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Conflict of Interest and Commercialization of Biomedical Research

What is the Role of Research Ethics Review?

  • Chapter
The Commercialization of Genetic Research

Abstract

Biomedical research results from the efforts of individuals as well as groups working in private laboratories, health care institutions, universities and research centres. In contemporary society, such research has become a more social or public enterprise, of interest not only to those who participate directly as researchers or research subjects, but to governments, commercial entities and the public at large. As with all human conduct, the process of developing hypotheses, designing research protocols and gathering, interpreting and reporting results has many moral aspects or “forks in the road” where the choices to be made may have implications for how one should, or should not act.

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References

  • Advisory Committee on Human Radiation Experiments 1996. Final Report, New York: Oxford University Press.

    Google Scholar 

  • American College of Physicians 1990. “Position Paper: Physicians and the Pharmaceutical Industry” Annals of Internal Medicine, Vol. 112(8), pp. 624–626.

    Google Scholar 

  • Annas, G. 1991. “Ethics Committees: From Ethical Comfort to Ethical Cover” Hastings Centre Report, Vol. 21, p. 18.

    Google Scholar 

  • Association of Academic Health Centres 1993. “New Opportunities Create New Problems” The Ethical Dimensions of the Biological Sciences, R.E. Bulger, E. Heitman & S.J. Reiser (Eds.), New York: Cambridge University Press, pp. 251–259.

    Google Scholar 

  • Beecher, H.K. 1966. “Ethics and Clinical Research” New England Journal of Medicine, Vol. 475, pp. 1354–1360.

    Article  Google Scholar 

  • Bell, J., Whiton, J. & Connelly, S. 1998. Final Report: Evaluation of NIH Implementation of Section 491 of the Public Health Service Act, Mandating a Program of Protection for Research Subjects, prepared for the Office of Extramural Research, National Institutes of Health.

    Google Scholar 

  • Bigorra, J. & Baños, J.E. 1990. “Weight of Financial Reward in the Decision by Medical Students and Experienced Healthy Volunteers to Participate in Clinical Trials” European Journal of Clinical Pharmacology, Vol.38, pp. 443–446.

    Article  Google Scholar 

  • Brody, B. 1996. “Conflicts of Interest and Validity of Clinical Trials” Conflicts of Interest in Clinical Practice and Research, R.G. Spece, D.S. Shimm & A.E. Buchanan (Eds.), New York: Oxford University Press, pp. 407–417.

    Google Scholar 

  • Bulger, R.E., Heitman, E. & Reiser, S.J. 1993. “The Scientist and Industry: Conflicts of Interest and Conflicts of Commitment” The Ethical Dimensions of the Biological Sciences, R.E. Bulger, E. Heitman & S.J. Reiser (Eds), New York: Cambridge University Press, p. 221.

    Google Scholar 

  • Canadian Medical Association 1994. “Physicians and the Pharmaceutical Industry” Canadian Medical Association Journal, Vol. 150(2), pp. 256A-C (Updated version available at http://www.cma.ca/inside/policybase/1998/05–09a.htm).

    Google Scholar 

  • Davidson, R.A. 1986. “Source of Funding and Outcome of Clinical Trials” Journal of General Internal Medicine, Vol. 1, pp. 155–158.

    Article  Google Scholar 

  • Declaration of Indigenous Peoples of the Western Hemisphere Regarding the Human Genome Diversity Project 1995. Phoenix, Arizona February 19, 1995.

    Google Scholar 

  • Emanuel, E.J. & Steiner, D. 1995. “Sounding Board: Institutional Conflict of Interest” New England Journal of Medicine, Vol. 332(4), pp. 262–267.

    Article  Google Scholar 

  • Endersbe, E., 1998 (Nov. 17). “Lure of Riches Fuels Testing”, Boston Globe.

    Google Scholar 

  • Francis, L. 1996. “IRBs and Conflicts of Interest” Conflicts of Interest in Clinical Practice and Research, R.G. Spece, D.S. Shimm & A.E. Buchanan (Eds.), New York: Oxford University Press, pp. 418–437.

    Google Scholar 

  • Freedman, B., Weijer, C. & Glass, K. 1996a. “Placebo Orthodoxy in Clinical Research I: Empirical and Method-ological Myths” Journal of Law, Medicine & Ethics, Vol. 24(3), pp. 243–251.

    Article  Google Scholar 

  • Freedman, B., Glass, K. & Weijer, C. 1996b. “Placebo Orthodoxy in Clinical Research II: Ethical, Legal, and Regulatory Myths” Journal of Law, Medicine & Ethics, Vol. 24(3), pp. 252–259.

    Article  Google Scholar 

  • Freestone, D.S. & Mitchell, H. 1993. “Inappropriate Publication of Trial Results and Potential for Allegations of Illegal Share Dealing” British Medical Journal, Vol. 306(6885), pp. 1112–1114.

