Expanding the frame of "Voluntariness" in informed consent: Structural coercion and the power of social and economic context

Kennedy Institute of Ethics Journal

Volumn 23, Issue 4, 2013, Pages 355-379

  Fisher, Jill A ^a  

^a UNIVERSITY OF NORTH CAROLINA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DECISION MAKING; ECONOMICS; ETHICS; HEALTH CARE COST; HUMAN; HUMAN EXPERIMENT; HUMAN RELATION; INFORMED CONSENT; ORGANIZATION AND MANAGEMENT; PERSONNEL; PERSUASIVE COMMUNICATION; PSYCHOLOGICAL ASPECT; RESEARCH ETHICS; RESEARCH SUBJECT; SOCIOECONOMICS; VOLUNTEER;

CHOICE BEHAVIOR; COERCION; DECISION MAKING; ETHICS, RESEARCH; HEALTH CARE SECTOR; HUMAN EXPERIMENTATION; HUMANS; INFORMED CONSENT; RESEARCH PERSONNEL; RESEARCH SUBJECTS; RESEARCHER-SUBJECT RELATIONS; SOCIOECONOMIC FACTORS; VOLUNTEERS;

EID: 84891425830     PISSN: 10546863     EISSN: 10863249     Source Type: Journal    
DOI: 10.1353/ken.2013.0018     Document Type: Article

References (97)

1. Abadie, Roberto. 2010. The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects. Durham, NC: Duke University Press. Almeida, Luis, Benedita Azevedo, Teresa Nunes, Manuel Vaz-Da-Silva, and
2. Patricio Soares-Da-Silva. 2007. Why Healthy Subjects Volunteer for Phase I Studies and How They Perceive Their Participation. European Journal of Clinical Pharmacology 63 (11): 1085-1094.
3. Angell, Marcia. 2004. The Truth about the Drug Companies: How They Deceive Us and What to Do about It. New York: Random House.
4. Anglin, Mary K. 1998. Feminist Perspectives on Structural Violence. Identities 5 (2): 145-151.
5. Appelbaum, Paul S., Charles W. Lidz, and Thomas Grisso. 2004. Therapeutic Misconception in Clinical Research: Frequency and Risk Factors. IRB: Ethics and Human Research 26 (2): 1-8.
6. Ashcroft, Richard E. 2001. Money, Consent, and Exploitation in Research. American Journal of Bioethics 1 (2): 62-63.
7. Bosk, Charles. 1995. All God's Mistakes: Genetic Counseling in a Pediatric Hospital. Chicago: University of Chicago Press.
8. Bourgois, Philippe I. 2003. U.S. Inner-City Apartheid: The Contours of Structural and Interpersonal Violence. In Violence in War and Peace: An Anthology, ed. Nancy Scheper-Hughes and Philippe I. Bourgois, 301-307. Malden, MA: Blackwell.
9. Chambliss, Daniel F. 1996. Beyond Caring: Hospitals, Nurses, and the Social Organization of Ethics. Chicago: University of Chicago Press.
10. Chambré, Susan M. and Melinda Goldner. 2008. Patients, Consumers and Civil Society. Vol. 10 of Advances in Medical Sociology. Bingley, UK: Emerald Publishing.
11. Corrigan, Oonagh P. 2003. Empty Ethics: The Problem with Informed Consent. Sociology of Health and Illness 25: 768-792.
12. Cox, Karen. 2002. Informed Consent and Decision-Making: Patients' Experiences of the Process of Recruitment to Phases I and II Anti-Cancer Drug Trials. Patient Education and Counseling 46: 31-38.
13. Cryder, Cynthia E., Alex John London, Kevin G. Volpp, and George Loewenstein. 2010. Informative Inducement: Study Payment as a Signal of Risk. Social Science and Medicine 70 (3): 455-464.
