Hostname: page-component-8448b6f56d-mp689 Total loading time: 0 Render date: 2024-04-18T21:18:27.660Z Has data issue: false hasContentIssue false

Involuntary Consent: Conditioning Access to Health Care on Participation in Clinical Trials

Published online by Cambridge University Press:  01 January 2021

Abstract

American bioethics has served as a safety net for the rich and powerful, often failing to protect minorities and the economically disadvantaged. For example, minorities and the economically disadvantaged are often unduly influenced into participating in clinical trials that promise monetary gain or access to health care. This is a violation of the bioethical principle of “respect for persons,” which requires that informed consent for participation in clinical trials is voluntary and free of undue influence. Promises of access to health care invalidate the voluntariness of informed consent not only because it unduly induces minorities and the economically disadvantaged to participate in clinical trials to obtain access to potentially life saving health care, but it is also manipulative because some times the clinical trial is conducted by the very institutions that are denying minorities and the economically disadvantaged access to health care. To measure whether consent is voluntary and free of undue influence, federal agencies should require researchers to use the Vulnerability and Equity Impact Assessment tool, which I have created based on the Health Equity Impact Assessment tool, to determine whether minorities and the economically disadvantaged are being unduly influenced into participating in clinical trials in violation of the “respect for persons” principle.

Type
Symposium Articles
Copyright
Copyright © American Society of Law, Medicine and Ethics 2016

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Washington, H. A., Medical Apartheid (New York: Anchor Books, 2007): at 236-237; S. Lederer and M. Grodin, “Historical Overview: Pediatric Experimentation,” in M. A. Grodin and L. H. Glantz, eds., Children as Research Subjects: Science, Ethics, and Law (New York: Oxford University Press, 1994): at 19.Google Scholar
Washington, H. A., “Tuskegee Experiment Was But One Medical Study That Exploited African-Americans Infamous Research,” Baltimore Sun, March 19, 1995, at 1F.Google Scholar
Katz, J. and Capron, A., Experimentation with Human Beings (New York: Russell Sage Foundation, 1972); H. A. Washington, “Born for Evil: Stereotyping the Karyotype: A Case History in the Genetics of Aggressiveness,” in V. Roelcke and G. Maio, eds., Twentieth Century Ethics of Human Subjects Research: Historical Perspectives on Values, Practices, and Regulations (Stuttgart, Germany: Franz Steiner Verlag: 2004): at 319-334,Google Scholar
The Belmont Report, 76 Fed. Reg. 23192, 23193 and 23195 (Apr. 18, 1979).Google Scholar
King, P., “Reflections on Race and Bioethics in the United States,” Health Matrix 14, no. 1 (2004): 149-153, at 151.Google Scholar
See Yearby, R., “Breaking the Cycle of ‘Unequal Treatment’ with Health Care Reform: Acknowledging and Addressing the Continuation of Racial Bias,” University of Connecticut Law Review 44, no. 4 (2012): 1281-1324, at 1315-1317; B. R. Clark, “Hospital Flight from Minority Communities: How Our Existing Civil Rights Framework Fosters Racial Inequality in Healthcare,” DePaul Journal of Health Care Law 9, no. 2 (2005): 1023-1100, at 1035; A. Sager and D. Socolar, Closing Hospitals in New York State Won't Save Money but Will Harm Access to Care (2006): at 27-31, available at <http://www.bu.edu/sph/files/2015/05/Sager-Hospital-Closings-Short-Report-20Nov06.pdf> (last visited February 5, 2016).Google Scholar
Annas, G. J., American Bioethics: Crossing Human Rights and Health Law Boundaries (New York: Oxford University Press, 2005): at xv-xvi.Google Scholar
Washington, H. A., Medical Apartheid (New York: Anchor Books, 2007): at 164; see also D. Alford, “Examining the ‘Stick’ of Accreditation for Medical Schools through Reproductive Justice Lens: A Transformative Remedy for Teaching the Tuskegee Syphilis Study,” St. John's Journal of Civil Rights & Economic Development 26, no. 1 (2012): 153-195; J. H. Jones, Bad Blood: The Tuskegee Syphilis Experiment (New York: The Free Press, 1981): at 206–219.Google Scholar