    Article  Google Scholar 

  • Genewatch, 1990. “Proposed Conflict-of-Interest Guidelines Withdrawn” Vol. 6(2–3), p. 5.

    Google Scholar 

  • Glass, B. 1993. “The Ethical Basis of Science” The Ethical Dimensions of the Biological Sciences, R.E. Bulger, E. Heitman & S.J. Reiser (Eds.), New York: Cambridge University Press, pp. 43–55.

    Google Scholar 

  • Glass, B. 1965, “The Ethical Basis of Science” Science, Vol. 150, pp. 1254–1261.

    Article  Google Scholar 

  • Glass, K.C., Weijer, C., Palmour, R.M., Lemmens, T.M. & Shapiro, S.H. 1997. “Structuring the Review of Human Genetics Protocols Part II: Diagnostic and Screening Studies” IRB: A Review of Human Subjects Research, Vol. 19(3–4), pp. 1–13.

    Google Scholar 

  • Horton, R. 1997. “Conflicts of Interest in Clinical Research: Opprobrium or Obsession” The Lancet, Vol. 349, pp. 1112–1113.

    Article  Google Scholar 

  • Horton, R. 1995. “The Rhetoric of Research” British Medical Journal, Vol. 310, pp. 985–88.

    Article  Google Scholar 

  • Huth, E.J. 1993. “Irresponsible Authorship and Wasteful Publication” The Ethical Dimensions of the Biologi-cal Sciences, R.E. Bulger, E. Heitman & S.J. Reiser (Eds.), New York: Cambridge University Press, pp. 134–137.

    Google Scholar 

  • International Committee of Medical Journal Editors 1993. “Uniform Requirements for Manuscripts Submitted to Biomedical Journals” JAMA, Vol. 269, pp. 2282–2286.

    Google Scholar 

  • Katz, J. 1972. Experimentation with Human Beings, New York: Russell Sage Foundation.

    Google Scholar 

  • Katz, J. 1996. “Informed Consent to Medical Entrepreneurialism” Conflicts of Interest in Clinical Practice and Research, R.G. Spece, D.S. Shimm & A.E. Buchanan (Eds.), New York: Oxford University Press, pp. 286–299.

    Google Scholar 

  • Korenman, S. 1993. “Conflict of Interest and Commercialization of Research” Academic Medicine, Vol. 68(9, supp.3), pp. S18–S22.

    Article  Google Scholar 

  • The Lancet [Editorial]. 1997a. “Good Manners for the Pharmaceutical Industry” Vol. 349, p. 1635.

    Google Scholar 

  • The Lancet [Editorial]. 1997b. “A Curious Stopping Rule from Hoechst Marion Roussel” Vol. 350, p. 155.

    Google Scholar 

  • Lemmens, T. & Elliott C. (in press) “Guinea Pigs on the Payroll: the Ethics of Paying Research Subjects” Accountability in Research.

    Google Scholar 

  • Lemmens, T. & Freedman, B. 1997. “Selling Ethics and Protecting Subjects? Conflict of Interest and Commercial Research Review” (submitted for publication).

    Google Scholar 

  • Lemmens, T. & Singer, P. 1998. “Bioethics for Clinicians, 17: Conflict of Interest in Research, Education and Patient Care” Canadian Medical Association Journal, Vol. 159(8), pp. 960–965.

    Google Scholar 

  • Levine, R. 1986. Ethics and Regulation of Clinical Research (2nd ed.), Baltimore: Urban and Schwarzenberg.

    Google Scholar 

  • Lexchin, J. 1993. “Interactions Between Physicians and the Pharmaceutical Industry: What Does the Literature Say?” Canadian Medical Association Journal, Vol. 149(10), pp. 1401–1407.

    Google Scholar 

  • Lind, S.E. 1990. “Finder’s Fees for Research Subjects” New England Journal of Medicine, Vol. 323, pp. 192–195.

    Article  Google Scholar 

  • Maatz, C.T. 1992. “University Physician-Researcher Conflicts of Interest: the Inadequacy of Current Controls and Proposed Reform” High Technology Law Journal, Vol. 7(1), pp. 138–188.

    Google Scholar 

  • Marshall, E. 1999. “NIMH to Screen Studies for Science and Human Risks” Science, Vol. 283(5401), pp. 464–465.

    Article  Google Scholar 

  • Medical Research Council of Canada, Natural Sciences and Engineering Research Council of Canada and Social Sciences and Humanities Research Council of Canada 1998. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. Ottawa: Minister of Supply and Services.

    Google Scholar 

  • Moore v Regents of the University of California 793 P.2d 479, 481 (Cal. 1990).

    Google Scholar 

  • National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research 1979. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC.

    Google Scholar 

  • National Bioethics Advisory Commission 1998. Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. Volume I: Report and Recommendations of the National Advisory Commission. Maryland: National Bioethics Advisory Commission.

