New European guidelines for the use of stored human biological materials in biomedical research

Journal of Medical Ethics

Volumn 30, Issue 1, 2004, Pages 99-103

  Trouet, Caroline ^a  

^a NONE   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

BIOMATERIAL;

ARTICLE; BIOTECHNOLOGY; CLINICAL RESEARCH; CONSULTATION; EUROPEAN UNION; GENETICS; HUMAN; HUMAN RIGHTS; INFORMED CONSENT; LEGAL ASPECT; MEDICAL ETHICS; MEDICAL RESEARCH; PRACTICE GUIDELINE; RISK BENEFIT ANALYSIS; TISSUE ENGINEERING;

BIOMEDICAL AND BEHAVIORAL RESEARCH; COUNCIL OF EUROPE;

BIOMEDICAL RESEARCH; CONFIDENTIALITY; ETHICS COMMITTEES, RESEARCH; HUMANS; INFORMED CONSENT; PRACTICE GUIDELINES; TISSUE PRESERVATION;

EID: 1342266574     PISSN: 03066800     EISSN: None     Source Type: Journal    
DOI: 10.1136/jme.2003.003467     Document Type: Article

References (42)

1. Jonsson L, Landegren U. Storing and Using Bio Banks for Research. In: Hansson MG, ed. The Use of Human Bio Banks. Ethical, Social, Economical and Legal Aspects. Uppsala: Universitetstryckeriet, 2001:4.
2. For example the Alder Hey scandal.
3. Steering Committee on Bioethics. Proposal for an instrument on the use of archived human biological materials in biomedical research, 14 October 2002, http://www.coe.int.
4. Anonymous materials: for these tissue samples no identifiable personal information was collected or when it was collected, it was not maintained. Anonymised materials: for these tissues identifiers or codes linking the tissues to personal information were removed.
5. The definitions in the instrument referring to the ability to identify the biological materials are complex and one could question their relevance for the subject treated. The distinction which is made between coded and linked anonymised materials does not come back in the instrument. In both cases, the human biological materials are identifiable (whether they can be linked back by the researcher or by a third party). "Unlinked anonymised" materials are the only actual anonymous materials. Moreover, nothing is addressed with regard to anonymous materials.
6. The reason for this exclusion is not clear, no explanation is offered in the Explanatory Report. It is strange that this specific exclusion for cell lines should be mentioned if the Explanatory Report is correct in saying that the instrument does not apply to unlinked anonymised materials in general.
7. See also Gassner UM. Tissue engineering in Normendschungel. Medizinrecht 2001;19:553-61.
8. Irreversible anonymity can cause problems both for the research and the donor. Anonymity for example eliminates any possibility of obtaining further information about the source and makes it impossible to provide any information to the source. See Royal College of Pathologists. Transitional guidelines to facilitate changes in procedures for handling "surplus" and archival material from human biological samples, 2001.
9. Wright Clayton E. Prospective uses of DNA samples for research. In: Knoppers BM, ed. Human DNA: low and policy. International and comparative perspectives. The Hague: Kluwer Law International, 1997:294
10. American College of Medical Genetics. Statement on the storage and use of genetic materials. Am J Hum Genet 1995;57:1499-500.
11. Article 10 stipulates that in the case of unlinked anonymised research, anonymity shall be confirmed by a review procedure. Research projects with anonymised human biological materials are evaluated by the competent body in order to know whether human biological materials and related data are indeed unlinked anonymised.
12. See for more information on different regulation models for the research use of human biological materials Trouet C, Sprumont D. Bio Banks: Investing in regulation. In: Ziemele I, ed. Baltic Yearbook of International Law. The Hague: Kluwer Law International, 2002;2:11-19.
13. See for example Boel E. Human gene- and tissue banks as tools in pharmaceutical discovery. In: Sorsa M, Eyfjörö J, eds. Human Bio Banks - ethical and social issues. Copenhagen: Nordic Committee on Bioethics, 1997:107: "but the public opinion has never really got to terms with the thought that human material, from living or deceased individuals, should be exploited by the pharmaceutical industry for neither research nor production purposes".
14. Also see Perley SN. From control over one's body to control over one's body parts. New York: University Law Review, 1992;13:345.
15. Clayton EW. Prospective uses of DNA samples for research. In: Knoppers BM, ed. Human DNA: low and policy. International and comparative perspectives. The Hague: Kluwer Law International, 1997:298.
