Regulating tissue research: Do we need additional rules to protect research participants?

European Journal of Health Law

Volumn 17, Issue 5, 2010, Pages 455-469

  Wright, Jessica ^a   Ploem, Corrette ^b   Šliwka, Marcin ^c   Gevers, Sjef ^b  

^a UNIVERSITY OF LEICESTER   (United Kingdom)

^b UNIVERSITY OF AMSTERDAM   (Netherlands)

^c NICOLAUS COPERNICUS UNIVERSITY   (Poland)

Author keywords

clinical trials; data protection; genetic research; human rights; medical research; privacy; tissue research

Indexed keywords

ARTICLE; EUROPE; HEALTH CARE FACILITY; HUMAN; HUMAN RIGHTS; LEGAL ASPECT; RESEARCH SUBJECT;

EUROPE; HUMAN RIGHTS; HUMANS; RESEARCH SUBJECTS; TISSUE BANKS;

EID: 77957204692     PISSN: 09290273     EISSN: 15718093     Source Type: Journal    
DOI: 10.1163/157180910X525295     Document Type: Article

References (35)

1. At the international level see the Council of Europe Committee of Ministers, Recommendation (2006)4 of the Committee of Ministers to member states on research on biological materials of human origin (Strasbourg, 2006); specifically for biobanks see the OECD Guidelines on Human Biobanks and Genetic Research Databases (HBGRDs)(Paris, 2009).
2. Other documents include the Council of Europe, Additional Protocol to the Convention on Human Rights and Biomedicine, Concerning Biomedical Research (hereinafter the Additional Protocol Concerning Biomedical Research) (ETS 195, Strasbourg, 2005) and the World Medical Association Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects (Seoul, 2008).
3. See for instance the Council of Europe Committee of Ministers Recommendation No. R (97) 5 of the Committee of Ministers to Member States on the Protection of Medical Data (Strasbourg, 1997).
4. Council of Europe Convention for the Protection of Human Rights and Fundamental Freedoms, ETS 005 (Rome, 1950); and EU Charter of Fundamental Rights of the European Union Official Journal C 364/01, 18/12/2000.
5. Other relevant rights and freedoms are the freedom from discrimination (Article 14 of the ECHR), freedom of scientific research and primacy of human beings (Articles 2 and 15 of the 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 (hereinafter the Convention on Human Rights and Biomedicine) (ETS 164, Oviedo, 1997) and protection of property (Article 1 of the First Protocol of the ECHR).
6. Article 8 ECHR jurisprudence on private life covers the physical integrity of a person, and in the case Y.F. v. Turkey it was held that 'any interference with a person's physical integrity must be prescribed by law and requires the consent of that person', see Y.F. v. Turkey European Court of Human Rights (ECtHR) Judgment 22 July 2003, at 43.
7. See the Spanish Law 14/2007, of 3 July, on Biomedical Research; the Portuguese Law no. 12/2005, January 26, Act on Personal Genetic Information and Information Regarding Health (hereinafter the Portuguese Act on Personal Genetic information); and the Hungarian Act No XXI of 2008 on the protection of human genetic data and the regulation of human genetic studies, research and biobanks.
8. As Annas stresses 'the DNA molecule itself holds much currently undecipherable information and may be usefully be analogized to one's "future diary" written in a code we have not yet broken'. G.J. Annas, 'Privacy Rules for DNA Databanks Protecting Coded "Future Diaries"', Journal of the American Medical Association 270 (1993) 2346-2350.
9. S. and Marper v. The United Kingdom ECtHR Judgment 4 December 2008, at 72-73.
10. (UNESCO, 16 October 2003), Article 10.
11. CoE Additional Protocol Concerning Biomedical Research, Article 27.
12. Some laws may allow a research participant the right to access individual research results relevant for health (cf. Estonian Human Genes Research Act, 13 December 2000; French Code de la Santé Publique Article 1111-7; Latvian Human Genome Research Law amended 12 June 2003 and 24 February 2005; and the Norwegian Act 2008-06-20 no. 44 on Medical and Health Research) or genetic information held on genetic databases (Portuguese Act on Personal Genetic Information; supra note 7), and others include a duty to inform in certain circumstances (Spanish Law on Biomedical Research, supra note 7; Danish Consolidation Act No. 95 of 7 February 2008, with later amendments, on Health).
13. J. Kaye, 'Data Sharing - What are the implications?' (paper presented at the PRIVILEGED stage three project workshop in Vilnius, 21-24 June 2009).
14. See S and Marper, supra note 9.
15. M.C. Ploem et al., 'Tumour tissue: who is in control?' The Lancet Oncology 11(1) (2010) 9.
16. Moore v. Regents of the University of California 271 Cal. Rptr. 146, 793 P.2d 479 (1990).