14. De Vries, Raymond G. 2004. How Can We Help? From "Sociology in" to "Sociology of" Bioethics. Journal of Law, Medicine and Ethics 32: 279-292.
15. Derr, Patrick. 1981. The Nature of Consent. Environment 23 (9): 15.
16. Dresser, Rebecca. 2001. Payments to Research Participants: The Importance of Context. American Journal of Bioethics 1 (2): 47.
17. Dresser, Rebecca. 2009. First-in-Human Trial Participants: Not a Vulnerable Population, but Vulnerable Nonetheless. Journal of Law, Medicine and Ethics 37 (1): 38-50.
18. Duggan, Lisa. 2003. The Twilight of Equality? Neoliberalism, Cultural Politics, and the Attack on Democracy. Boston: Beacon Press.
19. Dunn, Laura B. and Nora E. Gordon. 2005. Improving Informed Consent and Enhancing Recruitment for Research by Understanding Economic Behavior. Journal of the American Medical Association 293 (5): 609-612.
20. Eckenwiler, Lisa. 2001. Moral Reasoning and the Review of Research Involving Human Subjects. Kennedy Institute of Ethics Journal 11 (1): 37-69.
21. Edwards, Sarah J. L., Richard J. Lilford, Jim Thornton, and Jenny Hewison. 1998. Informed Consent for Clinical Trials: In Search of the "Best" Method. Social Science and Medicine 47 (11): 1825-1840.
22. Elliott, Carl and Roberto Abadie. 2008. Exploiting a Research Underclass in Phase 1 Clinical Trials. New England Journal of Medicine 358 (22): 2316-2317.
23. Epstein, Steven. 1996. Impure Science: AIDS, Activism, and the Politics of Knowledge. Berkeley: University of California Press.
24. Eubanks, Virginia. 2011. Digital Dead End: Fighting for Social Justice in the Information Age. Cambridge, MA: MIT Press.
25. Evans, John H. 2002. Playing God? Human Genetic Engineering and the Rationalization of Public Bioethical Debate. Chicago: University of Chicago Press.
26. Farmer, Paul. 1996. On Suffering and Structural Violence: A View from Below. Daedalus 125 (1): 261-283.
27. Farmer, Paul. 2004. An Anthropology of Structural Violence. Current Anthropology 45 (3): 305-325.
28. Farmer, Paul E., Bruce Nizeye, Sara Stulac, and Salmaan Keshavjee. 2006. Structural Violence and Clinical Medicine. PLoS Medicine 3 (10): e449.
29. Featherstone, Katie and Jenny L. Donovan. 2002. "Why Don't They Just Tell Me Straight, Why Allocate It?" The Struggle to Make Sense of Participating in a Randomised Controlled Trial. Social Science and Medicine 55: 709-719.
30. Fisher, Jill A. 2006a. Co-Ordinating "Ethical" Clinical Trials: The Role of Research Coordinators in the Contract Research Industry. Sociology of Health and Illness 28 (6): 678-694.
31. Fisher, Jill A. 2006b. Procedural Misconceptions and Informed Consent: Insights from Empirical Research on the Clinical Trials Industry. Kennedy Institute of Ethics Journal 16 (3): 251-268.
32. Fisher, Jill A. 2007a. Governing Human Subjects Research in the USA: Individualized Ethics and Structural Inequalities. Science and Public Policy 34 (2): 117-126.
33. Fisher, Jill A. 2007b. "Ready-to-Recruit" or "Ready-to-Consent" Populations? Informed Consent and the Limits of Subject Autonomy. Qualitative Inquiry 13 (6): 875-894.
34. Fisher, Jill A. 2009. Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials. New Brunswick, NJ: Rutgers University Press.
35. Frank, Arthur W. 2002. What's Wrong with Medical Consumerism? In Consuming Health: The Commodification of Health Care, ed. Saras Henderson and Alan Petersen, 13-30. New York: Routledge.