The Belmont Report, 76 Fed. Reg. 23192, 23195 (Apr. 18, 1979).Google Scholar
O'Neil, O., “Some Limits of Informed Consent,” Journal of Medical Ethics 29, no. 1 (2003): 4-7, at 5.Google Scholar
45 C.F.R. §46.116 (2005).Google Scholar
There are several types of assurances. For more information, see generally, Coleman, C. et al., “The Federal and State Regulatory Structure,” in Coleman, C. et al., eds., The Ethics and Regulations of Research with Human Subjects (Newark: Matthew Bender & Company, Inc.: 2005): at 137.Google Scholar
21 C.F.R §§ 50.23 and 50.24 (2005).Google Scholar
45 C.F.R. § 46.103 (Assuring Compliance with this policy) (2015).Google Scholar
Coleman, C. et al., “The Federal and State Regulatory Structure,” in Coleman, C. et al., eds., The Ethics and Regulations of Research with Human Subjects (Newark: Matthew Bender & Company, Inc., 2005): at 136; Memorandum from Director, OHRP, to OHRP Staff, Regarding Compliance Oversight Procedures (Dec. 4, 2000), in C. Coleman et al., eds., The Ethics and Regulations of Research with Human Subjects (Newark: Matthew Bender & Company, Inc., 2005): at 139. For government funded clinical trials in which there has been an allegation of noncompliance, Office of Human Rights Protections' (OHRP) initiates an investigation. Id., at 138-141. For a detailed sequence of events in compliance investigations, see id., at 140–141.Google Scholar
Memorandum from Director, OHRP, to OHRP Staff, Regarding Compliance Oversight Procedures (December 4, 2000), in Coleman, C. et al., eds., The Ethics and Regulations of Research with Human Subjects (Newark: Matthew Bender & Company, Inc., 2005): at 139.Google Scholar
Id., at 140. Many, including the former Secretary of HHS, have argued that OHRP has failed to issue meaningful sanctions. See Richardson, L. S., “When Human Experimentation Is Criminal,” Northwestern Journal of Criminal Law and Criminology 99, no. 1 (2008): 89-134, at 126; D. Shalala, “Protecting Research Subjects – What Must Be Done,” New England Journal of Medicine 343, no. 11 (2000): 808-11. Usually, the only sanctions that OHRP imposes is posting a letter of violation on its website. However, in the past when the public pressure has become too much, the institution will voluntarily stop the research studies. But this is an erratic outcome that simply depends on how much media attention the study received. Id.Google Scholar
45 C.F.R. § 46.101(a)(2) (2015).Google Scholar
45 C.F.R. § 46.103(b)(1) (2015).Google Scholar
See 10 C.F.R. § 745.101 (20015), 28 C.F.R. § 46.101 (2015); 45 C.F.R. § 46.109(a) (2015).Google Scholar
45 C.F.R. §46.116 (2005).Google Scholar
OHRP, Institutional Review Guidebook (1993), available at <http://www.hhs.gov/ohrp/compliance/index.html> (last visited July 11, 2016).+(last+visited+July+11,+2016).>Google Scholar
Waidmann, T., Estimating the Cost of Racial and Ethnic Health Disparities, Urban Institute, (September 2009), available at <http://www.urban.org/sites/default/files/alfresco/publication-pdfs/411962-Estimating-the-Cost-of-Racial-and-Ethnic-Health-Disparities.PDF> (last visited March 16, 2016); Bonilla-Silva, E., Racism without Racists: Color Blind Racism and the Persistence of Racial Inequality in the United States, 3rd ed. (New York: Rowman & Littlefield Publishers, Inc., 2006): at 16; L. Darling-Hammond, “Unequal Opportunity: Race and Education,” The Brookings Institute, Spring 1998, available at <http://www.brookings.edu/research/articles/1998/03/spring-education-darling-hammond> (last visited March 16, 2016); R. Blauner, Racial Oppression in America (New York: Harper & Row, 1972).Google Scholar
U.S. Census Bureau, Income and Poverty in the United States: 2014 (2015), available at <https://www.census.gov/content/dam/Census/library/publications/2015/demo/p60-252.pdf> (last visited March 16, 2016).+(last+visited+March+16,+2016).>Google Scholar
Wolff, E. N., “Household Wealth Trends in the United States, 1962-2013: What Happened Over the Great Recession?” NBER Working Paper 20733 (December 2014); K. A. Hassett and A. Mathue, A New Measure of Consumption Inequality, American Enterprise Institute, June 2012, available at <https://www.aei.org/wp-content/uploads/2012/06/-a-new-measure-of-consumption-inequality_142931647663.pdf> (last visited March 16, 2016).Google Scholar
