Publication Cover
Accountability in Research
Ethics, Integrity and Policy
Volume 24, 2017 - Issue 1
953
Views
12
CrossRef citations to date
0
Altmetric
Articles

The Role of Intuition in Risk/Benefit Decision-Making in Human Subjects Research

, J.D., Ph.D.

References

  • Audi, R. 2001. The architecture of reason. New York, NY: Oxford University Press.
  • Audi, R. 2004. The good in the right. Princeton, NJ: Princeton University Press.
  • Audi, R. 2010. Epistemology: A contemporary introduction to the theory of knowledge, 3rd ed. New York, NY: Routledge.
  • Australian National Government. (2015). National Statement on Ethical Conduct in Human Research, Updated 2015. http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/e72_national_statement_may_2015_150514_a.pdf. accessed June 30, 2015.
  • Ayer, A. J. 1952. Language, Truth, and Logic, 2nd ed. New York, NY: Dover.
  • Bernabe, R. D., G. J. Van Thiel, J. A. Raaijmakers, and J. J. Van Delden. 2012a. The risk-benefit task of research ethics committees: An evaluation of current approaches and the need to incorporate decision studies methods. BMC Medical Ethics 13:6. doi:10.1186/1472-6939-13-6.
  • Bernabe, R. D., G. J. Van Thiel, J. A. Raaijmakers, and J. J. Van Delden. 2012b. Decision theory and the evaluation of risks and benefits of clinical trials. Drug Discovery Today 17 (23–24):1263–69. doi:10.1016/j.drudis.2012.07.005.
  • Canadian Institutes of Health Research, Natural Sciences and Engineering, Research Council of Canada, Social Sciences and Humanities Research Council of Canada. (2005). Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. http://www.pre.ethics.gc.ca/archives/tcps-eptc/docs/TCPS%20October%202005_E.pdf. accessed June 29, 2015.
  • Chuang-Stein, C. 1994. A new proposal for benefit-less-risk analysis in clinical trials. Controlled Clinical Trials 15 (1):30–43. doi:10.1016/0197-2456(94)90026-4.
  • Council for International Organizations of Medical Science. (2002). International Ethical Guidelines for Biomedical Research Involving Human Subjects. http://www.cioms.ch/publications/layout_guide2002.pdf. accessed August 17, 2015.
  • Cushman, F., L. Young, and M. Hauser. 2006. The role of conscious reasoning and intuition in moral judgment: Testing three principles of harm. Psychological Science 17 (12):1082–89. doi:10.1111/psci.2006.17.issue-12.
  • Daniels, N. 1996. Justice and justification: Reflective equilibrium in theory and practice. New York, NY: Cambridge University Press.
  • Daniels, N., and J. E. Sabin. 2002. Setting limits fairly: Can we learn to share medical resources? New York, NY: Oxford University Press.
  • Department of Health and Human Services. (2009). Protection of Human Subjects. 45 CFR 46.
  • Descartes, R. 1993 [1637]. Meditations on first philosophy. 3rd ed. Cress DA (transl.). Indianapolis: Hackett.
  • Earman, J. 1992. Bayes of bust? A critical examination of Bayesian confirmation theory. Cambridge, MA: M.I.T. Press.
  • Emanuel, E. J., D. Wendler, and C. Grady. 2000. What makes clinical research ethical? Journal of the American Medical Association 283 (20):2701–11. doi:10.1001/jama.283.20.2701.
  • Feinberg, M., R. Willer, O. Antonenko, and O. P. John. 2012. Liberating reason from the passions: Overriding intuitionist moral judgments through emotion reappraisal. Psychological Science 23 (7):788–95. doi:10.1177/0956797611434747.
  • Fumerton, R. (2010). Foundationalist Theories of Epistemic Justification. Stanford Encyclopedia of Philosophy. http://plato.stanford.edu/entries/justep-foundational/. accessed August 23, 2015.
  • Giere, R. N., J. Bickle, and R. Mauldin. 2005. Understanding scientific reasoning, 5th ed. Belmont, CA: Wadsworth.
  • Goldman, A. 1988. Epistemology and Cognition. Cambridge, MA: Harvard University Press.
  • Green, L. A., J. C. Lowery, C. P. Kowalski, and L. Wyszewianski. 2006. Impact of institutional review board practice variation on observational health services research. Health Services Research 41 (1):214–30. doi:10.1111/hesr.2006.41.issue-1.