36. Gilliom, John. 2001. Overseers of the Poor: Surveillance, Resistance, and the Limits of Privacy. Chicago: University of Chicago Press.
37. Giroux, Henry A. 2004. The Terror of Neoliberalism: Authoritarianism and the Eclipse of Democracy. Boulder, CO: Paradigm Publishers.
38. Grady, Christine. 2001. Money for Research Participation: Does It Jeopardize Informed Consent? American Journal of Bioethics 1 (2): 40-44.
39. Gray, Bradford H. 1993. The Profit Motive and Patient Care: The Changing Accountability of Doctors and Hospitals. Cambridge, MA: Harvard University Press.
40. Harvey, David. 2005. A Brief History of Neoliberalism. New York: Oxford University Press.
41. Hawkins, Jennifer S. and Ezekiel J. Emanuel. 2005. Clarifying Confusions about Coercion. Hastings Center Report 35 (5): 16-19.
42. Henderson, Gail E., et al. 2006. Therapeutic Misconception in Early Phase Gene Transfer Trials. Social Science and Medicine 62 (1): 239-253.
43. Henderson, Saras and Alan R. Petersen. 2002. Consuming Health: The Commodification of Health Care. New York: Routledge.
44. Hermansson, Hélène. 2005. Consistent Risk Management: Three Models Outlined. Journal of Risk Research 8 (7-8): 557-768.
45. Hess, David J. 2004. Medical Modernisation, Scientific Research Fields and the Epistemic Politics of Health Social Movements. Sociology of Health and Illness 26 (6): 695-709.
46. Horton, Sarah. 2006. The Double Burden on Safety Net Providers: Placing Health Disparities in the Context of the Privatization of Health Care in the US. Social Science and Medicine 63 (10): 2702-2714.
47. Joseph, Galen and Daniel Dohan. 2009a. Diversity of Participants in Clinical Trials in an Academic Medical Center: The Role of the "Good Study Patient"? Cancer 115 (3): 608-615.
48. Joseph, Galen and Daniel Dohan. 2009b. Recruiting Minorities Where They Receive Care: Institutional Barriers to Cancer Clinical Trials Recruitment in a Safety Net Hospital. Contemporary Clinical Trials 30 (6): 552-559.
49. Klawiter, Maren. 2008. The Biopolitics of Breast Cancer: Changing Cultures of Disease and Activism. Minneapolis: University of Minnesota Press.
50. Kolata, Gina and Kurt Eichenwald. 1999. Stopgap Medicine: For the Uninsured, Drug Trials Are Health Care. New York Times (22 June): A section.
51. Konrad, Monica. 2005. Narrating the New Predictive Genetics: Ethics, Ethnography, and Science. Cambridge: Cambridge University Press.
52. Kuczewski, Mark. 2001. Is Informed Consent Enough? Monetary Incentives for Research Participation and the Integrity of Biomedicine. American Journal of Bioethics 1 (2): 49-51.
53. Largent, Emily A., Christine Grady, Franklin G. Miller, and Alan Wertheimer. 2012. Money, Coercion, and Undue Inducement: Attitudes about Payments to Research Participants. IRB: Ethics and Human Research 34 (1): 1-8.
54. Lemmens, Trudo and Paul B. Miller. 2003. The Human Subjects Trade: Ethical and Legal Issues Surrounding Recruitment Incentives. Journal of Law, Medicine and Ethics 31: 398-418.
55. Maskovsky, Jeff. 2005. Do People Fail Drugs, or Do Drugs Fail People? The Discourse of Adherence. Transforming Anthropology 13 (2): 136-142.
56. Menikoff, Jerry. 2001. Just Compensation: Paying Research Subjects Relative to the Risks They Bear. American Journal of Bioethics 1 (2): 56-58.
57. Metzl, Jonathan M. 2010. Introduction: Why against Health? In Against Health: How Health Became the New Morality, ed. Jonathan M. Metzl and Anna Kirkland, 1-11. New York: New York University Press.