Fry, R. and Kochhar, R., “America's Wealth Gap between Middle-Income and Upper-Income Families Is Widest on Record,” Pew Research Center (December 17, 2014), available at <http://www.pewresearch.org/fact-tank/2014/12/17/wealth-gap-upper-middle-income/> (last visited July 11, 2016).+(last+visited+July+11,+2016).>Google Scholar
Jargowsky, P. A., “The Architecture of Segregation: Civil Unrest, the Concentration of Poverty, and Public Policy,” The Century Foundation (August 9, 2015), available at <http://www.tcf.org/assets/downloads/Jargowsky_ArchitectureofSegregation.pdf> (last visited July 11, 2016).+(last+visited+July+11,+2016).>Google Scholar
Thomas, M. and James, C., The Role of Health Coverage for Communities of Color 2-5 (2009), Kaiser Family Foundation.Google Scholar
Guynn, J., “High-Tech Pay Gap: Minorities Earn Less In Skilled Jobs,” USA Today, October 9, 2014.Google Scholar
Shapiro, T. et al., The Roots of the Widening Racial Wealth Gap: Explaining the Black-White Economic Divide, Brandeis Institute on Assets and Social Policy, Research and Policy Brief (February 2013), available at <http://iasp.brandeis.edu/pdfs/Author/shapiro-thomas-m/racialwealthgapbrief.pdf> (last visited July 11, 2016).+(last+visited+July+11,+2016).>Google Scholar
Luo, M., “In Job Hunt, College Degree Can't Close Racial Gap,” New York Times, November 30, 2009.Google Scholar
Vega, T., “2 out of 5 Black Children Are Living in Poverty,” CNN Money, July 15, 2015.Google Scholar
Mullings, L. and Schulz, A., “Intersectionality and Health: An Introduction,” in Mullings, L. and Schulz, A., eds., in Gender, Race, Class, And Health (San Francisco: John Wiley & Sons, Inc., 2006): at 12; R. Bowser, “Racial Profiling In Health Care: An Institutional Analysis of Medical Treatment Disparities,” Michigan Journal of Race & Law 7, no. 1 (2001): 79-133, at 85.Google Scholar
Yearby, R. A., “Racial Inequities in Mortality and Access to Health Care: The Untold Peril of Rationing Health Care in the United States,” Journal of Legal Medicine 32, no. 1 (2011): 77-91, at 83 (describing racial inequalities in access to health care).Google Scholar
U.S. Census Bureau, Income and Poverty in the United States: 2014 (2015), available at <https://www.census.gov/content/dam/Census/library/publications/2015/demo/p60-252.pdf> (last visited July 11, 2016).+(last+visited+July+11,+2016).>Google Scholar
Garfield, R. et al., New Estimates of Eligibility for ACA Coverage among the Uninsured (January 2016), Kaiser Family Foundation.Google Scholar
Majerol, M. et al., The Uninsured: A Primer (November 2015), Kaiser Family Foundation.Google Scholar
U.S. Census Bureau, Poverty Rates for Selected Detailed Race and Hispanic Groups by State and Place: 2007-2011, available at <https://www.census.gov/prod/2013pubs/acsbr11-17.pdf> (last visited July 11, 2016).+(last+visited+July+11,+2016).>Google Scholar
U.S. Census Bureau, Income, Poverty, and Health Insurance Coverage in the United States: 2007-12 (2008), available at <https://www.census.gov/prod/2008pubs/p60-235.pdf> (last visited July 11, 2016). This poverty was in part because of low income. The average African-American family median income was $33,916, 62% of the median income for Caucasians, while the median income for Hispanic households was $38.679, 70% of the median income for Caucasians. Id.+(last+visited+July+11,+2016).+This+poverty+was+in+part+because+of+low+income.+The+average+African-American+family+median+income+was+$33,916,+62%+of+the+median+income+for+Caucasians,+while+the+median+income+for+Hispanic+households+was+$38.679,+70%+of+the+median+income+for+Caucasians.+Id.>Google Scholar
See, e.g., 26 U.S.C.A. § 501 (West 2003 & Supp. 2011).Google Scholar
Bernstein, N., “Chefs, Butlers, Marble Baths: Hospitals Vie for the Affluent,” New York Times, January 22, 2012, at A1.Google Scholar
Hoffman, B., Health Care for Some: Rights and Rationing in the United States Since 1930 (Chicago: The University Chicago Press, 2012): at 198.Google Scholar
