Informed consent for the research use of human biological materials

Medicine and Law

Volumn 22, Issue 3, 2003, Pages 411-419

  Trouet, Caroline ^a  

^a UNIVERSITY OF LEUVEN   (Belgium)

Author keywords

Biomedical research; Human biological materials; Informed consent; Right to privacy; Secondary use

Indexed keywords

COMMERCIAL PHENOMENA; CONFIDENTIALITY; HUMAN; HUMAN CELL; HUMAN RIGHTS; HUMAN TISSUE; INFORMED CONSENT; MEDICAL INFORMATION; MEDICAL INSTRUMENTATION; MEDICAL RESEARCH; MEDICOLEGAL ASPECT; ORGAN PRESERVATION; ORGANIZATION; PRACTICE GUIDELINE; REVIEW;

EID: 0242363743     PISSN: 07231393     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (25)

1. Jonsson L. & Landegren U. Storing and using biobanks for research in Hansson M.G. (ed.), The Use of Human Biobanks. Ethical, Social, Economical and Legal Aspects (2001), Uppsala Universitetstryckeriet, 4.
2. On a European level, instruments are being proposed to regulate the (therapeutic and/or research) use of human biological materials, but they are still in a drafting stage. See for example the Council of Europe proposal for an instrument on the use of archived human biological materials in biomedical research, http://www.coe.int and the proposal for a new Commission Directive on tissues and cells, adopted by the Commission on 19 June which aims to establish rules that would make sure that a high level of quality and safety throughout the "tissue and cell transplantation chain" in all the Member States is attained, http://europa.eu.int/comm/dgs/health_consumer/newsletter/200207/07_ en.htm.
3. Medical Research Council (U.K.), Human Tissue and Biological Samples for Use in Research - Operational and Ethical Guidelines (2001) and
4. Federatie van Medisch Wetenschappelijke Verenigingen (Netherlands), Code Goed Gebruik. Procedures Rond het Nadir Gebruik van Lichaamsmateriaal voor Medisch Wetenschappelijk Onderzoek (2001). It is obvious that these texts emanate from research organisms.
5. Annas G.J. Privacy rules for DNA databanks 1993 JAMA, 2347;
6. Andrews L. & Nelkin D. Whose body is it anyway? Disputes over body tissue in a biotechnology age 1998 The Lancet 351: 53-57.
7. Boel E. Human gene- and tissue banks as tools in pharmaceutical discovery in Sorsa M. & Eyfjörö J. (eds.) Human Biobanks - Ethical and Social Issues (1997) Copenhague, Nordic Committee on Bioethics, 107;
8. Clayton E.W. Prospective uses of DNA samples for research in Knoppers B.M. (ed.) Human DNA: Law and Policy. International and Comparative Perspectives (1997) The Hague, Kluwer Law International, 298.
9. Trouet C. Van Lichaan naar Lichaamsmateriaal. Recht en het Nader Gebruik van Cellen en Weefsels (2003), Antwerpen, Intersentia.
10. ECRM, 10 March 1981, X/Duitsland, 8741/79, D.R., vol. 24, 137.
11. See for an enumeration of the relevant case law Harris D.J., O'Boyle M. & Warbrick C. Law of the European Convention on Human Rights (1995) London, Butterworths, 306.
12. Harris D.J., O'Boyle M. & Warbrick C. Law of the European Convention on Human Rights (1995) London, Butterworths, 301;
13. Roscam Abbing H.D.C. Artikel 8: Recht op privé-leven in Gevers J.K.M. Het EVRM en de Gezondheidszorg (1994) Nijmegen, Ars Aequi Libri, 117.
14. Council of Europe, Proposal for an instrument on the use of archived human biological materials in biomedical research, http://www.coe.int/T/E/Legal_Affairs/Legal_co-operation/Bioethics/Activities/Bio medical_research/.
15. Trouet C. & Sprumont D. Biobanks: Investing in regulation? in Ziemele I. (ed.), Baltic Yearbook of International Law, Volume 2 (2002) The Hague, Kluwer Law International, 3-19.
16. See for example the Dutch legislation (art. 1653w Wet Geneeskundige Behandelingsovereenkomst).
17. See for example the Council of Europe proposal for an instrument on the use of archived human biological materials in biomedical research.
18. Examination of consent forms currently used reveals that they show most of the time important lacunas. Most of the consent forms only mention succinctly the use of human biological materials for further research. See for example McEwen J.E. & Reilly P.R. A survey of DNA diagnostic laboratories regarding DNA banking 1995 Am. J. Hum. Genet. 5: 1477. Experience from participating in research ethics committees shows that this is still very much the case.
19. See Medical Research Council and Wellcome Trust, Public perceptions of the collection of human biological materials, 2001, http://www.mrc.ac.uk/publicperceptions.htm.
20. Beskow L.M., Burke W., Merz J.F. e.a., Informed consent for population-based research involving genetics 2001 JAMA 2319 and
21. and Wertz D.C. Archived specimens: A platform for discussion 1999 Comm. Genet. 57.
22. See for example Glass K.C., Weiner C., Palmour R.M., Shapiro S.H., Lemmens T.M. & Lebacqz K. Stucturing the review of human genetic protocols: Gene localizations and identification studies 1996 IRB 4: 1-9.
23. European Parliament and Council Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions, Official Journal L 213, 30.7.1998.
24. See also Reilly P.R., Boshar M.F. & Holtzman S.H. Ethical issues in genetic research: Disclosure and informed consent 1997 Nature Genetics, 19.
25. In that case, by definition, re-contact and withdrawal is not possible any more.