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Initial Conceptual Clarifications

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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

In Chapter 3 central concepts are discussed, analyzed and defined. These being “risk”, “burden and inconvenience”, “potential (anticipated) benefit”, “direct benefit”, “therapeutic research and non-therapeutic research”, and “vulnerable person”. Included is also a glossary for further conceptual clarifications.

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Notes

  1. 1.

    See Meslin (1989, pp. 14–75), who has a more detailed (philosophical) discussion of this subject.

  2. 2.

    Oxford Advanced Dictionary (1990, p. 1093).

  3. 3.

    BMJ Living with (Risk 1987, p. 13).

  4. 4.

    p. 17.

  5. 5.

    The WMA Medical Ethics Manual (2009, p. 104).

  6. 6.

    The US Belmont Report 1979 Part C.2.

  7. 7.

    The US Federal law 45CFR46 §46.102 (i).

  8. 8.

    Oxford Advanced Dictionary (1990, p. 1093).

  9. 9.

    The Meningococcal B Vaccine Trial is accounted for in Sections 11.3. and 11.4.

  10. 10.

    The researchers risk report in the Meningococcal B Vaccine Trial, see Report on the Norwegian Meningococcal B Vaccine Trial (2007, pp. 53–62).

  11. 11.

    Clinical Trials Directive Article 2 (m): “‘adverse event’: any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment”.

  12. 12.

    See the Additional Protocol Article 31 and Chapter 17 of this book. The legal liability for damages may vary among jurisdictions.

  13. 13.

    On the issue of foreseeability and causation see Chapter 7.

  14. 14.

    The Obesity Study is accounted for in Section 10.3.

  15. 15.

    US Federal law 45CFR46 § 46.102 (i).

  16. 16.

    See Part III and Chapter 10.

  17. 17.

    The Oxford Advanced Dictionary (1990, p. 100).

  18. 18.

    See Section 5.2 where possible interests and stakeholders are explored.

  19. 19.

    See Part III.

  20. 20.

    See US Federal law 45 CFR 46.

  21. 21.

    See Part III.

  22. 22.

    Accounted for in Section 10.3.

  23. 23.

    Accounted for in Sections 11.3 and 11.4.

  24. 24.

    Lötjönen (2002, p. 186).

  25. 25.

    The US National Bioethics Advisory Commission (2001, p. 73).

  26. 26.

    The US National Bioethics Advisory Commission (2001, pp. 73–74).

  27. 27.

    Lötjönen (2002, p. 186).

  28. 28.

    These issues are further pursued in other parts of this book.

  29. 29.

    These issues are further pursued in Part II of this book on causality and relevancy.

  30. 30.

    See Chapter 5 of this book.

  31. 31.

    See Section 3.6 on the concept of “direct benefit”.

  32. 32.

    See The US National Bioethics Advisory Commission (2001, pp. 76–80) who, in my opinion, unsuccessfully pursues this approach.

  33. 33.

    See Section 14.5.

  34. 34.

    See also Article 12 of the Additional Protocol, which also uses the concept.

  35. 35.

    See Chapter 4.

  36. 36.

    The implications of vulnerability in the assessment of proportionality are investigated in Chapter 12.

  37. 37.

    Paragraph 68; See the US National Bioethics Advisory Commission (2001, p. 85) which appear to be the origin of the statement in the Explanatory Report.

  38. 38.

    See Article 15 of the Additional Protocol and Articles 4 and 5 of the Clinical Trials Directive, see Part VII; this was also the conclusion reached by Anne Gammelgaard and colleagues in their investigations of the consent process involving acute patients with a serious disease (Gammelgaard 2003).

  39. 39.

    See Section 8.4.

  40. 40.

    Explanatory Report Paragraph 110.

  41. 41.

    Explanatory Report Paragraph 110.

  42. 42.

    Explanatory Report Paragraph 111.

  43. 43.

    Explanatory Report Paragraph 111.

  44. 44.

    ICH GCP section 1.61.

  45. 45.

    Paragraphs 65–69.

  46. 46.

    Paragraph 69.

  47. 47.

    The US National Bioethics Advisory Commission (2001, pp. 85 et seq.); Kipnis (2001).

  48. 48.

    Explanatory Report, Paragraph 69.

  49. 49.

    Explanatory Report, Paragraph 69.

  50. 50.

    See Chapter 4 and, for example, the US Advisory Committee on Human Radiation Experiments (1995); Ruyter (1997).

  51. 51.

    Explanatory Report, Paragraph 69.

  52. 52.

    Beecher (1966).

  53. 53.

    Explanatory Report, Paragraph 69.

  54. 54.

    The issue is not pursued here, because it refers more to the requirement of a “free” consent. In Norway, research ethics committees have a strict practice, while the practice appears to be more liberal in the UK. Nevertheless, payment cannot be considered a relevant benefit in the assessment of proportionality.

  55. 55.

    Explanatory Report, Paragraph 69.

  56. 56.

    In Paragraph 70 of the Explanatory Report examples of undue influence are offered, such as “veiled threats to deny access to services to which the person would otherwise be entitled, the insinuation of looking favourably on academic work to be submitted in the future, veiled threats of punishment that the person would otherwise receive or that refusal will diminish the likelihood of career advancement, or the offer of amounts of money large enough to influence the giving or denial of consent.”

  57. 57.

    Paragraph 70.

  58. 58.

    See Section 5.3 concerning researchers’ duty of care and Part III concerning the assessment of proportionality, and the implications of vulnerability in Chapter 12.

  59. 59.

    The US Advisory Committee on Human Radiation Experiment, Final Report, Chapter 2.

  60. 60.

    The US Advisory Committee on Human Radiation Experiment, Final Report, Chapter 2.

  61. 61.

    The US Advisory Committee on Human Radiation Experiment, Final Report, Chapter 2.

  62. 62.

    But not all patients are “vulnerable persons”. Neither are all patients necessarily less able to protect their own interests and carry risks for the sake of others than “healthy volunteers”, see above.

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). Initial Conceptual Clarifications. 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_3

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