Abstract
In the previous chapter I argued that a review of the history of the ethics of research with human subjects indicates that the regulations and ethical guidelines have evolved in response to egregious abuses of human subjects and ethically questionable research. Society has adopted rules to prevent these problems from occurring again and to restore and maintain public trust in research. The regulations and guidelines form a system of rules designed to protect the rights and welfare of human research subjects. Ethical dilemmas involving research with human subjects continue to emerge, however, because the rules do not completely resolve fundamental questions related to the conflict between the rights and welfare of human subjects and the goal of advancing human knowledge to benefit society. To be sure, regulations and guidelines can help investigators, IRBs, institutional leaders, policymakers, and concerned citizens address these issues, but questions remain because dilemmas occur when interpreting, applying, prioritizing, and revising regulations and guidelines. What is needed, I argued, is an ethical decision-making framework which justifies rules and policies and can establish priorities when ethical conflicts arise. This chapter will consider whether moral theories can provide such a framework.
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Notes
- 1.
There are also many variations of this thought experiment. In one variation, the five people are all 90Â years old, whereas the one person is only 12; in another variation, the five are strangers, whereas the one is your spouse or child; and in another variation, you can flip a switch that will make a robot push the man onto the tracks (see Greene 2013).
- 2.
Natural law theorists would be able to distinguish between these two cases. Pulling the switch would be ethical, because the bad effect (i.e. killing one person) would not be intended, whereas pushing the man off the footbridge would be unethical because the bad effect would be intended, since the fat man must be hit by the trolley to stop it. Virtue ethicists could say that pushing the man onto the tracks would be wrong because a virtuous person would not do this.
- 3.
For a discussion of the other versions of the CI and the relationship among the versions, see Hill Jr. (1992).
- 4.
For further discussion of these principles and their underlying concepts, see Beauchamp and Childress (2012).
- 5.
The similarity between Beauchamp and Childress’ four principles and the Belmont Report’s three principles is not a mere coincidence, since both of these authors wrote papers for the National Commission and Beauchamp was a staff member (Beauchamp 2005). The Council for the International Organizations of Medical Sciences (2002, 2016) has also adopted the Belmont Report’s principles guidelines for ethical research involving human subjects
References
Afifi, R.Y. 2007. Biomedical research ethics: An Islamic view part II. International Journal of Surgery 5 (6): 381–383.
Aquinas, S.T. 1988 [1265–1275]. On politics and ethics. Trans. P.E. Sigmund. New York: W.W. Norton.
Aristotle. 2003 [350 BCE]. Nichomachean ethics. Ed. H. Tredennick and Trans. J.A. Thompson. New York: Penguin Books.
Athanassoulis N. 2015. Virtue ethics. Internet encyclopedia of philosophy. Available at: http://www.iep.utm.edu/virtue/ . Accessed 6 Aug 2017.
Ayer, A.J. 1952. Language, truth, and logic. 2nd ed. New York: Dover.
Barcalow, E. 1994. Moral philosophy: Theory and issues. Belmont: Wadsworth.
Barron, J.A., and C.T. Dienes. 2013. Constitutional law. 8th ed. Saint Paul: West Publishing.
Beauchamp, T.L. 2005. The origins and evolution of the Belmont report. In Belmont revisited: Ethical principles for research with human subjects, ed. J.F. Childress, E.M. Meslin, and H.T. Shapiro, 12–25. Washington, DC: Georgetown University Press.
Beauchamp, T.L., and J.F. Childress. 2012. Principles of biomedical ethics. 7th ed. New York: Oxford University Press.
Benedict, R. 1946. Patterns of culture. New York: Penguin Books.
Billings, J.A. 2011. Double effect: A useful rule that alone cannot justify hastening death. Journal of Medical Ethics 37 (7): 437–440.
Brandt, R. 1998. A theory of the good and the right. revised ed. New York: Prometheus Books.
Brink, D.O. 1989. Moral realism and the foundations of ethics. Cambridge: Cambridge University Press.
Brock, D.W. 2008. Philosophical justifications of informed consent in research. In The Oxford handbook of clinical research ethics, ed. E.J. Emanuel, C. Grady, R.A. Crouch, R.K. Lie, F.G. Miller, and D. Wendler, 606–612. New York: Oxford University Press.
Callahan, D. 1981. Minimalist ethics. Hastings Center Report 11 (5): 19–25.
———. 2016. International ethical guidelines for health-related research involving humans. Geneva: Council for the International Organizations of Medical Sciences.
