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Erschienen in: Health Care Analysis 1/2018

04.07.2016 | Original Article

Examining the Social Benefits Principle in Research with Human Participants

verfasst von: David B. Resnik

Erschienen in: Health Care Analysis | Ausgabe 1/2018

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Abstract

The idea that research with human participants should benefit society has become firmly entrenched in various regulations, policies, and guidelines, but there has been little in-depth analysis of this ethical principle in the bioethics literature. In this paper, I distinguish between strong and weak versions and the social benefits principle and examine six arguments for it. I argue that while it is always ethically desirable for research with human subjects to offer important benefits to society (or the public), the reasonable expectation of substantial public benefit should be a necessary condition for regarding research as ethical only when (a) it imposes more than minimal risks on non-consenting subjects; or (b) it is supported by public resources.
Fußnoten
1
The interpretation of “minimal risk” has been controversial but I will not explore that issue here [36, 4446].
 
2
It is worth noting that some versions of utilitarianism and Christian ethics may also imply strong duties to sacrifice our own well-being for the sake of others. For example, Singer [42] argues that our obligation to help others implies that we should be willing to bring our own well-being down to the level of those who are worse-off than we are. If there are people starving in the world, we should give them aid until our own well-being is not greater than theirs [42]. Others argue that Singer’s view is too demanding and moralistic. Our duties to help others are not as extensive as Singer supposes [15].
 
3
Beneficent actions are morally required when you have fiduciary relationships to other people. For example, parents have fiduciary obligations to benefit their children and doctors have fiduciary obligations to benefit their patients. The beneficence argument focuses on our obligations to help individuals we do not have fiduciary relationships with.
 
