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Legal Landscape of Neuroscientific Research and Its Applications in Finland

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International Neurolaw

Abstract

This article focuses on the regulation of research and use of neuroscientific knowledge in Finland. As no separate regulation on neuroscientific research exists, legislation on medical research has been taken as a starting point for the legal analysis. The recently extended scope of application of the Medical Research Act has both positive and negative effects to multidisciplinary research projects such as neuroscientific research. Although the Act now takes better account of novel research areas outside the scope of traditional medical science, relevant expertise in the ethics committees may be difficult to find. Generally, the Finnish legislation responds reasonably well to the particularities of neuroscientific research such as incidental findings. As the application of neuroscientific knowledge in many areas is still rather sporadic, there has not been sufficient incentive to introduce legislation in the area. The only recorded demands for guidance in the area involve the use of polygraphs in criminal investigation and court proceedings.

Salla Silvola, LLD (Helsinki), MA (London), Docent in Medical and Bio Law, University of Helsinki, Finland; supported by the project “NeuroSCAN: Ethical Concept and Norms”, Academy of Finland (SA 1124638).

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Notes

  1. 1.

    Revonsuo (2009).

  2. 2.

    Nr. 488 of 1999.

  3. 3.

    Medical Research Act, Section 2.

  4. 4.

    National Advisory Board on Research Ethics (2009).

  5. 5.

    Act on the Amendment of the Medical Research Act Nr. 794 of 2010.

  6. 6.

    Lötjönen (2009b), p. 216.

  7. 7.

    Another question is whether all parts of the research protocol should be scrutinised against the standards stated in the Medical Research Act, or only the part that falls under the broadened scope of the Act.

  8. 8.

    Act Nr. 731 of 1999.

  9. 9.

    Section 16, para 3.

  10. 10.

    Bill Nr. 1 of 1998 and Bill Nr. 309 of 1993.

  11. 11.

    Bill Nr. 309 of 1993, p. 64. See also Miettinen (2001).

  12. 12.

    Sections 7 and 10 of the Constitution of Finland.

  13. 13.

    Council of Europe (1997, 1998, 2002).

  14. 14.

    Immonen (1992), p. 26. See also Lötjönen (1997), p. 874.

  15. 15.

    Alone in the connection of the Helsinki University Central Hospital, more than 32 ethics committees were in operation in 1986. Penttilä (1992), p. 81.

  16. 16.

    Sections 18 and 19.

  17. 17.

    The committee’s official name (translated from Finnish) was Sub-Committee on Medical Research of the National Advisory Board on Health Care. It was founded by Decree on the National Advisory Board on Health Care, Nr. 494 of 1998.

  18. 18.

    Bill nr. 65 of 2010, p. 12.

  19. 19.

    The name and organisation of the national ethics committee was changed by an amendment to the Medical Research Act, Nr. 794 of 2010, and by Decree on National Committee on Medical Research Ethics, Nr. 820 of 2010.

  20. 20.

    The Hospital District of Helsinki and Uusimaa is an example of the first option, and the ethics committee of the Hospital District of Southwest Finland is an example of the second approach.

  21. 21.

    Medical Research Act, Section 5, Subsection 2.

  22. 22.

    Medical Research Act, Section 5, Subsection 3.

  23. 23.

    Medical Research Act, Section 5, Subsection 1 and Bill Nr. 65 of 2010, p. 19.

  24. 24.

    European Union (2001).

  25. 25.

    Article 9, para 2.

  26. 26.

    In the case of xenogenic cell therapy, there is no time limit to the authorisation period. See Article 9, paras 4 and 6 of the Directive. In Finland, the requirements of the Clinical Trials Directive have been implemented in the Medical Research Act and the Act on the Finnish Medicines Agency Nr. 593 of 2009 (which replaced the earlier Act on the National Agency of Medicines Nr. 35 of 1993).

  27. 27.

    Nr. 377 of 1995. See also Lehtonen (2006), pp. 246–249.

  28. 28.

    European Union (1993). See also the Regulation on Clinical Investigation on Medical Devices and their Accessories, National Supervisory Authority for Welfare and Health (2010). The National Supervisory Authority for Welfare and Health is also responsible for issuing licenses for research on embryos and for research on human tissues and cells, if the consent of the tissue or cell donor cannot be acquired. See Medical Research Act, Section 11, and Act on the Medical Use of Human Organs and Tissues, Nr. 101 of 2001, Sections 19 and 20.

  29. 29.

    Nr. 592 of 1991.

  30. 30.

    Nr. 785 of 1992.

  31. 31.

    In other types of research it could be possible, by exception, to get access to patient records without individual written consent. According to Section 28 of the Act on the Openness of Government Activities (Nr. 621 of 1999), the public authority (e.g. a health care centre or a hospital district), in whose care the documents are, may in individual cases give access to patient documents for the purpose of scientific research, if it is obvious that the giving of the information does not violate the interests for the protection of which the secrecy obligation has been prescribed. When considering an application for permission, it must been taken care that the freedom of scientific research is secured. If documents are needed from more than one health care unit, may the National Institute for Health and Welfare grant the permission on behalf of individual health care units (Act on the Status and Rights of Patients, Section 13, Subsection 4).

  32. 32.

    Lötjönen (2008, 2009a) and Nieminen (2009).

  33. 33.