Crocco, A., and D. D’Elia. 2007. Adverse reactions during voluntary donation of blood and/or blood components. A statistical-epidemiological study. Blood Transfusion 5 (3): 143–152.
Darrow, J.J., A. Sarpatwari, J. Avorn, and A.S. Kesselheim. 2015. Practical, legal, and ethical issues in expanded access to investigational drugs. New England Journal of Medicine 372 (3): 279–286.
DeAngelis, C.D. 2000. Conflict of interest and the public trust. Journal of the American Medical Association 284 (17): 2237–2238.
Dworkin, G. 2014. Paternalism. Stanford Encyclopedia of Philosophy. Available at: http://plato.stanford.edu/entries/paternalism/. Accessed 26 July 2017.
Earl, C.E., and P.J. Penney. 2001. The significance of trust in the research consent process with African Americans. Western Journal of Nursing Research 23 (7): 753–762.
Falk, M.J., R.B. Dugan, M.A. O’Riordan, A.L. Matthews, and N.H. Robin. 2003. Medical Geneticists’ duty to warn at-risk relatives for genetic disease. American Journal of Medical Genetics A 120A (3): 374–380.
Fleischman, A.R. 2005. Regulating research with human subjects—Is the system broken? Transactions of the American Clinical and Climatological Association 116: 91–101.
Ford, J.G., M.W. Howerton, G.Y. Lai, T.L. Gary, S. Bolen, M.C. Gibbons, J. Tilburt, C. Baffi, T.P. Tanpitukpongse, R.F. Wilson, N.R. Powe, and E.B. Bass. 2008. Barriers to recruiting underrepresented populations to cancer clinical trials: A systematic review. Cancer 112 (2): 228–242.
Gifford, F. 2000. Freedman’s ‘clinical equipoise’ and ‘sliding-scale all-dimensions-considered equipoise’. Journal of Medicine and Philosophy 25 (4): 399–426.
Glendon, M.A. 1991. Rights talk: The impoverishment of political discourse. New York: Free Press.
Goel, V. 2014. As data overflows online, researchers grapple with ethics. New York Times, August 14, 2014:B1.
Grimes v. Kennedy Krieger Institute, Inc. 2001. 782 A.2d 807 (MD 2001).
Hall, M.A., E. Dugan, B. Zheng, and A.K. Mishra. 2001. Trust in physicians and medical institutions: What is it, can it be measured, and does it matter? Milbank Quarterly 79 (4): 613–639.
Hawkins, J.L., and E.J. Emanuel, eds. 2008. Exploitation and developing countries: The ethics of clinical research. Princeton: Princeton University Press.
Hobbes, T. 2006. [1651] Leviathan. New York: Dover.
Hodge, J.G., and L.O. Gostin. 2008. Confidentiality. In The Oxford handbook of clinical research ethics, ed. E.J. Emanuel, C. Grady, R.A. Crouch, R.K. Lie, F.G. Miller, and D. Wendler, 673–681. New York: Oxford University Press.
Hornblum, A.M. 1999. Acres of skin: Human experiments at Holmesburg prison. New York: Routledge.
Jones, J.H. 1981. Bad blood. New York: Free Press.
Karlawish, J.H. 2008. Emergency research. In The Oxford handbook of clinical research ethics, ed. E.J. Emanuel, C. Grady, R.A. Crouch, R.K. Lie, F.G. Miller, and D. Wendler, 280–289. New York: Oxford University Press.
KPLR. 2013. Volunteers needed to help sandbag in Clarkesvill, MO. April 18, 2013. Available at: http://kplr11.com/2013/04/18/volunteers-needed-to-help-sandbag-in-clarksville-mo-2/. Accessed 16 Aug 2017.
Lockwood, A.H. 2004. Human testing of pesticides: Ethical and scientific considerations. American Journal of Public Health 94 (11): 1908–1916.
Lowrance, W.W., and F.S. Collins. 2007. Ethics. Identifiability in genomic research. Science 317 (5838): 600–602.
MacKay, D. 2015. Opt-out and consent. Journal of Medical Ethics 41 (10): 832–835.
———. 2003. Bioethics, vulnerability, and protection. Bioethics 17 (5-6): 472–486.
———. 1979 [1861]. Utilitarianism, ed. G. Sher. Indianapolis: Hackett.
Miller, M. 2000. Phase I cancer trials: A collusion of misunderstanding. Hastings Center Report 30 (4): 34–43.