58. Minogue, Brendan P., Gabriel Palmer-Fernandez, and Larry Udell. 1995. Individual Autonomy and the Double-Blind Controlled Experiment: The Case of Desperate Volunteers. Journal of Medicine and Philosophy 20: 43-64.
59. Mirowski, Philip. 2011. Science-Mart: Privatizing American Science. Cambridge, MA: Harvard University Press.
60. Monahan, Torin. 2010. Surveillance in the Time of Insecurity. New Brunswick, NJ: Rutgers University Press.
61. Morgen, Sandra and Jeff Maskovsky. 2003. The Anthropology of Welfare "Reform": New Perspectives on U.S. Urban Poverty in the Post-Welfare Era. Annual Review of Anthropology 32 (1): 315-338.
62. Mueller, Mary-Rose. 2004. Involvement and (Potential) Influence of Care Providers in the Enlistment Phase of the Informed Consent Process: The Case of AIDS Clinical Trials. Nursing Ethics 11 (1): 42-52.
63. Murthy, Vivek H., Harlan M. Krumholz, and Cary P. Gross. 2004. Participation in Cancer Clinical Trials: Race-, Sex-, and Age-Based Disparities. Journal of the American Medical Association 291 (22): 2720-2726.
64. Oberlander, Jonathan. 2010. Long Time Coming: Why Health Reform Finally Passed. Health Affairs 29 (6): 1112-1116.
65. Pace, Christine, Franklin G. Miller, and Marion Danis. 2003. Enrolling the Uninsured in Clinical Trials: An Ethical Perspective. Critical Care Medicine 31 (3): S121-S125.
66. Permuth-Wey, Jennifer and Amy R. Borenstein. 2009. Financial Remuneration for Clinical and Behavioral Research Participation: Ethical and Practical Considerations. Annals of Epidemiology 19: 280-285.
67. Piven, Frances Fox. 2001. Welfare Reform and the Economic and Cultural Reconstruction of Low Wage Labor Markets. In The New Poverty Studies: The Ethnography of Power, Politics, and Impoverished People in the United States, ed. Judith G. Goode and Jeff Maskovsky, 135-151. New York: New York University Press.
68. Polinski, Jennifer M., William H. Shrank, Haiden A. Huskamp, Robert J. Glynn, Joshua N. Liberman, and Sebastian Schneeweiss. 2011. Changes in Drug Utilization during a Gap in Insurance Coverage: An Examination of the Medicare Part D Coverage Gap. PLoS Medicine 8 (8): e1001075.
69. Rabin, Cheryl and Nili Tabak. 2006. Healthy Participants in Phase I Clinical Trials: The Quality of Their Decision to Take Part. Journal of Clinical Nursing 15: 971-979.
70. Reiman, Jeffrey. 2012. As Free and as Just as Possible: The Theory of Marxian Liberalism. Malden, MA: Wiley-Blackwell.
71. Ridgeway, James. 2008. Medicare's Poison Pill. Mother Jones. Available at http:// www.motherjones.com/politics/2008/09/medicares-poison-pill, accessed 24 September 2013.
72. Rylko-Bauer, Barbara and Paul Farmer. 2002. Managed Care or Managed Inequality? A Call for Critiques of Market-Based Medicine. Medical Anthropology Quarterly 16 (4): 476-502.
73. Scheper-Hughes, Nancy and Philippe I. Bourgois. 2003. Violence in War and Peace: An Anthology. Malden, MA: Blackwell.
74. Schoen, Johanna. 2005. Choice and Coercion: Birth Control, Sterilization, and Abortion in Public Health and Welfare. Chapel Hill: University of North Carolina Press.
75. Schram, Sanford F. 2006. Welfare Discipline: Discourse, Governance and Globalization. Philadelphia: Temple University Press.
76. Scott, W. Richard, Carol A. Caronna, Martin Ruef, and Peter J. Mendel. 2000. Institutional Change and Healthcare Organizations: From Professional Dominance to Managed Care. Chicago: University of Chicago Press.
