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Protecting and respecting the vulnerable: existing regulations or further protections?

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Abstract

Scholars and policymakers continue to struggle over the meaning of the word “vulnerable” in the context of research ethics. One major reason for the stymied discussions regarding vulnerable populations is that there is no clear distinction between accounts of research vulnerabilities that exist for certain populations and discussions of research vulnerabilities that require special regulations in the context of research ethics policies. I suggest an analytic process by which to ascertain whether particular vulnerable populations should be contenders for additional regulatory protections. I apply this process to two vulnerable populations: the cognitively vulnerable and the economically vulnerable. I conclude that a subset of the cognitively vulnerable require extra protections while the economically vulnerable should be protected by implementing existing regulations more appropriately and rigorously. Unless or until the informed consent process is more adequately implemented and the distributive justice requirement of the Belmont Report is emphasized and operationalized, the economically disadvantaged will remain particularly vulnerable to the harm of exploitation in research.

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Notes

  1. This topic is the focus of a Target Article and accompanying Open Peer Commentaries in the August 2004 issue of the American Journal of Bioethics [3].

  2. This is also frequently construed as minimizing harms and maximizing benefits or as a ratio that a “reasonable person” would agree to.

  3. I will label this vulnerability “economic” as opposed to Kipnis’s “allocational” because it is plausible to consider education as a social good, and I want to distinguish economic from educational vulnerability for reasons that will emerge later.

  4. Designating cognitive incapacity in the research context is beyond the scope of this paper, but extensive work has been done on this topic. See the 2002 issue of the American Journal of Geriatric Psychiatry for a representation of these discussions [24].

  5. Although the federal regulations requiring informed consent were not adopted until 1974, both the Nuremberg Code and the Balfour Declaration were in place long before, and both had specific requirements for adequate informed consent.

  6. Other notions of exploitation refer to instrumentally using other people or taking advantage of people in a way that undermines their autonomy.

  7. Although many argue that compensation should be distinguished from the benefits of a study (manifest most clearly in the different sections for benefits and compensation in Informed Consent forms), this does not entail that those consenting to the studies recognize this distinction.

  8. This, of course presupposes that the review mechanisms work properly, which is not always the case. But adding more protections to compensate for the failings of already existing ones, rather than better oversight to make sure that protocols are evaluated properly in the first place, seems counterproductive. It also presumes that if one should not be allowed to engage in a risky trial because of money, one should not be allowed to engage in it for altruism’s sake either; the same threshold should apply to both.

  9. This suggestion may also have the benefit of reducing the price difference between local and international human subjects research since the research funders must also allocate funds for resource distribution. This may result in a more consistent approach to ethical research in both local and international contexts—a balance that is severely lacking at present.

References

  1. Levine, Carol, Ruth Faden, Christine Grady, Dale Hammerschmidt, Lisa Eckenwiler, and Jeremy Sugarman. 2004. The limitations of “vulnerability” as a protection for human research participants. American Journal of Bioethics 4(3): 44–49.

    Article  Google Scholar 

  2. Ruof, Mary C. 2004. Vulnerability, vulnerable populations, and policy. Kennedy Institute of Ethics Journal 14(4): 411–425.

    Article  Google Scholar 

  3. McGee, Glen, ed. 2004. American Journal of Bioethics 4(3).

  4. Moreno, Jonathan, Arthur L. Caplan, and Paul Root Wolpe. 1998. Updating protections for human subjects involved in research. Journal of the American Medical Association 280(22): 1951–1958.

    Article  Google Scholar 

  5. Rose, Susan L., and Charles E. Pietri. 2002. Workers as research subjects: A vulnerable population. Journal of Occupational and Environmental Medicine 44(9): 801–805.

    Article  Google Scholar 

  6. Stineman, Margaret G., and David W. Musick. 2001. Protection of human subjects with disability: Guidelines for research. Archives of Physical Medicine and Rehabilitation 82(12S): 9–14.

    Google Scholar 

  7. National Commission for the Protection of Human Subjects of Biomedical Research. 1978. The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. Washington: US Government Printing Office.

    Google Scholar 

  8. White, Ronald F. 2007. Institutional Review Board mission creep: The Common Rule, social science, and the nanny state. Independent Review 11(4): 547–564.

    Google Scholar 

  9. U.S. Code of Federal Regulations. 2009. Protection of human subjects. 45 CFR 46. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html. Accessed Jan 9, 2013.

  10. Sun, M. 1981. Inmates sue to keep research in prisons. Science 212(4495): 650–651.

    Article  Google Scholar 

  11. Epstein, Steven. 2007. Inclusion: The politics of difference in medical research. Chicago: University of Chicago Press.

    Google Scholar 

  12. Mastroianni, Anna, and Jeffrey Kahn. 2001. Swinging on the pendulum: Shifting views of justice in human subjects’ research. Hastings Center Report 31(3): 21–28.

    Article  Google Scholar 

  13. Keith-Spiegel, Patricia, and Gerald P. Koocher. 2005. The IRB paradox: Could the protectors also encourage deceit? Ethics and Behavior 15(4): 339–349.

