Theoretical Medicine and Bioethics

, Volume 27, Issue 3, pp 245–264 | Cite as

Vulnerable Populations in Research: The Case of the Seriously Ill



This paper advances a new criterion of a vulnerable population in research. According to this criterion, there are consent-based and fairness-based reasons for calling a group vulnerable. The criterion is then applied to the case of people with serious illnesses. It is argued that people with serious illnesses meet this criterion for reasons related to consent. Seriously ill people have a susceptibility to “enticing offers” that hold out the prospect of removing or alleviating illness, and this susceptibility reduces their ability to safeguard their own interests. This explains the inclusion of people with serious illnesses in the Belmont Report’s list of populations needing special protections, and supports the claim that vulnerability is the rule, rather than the exception, in biomedical research.


autonomy Belmont Report biomedical research ethics consent fairness serious illness vulnerable population 


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  1. Applebaum P., Roth L., Lidz C., Benson P., Winslade W. (1987) False Hopes and Best Data: Consent to Research and the Therapeutic Misconception. Hastings Center Report 17(2):20–24CrossRefGoogle Scholar
  2. Beauchamp T., Jennings B., Kinney E., Levine R. (2002). Pharmaceutical Research Involving the Homeless. Journal of Medicine and Philosophy 27(5):547–564CrossRefGoogle Scholar
  3. Brody B.A. (1998). Research on the Vulnerable Sick. In: Kahn J.P., Mastroianni A.C., Sugarman J. (eds), Beyond Consent: Seeking Justice in Research. New York, Oxford University Press, pp. 32–46Google Scholar
  4. Dekkers W.J.M. (2001). Autonomy and dependence: Chronic physical illness and decision-making capacity. Medicine, Health Care, and Philosophy 4:185–192CrossRefGoogle Scholar
  5. Eckstein Sue. (2003). Research Involving Vulnerable Participants: Some Ethical Issues. In: Eckstein Sue (eds), Manual for Research Ethics Committees 6th ed. Cambridge, England, Cambridge University Press, pp. 105–109Google Scholar
  6. Englehardt H.T. Jr. (1984). Clinical Problems and the Concept of Disease. In: Nordenfelt L., Lindahl B., Ingemar B. (eds), Health, Disease, and Causal Explanation in Medicine. Philosophy and Medicine series vol 16. Dordrecht, D. Reidel, pp. 27–41Google Scholar
  7. Jennings, Bruce; Callahan, Daniel; and Caplan, Arthur. “Ethical Challenges of Chronic Illness.” Hastings Center Report 18, (1) (1988): Special Supplement 1–16Google Scholar
  8. Kipnis, Kenneth. “Vulnerability in Research Subjects: A Bioethical Taxonomy.” In Ethical and Policy Issues in Research Involving Human Research Participants. Bethesda, MD: National Bioethics Advisory Commision, 2001: G1–G12Google Scholar
  9. Kipnis K. (2003) Seven Vulnerabilities in the Pediatric Research Subject. Theoretical Medicine and Bioethics 24:107–120CrossRefGoogle Scholar
  10. Levine C. (2004). The Concept of Vulnerability in Disaster Research. Journal of Traumatic Stress 17(5):395–402CrossRefGoogle Scholar
  11. Levine C., Faden R., Grady C., Hammerschmidt D., Eckenwiler L., Sugarman J. (2004). The Limitations of ’Vulnerability’ as a Protection for Human Research Participants. American Journal of Bioethics 4:44–49Google Scholar
  12. Levine C., Faden R., Grady C., Hammerschmidt D., Eckenwiler L., Sugarman J. (2004). Special Scrutiny: A Targeted Form of Research Protocol Review. Annals of Internal Medicine 140:220–223Google Scholar
  13. Lidz C.W., Appelbaum P.S., Grisso T., Renaud M. (2004). Therapeutic misconception and the appreciation of risks in clinical trials. Social Science and Medicine 58:1689–1697CrossRefGoogle Scholar
  14. Macintyre A. (1999). Dependent Rational Animals: Why Human Beings Need the Virtues. Chicago and La, Salle Illinois, Open CourtGoogle Scholar
  15. Mele A.R. (2001) Autonomous Agents: From Self-Control to Autonomy. New York, Oxford University PressGoogle Scholar
  16. Miller F.G., Brody H. (2003). A Critique of Clinical Equipoise. Hastings Center Report 33(3):19–28CrossRefGoogle Scholar
  17. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report . Available at the U.S. Department of Health and Human Services Website, <> Original report published1979.
  18. Nordenfelt L. (1987) On the Nature of Health: An Action-Theoretic Approach Philosophy and Medicine series, vol 26. Dordrecht, D. ReidelGoogle Scholar
  19. Ratzan R.M. (2000). ‘Being Old Makes You Different’: The Ethics of Research with Elderly Subjects. In: Boetzkes E., Waluchow W.J. (eds), Readings in Health Care Ethics. New York, USA, Broadview Press, pp. 454–468Google Scholar
  20. Rawls J. (1971). A Theory of Justice. Cambridge, Mass, Harvard University PressGoogle Scholar
  21. Rawls J. (1999). Collected Papers. Cambridge, Mass, Harvard University PressGoogle Scholar
  22. Rawls J. (2001). Justice as Fairness: A Restatement. Cambridge Mass, Harvard University PressGoogle Scholar
  23. Raz J. (1986). The Morality of Freedom. New York, Oxford University PressGoogle Scholar
  24. Richardson H.S., Belsky L. (2004). The Ancillary-Care Responsibilities of Medical Researchers. Hastings Center Report 34(1):25–33CrossRefGoogle Scholar
  25. Rose S.L., Pietri C.E. (2002). Workers as Research Subjects: A Vulnerable Population. Journal of Occupational and Environmental Medicine 44(9):801–805CrossRefGoogle Scholar
  26. Schneider C. (1998). The Practice of Autonomy. New York, Oxford University PressGoogle Scholar
  27. Shamoo A.E., Resnik D. (2003). Responsible Conduct of Research. New York, Oxford University PressGoogle Scholar
  28. Thomson J.J. (1990). The Realm of Rights. Cambridge, Mass, Harvard University PressGoogle Scholar
  29. U.S. Code of Federal Regulations. Title 45, Part 46. Available at <>.
  30. Wendler D. (2005) Protecting Subjects Who Cannot Give Consent: Toward a Better Standard for “Minimal” Risks. Hastings Center Report 35(5):37–43CrossRefGoogle Scholar
  31. World Medical Association. Declaration of Helsinki. October 2000. Available at <>.
  32. Zion D., Gilliam L., Loff B. (2000). The Declaration of Helsinki, CIOMS and the ethics of research on vulnerable populations. Nature Medicine 6(6):615–617CrossRefGoogle Scholar

Copyright information

© Springer 2006

Authors and Affiliations

  1. 1.Department of PhilosophyUniversity of CaliforniaIrvineU.S.A

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