16. Lawrence SC. Beyond the grave - the use and meaning of human body parts a historical introduction. In: Weir RF, eds. Stored tissue samples. Ethical, legal and public policy implications. Iowa City: University of Iowa Press, 1998:113.
17. Article 22 deals with any part of a human body, it is not limited to identifiable materials (explanatory report to the Convention, no 135).
18. "Parties to the instrument shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their right to private life and other rights and fundamental freedoms with respect to any research governed by the instrument" (Article 1). This protection is limited to the extent that Article 2 of the instrument defines research as "research with human biological materials and personal data for health purposes or for scientific research linked to health purposes". This means that research with anonymous or anonymised materials is not covered by Article 1 (see also Article 5).
19. See Warbrick C. The structure of Article 8. European Human Rights Law Review 1998:33.
20. ECHR, PG, JH/UK 25 September 2001, http://hudoc.echr.coe.int/, p 15, § 56.
21. ECHR, Pretty/UK 29 April 2002, http://hudoc.echr.coe.int/.
22. Loucaides LG. Personality and privacy under the European Convention on Human Rights. In: The British Yearbook of International Law 1990. Oxford: Oxford University Press, 1991:178.
23. Harris DJ, O'Boyle M, Warbrick C. Law of the European Convention on Human Rights. London: Butterworths, 1995:306.
24. Loucaides LG. Personality and privacy under the European Convention on Human Rights. In: The British Yearbook of International Law 1990. Oxford: Oxford University Press, 1991:176.
25. ECommHR, 10 March 1981, X/Germany, 874/79, DR, vol 24, 137.
26. Also see Annas GJ. Privacy rules for DNA databanks. JAMA 1993;270:2347.
27. See for example Daniels LB. Commercialization of human tissues: has biotechnology created the need for an expanded scope of informed consent? California Western School of Law 1990:210
28. Labrusse-Riou C, Baudouin J-L. Produire l'homme: de quel droit? Paris: Presses Universitaires, de France, 1997:196.
29. De Hert P. Artikel 8 EVRM en het Belgisch recht. De bescherming van privacy, gezin, woonst en communicatie. Gent: Mys&Breesch, 1998:75-6.
30. Article 1653w of the Law on the medical treatment contract.
31. Act on Bio Banks, 2000; Winickoff DE. Biosamples, Genomics and human rights: context and content of Iceland's biobanks act. Journal of Bio Law and Business 2000;4:11-17.
32. Office Parlementaire d'évaluation des choix scientifiques et technologiques. Rapport sur l'application de la loi no 94-654 du 29 juillet, 1994:34; Conseil d'Etat. Les lois de bioéthique: cinq ans après. Paris: La Documentation française, 1999:100.
33. See the bill proposed to implement the EU Directive on the legal protection of biotechnological inventions: Chamber, 2001-2002, no 1886-001.
34. Article 6: "...shall not involve risks to the private life of individuals or a group of individuals disproportionate to its potential benefit" and explanatory report no 32: "research on archived human biological materials may not carry great risks for individual research subjects if sufficient anonymisation has been carried out".
35. For example explanatory report no 60: "it acknowledges the fact that the motivation for allowing the use of one's biological materials and personal data in biomedical research might be out of solidarity, and information on foreseen commercial uses of their contribution to the research may be important to them in taking their decision". These aspects also apply to anonymised materials.
36. Inspiration for this proposal has clearly been found in the guidelines of the Medical Research Council (UK) Human tissue and biological samples for use in research, 2001. Should guidelines drafted by a professional research organisation determine the protection to be offered to sources of tissues on a European (human rights) level?
37. Hermitte M-A. Le séquençage du génome humain: liberté de la recherche et démarche démocratique. In: F Furkel F, Jung H, eds. Bioéthique et droits de l'homme - Bioethik und Menschenrechte. Köln: Carl Heymanns Verlag KG, 1993:50.
38. Gutwirth S. Waarheidsaanspraken in recht en wetenschap. Antwerp: Maklu, 1993:23.
39. Leenen HJJ. Handboek gezondheidsrecht, I, Rechten van mensen in de gezondheidszorg. Diegem: Bohn Stfleu Van Loghum, 2000:36.
40. Wertz DC. Archived specimens: a platform for discussion. Community Genet 1999;2:51-60.
41. See also Council of Europe. Ethical review of biomedical research in Europe: suggestions for best national practices. Strasbourg, 23 June 1998.
42. See also Knoppers BM. Biotechnology. Sovereignty and sharing. In: Caulfield TA, Williams-Jones B, eds. The commercialization of genetic research. Ethical, legal and policy issues. New York: Kluwer Academic/Plenum, 1999:1-12.