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Nontherapeutic Research

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Acceptable Risk in Biomedical Research

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

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Abstract

Chapter 11 addresses what level of risks and burdens is acceptable when the research participant may not expect any direct health benefits (nontherapeutic research). The question is, in other words, what level of risks a person may consent to being exposed to for the sake of others. First and foremost, this includes research on healthy volunteers, but patients may also be included in such research. The weighing of potential benefits to others, as well as the assessment of risks, from high-risk trials (phase I) to more ordinary trials are investigated, including in so called self-experimentation. In this chapter, the level of acceptable risks and burdens is also attempted quantified, offering examples from other writers as well as existing guidelines. A central question is whether there are limits as to what level of risk a healthy volunteer may consent to.

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Notes

  1. 1.

    See Chapter 9; nontherapeutic research and therapeutic research are defined in Section 3.7.

  2. 2.

    Nontherapeutic research is defined in Section 3.7.

  3. 3.

    These concepts are defined in Chapter 3.

  4. 4.

    Bergkamp (2004, p. 66).

  5. 5.

    See Section 5.4.

  6. 6.

    Accounted for in Section 12.5.10 – although this is a US judgment, the result would most probably be the same in a European court.

  7. 7.

    Cited and discussed in Section 9.3.1.

  8. 8.

    See Section 5.4.3.

  9. 9.

    See Section 5.4.3.

  10. 10.

    Cf. Section 5.2.

  11. 11.

    See also Section 5.4.3 where this argumentation is addressed in full. See also Section 4.5.3 on the historical background of the requirement of REC review.

  12. 12.

    Rajczi (2004, p. 339).

  13. 13.

    REC Middle Norway 4.2007.1954

  14. 14.

    Belmont Report (1979, section C.2).

  15. 15.

    This is explicitly required in Article 3 (2) (a) of the Clinical Trials Directive, see also the Norwegian Health Research Act § 22 (2), first sentence. This is implied in Article 6 of the Additional Protocol; see the appendix to the Protocol; This issue was also partly addressed in Chapter 7.

  16. 16.

    See also Chapter 17 where the legal effects of disproportionality are outlined.

  17. 17.

    Accounted for in Section 11.3.

  18. 18.

    Report on the Norwegian Meningococcal B Vaccine Trial (2007) (which I co-authored).

  19. 19.

    See below in Sections 11.4.2 and 11.4.4 where the development of the trial, including the risks and burdens of the trial are investigated.

  20. 20.

    See Getz et al. (2008).

  21. 21.

    Paragraph 37.

  22. 22.

    Paragraph 37 of the Explanatory Report.

  23. 23.

    NOU (2005:1, chapter 25); Ot.prp. nr. 74 ((2006–2007), section 10.4).

  24. 24.

    Lund (2006).

  25. 25.

    Those two are the top European journals; the two top American journals, the New England Journal of Medicine and the Journal of the American Medical Association (JAMA), may also be mentioned.

  26. 26.

    See Section 9.5 on the requirement of lesser mean.

  27. 27.

    Kenter and Choen (2006).

  28. 28.

    Kenter and Choen (2006).

  29. 29.

    See Steinbrook (2002).

  30. 30.

    See the definition of “direct benefit” in Section 3.6.

  31. 31.

    See, amongst others, Article 6 (2) of the Additional Protocol and the Preamble of the Clinical Trials Directive.

  32. 32.

    Report on the Norwegian Meningococcal B Vaccine Trial (2007).

  33. 33.

    Ruyter (2003a).

  34. 34.

    Cited in Jonsen (1989); See Section 4.3 on the Nuremberg Doctors Trial.

  35. 35.

    Davis (2003).

  36. 36.

    See the discussion on individual autonomy in Section 5.4.3.

  37. 37.

    See Chapter 12.

  38. 38.

    Jonsen (1989). Jonsen is a Catholic priest with a doctorate in religious studies. Jonsen took part in the preparation of the Belmont report and was one of the first bioethicsts appointed to a medical faculty in the US.

  39. 39.

    Jonsen (1989, p. 207).

  40. 40.

    Jonsen (1989, p. 207) [My emphasis].

  41. 41.

    US National Digestive Diseases Information Clearinghouse a NIH (2009).

  42. 42.

    Zaman et al. (2008).

  43. 43.

    See Section 5.4.3.

  44. 44.

    AdventureStats.com (2009).

  45. 45.

    Skandia insurance company, cited in Meslin (1989, p. 326). Note that code 4, 6, 7, and 9, for unknown reasons, is nonexisting.

  46. 46.

    Accounted for in Section 10.2.

  47. 47.

    The legal basis discussed is (still) Article 6 of the Additional Protocol, and Article 3 (2) (a) of the Clinical Trials Directive, cf. Section 11.1.

  48. 48.

    See below on “the no harm rule”.

  49. 49.

    Patient.UK (2009).

  50. 50.

    See Chapter 9 on the direct benefit rule.

  51. 51.

    See the Article 5 of the Additional Protocol and Article 2 (1) of the GCP Directive.

  52. 52.

    TV2 news 03.12.08.

  53. 53.

    The Norwegian Institute of Public Health (2008a).

  54. 54.

    BMJ Living with risk (1987, p.123).

  55. 55.

    BMJ Living with risk (1987, p.124).

  56. 56.

    BMJ Living with risk (1987, p. 124).

  57. 57.

    Cf. Section 11.1.

  58. 58.

    Report on the Norwegian Meningococcal B Vaccine Trial (2007).

  59. 59.

    See the next chapter.

  60. 60.

    Report on the Norwegian Meningococcal B Vaccine Trial (2007).

  61. 61.

    See also the BMJ Report, Living with risk, which also holds that “safe” usually is understood as zero-risk, and therefore should be avoided as nothing is risk free. The researchers, on the other hand, claimed that “safe” meant “safe enough”, i.e. that the risks were minimal and therefore acceptable and (almost) neglectable.

  62. 62.

    See Jørstad and Kjønniksen (2008).

  63. 63.

    Article 6 (2), first sentence, of the Additional Protocol.

  64. 64.

    Jardine et al. (2003).

  65. 65.

    See Chapter 12; see also Maar (2007, pp. 400–405).

  66. 66.

    Cf. Section 4.3.

  67. 67.

    Cf. Section 4.3 and Chapter 12.

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Authors and Affiliations

  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). Nontherapeutic Research. 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_11

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  • DOI: https://doi.org/10.1007/978-94-007-2678-9_11

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