- Email: [email protected]
Data protection and consent to biomedical research: a step forward?
Correspondence
School of Public Health and Family Medicine, University of Cape Town, Observatory 7925, South Africa (RM, MC, JM); Burden of Disease Research Unit, Medical Research Council, Johannesburg, South Africa (RM); and Department of Psychology, School of Human and Community Development, University of the Witwatersrand, Johannesburg, South Africa (BB) 1
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Lozano R, Naghavi M, Foreman K, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380: 2095–128. 67th World Health Assembly. Strengthening the role of the health system in addressing violence, in particular against women and girls, and against children. http://apps.who. int/gb/ebwha/pdf_files/WHA67/A67_ ACONF1Rev1-en.pdf (accessed July 14, 2014). Hawkes S, Buse K. Gender and global health: evidence, policy, and inconvenient truths. Lancet 2013; 381: 1783–87. Bowman B, Matzopoulos R, Butchart A, Mercy JA. The impact of violence on development in low- to middle-income countries. Int J Inj Control Saf Promot 2008; 15: 209–19.
Data protection and consent to biomedical research: a step forward? Many in the biomedical research community have expressed concern with the draft General Data Protection Regulation, as amended by a European Parliament Committee in 2013 and endorsed by the Parliament in March, 2014.1 Criticism has especially targeted Article 81, which would enable member states to legislate for an exemption from the need for specific, explicit consent to research use of health data only where research serves “a high public interest” and the data are anonymised or pseudonymised “under the highest technical standards”. Commentators 2–7 have noted that this overlooks robust broad consent models and research oversight mechanisms. Commentators 2–7 also noted that Article 81 introduces a disproportionate threshold for the consent exemption and would cause a major burden for and threat to biomedical research, large-scale www.thelancet.com Vol 384 September 6, 2014
studies, and research infrastructures such as biobanks. We are cautiously optimistic that this stringent provision might be revised. On June 30, 2014, a draft text based on discussions held during European Council’s Greek Presidency (first half of 2014) and amending the original 2012 European Commission text, was released.8 Reference to so-called specific consent and “research that serves a high public interest” has been removed in the new draft text, reflecting the original 2012 Commission text.9 Caution is warranted, however. The new draft ( June 30) text contains other provisions that create a challenging environment for researchers. It also remains to be seen whether the three European bodies (Commission, Parliament, and Council) can forge a common position on the Regulation, and how that negotiation will balance the current competing positions about health-related data and processing of personal data for scientific purposes. Indeed, the Council has not agreed to this text and it will change again as negotiations continue between member states. For these reasons, we encourage the biomedical research community to lobby the Council to aim for a more ambitious text, closer to the 2012 Commission version, 9 while there is still the opportunity to do so. If the potential benefits of public health and social needs are to be realised and not thwarted by the new Regulation, European political bodies should agree that the use of personal and pseudonymised data in biomedical research must be regulated proportionately to the real risks, and should acknowledge that techno logies increasingly allow research participants to make enlightened and autonomous decisions about the scope of consent to research. Now is the time for medical researchers and practitioners to explain these potential benefits,
harms, and safeguards to their recently elected Members of the European Parliament. We declare no competing interests.
Edward S Dove, David Townend, *Bartha M Knoppers [email protected] Centre of Genomics and Policy, McGill University, Montreal, QC H3A 0G1, Canada (ESD, BMK); and Department of Health, Ethics & Society, Maastricht University, Netherlands (DT) 1
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European Parliament. Legislative resolution of 12 March 2014 on the proposal for a regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation). March 12, 2014. http://www.europarl.europa.eu/ sides/getDoc.do?pubRef=-//EP//TEXT+TA+P7TA-2014-0212+0+DOC+XML+V0//EN (accessed Aug 21, 2014). Casali PG. Risks of the new EU Data protection regulation: an ESMO position paper endorsed by the European oncology community. Ann Oncol 2014; 25: 1458–61. Di Iorio CT, Carinci F, Oderkirk J. Health research and systems’ governance are at risk: should the right to data protection override health? J Med Ethics 2014; 40: 488–92. Ploem MC, Essink-Bot ML, Stronks K. Proposed EU data protection regulation is a threat to medical research. BMJ 2013; 346: f3534. McCall B. European Parliament supports data protection reforms. Lancet 2014; 383: 1115. Mascalzoni D, Knoppers BM, Aymé S, et al. Rare diseases and now rare data? Nat Rev Genet 2013; 14: 372. Protecting health and scientific research in the Data Protection Regulation (2012/0011(COD)): Position of non-commercial research organisations and academics– July 2014. http://www.wellcome. ac.uk/stellent/groups/corporatesite/@ policy_communications/documents/web_ document/WTP055584.pdf (accessed Aug 7, 2014). Council of the European Union. Proposal for a regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation). June 30, 2014. http://register.consilium. europa.eu/doc/srv?l=EN&f=ST%2011028%20 2014%20INIT (accessed Aug 7, 2014). European Commission. Proposal for a regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation). Jan 25, 2012. http://ec.europa.eu/justice/ data-protection/document/review2012/ com_2012_11_en.pdf (accessed Aug 21, 2014).
