Abstract
Chapter 7 clarifies relevant risks, burdens and potential benefits in the assessment of the proportionality. The grey zone between clinical interventions, clinical intervention combined with research interventions, and solely research interventions is investigated. That risk, burdens or potential benefit is relevant means that it is generally legally, permissible, and maybe also obligatory to take it into account in the assessment of proportionality.
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Notes
- 1.
Similar Eckhoff (revised by Helgesen) (2001, p. 25), and Nygaard (2004, p. 111), in relation to general legal method.
- 2.
This starting point is natural and follows from general legal principles on causality, see Nygaard (2002) with further references to Norwegian case-law. In US Federal law this is stated explicitly in the “Common Rule” “46.111: In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research).”
- 3.
The European Group on Tort Law, which has drafted Principles of European Tort Law intended to express common legal principles. Article 3:101.
- 4.
I mention this as it is a condition for liability on a no-fault basis in Norwegian Tort law, cf. Rt.1960.841 “Vaccine judgment” where the Norwegian Supreme Court found that risks of vaccination was extraordinary (although remote) and something individuals was not exposed to in daily life. Moreover, vaccination was undertaken in the interest of society: In Rt. 1960.429 “Tuberculoses Judgment No. I”, the result was opposite as the risk of being infected with tuberculosis was just as high in the civil society as it was in the army (a recruit had sued the Army because he had been infected with tuberculosis). The risk was therefore not extraordinary in the latter case; see further Kjønstad (2005a, pp. 110 et seq); Simonsen and Nylenna (2005, pp. 287–302).
- 5.
European Group on Tort Law. Article 3:103 (1).
- 6.
Harpwood (2005).
- 7.
Cf. Rt. 1960.841 Norwegian Supreme Court, the Vaccine Judgement.
- 8.
See Section 2.3.
- 9.
REC meeting 21 February 2008.
- 10.
The National Committee overruled the REC decision; but this may have been for other reasons (an overall judgement) which also were discussed in that case.
- 11.
See, for example, Rt. 1992 p. 64 The Norwegian Supreme Court in the second contraceptive pill judgment, and Rt. 1997 p. 1 the Rossnes judgment; see Kjelland (2008) for an in-dept account of the “vulnerability-principle” in Norwegian Tort Law.
- 12.
See Part III where the acceptable risk is sought clarified and calculated.
- 13.
Accounted for in Section 12.5.8.
- 14.
Article 3 (2) (a).
- 15.
In Norwegian Tort law the risks would be typical [“særegen”] and common [“stadig”], see Rt. 1905.715 the Norwegian Supreme Court in the Water drain judgment, and Rt. 1960.841 the Vaccine judgment.
- 16.
Hagstrøm (1985) on explaining harms covered by a no-fault responsibility.
- 17.
Accounted for in Sections 11.3 and 11.4.
- 18.
Guidelines on Paediatric Research 2008.
- 19.
See Section 9.5 on the requirement of necessity.
- 20.
References
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Hagstrøm, V. 1985. Culpanormen. Oslo: Aschehoug.
Harpwood, V. 2005. Modern Tort law. London: Routledge-Cavendish.
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Simonsen, S. (2012). Which Risks, Burdens and Potential Benefits Are Relevant?. 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_7
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