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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 1 presents the topic which is what level of risks and burdens is it acceptable to expose participants to in European biomedical research. The legal base for the requirement of proportionality between risks and benefits is presented, as well as what we know and what we do not about this requirement in European law. Lastly, the objectives and scope is outlined.

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Notes

  1. 1.

    See for example Beecher (1966); Pappworth (1967); Annas and Grodin (1995); Porter (1997); Moreno (2001); Ruyter (1997).

  2. 2.

    See Explanatory Report to the Additional Protocol, Paragraphs 1–2.

  3. 3.

    McLeod (2005, p. 89); See Statute of the Council of Europe of 1949.

  4. 4.

    Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine.

  5. 5.

    Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research.

  6. 6.

    Convention for the Protection of Human Rights and Fundamental Freedoms.

  7. 7.

    The Committee of Ministers authorised its publication on 30 June 2004. There is also an Explanatory Report to the Oviedo Convention.

  8. 8.

    McLeod (2005, pp. 68–69).

  9. 9.

    Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.

  10. 10.

    Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.

  11. 11.

    The provision is a restatement of Article 16 (ii) of the Oviedo Convention (with the addition of the word “burden”).

  12. 12.

    However, not all members of the CoE have ratified the Oviedo Convention, and even fewer, the Additional Protocol.

  13. 13.

    See Article 1 of the Oviedo Convention and Article 3 (1) of the Clinical Trials Directive.

  14. 14.

    Jebens (2004, pp. 41 et seq.). See also Judgement by the ECtHR in Handyside v. UK, A 24 1976.

  15. 15.

    See Article 249 of the EC Treaty and Article 1 of the Oviedo Convention.

  16. 16.

    See respectively the Health Research Act of 2008 § 22 (2), and Secondary legislation concerning clinical trials of 2003 § 1–5 (b).

  17. 17.

    See Simonsen (2011) on the feasibility and necessity of legal harmony and consistency in European Law.

  18. 18.

    See, for example, the Judgement by the ECtHR in Shtukaturov v. Russia, Judgment of 27 March 2008. See also Aall (2004) and Section 9.3.

  19. 19.

    See Simonsen and Nylenna (2006).

  20. 20.

    Simonsen and Nylenna (2006) where ten basic ethical, professional, and legal principles of biomedical research are identified.

  21. 21.

    See the Additional Protocol Article 13 and 14. Often the requirement of consent is called a requirement of “informed” consent. See Article 14 of the Additional Protocol. Article 2 (j) of the Clinical Trials Directive defines an “informed consent” (and valid) as: “‘informed consent’: decision, which must be written, dated and signed, to take part in a clinical trial, taken freely after being duly informed of its nature, significance, implications and risks and appropriately documented, by any person capable of giving consent or, where the person is not capable of giving consent, by his or her legal representative; if the person concerned is unable to write, oral consent in the presence of at least one witness may be given in exceptional cases, as provided for in national legislation.” The better formulation is, however, to speak about a requirement of “legally valid” consent, in which adequate information is but one central component, see Syse (2000). For simplistic reasons I speak about “the requirement of consent”.

  22. 22.

    See, for example, Bergkamp (2004) and Rosenau (2000).

  23. 23.

    IRB stands for Institutional Review Board, comparable with Research Ethics Committees (REC) found in most European countries.

  24. 24.

    The US National Bioethics Advisory Commission, Final Report (2001, p. 74).

  25. 25.

    See Chapter 4 that traces the origin of the requirement.

  26. 26.

    See Section 2.2 on the review of relevant literature.

  27. 27.

    Ellis (1999).

  28. 28.

    See, for example, Bergkamp (1989, 2004); Rosenau (2000); Lötjönen (2002).

  29. 29.

    See Westra et al. (2009) who identify inconsistency, but does not provide solutions, only some broad suggestions; see also de Bijl (2004).

  30. 30.

    See, for example, Weijer and Miller (2007); Miller and Brody (2007).

  31. 31.

    See Section 2.3.

  32. 32.

    The US National Bioethics Advisory Commission (2001, p. 71).

  33. 33.

    Lenk et al. (2004).

  34. 34.

    Respectively [Helseforskningsloven] § 22 (2) and (4); [Legemiddelutprøvingsforskriften] § 2–1.

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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). Introduction. 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_1

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  • DOI: https://doi.org/10.1007/978-94-007-2678-9_1

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