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Acceptable Risk in Biomedical Research pp 91–101Cite as

How to Estimate Risks, Burdens, and Potential Benefits

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Part of the book series: International Library of Ethics, Law, and the New Medicine ((LIME,volume 50))

Abstract

Chapter 8 addresses the question of how to estimate and describe relevant risks, burdens and potential benefits. The delicate question is raised of who should decide what risks are great or small, and acceptable. Should it be the researcher him- or herself, the doctors, the REC, or should it be lay people, or the research participant him- or herself? This chapter also addresses the question of burden of proof. That is, who must document that the requirement of proportionality is fulfilled, and that the risk is acceptable? And who should have the benefit of the doubt? The dual requirements of minimizing risks and maximizing benefits are also addressed.

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Notes

  1. 1.

    See Chapter 7 for the explicit legal foundation.

  2. 2.

    See Section 2.3.

  3. 3.

    FDA (2009); See Tanne (2009).

  4. 4.

    Article 5 (f) of the Clinical Trials Directive: “clinical trials have been designed to minimise pain, discomfort,

    fear and any other foreseeable risk in relation to the disease and developmental stage; both the risk threshold

    and the degree of distress shall be specially defined and constantly monitored”.

  5. 5.

    See Section 5.3.2 where the reasonable person test is explained.

  6. 6.

    See Section 5.3 where researchers’ duty of care and the role of professional standards are explored.

  7. 7.

    Explanatory Report to Article 21 (2), Paragraph 116.

  8. 8.

    REC Middle Norway Case 4.2006.2737.

  9. 9.

    Weijer and Fuks (1994).

  10. 10.

    See Section 5.3.

  11. 11.

    Accounted for in Section 14.4.2.

  12. 12.

    Report on the Norwegian Meningococcal B Vaccine Trial (2007): Accounted for in Section 11.4.2.

  13. 13.

    The issue concerning liability for damages is discussed in Chapter 17 concerning legal effects of disproportionality.

  14. 14.

    Report on the Norwegian Meningococcal B Vaccine Trial (2007, pp. 163–168).

  15. 15.

    See, for example, The US National Bioethics Advisory Commission, Final report (2001, p. 71).

  16. 16.

    See, for example, Slovic (2000); Adams (2001); Nicholson (1986).

  17. 17.

    Meslin (1989).

  18. 18.

    Meslin (1989, p. 130).

  19. 19.

    See Section 5.3.2 and the statements in the Bolam Case (UK), the Bolitho Case (UK).

  20. 20.

    See Meslin (1989, pp 94–143) who gives a thoughtful and comprehensive account of the issue.

  21. 21.

    See for example Slovic (2000); Adams (2001).

  22. 22.

    Slovic (2000, p. Xxiii).

  23. 23.

    Slovic (2000).

  24. 24.

    See Section 5.4.2; see also Meslin (1989).

  25. 25.

    Slovic et al. (2004).

  26. 26.

    Slovic (2001, p. 17).

  27. 27.

    Slovic (2001, p. 17).

  28. 28.

    See also Meslin (1989, p. 101).

  29. 29.

    See Section 5.2 on the involved interests, and the legal instruments’ preferences.

  30. 30.

    See also Meslin (1989, pp. 94 et seq.).

  31. 31.

    In Meslin (1989, p. 110).

  32. 32.

    In Meslin (1989, p. 110).

  33. 33.

    Meslin (1989).

  34. 34.

    IRB Handbook (2009, chapter III.A).

  35. 35.

    See Chapter 5 for a detailed account of the purpose.

  36. 36.

    Rosenau (2000).

  37. 37.

    Bergkamp (2004).

  38. 38.

    See Section 5.2.5 where this principle is investigated.

References

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  1. Norwegian University of Science and Technology (NTNU), Royal Norwegian Air Force Academy, Pb. 4133, 7450, Trondheim, Norway

    Sigmund Simonsen (Dr. philos./Associate Professor)

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Simonsen, S. (2012). How to Estimate Risks, Burdens, and Potential Benefits. In: Acceptable Risk in Biomedical Research. International Library of Ethics, Law, and the New Medicine, vol 50. Springer, Dordrecht. https://doi.org/10.1007/978-94-007-2678-9_8

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  • DOI: https://doi.org/10.1007/978-94-007-2678-9_8

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