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The Upper Limits of Pain and Suffering in Animal Research: A Moral Assessment of the European Union’s Legislative Framework

  • TOM L. BEAUCHAMP and DAVID B. MORTON

Abstract:

The control of risk and harm in human research often calls for the establishment of upper limits of risk of pain, suffering, and distress that investigators must not exceed. Such upper limits are uncommon in animal research, in which limits of acceptability are usually left to the discretion of individual investigators, institutions, national inspectors, or ethics review committees. We here assess the merits of the European Directive 2010/63/EU on the Protection of Animals Used for Scientific Purposes and its accompanying instruments, such as guides and examples. These documents present a body of legislation governing animal research in the European Union. We argue that the directive supplies a promising approach, but one in need of revision. We interpret the directive’s general conception of upper limits and show its promise for the establishment of high-quality policies. We provide a moral rationale for such policies, address the problem of justified exceptions to established upper limits, and show when causing harm is and is not wrongful. We conclude that if the standards we propose for improving the directive are not realized in the review of research protocols, loose and prejudicial risk-benefit assessments may continue to be deemed sufficient to justify morally questionable research. However, a revised EU directive and accompanying instruments could have a substantial influence on the ethics of animal research worldwide, especially in the development of morally sound legal frameworks.

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Notes

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3. United States Code of Federal Regulations, at 45 CFR 46 Subpart D (§46.404 and §46.406), contains an influential regulation governing nontherapeutic research involving children that limits risk to a “minor increase over minimal risk.”

4. National Human Research Protections Advisory Committee (NHRPAC). Clarifying a specific portion of 45 CFR 46 subpart D that governs children’s research; available at http://ctep.cancer.gov/investigatorResources/childhood_cancer/docs/nhrpac16.pdf (last accessed 7 Oct 2014).

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6. Binik, A. Why the debate over minimal risk needs to be reconsidered. Journal of Medicine and Philosophy 2014;39:387405.

7. Directive 2010/63/EU on the Protection of Animals Used for Scientific Purposes. Official Journal of the European Union L 276/33; adopted 2010 Sept 22; available at http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32010L0063 (last accessed 26 Dec 2014). Quotations from this directive, as presented herein, often have italics added for emphasis.

8. European Commission. Applying EU law. The European Commission at Work; available at http://ec.europa.eu/atwork/applying-eu-law/index_en.htm; see also http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:12012E/TXT (both last accessed 19 Feb 2015).

9. National Competent Authorities for the Implementation of Directive 2010/63/EU on the Protection of Animals Used for Scientific Purposes. Working Document on Project Evaluation and Retrospective Assessment. Brussels; 2013 Sept 18–19; available at http://ec.europa.eu/environment/chemicals/lab_animals/pdf/Endorsed_PE-RA.pdf (last accessed 19 Feb 2015).

10. Lov om Dyreforsøg [Act on Animal Testing, Animal Studies]; available at https://www.retsinformation.dk/Forms/R0710.aspx?id=162938 (last accessed 11 Jan 2015). See §7 stk 4 (Article 7, point 4).

12. National Competent Authorities for the Implementation of Directive 2010/63/EU on the Protection of Animals Used for Scientific Purposes. Working Document on a Severity Assessment Framework. Brussels; 2012 July 11–12; available at http://ec.europa.eu/environment/chemicals/lab_animals/pdf/Endorsed_Severity_Assessment.pdf (last accessed 28 Jul 2015); accompanying examples available at http://ec.europa.eu/environment/chemicals/lab_animals/pdf/examples.pdf (last accessed 28 Jul 2015).

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15. See, for example, Australian Government, National Health and Medical Research Council. Australian Code for the Care and Use of Animals for Scientific Purposes. 8th ed. Canberra: National Health and Medical Research Council; 2013. This Australian code sets no upper limit, but it consistently demands that researchers minimize pain and distress.

16. Meisel, A. The “exceptions” to the informed consent doctrine: Striking a balance between competing values in medical decisionmaking. Wisconsin Law Review 1979;1979:413–88.

17. Committee on the Use of Chimpanzees in Biomedical and Behavioral Research, Institute of Medicine. Chimpanzees in Biomedical and Behavioral Research: Assessing the Necessity. Washington, DC: National Academies Press; 2011; available at http://iom.edu/∼/media/Files/Report%20Files/2011/Chimpanzees/chimpanzeereportbrief.pdf (last accessed 25 Dec 2014).

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19. Feinberg, J. The Moral Limits of the Criminal Law, Vol. 3: Harm to Self. New York: Oxford University Press; 1986.

We are indebted to David DeGrazia, David Lamb, James Yeates, John Gluck, Hope Ferdowsian, Lise Bitsch, Mette Ebbesen, and Penny Hawkins for critical assessments of this article.

Keywords

The Upper Limits of Pain and Suffering in Animal Research: A Moral Assessment of the European Union’s Legislative Framework

  • TOM L. BEAUCHAMP and DAVID B. MORTON

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