Literatur
1.
Zurück zum Zitat Annas, G. J., & Grodin, M. A. (Eds.). (1995). The Nazi doctors and the Nuremberg Code: Human rights in human experimentation. New York: Oxford University Press. Annas, G. J., & Grodin, M. A. (Eds.). (1995). The Nazi doctors and the Nuremberg Code: Human rights in human experimentation. New York: Oxford University Press.
3.
Zurück zum Zitat Council for the Organizations of Medical Sciences (CIOMS). (2002). International ethical guidelines for biomedical research involving human subjects. Geneva: Council for the Organizations of Medical Sciences. Council for the Organizations of Medical Sciences (CIOMS). (2002). International ethical guidelines for biomedical research involving human subjects. Geneva: Council for the Organizations of Medical Sciences.
4.
Zurück zum Zitat Department of Health and Human Services. (2009). Protection of human subjects. 45 CFR 46. Department of Health and Human Services. (2009). Protection of human subjects. 45 CFR 46.
5.
Zurück zum Zitat Emanuel, E. J. (2008). Benefits to host countries. In E. J. Emanuel, C. Grady, R. A. Crouch, R. K. Lie, F. G. Miller, & D. Wendler (Eds.), The Oxford handbook of clinical research ethics (pp. 719–728). New York: Oxford University Press. Emanuel, E. J. (2008). Benefits to host countries. In E. J. Emanuel, C. Grady, R. A. Crouch, R. K. Lie, F. G. Miller, & D. Wendler (Eds.), The Oxford handbook of clinical research ethics (pp. 719–728). New York: Oxford University Press.
6.
Zurück zum Zitat Emanuel, E. J., Wendler, D., & Grady, C. (2000). What makes clinical research ethical? Journal of the American Medical Association, 283(20), 2701–2711.CrossRefPubMed Emanuel, E. J., Wendler, D., & Grady, C. (2000). What makes clinical research ethical? Journal of the American Medical Association, 283(20), 2701–2711.CrossRefPubMed
7.
Zurück zum Zitat Emanuel, E. J., Wendler, D., Killen, J., & Grady, C. (2004). What makes clinical research in developing countries ethical? The benchmarks of ethical research. Journal of Infectious Diseases, 189(5), 930–937.CrossRefPubMed Emanuel, E. J., Wendler, D., Killen, J., & Grady, C. (2004). What makes clinical research in developing countries ethical? The benchmarks of ethical research. Journal of Infectious Diseases, 189(5), 930–937.CrossRefPubMed
8.
Zurück zum Zitat Feinberg, J. (1986). Harm to self. New York: Oxford University Press. Feinberg, J. (1986). Harm to self. New York: Oxford University Press.
9.
Zurück zum Zitat Feinberg, J. (1987). Harm to others. New York: Oxford University Press. Feinberg, J. (1987). Harm to others. New York: Oxford University Press.
10.
Zurück zum Zitat Frankena, W. F. (1988). Ethics (2nd ed.). Upper Saddle River: Pearson. Frankena, W. F. (1988). Ethics (2nd ed.). Upper Saddle River: Pearson.
11.
Zurück zum Zitat Habets, M. G., van Delden, J. J., & Bredenoord, A. L. (2014). The social value of clinical research. BMC Medical Ethics, 5(15), 66.CrossRef Habets, M. G., van Delden, J. J., & Bredenoord, A. L. (2014). The social value of clinical research. BMC Medical Ethics, 5(15), 66.CrossRef
12.
Zurück zum Zitat Hawkins, J. S., & Emanuel, E. J. (Eds.). (2008). Exploitation and developing countries: The ethics of clinical research. Princeton: Princeton University Press. Hawkins, J. S., & Emanuel, E. J. (Eds.). (2008). Exploitation and developing countries: The ethics of clinical research. Princeton: Princeton University Press.
13.
Zurück zum Zitat Iltis, A. (2007). Pediatric research posing a minor increase over minimal risk and no prospect of direct benefit: challenging 45 CFR 46.406. Accountability in Research, 14(1), 19–34.CrossRefPubMed Iltis, A. (2007). Pediatric research posing a minor increase over minimal risk and no prospect of direct benefit: challenging 45 CFR 46.406. Accountability in Research, 14(1), 19–34.CrossRefPubMed
14.
Zurück zum Zitat Kant, I. (1964)[1785]. Groundwork of the metaphysics of morals (H.D, Paton, Trans.). New York: Harper and Rowe. Kant, I. (1964)[1785]. Groundwork of the metaphysics of morals (H.D, Paton, Trans.). New York: Harper and Rowe.
15.
Zurück zum Zitat Kekes, J. (2002). On the supposed obligation to relieve famine. Philosophy, 77(302), 503–517. Kekes, J. (2002). On the supposed obligation to relieve famine. Philosophy, 77(302), 503–517.
16.
Zurück zum Zitat Kitcher, P. (2001). Science, truth, and democracy. New York: Oxford University Press.CrossRef Kitcher, P. (2001). Science, truth, and democracy. New York: Oxford University Press.CrossRef