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School of Public Health and Family Medicine, University of Cape Town, Observatory 7925, South Africa (RM, MC, JM); Burden of Disease Research Unit, Medical Research Council, Johannesburg, South Africa (RM); and Department of Psychology, School of Human and Community Development, University of the Witwatersrand, Johannesburg, South Africa (BB) 1
2
3
4
Lozano R, Naghavi M, Foreman K, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380: 2095–128. 67th World Health Assembly. Strengthening the role of the health system in addressing violence, in particular against women and girls, and against children. http://apps.who. int/gb/ebwha/pdf_files/WHA67/A67_ ACONF1Rev1-en.pdf (accessed July 14, 2014). Hawkes S, Buse K. Gender and global health: evidence, policy, and inconvenient truths. Lancet 2013; 381: 1783–87. Bowman B, Matzopoulos R, Butchart A, Mercy JA. The impact of violence on development in low- to middle-income countries. Int J Inj Control Saf Promot 2008; 15: 209–19.
Data protection and consent to biomedical research: a step forward? Many in the biomedical research community have expressed concern with the draft General Data Protection Regulation, as amended by a European Parliament Committee in 2013 and endorsed by the Parliament in March, 2014.1 Criticism has especially targeted Article 81, which would enable member states to legislate for an exemption from the need for specific, explicit consent to research use of health data only where research serves “a high public interest” and the data are anonymised or pseudonymised “under the highest technical standards”. Commentators 2–7 have noted that this overlooks robust broad consent models and research oversight mechanisms. Commentators 2–7 also noted that Article 81 introduces a disproportionate threshold for the consent exemption and would cause a major burden for and threat to biomedical research, large-scale www.thelancet.com Vol 384 September 6, 2014
studies, and research infrastructures such as biobanks. We are cautiously optimistic that this stringent provision might be revised. On June 30, 2014, a draft text based on discussions held during European Council’s Greek Presidency (first half of 2014) and amending the original 2012 European Commission text, was released.8 Reference to so-called specific consent and “research that serves a high public interest” has been removed in the new draft text, reflecting the original 2012 Commission text.9 Caution is warranted, however. The new draft ( June 30) text contains other provisions that create a challenging environment for researchers. It also remains to be seen whether the three European bodies (Commission, Parliament, and Council) can forge a common position on the Regulation, and how that negotiation will balance the current competing positions about health-related data and processing of personal data for scientific purposes. Indeed, the Council has not agreed to this text and it will change again as negotiations continue between member states. For these reasons, we encourage the biomedical research community to lobby the Council to aim for a more ambitious text, closer to the 2012 Commission version, 9 while there is still the opportunity to do so. If the potential benefits of public health and social needs are to be realised and not thwarted by the new Regulation, European political bodies should agree that the use of personal and pseudonymised data in biomedical research must be regulated proportionately to the real risks, and should acknowledge that techno logies increasingly allow research participants to make enlightened and autonomous decisions about the scope of consent to research. Now is the time for medical researchers and practitioners to explain these potential benefits,
harms, and safeguards to their recently elected Members of the European Parliament. We declare no competing interests.
Edward S Dove, David Townend, *Bartha M Knoppers [email protected] Centre of Genomics and Policy, McGill University, Montreal, QC H3A 0G1, Canada (ESD, BMK); and Department of Health, Ethics & Society, Maastricht University, Netherlands (DT) 1
2
3
4
5 6
7
8
9
European Parliament. Legislative resolution of 12 March 2014 on the proposal for a regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation). March 12, 2014. http://www.europarl.europa.eu/ sides/getDoc.do?pubRef=-//EP//TEXT+TA+P7TA-2014-0212+0+DOC+XML+V0//EN (accessed Aug 21, 2014). Casali PG. Risks of the new EU Data protection regulation: an ESMO position paper endorsed by the European oncology community. Ann Oncol 2014; 25: 1458–61. Di Iorio CT, Carinci F, Oderkirk J. Health research and systems’ governance are at risk: should the right to data protection override health? J Med Ethics 2014; 40: 488–92. Ploem MC, Essink-Bot ML, Stronks K. Proposed EU data protection regulation is a threat to medical research. BMJ 2013; 346: f3534. McCall B. European Parliament supports data protection reforms. Lancet 2014; 383: 1115. Mascalzoni D, Knoppers BM, Aymé S, et al. Rare diseases and now rare data? Nat Rev Genet 2013; 14: 372. Protecting health and scientific research in the Data Protection Regulation (2012/0011(COD)): Position of non-commercial research organisations and academics– July 2014. http://www.wellcome. ac.uk/stellent/groups/corporatesite/@ policy_communications/documents/web_ document/WTP055584.pdf (accessed Aug 7, 2014). Council of the European Union. Proposal for a regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation). June 30, 2014. http://register.consilium. europa.eu/doc/srv?l=EN&f=ST%2011028%20 2014%20INIT (accessed Aug 7, 2014). European Commission. Proposal for a regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation). Jan 25, 2012. http://ec.europa.eu/justice/ data-protection/document/review2012/ com_2012_11_en.pdf (accessed Aug 21, 2014).
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