Paternalism and Utilitarianism in Research with Human Participants
- David B. Resnik
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In this article I defend a rule utilitarian approach to paternalistic policies in research with human participants. Some rules that restrict individual autonomy can be justified on the grounds that they help to maximize the overall balance of benefits over risks in research. The consequences that should be considered when formulating policy include not only likely impacts on research participants, but also impacts on investigators, institutions, sponsors, and the scientific community. The public reaction to adverse events in research (such as significant injury to participants or death) is a crucial concern that must be taken into account when assessing the consequences of different policy options, because public backlash can lead to outcomes that have a negative impact on science, such as cuts in funding, overly restrictive regulation and oversight, and reduced willingness of individuals to participate in research. I argue that concern about the public reaction to adverse events justifies some restrictions on the risks that competent, adult volunteers can face in research that offers them no significant benefits. The paternalism defended here is not pure, because it involves restrictions on the rights of investigators in order to protect participants. It also has a mixed rationale, because individual autonomy may be restricted not only to protect participants from harm but also to protect other stakeholders. Utility is not the sole justification for paternalistic research policies, since other considerations, such as justice and respect for individual rights/autonomy, must also be taken into account.
- Arneson, R. (1989). Paternalism, utility and fairness. Revue Internationale de Philosophie, 170, 409–423.
- Brandt, R. (1998) A Theory of the good and the right (revised ed). New York: Prometheus Books.
- Council for International Organizations of Medical Sciences. (2002). International ethical guidelines for biomedical research involving human subjects, 2002 revision. Available at: http://www.cioms.ch/publications/layout_guide2002.pdf. Accessed: 28 June 2012.
- Department of Health and Human Services. (2009). Protection of Human Subjects, 45 CFR 46.
- Dworkin, G. (1972). Paternalism. The Monist, 56, 64–84.
- Dworkin, G. (2012) Paternalism. Stanford Encyclopedia of Philosophy. Available at: http://plato.stanford.edu/entries/paternalism/. Accessed: 29 June 2012.
- Edwards, S. J., & Wilson, J. (2012). Hard paternalism, fairness and clinical research: Why not? Bioethics, 26, 68–75. CrossRef
- Edwards, S. J., Kirchin, S., & Huxtable, R. (2004). Research ethics committees and paternalism. Journal of Medical Ethics, 30, 88–91. CrossRef
- Feinberg, J. (1986). Harm to self. New York: Oxford University Press.
- Goodyear, M. (2006). Learning from the TGN1412 trial. British Medical Journal, 332, 677–678. CrossRef
- Grady, C., Dickert, N., Jawetz, T., Gensler, G., & Emanuel, E. (2005). An analysis of U.S. practices of paying research participants. Contemporary Clinical Trials, 26, 365–375. CrossRef
- Jansen, L. A., & Wall, S. (2009). Paternalism and fairness in clinical research. Bioethics, 23, 172–182. CrossRef
- Jonas, H. (1969). Philosophical reflections on experimenting with human subjects. Daedalus, 98, 219–247.
- Jonsen, A. (1988). The birth of bioethics. New York: Oxford University Press.
- Kleinig, J. (1983). Paternalism. Manchester: Manchester University Press.
- Lederer, S. (2008). Walter reed and the yellow fever experiments. In E. Emanuel, C. Grady, R. Crouch, R. Lie, F. Miller, & D. Wendler (Eds.), The Oxford textbook of clinical research ethics (pp. 9–17). New York: Oxford University Press.
- Mill, J. S. (1869) . On liberty. Indianapolis, IN: Hackett Publishing Company.
- Miller, F. G., & Wertheimer, A. (2007). Facing up to paternalism in research ethics. Hastings Center Report, 37(3), 24–34. CrossRef
- National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. Washington, DC: Department of Health, Education, and Welfare.
- Nuremberg Code. (1949). Directives for human experimentation. http://ohsr.od.nih.gov/guidelines/nuremberg.html. Accessed 2 July 2012.
- Resnik, D. B. (2007). The new EPA regulations for protecting human subjects: Haste makes waste. Hastings Center Report, 37(1), 17–21. CrossRef
- Resnik, D. B. (2007). Are the new EPA regulations concerning intentional exposure studies with children overprotective? IRB, 29(5), 5–7.
- Resnik, D. B. (2012). Limits on risks for healthy volunteers in biomedical research. Theoretical Medicine and Bioethics, 33, 137–149. CrossRef
- Shamoo, A. S., & Resnik, D. B. (2009). Responsible conduct of research (2nd ed.). New York: Oxford University Press. CrossRef
- Smart, J. J. C., & Williams, B. (1973). Utilitarianism: For and against. Cambridge: Cambridge University Press.
- Steinbrook, R. (2002). Protecting research subjects—the Crisis at Johns Hopkins. New England Journal of Medicine, 346, 716–720. CrossRef
- Wertheimer, A. (2008). Rethinking the ethics of clinical research: Widening the lens. New York: Oxford University Press.
- World Medical Association. (2008). Declaration of Helsinki, 2008 revision. Available at: http://www.wma.net/en/30publications/10policies/b3/index.html. Accessed: 28 June 2012.
- Yarborough, M., & Sharp, R. (2009). Public trust and research a decade later: What have we learned since Jesse Gelsinger’s death? Molecular Genetics and Metabolism, 97, 4–5. CrossRef
- Paternalism and Utilitarianism in Research with Human Participants
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- David B. Resnik (1)
- Author Affiliations
- 1. National Institute of Environmental Health Sciences, National Institutes of Health, Box 12233, Mail Drop CU 03, Research Triangle Park, NC, 27709, USA