    Article  Google Scholar 

  14. Martinson, Brian C., Melissa S. Anderson, and Raymond De Vries. 2005. Scientists behaving badly. Nature 435: 737–738.

    Article  Google Scholar 

  15. Edwards, S.J.L., S. Kirchin, and R. Huxtable. 2004. Research ethics committees and paternalism. Journal of Medical Ethics 30(1): 88–91.

    Article  Google Scholar 

  16. Garrard, E., and A. Dawson. 2005. What is the role of the research ethics committee? Paternalism, inducements, and harm in research ethics. Journal of Medical Ethics 31(7): 419–423.

    Article  Google Scholar 

  17. Miller, Franklin G., and Allen Wertheimer. 2007. Facing up to paternalism in research ethics. Hastings Center Report 37(3): 24–34.

    Article  Google Scholar 

  18. Kipnis, Kenneth. 2001. Vulnerability in research subjects: A bioethical taxonomy. In Ethical and policy issues in research involving human participants, vol. 2, G-1. Bethesda: National Bioethics Advisory Council.

  19. Paasche-Orlow, Michael K., Holly A. Taylor, and Frederick L. Brancati. 2003. Readability standards for informed-consent forms as compared with actual readability. New England Journal of Medicine 348(8): 721–726.

    Article  Google Scholar 

  20. Joffe, Steven, E. Francis Cook, Paul D. Cleary, Jeffrey W. Clark, and Jane C. Weeks. 2001. Quality of informed consent in cancer clinical trials: A cross-sectional survey. Lancet 358(9295): 1772–1777.

    Article  Google Scholar 

  21. Marshall, Patricia A. 2006. Informed consent in international health research. Journal of Empirical Research on Human Research Ethics 1(1): 25–42.

    Article  Google Scholar 

  22. Sudore, Rebecca L., Seth C. Landefeld, Brie A. Williams, Deborah E. Barnes, Karla Lindquist, and Dean Schillinger. 2006. Use of a modified informed consent process among vulnerable patients. Journal of General Internal Medicine 21(8): 867–873.

    Article  Google Scholar 

  23. DuBois, James M., Laura Beskow, Jean Campbell, Karen Dugosh, David Festinger, Sarah Hartz, Rosalina Hartz, and Charles Lidz. 2012. Restoring balance: A consensus statement on the protection of vulnerable research participants. American Journal of Public Health 102(12): 2220–2225.

    Article  Google Scholar 

  24. Jeste, Dilip V., ed. 2002. American Journal of Geriatric Psychiatry 10(2).

  25. Denny, Colleen C., and Christine Grady. 2007. Clinical research with economically disadvantaged populations. British Medical Journal 33(7): 382–385.

    Google Scholar 

  26. Stone, T.Howard. 2003. The invisible vulnerable: The economically and educationally disadvantaged subjects of clinical research. Journal of Law, Medicine and Ethics 31(1): 149–154.

    Article  Google Scholar 

  27. Emanuel, Ezekiel J. 2005. Undue inducement: Nonsense on stilts? The American Journal of Bioethics 5(5): 9–13.

    Article  Google Scholar 

  28. Bentley, J.P., and P.G. Thacker. 2004. The influence of risk and monetary payment on the research participation decision making process. Journal of Medical Ethics 30(3): 293–298.

    Article  Google Scholar 

  29. Halpern, Scott D., H.T. Jason, David Casarett Karlawish, Jesse A. Berlin, and David A. Asch. 2004. Empirical assessment of whether moderate payments are undue or unjust inducements for participation in clinical trials. Archives of Internal Medicine 164(7): 801–803.

    Article  Google Scholar 

  30. Emanuel, Ezekiel J., David Wendler, Jack Killen, and Christine Grady. 2004. What makes clinical research in developing countries ethical? The benchmarks of ethical research. Journal of Infections Disease 189(5): 930–937.

    Article  Google Scholar 

  31. Wertheimer, Allen. 1999. Exploitation. Princeton: Princeton University Press.

    Google Scholar 

  32. Varmus, Harold. 1994. NIH guidelines on the inclusion of women and minorities as subjects in clinical research. Federal Register 59(59): 14508–14513.

    Google Scholar 

  33. Weijer, Charles, and Ezekiel J. Emanuel. 2000. Protecting communities in biomedical research. Science 289(5482): 1142–1144.

    Article  Google Scholar 

  34. Weijer, Charles, Gary Goldsand, and Ezekiel J. Emanuel. 1999. Protecting communities in research: Current guidelines and limits of extrapolation. Nature Genetics 23: 275–280.

    Article  Google Scholar 

  35. Benatar, Solomon R. 2002. Reflections and recommendations on research ethics in developing countries. Social Science and Medicine 54(7): 1131–1141.

    Article  Google Scholar 

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Acknowledgments

The author would like to thank Ann Jeschke for her tireless editing and formatting assistance. The author also acknowledges the financial support from grant UL1 RR024992 from the NIH National Center for Research Resources.

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Correspondence to Stephanie R. Solomon.

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Solomon, S.R. Protecting and respecting the vulnerable: existing regulations or further protections?. Theor Med Bioeth 34, 17–28 (2013). https://doi.org/10.1007/s11017-013-9242-8

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