Smith, D. B., Health Care Divided: Race and Healing a Nation (New York: The University of Michigan, 1999): at 200 (citing D. G. Whiteis, “Hospital and Community Characteristics in Closures of Urban Hospitals, 1980-87,” Public Health Report 107, no. 4 [1992]: 409-416).Google Scholar
Sager, A., “Urban Hospital Closings: Why Care? What to Do? Policy and Financial Remedies for a Race-linked Health Problem,” paper presented at the Annual Case Western Reserve University School of Law, Law-Medicine Symposium, March 28, 2014 (presentation on file with the author).Google Scholar
See Clark, B. R., “Hospital Flight from Minority Communities: How Our Existing Civil Rights Framework Fosters Racial Inequality in Healthcare,” DePaul Journal of Health Care Law 9, no. 2 (2005): 1023-1100, at 1035 (“Hospital closures set into motion a chain of events that threaten minority communities' immediate and long term access to primary care, emergency and nonemergency hospital care….”).Google Scholar
Majette, G. R., “Access to Health Care: What a Difference Shades of Color Make,” Annals of Health Law 12, no. (2003): 121-42, at 130.Google Scholar
Alexander, A. and Raynor, D., “Charlotte Hospital System Sues Thousands of Patients,” Charlotte Observer, April 24, 2012.Google Scholar
Cozier, Y. et al., “Racial Discrimination and the Incidence of Hypertension in US Black Women,” Annals of Epidemiology 16, no. 9 (2006): 681-687, at 681, 682-683; N. Krieger, “Racial and Gender Discrimination: Risk Factors for High Blood Pressure?” Social Science & Medicine 30, no. 12 (1990): 1273-1281, at 1276–1277.Google Scholar
Williams, D. R. et al., “Racial/Ethnic Discrimination and Health: Findings from Community Studies,” American Journal of Public Health 93, no. 2 (2003): 200-208, at 200, 201 (citing three studies that found a positive correlation between discrimination and cigarette smoking, two studies that reported a similar correlation between discrimination and alcohol use, and two studies that showed that perceptions of discrimination made an “incremental contribution” to differences in health between blacks and whites).Google Scholar
Collins, J. W. Jr., et al., “Very Low Birthweight in African American Infants: The Role of Maternal Exposure to Interpersonal Racial Discrimination,” American Journal of Public Health 94, no. 12 (2004): 2132-2138, at 2132, 2135 (stating that African American mothers who delivered preterm infants of “very low birth weight” (VLBW), which “accounts for more than half of the neonatal deaths and 63% of the black–white gap in infant mortality in the United States,” were more likely to report interpersonal racial discrimination during their lifetime than were African American mothers who delivered infants at term).Google Scholar
Chase, D. H. et al., “Discrimination, Racial Bias, and Telomere Length in African-American Men,” American Journal of Preventative Medicine 46, no. 2 (2014): 103-111, at 103, 107–108.Google Scholar
Lang, M. E. and Bird, C. E., “Understanding and Addressing the Common Roots of Racial Disparities: The Case of Cardiovascular Disease & HIV/AIDS in African Americans,” Health Matrix 25, no. 1 (2015): 109-138, at 121–124.Google Scholar
Ellen, I. G. et al., “Neighborhood Effects on Health: Exploring the Links and Assessing the Evidence,” Journal of Urban Affairs 23, no. 3-4 (2001): 391-408, at 393; A. V. Diez Roux, “Investigating Neighborhood and Area Effects on Health,” American Journal of Public Health 91, no. 11 (2001): 1783-1789, at 1786.Google Scholar
Mobley, L. R. et al., “Environment, Obesity, and Cardiovascular Disease Risk in Low-Income Women,” American Journal of Preventative Medicine 30, no. 4 (2006): 327-332, at 327.Google Scholar
Walker, R. E. et al., “Disparities and Access to Healthy Food in the United States: A Review of Food Deserts Literature,” Health & Place 16, no. 5 (2010): 876-884, at 881; N. I. Larson et al., “Neighborhood Environments: Disparities in Access to Healthy Foods in the U.S.,” American Journal of Preventative Medicine 36, no. 1 (2009): 74-81, at 74 (2009); L. B. Lewis et al., “African Americans' Access to Healthy Food Options in South Los Angeles Restaurants,” American Journal of Public Health 95, no. 4 (2005): 668-673, at 672.Google Scholar
