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Research Integrity

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Book cover The Ethics of Research with Human Subjects

Part of the book series: International Library of Ethics, Law, and the New Medicine ((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.

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References

  • 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.

    Article  Google Scholar 

  • ———. 2008. Industry-sponsored clinical research: A broken system. Journal of the American Medical Association 300 (9): 1069–1071.

    Article  Google Scholar 

  • 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.

  • ———. 2012b. The value of accreditation. Available: http://www.aahrpp.org/learn/considering-accreditation/value-of-accreditation. Accessed 26 July 2017.

  • 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.

    Article  Google Scholar 

  • Brown, J.R. 2000. Essays on science and society: Privatizing the university—The new tragedy of the commons. Science 290 (5497): 1701–1702.

    Article  Google Scholar 

  • ———. 2002. Funding, objectivity and the socialization of medical research. Science and Engineering Ethics 8 (3): 295–308.

    Article  Google Scholar 

  • 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.

    Article  Google Scholar 

  • ———. 2017. FDAAA 801 requirements. Available at: https://clinicaltrials.gov/ct2/manage-recs/fdaaa. Accessed 17 Aug 2017.

  • 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.

  • Coombes, K.R., J. Wang, and K.A. Baggerly. 2007. Microarrays: Retracing steps. Nature Medicine 13 (11): 1276–12777.

    Article  Google Scholar 

  • 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.

    Article  Google Scholar 

  • 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.

    Article  Google Scholar 

  • Davis, M. 1982. Conflict of interest. Business and Professional Ethics Journal 1 (4): 17–27.

    Article  Google Scholar 

  • DeAngelis, C.D. 2000. Conflict of interest and the public trust. Journal of the American Medical Association 284 (17): 2237–2238.

    Article  Google Scholar 

  • 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.

    Article  Google Scholar 

  • ———. 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 

  • Dickersin, K., and D. Rennie. 2003. Registering clinical trials. Journal of the American Medical Association 290 (4): 516–523.

    Article  Google Scholar 

  • ———. 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.

    Article  Google Scholar 

  • Dubois, J.M., J.T. Chibnall, R. Tait, and Wal J. Vander. 2016. Lessons from researcher rehab. Nature 534 (7605): 173–175.

    Article  Google Scholar 

  • Elliott, K.C. 2008. Scientific judgment and the limits of conflict-of-interest policies. Accountability in Research 15 (1): 1–29.

    Article  Google Scholar 

  • Fanelli, D. 2009. How many scientists fabricate and falsify research? A systematic review and meta-analysis of survey data. PLoS One 4 (5): e5738.

    Article  Google Scholar 

  • 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.

    Article  Google Scholar 

  • 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.

    Article  Google Scholar 

  • 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.

    Article  Google Scholar 

  • Gilchrest, B.A. 1988. At last! A medical treatment for skin aging. Journal of the American Medical Association 259 (4): 569–570.

    Article  Google Scholar 

  • 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.

  • 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.

  • 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.

    Article  Google Scholar 

  • 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 

  • Hull, D. 1988. Science as process. Chicago: University of Chicago Press.

    Book  Google Scholar 

  • ———. 2002a. Responsible research: A systems approach to protecting research participants. Washington, DC: Institute of Medicine.

    Google Scholar 

  • ———. 2002b. Integrity in scientific research: Creating and environment the promotes responsible conduct. Washington, DC: National Academy Press.

    Google Scholar 

  • ———. 2009. Conflict of interest in medical research, education, and practice. Washington, DC: National Academies Press.

    Google Scholar 

  • Kaiser, J. 2004. Biomedical research. Senators probe alleged financial conflicts at NIH. Science 303 (5658): 603–655.

    Article  Google Scholar 

  • 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.

    Article  Google Scholar 

  • 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.

    Article  Google Scholar 

  • Krimsky, S. 2003. Science in the private interest—Has the lure of profits corrupted biomedical research? Lanham: Rowman and Littlefield.

    Google Scholar 

  • 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.

    Article  Google Scholar 

  • 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.

    Article  Google Scholar 

  • Malek, J. 2010. To tell or not to tell? The ethical dilemma of the would-be whistleblower. Accountability in Research 17 (3): 115–129.

    Article  Google Scholar 

  • Michaels, D. 2008. Doubt is their product: How industry’s assault on science threatens your health. New York: Oxford University Press.