———. 2003. A critique of clinical equipoise. Therapeutic misconception in the ethics of clinical trials. Hastings Center Report 33 (3): 9–28.
National Health and Nutrition Examination Survey. 2007. Oral Glucose Tolerance Test (OGTT) procedures manual. Available at: http://www.cdc.gov/nchs/data/nhanes/nhanes_07_08/manual_ogtt.pdf. Accessed 11 Aug 2017.
Nuremberg Code. 1949. Trials of war criminals before the Nuremberg military tribunals under Control Council Law No. 10. Vol. 2, 181–182. Washington, DC: U.S. Government Printing Office.
O’Mathúna, D.P. 2010. Conducting research in the aftermath of disasters: Ethical considerations. Journal of Evidence Based Medicine 3 (2): 65–75.
O’Neill, O. 1989. Constructions of reason. Cambridge: Cambridge University Press.
Plato. 2002 [395–399 BCE]. Five dialogues: Euthyphro, apology, crito, meno, phaedo, ed. J.M. Cooper. Trans. J.M.A. Grube. Indianapolis: Hackett.
Pojman, L.P. 2005. Ethics: Discovering right and wrong. 5th ed. Belmont: Wadsworth.
Rawls, J. 1971. A theory of justice. Cambridge, MA: Harvard University Press.
———. 2012a. Environmental health ethics. Cambridge: Cambridge University Press.
———. 2012b. Ethical virtues in scientific research. Accountability in Research 19 (6): 329–343.
Richardson, H.S. 2000. Specifying, balancing, and interpreting bioethical principles. Journal of Medicine and Philosophy 25 (3): 285–307.
Ross, W.D. 1930. The right and the good. Oxford: Oxford University Press.
Sandel, M.J. 2010. Justice: What’s the right thing to do? New York: Farrar, Straus and Giroux.
Sayre-McCord, G. 1996. Coherentist epistemology and moral theory. In Moral knowledge? ed. W. Sinnott-Armstrong and M. Timmons, 137–189. New York: Oxford University Press.
Shavers, V.L., C.F. Lynch, and L.F. Burmeister. 2000. Knowledge of the Tuskegee study and its impact on the willingness to participate in medical research studies. Journal of National Medical Association 92 (12): 563–572.
Singer, E., and M.P. Couper. 2008. Do incentives exert undue influence on survey participation? Experimental evidence. Journal of Empirical Research on Human Research Ethics 3 (3): 49–56.
Sinnott-Armstrong, W. 1996. Moral dilemmas and rights. In Moral dilemmas and moral theory, ed. H.E. Mason, 48–65. New York: Oxford University Press.
———. 2008b. How pharmaceutical industry funding affects trial outcomes: Causal structures and responses. Social Science and Medicine 66 (9): 1909–1914.
Tilousi, C. 2011. Testimony before the President’s commission for the study of bioethical issues. August 30: 2011.
Timmons, M. 2002. Moral theory: An introduction. Lanham: Rowman and Littlefield.
Tramel, P. 2015. Moral epistemology. Internet encyclopedia of philosophy. Available at: http://www.iep.utm.edu/mor-epis/. Accessed 7 Aug 2017.
Tsuchiya, T. 2008. The imperial Japanese experiments in China. In The Oxford handbook of clinical research ethics, ed. E.J. Emanuel, C. Grady, R.A. Crouch, R.K. Lie, F.G. Miller, and D. Wendler, 31–45. New York: Oxford University Press.
United States Bureau of Labor Statistics. 2015. Census of fatal occupational injuries. Available at: https://www.bls.gov/news.release/cfoi.toc.htm. Accessed 11 Aug 2017.
United States Congress, Committee on Government Operations. 1990. Are scientific misconduct and conflicts of interest hazardous to our health? Washington, DC: U.S. Government Printing Office.
Veatch, R.M. 1987. The patient as partner: A theory of human experimentation ethics. Bloomington: Indiana University Press.
———. 2008. The assent requirement in pediatric research. In The Oxford textbook of clinical research ethics, ed. E.J. Emanuel, C. Grady, R.A. Crouch, R.K. Lie, F.G. Miller, and D. Wendler, 661–669. New York: Oxford University Press.
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Resnik, D.B. (2018). Moral Theory. In: The Ethics of Research with Human Subjects. International Library of Ethics, Law, and the New Medicine, vol 74. Springer, Cham. https://doi.org/10.1007/978-3-319-68756-8_3
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