Dimick, J. et al., “Black Patients More Likely Than Whites to Undergo Surgery at Low-Quality Hospitals in Segregated Regions,” Health Affairs 32, no. 6 (2013): 1046-1053, at 1050–1051.CrossRefGoogle Scholar
Dorn, S., Uninsured and Dying Because of It: Updating the Institute of Medicine Analysis on the Impact of Uninsurance on Mortality, Urban Institute, 2008, at 2, explaining a study 460 journal of law, medicine & ethics Ruqaiijah A. Yearby that revealed the high mortality rate among the uninsured: at 2; Institute of Medicine, Care Without Coverage: Too Little, Too Late 1 (2002): at 1, stating that “working-age Americans without health insurance are more likely to…[b]e sicker and die sooner”.Google Scholar
Dorn, S., “Uninsured and Dying Because of It: Updating the Institute of Medicine Analysis on the Impact of Uninsurance on Mortality,” Urban Institute (2008): at 2.Google Scholar
Institute of Caring, Caring without Coverage: Too Little, Too Late (2002): at 13.Google Scholar
Thomas, M. and James, C., The Role of Health Coverage for Communities of Color Kaiser Family Foundation (2009): at 6, available at <http://www.kff.org/healthreform/upload/8017.pdf> (last visited March 16, 2016)Google Scholar
Blendon, R. et al., “Access to Medical Care for Black and White Americans,” Journal of the American Medical Association 261, no. 2 (1989): 278-281, at 279.Google Scholar
King, P., “Reflections on Race and Bioethics in the United States,” Health Matrix 14, no. 1 (2004): 149-153, at 150.Google Scholar
Arnold, C. and Kiel, P., “When Nonprofit Hospitals Sue Their Poorest Patients,” NPR, December 12, 2014.Google Scholar
Luden, K., “Chicago Hospital to Halt New Emergency Department Policies After Criticism,” Medscape News, March 16, 2009.Google Scholar
Ross, L., Children in Medical Research: Access versus Protection (New York: Oxford University Press, 2006): at 48.Google Scholar
42 U.S.C.A. § 1395dd (West 2016).Google Scholar
Luden, K., “Chicago Hospital to Halt New Emergency Department Policies After Criticism,” Medscape News, March 16, 2009.Google Scholar
The studies tested various different drugs including protease inhibitors, Ritonavir therapy, and the live-attenuated Varicella vaccine. See Letter from Karen Cooper, Compliance Oversight Coordinator, Office for Human Research Protections (OHRP), to Harvey R. Colten, Vice Present and Senior Associate Dean, Columbia University Medical Center (May 23, 1005) (on file with author).Google Scholar
Solomon, J., “Researchers Tested AIDS Drugs on Children,” San Francisco Chronicle, May 4, 2005, at A2.Google Scholar
45 C.F.R. § 46.116 (2005); 1 C.F.R. §§50.23 and 50.24 (2005). There is also a requirement that researchers assess the risks and benefits of children participating in clinical trials. This is governed by the “beneficence” principle found in the Belmont Report and the Common Rule. 45 C.F.R. §§46.404-407. A discussion of the “beneficence” principle is outside the scope of this article. However, one could argue that the researchers also violated this principle because they enrolled healthy children into clinical trials that involved a greater than minimal risk with no prospect of direct benefit with no likelihood to yield generalizable knowledge of the children's condition.Google Scholar
Levine, C., “Changing Views of Justice after Belmont: AIDS and the Inclusion of ‘Vulnerable’ Subjects,” in Vanderpool, H., ed., The Ethics of Research Involving Human Subjects: Facing the 21st Century (Fredrick, MD: University Publishing Group, 1996): at 121.Google Scholar
Ontario Ministry of Health and Long-term Care, The Health Equity Impact Assessment Tool and Workbook (2009), available at <http://www.health.gov.on.ca/en/pro/programs/heia/docs/workbook.pdf> (last visited July 11, 2016).+(last+visited+July+11,+2016).>Google Scholar
Id., at 6–7.Google Scholar
Id., at 7.Google Scholar
Keleher, T., An Introduction to Racial Equity Assessment Tools, available at <http://grenetwork.org/wp/wp-content/uploads/2014/04/An-Introduction-to-Racial-Equity-Assessment-Tools.pdf> (last visited July 11, 2016).+(last+visited+July+11,+2016).>Google Scholar
See Richardson, supra note 18, at 126.Google Scholar