Voluntariness of consent to research: A conceptual model

Hastings Center Report

Volumn 39, Issue 1, 2009, Pages 30-39

  Appelbaum, Paul S ^a   Lidz, Charles W ^a   Klitzman, Robert ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

BIOETHICS; CLINICAL PRACTICE; CLINICAL RESEARCH; DECISION MAKING; HEALTH CARE POLICY; HUMAN; ILLEGITIMACY; INFORMED CONSENT; MOTIVATION; REVIEW; THERAPY EFFECT;

COERCION; DECISION MAKING; HUMAN EXPERIMENTATION; HUMANS; INFORMED CONSENT; PATIENT PARTICIPATION; PERSONAL AUTONOMY; PERSUASIVE COMMUNICATION;

EID: 59949096359     PISSN: 00930334     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (81)

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8. Protection of Human Subjects, 46 C.F.R. 111(b).
9. Ibid.
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11. Ibid.; Office of the Inspector General, Department of Health and Human Services, Recruiting Human Subjects: Pressures in Industry-Sponsored Clinical Research, report no. OEI-01-97-00195, June 2000;
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25. Protection of Human Subjects, 46 C.F.R. 45 Subpart C.
26. Protection of Human Subjects, 46 C.F.R. 45 Subparts B and D.
27. Tindana et al., "The Informed Consnt Process in a Rural African Setting."
28. See, for example, Kuczewski and Marshall, "The Decision Dynamics of Clinical Research"; D. Orentlicher, "Making Research a Requirement of Treatment: Why We Should Sometimes Let Doctors Pressure Patients to Participate in Research," Hastings Center Report 35, no. 5 (2005): 20-28;
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32. For conceptualization of voluntariness, see Nelson and Merz, "Voluntariness of Consent for Research," and R.R. Faden and T.L. Beauchamp, A History and Theory of Informed Consent (New York: Oxford University Press, 1986); for what constitutes voluntary choice in other contexts.
33. see A. Wertheimer, Coercion (Princeton, N.J.: Princeton University Press, 1987) and J.S. Carroll, "Consent to Mental Health Treatment: A Theoretical Analysis of Coercion, Freedom, and Control," Behavioral Sciences and the Law 9, no. 2 (1991): 129-42.
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50. S. Maasen, W. Prinz, and G. Roth, Voluntary Action: Brains, Minds, and Sociality (Oxford, U.K.: Oxford University Press, 2003).
51. J.R. Searle, The Rediscovery of the Mind (Cambridge, Mass.: MIT Press, 2002).
52. D.M. Wegner, The Illusion of Conscious Will (Cambridge, Mass.: MIT Press, 2003).
53. Wertheimer, Coercion.
54. American Law Institute, Restatement of the Law (Second), Torts (St. Paul, Minn.: American Law Institute, 1979), sec. 892B.
55. American Law Institute, Restatement of the Law (Third), Property (Wills and Other Donative Transfers) (St. Paul, Minn.: American Law Institute, 2003).
56. Colorado v. Connelly, 497 U.S. 157 (1986).
57. American Law Institute, Restatement of the Law (Second), Contracts (St. Paul, Minn.: American Law Institute, 1981).
58. U.S.A. v. Karl Brandt et al, in Trials of War Criminals Before the Nuremberg Military Tribunals under Control Council Law.
59. Berg et al., Informed Consent, Faden and Beauchamp, A History and Theory of Informed Consent.
60. Ibid.
61. F. Verheggen, F. Nieman, and R. Jonkers, "Determinants of Patient Participation in Clinical Studies Requiring Informed Consent: Why Patients Enter a Clinical Trial," Patient Education and Counseling 35 (1998): 111-25.
62. Ibid.; J. Sugarman, N.E. Kass, S.N. Goodman, et al., "What Patients Say about Medical Research," IRB: A Review of Human Subjects Research 20, no. 4 (1998): 1-7.
63. J.S. Hawkins and E.J. Emanuel, "Clarifying Confusions about Coercion," Hastings Center Report 35 (2005): 16-19.
64. Colorado v. Connelly.
65. Wertheimer, Coercion.
66. Faden and Beauchamp, A History and Theory of Informed Consent.
67. Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Biomedical Research Involving Human Subjects (Geneva, Switzerland: CIOMS, 2002), http://www.cioms.ch/guidelines- nov-2002-blurb.htm.
68. Wertheimer, Coercion.
69. Faden and Beauchamp, A History and Theory of Informed Consent.
70. Roberts, "Informed Consent and the Capacity for Voluntarism," 707.
71. T. Parsons, "On the Concept of Influence," in T. Parsons, Sociological Theory and Modern Society (New York: Free Press, 1967).
72. The latter three categories are similar to, but not homologous with, Faden and Beauchamp's categories of persuasion, manipulation, and coercion. See Faden and Beauchamp, A History and Theory of Informed Consent. Note, though, that what Parsons referred to as inducement is closer to what Faden and Beauchamp call persuasion, and Parsons' persuasion is more like Faden and Beauchamp's manipulation-a situation that reflects the lack of conceptual agreement in the field.
73. Wertheimer, Coercion.
74. Grady et al., "An Analysis of U.S. Practices of Paying Research Participants."
75. E.J. Emanuel, "Undue Inducement: Nonsense on Stilts?" American Journal of Bioethics 5, no. 5 (2005): 9-13.
76. Faden and Beauchamp, A History and Theory of Informed Consent, 365-68.
77. Shimm and Spece, "Rate of Refusal to Participate in Clinical Trials."
78. J. Monahan, C.W Lidz, S.K. Hoge, et al., "Coercion in the Provision of Mental Health Services: The MacArthur Studies," in J.P. Morrissey and J. Monahan, eds., Research in Community and Mental Health, Volume 10 (Westport, Conn.: JAI Press, 1999).
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80. Protection of Human Subjects, 46 C.F.R. 111(b).
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