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Ending Concerns about Undue Inducement

Published online by Cambridge University Press:  01 January 2021

Extract

For decades, worries about undue inducement have Pervaded clinical research, and are especially common when research is accompanied by payment or conducted in developing countries. Few ethical judgments carry as much moral opprobrium or are thought to undermine the ethical soundness of a clinical trial as thoroughly as undue inducement. Indeed, the admonition to prevent undue inducement is one of the few explicit instructions in the Common Rules requirements for informed consent.

Despite their long history and pervasiveness, charges of undue inducement in clinical research are almost always mistaken. Indeed, I will advance an even more radical claim: Aresearch trial that otherwise fulfills the fundamental ethical requirements for human subjects research inherently cannot create the possibility of undue inducement because substantial risk of serious harm isprecluded. Charges of undue inducement tend to express displaced and mislabeled ethical concerns about other aspects of human subjects research. Consequently, claims of undue inducement should rarely be made, and when they are advanced should be treated with skepticism, placing a heavy burden of proofon those advancing such charges.

Type
Article
Copyright
Copyright © American Society of Law, Medicine and Ethics 2004

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References

45 CFR §46.116; Council for International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects (Geneva: World Health Organization, 2002): Guideline 7.Google Scholar
45 CFR 46, supra note 1.Google Scholar
45 CFR 46, supra note 1.Google Scholar
Levine, R.J., Ethics and Regulation of Clinical Research, second ed. (New Haven: Yale University Press, 1988): at 82.Google Scholar
Office of Human Research Protection, Protecting Human Research Subjects: Institutional Review Board Guidebook, hereinafter cited as IRB Guidebook (Washington D.C.: U.S. Government Printing Office, XXXX).Google Scholar
Grant, R., “The Ethics of Incentives: Historical Origins and Contemporary Understandings,” Economics and Philosophy 18(2002): 111139.CrossRefGoogle Scholar
Grant supra note 6;Newton, L.H., “Inducement, Due and Otherwise,” IRB 4, no. 3 (1982): 4–6.CrossRefGoogle Scholar
Newton, , supra note 7;Lemmens, T. Elliott, C., “Guinea Pigs on the Payroll: The Ethics of Paying Research Subjects,” Accountability in Research 7 (1999): 3–20;Macklin, R., “On Paying Money to Research Subjects,” IRB3, no. 5 (1981):l–6;Faden, R.R. Beauchamp, T.L., A History and Theory of Informed Consent (New York: Oxford University Press, 1986): Chapter 10.Google Scholar
IRB Guidebook, supra note 5.Google Scholar
CIOMS, supra note 1.Google Scholar
Faden, Beauchamp, , supra note 8.Google Scholar
Grant, supra note 6;Newton, , supra note 7;Lemmens, Elliot, , supra note 7.Google Scholar
McNeill, P., “Paying People to Participate in Research: Why Not?” Bioethics 11 (1997): 390–96.CrossRefGoogle Scholar
Faden, Beauchamp, , supra note 8;Wertheimer, A., Coercion (Princeton, N.J.: Princeton University Press, 1987);Wilkinson, M. Moore, A., “Inducement in Research,” Bioethics 11 (1997): 373–89.CrossRefGoogle Scholar
Wertheimer, A., Exploitation (Princeton, N.J.: Princeton University Press, 1996): Introduction and chapter 7.Google Scholar
Wertheimer, , supra note 15;Participants in 2001 Conference on Ethical Aspects of Research in Developing Countries, “Fair Benefits for Research in Developing Countries,” (hereinafter cited as Fair Benefits) Science 298 (2002): 2133–34.CrossRefGoogle Scholar
Harris, J., Wonderwoman and Superman: The Ethics of Human Biotechnology (Oxford: Oxford University Press, 1992): Chapter 6.Google Scholar
Lemmens, Elliot, , supra note 8;Macklin, , supra note 8;Harris, , supra note 17;Feinberg, J., Harm to Self (New York: Oxford University Press, 1986): at 118–121.Google Scholar
Harris, , supra note 17;Feinberg, , supra note 18.Google Scholar
Emanuel, E.J. Wendler, D. Grady, C., ,. “What Makes Clinical Research Ethical?” JAMA 283 (2000): 2701–11;Emanuel, E.J. Wendler, D Killen, J Grady, C. “What Makes Clinical Research in Developing Countries Ethical? Benchmarks of Ethical Research,” Journal of Infectious Diseases 189 (2004).CrossRefGoogle Scholar
IRB Guidebook, supra note 5;Emanuel, Wendler, Grady, , supra note 20.Google Scholar
Wilkinson, Moore, , supra note 14;Harris, , supra note 17.Google Scholar
Wilkinson, Moore, , supra note 14.Google Scholar
Wilkinson, Moore, , supra note 14;Harris, , supra note 17.Google Scholar
Macklin, , supra note 8;McNeill, , supra note 13.Google Scholar
Feinberg, , supra note 18.Google Scholar
Emanuel, E.J. Emanuel, L.L., “Four Models of the Physician-Patient Relationship,” JAMA 267 (1992): 2221–6.CrossRefGoogle Scholar
McNeill, , supra note 13.Google Scholar
Harris, supra note 17.Google Scholar
45 CFR 46.Google Scholar
Wilkinson, Moore, , supra note 14;Harris, , supra note 17.Google Scholar
McNeill, , supra note 13.Google Scholar
Wilkinson, Moore, , supra note 14;Harris, , supra note 17.Google Scholar
Feinberg, , supra note 18.Google Scholar
McNeill, , supra note 13.Google Scholar
Wertheimer, , supra note 15.Google Scholar
Wertheimer, , supra note 15;Fair Benefits, supranote 16.Google Scholar
Macklin, supra note 8.Google Scholar
Kolata, G.B., “NIH Shaken by Death of Research Volunteer,” Science 209 (1980): 475–79;Kolata, G.B., “The Death of a Research Subject,” Hasting Center Report 10, no. 4 (1980): 5–6.CrossRefGoogle Scholar
Jonas, H., “Philosophical Reflections on Experimenting with Human Subjects,” Daedalus 98 (1969): 219247.Google Scholar
Newton, , supra note 7;Lemmens, Elliot, , supra note 7.Google Scholar
Emanuel, Emanuel, , supra note 27.Google Scholar
Grant, , supra note 6;Emanuel, Emanuel, , supra note 27.Google Scholar
McNeill, , supra note 13.Google Scholar
Dicker, N. Grady, C., “What’s the Price of a Research Subject? Approaches to Payment for Research Participation,” N Engl J Med 341 (1999):198203.CrossRefGoogle Scholar