17. Portuguese Act on Personal Genetic Information, no. 7 supra, Article 18(8). In Norway the ban extends to research participants, human biological information and health information (the Act on Medical and Health Research, supra note 12, Section 8).
18. Yearworth and others v North Bristol NHS Trust (Court of Appeal) [2009] EWCA Civ 37 (at 45).
19. In Estonia, following the Human Genes Research Act, no. 12 supra, the property right is limited as the tissues owned by the Chief Processor are non-transferable (Section 15). There are also similar property rights for information on the state of health and genealogy.
20. Portuguese Act on Personal Genetic Information, supra note 7 (Article 18(2)). The property right in tissue is inheritable. Similar provisions on property for health related information are also found in the Act.
21. See on this question also Sjef Gevers, Human Tissue Research, with Particular Reference to DNA Banking, in J.K.M. Gevers, E.H. Hondius and J.H. Hubben (eds.) Health Law, Human Rights and the Biomedicine Convention. Essays in Honour of Henriette Roscam Abbing (Leiden: Brill Academic Publishers, 2005) pp. 234-236.
22. The most significant instruments within this regulatory field are the Council of Europe Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data, ETS 108 (Strasbourg, 1981) (hereinafter the Data Protection Convention) and the European Parliament and Council Directive 95/46/EC on the Protection of Individuals with Regard to the Processing of Personal Data and on the Free Movement of Such Data, Official Journal of the European Communities No. L. 281/31 (1995) (hereinafter EC Directive 95/46/EC).
23. Council of Europe Recommendation No. (97)5 on the Protection of Medical Data, no. 3 supra, introduced a very specific form of supervision, i.e. that a body designated by law can authorise disclosure of data for the purpose of a defined research project in situations in which despite reasonable efforts, it would be impracticable to contact the data subject to seek his consent (Article 12.2(c)).
24. However, national data protection laws may contain these requirements.
25. See, for example, the WMA Declaration of Helsinki, no. 2 supra; the Council of International Organisations of Medical Sciences (CIOMS) and World Health Organisation (WHO) International Ethical Guidelines for Biomedical Research Involving Human Subjects (Geneva, 2002); and the Council of Europe Additional Protocol Concerning Biomedical Research, no. 2 supra.
26. European Commission Directive 2005/28/EC laying down principles and detailed guidance for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products, Official Journal of the European Union No. L. 91/13 (2005) and EC Directive 2001/20/EC 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 L121/34 (2001).
27. US Code of Federal Regulations Title 45 (Public Welfare) Part 46 (Protection of Human Subjects), Department of Health and Human Services (2005).
28. Therefore, Council of Europe Recommendation 2006(4), no. 1 supra, stipulates that an intervention to obtain tissue for storage for research purposes should only be carried out if it complies with the Additional Protocol Concerning Biomedical Research, no. 2 supra, Article 11.
29. For the concept of informational harm, see H.D.C. Roscam Abbing, Research with Human Tissue; some Major Human Rights Aspects, paper presented at the 8th European Conference of National Ethics Committees, Strasbourg, 1-2 December 2003.
30. R. Ravitsky and B.S. Wilfond, 'Disclosing individual genetic research results to research participants', Am J. Bioethics 6(6) (2006) 8-17;
31. B.M. Knoppers et al., 'The emergence of an ethical duty to disclose genetic research results: international perspectives', Eur. J. Human Genetics 14(11) (2006) 1170-1178.
32. See the Estonian Human Genes Research Act, supra note 12, Sections 7(1) and 28; and the Latvian Human Genome Research Law, supra note 12, Section 21.
33. For specific points of information to be given to participants see the European Group on Ethics in Science and New Technologies (EGE) Opinion No. 11 on Human Tissue Banking (1998); the Spanish Law on Biomedical Research, supra note 7; and the Portuguese Act on Personal Genetic information, supra note 7.
34. J. Bovenberg et al., 'Biobank Research: Reporting Results to Individual Participants', European Journal of Health Law 16(3) (2009) 229-247.
35. For example, Council of Europe Recommendation (2006)4, supra note 1, applies the Chapter on ethics review from the Additional Protocol on Biomedical Research (supra note 2) to research involving biological materials, which means that (independent) ethics committee review is required for every research project involving biological materials following Article 24. The OECD guidelines, no. 1 supra, suggest ethics review of a HBGRD's protocols and processes, as well as for their establishment, management and operation (1.2).