Abstract
Chapter 9 is an introductory chapter to the complex assessment of proportionality investigated in the subsequent chapters. This chapter addresses the wording of the relevant legal instruments, and the requirement’s core content. The question is what the differences in wording imply. Do the expression of the requirement of proportionality in different legal instruments with different wording, mean that they are different norms with a differing normative content? The difference between therapeutic research and non-therapeutic research, and between research on participants able to consent and participants not able to content, is also discussed, as this is of importance for the systematic of the subsequent analysis the more concrete level of acceptable risk.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Notes
- 1.
The provision is a restatement of Article 16 (ii) of the Oviedo Convention. The corresponding provisions in Norwegian law are § 22 (2) of the Health Research Act of 2008 § 22 (2), and § 2-1 of the Secondary legislation concerning clinical trials of 2009.
- 2.
See Vienna Convention Article 31; see also Judgement by the ECtHR in Johnston v. Ireland, A 112 1986.
- 3.
Fourth edition, 1989, p. 348.
- 4.
The treaty and directive texts in other languages, for example, French, could have been checked for significant linguistic nuances, but has not been undertaken as it is unlikely that it would have revealed significant nuances.
- 5.
Fourth edition, 1989, p. 680.
- 6.
Fourth edition, 1989, p. 1001.
- 7.
Draft Article 3 (2).
- 8.
See Chapter 4 for wording and an account of the development.
- 9.
General Convention law and Community law are used in contrast to Convention law and Community law in this particular legal field; the field of biomedical research. See Chapter 10 where it is showed that the Norwegian Health Research Act § 22 (2) (2) uses this language; see also Rasmussen (1995) and Graver (2002).
- 10.
The wording “fair balance” is also occasionally used by the European Court of Human Rights when there is a reasonable relationship between legitimate but conflicting interests, typically between the individual and the society at large. See, for example, the Case of Saadi v. The United Kingdom (Judgement by the ECtHR of 29. January 2008).
- 11.
Preparatory works to the other provisions have not been available.
- 12.
See Wicker (2006, pp. 81et seq.).
- 13.
See Wicker (2006, pp. 81et seq.).
- 14.
See Section 8.4.
- 15.
Bergkamp (2004).
- 16.
See Section 8.4 where this issue is addressed.
- 17.
Explanatory Report to Article 6 of the Protocol, Paragraphs 25–27. See Section 3.4 for the definition.
- 18.
Paragraph 27.
- 19.
Article 6 (1) of the Additional Protocol and Article 3 (2) (a) of the Clinical Trials Directive; Article 15 (1) which regulate therapeutic research on persons able to consent is “silent” on the level of acceptable risks and burdens, which implies that the “general” requirement of proportionality apply. Thus the category could have been split up in two categories, but since the “rule” is the same they are treated simultaneously, see, however, Section 10.3.5 where the “differences” are addressed, see also Section 9.3.2.
- 20.
Article 6 (2) (1) of the Additional Protocol, cf. Article 3 (2) (a) of the Clinical Trials Directive.
- 21.
Article 6 (2) (2), cf. Articles 15–20 of the Additional Protocol and Articles 4 and 5 of the Clinical Trials Directive.
- 22.
See Chapter 5.
- 23.
See Chapters 11 and 12 respectively; The same will then also apply to Norwegian secondary legislation concerning clinical trials § 2-1. But this provisions must also be interpreted in light of and in harmony with § 22 (2) of the Health Research Act.
- 24.
See Section 10.3.8 where the reason for this position is further elaborated.
- 25.
See further Chapter 11.
- 26.
Addressed in Section 10.3.6.
- 27.
See Section 5.2.
- 28.
These provisions are further investigated below in Chapter 12.
- 29.
Paragraph 87 [italics added].
- 30.
Nontherapeutic research on children and adult persons not able to consent is analysed in Chapter 19.
- 31.
The same is clear in Norwegian law, see Norwegian Health Research Act § 18, and Norwegian secondary legislation concerning clinical trials § 2-8 and § 2-9; see Chapter 12.
- 32.
Investigated in Section 5.2.5.
- 33.
See Bergkamp (2004) who seem to promote this perspective.
- 34.
Cf. Section 5.3; See Preamble of the Additional Protocol, cited in Section 5.2.4 and Article 23 (1) in the Additional Protocol, discussed in Chapter 13.
- 35.
There are, however, differences. These are investigated in Section 10.3, see in particular Section 10.3.7.
- 36.
Paternalism refers to situations where the physician or a governmental agency (fatherly) takes choices for the individual, and thus limits the individual’s self-determination. Physician paternalism has been prevalent in clinical practice (also research), see Chapter 4. Paternalism is nowadays largely replaced by patients and research subjects’ right to self-determination and a fundamental requirement of informed consent; see the Oviedo Convention Article 5.
- 37.
These are investigated in Section 10.3, see in particular Section 10.3.7.
- 38.
Explanatory Report to Article 6 of the Protocol, Paragraphs 25–27.
- 39.
See Section 5.2.
- 40.
Article 6 (1) of the Additional Protocol and Article 3 (2) (a) of the Clinical Trials Directive; Article 15 (1) which regulate therapeutic research on persons able to consent is “silent” on the level of acceptable risks and burdens, which implies that the “general” requirement of proportionality apply. Thus the category could have been split up in two categories, but since the “rule” is the same they are treated simultaneously, see, however, Section 10.3.5 where the “differences” are addressed, see also Section 9.3.2.
- 41.
Article 6 (2) (1) of the Additional Protocol, cf. Article 3 (2) (a) of the Clinical Trials Directive.
- 42.
Article 6 (2) (2), cf. Articles 15–20 of the Additional Protocol and Articles 4 and 5 of the Clinical Trials Directive.
References
Bergkamp, L. 2004. Medical research involving human beings: Some reflections on the main principles of the international regulatory instruments. European Journal of Health Law 11:61–69.
Graver, H.P. 2002. Alminnelig forvaltningsrett. Oslo: Universitetsforlaget.
Wicker, C. 2006. The concepts of proportionality and state crimes in international law: An analysis of the scope of proportionality in the right of self-defence and in the regime of international countermeasures and an evaluation of the concept of state crimes. Frankfurt am Main: Peter Lang.
Rasmussen, Ø. 1995. Forholdsmessighetsprinsippet i forvaltningsretten. Lov og Rett. 307–322.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
Copyright information
© 2012 Springer Science+Business Media B.V.
About this chapter
Cite this chapter
Simonsen, S. (2012). The Requirement of Proportionality – Initial 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_9
Download citation
DOI: https://doi.org/10.1007/978-94-007-2678-9_9
Published:
Publisher Name: Springer, Dordrecht
Print ISBN: 978-94-007-2677-2
Online ISBN: 978-94-007-2678-9
eBook Packages: MedicineMedicine (R0)