  • Greene, J. 2013. Moral tribes: Emotion, reason, and the gap between us and them. New York, NY: Penguin Press.
  • Greene, J. D., R. B. Sommerville, L. E. Nystrom, J. M. Darley, and J. D. Cohen. 2001. An fMRI investigation of emotional engagement in moral judgment. Science 293 (5537):2105–08. doi:10.1126/science.1062872.
  • Gutmann, A., and D. Thompson. 1998. Democracy and disagreement. Cambridge, MA: Harvard University Press.
  • Haidt, J. 2001. The emotional dog and its rational tail: A social intuitionist approach to moral judgment. Psychology Review 108 (4):814–34. doi:10.1037/0033-295X.108.4.814.
  • Haidt, J. 2007. The new synthesis in moral psychology. Science 316 (5827):998–1002. doi:10.1126/science.1137651.
  • Hansson, S. O. 2003. Ethical criteria of risk acceptance. Erkenntnis 59:291–309. doi:10.1023/A:1026005915919.
  • Howson, C., and P. Urbach. 1993. Scientific reasoning: The Bayesian approach. Chicago, IL: Open Court.
  • Hume, D. 2000 [1739]. A treatise of human nature. eds. D. F. Norton, and M. J. Norton, New York, NY: Oxford University Press.
  • Iltis, A. S. 2000. Bioethics as methodological case resolution: Specification, specified principlism and casuistry. The Journal of Medicine and Philosophy 25 (3):271–84. doi:10.1076/0360-5310(200006)25:3;1-H;FT271.
  • Jonsen, A. R., and S. Toulmin. 1990. The abuse of casuistry: A history of moral reasoning. Berkeley, CA: University of California Press.
  • Kahneman, D. 2011. Thinking, Fast, and Slow. New York, NY: Farrar, Straus, and Giroux.
  • Kahneman, D., P. Slovic, and A. Tversky, eds. 1983. Judgment under uncertainty: Heuristics and biases. Cambridge, UK: Cambridge University Press.
  • Kant, I. 1964 [1785]. Groundwork for the metaphysics of morals. H.D. Paton (transl). New York: Harper and Rowe.
  • Kimmelman, J. 2004. Valuing risk: The ethical review of clinical trial safety. Kennedy Institute of Ethics Journal 14 (3):369–93. doi:10.1353/ken.2004.0041.
  • Kimmelman, J., and V. Henderson. 2016. Assessing risk/benefits trials for using preclinical evidence: A proposal. Journal of Medical Ethics 42 (1):50–53. doi:10.1136/medethics-2015-102882.
  • Klitzman, R. L. 2015. The ethics police? The struggle to make human research safe. New York, NY: Oxford University Press.
  • Kohlberg, L. 1981. The philosophy of moral development, vol. 1. New York, NY: Harper and Rowe.
  • Kuczewski, M. 1998. Casuistry and principlism: The convergence of method in biomedical ethics. Theoretical Medicine and Bioethics 19 (6):509–24. doi:10.1023/A:1009904125910.
  • Levine, R. J. 1988. Ethics and the regulation of clinical research, 2nd ed. New Haven, CT: Yale University Press.
  • London, A. J. 2006. Reasonable risks in clinical research: A critique and a proposal for the Integrative Approach. Statistics in Medicine 25 (17):2869–85. doi:10.1002/(ISSN)1097-0258.
  • Martin, D. K., E. M. Meslin, N. Kohut, and P. A. Singer. 1995. The incommensurability of research risks and benefits: Practical help for research ethics committees. Irb 17 (2):8–10. doi:10.2307/3563530.
  • Meslin, E. M. 1990. Protecting .human subjects from harm through improved risk judgments. Irb 12 (1):7–10. doi:10.2307/3563683.
  • Mill, J. S. 1979 [1863]. Utilitarianism. Indianapolis, IN: Hackett Publishing Company.
  • Miller, A. D., and R. Perry. 2012. The reasonable person. New York University Law Review 97 (2):323–92.
  • Miller, F. G., and S. Joffe. 2009. Limits to research risks. Journal of Medical Ethics 35 (7):445–49. doi:10.1136/jme.2008.026062.
  • Moore, G. E. 2004 [1903]. Principia ethica. New York, NY: Dover.
