From research exemption to research norm: Recognising an alternative to consent for large scale biobank research

Medical Law International

Volumn 10, Issue 4, 2010, Pages 287-313

  Ruyter, Knut W ^a   Lõuk, Kristi ^b   Jorqui, Maria ^c   Kvalheim, Vigdis ^d   Cekanauskaite, Asta ^e   Townend, David ^f  

^a UNIVERSITY OF OSLO   (Norway)

^b UNIVERSITY OF TARTU   (Estonia)

^c UNIVERSITY OF THE BASQUE COUNTRY UPV EHU   (Spain)

^d Norwegian Social Science Data Service   (Norway)

^e VILNIUS UNIVERSITY   (Lithuania)

^f MAASTRICHT UNIVERSITY   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

BIOBANK; BIOSAFETY; HEALTH CARE FACILITY; HEALTH CARE ORGANIZATION; HUMAN; INFORMATION PROCESSING; INFORMED CONSENT; LEGAL ASPECT; MEDICAL INFORMATION; MEDICAL RESEARCH; PATIENT PARTICIPATION; PRIVACY; PROTECTION; REGISTER; REVIEW; TRUST;

EID: 79951781571     PISSN: 09685332     EISSN: None     Source Type: Journal    
DOI: 10.1177/096853321001000403     Document Type: Review

References (51)

1. Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. Official Journal L281 23/11/1995 P. 0031-0050. http://eur-lex.europa.eu/LexUriServ/LexUriServ. do?uri=CELEX:31995L0046:en:HTML (last accessed 27th August 2010).
2. Recital 6 of the Directive shows something of the reasoning for this, stating 'the increase in scientific and technical cooperation and the coordinated introduction of new telecommunications networks in the Community necessitate and facilitate cross-border flows of personal data'.
3. Scientific and Research purposes are dealt with in Recitals 6, 29, 34, 40, and 42, and Articles 6, 11, 13, and 32. Although the term 'Research Exemption' is not specifically used, Article 13 concerns 'Exemptions and Restrictions' (making the provisions for research in Article 13(2) an exemption from the normal course of the Directive). 'Research Exemption' is, however, commonly used in discussions about the Directive in relation to its various provisions for processing for research, scientific and historical purposes (see below).
4. The authors were members of PRIVILEGED project, and particularly the subgroup considering the extent of the research exemption in relation to medical research using genetic information and biobanking. Their views were informed by the general discussions within that project. However, the views expressed in this paper are those of the sub-group and do not necessarily reflect the views of all the members of the PRIVILEGED project.
5. EC FP5 project on the implementation of the Directive in the Member States in relation to medical research. See http://www.privireal.org/ (last visited 27th August 2010).
6. Denise Lievesley and Ian Master (1993) Geographic Information in Europe: An Overview and a Research Agenda. Report TRP 119. University of Sheffield: Department of Town and Regional Planning.
7. See also European Science Foundation Social Science Programme (1994) European Data Strategic Review. Malgrate, Italy;
8. Commission of the European Communities (1992) A revised proposal for a Council Directive on the protection of individuals with regard to the processing of personal data and the free movement of such data. Brussels: COM (92) 395 Final.
9. See Articles 6, 11, 13, and 32.
10. It appears in Recitals 6, 29, 34, 40, and 42 and Articles 6, 11, 13, and 32.
11. To be read in conjunction with Recitals 28 and 29.
12. To be read in conjunction with Recitals 38, 39, and 40.
13. Article 10.
14. Article 11.
15. Article 11.
16. Article 2(a).
17. Article 11(2).
18. Article 11 also applies to the person who receives personal data from the data controller but is not under the direct authority of that controller. Here Article 11 is at pains to ensure, if possible and not requiring disproportionate effort, that this 'third party' is identified to the data subject and the purpose of the processing is disclosed to the data subject (again, with the appropriate safeguards of Article 11(2) in operation).
19. See also: Townend, D. (forthcoming) 'Privacy, Health Insurance and Medical Research: Tensions Raised by European Data Protection Law.' New Genetics and Society.
20. Article 6 of the Treaty of European Union, following the amendments of the Treaty of Lisbon, must now require these lists to be read in relation to Article 8 of the European Convention on Human Rights.
21. Although Article 8(3) does provide that 'Paragraph 1 shall not apply where processing of the data is required for the purposes of preventive medicine, medical diagnosis, the provision of care or treatment or the management of health-care services, and where those data are processed by a health professional subject under national law or rules established by national competent bodies to the obligation of professional secrecy or by another person also subject to an equivalent obligation of secrecy' it is not clear that this applies to medical research: the emphasis appears to be upon processing necessary to deliver health care directly.
22. For example, in Article 9 in relation to journalism and artistic and literary purposes to ensure a proper balance with the competing rights to freedom of expression.
23. This is noteworthy as 13(1)(a)-(f) are issues that are largely beyond the 1995 competence of the Union.
24. Recitals 6, 29, 34, 40, and 42 and Articles 6, 11, 13, and 32.
25. Ségolène Rouillé-Mirza and Jessica Wright. 'Comparative Study on the Implementation and Effect of Directive 95/46/EC on Data Protection in Europe: Medical Research.' pp. 189-230 in D. Beyleveld, D. Townend, S. Rouillé-Mirza and J. Wright (eds.) (2004) The Data Protection Directive and Medical Research Across Europe. Aldershot: Ashgate Publishing Ltd.
26. Sverre Engelschiön (2002) 'The Implementation of Directive 95/46 in Norway. Especially with Regard to Medical Data.' European Journal of Health Law 9:189-200.
27. Response from the Institute of Public Health, dated 18.4.2008. Quoted from the appeal case: www.etikkom.no/Documents/Vedtak-i-klagesaker/2008-5.pdf (last visited 27th August 2010).
28. Final decision by the Regional Committee for Research Ethics in Medicine and Health Care, Health Region South and East, dated 26.6.2008. Quoted from the appeal case: www.etikkom.no/Documents/Vedtak-i-klagesaker/2008-5.pdf (last visited 27th August 2010).
29. Appeal case decision by the National Committee for Research Ethics in Medicine and Health Care, dated 6.10.2008, ref. no. 2008/89. www.etikkom. no/Documents/Vedtak-i-klagesaker/2008-5.pdf (last visited 27th August 2010).
30. Although within that information provision structure Articles 6(1)(b) and Article 11 (2) also operate, as discussed above.
31. http://www.bbmri.eu/ (last visited 27th August 2010). BBMRI is a large-scale EC FP7 project seeking to optimise research using biobanks, particularly through the effective linking of biobanks.
32. See Onora O'Neill (2002) Autonomy and Trust in Bioethics. Cambridge: Cambridge University Press;
33. idem. (2002) A Question of Trust. Cambridge: Cambridge University Press (especially chapter 4, "Trust and transparency").
34. John-Arne Skolbekken, Lars Øystein Ursin, Berge Solberg, Erik Christensen and Borgunn Ytterhus (2005) 'Not Worth the Paper It's Written On? Informed consent and biobank research in a Norwegian context.' Critical Public Health 15: 335-347.
35. Jan Helge Solbakk, Søren Holm and Bjørn Hofmann (eds.) (2009) The Ethics of Research Biobanking. Springer Verlag.
36. See Article 1 and Recitals 1 to 10.
37. David Hume 'Of the Independency of Parliament'. Part I, Essay iv in D. Hume Essays Moral, Political and Literary, edited by Eugene F. Miller (1985) Indianapolis: Liberty Classics.
38. See, for example, the German sociologist Niklas Luhmann. 'Familiarity, Confidence, Trust: Problems and Alternatives,' pp 94-107 in D. Gambetta (ed.) Trust: Making and Breaking Cooperative Relations, Oxford: Basil Blackwell.
39. See also Piotr Sztompka (1999) Trust. A Sociological Theory. Cambridge: Cambridge University Press;
40. and, Mark E. Warren (ed.) (1999) Democracy and Trust. Cambridge: Cambridge University Press.
41. The mechanism that triggers this assessment is the notification of the processing from the data controller to the national data protection authority: Article 20(2).
42. For example, as stated by Lee A. Bygrave and Dag W. Schartum. "Consent, proportionality and collective power" pp. 157-173 in S. Gutwirth, Y. Poullet, P. De Hert, C. de Terwangne and S. Nouwt (eds.) (2009) Reinventing Data Protection? Springer Verlag.
43. In this we differ from, for example, Bygrave and Schartum who argue for the interaction of proportionality and consent, also by introducing, for example, "collective consent". We read it as an attempt to remain within the prioritised paradigm within the perceived legal limits, without taking the consequences of establishing an equally acceptable processing without any consent. Of course consent by a controller or a relevant organisation can be construed as a collective consent on behalf of data subjects, but consent for the individual is void of content. We think therefore it is better to accept that consent is no longer a meaningful category. The function of "collective consent" could be better realised by processes of public participation in planning and executing large scale biobank research (see below).
44. http://conventions.coe.int/treaty/en/treaties/html/195.htm (last visited 27th August 2010).
45. See, for example: Bygrave and Schartum, op.cit.;
46. Richard Ashcroft (2004) 'From Public Interest to Political Justice.' Cambridge Quarterly of Health Care Ethics 13: 20-27;
47. and, Yue Liu (2009) 'The Principle of Proportionality in Biometrics: case studies from Norway.' Computer Law & Security Review 25: 237-250.
48. Bygrave and Schartum, op.cit..
49. Act 2008-06-20 nr. 44. Act on medical and health research (The Health Research Act), § 28. http://www.ub.uio.no/ujur/ulovdata/lov-20080620-044- eng.pdf (last visited 27th August 2010). The register is limited to research on biological material. The purpose of the register is to give patients an opportunity to opt- out of any research use of their material.
50. L.Ø. Ursin and B. Solberg. 'The Health Dugnad: Biobank Participation as the Solidarity Pursuit of the Common Good,' pp. 219-236 in Jan Helge Solbakk, Søren Holm and Bjørn Hofmann (eds.) (2009) The Ethics of Research Biobanking. Springer Verlag.
51. See http://ec.europa.eu/research/science-society (last visited 27th August 2010).