Policy. 2000. Federal policy on research misconduct. Federal Register 65 (235): 76260–76264.Google Scholar
  49. Olivieri, N.F. 2003. Patients’ health or company profits? The commercialisation of academic research. Science and Engineering Ethics 9 (1): 29–41.CrossRefGoogle Scholar
  50. Potti, A., H.K. Dressman, A. Bild, R.F. Riedel, G. Chan, R. Sayer, J. Cragun, H. Cottrill, M.J. Kelley, R. Petersen, D. Harpole, J. Marks, A. Berchuck, G.S. Ginsburg, P. Febbo, J. Lancaster, and J.R. Nevins. 2006. Genomic signatures to guide the use of chemotherapeutics. Nature Medicine 12 (11): 1294–1300.CrossRefGoogle Scholar
  51. ———. 2003a. From Baltimore to Bell labs: Reflections on two decades of debate about scientific misconduct. Accountability in Research 10 (2): 123–135.CrossRefGoogle Scholar
  52. ———. 2003b. Owning the genome: A moral analysis of DNA patenting. Albany: SUNY Press.Google Scholar
  53. ———. 2003c. Exploitation in biomedical research. Theoretical Medicine and Bioethics 24 (3): 233–259.CrossRefGoogle Scholar
  54. ———. 2004. Disclosing conflicts of interest to research subjects: An ethical and legal analysis. Accountability in Research 11 (2): 141–159.CrossRefGoogle Scholar
  55. ———. 2005b. Conflicts of interest at the NIH: No easy solution. Hastings Center Report 35 (1): 18–20.CrossRefGoogle Scholar
  56. ———. 2007a. The price of truth: How money affects the norms of science. New York: Oxford University Press.CrossRefGoogle Scholar
  57. ———. 2015a. Paternalism and utilitarianism in research with human participants. Health Care Analysis 23 (1): 19–31.CrossRefGoogle Scholar
  58. ———. 2015b. Bioethical issues in providing financial incentives to research participants. Medicolegal and Bioethics 5: 35–41.CrossRefGoogle Scholar
  59. Resnik, D.B., and K.C. Elliott. 2013. Taking financial relationships into account when assessing research. Accountability in Research 20 (3): 184–205.CrossRefGoogle Scholar
  60. Resnik, D.B., and A.E. Shamoo. 2002. Conflict of interest and the university. Accountability in Research 9 (1): 45–64.CrossRefGoogle Scholar
  61. Resnik, D.B., S. Peddada, and W. Brunson Jr. 2009. Research misconduct policies of scientific journals. Accountability in Research 16 (5): 254–267.CrossRefGoogle Scholar
  62. Resnik, D.B., T. Neal, A. Raymond, and G.E. Kissling. 2015b. Research misconduct definitions adopted by U.S. research institutions. Accountability in Research 22 (1): 14–21.CrossRefGoogle Scholar
  63. Resnik, D.B., L.M. Rasmussen, and G.E. Kissling. 2015c. An international study of research misconduct policies. Accountability in Research 22 (5): 249–266.CrossRefGoogle Scholar
  64. Resnik, D.B., E. Wager, and G.E. Kissling. 2015d. Retraction policies of top scientific journals ranked by impact factor. Journal of the Medical Library Association 103 (3): 136–139.CrossRefGoogle Scholar
  65. Ridker, P.M., and J. Torres. 2006. Reported outcomes in major cardiovascular clinical trials funded by for-profit and not-for-profit organizations: 2000–2005. Journal of the American Medical Association 295 (19): 2270–2274.CrossRefGoogle Scholar
  66. Shamoo, A.E. 1999a. Institutional review boards (IRBs) and conflict of interest. Accountability in Research 7 (2–4): 201–212.CrossRefGoogle Scholar
  67. ———. 2013. Data audit as a way to prevent/contain misconduct. Accountability in Research 20 (5-6): 369–379.CrossRefGoogle Scholar
  68. ———. 2015. Responsible conduct of research. 3rd ed. New York: Oxford University Press.Google Scholar
  69. Sismondo, S. 2008a. Pharmaceutical company funding and its consequences: A qualitative systematic review. Contemporary Clinical Trials 29 (2): 109–113.CrossRefGoogle Scholar
  70. Stancil, J. 2015. US says Anil Potti, former Duke doctor, falsified research. Raleigh News and Observer, 9 November 2015:A1.Google Scholar
  71. Stelfox, H.T., G. Chua, K. O’Rourke, and A.S. Detsky. 1998. Conflict of interest in the debate over calcium-channel antagonists. New England Journal of Medicine 338 (2): 101–106.CrossRefGoogle Scholar
  72. Thompson, D.F. 1993. Understanding financial conflicts of interest. New England Journal of Medicine 329 (8): 573–576.CrossRefGoogle Scholar
  73. United States Congress, Committee on Government Operations. 1990. Are scientific misconduct and conflicts of interest hazardous to our health? Washington, DC: U.S. Government Printing Office.Google Scholar
  74. Weiss, J.S., C.N. Ellis, J.T. Headington, T. Tincoff, T.A. Hamilton, and J.J. Voorhees. 1988. Topical tretinoin improves photoaged skin. A double-blind vehicle-controlled study. Journal of the American Medical Association 259 (4): 527–532.CrossRefGoogle Scholar
  75. Whitbeck, C. 1995. Truth and trustworthiness in research. Science and Engineering Ethics 1 (4): 403–416.CrossRefGoogle Scholar
  76. Wolf, L.E., and J. Zandecki. 2007. Conflicts of interest in research: How IRBs address their own conflicts. IRB 29 (1): 6–12.Google Scholar

Copyright information

© Springer International Publishing AG 2018

Authors and Affiliations

  • David B. Resnik
    • 1
  1. 1.National Institutes of HealthNational Institute of Environmental Health SciencesResearch Triangle ParkUSA

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