    Google Scholar 

  • Miller, A., and M. Davis. 2011. Intellectual property. 4th ed. St. Paul: West Publishing.

    Google Scholar 

  • 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.

    Article  Google Scholar 

  • 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.

    Article  Google Scholar 

  • ———. 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.

  • Office of Research Integrity. 2015. Case summary: Anil Potti. Available at: https://ori.hhs.gov/content/case-summary-potti-anil. Accessed 17 Aug 2017.

  • Office of Science and Technology Policy. 2000. Federal policy on research misconduct. Federal Register 65 (235): 76260–76264.

    Google Scholar 

  • Olivieri, N.F. 2003. Patients’ health or company profits? The commercialisation of academic research. Science and Engineering Ethics 9 (1): 29–41.

    Article  Google Scholar 

  • 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.

    Article  Google Scholar 

  • ———. 2003a. From Baltimore to Bell labs: Reflections on two decades of debate about scientific misconduct. Accountability in Research 10 (2): 123–135.

    Article  Google Scholar 

  • ———. 2003b. Owning the genome: A moral analysis of DNA patenting. Albany: SUNY Press.

    Google Scholar 

  • ———. 2003c. Exploitation in biomedical research. Theoretical Medicine and Bioethics 24 (3): 233–259.

    Article  Google Scholar 

  • ———. 2004. Disclosing conflicts of interest to research subjects: An ethical and legal analysis. Accountability in Research 11 (2): 141–159.

    Article  Google Scholar 

  • ———. 2005b. Conflicts of interest at the NIH: No easy solution. Hastings Center Report 35 (1): 18–20.

    Article  Google Scholar 

  • ———. 2007a. The price of truth: How money affects the norms of science. New York: Oxford University Press.

    Book  Google Scholar 

  • ———. 2015a. Paternalism and utilitarianism in research with human participants. Health Care Analysis 23 (1): 19–31.

    Article  Google Scholar 

  • ———. 2015b. Bioethical issues in providing financial incentives to research participants. Medicolegal and Bioethics 5: 35–41.

    Article  Google Scholar 

  • Resnik, D.B., and K.C. Elliott. 2013. Taking financial relationships into account when assessing research. Accountability in Research 20 (3): 184–205.

    Article  Google Scholar 

  • Resnik, D.B., and A.E. Shamoo. 2002. Conflict of interest and the university. Accountability in Research 9 (1): 45–64.

    Article  Google Scholar 

  • Resnik, D.B., S. Peddada, and W. Brunson Jr. 2009. Research misconduct policies of scientific journals. Accountability in Research 16 (5): 254–267.

    Article  Google Scholar 

  • 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.

    Article  Google Scholar 

  • 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.

    Article  Google Scholar 

  • 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.

    Article  Google Scholar 

  • 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.

    Article  Google Scholar 

  • Shamoo, A.E. 1999a. Institutional review boards (IRBs) and conflict of interest. Accountability in Research 7 (2–4): 201–212.

    Article  Google Scholar 

  • ———. 2013. Data audit as a way to prevent/contain misconduct. Accountability in Research 20 (5-6): 369–379.

    Article  Google Scholar 

  • ———. 2015. Responsible conduct of research. 3rd ed. New York: Oxford University Press.

    Google Scholar 

  • Sismondo, S. 2008a. Pharmaceutical company funding and its consequences: A qualitative systematic review. Contemporary Clinical Trials 29 (2): 109–113.

    Article  Google Scholar 

  • Stancil, J. 2015. US says Anil Potti, former Duke doctor, falsified research. Raleigh News and Observer, 9 November 2015:A1.

    Google Scholar 

  • 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.

    Article  Google Scholar 

  • Thompson, D.F. 1993. Understanding financial conflicts of interest. New England Journal of Medicine 329 (8): 573–576.

    Article  Google Scholar 

  • 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 

  • 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.

    Article  Google Scholar 

  • Whitbeck, C. 1995. Truth and trustworthiness in research. Science and Engineering Ethics 1 (4): 403–416.

    Article  Google Scholar 

  • 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 

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Resnik, D.B. (2018). Research Integrity. In: The Ethics of Research with Human Subjects. International Library of Ethics, Law, and the New Medicine, vol 74. Springer, Cham. https://doi.org/10.1007/978-3-319-68756-8_10

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