    Google Scholar 

  • Office of Inspector General 1998a. Institutional Review Boards: Their Role in Reviewing Approved Research, Department of Health and Human Services.

    Google Scholar 

  • Office of Inspector General 1998b. Institutional Review Boards: Promising Approaches, Department of Health and Human Services.

    Google Scholar 

  • Office of Inspector General 1998c. Institutional Review Boards: The Emergence of Independent Boards, Department of Health and Human Services.

    Google Scholar 

  • Office of Inspector General 1998d. Institutional Review Boards: A Time for Reform, Department of Health and Human Services.

    Google Scholar 

  • Perry, C.B. 1994. “Conflicts of Interest and the Physician’s Duty to Inform” American Journal of Medicine, Vol. 96, pp. 375–380.

    Article  Google Scholar 

  • Petersdorf, R.G. 1993. “The Pathogenesis of Fraud in Science” The Ethical Dimensions of the Biological Sci-ences, R.E. Bulger, E. Heitman & S.J. Reiser (Eds.), New York: Cambridge University Press, pp. 95–98.

    Google Scholar 

  • Phillips, R.A. & Hoey, J. 1998. “Constraints of Interest: Lessons at the Hospital for Sick Children” Canadian Medical Association Journal, Vol. 159(8), pp. 955–957.

    Google Scholar 

  • Pincus, H.A., Lieberman, JA. & Ferris, S. (Eds.) 1999. Ethics in Psychiatric Research, A Resource Manual for Human Subjects Protection, American Psychiatric Association: Washington.

    Google Scholar 

  • Reibl e Hughes 1980. 114 D.L.R. (3d) 1 (Supreme Court of Canada).

    Google Scholar 

  • Rothman, K.J. 1993. “Conflict of Interest: The New McCarthyism in Science.” JAMA, Vol. 269, pp. 2782–2784.

    Article  Google Scholar 

  • Smith, R. 1996. “Time to Face Up to Research Misconduct” British Medical Journal, Vol. 312(7034), pp. 789–790.

    Google Scholar 

  • Spece, R.G., Shimm, D.S. & Buchanan, A.E. (Eds.) 1996. Conflicts of Interest in Clinical Practice and Research, New York: Oxford University Press.

    Google Scholar 

  • Stelfox, H.T., Chua, G., O’Rourke, K. & Detsky, A.S. 1998. “Conflict of Interest in the Debate Over Calcium-Channel Antagonists” New England Journal of Medicine, Vol. 338(2), pp. 101–106.

    Article  Google Scholar 

  • Thompson, D. 1993. “Understanding Financial Conflicts of Interest” New England Journal of Medicine, Vol. 329(8), pp. 573–576.

    Article  Google Scholar 

  • U.S. Department of Health, Education and Welfare 1973. Final Report of the Tuskegee Syphilis Study Ad Hoc Panel, Washington, D.C.: Government Printing Office.

    Google Scholar 

  • U.S. General Accounting Office 1996. Scientific Research: Continued Vigilance Critical to Protecting Human Subjects, GAO/HEHS-96–72.

    Google Scholar 

  • van Gelderen, C.E.M., Savelkoul, T.J.F., van Dokkum, W & Meulenbelt, J. 1993. “Motives and Perception of Healthy Volunteers Who Participate in Experiments” European Journal of Clinical Pharmacology, Vol. 45, pp. 15–21.

    Article  Google Scholar 

  • World Medical Association 1995 [1964, rev. 1975, 1983, 19891 “Declaration of Helsinki” W.T. Reich (Ed.), Encyclopedia of Bioethics (rev. ed.), New York: Simon and Schuster/Macmillan, pp. 2765–2767.

    Google Scholar 

  • Woolf, P.K. 1993. “Pressure to Publish and Fraud in Science” The Ethical Dimensions of the Biological Sciences, R.E. Bulger, E. Heitman & S.J. Reiser (Eds.), New York: Cambridge University Press, pp. 100–103.

    Google Scholar 

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Authors
  1. Kathleen Cranley Glass
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  2. Trudo Lemmens
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Editor information

Editors and Affiliations

  1. Health Law Institute, University of Alberta, Edmonton, Alberta, Canada

    Timothy A. Caulfield

  2. Centre for Applied Ethics, University of British Columbia, Vancouver, British Columbia, Canada

    Bryn Williams-Jones

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© 1999 Springer Science+Business Media New York

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Glass, K.C., Lemmens, T. (1999). Conflict of Interest and Commercialization of Biomedical Research. In: Caulfield, T.A., Williams-Jones, B. (eds) The Commercialization of Genetic Research. Springer, Boston, MA. https://doi.org/10.1007/978-1-4615-4713-6_6

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  • DOI: https://doi.org/10.1007/978-1-4615-4713-6_6

  • Publisher Name: Springer, Boston, MA

  • Print ISBN: 978-1-4613-7135-9

  • Online ISBN: 978-1-4615-4713-6

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