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

David B Resnik
Author Information
  1. David B Resnik: a National Institute of Environmental Health Sciences, National Institutes of Health , Research Triangle Park , North Carolina , USA.

Abstract

One of the key principles of ethical research involving human subjects is that the risks of research to should be acceptable in relation to expected benefits. Institutional review board (IRB) members often rely on intuition to make risk/benefit decisions concerning proposed human studies. Some have objected to using intuition to make these decisions because intuition is unreliable and biased and lacks transparency. In this article, I examine the role of intuition in IRB risk/benefit decision-making and argue that there are practical and philosophical limits to our ability to reduce our reliance on intuition in this process. The fact that IRB risk/benefit decision-making involves intuition need not imply that it is hopelessly subjective or biased, however, since there are strategies that IRBs can employ to improve their decisions, such as using empirical data to estimate the probability of potential harms and benefits, developing classification systems to guide the evaluation of harms and benefits, and engaging in moral reasoning concerning the acceptability of risks.

Keywords

References

  1. Account Res. 2010 Jul;17(4):198-210 [PMID: 20597018]
  2. JAMA. 2000 May 24-31;283(20):2701-11 [PMID: 10819955]
  3. J Law Med Ethics. 2000 Winter;28(4):344-61 [PMID: 11317427]
  4. JAMA. 2004 Jan 28;291(4):476-82 [PMID: 14747505]
  5. J Empir Res Hum Res Ethics. 2011 Jun;6(2):31-46 [PMID: 21680975]
  6. J Med Ethics. 2007 Aug;33(8):481-6 [PMID: 17664310]
  7. Ann Oncol. 2002 Aug;13(8):1307-13 [PMID: 12181256]
  8. Theor Med Bioeth. 1998 Dec;19(6):509-24 [PMID: 10051788]
  9. IRB. 2006 Jul-Aug;28(4):1-7 [PMID: 17036432]
  10. J Med Ethics. 2016 Jan;42(1):50-3 [PMID: 26463620]
  11. Milbank Q. 2011 Dec;89(4):599-627 [PMID: 22188349]
  12. Bull Med Ethics. 2002 Oct;(182):17-23 [PMID: 14983848]
  13. JAMA. 2010 Oct 6;304(13):1472-9 [PMID: 20924013]
  14. Psychol Sci. 2012 Jul 1;23(7):788-95 [PMID: 22636202]
  15. Drug Discov Today. 2012 Dec;17(23-24):1263-9 [PMID: 22819925]
  16. Theor Med Bioeth. 2012 Apr;33(2):137-49 [PMID: 22198413]
  17. JAMA. 2005 Aug 17;294(7):826-32 [PMID: 16106008]
  18. Nat Med. 2004 Jun;10(6):570-3 [PMID: 15170195]
  19. Kennedy Inst Ethics J. 2004 Dec;14 (4):369-93 [PMID: 15812985]
  20. Science. 1974 Sep 27;185(4157):1124-31 [PMID: 17835457]
  21. IRB. 1990 Jan-Feb;12(1):7-10 [PMID: 11651973]
  22. J Neurosci. 2014 Aug 6;34(32):10459-61 [PMID: 25100580]
  23. J Med Philos. 2000 Jun;25(3):323-41 [PMID: 10852337]
  24. Account Res. 2007 Jul-Sep;14(3):179-96 [PMID: 17877107]
  25. Psychol Rev. 2003 Jan;110(1):193-6; discussion 197-8 [PMID: 12529062]
  26. IRB. 1995 Mar-Apr;17 (2):8-10 [PMID: 11653055]
  27. Science. 2007 May 18;316(5827):998-1002 [PMID: 17510357]
  28. Stat Med. 2006 Sep 15;25(17):2869-85 [PMID: 16810711]
  29. J Med Ethics. 2012 Jul;38(7):423-7 [PMID: 22367000]
  30. Psychol Sci. 2006 Dec;17 (12 ):1082-9 [PMID: 17201791]
  31. J Med Philos. 2000 Jun;25(3):285-307 [PMID: 10852336]
  32. Science. 2001 Sep 14;293(5537):2105-8 [PMID: 11557895]
  33. J Med Philos. 2000 Jun;25(3):271-84 [PMID: 10852335]
  34. Control Clin Trials. 1994 Feb;15(1):30-43 [PMID: 7908619]
  35. Med Health Care Philos. 2001;4(3):277-88 [PMID: 11760227]
  36. J Med Ethics. 2009 Jul;35(7):445-9 [PMID: 19567696]
  37. Kennedy Inst Ethics J. 2011 Jun;21(2):141-79 [PMID: 21696094]
  38. Bioethics. 2013 Feb;27(2):105-16 [PMID: 21726261]
  39. BMC Med Ethics. 2012 Apr 20;13:6 [PMID: 22520714]
  40. Psychol Rev. 2001 Oct;108(4):814-34 [PMID: 11699120]
  41. Health Serv Res. 2006 Feb;41(1):214-30 [PMID: 16430608]
  42. J Law Med Ethics. 2004 Summer;32(2):338-48, 192 [PMID: 15301198]

Grants

  1. ZIA ES102646-01/Intramural NIH HHS

MeSH Term

Biomedical Research
Decision Making
Ethics Committees, Research
Humans
Intuition
Probability
Research Subjects
Risk Assessment

Word Cloud

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