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Legal Effects of the Requirement of Proportionality

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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 17 addresses the legal effects of the requirement of proportionality. The outline is brief as the exact legal effects usually depend on domestic legislation. The question is legal effects are at hand when there is a disproportionate relationship between risks, burdens and potential benefits in biomedical research? Several possible consequences are outlined, such as breach of researchers duty of care and the responsibility for negligence, compensation for damage, criminal liability and prosecution. Does disproportionate risks and inadequate information about risks and benefits make the consent invalid?

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Notes

  1. 1.

    Cf. Section 5.4; see Grimes v. Kennedy, accounted for in Section 12.5.10.

  2. 2.

    This principle has, at least, a firm basis in Norwegian Health Law, see the Norwegian Health Personnel Act § 4 and § 16; Kjønstad (2005a, p. 314).

  3. 3.

    Accounted for in Section 12.5.10.

  4. 4.

    This view was taken by the Court in Grimes v. Kennedy (see Section 12.5.10), and the same legal solution is highly probable in European law, at least, in Norwegian law.

  5. 5.

    Compare the CIOMS Guideline 19; Legal liability on a no-fault basis must be regarded as the general rule in Norwegian law, see Simonsen (2010a, b) in relation to the Norwegian Health Research Act § 51.

  6. 6.

    On “assult” in Norwegian Health law see Aasen (2000, pp. 290 et seq.).

References

  • Aasen, H.S. 2000. Pasientens rett til selvbestemmelse ved medisinsk behandling. Bergen: Fagbokforlaget.

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  • Kjønstad, A. 2005a. Helserett. Oslo: Gyldendal.

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  • Simonsen, S. 2010a. Kommentarer til helseforskningsloven. I: Norsk Lovkommentar. Publisert som del i oppslagsverk i bokform og som betalingstjeneste på internett. Også publisert som eget særtrykk. Gyldendal Rettsdata.

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  • Simonsen, S. 2010b. Erstatning for forskningsskader. Tidsskrift for Erstatningsrett.

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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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  1. Sigmund Simonsen
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Correspondence to Sigmund Simonsen .

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© 2012 Springer Science+Business Media B.V.

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Simonsen, S. (2012). Legal Effects of the Requirement of Proportionality. 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_17

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  • DOI: https://doi.org/10.1007/978-94-007-2678-9_17

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  • Publisher Name: Springer, Dordrecht

  • Print ISBN: 978-94-007-2677-2

  • Online ISBN: 978-94-007-2678-9

  • eBook Packages: MedicineMedicine (R0)

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