Abstract
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.
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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):20–24
Beauchamp T., Jennings B., Kinney E., Levine R. (2002). Pharmaceutical Research Involving the Homeless. Journal of Medicine and Philosophy 27(5):547–564
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. 32–46
Dekkers W.J.M. (2001). Autonomy and dependence: Chronic physical illness and decision-making capacity. Medicine, Health Care, and Philosophy 4:185–192
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. 105–109
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. 27–41
Jennings, Bruce; Callahan, Daniel; and Caplan, Arthur. “Ethical Challenges of Chronic Illness.” Hastings Center Report 18, (1) (1988): Special Supplement 1–16
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–G12
Kipnis K. (2003) Seven Vulnerabilities in the Pediatric Research Subject. Theoretical Medicine and Bioethics 24:107–120
Levine C. (2004). The Concept of Vulnerability in Disaster Research. Journal of Traumatic Stress 17(5):395–402
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 4:44–49
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 140:220–223
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 58:1689–1697
Macintyre A. (1999). Dependent Rational Animals: Why Human Beings Need the Virtues. Chicago and La, Salle Illinois, Open Court
Mele A.R. (2001) Autonomous Agents: From Self-Control to Autonomy. New York, Oxford University Press
Miller F.G., Brody H. (2003). A Critique of Clinical Equipoise. Hastings Center Report 33(3):19–28
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, <http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm> Original report published1979.
Nordenfelt L. (1987) On the Nature of Health: An Action-Theoretic Approach Philosophy and Medicine series, vol 26. Dordrecht, D. Reidel
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. 454–468
Rawls J. (1971). A Theory of Justice. Cambridge, Mass, Harvard University Press
Rawls J. (1999). Collected Papers. Cambridge, Mass, Harvard University Press
Rawls J. (2001). Justice as Fairness: A Restatement. Cambridge Mass, Harvard University Press
Raz J. (1986). The Morality of Freedom. New York, Oxford University Press
Richardson H.S., Belsky L. (2004). The Ancillary-Care Responsibilities of Medical Researchers. Hastings Center Report 34(1):25–33
Rose S.L., Pietri C.E. (2002). Workers as Research Subjects: A Vulnerable Population. Journal of Occupational and Environmental Medicine 44(9):801–805
Schneider C. (1998). The Practice of Autonomy. New York, Oxford University Press
Shamoo A.E., Resnik D. (2003). Responsible Conduct of Research. New York, Oxford University Press
Thomson J.J. (1990). The Realm of Rights. Cambridge, Mass, Harvard University Press
U.S. Code of Federal Regulations. Title 45, Part 46. Available at <http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm>.
Wendler D. (2005) Protecting Subjects Who Cannot Give Consent: Toward a Better Standard for “Minimal” Risks. Hastings Center Report 35(5):37–43
World Medical Association. Declaration of Helsinki. October 2000. Available at <http://www.wma.net/e/policy/b3.htm>.
Zion D., Gilliam L., Loff B. (2000). The Declaration of Helsinki, CIOMS and the ethics of research on vulnerable populations. Nature Medicine 6(6):615–617
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Nickel, P.J. Vulnerable Populations in Research: The Case of the Seriously Ill. Theor Med Bioeth 27, 245–264 (2006). https://doi.org/10.1007/s11017-006-9000-2
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DOI: https://doi.org/10.1007/s11017-006-9000-2