  • Murphy, P. (2015). Coherentism in epistemology. Stanford Encyclopedia of Philosophy. http://www.iep.utm.edu/coherent/#H2. accessed September 6, 2015.
  • Musschenga, A. W., H. E. Van Luijn, R. B. Keus, and N. K. Aaronson. 2007. Are risks and benefits of oncological research protocols both incommensurable and incompensable? Accountability in Research 14 (3):179–96. doi:10.1080/08989620701455217.
  • National Bioethics Advisory Commission. (2001). Ethical and policy issues in research involving human participants. Volume I: Report and Recommendations of the National Bioethics Advisory Commission. Bethesda, MD: National Bioethics Advisory Commission.
  • National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research. (1979). The Belmont Report. Washington, DC: Department of Health, Education, and Welfare. http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html. accessed June 17, 2015.
  • Nozick, R. 1974. Anarchy, State, Utopia. New York, NY: Basic Books.
  • Nussbaum, M. 2011. Creating capabilities: The human development approach. Cambridge, MA: Harvard University Press.
  • Pizarro, D. A., and P. Bloom. 2003. The intelligence of the moral intuitions: A comment on Haidt (2001).. Psychological Review 110 (1):193–96. doi:10.1037/0033-295X.110.1.193.
  • Pojman, L. P. 2005. Ethics: Discovering right and wrong, 5th ed. Belmont, CA: Wadsworth.
  • Poston, T. (2015). Foundationalism. Stanford Encyclopedia of Philosophy. http://www.iep.utm.edu/found-ep/. accessed August 30, 2015.
  • Pritchard, I. A. 2011. How do IRB members make decisions? A review and research agenda. Journal of Empirical Research on Human Research Ethics 6 (2):31–46. doi:10.1525/jer.2011.6.2.31.
  • Pust, J. (2012). Intuition. Stanford Encyclopedia of Philosophy. http://plato.stanford.edu/entries/intuition/. accessed August 23, 2015.
  • Rachels, J. 1993. The Elements of Moral Philosophy, 2nd ed. New York, NY: McGraw-Hill.
  • Rajczi, A. 2004. Making risk-benefit assessments of medical research protocols. The Journal of Law, Medicine & Ethics 32 (2):338–48. doi:10.1111/jlme.2004.32.issue-2.
  • Rawls, J. 1971. A theory of justice. Cambridge, MA: Harvard University Press.
  • Resnik, D. B. 2012. Limits on risks for healthy volunteers in biomedical research. Theoretical Medicine and Bioethics 33 (2):137–49. doi:10.1007/s11017-011-9201-1.
  • Resnik, D. B., and C. E. Kennedy. 2010. Balancing scientific and community interests in community-based participatory research. Accountability in Research 17 (4):198–210. doi:10.1080/08989621.2010.493095.
  • Resnik, D. B., M. Rehm, and R. B. Minard. 2001. The undertreatment of pain: Scientific, clinical, cultural, and philosophical factors. Medicine, Health Care, and Philosophy 4 (3):277–88. doi:10.1023/A:1012057403159.
  • Resnik, D. B., and R. R. Sharp. 2006. Protecting third parties in human subjects research. Irb 28 (4):1–7.
  • Richardson, H. S. 2000. Specifying, balancing, and interpreting bioethical principles. The Journal of Medicine and Philosophy 25 (3):285–307. doi:10.1076/0360-5310(200006)25:3;1-H;FT285.
  • Rid, A., E. J. Emanuel, and D. Wendler. 2010. Evaluating the risks of clinical research. Journal of the American Medical Association 304 (13):1472–79. doi:10.1001/jama.2010.1414.
  • Rid, A., and D. Wendler. 2011. A framework for risk-benefit evaluations in biomedical research. Kennedy Institute of Ethics Journal 21 (2):141–79. doi:10.1353/ken.2011.0007.
  • Rorty, R. 1967. Intuition. In Encyclopedia of philosophy, ed. P. Edwards, Vol. 3, 204–12. New York, NY: MacMillan.
  • Ross, W. D. 1930. The right and the good. Oxford, UK: Oxford University Press.
  • Rossi, J., and R. M. Nelson. 2012. Is there an objective way to compare research risks? Journal of Medical Ethics 38 (7):423–27.