    Medical Research Act, Section 4.

  34. 34.

    Personal Data Act, Section 12.

  35. 35.

    Additional conditions apply to research on minors or adults who do not have the legal capacity to consent themselves. In these cases, the consent of the representative of the participant is required and the level of risk to the participant is regulated more closely. On the problems involved with deteriorating legal capacity and a comparative account on respecting the self-determination of persons with cognitive impairment, see Lötjönen (2009a).

  36. 36.

    Personal Data Act, Section 26. See also the Medical Research Decree Nr. 986 of 1999, Section 3.

  37. 37.

    On the ethical dimensions of incidental findings in neuroscientific research, see Takala (2009).

  38. 38.

    Medical Research Act, Section 5, Subsection 3. This specific duty exists independent of the Sections 26 and 27 of the Personal Data Act, according to which the researchers are not legally obliged to give research-related information to the research participants, if the data in the file are used solely for scientific research.

  39. 39.

    Section 3.

  40. 40.

    Act on Health Care Professionals, Section 15.

  41. 41.

    The relevant provisions of the Personal Data Act (Sections 27–29) assume that the data subject has initiated the request for access to information and the Act on the Status and Rights of Patients states clearly that information shall not be given against the will of the patient (Section 5).

  42. 42.

    Personal Data Act, Section 27, and Act on the Status and Rights of Patients, Section 5.

  43. 43.

    Medical Research Act, Section 6.

  44. 44.

    Personal Data Act, Section 12, Subsection 2.

  45. 45.

    Working group set by the Finnish Medical Society Duodecim and the Finnish Society of Psychiatrists (2010). Current Care guideline on Depression. Current Care guidelines are evidence-based treatment guidelines prepared by the Current Care working groups (including approximately 700 volunteer health care top professionals from a range of fields across Finland) in cooperation with Current Care editors employed by the Finnish Medical Society and relevant interest groups in support of decision making in health care.

  46. 46.

    Soini (2009).

  47. 47.

    See, however, the decision by Vantaa District Court Nr. 7869 (00/6566, 3 November 2000) in Mäki-Petäjä-Leinonen (2003), p. 263.

  48. 48.

    According to Section 23, Subsection 2 of the Guardianship Services Act (Nr. 442 of 1999), a person who has been declared incompetent may self decide on matters pertaining to his or her person, if he or she understands the significance of the matter. According to Section 29, Subsection 2 of the Act, if the ward cannot understand the significance of the matter, the guardian shall be competent to represent the ward also in matters pertaining to his or her person, if the court has so ordered.

  49. 49.

    Mental Health Act (Nr. 1116 of 1990), Section 22 b.

  50. 50.

    According to Section 6 of the Act on the Status and Rights of Patients, possible proxies for an adult patient are his or her legal representative (by court order or by authorisation), a family member, or a person otherwise close to the patient (including a cohabitation partner).

  51. 51.

    Act nr. 559 of 1994, Section 15.

  52. 52.

    Section 22.

  53. 53.

    A new Decree (Nr. 1088 of 2010) on Prescribing Medicinal Products by the Ministry of Social Affairs and Health will come into force 1 January 2011.

  54. 54.

    Act on Health Care Professionals, Sections 26–33.

  55. 55.

    Summaries of the decisions are published by the National Supervisory Authority of Welfare and Health on their website (National Supervisory Authority of Welfare and Health 2010).

  56. 56.

    Klami (1996), p. 209.

  57. 57.

    Hamilo (2010).

  58. 58.

    The guilty knowledge test was developed already in the 1950s by David Lykken (Lykken 1959).

  59. 59.

    Jokinen (2005), p. 73. See also Iacono and Lykken (1997), who asked the members of Society for Psychophysiological Research and American Psychological Association about their opinion on the two tests. Seventy-seven percent of those who replied estimated the guilty knowledge test to be based on scientifically valid principles compared to 36%, who said the same about the control question test.

  60. 60.

    Klami (1996), p. 215.

  61. 61.

    According to the news article published in connection of a recent murder case where guilty knowledge test had been applied, hundreds of persons have been tested using the polygraph test, but the results have been used in court only in around ten times (Talja 2010).

  62. 62.

    Code of Judicial Procedure, Chapter 17, Section 2.

  63. 63.

    Juhani Sirén quotes Mr. Jorma Hautala, who is one of the police officers conducting polygraph tests in Finland in his article, Sirén (2003). See also Klami (1996), p. 216, who comments the need for legislation from the point of view of an attorney representing his clients.

  64. 64.

    Jokinen (2005), p. 12.

  65. 65.

    Nr. 759 of 2004.

  66. 66.

    In order to ensure the reliability of the tests and the qualifications of the experts, the employers work together with the professional unions such as the Finnish Psychological Association.

  67. 67.

    Section 13.

  68. 68.

    Section 14.

  69. 69.

    Section 15.

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  1. University of Helsinki, Yliopistonkatu 3, 400014, Helsinki, Finland

    Salla Silvola

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  1. , Institute of Science and Ethics, University of Bonn, Bonner Talweg 57, Bonn, 53113, Germany

    Tade Matthias Spranger

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Silvola, S. (2012). Legal Landscape of Neuroscientific Research and Its Applications in Finland. In: Spranger, T. (eds) International Neurolaw. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-21541-4_7

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