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The Admissibility of Research in Emergency Medicine

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Abstract

The main goal in this paper is to present the legal rules connected with medical experiment on human beings in emergency medicine and to explain the scope, significance, and meaning of these rules, especially with regard to their interpretation. As the provisions about medical experiments truly make sense only if they can be observed by the whole “civilised” international community, they are presented in the context of international law with reference to Polish law. By considering the appropriate regulations of research contained in legal documents, it is possible to formulate a catalogue of doctors’ duties and patients’ rights. This general catalogue refers to all kinds of medical research involving human beings. In the field of emergency medicine, general provisions are sometimes involved, and they are sometimes limited. The main and most important conclusion is that a medical experiment in emergency medicine is admissible only if previously indicated conditions based on general rules of conducting research are fulfilled.

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Notes

  1. About individual’s autonomy, see also: Naess et al. [1].

  2. About the Nuremberg Trials and the judgement see: Trial of War Criminals before the Nuremberg Military Tribunals under Control Council Law No.10 Nuremberg [2], or Cyprian and Sawicki [3] or Glueck [4].

  3. As it is stressed in the Explanatory Report on the Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine, the term “intervention” must be understood in a broad sense. It covers all medical acts (author’s own emphasis) in particular interventions performed for the purpose of preventive care, diagnosis, treatment or rehabilitation or in a research context (Par. 29), http://www.conventions.coe.int/Treaty/en/Reports/Html/164.htm

  4. See for example: Kornas [6], Giesen [7], Levine [8].

  5. http://www.en.wikipedia.org/wiki/Emergency-medicine, 27th June 2006.

  6. In this paper, “narrow meaning” means the provisions of hard law as opposed to soft law. This division is accepted in the theory of international law and, very briefly, the difference lies in the binding of a law. The notion of soft law as a phenomenon in international relations covers all those social rules generated by States or other subjects of international law which are not legally binding but which are nevertheless of special legal relevance (Bernhardt [9]). See for example: Bierzanek [10], or Boyle [11].

  7. English text on the Council’s of Europe web site: http://www.conventions.coe.int/Treaty/en/Treaties/Word/164.doc—19th May 2006.

  8. Vienna Convention on the Law of Treaties [12].

  9. Council of Europe: http://www.coe.int/T/E/Legal%5Faffairs/Legal%5Fco%2Doperation/Bioethics—19th May 2006.

  10. English version on the Council’s of Europe web site: http://www.coe.int/t/e/legal_affairs/legal_co-operation/bioethics/activities/biomedical_research/195%20Protocole%20recherche%20biomedicale%20e.pdf

  11. Council of Europe: http://www.coe.int/T/E/Legal_Affairs/Legal_co-operation/Bioethics/Activities/Biomedical_research/Protocol_intro.asp#TopOfPage—19th May 2006.

  12. Official Journal L 121, 01/05/2001: 0034–0044 [13].

  13. Barcz and Michoński [14].

  14. See also: Wnukiewicz-Kozłowska [15].

  15. Journal of Laws No. 02.21.204 [16].

  16. Journal of Laws No. 01.126.1381 [17].

  17. Journal of Laws No. 02.209.1783 [18].

  18. Journal of Laws No. 02.224.1882 [19].

  19. Journal of Laws No. 02.219.1844 [20].

  20. Journal of Laws No. 02.221.1864 [21].

  21. Journal of Laws No. 99.47.480 [22].

  22. Explanatory Report to the Additional Protocol concerning Biomedical Research, Par. 20 and 21: 6, http://www.coe.int/t/e/legal_affairs/legal_co-operation/bioethics/activities/biomedical_research/195%20ER%20recherche%20biomedicale%20e.pdf

  23. Frankowska [28].

  24. See par. 109 of Explanatory Report on the Bioethical Convention and par. 89 of the Explanatory Report to the Additional Protocol.

  25. Boratyńska and Konieczniak [29]; Kubicki [30].

  26. Declaration of Geneva adopted by the 2nd General Assembly of the World Medical Association, Geneva, Switzerland, September 1948 and amended by the 22nd World Medical Assembly, Sydney, Australia, August 1968, the 35th World Medical Assembly, Venice, Italy, October 1983, and the 46th WMA General Assembly, Stockholm, Sweden, September 1994, and editorially revised at the 170th Council Session, Divonne-les-Bains, France, May 2005, and the 173rd Council Session, Divonne-les-Bains, France, May 2006: http://www.wma.net/e/policy/c8.htm

  27. Boratyńska and Konieczniak [29].

  28. Explanatory Report to the Additional Protocol, par. 29.

  29. See e.g.: Brock [31], Foëx [32], Richardson [33].

  30. Salgo v. Leland Stanford etc. Bd. Trustees, 154 Cal.App.2d 560 [Civ. No. 17045. First Dist., Div. One. Oct. 22, 1957].

  31. Chatterton v. Gerson [1981] 1 All ER 257.

  32. See also: Kolasa [34].

  33. Resolution of the Polish Constitutional Court, W 16/92 OTK 1993/1/16.

  34. Individuals possess international legal status. They have a few obligations, derived from customary international law. In addition, procedural rights ensure to the benefit of individuals, not however vis à vis all States, but only towards the group of States that have concluded treaties (such as, for example, the parties to the Bioethical Convention) or the international organizations that have adopted resolutions (such as, for example, the Council of Europe, European Communities) envisaging such rights. Concluding, individuals possess a limited locus standi in international law. Furthermore, unlike states, individuals possess a limited array of rights and obligations, that is, a limited legal capacity. See also: Cassese [35] or Brownlie [36].

  35. Penal Code, Journal of Laws No. 97. 88. 553.

  36. Grzelak K, Klauzule limitacyjne i derogacyjne w Europejskiej Konwencji Praw Człowieka, http://www.umk.pl/∼homini/referaty/ref4.doc, 19th May 2006.

  37. Jasudowicz [37].

  38. Such a construction of the limitation clause is discussed in a critical manner. See more: T. Jasudowicz, op. cit.

  39. The Tribunal often points out that the exceptions included in the limitation clause are to be interpreted narrowly, while their need in a concrete example must be convincingly established. See e.g.: Case of Olsson v. Sweden (No. 2), Court Judgment of 27 November 1992, par. 90, or Case of Johansen v. Norway, Court Judgment of 7 August 1996, par. 78.

  40. See also: Marek [38], Buchała and Zoll [39].

  41. Spotowski [40].

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  1. Chair of Public International and European Law, Faculty of Law, Administration and Economy, Wroclaw University, ul. Uniwersytecka 22/26, Wroclaw, 50-145, Poland

    Agata Wnukiewicz-Kozłowska

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Wnukiewicz-Kozłowska, A. The Admissibility of Research in Emergency Medicine. Sci Eng Ethics 13, 315–332 (2007). https://doi.org/10.1007/s11948-007-9024-7

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