17.
Zurück zum Zitat Kopelman, L. M. (2000). Children as research subjects: A dilemma. Journal of Medicine and Philosophy, 25(6), 745–764.CrossRefPubMed Kopelman, L. M. (2000). Children as research subjects: A dilemma. Journal of Medicine and Philosophy, 25(6), 745–764.CrossRefPubMed
18.
Zurück zum Zitat Levine, R. J. (1988). Ethics and regulation of clinical research (2nd ed.). New Haven: Yale University Press. Levine, R. J. (1988). Ethics and regulation of clinical research (2nd ed.). New Haven: Yale University Press.
19.
Zurück zum Zitat London, A. J. (2003). Threats to the common good: Biological weapons and human subjects research. Hastings Center Report, 33(5), 17–25.CrossRefPubMed London, A. J. (2003). Threats to the common good: Biological weapons and human subjects research. Hastings Center Report, 33(5), 17–25.CrossRefPubMed
20.
Zurück zum Zitat London, A. J. (2005). Does research ethics rest on a mistake? The common good, reasonable risk and social justice. American Journal of Bioethics, 5(1), 37–39.CrossRefPubMed London, A. J. (2005). Does research ethics rest on a mistake? The common good, reasonable risk and social justice. American Journal of Bioethics, 5(1), 37–39.CrossRefPubMed
21.
Zurück zum Zitat London, A. J. (2012). A non-paternalistic model of research oversight: assessing the benefits of prospective review. Journal of Law, Medicine & Ethics, 40(4), 930–944.CrossRef London, A. J. (2012). A non-paternalistic model of research oversight: assessing the benefits of prospective review. Journal of Law, Medicine & Ethics, 40(4), 930–944.CrossRef
22.
Zurück zum Zitat London, A. J., Kimmelman, J., & Carlisle, B. (2012). Rethinking research ethics: The case of postmarketing trials. Science, 336(6081), 544–545.CrossRefPubMedPubMedCentral London, A. J., Kimmelman, J., & Carlisle, B. (2012). Rethinking research ethics: The case of postmarketing trials. Science, 336(6081), 544–545.CrossRefPubMedPubMedCentral
23.
Zurück zum Zitat McCormick, R. A. (1976). Experimentation in children: Sharing sociality. Hastings Center Report, 6(6), 41–46.CrossRefPubMed McCormick, R. A. (1976). Experimentation in children: Sharing sociality. Hastings Center Report, 6(6), 41–46.CrossRefPubMed
24.
Zurück zum Zitat Miller, F. G., & Wertheimer, A. (2007). Facing up to paternalism in research ethics. Hastings Center Report, 37(3), 24–34.CrossRefPubMed Miller, F. G., & Wertheimer, A. (2007). Facing up to paternalism in research ethics. Hastings Center Report, 37(3), 24–34.CrossRefPubMed
25.
Zurück zum Zitat 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: U.S. Department of Health, Education, and Welfare. 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: U.S. Department of Health, Education, and Welfare.
26.
Zurück zum Zitat Needleman, H. L., Reigart, J. R., Landrigan, P., Sass, J., & Bearer, C. (2005). Benefits and risks of pesticide testing on humans. Environmental Health Perspectives, 113(12), A804–A805.CrossRefPubMedPubMedCentral Needleman, H. L., Reigart, J. R., Landrigan, P., Sass, J., & Bearer, C. (2005). Benefits and risks of pesticide testing on humans. Environmental Health Perspectives, 113(12), A804–A805.CrossRefPubMedPubMedCentral
28.
Zurück zum Zitat Nussbaum, M. C. (2013). Creating capabilities: The human development approach. Cambridge: Harvard University Press. Nussbaum, M. C. (2013). Creating capabilities: The human development approach. Cambridge: Harvard University Press.
29.
Zurück zum Zitat Ramsey, P. (1976). A reply to Richard McCormick: The enforcement of morals: nontherapeutic research on children. Hastings Center Report, 6(4), 21–30.CrossRefPubMed Ramsey, P. (1976). A reply to Richard McCormick: The enforcement of morals: nontherapeutic research on children. Hastings Center Report, 6(4), 21–30.CrossRefPubMed
30.
Zurück zum Zitat Rawls, J. (1971). A theory of justice. Cambridge: Harvard University Press. Rawls, J. (1971). A theory of justice. Cambridge: Harvard University Press.
31.
Zurück zum Zitat Resnik, D. B. (2008). The social benefits of human subjects research. Journal of Clinical Research Best Practices, 4(11), 1–7.PubMedPubMedCentral Resnik, D. B. (2008). The social benefits of human subjects research. Journal of Clinical Research Best Practices, 4(11), 1–7.PubMedPubMedCentral
32.
Zurück zum Zitat Resnik, D. B. (2009). Playing politics with science. New York, NY: Oxford University Press.CrossRef Resnik, D. B. (2009). Playing politics with science. New York, NY: Oxford University Press.CrossRef