  • Sayre-McCord, G. 1996. Coherentist epistemology and moral theory. In Moral Knowledge? eds. W. Sinnott-Armstrong, and M. Timmons, 137–89. New York, NY: Oxford University Press.
  • Schneider, C. 2015. The censor’s hand: The Misregulation of human-subject research. Cambridge, MA: M.I.T. Press.
  • Sellars, W. 1956. Empiricism and the philosophy of mind. In Minnesota studies in the philosophy of science, ed. H. Feigl, and M. Scriven, Vol. I, 253–329. Minneapolis, MN: University of Minnesota Press.
  • Shah, S., A. Whittle, B. Wilfond, G. Gensler, and D. Wendler. 2004. How do institutional review boards apply the federal risk and benefit standards for pediatric research? Journal of the American Medical Association 291 (4):476–82.
  • Shamoo, A. E., and B. M. Ayyub. 2011. Risk/benefit estimates in clinical trials. Drug Information Journal 45:669–85.
  • Shamoo, A. E., and D. B. Resnik. 2015. Responsible conduct of research, 3rd ed. New York, NY: Oxford University Press.
  • Shrader-Frechette, K. S. 1991. Risk and rationality: Philosophical foundations for populist reforms. Berkeley, CA: University of California Press.
  • Silberman, G., and K. L. Kahn. 2011. Burdens on research imposed by institutional review boards: The state of the evidence and its implications for regulatory reform. Milbank Quarterly 89 (4):599–627.
  • Simon, H. A. 1957. Models of Man. New York, NY: John Wiley.
  • Simon, H. A. 1990. Reason in human affairs. Stanford, CA: Stanford University Press.
  • Stark, L. 2012. Behind closed doors: IRBs and the making of ethical research. Chicago, IL: University of Chicago Press.
  • Stratton-Lake, P. (2014). Intuitionism in ethics. Stanford Encyclopedia of Philosophy. http://plato.stanford.edu/entries/intuitionism-ethics/. accessed July 22, 2015.
  • Strong, C. 2000. Specified principlism: What is it, and does it really resolve cases better than casuistry? Journal of Medicine and Philosophy 25 (3):323–41.
  • Tversky, A., and D. Kahneman. 1974. Judgment under uncertainty: Heuristics and biases. Science 185 (4157):1124–31.
  • United Kingdom, Department of Health. (2011). Governance Arrangements for Research Ethics Committees: A Harmonized Edition. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/213753/dh_133993.pdf. Accessed June 30, 2015.
  • Van Luijn, H. E., A. W. Musschenga, R. B. Keus, W. M. Robinson, and N. K. Aaronson. 2002. Assessment of the risk/benefit ratio of phase II cancer clinical trials by Institutional Review Board (IRB) members. Annals of Oncology 13 (8):1307–13.
  • Van Riel, P. (2014). Scientific reduction. Stanford Encyclopedia of Philosophy. http://plato.stanford.edu/entries/scientific-reduction/. Accessed September 21, 2015.
  • Weijer, C. 2000. The ethical analysis of risk. Journal of Law, Medicine & Ethics 28 (4):344–61.
  • Weijer, C., and P. B. Miller. 2004. When are research risks reasonable in relation to anticipated benefits? Nature Medicine 10 (6):570–73.
  • Weiss, P. A. 2011. Introductory Statistics, 9th ed. Upper Saddles River, NJ: Pearson.
  • Wendler, D., L. Belsky, K. M. Thompson, and E. J. Emanuel. 2005. Quantifying the federal minimal risk standard: Implications for pediatric research without a prospect of direct benefit. Journal of the American Medical Association 294 (7):826–32.
  • Wendler, D., and F. G. Miller. 2007. Assessing research risks systematically: The net risks test. Journal of Medical Ethics 33 (8):481–86.
  • Wertheimer, A. 2013. Is payment a benefit? Bioethics 27 (2):105–16.
  • Will, G. J., and E. T. Klapwijk. 2014. Neural systems involved in moral judgment and moral action. The Journal of Neuroscience 34 (32):10459–61.
  • World Medical Association. (2013). Declaration of Helsinki. http://www.wma.net/en/30publications/10policies/b3/index.html. Accessed June 27, 2015.
  • Zimbardo, P. 2008. The Lucifer effect: Understanding how good people turn evil. New York, NY: Random House.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.