77. Sears, Jeanne M. 2001. Payment of Research Subjects: A Broader Perspective. American Journal of Bioethics 1 (2): 66-67.
78. Shapiro, Ian and Alexander Wendt. 1992. The Difference that Realism Makes: Social Science and the Politics of Consent. Politics and Society 20 (2): 197-223.
79. Siminoff, Laura A. 2001. Money and the Research Subject: A Comment on Grady. American Journal of Bioethics 1 (2): 65-66.
80. Siminoff, Laura A., Marie Caputo, and Christopher Burant. 2004. The Promise of Empirical Research in the Study of Informed Consent Theory and Practice. HEC Forum 16 (1): 53-71.
81. Sloan, Don. 2006. Practicing Medicine without a License: The Corporate Takeover of Healthcare in America. Ashland, OR: Caveat Press.
82. Smith, Tony. 1994. Flexible Production and the Capital/Wage Labour Relation in Manufacturing. Capital and Class 18 (2): 39-63.
83. Sofaer, Neema and Daniel Strech. 2011. Reasons Why Post-Trial Access to Trial Drugs Should, or Need Not Be Ensured to Research Participants: A Systematic Review. Public Health Ethics 4 (2): 160-184.
84. Stacey, Clare Louise, Stuart Henderson, Kelly R. Macarthur, and Daniel Dohan. 2009. Demanding Patient or Demanding Encounter? A Case Study of a Cancer Clinic. Social Science and Medicine 69 (5): 729-737.
85. Stark, Laura. 2012. Behind Closed Doors: IRBs and the Making of Ethical Research. Chicago: University of Chicago Press.
86. Sugarman, Jeremy, et al. 1999. Empirical Research on Informed Consent: An Annotated Bibliography. Hastings Center Report 29 (1): S1-S42.
87. Sunder Rajan, Kaushik. 2007. Experimental Values: Indian Clinical Trials and Surplus Health. New Left Review 45: 67-88.
88. Swanson, G. Marie and Amy J. Ward. 1995. Recruiting Minorities into Clinical Trials: Toward a Participant-Friendly System. Journal of the National Cancer Institute 87 (23): 1747-1759.
89. Tishler, Carl L. and Suzanne Bartholomae. 2002. The Recruitment of Normal Healthy Volunteers: A Review of the Literature on the Use of Financial Incentives. Journal of Clinical Pharmacology 42: 365-375.
90. Tishler, Carl L. and Suzanne Bartholomae. 2003. Repeat Participation among Normal Healthy Research Volunteers: Professional Guinea Pigs in Clinical Trials? Perspectives in Biology and Medicine 46 (4): 508-520.
91. Tolich, Martin. 2010. What If Institutional Review Boards (IRBs) Treated Healthy Volunteers in Clinical Trials as Their Clients? Australasian Medical Journal 3 (12): 767-771.
92. US Department of Health, Education, and Welfare. National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research. 1979. The Belmont Report. Available at http://www.hhs.gov/ohrp/humansubjects/ guidance/belmont.html, accessed 24 September 2013.
93. US House of Representatives. Committee on Oversight and Government Reform. 2008. Medicare Part D: Drug Pricing and Manufacturer Windfalls. Washington, DC.
94. Verheggen, Frank W. S. M. and Frans C. B. van Wijman. 1996. Informed Consent in Clinical Trials. Health Policy 36: 131-153.
95. Wacquant, Loïc. 2004. Reply to Farmer's "An Anthropology of Structural Violence". Current Anthropology 45 (3): 322.
96. Wertheimer, Alan. 2011. Rethinking the Ethics of Clinical Research: Widening the Lens. New York: Oxford University Press.
97. Zussman, Robert. 1997. Sociological Perspectives on Medical Ethics and Decision-Making. Annual Review of Sociology 23: 171-189.