Medical research on minors in Finland

European Journal of Health Law

Volumn 15, Issue 2, 2008, Pages 135-144

  Lötjönen, Salla ^a,b  

^a UNIVERSITY OF HELSINKI   (Finland)

^b UNIVERSITY OF MANCHESTER   (United Kingdom)

Author keywords

Children; EC directive on clinical trials; Guardian; Medical research; Self determination

Indexed keywords

BIOMEDICINE; CHILD WELFARE; CLINICAL TRIAL; DECISION MAKING; FINLAND; HUMAN; INFORMED CONSENT; JUVENILE; LEGAL ASPECT; MEDICAL RESEARCH; POLICY; PRACTICE GUIDELINE; REVIEW;

BIOMEDICAL RESEARCH; CHILD; CHILD WELFARE; DECISION MAKING; ETHICS COMMITTEES, RESEARCH; ETHICS, RESEARCH; FINLAND; HUMANS; MINORS;

EID: 53549111332     PISSN: 09290273     EISSN: 15718093     Source Type: Journal    
DOI: 10.1163/157180908X322932     Document Type: Review

References (28)

1. Medical Research Act No. 488 of Statutes, 9 April 1999.
2. 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. Official Journal of the European Communities L 121/34, 1 May 2001.
3. Definition of 'medical research' as stated in s. 2(1) of the Medical Research Act.
4. Governmental Bill No. 229/1998, 12. However, there are regional differences in the interpretation of the scope of the Act. Some hospital district ethics committees interpret the scope of the Act more widely.
5. Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, 4 April 1997, European Treaty Series No. 164.
6. Section 3 of the Child Custody and Right of Access Act (No. 361 of Statutes, 8 April 1983) and section 2 of the Guardianship Services Act (No. 442 of Statutes, 1 April 1999). According to s. 3 of the Child Custody and Right of Access Act, the guardianship of the minor ends, if the minor marries before the age of 18, but the marriage does not bring about maturity in terms of e.g. the right to vote.
7. Unofficial translation of the Medical Research Act by the Ministry of Social Affairs and Health. See, www.finlex.fi/en/laki/kaannokset/1999/ en19990488.pdf.
8. Article 4(a) of the Clinical Trials Directive.
9. Working group on medical research on children, "Perspectives on Medical Research conducted on Children", National Advisory Board on Health Care Ethics, August 2003, http://www.etene.org/dokumentit/ChresEN3.pdf.
10. European Medicines Agency, ICH Topic E 11, Note for Guidance on Clinical Investigation of Medicinal Products in the Paediatric Population (CPMP/ICH/2711/99) January 2001, www.emea.europa.eu/pdfs/human/ich/271199en.pdf.
11. Read more about the motivations and the results of the Working group in Halila, R., Lötjönen, S., "Children and Medical Research", Medicine and Law 24, (2005), 505-513.
12. Regulation No. 1901/2006 on medicinal products for paediatric use, Official Journal of the European Union L 378/1, 27 December 2006.
13. Section 5 of the Child Custody and Right of Access Act.
14. Section 3 of the Child Custody and Right of Access Act. See also, however, p. 8 of the Working group report (see fn 9), where the special cases are discussed. See also, S. Lötjönen, "The Regulation of Neonatal Research in Finland" p. 122-124, in: Mason, Megone (eds.), European Neonatal Research: Consent, Ethics Committees and Law (Aldershot, Ashgate, 2001), p. 121-135.
15. Parliamentary Ombudsman's Decision on the case no. 1016/4/04, 25 October 2006.
16. The main complaint by the The Breastfeeding Support Association in Finland did not involve the lack of informed consent from both parents, but inadequacies in providing sufficient information on the benefits and risks involved in the study, the person in charge of the study, the funding and the organisations behind the study (see further, HYPERLINK "http://www.imetys. fi/itu/english/findiasummary.php"). Indeed, the Parliamentary Ombudsman did find e.g. inadequacies in the information provided, the informed consent process, and issues with conflict of interest.
17. http://www.clinicaltrials.gov/ct/show/NCT00534638?order=1, accessed 31 March 2008.
18. National Public Health Institute press release "Nuorten papilloomavirusrokotetutkimus on saavuttanut 2/3 tavoitteestaan" (15 February 2008) http://www.ktl.fi/portal/suomi/osastot/lnto/ajankohtaista/?id= 169, accessed 31 March 2008.
19. News article in Mediuutiset by Mia Flygar, 12 October 2007, and an opinion article by Riku Mänttäri in Helsingin Sanomat, 15 October 2007.
20. Section 8 (3).
21. Section 8 (4).
22. More information on the network at: http://www.hyksinstituutti.fi/ document.asp?intSiteID=2&intDocID=350.
23. However, Finland has not signed (and therefore is not in the process of ratifying) the Additional Protocol on Biomedical Research, which was opened for signature in January 2005 (Council of Europe, Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research, European Treaty Series No. 195, 25 January 2005). Suspending to sign and ratify the Additional Protocol on Biomedical Research does not, however, have any implications to the regulation of medical research on children, as the reason for the delay lies in the interpretation of the scope of the Additional Protocol rather than any of its provisions of substance. If the scope of the Additional Protocol is seen to cover all research 'in the health field' including studies in nursing, psychology and social care, the scope of the Finnish Medical Research Act should be extended before signature and ratification. See more closely on the scope of the Additional Protocol, S. Lötjönen, "Research on Human Subjects", in: Gevers, Hondius, Hubben (eds.) Health Law, Human Rights and the Biomedicine Convention (Leiden, Koninklijke Brill NV, 2005), 175-190.
24. "Ethical Considerations for Clinical Trials on Medicinal Products conducted with the Paediatric Population: Recommendations of the ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use", January 2008, http://ec.europa.eu/enterprise/ pharmaceuticals/eudralex/vol-10/ethical_considerations.pdf.
25. Ibid., 5.
26. Ibid., 9.
27. Ibid., 8 and 11.
28. Sections 8 (3) and 8 (4) of the Medical Research Act.