33.
34.
Zurück zum Zitat Resnik, D. B., & Portier, C. (2005). Pesticide testing on human subjects: Weight benefits and risks. Environmental Health Perspectives, 113(7), 813–817.CrossRefPubMedPubMedCentral Resnik, D. B., & Portier, C. (2005). Pesticide testing on human subjects: Weight benefits and risks. Environmental Health Perspectives, 113(7), 813–817.CrossRefPubMedPubMedCentral
35.
Zurück zum Zitat Rid, A., & Wendler, D. (2011). A framework for risk-benefit evaluations in biomedical research. Kennedy Institute of Ethics Journal, 21(2), 141–179.CrossRefPubMed Rid, A., & Wendler, D. (2011). A framework for risk-benefit evaluations in biomedical research. Kennedy Institute of Ethics Journal, 21(2), 141–179.CrossRefPubMed
36.
Zurück zum Zitat Ross, L. F. (2006). Children in medical research: Access versus protection. New York: Oxford University Press.CrossRef Ross, L. F. (2006). Children in medical research: Access versus protection. New York: Oxford University Press.CrossRef
37.
Zurück zum Zitat Samuelson, P., & Nordhaus, W. (2009). Economics (19th ed.). New York: McGraw-Hill. Samuelson, P., & Nordhaus, W. (2009). Economics (19th ed.). New York: McGraw-Hill.
38.
Zurück zum Zitat Sen, A. J. (1987). On ethics and economics. Oxford: Basil Blackwell. Sen, A. J. (1987). On ethics and economics. Oxford: Basil Blackwell.
39.
Zurück zum Zitat Shah, S. (2006). The body hunters: Testing new drugs on the world’s poorest patients. New York: New Press. Shah, S. (2006). The body hunters: Testing new drugs on the world’s poorest patients. New York: New Press.
40.
Zurück zum Zitat Shamoo, A. E., & Resnik, D. B. (2015). Responsible conduct of research (3rd ed.). New York, NY: Oxford University Press. Shamoo, A. E., & Resnik, D. B. (2015). Responsible conduct of research (3rd ed.). New York, NY: Oxford University Press.
41.
Zurück zum Zitat Shuster, E. (1997). Fifty years later: The significance of the Nuremberg Code. New England Journal of Medicine, 337(20), 1436–1440.CrossRefPubMed Shuster, E. (1997). Fifty years later: The significance of the Nuremberg Code. New England Journal of Medicine, 337(20), 1436–1440.CrossRefPubMed
42.
Zurück zum Zitat Singer, P. (1972). Famine, affluence, and morality. Philosophy and Public Affairs, 1(1), 229–243. Singer, P. (1972). Famine, affluence, and morality. Philosophy and Public Affairs, 1(1), 229–243.
43.
Zurück zum Zitat Sox, H. C., & Rennie, D. (2008). Seeding trials: just say “no”. Annals of Internal Medicine, 149(4), 279–280.CrossRefPubMed Sox, H. C., & Rennie, D. (2008). Seeding trials: just say “no”. Annals of Internal Medicine, 149(4), 279–280.CrossRefPubMed
44.
Zurück zum Zitat Wendler, D. (2010). The ethics of pediatric research. New York: Oxford University Press.CrossRef Wendler, D. (2010). The ethics of pediatric research. New York: Oxford University Press.CrossRef
45.
Zurück zum Zitat Wendler, D. (2013). Do U.S. regulations allow more than minor increase over minimal risk pediatric research? Should they? IRB, 35(6), 1–8.PubMedPubMedCentral Wendler, D. (2013). Do U.S. regulations allow more than minor increase over minimal risk pediatric research? Should they? IRB, 35(6), 1–8.PubMedPubMedCentral
46.
Zurück zum Zitat Wendler, D., & Varma, S. (2006). Minimal risk in pediatric research. Journal of Pediatrics, 149(6), 855–861.CrossRefPubMed Wendler, D., & Varma, S. (2006). Minimal risk in pediatric research. Journal of Pediatrics, 149(6), 855–861.CrossRefPubMed
47.
Zurück zum Zitat Wertheimer, A. (1999). Exploitation. Princeton: Princeton University Press. Wertheimer, A. (1999). Exploitation. Princeton: Princeton University Press.
48.
Zurück zum Zitat Wertheimer, A. (2015). The social value requirement reconsidered. Bioethics, 29(5), 301–308.CrossRefPubMed Wertheimer, A. (2015). The social value requirement reconsidered. Bioethics, 29(5), 301–308.CrossRefPubMed
50.
Zurück zum Zitat Ziman, J. (2000). Real science. Cambridge: Cambridge University Press.CrossRef Ziman, J. (2000). Real science. Cambridge: Cambridge University Press.CrossRef
Metadaten
Titel
Examining the Social Benefits Principle in Research with Human Participants
verfasst von
David B. Resnik
Publikationsdatum
04.07.2016
Verlag
Springer US
Erschienen in
Health Care Analysis / Ausgabe 1/2018
Print ISSN: 1065-3058
Elektronische ISSN: 1573-3394
DOI
https://doi.org/10.1007/s10728-016-0326-2

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